U.S. GOVERNMENT PUBLISHING OFFICE

30–411 WASHINGTON : 2019

COMBATING THE OPIOID CRISIS: HELPING 

COMMUNITIES BALANCE ENFORCEMENT AND 

PATIENT SAFETY 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

FEBRUARY 28, 2018 

Serial No. 115–103 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

(III) 

SUBCOMMITTEE ON HEALTH

MICHAEL C. BURGESS, TEXAS

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

JOE BARTON, Texas 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MARSHA BLACKBURN, Tennessee 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

ANNA G. ESHOO, California 

DIANA DEGETTE, Colorado 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(V) 

C O N T E N T S 

Page 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 4 

Prepared statement .......................................................................................... 5 

Hon. Doris O. Matsui, a Representative in Congress from the State of California, prepared statement .................................................................................. 6 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 7 

Prepared statement .......................................................................................... 9 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 10 

Prepared statement .......................................................................................... 12 

WITNESSES

Susan A. Gibson, Deputy Assistant Attorney, Diversion Control Division, 

Drug Enforcement Administration ..................................................................... 13 

Prepared statement .......................................................................................... 16 

Answers to submitted questions ...................................................................... 246 

Frank L. Fowler, Chief of Police, Syracuse Police Department ........................... 62 

Prepared statement .......................................................................................... 64 

Patrick M. Beardsley, Ph.D., Professor, Department of Pharmacology and 

Toxicology, Virginia Commonwealth University ............................................... 67 

Prepared statement .......................................................................................... 69 

John Mulder, M.D., FAAHPM, HMDC, Director, Trillium Institute .................. 80 

Prepared statement .......................................................................................... 81 

Ponni Subbiah, M.D., Chief Medical Officer, Indivior PLC ................................. 89 

Prepared statement .......................................................................................... 91 

David Y. Kan, M.D., President, California Society of Addiction Medicine ......... 95 

Prepared statement .......................................................................................... 97 

Answers to submitted questions ...................................................................... 254 

Richard J. Nance, LCSW, Director, Utah County Department of Drug and 

Alcohol Prevention and Treatment ..................................................................... 109 

Prepared statement .......................................................................................... 111 

Thomas J. Cosgrove, Partner, Covington and Burling LLP ................................. 136 

Prepared statement .......................................................................................... 138 

Answers to submitted questions 1 ................................................................... 259 

Andrew Kolodny, M.D., Codirector, Opioid Policy Research, Brandeis University ......................................................................................................................... 141 

Prepared statement .......................................................................................... 143 

Answers to submitted questions ...................................................................... 261 

Richard N. Logan, Jr., Pharm.D., Owner, L&S Pharmacy .................................. 145 

Prepared statement .......................................................................................... 147 

SUBMITTED MATERIAL

Statement of Dr. Halberstadt, of the University of California, San Diego, 

submitted by Mr. Green ...................................................................................... 178 

Statement of the College on Problems of Drug Dependence, submitted by 

Mr. Green .............................................................................................................. 180 

Statement of Hon. Brad Schneider, a Representative in Congress from the 

State of Illinois, submitted by Mr. Green .......................................................... 182 

Statement of a public health group, submitted by Mr. Green ............................. 184 

Page

VI 

Statement of the American Society of Addiction Medicine, submitted by Mr. 

Green ..................................................................................................................... 186 

Statement of the Center for Lawful Access and Abuse Deterrence, submitted 

by Mr. Green ........................................................................................................ 188 

Statement of Catalent, submitted by Mr. Green .................................................. 189 

Statement of the Pharma & Biopharma Outsourcing Association, submitted 

by Mr. Green ........................................................................................................ 191 

Statement of the College on Problems of Drug Dependence, submitted by 

Mr. Green .............................................................................................................. 194 

Report from the Center for Budget and Policy Priorities, submitted by Mr. 

Green ..................................................................................................................... 196 

Article entitled, ‘‘The Opioid Epidemic: A Crisis Years in the Making,’’ The 

New York Times, October 26, 2017, submitted by Mr. Luja ́n .......................... 204 

Article entitled, ‘‘Inside the Story of America’s 19th-Century Opiate Addiction,’’ Smithsonian, January 4, 2018, submitted by Mr. Luja ́n ........................ 213 

Questions for the record from Representative David Kustoff, submitted by 

Mr. Burgess .......................................................................................................... 216 

Statement of Prime Therapeutics, submitted by Mr. Burgess ............................. 218 

Statement of the National Association of Chain Drug Stores, submitted by 

Mr. Burgess .......................................................................................................... 220 

Statement of the University of Texas Health Science Center, submitted by 

Mr. Burgess .......................................................................................................... 226 

Statement of Catherine M. Davis, Ph.D., Hopkins Bayview Medical Center, 

submitted by Mr. Burgess ................................................................................... 227 

Statement of CVS Health, submitted by Mr. Burgess .......................................... 229 

Statement of Braeburn, submitted by Mr. Burgess .............................................. 231 

Statement of the American Hospital Association, submitted by Mr. Burgess ... 232 

Statement of the Drug Policy Alliance, submitted by Mr. Burgess ..................... 238 

Statement of Andrew C. Kruegel of Columbia University, submitted by Mr. 

Burgess ................................................................................................................. 240 

Statement of Hon. Mark DeSaulnier, a Representative in Congress from 

the State of California, submitted by Mr. Carter .............................................. 245 

1 The committee did not receive a response to Mr. Cosgrove’s submitted 

questions for the record by the time of printing. 

(1) 

COMBATING THE OPIOID CRISIS: HELPING 

COMMUNITIES BALANCE ENFORCEMENT 

AND PATIENT SAFETY 

WEDNESDAY, FEBRUARY 28, 2018 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 1:04 p.m., in room 

2123, Rayburn House Office Building, Hon. Michael Burgess, M.D. 

(chairman of the subcommittee) presiding. 

Present: Representatives Burgess, Guthrie, Upton, Shimkus, 

Blackburn, Latta, Lance, Griffith, Long, Bucshon, Brooks, Mullin, 

Hudson, Carter, Walden (ex officio), Green, Matsui, Castor, Sarbanes, Luja ́n, Schrader, Degette, and Pallone (ex officio). 

Also Present: Representative Walberg. 

Staff Present: Jennifer Barblan, Chief Counsel, O&I; Mike 

Bloomquist, Staff Director; Adam Buckalew, Professional Staff 

Member, Health; Daniel Butler, Staff Assistant; Kelly Collins, Staff 

Assistant; Zachary Dareshori, Legislative Clerk, Health; Jordan 

Davis, Director of Policy and External Affairs; Paul Edattel, Chief 

Counsel, Health; Margaret Tucker Fogarty, Staff Assistant; Adam 

Fromm, Director of Outreach and Coalitions; Ali Fulling, Legislative Clerk, O&I, DCCP; Jay Gulshen, Legislative Associate, Health; 

Zach Hunter, Director of Communications; Ed Kim, Policy Coordinator, Health; Mark Ratner, Policy Coordinator; Kristen Shatynski, 

Professional Staff Member, Health; Jennifer Sherman, Press Secretary; Austin Stonebraker, Press Assistant; Hamlin Wade, Special 

Advisor, External Affairs; Waverly Gordon, Minority Health Counsel; Tiffany Guarascio, Minority Deputy Staff Director and Chief 

Health Advisor; Jourdan Lewis, Minority Staff Assistant; 

Samantha Satchell, Minority Policy Analyst; Andrew Souvall, Minority Director of Communications, Outreach, and Member Services; and Kimberlee Trzeciak, Minority Senior Health Policy Advisor. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. The Subcommittee on Health will now come to 

order. I will recognize myself for 5 minutes for the purpose of an 

opening statement. 

On the average, 115 Americans die every single day from an 

overdose of an opiate. Our nation remains in the grip of a frightVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
2 

ening epidemic. The latest report from the Centers for Disease 

Control and Prevention list West Virginia, Ohio, New Hampshire, 

Pennsylvania, and Kentucky, as the five States hardest hit, but we 

all know the crisis has ravaged every one of our States. The statistics are heartbreaking. Five people every hour on the hour die from 

an opioid overdose. It has been said before; it bears repeating: Now 

more than ever we must come together and strengthen our commitment to fight this. It requires an all-hands-on-deck approach. Today’s hearing is the first of three legislative hearings on combating 

this crisis. 

This hearing is the product of the Member Day the Health Subcommittee held last October where over 50 Members of Congress, 

bipartisan Members of Congress, both on and off the Energy and 

Commerce Committee, came to us and shared with us their personal stories of how the epidemic has devastated their communities, and they also offered potential legislative solutions. Since 

then, our teams have been hard at work examining these policies 

and engaging the relevant stakeholders. 

There are two panels of witnesses before our subcommittee 

today. First, I do want to welcome Susan Gibson, the Deputy Assistant Attorney in the Diversion Control Division at the Drug Enforcement Administration. Ms. Gibson, we look forward to hearing 

your thoughts and the progress the DEA has made to stem the flow 

of opiates through our neighborhood, and how these legislative proposals would strengthen the agency’s efforts in what is now a public health emergency in our country. On the next panel, we will 

hear from a cross section of stakeholders representing local law enforcement, physicians, pharmacists, hospice, on one hand, and to 

the anti-opioid researchers, manufacturers, and policy groups on 

the other. We will look forward to learning their insights on one 

or more of the bills being considered today and anticipate a robust 

debate on the merits of these policies, as the title of our hearing 

indicates. We are seeking help from the communities to balance enforcement and patient safety. 

Today, we will focus our attention specifically on the Controlled 

Substances Act. Over the last several months, the committee has 

come to realize that some areas of this law require an update or 

clarification. For example, synthetic opioids, like fentanyl, have 

flooded the United States cities and towns and pushed drug overdose deaths to levels never previously seen. H.R. 2851, the Stop the 

Importation and Trafficking of Synthetic Analogues Act, offered by 

Representative John Katko, will better equip law enforcement to 

get illicit synthetic drugs off of our streets while modernizing 

scheduling guidelines for these drugs. 

Another issue of critical importance is the growing risk of the 

misuse and diversion of controlled substances. Representatives Tim 

Walberg and Debbie Dingell introduced legislation, H.R. 5041, the 

Safe Disposal of Unused Medication Act, that would reduce the 

number of unused controlled substances at risk of diversion or misuse by allowing hospice workers to safely dispose of these drugs in 

patients’ homes. Another bill currently in discussion form, authored 

by Representatives Ryan Costello and Rick Nolan, will improve dispensing of implantable and injectable therapies that were developed to make misuse and diversion more difficult. 

3 

We will examine two telemedicine bills that will improve access 

for patients. The Special Registration for Telemedicine Clarification 

Act, written by Representatives Buddy Carter and Cheri Bustos, 

would clarify telemedicine waivers, and direct the Attorney General 

to issue regulations for healthcare providers to prescribe controlled 

substances through telemedicine in legitimate emergency situations. The Improving Access to Remote Behavioral Health Treatment Act, written by Representative Gregg Harper and Doris Matsui, would expand access for patients in rural and underserved 

areas to their closest community mental health or addiction treatment centers by allowing these facilities to be obtain a DEA registration and qualify for the telemedicine exception under the Ryan 

Haight Act. 

Lastly, the subcommittee will consider two provider education 

bills, the first bill, H.R. 4275, the Empowering Pharmacists in the 

Fight Against Opioid Abuse, authored by Representatives Mark 

DeSaulnier and Buddy Carter, would help pharmacists detect 

fraudulent prescriptions through new education materials. Another 

bill aims to improve doctors’ understanding of pain management 

and treatment guidelines and best practices, among other things, 

by mandating 12 hours of continuous medical education on the subject every 3 years. This policy contained in H.R. 2063, the Opioid 

Preventing Abuse through Continuing Education Act, authorized 

by Representative Brad Schneider, does concern me because it 

seems to suggest that doctors are primarily at fault for this epidemic, but as we consider solutions critical to blunting this crisis, 

we must strike a careful balance prior to casting blame. 

As I said earlier, an important aspect of today’s hearing is to 

think through the debate that all of these policies have before us. 

I believe what we accomplish here today will set the tone for the 

next two hearings in this subcommittee. 

With that, again, I want to welcome our witnesses, and thank 

you for being here. And I will recognize Mr. Green of Texas 5 minutes for an opening statement, please. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Our nation remains in the unrelenting grip of the opioid epidemic. While the latest report from the Centers for Disease Control and Prevention lists West Virginia, 

Ohio, New Hampshire, Pennsylvania, and Kentucky as the five States hardest hit, 

all of us know this crisis has ravaged other States, too. The statistics are heartbreaking: on average 115 Americans die every day from an opioid overdose—that 

is nearly 5 people per hour. I said it before and will say it again. Now more than 

ever, we must come together and strengthen our commitment to fight this scourge— 

it requires an all-hands-on-deck approach. 

Today’s hearing is the first of three legislative hearings on combating the opioid 

crisis. It is the product of the Member Day the Health Subcommittee held last October, where over 50 bipartisan Members of Congress—both on and off the Energy 

and Commerce Committee—shared their personal stories on how the opioid epidemic has devastated their communities while also offering potential legislative solutions. Since then, our teams have been hard at work examining these policies and 

engaging the relevant stakeholders. 

There are two panels of witnesses before our subcommittee today. First, I would 

like to welcome Susan Gibson, Deputy Assistant Attorney in the Diversion Control 

Division at the Drug Enforcement Administration (DEA). Ms. Gibson, we look forward to hearing your thoughts on the progress DEA has made to stem the flow of 

opioids through our neighborhoods and how these legislative proposals would 

strengthen the agency’s efforts in what is now a public health emergency for the 

4 

country. On the next panel, we will hear from a cross-section of stakeholders representing local law enforcement, physicians, pharmacists, and hospices on one hand 

to anti-opioid researchers, manufacturers, and policy groups on the other. We also 

look forward to learning their insights on one or more of the bills being considered 

today and anticipate a robust debate on the merits of these policies that, as the title 

of our hearing indicates, seek help communities balance enforcement and patient 

safety. 

Today, we will focus our attention specifically on the Controlled Substance Act. 

Over the last several months, the committee came to realize that some areas of this 

law required an update or clarification. For example, synthetic opioids, like fentanyl, 

has flooded U.S. cities and towns and pushed drug overdose deaths to levels never 

seen before. H.R. 2851, the Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act, authored by Rep. John Katko, will better equip law enforcement 

to get illicit synthetic drugs off our streets while modernizing scheduling guidelines 

for these drugs. 

Another issue of critical importance is the growing risk of misuse and diversion 

of controlled substances. Reps. Tim Walberg and Debbie Dingell introduced legislation, H.R. 5041, the Safe Disposal of Unused Medication Act, that would reduce the 

number of unused controlled substances at risk of diversion or misuse by allowing 

hospice workers to safely dispose these drugs in patients’ homes. Another bill, currently in discussion draft form, authored by Reps. Ryan Costello and Rick Nolan, 

will improve dispensing of implantable and injectable therapies that were developed 

to make misuse and diversion more difficult. 

Next, we will examine two telemedicine bills that will improve access for patients. 

The Special Registration for Telemedicine Clarification Act, written by Reps. Buddy 

Carter and Cheri Bustos, would clarify telemedicine waivers and direct the Attorney 

General to issue regulations for health care providers to prescribe controlled substances through telemedicine in legitimate emergency situations. The Improving Access to Remote Behavioral Health Treatment Act, written by Rep. Gregg Harper and 

Doris Matsui, would expand access for patients in rural and underserved areas to 

their closest community mental health or addiction treatment centers by allowing 

these facilities to obtain a DEA registration and qualify for the telemedicine exception under the Ryan Haight Act. 

Lastly, the subcommittee will discuss two provider education bills. The first bill, 

H.R. 4275, the Empowering Pharmacists in the Fight Against Opioid Abuse Act, authored by Reps. Mark DeSaulnier and Buddy Carter, would help pharmacists detect 

fraudulent prescriptions through new educational materials. Another bill aims to 

improve doctors’ understanding of pain management treatment guidelines and best 

practices, among other things, by mandating 12 hours of continuous medical education on these subjects every three years. This policy contained in H.R. 2063, the 

Opioid Preventing Abuse through Continuing Education (PACE) Act, authored by 

Rep. Brad Schneider, concerns me greatly because it seems to suggest that doctors 

are primarily at fault for the opioid epidemic. As we consider solutions critical to 

blunting this crisis, we must strike a careful balance before casting blame. 

As I said earlier, an important aspect of today’s hearing is to think through and 

debate the policies within these pieces of legislation. I believe what we accomplish 

here will set the tone for the next two hearings in our subcommittee. 

With that, I again want to welcome our witnesses and thank you for being here. 

I look forward to your testimony. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman. 

I want to thank you for the work on addressing the opioid epidemic that has impacted countless families and communities in our 

country. And as you said, according to the National Institute of 

Health, 115 Americans die every day after overdosing on opioids. 

The misuse and addiction that opioids, including prescription 

pain relievers, heroin, synthetic opioids, such as fentanyl, is a serious national crisis that affects public health as well as our social 

and economic welfare. The patterns of lives ruined and lost due to 

the opioid epidemic must be reversed. The opioid epidemic is comVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
5 

plex and multifaceted, as you said. However, there are no simple 

or quick solutions. 

Ending the crisis will require better coordination of care, community involvement, and finding solutions, and more consistent use of 

improved pain control options. A comprehensive response to this 

crisis must address the limited resources currently available, the 

societal ills that fuel addiction, and the stigma attached to drug 

use. 

In recent years, Congress has expanded in this space. The Affordable Care Act expanded healthcare coverage to 20 million nonelderly Americans, giving access to the medical and behavioral attention opioid victims need to overcome their addiction. Any honest 

efforts to address the opioid epidemic must include measures to 

stabilize and strengthen the exchanges, make coverage accessible 

for Americans who currently do not have health coverage, including 

the 3 million Americans who lost their health insurance in 2017. 

Last Congress, I was proud to support the passage of the 21st 

Century Cures Act and Comprehensive Addiction and Recovery 

Act, CARA. CARA authorized several grant programs to help prevent overdose, expand access to treatment, and help individuals recover. Unfortunately, some of the grants created under CARA have 

yet to receive funding through the appropriations process. I hope 

our committee will work with our colleagues on the Appropriations 

Committee to secure these necessary funds. 

Speaking with local stakeholders at home about the opioid crisis, 

I can share that more Federal assistance is needed to properly combat this epidemic. The committee needs to seriously consider authorizing the necessary resources, and our State and local partners 

need to help Americans struggling with opioid addiction and recovery. 

I look forward to hearing from our witnesses today, and continuing our committee’s examination at this nationwide problem in 

the weeks and months to come. 

Now, I would like to yield a minute and a half to my friend and 

colleague, Congresswoman Matsui, from California. 

[The prepared statement of Mr. Green follows:] 

PREPARED STATEMENT OF HON. GENE GREEN

Thank you, Mr. Chairman. I want to thank you for your work on addressing the 

opioid epidemic that has impacted countless families and communities in our country. 

According to the National Institutes of Health, 115 Americans die every day after 

overdosing on opioids. The misuse and addiction to opioids, including prescription 

pain relievers, heroin, and synthetic opioids, such as fentanyl, is a serious national 

crisis that affects public health, as well as our social and economic welfare. 

The pattern of lives ruined and lost due to the opioids epidemic must be reversed. 

The opioids epidemic is complex and multifaceted, however. There are no simple and 

quick fixes. 

Ending this crisis will require better coordination of care, community involvement 

in finding solutions, and more consistent use of improved pain-control options. A 

comprehensive response to this crisis must address the limited resources currently 

available, the societal ills that fuel addiction and the stigma attached to drug abuse. 

In recent years, Congress has acted in this space. The Affordable Care Act expanded health care coverage to 20 million non-elderly Americans, giving access to 

the medical and behavioral attention opioid victims need to overcome addiction. 

Any honest effort by Congress to address the opioids epidemic must include measures to stabilize and strengthen the exchanges, and make coverage accessible for 

6 

Americans who currently do not have health coverage, including the three million 

Americans who lost their health insurance in 2017. 

Last Congress, I was proud to support the passage of the 21st Century Cures Act 

and the Comprehensive Addiction and Recovery Act (CARA). CARA authorized several grant programs to help prevent overdose, expand access to treatment, and help 

individuals recover. Unfortunately, some of the grants created under CARA have yet 

to receive funding through the appropriations process. I hope our committee will 

work with our colleagues on the Appropriations Committee and secure these necessary funds. 

Speaking with local stakeholders at home about the opioids crisis, I can share 

that more federal assistance is needed to properly combat this epidemic. Our committee needs to seriously consider authorizing the necessary resources that our 

State and local partners need to help Americans struggling with opioids addiction 

and recovery. 

I look forward to hearing from our witnesses today and continuing our committee’s examination of this nationwide problem in the weeks and months ahead. 

Now, I would like to yield one-and-a-half minutes to my friend and colleague, Congresswoman Matsui of California. 

Ms. MATSUI. Thank you very much. 

Thank you for yielding. 

Mr. Chairman, I appreciate very much this hearing. As we continue this discussion, I look forward to working together in a bipartisan manner to effectively confront issues of access and affordability for addiction treatment. 

I am encouraged by the steps taken today, but want to emphasize that this is just the beginning of what must be an iterative 

and comprehensive approach to combating the opioid crisis. 

We can all acknowledge that, while controlled substances should 

be carefully regulated, they also play a vital role in the effective 

addiction treatment. Accessing treatment continues to be a major 

hurdle in many communities. Today, we are examining a discussion draft that I am working on with my colleagues on the committee, Representative Gregg Harper, that looks at ways that we 

can use telehealth to increase access to substance use treatment. 

We are also examining a bill authored by my colleague Representative Brad Schneider that requires providers to prescribe 

opioids for pain to undergo training on pain management. These 

are targeted strategies, among many that we must consider. It will 

also be imperative that we support Medicaid funding, which has already played a crucial role in reducing the treatment gap. 

I look forward to continuing discussions here. This conversation 

must be paired with the significant resources to help patients and 

families who are suffering. 

Thank you, and I yield back to the ranking member. 

[The prepared statement of Mrs. Matsui follows:] 

PREPARED STATEMENT OF HON. DORIS O. MATSUI

Thank you for yielding. Mr. Chairman, as we continue this discussion, I hope we 

can work together in a bipartisan manner to effectively confront issues of access and 

affordability for addiction treatment. 

I’m encouraged by the steps being taken today, but want to emphasize that this 

is just the beginning of what must be an iterative and comprehensive approach to 

combatting the opioid crisis. 

We can all acknowledge that. while Controlled Substances should be carefully regulated, they also play a vital role in effective addiction treatment. 

Accessing treatment continues to be a major hurdle in many communities. Today 

we’re examining a discussion draft that I am working on with my colleague on the 

Committee, Rep. Gregg Harper, that looks at ways we can use telehealth to increase 

access to substance use treatment. 

7 

We are also examining a bill authored by my colleague, Rep. Brad Schneider that 

would require providers that prescribe opioids for pain to undergo training on pain 

management. 

These are targeted strategies among many that we must consider. It will also be 

imperative that we support Medicaid funding. and the ACA. both of which have already played a crucial role in reducing the treatment gap. I look forward to continued discussions here. This conversation must be paired with significant resources 

to help patients and families who are suffering. 

Thank you, I yield back. 

Mr. GREEN. Thank you. 

Mr. Chairman, I have a number of statements that I would like 

to ask unanimous consent to place into the record. Documents: 

H.R. 2851, a letter from Dr. Halberstadt, of UC San Diego; a letter 

from College on Problems of Drug Dependence; H.R. 2063, a statement on support of the bill from Representative Brad Schneider; 

for Ensuring Patient Access to Substance Use Disorder Treatment 

Act, a Public Health Group letter regarding support for the Senate 

companion; a letter from ASAM and CLAAD, expressing the support for the Senate companion for Tableting and Encapsulating 

Machine Regulation Act; a letter from Catalent and PBOA. Plus I 

have a Center for Budget and Policy Priorities that was just released today on the Medicaid expansion drastically increased coverage for people with opioid use disorders. The latest data from the 

Federal Agency on Healthcare Research and Quality highlight the 

importance of the Affordable Care Act, the Medicaid expansion, 

and increasing insurance among people with opioid use disorders. 

Our analysis of these data will offer a comprehensive picture of 

opioid-related hospitalization around the country, finds that the 

share of hospitalization in which patients were uninsured failed 

dramatically in States that expanded Medicaid from 13.4 percent 

in 2013, the year before the expansion, to 2.9 percent 2 years later. 

This steep decline indicates that many uninsured people are coping 

with OUDs have gained covered through the Medicaid expansion. 

And I ask unanimous consent to place this in the record. 

Mr. BURGESS. OK. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. GREEN. Thank you. I yield back my time. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentleman from Oregon, the chairman 

of the full committee, Mr. Walden, for 5 minutes for an opening 

statement. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. I thank the chairman for his leadership on this and 

many other healthcare-related issues, and I want to welcome our 

witnesses, and we look forward to your testimony. 

No community is immune from the opioid epidemic. It is ripping 

apart the very fabric of our neighborhoods, from Oregon to Ohio, 

from one coast to the other, from Connecticut to California. Our 

friends and our neighbors are experiencing this epic tragedy neighborhood after neighborhood, one that is claiming the lives of more 

than 100 Americans each and every single day. 

8 

Working together, we can and we must continue to help. Congress must learn from the past. The Comprehensive Addiction and 

Recovery Act, or CARA, was an important milestone in helping 

States. The breakthrough 21st Century Cures Act struck a fair balance of speeding up the availability of innovative new drugs while 

maintaining patient safety, and it is already delivering. Those two, 

in fact, put more money into the opioid epidemic effort than Congress has ever put forward, and then we doubled down with a 

budget agreement that was just passed and signed into law by 

President Trump. 

Lawmakers must acknowledge the present. In 2016, opioid overdose deaths from both prescription and illicit drugs were five times 

higher than 1999. And as public officials representing our communities, we must plan for the future, and that is why we are here 

today, to work toward our shared goal of combating the opioid crisis. 

Each statistic is disturbing in and of itself. Even more tragic, 

every number has a name, a name like Mike. At a roundtable that 

I held in southern Oregon a year or two ago, a man named Mike 

simply showed up, sat in the chair next to the wall. Didn’t know 

who he was. And when we were done going around the room, he 

wanted to talk about his situation. 

You see, Mike’s son was injured in a high school sporting accident, and he became addicted to the prescription painkillers provided by his doctor to aid in his recovery. Eventually, Mike’s son 

made the all-too-familiar transition to the cheaper opioid source: 

heroin. And to this day, Mike’s son still struggles with his addiction that all began with opioid prescriptions. 

Mike then went on to talk about his sister, who also suffered 

from addiction. She was a nurse. He commented that she found 

herself with easier access to pills as a nurse, and when coworkers 

and others caught on, she moved and continued to procure pills 

elsewhere. Sadly, Mike’s sister died as a result of her addiction. So 

Mike came to the meeting, a roundtable of law enforcement and 

medical professionals, to share his story about what he had faced, 

what he had lost, and what he was coping with. 

His, tragically, is not a unique story; it is the story that is ripping apart families all across our country. So we have to act. And, 

as people know, this committee has had a very aggressive, ongoing, 

diligent, deep investigation through the Oversight and Investigations Committee on how we got to this place in this country, and 

we will hold people responsible from one end to the other. 

The second track, however, is about the legislative initiatives we 

can all wrap ourselves around in a bipartisan way and move forward to get illicit synthetic drugs off the streets. To safely dispose 

of unused controlled substances, to improve patient access to substance use disorder treatments and remote services, to help providers and pharmacists to better prevent addiction, these are 

among just a few of the bills today. And this is but one of three 

upcoming hearings on this subject, with legislation we hope to be 

able to move to the floor routinely and regularly between now and 

Memorial Day. 

So it is important to acknowledge that this legislative hearing is 

the appropriate venue to ask tough questions and to make conVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
9 

structive suggestions on how we can improve these bills. That is 

what the hearing is all about. Many of these are discussion drafts 

because they are admittedly in need of discussion. 

So I look forward to the feedback from our witnesses and our 

members. In the coming weeks, we will continue this hard work, 

and we will continue the legislature hearings, and we will get our 

job done. People like Mike and Mike’s son and his sister’s family 

are depending on us, and we have a big job to do here. 

So I thank the members who have been so active in participating. Together, we are going to get this job done, and we need 

your help. So I would like to thank our two panels of witnesses for 

being here today, and I look forward to your feedback on these important issues. 

I would also like to thank my colleagues for staying in town to 

have this vital discussion. When others went home to their districts, these Members said, ‘‘This matters,’’ and they stayed. So 

combating the opioid crisis requires an all-hands-on-deck approach, 

and I appreciate everyone’s shared commitment to that effort today 

and in the weeks and months ahead. 

With that, Mr. Chairman, I appear to have run out of time, and 

I will stop. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

No community is immune to the opioid epidemic. It’s ripping apart the very fabric 

of our neighborhoods. From Oregon to Ohio. From Connecticut to California. Our 

friends and our families are experiencing an epic tragedy—one that’s claiming the 

lives of more than 100 Americans each and every single day. 

Working together, we can help. 

Congress must learn from the past. The Comprehensive Addiction and Recovery 

Act, or CARA, was an important milestone in helping States. The breakthrough 21st 

Century Cures Act—striking a fair balance of speeding up the availability innovative treatments and safeguarding necessary public health protections—is already delivering. 

Lawmakers must acknowledge the present. In 2016, opioid overdose deaths—from 

both prescription and illicit drugs—were five times higher than in 1999. And as 

public officials representing our communities, we must plan for the future. This is 

why we’re here today—to work towards our shared goal of combating the opioid crisis. 

Each statistic is disturbing. Even more tragic, every number has a name. Like 

Mike. 

At a roundtable I held in Oregon, a man named ‘Mike’ showed up. Literally, he 

just showed up. Mike didn’t know anyone in the room. He’d heard of our meeting 

to discuss opioid abuse on the news and wanted to share his story. 

Mike’s son was injured in a school sporting accident, and he became addicted to 

the prescription painkillers provided by his doctor to aid in his recovery. Eventually, 

Mike’s son made the all-too-familiar transition to a cheaper opioid source: heroin. 

To this day, Mike’s son still struggles with his addiction that began with opioid 

abuse. 

Mike went on to speak about his sister who also suffered from addiction. A nurse, 

Mike commented that she found herself with easier access to the pills. When coworkers and others caught on, she moved and continued to procure pills elsewhere. 

Sadly, Mike’s sister died as a result of her addiction. Mike came to the meeting— 

a roundtable I held with law enforcement and medical professionals—in hopes that 

sharing his stories could help ensure it doesn’t happen to other families. 

Mike, and the countless other folks who have fallen victim to this crisis, is the 

reason we’re here today. 

Today marks our first of three legislative hearings this Congress. We’ll focus on 

equipping law enforcement with the necessary tools to fight the opioid epidemic with 

careful attention to not compromising important public health protections. 

10 

Getting illicit synthetic drugs off the streets, safely disposing of unused controlled 

substances, improving patient access to substance use disorder treatments and remote services, and helping providers and pharmacists better prevent addiction are 

among the handful of bills we’ll review today. 

It’s important to acknowledge that this legislative hearing is the appropriate 

venue to ask tough questions and make constructive suggestions on how to improve 

these bills. Many of these bills are discussion drafts because they are admittedly 

in need of discussion. I look forward to feedback from each of our witnesses as well 

as both the Democratic and Republican members of this subcommittee. 

In the coming weeks, this subcommittee will continue its hard work with legislative hearings related to public health and prevention efforts, as well as issues pertaining to insurance coverage. This is just the beginning and represents only a fraction of the ideas members from across the country have formulated to overcome this 

epidemic. 

I’d like to thank our two panels of witnesses for being here today, and I look forward to your feedback on these important issues. I’d also like to thank my colleagues for staying in town to have this vital discussion. Combating the opioid crisis 

requires all-hands-on-deck, and I appreciate everyone’s shared commitment in this 

effort. 

Mr. BURGESS. Do you yield to the gentlelady from Tennessee? 

Mr. WALDEN. I would be happy to yield to the gentlelady from 

Tennessee. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And I appreciate so much the hearing and our panels for being 

here today to work with us on this issue. Tennessee has seen a 10- 

percent increase in opioid deaths in 2015 and 2016. And while we 

have worked for years on this issue, first correspondence going 

back to 2012, on how we deal with this epidemic, we are pleased 

to have this—Representative Katko’s bill, SITSA. 

We are interested in your perspective on that. Dealing with the 

synthetics is going to be important. Looking at the scheduling of 

this, we know it needs to be a focus, because much of the increase 

in the deaths deals with the synthetics and the analogues. And 

thank you for being here. Thanks for the perspective that you 

bring. And, as the chairman said, we have got three hearings that 

are going to be on bills going forward. We want to do our part at 

the Federal level to work with our State and local responsibilities 

so that they have the ability to address this crisis. 

I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. 

The gentlelady yields back. 

The chair recognizes the gentleman from New Jersey, Mr. Pallone, the ranking member of the full committee, 5 minutes for an 

opening statement, please. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. 

Today is the first in a series of hearings meant to address the 

opioid and substance abuse crisis that is ravaging communities 

across the country. In my home State of New Jersey, more than 

2,200 people died from opioids in 2016 alone, but obviously, this is 

a national crisis that is devastating families every day, and, simply 

put, a lot more needs to be done. 

Now I must say that I am utterly confused as to why the Republican leadership has chosen to hold this hearing on a day when 

11 

Congress is not in session, because these are serious issues that deserve serious consideration. I know Chairman Walden was thanking those who didn’t go home and stayed, but, frankly, no Member, 

in my opinion, should have to choose between staying in Washington when we are not voting or going home. And I think it is unfair to all the witnesses who have flown here today and will likely 

end up with less engagement by the time the panel ends. 

I get the feeling that the Republican leadership is just checking 

the box instead of giving members, staff, and stakeholders the time 

to carefully consider the important issues like the opioid crisis. 

But last Congress, we took bipartisan action to pass CARA and 

21st Century Cures, both of which provided initial investments and 

steps to address this crisis. These laws are expanding access to 

treatments and providing recovery support services, financial resources to help States take action to prevent the misuse and abuse 

of opioids, and support the reduction of controlled substances in circulation. And I look forward to working to build on those efforts 

from both CARA and 21st Century Cures. 

The legislative proposals we are examining today strive to address a number of discreet policy problems under the Controlled 

Substances Act that healthcare practitioners and law enforcement 

officials face in combating the opioid and substance abuse crisis. 

For example, we are considering legislation from Congressman 

Walberg and Dingell that would empower hospice employees to dispose of unneeded controlled substances after a patient has passed 

away. 

Another proposal from Congressmen Costello and Nolan would 

allow pharmacies to dispense implantable and injectable controlled 

substances directly to a practitioner, reducing the ability for misuse 

or diversion. And we are also considering legislation from Congressman Schneider, who I note is here, that would require mandatory prescriber education as a condition of DEA licensure. This 

would ensure that all providers who treat patients for pain with 

opiates have training on the best practices for prescribing opioids, 

early detection of opioid addiction, and treatment and management 

of opioid dependent patients. 

I know that Chairman Burgess—I don’t know if he was being 

very critical—seemed to suggest that he didn’t like the fact that 

many of us consider doctors a part of the problem. I think doctors 

are part of the problem. Now, that doesn’t mean to say that they 

are intentionally trying to overprescribe or do anything bad. 

But my experience, Chairman Burgess, is that oftentimes doctors 

feel that they have to prescribe things and address pain problems. 

That comes from their education, that that is sort of their obligation. And so I think a lot of times we do get doctors overprescribing, not because they are intentionally trying to do anything 

abusive or criminal, but just because they have learned in medical 

school that they need to do this, they need to take care of pain if 

people are in pain. 

So I do think that we need more education. I think that many 

of the older doctors are not necessarily aware of the dangers of 

overprescribing. So I am not trying to be difficult with you, but I 

do think that is something that needs to be addressed and that 

Congressman Schneider’s bill does address effectively. 

12 

We also will discuss how we can employ telemedicine in treating 

those suffering from substance abuse and mental health disorders, 

including individual practitioners and community mental health 

centers and addiction treatment facilities. While this policy holds 

the potential to expand treatment options for those suffering, we 

must carefully consider how we can safeguard against further 

abuse or misuse of controlled substances. 

And, finally, we will consider two proposals that I continue to 

have strong concerns about. One is H.R. 2851, which attempts to 

address the problem of illicit synthetic analogues. And the second 

is the discussion draft that would propose scheduling tableting and 

encapsulating machine-like controlled substances. 

I recognize the importance of addressing illicit synthetics drugs 

and illegal importation, but both of these proposals would give the 

Attorney General broad and unprecedented new authority, including criminal penalties, as a way to deter traffickers that fuel our 

opioid crisis. 

I just want to say, Mr. Chairman, I do look forward to hearing 

more from DEA and our witnesses today on these issues, and I 

hope to work with all of us on a bipartisan basis to address these 

concerns. Thank you. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Today is the first in a series of hearings meant to address the opioid and substance abuse crisis that is ravaging communities across the country. In my home 

State of New Jersey, more than 2,200 people died from opioids in 2016 alone. This 

is a national crisis that is devastating families every day. Simply put, a lot more 

must be done. 

That is why I am utterly confused as to why the Republican leadership has chosen to hold this hearing on a day when Congress is not in session. These are serious 

issues that deserve serious consideration. I know Chairman Walden was thanking 

those who didn’t go home and stayed, but frankly in my opinion no Member should 

have to choose to stay in Washington when we are not voting or go home. It is also 

completely unfair to all the witnesses who have flown here and will likely end up 

with less engagement by the time their panel ends. I get the feeling that the Republican leadership is just checking the box instead of giving members, staff and stakeholders the time to consider important issues like the opioid crisis. 

Last Congress, we took bipartisan action to pass CARA and 21st Century Cures, 

both of which provided initial investments and steps to addressing this crisis. These 

laws are expanding access to treatment and providing recovery support services, financial resources to help States take action to prevent the misuse and abuse of 

opioids, and support the reduction of controlled substances in circulation. I look forward to working to build on these efforts. 

The legislative proposals we are examining today strive to address a number of 

discrete policy problems under the Controlled Substances Act that health care practitioners and law enforcement officials face in combatting the opioid and substance 

abuse crisis. For example, we are considering legislation from Congressmen Walberg 

and Dingell that would empower hospice employees to dispose of unneeded controlled substances after a patient has passed away. Another proposal from Congressmen Costello and Nolan would allow pharmacies to dispense implantable and 

injectable controlled substances directly to a practitioner reducing the ability for 

misuse or diversion. We also are considering legislation from Congressman Schneider that would require mandatory prescriber education as a condition of DEA licensure. This would ensure that all providers who treat patients for pain with opioids 

have training on the best practices for prescribing opioids, early detection of opioid 

addiction, and treatment and management of opioid-dependent patients. 

We will also discuss how we can employ telemedicine in treating those suffering 

from substance use and mental health disorders, including individual practitioners 

and community mental health centers and addiction treatment facilities. While this 

policy holds the potential to expand treatment options for those suffering, we must 

13 

carefully consider how we can safeguard against further abuse or misuse of controlled substances. 

Finally we will consider two proposals that I continue to have strong concerns 

about. The first is H.R. 2851, which attempts to address the problem of illicit synthetic analogues. The second is a discussion draft that would propose scheduling 

tableting and encapsulating machines like controlled substances. While I recognize 

the importance of addressing illicit synthetic drugs and illegal importation of industrial pill presses, both of these proposals would give the Attorney General broad and 

unprecedented new authority, including criminal penalties, as a way to deter traffickers that fuel our opioid crisis. 

I look forward to hearing more from DEA and our witnesses today on these issues, 

and hope to work with my colleagues to address these concerns so that we can all 

support legislation that will help to address the opioid crisis. 

Thank you, I yield back. 

Mr. BURGESS. The chair reluctantly thanks the gentleman. The 

gentlemen yields back. 

The chair now is pleased to—well, that will conclude members’ 

opening statements. 

I would remind members, pursuant to committee rules, all members’ opening statements will be part of the record. 

And we, again, want to thank our witnesses for being here today 

and taking the time to testify before the subcommittee. 

We do have two panels, and each witness will have the opportunity to give an opening statement followed by rounds of questions 

from members. Our first panel today, we are hearing from Ms. 

Susan Gibson, the Deputy Assistant Attorney, Diversion Control 

Division of the Drug Enforcement Administration. 

We do appreciate you being here with us today, Ms. Gibson. 

You are recognized for 5 minutes for an opening statement, 

please. 

STATEMENT OF SUSAN A. GIBSON, DEPUTY ASSISTANT ATTORNEY, DIVERSION CONTROL DIVISION, DRUG ENFORCEMENT 

ADMINISTRATION 

Ms. GIBSON. Chairman Walden, Subcommittee Chairman Burgess, Ranking Members Pallone and Green, and distinguished 

members of the Health Subcommittee, thank you for holding this 

legislative hearing today on several bills impacting the Controlled 

Substances Act aimed at combating the opioid epidemic. 

Let me say from the outset, the opioid crisis has been—and will 

unfortunately continue to be—the top threat facing our Nation. 

This epidemic includes not only prescription opioid medications but 

also the proliferation of heroin, illicit fentanyl, and fentanyl analogues. 

Despite record numbers of overdose deaths, 64,000 in 2016 alone, 

we are making progress on the prescription drug front. However, 

I fear that we are witnessing a fundamental shift toward cheaper, 

easier to obtain illicit fentanyl produced in foreign countries. This 

is where the opioid epidemic converges with the synthetic drug 

threat. 

Data has shown that the increase in opioid-related deaths is 

largely attributed to illicit fentanyl. Synthetic opioids, 

cannabinoids, stimulants are produced by rogue chemists who create new drugs with unknown pharmacological effects in humans. 

Because synthetic drugs are made in the lab, the profit potential 

14 

is enormous, and the ability to stay ahead of the law only requires 

a small tweak in a molecular structure. 

One kilogram of fentanyl purchased in China for roughly $5,000 can generate up to $1.5 million in drug proceeds. All the while, 

unsuspecting users of synthetics drugs are playing Russian roulette 

every time they use these deadly substances. The questionable 

legal status of these synthetics and their ever-changing chemical 

composition makes it difficult for our Federal, State, and local law 

enforcement counterparts to intercept these deadly substances before they hit our streets. 

This is not a U.S. problem. It is an international problem that 

is growing in scope. According to the United Nations, more than 

100 countries have reported the presence of synthetic drugs, and as 

of March 2017, approximately 750 substances have been reported 

to the U.N.’s early warning advisory. 

So what is the DEA doing about it? We are moving aggressively 

to place temporary Schedule I controls on new and emerging synthetic drugs. Since March 2011, DEA has utilized this authority on 

19 occasions to place 56 synthetic drugs in Schedule I on an emergency basis, including 17 fentanyl analogues. This process is unfortunately reactive and means that we first observe the deadly consequences of synthetic drug abuse before initiating control. 

On February 6, 2018, DEA temporarily placed emergency controls on the entire class of fentanyl-related substances in an unprecedented effort to curb the disturbing trend in fentanyl-related 

overdose death. Of course, we are continuing to conduct criminal 

investigations. For example, last year, DEA played a major role in 

helping take down AlphaBay, the largest criminal marketplace on 

the internet and a key source of illicit synthetics, including 

fentanyl, being shipped into the United States. 

Additionally, we have worked productively with China to try and 

stem the flow of synthetics to our shores, resulting in the scheduling of nearly 130 new psychoactive substances since October 

2015. Last month, domestic controls became effective in China for 

two essential fentanyl precursors: NPP and ANPP. 

Beyond the deadly synthetics threat, DEA is committed to combating the epidemic through several different avenues, including 

expansion, disposal, and treatment options, new pill press regulations, and outreach to practitioners regarding the prescription of 

opioids. The implementation of telemedicine regulations pursuant 

to the Ryan Haight Act of 2008 to the recent publishing of a final 

rule that help increase access to opioid addiction treatment, DEA 

believes that this is important to ensure access to opioid treatment 

options while mitigating the risk of diversion. 

In July 2017, DEA implemented a final rule pertaining to domestic and international transactions involving tableting and encapsulating machines. Overall, this rule will give DEA greater visibility of transactions involving tableting and encapsulating machines. 

Finally, DEA recognizes the importance of opioid prescription 

training for prescribers and has begun to ask whether they have 

received training regarding prescribing or dispensing of opioids. 

While this information is voluntary, it will provide better data to 

show how many prescribers are taking training. 

15 

Thank you for the committee’s focus on the opioid crisis, and I 

look forward to answering any questions you may have. 

[The prepared statement of Ms. Gibson follows:] 

16 


30411.001

ile.partment of Justite 

STATEMENT OF 

SUSAN A. GIBSON 

DEPUTY ASSISTANT ADMINISTRATOR 

OFFICE OF DIVERSION CONTROL REGULATORY 

DIVERSION CONTROL DIVISION 

DRUG ENFORCEMENT ADMINISTRATION 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

ENERGY AND COMMERCE COMMITTEE 

UNITED STATES HOUSE OF REPRESENTATIVES 

FOR A HEARING ENTITLED 

"COMBATING THE OPIOID CRISIS: HELPING COMMUNITIES 

BALANCE ENFORCEMENT AND PATIENT SAFETY" 

PRESENTED 

FEBRUARY 28, 2018 
17 


30411.002

Statement of 

Susan A. Gibson 

Deputy Assistant Administrator 

Office of Diversion Control Regulatory 

Diversion Control Division 

Drug Enforcement Administration 

Before the 

Subcommittee on Health 

Energy and Commerce Committee 

U.S. House of Representatives 

For a Hearing Entitled 

"Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient 

Safety" 

February 28, 2018 

INTRODUCTION 

Chairman Walden, Ranking Member Pallone, and Members of the Committee: on behalf 

ofthe approximately 9,000 employees of the Drug Enforcement Administration (DEA), thank 

you for the opportunity to discuss potential legislation intended to help combat the opioid 

epidemic. 

Drug overdoses, suffered by family, friends, neighbors, and colleagues, are now the 

leading cause of injury-related death in the United States, eclipsing deaths from motor vehicle 

crashes or firearms. 1 According to initial estimates provided by the Centers for Disease Control 

and Prevention (CDC), there were more than 64,000 overdose deaths in 2016, or approximately 

175 per day. Over 34,500 (54 percent) of these deaths were caused by opioids. The sharpest 

increase in drug overdose deaths from 2015 to 2016 was fueled by a surge in overdoses 

involving fentanyl, fentanyl analogues, and synthetic opioids. 2 

Reports on the ongoing misuse of controlled prescription drugs (CPDs) and the growing 

use of heroin, fentanyl, and fentanyl analogues in the United States are at unprecedented levels. 

DEA has become increasingly alarmed over the proliferation of illicit fentanyl and its analogues, 

which have been added to heroin and other illicit substances and have also been encountered as 

counterfeit tablets resembling CPDs. Fentanyl and fentanyl analogues are potent synthetic 

opioids that present a serious risk of overdose and death by those who abuse these substances. 

The yearly market for illegal, non-medical prescription pain relievers is estimated to be over 11.5 

million people, and if fentanyl and fentanyl analogues are introduced into even a small portion of 

the illicit opioids consumed, there is a likelihood overdoses will increase. 3 Fentanyl and fentanyl 

1 Rose A< Rudd, Noah Aleshire, Jon E. ZibbeH, & R Matthew Gladden. Increases in Drug and Opioid Overdose Deaths- United States, 2000-

2014 Morbidity and Mortality Weekly Report, 2016;64: 1378-1382. 2 CDC WONDER data, retrieved from the National Institute of Health website; http·//\V\V\l.l.drugabuse.gov a'> reported on NIDA's website. 3 Center for Behavioral Health Statistics and Quality. (2017). 2016 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse 

and Mental Health Services Administration, Rockville, MD 
18 


30411.003

analogues can be absorbed through the skin, inhaled, or introduced into the body via mucous 

membranes (e.g., mouth, nose, eyes, etc.), which makes them particularly dangerous for public 

safety personnel who encounter these substances during the course of their daily operations. 

Fentanyl and fentanyl analogues represent the deadly convergence ofthe synthetic drug threat 

and the current national opioid epidemic. 

On a broader scale, synthetic designer drugs, also known as New Psychoactive 

Substances (NPS) refer to man-made substances designed to mimic the effects of known licit and 

illicit controlled substances; while fentanyl and fentanyl analogues are scheduled, emerging NPS 

are oftentimes unscheduled and unregulated. 4 There are a variety of synthetic designer drugs, 

which are categorized based on the types of controlled substances they are intended to mimic: 

opioids (including fentanyl and fentanyl analogues), cannabinoids, cathinones, and hallucinogens 

known as phenethylamines. Other than synthetic opioids, the two most commonly used 

categories of synthetic designer drugs in the United States are synthetic cannabinoids and 

synthetic cathinones. NPS, including synthetic opioids, continue to pose a nationwide threat to 

the United States and tragically, overdoses and deaths attributable to those substances continue to 

occur. 

SYNTHETIC DESIGNER DRUGS OVERVIEW 

Fentanyl, Fentanyl Analogues, and Synthetic Opioids 

Fentanyl is a Schedule II controlled substance produced in the United States and used 

widely in medicine; its classification in Schedule II indicates its widely accepted medical use but 

high potential for abuse. It is an extremely potent analgesic indicated for use as an anesthetic or 

for use as a serious pain control option in opioid tolerant patients. 5 

In 2016, almost 3.4 million Americans age 12 or older reported misusing prescription 

pain relievers within the past month. 6 This makes prescription opioid misuse more common than 

use of any category of illicit drug in the United States except for marijuana. The illicit market 

for prescription drugs is of considerable size. Counterfeit versions of such drugs are easier and 

cheaper to produce, which significantly increases the risk that fentanyl or fentanyl analoguelaced counterfeit pills will be produced to meet the demand. Widespread use of these substances 

will cause more overdoses across the nation. 

According to the DEA National Forensic Laboratory Information System (NFLIS), from 

January 2013 through December 2016, federal, state, and local forensic laboratories identified 

4 On February 6, 2018, DEA published a final order in the Federal Register scheduling all fentanyl~related substances (i.e., fentanyl analogues) 

into Schedule I of the Controlled Substances Act on an emergency basis. The final order was made effective on the date ofpublicalion. 5 Patients considered tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 meg transdermal fentanyl per 

hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or 

an equianalgesic dose of another opioid. 6 Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health indicators in the United States: 

Results ffom the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17~5044, NSDUH Series H~52). Rockville, MD· 

Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from 

https://www.sarnhsa.gov/data/. 

-2-
19 


30411.004

fentanyl in over 58,000 toxicology reports. 7 During 2016, there were 36,061 fentanyl reports 

compared to 1,042 reports in 2013, 8 an exponential increase over four years. The consequences 

of fentanyl misuse are often fatal and occur amongst a diverse user base. According to a 

November 2017 CDC Morbidity and Mortality Weekly Report on data from 10 states, fentanyl 

and fentanyl analogues were detected in 56.3 percent (5,152) of all drug overdose deaths in a 6-

month period from July- December of2016. 9 

Illicit fentanyl, fentanyl analogues, and their immediate precursors are often produced in 

China. From China, these substances are shipped through private couriers or mail carriers 

directly to the United States or alternatively shipped to transnational criminal organizations 

(TCOs) in Mexico, Canada, and the Caribbean using mail carriers or parcel delivery services. 

Once there, fentanyl or its analogues are prepared to be mixed into the heroin and cocaine supply 

domestically, or pressed into a pill form, and then moved to the illicit U.S. market where demand 

for prescription opioids and heroin remains at epidemic levels. In some cases, traffickers have 

industrial pill presses shipped into the United States directly from China and operate illegal 

fentanyl pill press mills domestically. Mexican TCOs have seized upon this business 

opportunity because of the profit potential, and have invested in growing their share of this 

market. Because of its high potency, one kilogram of illicit fentanyl purchased in China for 

$3,000- $5,000 can generate upwards of $1.5 million in revenue on the illicit market. 

Synthetic Cannabinoids and Synthetic Cathinones 

Synthetic cannabinoids and their byproducts (sometimes sold under brand names such as 

K2 or Spice) continue to be a significant threat to public health and safety. These substances 

have a similar mechanism of action to that of delta-9-tetrahydrocannabinol (THC), the primary 

psychoactive constituent in marijuana, but they are much more powerful and significantly more 

toxic. Similar to fentanyl and its analogues, synthetic cannabinoids are sourced from chemical 

manufacturers and suppliers primarily in China. Products containing synthetic cannabinoids are 

typically prepared for packaging in the United States and marketed over the Internet or supplied 

to retail distributors before being sold to the public at retail stores (e.g., convenience stores, gas 

stations, and liquor stores). Laws governing the legality of the substances vary widely between 

states and the chemical components are frequently altered, making it an ongoing challenge for 

DEA to schedule these substances in a timely manner to protect the public. 

Synthetic cathinones, often marketed to consumers as "bath salts" or "glass cleaner," can 

produce pharmacological effects that are substantially similar to cathinone, methcathinone, 

MDMA, amphetamine, methamphetamine, and cocaine. Whereas individuals consume 

stimulants for desired psychoactive effects such as euphoria, empathy, elevated mood, and 

1 U.S. Department of Justice, Drug Enforcement Administration, National Forensic Laboratory Information System, actual data queried on 

October 13,2017. 8 U.S. Department of Justice, Drug Enforcement Administration, National Forensic Laboratory Infonnation System, actual data queried on 

October 13,2017. 9

0'Donne!l JK, Halpin J, Mattson CL, Goldberg BA, Gladden RM. Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700- lO States, July~ 

December 20 !6. MMWR Morb Mortal Wkly Rep 2017: 66:1197-1202. DO!: http://dx.doi.org/l 0.15585/mmwr mm6643el 

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improved mental function, 10,

11 patients who present to first responders and emergency 

departments with sympathetic stimulation have profoundly altered mental status, Altered mental 

status presents as severe panic attacks, agitation, paranoia, hallucinations, and violent behavior 

(e,g,, self-mutilation, suicide attempts, and homicidal activity), 12 These substances are often 

labeled "not intended for human consumption" in an attempt to skirt the Government's 

utilization ofthe federal Controlled Substance Analogue Enforcement Act (Analogue Act), 

While the Department of Justice (DOJ) has had successful prosecutions under the Analogue Act, 

hundreds, if not thousands of these substances are sold to unsuspecting consumers in the 

meantime, Synthetic cathinones are widely available and have been encountered as a 

replacement for MDMA, a Schedule I controlled substance that is often referred to as "Molly!' 

Synthetic cathinones are usually snorted or swallowed in their powder or crystal forms, 

Many drugs in this class have been placed in Schedule I, either through legislative action or 

through DEA-initiated administrative action, to temporarily control the drug when the 

Administrator concludes that such action is necessary to avoid an imminent hazard to public 

safety, Unfortunately, when DEA initiates temporary control of a synthetic designer drug, those 

who produce and traffic the drug frequently alter the chemical composition of those drugs. 

These new substances, like the original substance, have serious adverse health effects including 

death and thus pose a severe public health threat. 

Synthetic cannabinoids and synthetic cathinones are a significant area of concern for 

DEA, According to NFLIS, from January 2013 through December 2015, the 25 most frequently 

identified synthetic cannabinoids were identified in a total of95,143 state and local forensic 

laboratory reports submitted to NFLIS. During the same period, state and local forensic 

laboratories reported finding the 20 most frequently identified synthetic cathinones a total of 

51,824 times through the data submitted to NFLIS. 13 In 2016, synthetic cannabinoids were 

identified in 25,250 such reports. 

CURRENT CHALLENGES WITH SYNTHETIC ANALOGUES 

Traffickers Adapting to the Law 

Even though fentanyl and fentanyl analogues, as well as NPS compounds have been 

controlled in Schedule I or Schedule II of the Controlled Substances Act (CSA), entrepreneurs 

procure new synthetic compounds with relative ease, 14 Over the past several years, DEA has 

10 L Kurila and M Reynaud. GHB and synthetic cathinones; clinical effects and potential consequences. Drog Testing and Analy~is 2010,3: 552-

559~ JP Kelly. Cathinone Derivatives: A Review of their Chemistry, Pharmacology, and Toxicology. Drug Testing Analysis 2011, 3:4l9-453; JB 

Zawilska and J Wojcieszak. Designer cathinones- An emerging class of novel recreational drugs. Forensic Science !nternationa/2013, 231:42-

53; JB Zawilska. Mcphedrone and other cathinones. Current Opinion in Psychiatry 2014,27: 256·262; CL Gennan, AE Fleckenstein, and GR 

Hanson. Bath salts and synthetic cathinones: An emerging designer drug phenomenon. Life Sciences 2014, 97:2·8; PS Johnson, MW Johnson. 

Investigation of "bath salts 11 use patterns within an online sample of users in the United States. Journal of Psychoacti11e Drogs 2014. 46:369·378. 1 

t M F Measham, K Moore, R Newcombe and Z Welch. Tweaking, bombing, dabbing and stockpiling: the emergence of mephedrone and the 

perversity of prohibition. Drogs and Alcohol Today 20 I 0, J 0: 14·21; Psychonaut WebMapping Research Group. Ivory Wave report, Institute of 

Psychiatry 2010, King's College London: London, UK. [Paolo Deluca et al.J; EMCDDA. European Monitoring Centre for Drugs and Drug 

Addiction. Report of the risk assessment of mephedrone in the framework of the Council Decision on new psychoactive substances. 

Luxembourg: Publications Office of the European Union, 2011, doL 10.2810/40800. 

n EA Ross, M Watson and B Gold berber. "Bath salts" intoxication. New England Journal of Medicine 2011, 967*968. 13 U.S. Drug Enforcement Administration, Diversion Control Division. (2016). Synthetic Cannabinoids and Synthetic Cathinones Reported in 

NFUS, 2013-2015. Springfield, VA: U.S. Drug Enforcement Administration, accessed on March 8, 2017 at https;//www.nt1is.deadiversion. 

usdoj.gov/ 

14 On February 6, 2018, DEA published a ftnal order in the Federal Register scheduling all fentanyf.related substances (i.e., fentanyl analogues) in 

Schedule I on an emergency basis.The final order was made effective on the date of publication. 

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identified numerous fentanyl class substances and hundreds of designer drugs from at least eight 

different drug classes, the vast majority of which are manufactured in China. 

Regarding NPS more broadly, clandestine chemists can easily continue 

developing/synthesizing new synthetic opioid, cannabinoid, and cathinone products that do not 

appear on any schedule of controlled substances. Data from the patent and scientific literature 

for structures with psychoactive effects have provided clandestine laboratory operators with a 

blueprint to produce hundreds ofNPS for the illicit market. When DEA has taken an action to 

temporarily schedule a substance, traffickers begin selling new versions oftheir products made 

from new, noncontrolled substances. In addition, manufacturers provide traffickers with 

spurious chemical analyses that purport to document that the new product does not contain a 

controlled substance. Manufacturers and distributors will continue to stay one step ahead of any 

state or federal drug-specific banning or control action by introducing and repackaging new 

synthetic products that are not listed as such in any of the controlled substance schedules. 

Importation vs. Domestic Production and Use of the Internet 

Fentanyl, fentanyl analogues, synthetic cannabinoids, and synthetic cathinones are 

relatively inexpensive, available via the Internet and are often manufactured in China where they 

may be shipped (via U.S. mail or express consignment couriers) to the United States or 

alternatively shipped directly to transnational criminal organizations in Mexico, Canada, and the 

Caribbean. Once in the Western Hemisphere, fentanyl and fentanyl analogues in particular are 

combined with heroin and pressed into counterfeit pills made to look like controlled prescription 

drugs containing oxycodone or hydrocodone and sold online from anonymous darknet markets 

and even overtly operated websites. Similarly, bulk powders containing synthetic cannabinoids 

produced in China are imported into the United States where they are sprayed or otherwise 

applied onto plant matter, packaged into individual saleable units, and distributed for sale at gas 

stations and convenience stores, or sold directly to individuals via the Internet. The combination 

of the questionable legal status of these substances that are not specifically named in the CSA 

itself or by DEA through scheduling actions, the enonnous volume of international parcel traffic 

by mail and express consignment couriers, and technological and logistical challenges of 

detection and inspection, make it extremely difficult for the U.S. Customs and Border Protection 

(CBP) to effectively address the threat at ports of entry and pave the way for non-cartel-affiliated 

individuals to undertake fentanyl trafficking. DEA is working with CBP to increase coordination 

on seized parcels. 

Use of Freight Forwarders 

Traffickers often use freight forwarders to ship fentanyl, fentanyl analogues, and other 

NPS from China. Several DEA investigations have revealed that the original supplier will 

provide the package to a freight forwarding company or individual, who transfers it to another 

freight forwarder, who then takes custody and presents the package to customs for export. The 

combination of a chain of freight forwarders and multiple transfers of custody makes it difficult 

for law enforcement to track these packages. Often, the package will intentionally have missing, 

incomplete, and/or inaccurate infonnation. 

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Prosecutions Pursuant to the Analogue Act 

A compound, including a fentanyl analogue, may be a "controlled substance analogue" 

pursuant to the CSA if it is found to have a substantially similar chemical structure to and 

substantially similar or greater depressant, stimulant, or hallucinogenic effect on the central 

nervous system as a Schedule I or II controlled substance, or is represented to have such an 

effect. Even if a particular substance is widely regarded as a "controlled substance analogue" 

under the CSA, each criminal prosecution must establish that fact anew. The primary challenge 

to preventing the distribution and abuse of a controlled substance analogue, as opposed to a 

controlled substance per se, is that the latter is specifically identified (by statute or regulation) as 

a controlled substance to which clear statutory controls automatically attach, while the former is 

not specifically identified (by statute or regulation) and is treated as a Schedule I controlled 

substance in a given case only once proven to meet the definition of a controlled substance 

analogue. In addition to proving a .material is a controlled substance analogue, prosecutors must 

also prove that the substance was intended for human consumption. Accordingly, each 

prosecution requires expert testimony to obtain a conviction, even ifthe same substance was 

determined by a jury to meet the criteria of the analogue definition in a prior case. This holds 

true even if a prior conviction was in the same District Court or even in front of the same judge. 

This process is workable, but resource-intensive for DEA, federal prosecutors serving in United 

States Attorney's Offices, the defense bar, and the court system. 

The above considerations, along with the increasing volume and variety of designer drugs 

available today and the sophisticated methods and routes of distribution, render the Analogue 

Act a cumbersome and resource-intensive tool to prevent manufacturing, trafficking, and abuse 

of designer drugs. Furthermore, clandestine manufacturers are continually introducing unique 

substances that have abuse liability but do not meet the legal definition of an analogue. That 

said, agents, chemists, pharmacologists, and prosecutors have worked together tirelessly to make 

the Analogue Act work, with many successful prosecutions to show for it. The Synthetic Drug 

Abuse Prevention Act of2012 (SDAPA) approach to control specific, known, synthetic 

substances in some instances by a description of chemical characteristics, was a swift and 

effective contribution to the overall effort to combat the designer drug threat. 15 DEA will 

continue to identify ways to better combat the designer drug threat. 

The Drug Control Process under the CSA is Reactive and Requires Evidence of Harm 

The CSA provides the Attorney General (delegated to the DEA Administrator) with a 

mechanism to bring new drugs of abuse under CSA control and subject them to a regulatory 

scheme to protect the public. Through an interagency process, determinations about placement 

in the CSA are dictated by the following eight enumerated scientific factors: 16 the state of 

current scientific knowledge about the substance; its pharmacological effect; its risk to the 

public health; its psychic or psychological dependence liability; whether the substance is an 

immediate precursor of a controlled substance; its actual or relative potential for abuse; its 

history or current pattern of abuse and its scope; and the scope, duration, and significance of use. 

In this process, the Secretary of Health and Human Services (HHS) is responsible for any 

15 P.L. 112-144- Food and Drug Administration Safety and Innovation Act, SubtitleD, Section 1151, titled "Synthetic Drug Abuse and 

Prevention Act of2012. 16 The eight factors are enumerated in 21 U.S.C. § 8ll(c) 

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scientific and medical considerations about a substance and the DEA Administrator considers a 

recommendation made by the HHS Secretary along with other relevant facts to determine 

whether there is substantial evidence to warrant control. These scheduling evaluations by both 

HHS and DEA require extensive collection and evaluation of scientific, medical, law 

enforcement, and other data. The acquisition of this data is often an arduous and timeconsuming process which often relies heavily on actual evidence of harm to the public. 

When the DEA Administrator concludes that control of a substance is necessary to avoid 

an "imminent hazard to public safety," the DEA Administrator may initiate temporary control of 

that substance for a period of two years, subject to possible extension for up to one year, 17 during 

which time the interagency conducts the above mentioned scientific review for permanent 

placement under the CSA. 18 

DEA believes a coordinated response by public health and law enforcement and other 

stakeholders remains the most effective response to this problem. Further, DEA will continue to 

share information and engage stakeholders to decrease the demand for NPS. 

DEA RESPONSE TO THE THREAT OF FENTANYL, FENTANYL ANALOGUES AND 

OTHER SYNTHETIC DRUGS 

Scheduling by Administrative Rule making: Temporary Control 

DEA continues to utilize its regulatory authority to place many synthetic substances into 

the CSA pursuant to the aforementioned temporary scheduling authority. Once a substance is 

temporarily placed in Schedule I, DEA moves towards permanent control by requesting a 

scientific and medical evaluation and scheduling recommendation from HHS and gathering and 

analyzing additional scientific data and other information collected from all sources, including 

poison control centers, hospitals, medical examiners, treatment professionals, and law 

enforcement agencies, in order to consider the additional factors warranting its permanent 

control. Since March 2011, DEA has utilized this authority on nineteen occasions to place 56 

synthetic designer drugs temporarily (emergency control) into Schedule I, including 17 fentanyl 

analogues. In comparison, over the first 25 years (1985-201 0) after Congress created this 

authority, DEA utilized it a total of 13 times to control 25 substances. In addition, on February 

6, 2018, DEA temporarily placed Schedule I controls on "fentanyl related substances" which 

includes any substance structurally related to fentanyl based on specific chemical changes not 

otherwise controlled in any other schedule. 19 

Significant Enforcement Efforts 

The DEA Special Operations Division (SOD) Heroin/Fentanyl Task Force (HFTF) 

Working Group consists of several agencies using a joint "whole of government" approach to 

counter the fentanyl/opioid epidemic in the United States. The HFTF consists of personnel from 

17 The procedure for the temporary control of a substance is enumerated in 21 U.S.C § 8lt(h). 18 Temporary control of a substance may be extended for a period of 1 year ifDEA receives. the Secretary's scientific and medical evaluation and 

scheduling recommendation within the 2~year temporary control period. 19 83 FR 5188 (Feb. 6, 2018). 

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30411.009

DEA, U.S. Immigration and Custom Enforcement (ICE) Homeland Security Investigations (HSI) 

and CBP; supplemented by the Federal Bureau oflnvestigation (FBI), and the U.S. Postal 

Inspection Service. HFTF uses every resource available, including support from the multiagency Organized Crime Drug Enforcement Task Forces (OCDETF) and the OCDETF Fusion 

Center (OFC), the Department of Justice's Criminal Division, the Department of Defense 

(DOD), Intelligence Community (IC), and other government entities, and provides field offices 

(all agencies) with valuable support in their respective investigations. 

The HFTF mission aims to: 

Identify, target, and dismantle command and control networks of national and 

international fentanyl and NPS trafficking organizations. 

Provide case coordination and de-confliction on all domestic and foreign investigations to 

ensure that multi-jurisdictional, multi-national, and multi-agency investigations and 

prosecutions have the greatest impact on targeted organizations. 

Provide direct and dynamic operational and investigative support for domestic and foreign 

field offices for all agencies. 

Identify new foreign and domestic trafficking, manufacturing, importation, production, 

and financial trends utilized by criminal enterprises. 

Analyze raw intelligence and documented evidence from multiple resources to develop 

actionable leads on viable target(s) involved in possible illicit pill production and/or 

distribution networks. 

Educate overall awareness, handling, trafficking trends, investigative techniques, and 

safety to domestic and foreign field offices for all law enforcement, DOD, lC, and 

governmental agencies. 

Facilitate, coordinate, and educate judicial districts during prosecutions of fentanyl and 

other NPS related cases. 

Close interagency cooperation via the HFTF has led to several large enforcement actions, 

including two separate OCDETF investigations centered in North Dakota and Southern 

Mississippi that resulted in the first-ever indictments in September 2017 of two Chinese 

nationals responsible for the manufacturing, importation, and distribution of illicit fentanyl and 

otherNPS in the United States. On October 17,2017, the Deputy Attorney General and the 

DEA Acting Administrator announced the indictments of the Chinese nationals, who were the 

first manufacturers and distributors of fentanyl and other opiate substances to be designated as 

Consolidated Priority Organization Targets (CPOTs). CPOT designations are of those who have 

"command and control" elements of the most prolific international drug trafficking and money 

laundering organizations operating in the world. 

In addition, SOD's HFTF played an integral role in the July 2017 seizing of assets and 

shutting down of the largest criminal marketplace on the Internet, AlphaBay. As outlined by the 

Attorney General and the DEA Acting Principal Deputy Administrator in July, AlphaBay 

operated for over two years on the dark web and was used to sell deadly illegal drugs, stolen and 

fraudulent identification documents and access devices, counterfeit goods, malware and other 

computer hacking tools, firearms, and toxic chemicals throughout the world. The international 

operation to seize AlphaBay's infrastructure was led by the United States and involved 

cooperation between law enforcement authorities in Thailand, the Netherlands, Lithuania, 

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Canada, the United Kingdom, and France, as well as the European law enforcement agency, 

Europol. Multiple interagency OCDETF investigations into AlphaBay revealed that numerous 

vendors, including many in China, sold illicit fentanyl and heroin on the site, and that there had 

been a substantial number of overdose deaths across the country attributed to such purchases. 

China: Government Action and Cooperation 

Recognizing that synthetic drugs are manufactured in China, Attorney General Sessions 

and Deputy Attorney General Rosenstein both requested that China take action during meetings 

with then-State Councilor Guo Shengkun ofthe Chinese Ministry of Public Security. Deputy 

Attorney General Rosenstein met with Guo in Beijing, China on September 25,2017, followed 

by a meeting with the Attorney General in Washington, D.C. on October 3 and October 4, 2017. 

The Attorney General and the Deputy Attorney General's efforts built on long-standing 

working-level engagements with the Chinese on a number of levels. For example, DEA has 

maintained a liaison presence in the People's Republic of China, with an office in Beijing, for the 

last three decades. DEA is currently working to staff a second office to be located in 

Guangzhou. DE A's office in Beijing has direct engagement with drug control officials from 

China's Ministry of Public Security, Narcotics Control Bureau (NCB). DEA's well-established 

relationship with Chinese drug control authorities is the primary bilateral conduit for addressing 

the threat resulting from the shipment of illicit fentanyls, their precursors, and other synthetic 

drugs from China to the United States and elsewhere. 

At a higher policy level, the U.S. Government has also engaged China through an 

interagency working forum that operates under the U.S.-China Joint Liaison Group (JLG). The 

JLG is chaired by DOJ, the Department of State's Bureau oflnternational Narcotics and Law 

Enforcement Affairs, and the Department of Homeland Security. DEA and the NCB participate 

in the Counter Narcotics Working Group (CNWG) and the BDlWG within the JLG framework 

that are chaired, respectively, by DOJ and DEA on the U.S. side, and the Ministry of Public 

Security on the Chinese side. DEA and the NCB share drug-related intelligence and trends 

through the Bilateral Drug Intelligence Working Group (BDIWG), led by DEA's Intelligence 

Division. This annual engagement was established through a memorandum of agreement 

between DEA and the NCB in 2002. 

Engagement in the efforts mentioned above has resulted in positive actions by the 

Government of China taken over the last year. These actions are a step in the right direction, but 

much more needs to be done. Since 2014, the DOJ, DEA, and Chinese officials have met 

regularly to discuss bilateral efforts to counter the threat to the United States from synthetic 

drugs, including illicit fentanyl and its analogues. For the past four years, representatives from 

China's National Narcotics Laboratory have met with DEA experts to exchange information on 

emerging substances, trafficking trends, and drug sampling standards. This dialogue fosters 

information exchange about new substances of abuse in the United States to be considered for 

control in China. A larger and more formal bilateral exchange between legal and (especially) 

scientific experts took place in Beijing in May 2017. Plans are underway for DEA to welcome 

its scientific counterparts to Washington in early spring 2018. 

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30411.011

A key moment in enhanced cooperation on synthetic drugs came in October 2015, when, 

following similar discussions, China implemented domestic control on 116 NPS, including a 

number of fentanyl analogues, and streamlined its procedures to control additional substances. 

In total, China has scheduled 138 different NPS. 

On March 1, 2017, China's National Narcotics Control Commission announced 

scheduling controls on four fentanyl-class substances: carfentanil; furanyl fentanyl; valery! 

fentanyl; and aery! fentanyl. This announcement followed ongoing collaboration between DOJ 

and the Government of China, and reaffirms an expanding collaborative commitment to 

countering illicit fentanyl. On July 1, 2017, China announced implementation of controls on 

U-47700. While not a fentanyl class substance, U-47700 is a powerful synthetic opioid that has 

been trafficked and abused in the United States and a substance that DEA placed in Schedule I 

on a temporary basis following significant evidence of abuse. 

After requests by Administration officials, including the Attorney General and Deputy 

Attorney General, and in accordance with its obligations under the 1988 U.N. Convention, on 

December 28, 2017, China's Ministry of Public Security announced scheduling controls on two 

fentanyl precursor chemicals, NPP and 4ANPP. The scheduling controls took effect on February 

l, 2018. Implementation of Chinese controls on all ofthese substances, and the effect that prior 

control efforts have had on the availability of these substances in the United States, is 

encouraging and affirms the need for the continued collaborative commitment between DEA and 

the NCB. 

In 2018, DEA will continue to engage the Chinese on the control of emerging fentanyl 

analogues and other NPS. We are further encouraged that the Chinese are willing to engage in 

discussions and technical exchanges with DEA regarding scheduling fentanyl as a class. 

Officials from the NCB indicated that their scheduling process is long and complicated, that 

China has always scheduled one drug at a time, pursuant to its law, and that any change in that 

process would be groundbreaking for China. In spite of the complexity of this process, and the 

fact that domestic abuse of fentanyl and related substances has not been a problem in China, they 

have continued to show an understanding of the problem and a willingness to listen and at least 

discuss class scheduling. 

Recent Major Synthetic Cannabinoid and Cathinone Enforcement Operations 

Over the past six years, DEA has conducted two primary, national efforts (Operation Log 

Jam and Project Synergy) related to countering the threat from synthetic cannabinoid and 

cathinone operations, in addition to all other synthetic investigations executed by DEA field 

offices. 

DEA's Operation Log Jam launched in 2011 and culminated in a nationwide takedown 

on July 25,2012. This DEA SOD Operation resulted in multiple OCDETF Operations 

throughout the United States, including 25 federal districts. This operation was coordinated by 

DEA in cooperation with HSI, FBI, CBP, and the Internal Revenue Service (IRS). The goals of 

this operation included the targeting of manufacturers, wholesale distributors, and retail 

distributors of designer drug products, the development of information on foreign-based sources 

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30411.012

of supply, raising public awareness of the dangers associated with the use of these drugs, and the 

development of leads for a Phase II initiative (Project Synergy). 

Operation Log Jam resulted in I 00 arrests, the execution of300 search warrants and 80 

consent searches, and the identification of 3 8 manufacturing sites. Law enforcement seized \96 

kilograms of raw synthetic cathinones, 722 kilograms of raw synthetic cannabinoids, 167,187 

packets of synthetic cathinones ready for distribution, 4,852,099 packets of synthetic 

cannabinoids ready for distribution, 4,766 kilograms of plant material treated with synthetic 

cannabinoids ready to be packaged, 21,933 kilograms of untreated plant material, over 

$45,000,000 in U.S. currency and bank accounts, 88 vehicles, 77 firearms, additional assets 

valued at $5,688,500, and I ,096 gallons of acetone. 

Project Synergy, the second phase of a national cooperative effort in combating synthetic 

designer drug distribution, has resulted in multiple OCDETF operations in at least 13 federal 

districts. Project Synergy has resulted in nationwide take downs in 2013,2014, and 2015 by 

DEA, HSI, FBI, CBP, IRS, and domestic law enforcement departments in 45 states, and 

international partners in Australia, New Zealand, Canada, and Barbados. Over 400 individuals 

were arrested and authorities seized assets valued at nearly $75 million. In addition to curbing 

the flow of synthetic drugs into the country, Project Synergy Ill continued to reveal the flow of 

millions of dollars in U.S. synthetic drug proceeds to countries in the Middle East. 

OTHER AREAS OF DEA FOCUS TO COMBAT THE OPIOID EPIDEMIC 

Medication Assisted Treatment (MAT) 

DEA plays an important part in the U.S. government's drug control strategy, which 

includes enforcement, treatment, and prevention. It is important to consider medication assisted 

treatment (MAT) as a part of any successful strategy to combat the opioid epidemic. It is 

imperative to determine how to best balance access to MAT against the potential for the 

diversion of the FDA-approved drugs to be used in the treatment of substance abuse disorder, 

such as buprenorphine. 

As you are aware, the Comprehensive Addiction and Recovery Act (CARA) (P.L. 114-

198) was enacted to address the opioid epidemic. One of CARA's important provisions expands 

access to MAT by authorizing certain mid-level practitioners (i.e., nurse practitioners and 

physicians assistants) to dispense or prescribe schedule Ill, IV, or V controlled substances that 

are FDA-approved for the treatment of opioid use disorder. This prescribing authority was 

previously limited to physicians only. In February 2017, the Substance Abuse and Mental 

Health Services Adminstration (SAMSHA) began providing waivers to qualifying practicioners 

and DEA published regulations in January 2018 to implement this provision. 

Telemedicine and the Ryan Haight Act 

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was signed into 

law in October 2008 and authorized DEA-registered practitioners to prescribe controlled 

substances listed in Schedules II- V using telemedicine under seven distinct circumstances when 

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30411.013

the prescriber is otherwise unable to fulfill the in-person medical evaluation required under the 

CSA. 

DEA's implementing regulations (published in April 2009) lay out the following 

requirements that must be met in order for a practitioner to prescribe controlled substances using 

telemedicine: 1) the prescribing practitioner who is at a location remote from the patient must be 

acting in the usual course of his/her professional practice; 2) the practitioner's activity must be 

done in accordance with applicable federal and State laws; 3) the practitioner must be 

communicating with the patient (or health care professional who is treating the patient) using 

multimedia communications equipment referred to in section 1834(m) of the Social Security Act; 

and; 4) the patient must be physically located at a DEA-registered hospital or clinic or must be in 

the physical presence of a DEA-registered practitioner. 

There is confusion over whether a doctor authorized to treat opioid use disorder utilizing 

MAT can perform these services utilizing telemedicine. Some have sought the assistance of the 

Secretary of the Department of Health and Human Services (HHS) to use his authority to 

authorize telemedicine for MAT pursuant to a public health emergency declaration. We are 

working closely with HHS, the Department of Veterans Affairs and other federal partners to 

identify opportunities to improve access to MAT as DEA continues the drafting process to 

implement regulations regarding special registration for telemedicine. 

Proper Medication Disposal 

On September 9, 2014, DEA issued a final rule, titled "Disposal of Controlled 

Substances." These regulations implement the Secure and Responsible Drug Disposal Act of 

2010 and expand upon the previous methods of disposal by including disposal at drop-boxes in 

pharmacies and law enforcement agencies, mail back programs, and drug deactivation systems if 

they render the product irretrievable. Through these regulations, DEA continues to focus its 

national attention on the misuse of prescription drugs and related substance use disorders 

(SUDs), and promotes awareness that one source of these drugs is often the home medicine 

cabinet, as 53% of persons aged 12 or older who misused pain relievers in the past year bought 

or took the pain relievers from a friend or relative, or that friend or relative gave it to the user for 

free. 20 These regulations provide a safe and legal method for the public to dispose of unused or 

expired CPDs. As of february 12,2018,3,450 DEA registrants have become "authorized 

collectors." 

Since 2010, DEA has held its National Drug "Take Back" Initiative (NTBI) to provide a 

convenient and safe option to dispose of unused, expired, and/or unwanted prescription drugs. 

DEA's most recent NTBI was held on October 28, 2017. As a result of all fourteen National 

Take Back Days, DEA, in conjunction with its state, local, and tribal law enforcement partners, 

has removed over 9 million pounds (4,508 tons) of medications from circulation. DEA is 

conducting its fifteenth National Drug Take Back Day on April28, 2018. 

20 Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health indicators in the United States: 

Results from the 2016 National Survey on Drug Use and Health (HHS Pubhcation No. SMA 17-5044, NSDUH Series H~52). Rockville, MD: 

Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from 

https://WW'N samhsa.gov/datal. 

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30411.014

Tab/eting and Encapsulating Machines 

In December 2016, DEA concluded several years of regulatory work to implement a 

2014 Executive Order (E.O. 13659) which aimed to streamline federal import and export 

processes by utilizing a government-wide system called the International Trade Data System 

(ITDS). As part of that effort, DEA amended its regulations pertaining to domestic transactions 

and import/export transactions involving tableting and encapsulating machines (21 C.F.R. 

131 0.05(a)(4)). The rule became effective on January 30, 2017 and regulated persons were 

required to comply no later than July 30, 2017. The information below outlines the CSA's 

regulatory requirements pertaining to the trade of pill presses. 

Domestic Transactions: Previously in 21 C.F.R 1310.05(a)(4) and (b), regulated persons 

who engaged in a domestic regulated transaction in a tableting or encapsulating machine were 

required, whenever possible, to make an oral report to the DEA Divisional Office in advance of 

the transaction, followed by a written report. The new rule makes the oral reporting mandatory 

and mandates the electronic filing of a written report (DEA Form 452). In addition, the amended 

regulations require regulated persons to orally report domestic regulated transactions in a 

tableting machine or an encapsulating machine when an order is placed rather than at the earliest 

practicable opportunity after the regulated person becomes aware of the circumstances involved. 

The written report (DEA Form 452) is required to be filed within 15 calendar days after the order 

has been shipped by the seller. 

Import/Export Transactions: An electronic report filing (DEA Form 452) is required to 

be submitted to DEA 15 calendar days before the anticipated date of arrival at the port of entry or 

port of export. In addition, the importer or exporter may not initiate an import or export 

transaction involving a tableting machine or encapsulating machine until the regulated person 

has been issued a transaction identification number from DEA. The importer or exporter may 

proceed with the import or export of the machine(s) as soon as the transaction identification 

number has been issued. In addition, these new regulations require electronic filing of return 

information, specifying the particulars of the transaction, fortableting and encapsulating 

machines imported or exported within 30 calendar days after actual receipt of a tableting or 

encapsulating machine, or within I 0 calendar days after receipt of a written request by DEA to 

the importer. 

CONCLUSION 

Synthetic opioids, cannabinoids, cathinones, and phenethylamines will continue to pose a 

nationwide threat. Synthetic drug producers modify and experiment with chemical formulas in 

search of new psychoactive substances. Once a new drug is formulated, the Internet and social 

media are used to market its arrival on the scene, allowing for its fast adoption and use. Due to 

the changing nature of the chemical formulas for synthetic designer drugs, distributors are able to 

reap significant profits before legislative and regulatory controls of these specific psychoactive 

substances are implemented. Sadly, it is likely the United States will continue to see overdoses 

and deaths as a result of synthetic drug use. 

Additionally, the United States continues to be affected by a national opioid epidemic, 

which has been spurred, in part, by the rise of nonmedical prescription opioid use and the large 

- 13 -
30 


30411.015

number of people with active SUDs who are not currently in treatment. It is likely that this 

demand will continue to be met in part by counterfeit prescription opioids which are being laced 

with fentanyl, fentanyl analogues, and other synthetic opioids (e.g., U-4 7700), and that Mexicanbased TCOs will push to expand their profits. DEA will continue to address this threat by 

pursuing the Mexican-based TCOs which have brought tremendous harm to our communities. 

Additionally, DEA's Diversion Control Division will use all criminal and regulatory tools 

possible to identify, target, disrupt, and dismantle individuals and organizations responsible for 

the illicit distribution of pharmaceutical controlled substances in violation of the CSA. Finally, 

DEA is committed to looking at all available options to combat the opioid epidemic and will 

continue to work with the Committee to provide legislative assistance on bills aiming to attack 

this public health emergency. 

- 14 -
31 

Mr. BURGESS. We thank you for your testimony. 

We will now move on to the portion of the hearing where Members will be recognized to ask questions, and I am going to begin 

the questioning by recognizing myself for 5 minutes for questions. 

On the proposed legislation offered by Mr. Katko on the creating 

a new level of scheduling on the fentanyl analogues, I guess, primarily, but I guess it could include other compounds as well. Now, 

we are going to hear some testimony from our stakeholders on the 

second panel about how that will perhaps increase the bureaucratic 

load on people who are involved in the research on these compounds. 

Do you see the potential for any difficulty there or any conflict 

there? 

Ms. GIBSON. Sir, I understand your concern for research, and it 

is our concern, too. DEA supports research. We have never denied 

a valid FDA research application, especially on synthetic drugs. We 

welcome research on synthetic drugs. Right now, we have 600 

Schedule I researchers that are approved. We have 420 that are 

approved regarding THC extract. And then we have another 120 

that are approved on an additional CBD extract. So DEA is fully 

behind research. 

Mr. BURGESS. So, again, one of the observations that will likely 

be made by a witness in the second panel is concerning compounds 

that are put on a scheduling list, that once they get on, it is almost 

impossible to get off. And I believe the point is going to be made 

that the difference, the molecular difference, between agonist and 

an antagonist can be quite small. And if we restrict the access to 

molecules of a certain class, that we may in fact be limiting the 

ability to research drugs or compounds that would be helpful as antagonists. 

Is that something that your agency is looking at or concerned 

about? 

Ms. GIBSON. Sir, I understand your concern about the analogues 

and the quick-changing nature of it, and I believe with the bill that 

we are trying to pass here, it could be more proactive in that arena. 

I think the biggest problem is exactly what you said. We have a 

substance that we get; we identify it as a problem. They change 

one atom on it, and then it is a whole new substance. It is labeled 

differently, and it is another problem to attack. 

We do believe that fentanyl analogues belong in Schedule I. We 

will look at every substance differently. And we work with our 

counterparts at HHS and make sure all the scientific data is there, 

and we make sure that we do it right as much as we can. But we 

look forward to working with the committee about any kind of concerns regarding that. 

Mr. BURGESS. And that is, of course, the whole purpose in having 

the hearing, to explore some of these issues that are brought up. 

You all will work closely with the Food and Drug Administration 

as far as scheduling things in that class. Is that correct? 

Ms. GIBSON. Sir, we work very closely with our counterparts at 

HHS, FDA, and we rely on them and their expertise, yes. 

Mr. BURGESS. Let me just ask you a question. And you mentioned it. Mr. Pallone mentioned it, as far as the educational aspect. I am a physician, and I did receive training on the use and 

32 

potential misuse of opiates. It was called medical school. I would 

just ask you, as far as the agency is concerned, you see legislation 

being proposed where you are going to be responsible for the oversight of an educational activity that will be administered to the Nation’s physicians. I would just ask the question: Is the agency set 

up to do that? Is the agency set up to handle that? 

Ms. GIBSON. Sir, I understand your concern for continuing medical education, and we think it is paramount. We think it is critical. 

Mr. BURGESS. Let me just—I do, too. And, historically, that is an 

activity that has been regulated by the State. My state requires me 

to receive a certain number of hours of continuing education. Although I am not active and in practice, I do keep my license active. 

So, yes, I am required to do those things every year before that license can be renewed. So they are set up, and that is part of the 

process. 

Do you feel like your agency is ready to administer to the continuing educational needs on this front the same as, say, a State 

licensing agency is already doing? 

Ms. GIBSON. Sir, we definitely work closely with the States regarding that, and that is a procedure that we would have to look 

extremely close at, and we would have to work with the committee 

to make sure that we would get that right. Again, we do believe 

in continuing medical education. I don’t think we can dictate exactly what they take. It is—— 

Mr. BURGESS. And therein is the problem. I will just pledge to 

you that, yes, it is an issue that is important to me, and we will 

work closely on that. 

Ms. GIBSON. I look forward to working with you. 

Mr. BURGESS. I will yield back my time. 

I am pleased to recognize the ranking member of the subcommittee, Mr. Green, 5 minutes for questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. 

And welcome, Deputy Assistant Administrator Gibson. Thank 

you for joining us today. 

I want to focus my questions on the impact of scheduling substances in Schedule I, which you mentioned in your testimony, or 

under the proposed Schedule A that H.R. 2851 would have on research. 

We hear from Dr. Beardsley in our second panel about the difficulty associated with conducting research with Schedule I substances. He noted in his written testimony that it can take over a 

year to obtain a Schedule I registration. I heard from others that 

requirements associated with Schedule I substances, such as the 

storage and security requirements, can be very costly. The time 

and resource burdens have, in some instances, been a disincentive 

for young and promising researchers who examine these substances 

for their therapeutic value. 

My first question is, can you describe current requirements DEA 

imposes on researchers who wish to study Schedule I drugs? And 

I am particularly interested in whether you offer any accommodations today for researchers. 

Ms. GIBSON. Sir, I appreciate your concerns for research, and it 

is critical. We do have a strict process regarding research as far as 

the application process. And the reason it is strict and it has to be 

33 

FDA approved is because we have to prevent diversion. That is the 

bottom line. And we have to make sure that everything that a researcher receives as product has to be retained and secured. 

But as far as research, if somebody brings a valid FDA application to us, we will be approving it. In fact, if it is a synthetic analogue research application, I will expedite it because we need it 

done. We need it done. 

Mr. GREEN. One concern I have heard from the registration process today is confusing nature and how Federal and State registrations interact. Some States require Federal registration prior to application, yet the DEA advises a State registration is needed prior 

to Federal application. 

What guidance does DEA offer to researchers at States regarding 

their registration process? 

Ms. GIBSON. Sir, I understand interaction with the States and 

your concern how that could be different between State and Federal. It is kind of shocking sometimes the difference between the 

State and Federal Government on various issues. However, when 

it comes to working in this arena, it is critical for the Federal Government and the State government to work together. And in order 

for the Federal Government to operate in a State, we need their 

compliance, we need their understanding. 

So we are more than happy to work with each State individually 

and make sure that we come up with a proper procedure, and we 

get it done right. Yes. 

Mr. GREEN. Yes, it is confusing if the State requires Federal and 

Federal also requires State, so I don’t know if we could do it simultaneously. That might be much easier for the researchers. One of 

the bills before us today, H.R. 2851, attempts to streamline the research registration process. We heard from HHS, however, that 

this process could still constitute a burden or barrier to research 

and could have a negative impact on drug development. 

Can you share what discussions, if any, DEA is having with 

Health and Human Services regarding the registration process for 

researchers, and how such process could be streamlined? 

Ms. GIBSON. Again, definitely research is a big concern for us, 

too. We work closely with HHS regarding applications for research. 

And, again, we do have 600 Schedule I researchers already that are 

ready to go. Again, we believe the new regulations could help 

streamline that process. So we look forward to any kind of tool that 

the Congress could provide to us to streamline that process, absolutely. 

Mr. GREEN. Well, Congress doesn’t always provide the funding 

for a lot of agencies. We wish we were the Appropriations Committee sometimes. 

While I want to ensure that we are properly protecting against 

abuse, misuse, and diversion of synthetic substances, I also want 

to ensure that we are not unintentionally restricting the ability of 

researchers and drug developers to discover new and promising 

therapies. 

Would you work with us on legislation to ensure that we do not 

impede or inhibit or otherwise disincentivize research? 

Ms. GIBSON. Sir, I would absolutely love to work with you. 

Mr. GREEN. Thank you. 

34 

And I yield back my time, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. 

The chair thanks the gentleman. The chair recognizes the gentleman from Oregon, the chairman of the full committee, Mr. Walden, for 5 minutes for your questions, please. 

Mr. WALDEN. Thank you, again, Dr. Burgess. 

And to our witness, thank you for being here today. So, in your 

testimony and in other people’s comments this morning, we have 

heard a lot of statistics, so I want to repeat a line from your written comments that says, ‘‘The sharpest increase in drug overdose 

deaths in 2015 to 2016 was fueled by a surge in overdoses involving fentanyl, fentanyl analogues, and synthetic opioids.’’ This was 

reported by the National Institute of Drug Abuse or NIDA. 

You go on to build a compelling case to give DEA additional authority to get synthetics off of our streets. Under current law, the 

DEA Administrator acting on behalf of the Attorney General can 

temporarily schedule substances for a 2-year period, with a possible 

1-year extension to avoid imminent hazard to public health. 

And on February 6, 2018, this administrative tool was utilized to 

place classwide Schedule I controls on fentanyl-related substances. 

My question is this: What additional tools would SITSA give special agents to investigate and prosecute these substances that they 

do not have today? 

Ms. GIBSON. Thank you, sir. I understand and I appreciate your 

efforts to give us any kind of tools that we can to get this job done 

because it is unprecedented, and it calls for unprecedented measures to get this done. 

Mr. WALDEN. Right. 

Ms. GIBSON. I do believe that the SITSA law outlines sentencing, 

which makes it a lot easier to prosecute, even though the prosecution sentencing guidelines are that of Schedule III. But I think it 

streamlines the process, which helps us tremendously. I think also, 

too, the false labeling I truly support because they take a substance, they change the atoms, and then they relabel it something, 

and it is a whole new product. So—— 

Mr. WALDEN. What happens in your world, the enforcement 

world, when that occurs? 

Ms. GIBSON. Well, right now, that we did the class of the 

fentanyl, that helped us out tremendously. It was the first time we 

ever did anything like that, and we are proud of that. But it does 

make it very difficult. We have gone out to convenience stores, 

banks. We have reached out to many people regarding the purchasing of these synthetic fentanyls online, the selling of them at 

the local shops—they got to know what they are selling, and it is 

a difficult arena. And especially my biggest concern is working with 

our counterparts because they are on the front lines; they have to 

be armed with the information they need to do their job. 

And the dissemination of information, education to our counterparts, that is critical. And I think DEA is doing a pretty good job 

of that, as far as communicating with our task forces out there. We 

have expanded our tactical division squads, which I think can also 

provide a lot of expertise out there. And I think that is the wave 

of the future as far as tackling this subject. 

35 

Mr. WALDEN. Congressman John Katko, who brought this issue 

to our attention, is a prosecutor and won a national award from the 

former U.S. attorney for his work going after narcotics and organized crime in the narcotics world, and brought us this measure. 

And we want to make sure that—because he has been on the front 

lines there. He has prosecuted these cases, and he says, they 

change one thing, and then there you are out there. It just 

bollocks-es up the whole process to go shut down. 

And he brought a woman to the State of the Union Address 

whose 19-year-old son, if I recall the story correctly, smoked something that he got at a head shop that I think had been sprayed 

with a synthetic fentanyl, and I remember his mother said—or her 

son said, ‘‘What could be wrong with this? It is natural,’’ even 

though it was labeled ‘‘not for human consumption’’ potpourri or 

something like that. 

It is the wink and nod behind the curtain. They think they are 

getting off on their liability when in fact they are poisoning a generation. Her son died. So that is—in this bill—one of the things we 

are trying to get at. Does this bill get to that? 

Ms. GIBSON. It is a massive problem. And I think this bill can 

help us get there. And, again, it is such a serious topic right now 

because we have people out there, we have kids out there, purchasing this stuff thinking it is a legal alternative to the actual 

substance. 

Mr. WALDEN. Exactly. And ‘‘because it is natural,’’ that was the 

argument her son made. 

Ms. GIBSON. Absolutely. 

We are facing cannibalism in certain States when they take some 

of these substances. There has been a couple incidents in Florida 

where the person took a cannabinoid or a cathinone and actually 

started eating somebody. That is how serious of a situation we 

have here. 

Taking these synthetic drugs is similar to taking meth and PCP 

at the same time. And the scientific term is excitable delirium. So 

imagine that: meth and PCP at the same time. These products are 

killing our kids out there. We have 750 substances right now that 

we have identified. We took 56; aggressively, we put them on the 

schedule. And out of that, what, I think my math is 696 that are 

still out there that can kill our kids—696 different substances—— 

Mr. WALDEN. Will this help get to that, or do we need more? 

Ms. GIBSON. It is going to streamline it. But we have to look at 

the sentencing. We have to make sure that we are—these people 

are peddling death. It is not a victimless crime when you are dealing drugs. 

Mr. WALDEN. That is right. 

Ms. GIBSON. And that is my biggest concern. I love to put handcuffs on people that violate the CSA. And this law can help us. And 

any other tool Congress can give us to tackle this problem, I will 

take. 

Mr. WALDEN. We want to be your partner in this effort. And just 

to make clear, this is the first of three legislative hearings we have 

announced. This one is focused more on the enforcement effort. We 

fully understand we need to do more on helping people who are addicted and treating—the treatment piece, the mental health piece. 

36 

This is going to be across the whole spectrum. This begins the process to try and turn off the access to these illicit drugs. 

So thank you for your good work, and we look forward to an 

ever-improving partnership between the administration and this 

committee on this matter. And we are going to get this done. 

So, with that, Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentleman from New Jersey for 5 minutes for questions, please. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Ms. Gibson, in your testimony, you note that some traffickers of 

fentanyl and fentanyl analogues have had industrial pill presses 

shipped into the United States directly from China and have been 

operating fentanyl pill press mills domestically. 

Now, DEA has also acknowledged that industrial pill press machines are widely available on the open internet and that some 

vendors mislabel the equipment or ship it disassembled so as to 

evade regulatory oversight. And this is clearly one way traffickers 

have been able to further increase the production and availability 

of illicit fentanyl and other synthetic opioids. 

So my question is—I have several. Under current law, importers 

and exporters are required to notify DEA of the shipment of 

tableting and encapsulating machines. So how does DEA ensure 

compliance with those requirements? 

Ms. GIBSON. Sir, I appreciate your concerns about those machines, and I am happy that DEA did take that measure and get 

up that regulation and get it in place. That requires any importation of a tabulating and encapsulating machine 15 days prior to it 

coming to the country. 

Obviously, you are going to have the legal people out there that 

abide by the laws, and they are going to be telling us they are 

bringing it in. But we, as DEA, I have to worry about the ones that 

aren’t playing fair. 

Mr. PALLONE. The bad actors. 

Ms. GIBSON. Exactly. As an agent in New York City, I know the 

criminals are very industrious. They are very creative; that is their 

job. So they make their own kilo presses; I am sure they can figure 

out a way to make their own pill presses. And that is something 

else we can address in the sentencing guidelines with SITSA. However, some organizations also piecemeal it into the country, too. 

And then from different sources, different shippers, they get one 

part of the machine, and another part of the machine coming in 

separately. So that is the problem. 

But we are excited at least to see how the regulation works and 

to see how many actually are coming into the country and go from 

there. So it is really fairly new; it is July 2017 that we started that. 

Mr. PALLONE. Do you think that DEA needs additional authority 

over tableting and encapsulating machines? 

Ms. GIBSON. Sir, any kind of control regarding those machines 

getting into the wrong hands, we would love a tool, any kind of 

mechanism to prevent that from happening, yes. We also have to 

understand that there are some people out there that bring them 

37 

in for legitimate business purposes, like vitamins and different 

things like that. 

So it is, again, a balance. And that is what I feel like, since I took 

this position, you got to have that balance. And making sure that 

people can do their job in the personal arena and the business 

arena, that is important. 

Mr. PALLONE. Yes. 

Ms. GIBSON. But also to keep these machines out of the hands 

of the people that don’t need them is a problem. 

Mr. PALLONE. Well, let me go to the bill that we have, this 

Tableting and Encapsulating Machine Regulation Act that we are 

considering, that would define in statute tableting machine and encapsulating machine. In addition, it would also propose a schedule 

of such machines in a to-be-determined schedule. 

Is there a precedent under the Controlled Substance Act for 

scheduling machines or other devices? 

Ms. GIBSON. Sir, again, this is an unprecedented time. So I can 

understand thinking outside the box. We never at DEA have ever 

scheduled a machine. So that would be a new arena for us, and 

that would be something that we would have to work closely with 

you regarding. 

Mr. PALLONE. Let me just ask this because I know we are going 

to run out of time. Can you describe for us the types of requirements that tableting and encapsulating machine owners would be 

subject to if they were placed into Schedule I? And then I will ask 

also, what would be the penalties an owner could potentially be 

subject to if they were not in compliance with those requirements? 

Ms. GIBSON. Well, again, if you put a machine under a schedule, 

they would have to obtain a DEA registration to obtain that machine. So they would have to go through the DEA registration process. Again, that is something we would have to discuss with you 

further. We can definitely talk to our counterparts at DOJ to see 

if they have any kind of understanding of how we could go forward 

with a process like that, but we would definitely have to talk to you 

more about it. 

Mr. PALLONE. What about penalties? You don’t want to comment 

on what penalties an owner could potentially be subject to if they 

are not in compliance? 

Ms. GIBSON. I think penalties could be addressed in SITSA as far 

as sentencing, if you have a tableting machine or encapsulating 

machine in your possession and you are not using for it a legitimate purpose, I think that could be a sentencing guideline that we 

could use, and that could be an option. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Michigan, Mr. Upton, 

5 minutes for questions, please. 

Mr. UPTON. Thank you, Mr. Chairman. 

And I really appreciate your remarks and the full committee 

chairman’s as well. This is something that we need to deal with, 

and I am glad to say that it is, for the most part, it has been bipartisan from the get-go. We want to provide you all the tools that you 

need. I dare say that every one of us knows someone that it has 

38 

impacted, and with the budget agreement that we passed and the 

President signed—when we did sequestration a number of years 

ago, no one ever heard of opioids for the most the part in terms 

of where things are today. No one would have thought that we 

would lose 65,000 people a year 8 to 10 years ago on this thing. 

So I am glad to say that the budget agreement did increase 

money versus what otherwise would have been a cut, and specifically earmarked opioid abuse as one of the increases that I know 

that the appropriators are going to come back with us for before 

that March 23 deadline. And, of course, all of us here on this committee supported 21st Century Cures, 51 to nothing. And in that 

bill, we included a billion dollars for opioids, and we know that that 

was only a 2-year bill, so it expires. So that is one of the reasons 

this budget agreement is so important where we focus on opioid 

abuse. 

Last year, I met with a number of my law enforcement officers 

undercover, and we talked—I met with a good number of folks in 

southwest Michigan, but I wanted to spend some time with my law 

enforcement folks to find out how easy is it to get fentanyl and 

some of these other products like heroin and others into west 

Michigan. They said it is real easy, because it comes in oftentimes 

through the postal center. And Grand Rapids is sort of the postal 

distribution center. They have one postal inspector for all of west 

Michigan. 

And it comes in in counterfeit labeling, and it changes. They felt 

that they had good cooperation with FedEx and UPS, but in fact, 

they know that it comes in there, too. And particularly for the drug 

dealers, the folks that are getting it, they can track it. They can 

find if it is delayed even 1 day, they are not going to be there to 

pick it up, go someplace else. It is a huge enormous problem. 

So I cosponsored a bill that would require the Postal Service to 

provide package level detail, information for packages imported 

from overseas to Customs and Border Patrol as private carriers 

like UPS and FedEx are already required to do. Because of that— 

and I applaud the President, he had a number of us, on a bipartisan basis, down to the White House last summer—I raised this 

issue with him and how we needed more resources. And, frankly, 

when you think about trying to identify some of these drugs coming 

in and we have seen cases where just, you know, because of its potency, just any contact at all can actually kill, whether it is dogs 

or people, so there is an enormous problem. 

Can you tell us how are you interacting with where—as we 

know, when the President went to China a few months ago, I 

signed a letter with a number of my colleagues to raise the 

fentanyl issue to see what China can actually do to stop some of 

this junk coming here. 

But how is your frustration level with the law enforcement, or 

with the shippers, and what can we do to help you there as well? 

Ms. GIBSON. I understand your concern about tackling this problem, and it is daunting. And that is one of the reasons why I am 

proud of DEA, because we never give up. And drug work is the 

most labor-intensive, frustrating entity that you can encounter in 

law enforcement. 

39 

I know, when I was an agent in New York City, we routinely 

worked with the postal inspectors. We have worked with different 

shipping companies in various capacities, and we have had a lot of 

success with them. Sometimes you strike out, but you just got to 

keep on getting up to the plate and taking another swing. 

It is too important of a problem to just give up on. But we definitely will take any kind of resources, any extra resources that can 

be given to us. Specifically, if you have one major concern, please 

let me know. 

Mr. UPTON. Let me ask you one quick question. Disposal of pharmaceutical waste in the hospital requires strict adherence to necessary protocols to avoid diversion of opioid waste, primarily administrated doses that are medically necessary for most surgical 

procedures from being improperly disposed of. 

So to render those opioid nonretrievable and unusable products 

for DEA regs at a much lower compliance burden than what many 

providers currently experience, what are you doing to help being 

able to dispose some of these that people may voluntarily bring in 

that they can then rest assured they are not going to be abused by 

someone later on? 

Ms. GIBSON. Sir, I understand your concern because I think we 

have all been there where we had a loved one that passed and we 

had all this medication that we didn’t know what to do with it. 

DEA prides itself on the National Take Back Initiative, where we 

actually have one coming up April 28. Through the beginning and 

the inception of that program, we have taken 9 million pounds of 

prescription drugs off the street—9 million pounds. And, unfortunately, four out of five heroin users right now start with taking the 

pills out of the medicine cabinet and going ahead, using them, and 

developing a horrible habit. 

So it is incumbent for us to get those pills. And we do a lot with 

operation prevention. We get information out to parents, students, 

teachers. Operation 360 right now. We are working with communities to get the information out there. DEA wears many hats, and 

I think a lot of times people think we are just kicking in doors and 

arresting bad guys, but our Diversion Control Unit, we tackle those 

problems as far as making sure we get the information out there. 

Mr. UPTON. I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentlelady from California, Ms. Matsui, 

for 5 minutes for your questioning, please. 

Ms. MATSUI. Thank you, Mr. Chairman, and I want to thank all 

the witnesses who are yet to testify yet for being here today and 

also you, too. My priority here is to improve access to care. And, 

as mentioned before, I am working on improving access to remote 

behavioral health treatment. It is a discussion draft, which is what 

it means: It is a discussion draft. And we are still working on it, 

but I think it is important to lay it out there so we can have a conversation as to how we might improve it. 

This is with Representative Harper. And both of us believe that 

telemedicine has the potential to improve access, especially in the 

midst of this opioid epidemic. However, I am looking forward to 

40 

hearing from stakeholders—all the stakeholders—about how best 

to improve access via telemedicine without creating new problems. 

The last thing we want to do is to make it easier for unscrupulous actors to prescribe controlled substances. And I think you 

mentioned before that the bad actors are always the ones who, I 

don’t know, that is their job to figure out how to mess up things, 

right? 

Ms. GIBSON. Yes. 

Ms. MATSUI. So we are going to have to try to figure out what 

to do to prevent that. But I do though believe that many people in 

our communities are receiving high-quality comprehensive care in 

their local community behavioral health clinics. And access to 

medication can be a part to treating patients suffering from opioid 

use disorder and other mental illnesses. 

Ms. Gibson, according to DEA’s interpretation of the Ryan 

Haight Act, a hospital or clinic must first be licensed by the State 

before registering with the DEA. Can you provide us with some insight into the reasoning for DEA’s narrow interpretation? 

Ms. GIBSON. Ma’am, DEA agrees with any kind of efforts that we 

can do to get somebody on the right path forward, and to get them 

help. So I understand your concern, and I would love to work with 

you. 

It is incumbent that DEA works with the State government regarding registrations. A lot of times, active investigations, whether 

criminal or administrative in nature, we work hand-in-hand with 

our State. So if there is a problem going forward with having registrations, and if State is the problem, we can figure that out and 

get you information that you need. 

Ms. MATSUI. So are there circumstances, then, under which DEA 

could modify, work with this requirement to be more inclusive at 

clinics that may be authorized by the State or county but not licensed by the State? 

Ms. GIBSON. Again, this is where I have to put my DEA hat on 

as though we were enforcement and regulation, because it is so important to make sure that these clinics are abiding by Federal and 

State laws. 

Ms. MATSUI. Right. 

Ms. GIBSON. So if a clinic wants to move forward with obtaining 

registration for a narcotic treatment program and to dispense 

MAT, medical assistance treatment, we would be more than happy 

to work with them, because we want to make sure that people have 

access to those types of treatment centers. 

Ms. MATSUI. Right. I am looking at it from a drug enforcement 

perspective, and you are looking at certain guardrails that must be 

put in place to assure appropriate prescribing of controlled substances for a medication-assisted treatment via telemedicine. That 

is the aspect of it here that we are trying to address. 

And it is a little bit different, but on the other hand, is there a 

situation, I am trying to get to where we can narrow this in a way, 

not so widely but not so narrowly as it is today so that we might 

be able to have this remote telemedicine ways of treatment in this 

crisis. 

Ms. GIBSON. Well, ma’am, as it stands right now, telemedicine is 

authorized. 

41 

If we can get the patient to either a registered hospital or clinic, 

with DEA, or a registered physician, physician assistant, nurse 

practitioner, they use appropriate audio-visual equipment, to their 

prescription and data-waived physician, it can happen. 

Ms. MATSUI. The only problem, though, is that in a situation, you 

would want the person to be in place and we are looking at community clinics where that is not necessarily a hospital or something 

that is licensed by the State. And that would take away the efficiency of the telemedicine then. And we are trying to get to that 

place where we can get the community health clinics to be able to 

be participants in this with the patient without having to move 

them somewhere, if you know what I mean. 

So anyway, it is something that we are trying to figure out, Congressman Harper and I, to figure out how to get the guardrails in 

place but have it flexible enough so we can do this. 

So thank you very much. We are going to be working with you, 

I believe. 

Ms. GIBSON. Absolutely. I want to work with you and see how 

we can figure that problem out. 

Ms. MATSUI. Thank you. I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. The chair recognizes the gentleman from Illinois, Mr. 

Shimkus, 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. Thanks for being here. 

I want to applaud my colleagues on both sides who—it is easy for 

us to try to run home when we are not voting and they are here 

working. And so hats off to both sides, because it is such a national 

issue and a national concern. And we have got a long way to go. 

This is a plethora of options and bills. There is a lot of ideas out 

there, and a lot of them sponsored by my colleagues on this committee and some outside the committee. 

So I want to focus on this issue of FDA and DEA and this pseudo, not a conflict, but the scheduling and the FDAs approval for scientific safety and efficacy, and then the listing. Where on this what 

we need to do is try to keep people from taking the first dose and 

getting hooked, and that is a whole set of problems, but then the 

other side is the treatment. And some of this treatment has opioidtype events. And so it is a total ban when you got to use that on 

the treatment end, there is also a concern. 

So I want to make sure the FDA’s role in the scheduling process 

is strong and solid. I think both sides talked highly about the 

strength of FDA and its record, but it seems like there is certain 

factors within the current eight-step process to bring new drugs 

under the Controlled Substances Act such as the state of the current scientific knowledge about the substance or its risk to public 

health, are better suited for the FDA and agency focused on scientific safety and efficacies of drugs than the DEA, which enforces 

the criminal and civil justice on controlled substances. 

Does the DEA believe that in order to strike the balance between 

addressing the risk posed by illicit use and allowing the scientific 

research needed to develop new therapies that the FDA should continue to have some role in the temporary and permanent scheduling of controlled substances? 

42 

Ms. GIBSON. Sir, I appreciate your concern about scheduling substances and getting them out of the hands of our kids as quickly 

as possible, too. It is critical to work with our counterparts at FDA 

and HHS. I have the utmost respect for them and I look forward 

to working with them in the future. 

The only way we can tackle this problem is together. I came from 

a task force in New York City comprised of DEA, NYPD, and New 

York State Police, and the only way that we were as successful as 

we were is because we worked together. So I promise you that any 

kind of scientific data, anything that FDA, HHS can bring to the 

table, I will be more than happy to work with. 

Mr. SHIMKUS. Yes, because the concern is to make sure that you 

all make reasonable technical accommodations for research, which 

is critical, and that FDA should continue to have some role in the 

scheduling process. I appreciate your comments. What we had hope 

was that you all, the DEA, would help provide some technical comments to, in essence, the Katko bill, which is the H.R. 2851, which 

I scribbled—I don’t like to use acronyms, so I try to scribble down, 

but then I can’t read my writing, so Stop the Importation and Trafficking—— 

Ms. GIBSON. Synthetic Analogues—— 

Mr. SHIMKUS. Yes, you got it. So if you could provide us some 

feedback on how we can address this concern about making sure 

that the FDA can be involved in this process and what your concerns will be as this bill—my guess would be this bill would get a 

fair hearing and will move through the process. And we would like 

to have your input on that. 

Ms. GIBSON. Again, sir, I understand all your concerns. And especially being that I just came to this position, I have been here 

a month-and-a-half. 

Mr. SHIMKUS. Welcome. What a time. 

Ms. GIBSON. Thank you. But you know what, I think it is a great 

time to be a part of it because it is such a massive problems that 

it takes all hands on deck, and it takes everybody to get on the 

same page and figure this out. 

So I promise you, that is my motto. I need to work with people. 

We need to bring people into this conversation. Because I can talk 

about regulation all day long and making sure the stuff stays out 

of the bad guys’ hands, but I need to rely on my scientific counterparts to understand everything going on. 

Mr. SHIMKUS. We just don’t want the two agencies to trip over— 

we have the same objective. We just don’t want the two agencies 

to trip over each other. And so we need help clarifying the language, that suits both sides, that would be helpful. 

And with that, I yield back. Mr. Chairman, thank you. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. The chair recognizes the gentlelady from Florida, Ms. 

Castor. 5 minutes for your questions, please. 

Ms. CASTOR. Thank you, Mr. Chairman. Welcome, Ms. Gibson. 

A U.S. District Court judge in Ohio, who is overseeing hundreds 

of lawsuits that have now been consolidated into one, these are 

lawsuits filed against opioid manufacturers and distributors. The 

judge has directed DEA to release data about the national distribution of opioids. The judge ordered the DEA to inform him very soon 

43 

that it will consent to releasing data from the automation of reports and consolidated order systems, ARCOS. ARCOS data, which 

drug companies must provide to the government under the Controlled Substances Act shows transactions made by opioid manufacturers and distributors. 

The database shows how many pills were sold, where in the U.S. 

they were sent, and what pharmacies bought them. The database, 

as you know, is often used by agents conducting criminal investigations into trafficking of prescription opioids. 

The judge proposed that the DEA give a list of drug companies 

that manufacture and distribute 95 percent of the opioids in each 

State broken down by each State for each year between 2006 and 

2014. The judge also would like the data to include the total number of pills sold in every State each year and how much market 

share each company enjoys. 

Will the DEA comply with the judge’s request? 

Ms. GIBSON. Ma’am, I understand what you are discussing right 

now, because it has been a big part of my time since I have been 

here in this position. I know personally, and I have been part of 

the meetings, that we are working as much as we can with the coalitions. We understand their goals. We have, though, a right—well, 

not a right, but we have to protect business proprietary information. We are working with them right now to come up with the 

mechanism. 

Ms. CASTOR. That is the business information of drug manufacturers and distributors? 

Ms. GIBSON. Proprietary information, yes. And that is statute. 

That is not something that I can chose to do. It is statute. 

Ms. CASTOR. But the DEA said you would provide a couple of 

years of information. What is the difference? 

Ms. GIBSON. Ma’am, there are multiple lawsuits going on right 

now, so I have to clarify actually which one, if you are specifically 

talking about Ohio. 

Ms. CASTOR. Yes. 

Ms. GIBSON. I know we have moved forward with several States 

as far as giving them information. Some States we have already. 

Some States we are still trying to work that out. So I would have 

to get back with you regarding exactly Ohio. 

Ms. CASTOR. I know the DEA will have to get back to the Federal 

District Court judge. 

Ms. GIBSON. We have. We absolutely have. 

Ms. CASTOR. —shortly. 

Ms. GIBSON. We absolutely have. 

Ms. CASTOR. I would just encourage the DEA to be as responsive 

as possible. 

If there is a law that is preventing you from sharing certain 

data, the Congress needs to understand that. And I know there has 

been a lot of press reports about what has happened with drug 

laws and things, but we need some honest brokers in this business 

to help us combat it. 

And you said you are committed to combating the epidemic. And 

I would think DEA’s full compliance with the District Court judge’s 

request for information would go a long way to doing that. 

44 

Now, the Controlled Substances Act requires drug companies to 

report the unusually large or suspicious orders, and if they fail to 

do so, they are fined or they are suspended, or they lose their registration. Then DEA has the ability, if they are not complying, to 

issue orders to show cause or immediately suspend them. 

I am wondering, in this physical year, how many enforcement actions have been taken by DEA, and can you characterize that? Do 

you have those statistics in front of you? 

Ms. GIBSON. As far as enforcement action, we have taken approximately 900 registrations per year in the past 7 years. In the 

past 7 years, I believe we opened, what 10,000 cases, about a couple thousand cases a year. So we are aggressively going after people and we are opening up cases, and we are using every tool that 

we have—— 

Ms. CASTOR. Could you provide those specific statistics to the 

committee, up-to-date? Because looking on the website, the data 

only goes through 2016, and it would be very helpful. 

Also, there has been a lot of criticism about the DEA and the revolving door between the DEA and drug companies and manufacturers. What regulations are in place right now that—just like Congress, we are prevented from lobbying for a couple of years—what 

is in place right now, in ethics and government that prevents an 

employee from the DEA leaving and going to work for a drug manufacturer or a law firm that represents them or a drug distributor 

right now currently in law or in agency regulation? 

Ms. GIBSON. Ma’am, I wish I was close enough to retirement to 

have to worry about something like that, but unfortunately you are 

stuck with me for several years. I would have to get back to you 

with specific information regarding that. We do have an ethics committee and counsel back at DEA, and he can provide exactly what 

you need regarding that. 

Ms. CASTOR. Do you know of any restriction that is currently operative at the agency? 

Ms. GIBSON. Again, I wish I had the opportunity to know. That 

meant I was closer to retirement. But I—— 

Ms. CASTOR. Please get us that information. 

Ms. GIBSON. Absolutely. 

Ms. CASTOR. Thank you very much. I yield back. 

Mr. BURGESS. The gentlelady yields back. The chair thanks the 

gentlelady. The chair recognizes the gentleman from Ohio, Mr. 

Latta for 5 minutes for your questions, please. 

Mr. LATTA. Thank you, Mr. Chairman, and thank you very much 

for being with us today on this panel. Being from Ohio, we are, unfortunately, right in the middle of this. We have seen some sobering statistics that we had from overdose deaths. We go back to 

2015, we had 3,050 people lose their lives. In 2016, that number 

went up by 1,000 to 4,050 people. And just in the period ending 

from the physical year from the end of June of 2016 to 2017, that 

number went to 5,232. So we are seeing this horrible increase in 

the State of Ohio. And also, a lot of this is being caused because 

of fentanyl. 

And when you look at in 2016, we saw about 58.2 percent of all 

the overdose deaths because of something involving fentanyl. So, 

45 

our topic today is on the opioid crisis, but for us in Ohio, we are 

going through an epidemic because of how bad it is out there. 

And if I could, because it is important for you, and I know there 

is a little bit of discussion that you have had already talking about 

drug take-back days and things like that. We have participated in 

two within Lucas County with the sheriff. I was absolutely astounded at how much came in that day. And then I was with the 

Findlay Police Department, just south of there in my district on another drug take-back day, and the amount of drugs that were taken 

back that day. 

So, there are things happening out there, and it is important, but 

I am also working with legislation on getting the information out 

for my communities. And it is the Info Act. Because one of the 

things I have heard from my communities, because I represent a 

lot of small areas. And the problem is that they don’t have the 

grant writers, they don’t have the information. They need to have 

some place they can go to get the information, what is happening 

on the Federal side. And also, just as importantly, where the 

money is to help. So, we have been working on that because it is 

very, very important. 

But let me ask you, because in your testimony, again, just this 

data information back and forth, but in your testimony you talk 

about the heroin-fentanyl task force which is the intergovernmental working group, and you have a lot of law enforcement, 

Homeland Security, investigative Postal, even Defense and Intelligence Agency. Is it an oversight or is HHS not part of that working group? 

Ms. GIBSON. Sir, which working group? 

Mr. LATTA. OK. This is the heroin-fentanyl task force that you 

mentioned in your testimony. I see that HHS is not in that group. 

Ms. GIBSON. Sir, I would have to get back with you exactly what 

the role would be. But I know for a fact anything that comes across 

my desk, I reach out for HHS immediately because they provide 

the scientific expertise that I need to get this job done. I have a 

lot of experts at DEA also, but we work hand-in-hand with them. 

So even if it is not listed, we would be more than happy to partner 

with anybody—— 

Mr. LATTA. OK. Well, if you could just tell me if they are in that 

working group, that would be important. Let me go on. Because, 

again, when you are talking about fentanyl, and when you are talking about the importation, especially from China, and, again, I 

have had meetings with my 14 county sheriffs in conference calls 

and meeting with them personally, and also with my police chiefs 

across the districts. 

One of the concerns out there, what is happening is, we are seeing that fentanyl is now being laced with marijuana. And not specifically in this case, but a young individual died in my district recently from fentanyl about the size of three grains of salt that took 

that person’s life. 

And what is DEA trying to do right now, trying to stop the importation? I know a lot of it is coming across from there. You 

brought up the fact it is $3,000-$4,000 and how much you can get 

on the street level, out there on the street with it over $1 million. 

But what is the active role DEA right now is taking on stopping 

46 

the fentanyl from coming into the country, especially from China 

or if it is being sent to Mexico or into Canada and somehow getting 

brought back in the United States. But what exactly are we doing 

at DEA? 

Ms. GIBSON. Sir, I appreciate your question, because I am really 

proud to be sitting here saying that our DEA Beijing country office 

works closely with the Chinese Government. 

China has been a very good friend to us. And the fact that they 

have put I think 138 new psychoactive substances. They regulated 

them over in China for us, and they are not even a problem over 

there. And statistics have shown if they regulate a substance over 

there, it has a direct impact on law enforcement encounters. It dramatically declines. 

So DEA, we are very present in a lot of foreign countries that 

I am very proud of, and I think our job starts thousands and thousands of miles away from the United States borders, and I think 

that is just one example of it. And we are really appreciative for 

anything that the Chinese government can do regarding regulating 

those substances. 

Mr. LATTA. Mr. Chairman, my time has expired. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes for your questions, please. 

Mr. SARBANES. Thank you, Mr. Chairman. Thank you, Ms. Gibson, for being here. I appreciate it. 

I was looking at the website of the Diversion Control Division 

and some frequently asked questions on there. And I was focusing 

on a part of it that talks about how while DEA doesn’t directly regulate the marketing of control substances, it is in keeping with 

your mandate to ensure appropriate safeguards against diversion, 

and you do have concerns when marketing and advertising tactics 

appear to create increased possibility for diversion or misuse. 

And if you see such tactics leading to oversupply or minimizing 

risk of abuse, you make every effort to work with pharmaceutical 

companies and the FDA to find appropriate solutions to these problems. 

And I am really curious about the history of OxyContin and the 

extent to which the Diversion Control Division had its wits about 

it when it came to the marketing practices of Purdue Pharmaceuticals and anybody else who was using unscrupulous marketing 

techniques and what kind of lens that the vision that you head up 

brought to that and continues to bring to that since it is something 

that appears to fall within the mission of the agency. 

Ms. GIBSON. Sir, I appreciate your concern. 

The bottom line is the prescriber. One of our goals for 2018 is 

to have conferences regarding prescribers. Our goal is to get as 

much information out there to prevent a physician falling for those 

ads, and to make sure that opioid prescription is done correctly. 

Just recently over our website we added the link to the CDC 

opioid prescription guidelines. So right now when it comes—— 

Mr. SARBANES. So let me just interrupt. So your focus is on the 

prescriber but let’s say you see a pattern of prescribers being 

bombarded with marketing tactics, false and misleading informaVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
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tion, broad campaigns to stretch the facts on what a particular 

drug can and cannot do, the harm it may present, and so forth. 

Presumably, if you see a pattern of that among the prescribers that 

you are focused on, you would say you are, in effect, trying to protect from some of those marketing tactics, you then turn your attention, at least in part or in concert with other agencies that have 

jurisdiction, to the source of the marketing and bring some attention to that. 

So that is what I am interested in right now. What is that kind 

of focus? What are the questions you bring to those doing the marketing? What is the inquiry, and investigation, and pressure you 

bring to bear so that these marketing practices aren’t bombarding 

these physicians, or pulling them in to a large disinformation enterprise? 

Ms. GIBSON. Sir, I appreciate your question because I have to 

say, that is something that I have not encountered and or really 

addressed since I have been here. So that would be a learning 

curve for me, too. I would definitely want to sit down with you and 

get you information regarding that because that is information, too, 

the marketing tactics I think would have to go a few years back 

for what your scenario is that you are giving to me. And I would 

love to find out myself exactly what we do. 

Mr. SARBANES. Well, I hope you get interested and it does seem 

to fall squarely within the mission to pay attention to these marketing practices. And there is a lot of history to look at with how 

OxyContin was marketed, how Purdue managed to overcome wellfounded concerns and anxieties in the medical community about 

the addictive nature of that particular medication. 

And the reason to study the history of it is because from what 

I can tell, those kinds of marketing practices continue in force. 

They may have, you know, altered them slightly to respond to pressure in the public and from some agencies, but I think the practices 

continue and we need you all to cooperate with any agency that 

has relevant jurisdiction on this to make sure we shut those kind 

of practices, marketing practices down to protect people out there 

in the country. So I hope you will bring attention to it. 

Thank you. And I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. The Chair recognizes the gentleman from Indiana, 

Dr.Bucshon. 5 minutes for your question, please. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

I was a practicing cardiothoracic surgeon for 15 years prior to 

coming to Congress. I have known about this opioid situation for 

probably 25, 20–25 years. This is not a new problem, but it kind 

of reached the tipping point, and it has gotten dramatically worse, 

but the tipping point where it is become a public health issue, specifically. 

And a little background from a physician perspective. Back in 

the 1990s there was a big push to control pain, both chronic and 

acute pain. And that came really from everywhere. It came from 

accrediting agencies for hospitals, it came from inpatient advocacy 

groups, it came from nursing groups, doctor groups. The little 

smiley face, frowny face on the patient’s chart. Your pain from 1- 

to-10 type of thing. 

48 

And so what happened is—and I am going to be quick here because I have a question—what happened is that we somewhat as 

a society started to create a culture of, in my view, of prescribing 

opioid-type pain medicine, probably in many cases, inappropriately 

when there were non-opioid alternatives that could have been used 

for both chronic and acute pain. 

And then it started to get linked to payment, where patient satisfaction scores, hospitals, and others were worried about getting 

their payment cut because of patient satisfaction scores. And that 

included the ‘‘fifth vital sign,’’ which was pain. 

That is not a defense of practitioners, but it also is the truth. 

And I think our society has created a culture that it is going to 

take a while to turn the Titanic, right? We are not turning the 

speedboat here. We are going to have to change our medical culture 

to fix some of that. 

So a couple questions: What percentage, approximately, do you 

think of heroin being abused in the United States comes across the 

southern border of the United States? 

Ms. GIBSON. I don’t know if I can give you a specific number, but 

I would think a fair majority of it would be coming—— 

Mr. BUCSHON. The majority comes across there. So, we have 

some, not only in areas where we have the international shipping, 

that is a huge issue, but my parents stayed down in the Brownsville area for 20 years over the summer. And almost weekly they 

would catch a semi-load full of either cocaine or heroin, or something, right? And that is the ones they caught. So, I think we do 

have an issue down there. 

So in Indiana served the 8th district. It is very rural. And this 

is going to change, we are going to change to a different direction 

here a little bit. And we have a problem with access to medication 

assisted treatment and I support the use of telemedicine. 

In your testimony, you mentioned that there is confusion over 

whether a doctor is authorized to treat opioid-use disorder using 

MAT, medication assisted treatment, can perform the services via 

telemedicine, and the DEA is in drafting process to implement regulations regarding special registration for telemedicine. 

Do you have a timeline of when you expect to promulgate these 

types of regulations? 

Ms. GIBSON. Sir, I understand your concern about the special 

registration. Upon my arrival here, I met with my drafting unit, 

and I realize that that has been pending a while, and it has been 

put on our unified agenda. And we are going to make it a priority 

right now. But I really think it is important for me to get out to 

1.7 million registrants that it can be done. 

Mr. BUCSHON. Yes. 

Ms. GIBSON. In certain circumstances it can be done. So the special registration has nothing to do with telemedicine being done 

now. 

Mr. BUCSHON. Right. Yes, just do your best to tell everybody 

what the rules are. I think that is the bottom line, right? 

With that, Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. The Chair recognizes the gentlelady from Colorado for 

5 minutes for your questions, please. 

49 

Ms. DEGETTE. Thank you so much, Mr. Chairman. Before I ask 

my questions, I just want to take a moment of personal privilege 

and thank my wonderful healthcare staffer, Polly Webster, whose 

last day is today, as a matter of fact. Polly was instrumental in 

helping—Fred Upton is sitting here, and he will tell you, she was 

instrumental in getting 21st Century Cures over the finish line. 

And we are going to really miss her. So thanks for all your good 

work, Polly. I appreciate it. 

I also want to just make an observation, Mr. Chairman, which 

is I am hoping, I know there was some disappointment that a lot 

of the members left, but we had a very good showing on both sides 

of the aisle today for this hearing. And when the hearing was originally scheduled, it was scheduled for a day when we thought we 

would be having votes. But having said that, and listening to Ms. 

Gibson’s testimony here, unfortunately, I am going to have to miss 

the second panel because I am going to have to go home—but I 

think there are so many issues around this opioid issue, and certainly the scheduling of fentanyl and other compounds is one issue. 

Some of the other members have raised other issues. I believe that 

you are intending to have a whole series of these hearings. And I 

think that it really will be worth it. 

Some of you know, everybody on the committee knows, I am the 

ranking Democrat on the Oversight Subcommittee. And over the 

last few years, we have had a number of hearings on the Oversight 

Subcommittee around the opioid issue, so if there is anything we 

can do to assist this committee, we could have some joint hearings, 

or whatever. 

Someone said it has reached a tipping point, and it really has in 

every community in this country. And we need to take aggressive 

action. Ms. Gibson, when I hear you talking about the struggles 

with telemedicine and how are we listing these substances and so 

on, it is just really clear there are a lot of facets to this and a lot 

of things that can be tightened up. So consider us to be your partners in this. 

I did want to ask you about something that hasn’t really been 

discussed today. As tempting as it is to go very deep into the issue 

of synthetic opioids, I want to ask you about drug take-back programs. As you know there is a lot of unused prescription drugs 

lying around in homes. And so Congress passed the Secure and Responsible Drug Disposal Act in 2010. What that says is it allows 

DEA registered entities like pharmacies and hospitals to collect 

prescription drugs for disposal. 

Now in Colorado, my home State, the Consortium For Prescription Drug Abuse Prevention has piloted a number of successful 

drug take-back programs that have helped remove these unused 

opioids. But unfortunately, as I understand it, the Colorado Consortium is the exception not the rule. 

Last October, the GAO released a report that said nationally just 

3 percent of DEA-registered facilities are operating take-back programs. So I am wondering, Ms. Gibson, if you know what the primary challenges that DEA registered facilities face when they are 

trying to operate this program? Is there something that you can do 

or we can help you do to make this program more robust? 

50 

Ms. GIBSON. Ma’am, I appreciate your endeavors to expand upon 

this process because it is so critical getting this stuff off the streets 

for our kids. I know what keeps me going during the day is thinking about diversion and making sure that anything that is taken 

from our citizens out there, get it out of the hands of the kids to 

take is paramount to me. But I have to make sure that it goes to 

the right person and that it is not being diverted from that person 

and it goes to an entity where it is secured and it is not going to 

be stolen. So there is a lot of—— 

Ms. DEGETTE. Well, you are totally right, but those are called 

DEA-registered facilities, and they are supposed to be implementing this program. But only 3 percent of them are. I am not 

talking about getting people who aren’t registered to do it. I am 

talking about people who are OK to do it, to do it. Do you know 

if DEA has programs to bolster up these facilities doing the takeback programs? 

Ms. GIBSON. I am going to have to look at that. I know we have 

one coming up in April. And if I can address that and take that 

back to my counterparts—— 

Ms. DEGETTE. That would be great, because if—— 

Ms. GIBSON. Right. 

Ms. DEGETTE. We are all committed to it. 

Ms. GIBSON. Yes. 

Ms. DEGETTE. We just need to make it happen. 

Ms. GIBSON. Thank you. 

Ms. DEGETTE. We have to make that happen. 

Ms. GIBSON. All right. 

Mr. BURGESS. The gentlelady yields back. The chair thanks the 

gentlelady. The chair recognizes the gentleman from Missouri, Mr. 

Long. 5 minutes for your questions, please. 

Mr. LONG. Thank you, Mr. Chairman. And Ms. Gibson, you mentioned in your testimony that the drug control process under the 

Controlled Substances Act is reactive, and that it requires an extensive interagency collection and evaluation of data and an arduous and time-consuming process. Is this current process satisfactory? 

Ms. GIBSON. Sir, I appreciate your question. And I have to say, 

and I am just not saying this, since my time at Diversion Control 

Division, I am so impressed with the people that work there, primarily because we were able to do the class of fentanyls within 2 

months. It may not sound quick to some people, but to get that 

done and get those substances scheduled in 2 months, a whole 

class, I think that was pretty darn good. So you know, SITSA can 

help streamline that process a little bit, but I think we are also 

doing our job just because of the diligent efforts of the people in 

Diversion. 

Mr. LONG. So even though it is an arduous and time-consuming 

process, according to your testimony, they are doing it quick? 

Ms. GIBSON. We got it done in 2 months, and that is because people, they went above and beyond. 

Mr. LONG. You also mentioned the difficulty of preventing the 

distribution and abuse of controlled substances analogue, designer 

drug, and you state the Analogue Act is cumbersome and resourceVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
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intensive. Can you discuss what is and is not working with the current structure? 

Ms. GIBSON. There is a process. And a lot of times the process 

takes a little bit longer than what we want. Look, I have 696 substances that I wish tomorrow I could put on a schedule and get 

them dealt with and get them regulated. But there is a process. 

And I have to adhere to that process. And, again, it is up to the 

valiant people that work for me that do their job above and beyond 

and get the process done. 

Mr. LONG. Well, speaking of the process, what can we do to make 

it less cumbersome, or can we, so the DEA can use its resources 

more effectively? If you had your druthers, what would you rather 

them do? 

Ms. GIBSON. If I had my what? 

Mr. LONG. If you had your druthers. If you would rather do 

something, what would you rather them do? 

Ms. GIBSON. If I had a choice, what I could do to make this—— 

Mr. LONG. That is English, yes. Choice, yes. 

Ms. GIBSON. OK. Sorry, I am a simple girl from Pennsylvania. 

Again, I think that is one of the neat things, that I come from an 

enforcement background. I was an agent in New York City for 20 

years, and now I have this hat to put on under Diversion. And it 

is exciting because now I get to ask those questions, and in a perfect world, what can I do, what can I make better. And I ask that 

question a lot. 

And so I am still formulating exactly what I can do to think outside the box, but I know one thing I am definitely believing in is 

getting information out there. I just recently visited a methadone 

clinic. It was Dr.Hoffman’s methadone clinic here in D.C., PDARC, 

and I learned a lot of invaluable tools from that and dissemination 

of information to get people help, to get local law enforcement, help 

to tackle dealing with this issue. 

So, yes, sir, I can get back with you. Give me a month and maybe 

I can have a lot more ideas. I have ideas brewing. I just got to 

make sure that I take them into the right arena and move forward 

with them. But I promise you, I am thinking outside the box as 

much as I can. 

Mr. LONG. OK. Thank you. And thanks for being here. And 

Diana had my other question there, so we got that answered when 

she was asking her questions. So now that I have introduced your 

druthers to the committee, I yield back. 

Ms. GIBSON. Thank you. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. The chair recognizes the gentleman from New Mexico, 

Mr. Luja ́n for 5 minutes for questions, please. 

Mr. LUJA ́ N. Thank you, Mr. Chairman. Ms. Gibson, thank you so 

much for joining us today. According to the CDC, in 2013 providers 

wrote almost 250 million opioid prescriptions in the U.S. Enough 

for every American adult to have their own bottle of pills. 

Can you briefly explain how the high volume of opioids prescribed in the U.S. contributes to the misuse of prescription drugs? 

Ms. GIBSON. Sir, I appreciate your question. And from what I am 

experiencing and what I am learning here, regarding prescription 

of pills, we have a lot of doctors out there that do God’s work. They 

52 

do the right thing. But we have some people out there that have 

overprescribed. And it is incumbent upon DEA to make sure that 

we get the education out there and maybe provide guidance and 

correct some behavior, and go after the people that are stockpiling 

currency at their house because they are writing too many prescriptions, and they are doing nefarious things. And that is actually 

happening. So that is my concern, are those doctors. And I want 

to make sure I get the education out there to streamline prescriptions. 

Mr. LUJA ́ N. And so I think what you are referring to, Ms. Gibson, 

is that the DEA recently started asking if new or renewal of registrants for a DEA license have received training on safety prescribing, prescription drugs. 

Can you explain why the DEA took the action, and how the DEA 

will utilize data on prescriber opioid training? 

Ms. GIBSON. We did it on a voluntary basis right now, so any 

registrant that renews the registration or its initial application for 

registration, they voluntarily check a box to let us know that they 

received CME, continuing medical education. Again, we have a 

great website. I have got 1.7 million registrants. And the best way 

of me communicating with them is through that website so, and 

that is what I am intending to do. 

Mr. LUJA ́ N. So in the future, will the DEA increase supplement 

prescriber training on the dangers of opioid and safe prescribing 

practices for opioid medications? 

Ms. GIBSON. Absolutely, sir. 

Mr. LUJA ́ N. I appreciate your testimony in that space, Ms. Gibson. One thing I wanted to, I think, just bring up to the committee: 

Ms. Gibson, how long has this opioid crisis been affecting America? 

Ms. GIBSON. Sir, way too long. 

Mr. LUJA ́ N. Do you know when it started? 

Ms. GIBSON. According to another physician that was here, he 

has been a physician for 25 years, and he saw it. So I think prescribing of opioids have happened well before we actually recognized it as an epidemic. 

Mr. LUJA ́ N. Would it surprise you if I said that the opioid epidemic has been affecting America since before we were a country? 

Ms. GIBSON. It wouldn’t surprise me because I believe that methadone was actually a World War II development, if I remember correctly. 

Mr. LUJA ́ N. Well, let’s go back to the 1800s, at the very least. So 

as we talk about the 19th century. The reason I bring this up—and 

I am going to ask an article be submitted into the record—— 

[The information appears at the conclusion of the hearing.] 

Mr. LUJA ́ N. Is just so that we don’t lose sight that this problem 

is at least a couple hundred years old, if not over 300 years old, 

from where we are today, and what I hope that we realize is that 

while we are talking now about pills, that some of these drugs and 

strains that have hit the streets, these were developed by companies to deal with opioid addiction. They say, you are addicted to an 

opioid, so we are going to come up with another opioid to treat that 

opioid addiction, and we are going to warn about this one to treat 

that one. 

53 

And so the reason I ask that question, and I see some giggling 

in the audience, which alarms me, this is a serious epidemic, I 

think earlier someone said this was maybe 8 to 10 years old. People have been getting killed in all parts of America for too long. 

And I know that in my district, we have had problems in this space 

that whether they are prescription drugs or heroin, as we have 

seen grow across the America. 

I am real interested in going after all parts of the problem that 

we see. I think earlier you said that you never give up, ‘‘we never 

give up at the DEA.’’ Are there current investigations pending with 

companies that were recently fined to see if they have corrected 

their behavior about distributing large amounts of pills in our communities? 

Ms. GIBSON. Yes, sir. 

Mr. LUJA ́ N. I believe that Mr. McKinley joined our chairman and 

our ranking member of this committee to inquire about some of 

these questions to these manufacturers and distributors, and it is 

something that we need to get to the bottom of, and that we look 

forward to working with you. 

And with that, Mr. Chairman, I would like to submit two articles 

into the record, one titled, The Opioid Epidemic, a Crisis Years in 

the Making, from the New York Times, October 26th, 2017, and 

from Smithsonian.com, inside the story of America’s 19th Century 

opioid addiction. 

Mr. BURGESS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. LUJA ́ N. Thank you, Mr. Chairman. 

Mr. BURGESS. The gentleman’s time is expired. The gentleman 

yields back. The chair recognizes the lady from Indiana, Mrs. 

Brooks. 5 minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman, and thank you so 

much, Ms. Gibson, for being here. 

I have worked with the DEA. I was U.S. attorney in the southern 

district of Indiana from 2001 to 2007, worked very, very closely 

with the DEA during that time. Not only prosecuting large drug 

trafficking organizations and know the incredible dedication that 

agents have, but also worked with Diversion at that time, because 

we did a very significant case involving significant diversion of 

OxyContin by a physician. 

And so I know that DEA has been involved in the prescription, 

then-heroin problem for a long time, to my colleagues on both sides 

of the aisle. But what I think has changed over time is that we now 

know, because of the incredible epidemic, I think in large part 

fueled by far too many people being on opioids as a prescription initially, and I think the research has shown that, that about 80 percent or so, started with prescription drugs, moved to heroin, moved 

to fentanyl, and that is where our overdose deaths are. 

But I think we do have a lot of prescribers, not just physicians 

but nurse practitioners, dentists, podiatrists, lots of others that 

maybe have not had sufficient medical education or continuing 

medical education. 

And so in the spirit, in some ways, of Representative Schneider’s 

bill, I have been working on a bill as well, but in a bit different 

format, because you mentioned there has to be that interaction, 

54 

DEA—and I was looking at your Diversion website—between the 

States and the Federal Government on regulation and on licensing. 

Can you please talk with us about how DEA, DEA for anyone to 

be a prescriber, they have to get what is called the magical DEA 

number. Is that correct? 

Ms. GIBSON. Yes, ma’am. 

Mrs. BROOKS. And that is what it is called, isn’t it? 

Ms. GIBSON. Yes, the DEA registration number. 

Mrs. BROOKS. The DEA registration number. And am I missing 

categories of prescribers, besides physicians? We all know physicians. But who is eligible to get a DEA number? 

Ms. GIBSON. As far as prescribers? 

Mrs. BROOKS. Yes. 

Ms. GIBSON. Well, right now anyone that dispenses, that can 

write a prescription, needs a DEA number. Since I have been there 

at Diversion, I have definitely been made aware of data-waived 

prescribers, and that is for drug treatment. 

Mrs. BROOKS. And how long have you been there, in Diversion? 

I know you have been an agent in the field for a long time. 

Ms. GIBSON. A month and a half, ma’am. 

Mrs. BROOKS. OK. Well, welcome. 

Ms. GIBSON. Thank you. 

Mrs. BROOKS [continuing]. To leading the effort, because I really 

do believe you are and need to be the person leading the effort for 

DEA because we have to do a lot of things differently than what 

we have been doing. 

What we have been doing isn’t working. We haven’t turned the 

corner yet. We are not just at the tipping point. We are beyond the 

tipping point. We are losing far too many people. I attended a funeral of a family friend in December, far too many funerals last 

year. And we have not changed it. 

And yet, I know that our prescribers do not want to be a part 

of the problem, but I think we need more education. And I think 

in Indiana, our State medical association, as well as a number of 

the groups we have talked to are willing and want to be a part of 

the problem and get more education. And in fact, have done it in 

Indiana. Some States do. Some States don’t. 

And what I am asking is whether or not what we are working 

on is 3 hours of continuing medical education over the period which 

is every 3 years, is that correct? Do you know? 

Ms. GIBSON. According to your bill, I think it was 3 hours every 

3 years. 

Mrs. BROOKS. Correct. And that the States would then have jurisdiction over determining what is the appropriate training. And 

how do you feel about that? That the State medical associations 

and the State medical licensing boards would be the ones that 

would be in charge of working, of course, and looking for the best 

practices of training from HHS? 

Ms. GIBSON. Ma’am, we rely on our State counterparts. We need 

them. Hands down, we need them. 

Mrs. BROOKS. Well, in fact a prescriber can’t get a DEA license 

unless they show they have a valid medical—— 

Ms. GIBSON. Yes. 

Mrs. BROOKS [continuing]. Or a valid license—— 

55 

Ms. GIBSON. Yes. 

Mrs. BROOKS [continuing]. In the State, is that correct. 

Ms. GIBSON. Yes. And oftentimes we work with the States regarding, if a State can easily take away a registration, then if they 

don’t have that State registration, we are able to revoke their Federal registration. 

Mrs. BROOKS. Is there enough coordination between all 50 States 

and DEA, or are there some problem States? I won’t ask you to 

name them. 

Ms. GIBSON. I have to say, again, I am proud of Diversion investigators because they’re imbedded in these communities, and they 

all work closely with their States regarding those issues. So I 

haven’t heard of any issues, but obviously, if there are, I will make 

sure that they are addressed. 

Mrs. BROOKS. I have a number of other questions but will submit 

in writing. Thank you so much for your efforts. 

Ms. GIBSON. Thank you. 

Mr. BURGESS. The chair thanks the gentlelady. 

Mrs. BROOKS. I yield back. 

Mr. BURGESS. The gentlelady yields back. The chair recognizes 

the gentleman from North Carolina, Mr. Hudson. 5 minutes for 

questions, please. 

Mr. HUDSON. Thank you, Mr. Chairman. Ms. Gibson, thank you 

for being here today. 

As you know, the opioid epidemic is arguably one of the worst 

public health crises we have ever faced in this country. In North 

Carolina, we have 4 of the top 25 worst cities for abuse in the country, including Fayetteville, North Carolina, in my district. I don’t 

believe there is one silver-bullet solution, but I have homed in one 

area that I do believe we can make a big difference, and that is 

the proper disposal of opioids. 

As I examined disposal, I have found that almost every one I 

talked to back home, a light bulb goes off when we start talking 

about it, and they say, I have a bottle of pills in my medicine cabinet. I talked to one woman who for 5 years moved her bottle of 

opioids with her as she moved from apartment to apartment. 

And just a few statistics to provide: There are as many as 200 

million opioids prescriptions written each year. As many as 92 percent of patients don’t complete that. In other words, have pills left 

over. Less than 10 percent of those folks properly dispose of them. 

So we are talking about a huge amount. And according to the National Institutes of Drug Abuse, 70 percent of heroin addictions 

start by a product found in a home medicine cabinet. 

I went on the DEA website last night, and the recommendations 

for disposal of unused medications, including DEA take-back programs—which I participated in—flush them down the toilet, mix 

them up with something undesirable, such as kitty litter or coffee 

grounds or dirt in a resealable bag and throw them in the trash. 

These are recommendations updated as of October 25 of 2017. 

Given all the statistics I have just listed and the scope of the 

opioid epidemic we are facing, do you think these recommendations 

are effective? Just yes or no. 

Ms. GIBSON. Yes. 

56 

Mr. HUDSON. OK. And then would you agree that we might, 

though, need to explore some new ways to help patients dispose of 

unused prescription drugs, in particular opioids? 

Ms. GIBSON. Absolutely. 

Mr. HUDSON. Great. Would you be willing to work with me on 

some solutions we have been working on and taking a look at to 

try to bring more options for consumers? 

Ms. GIBSON. Absolutely. 

Mr. HUDSON. Great. Well, I appreciate your testimony and your 

time here today, and look forward to working with you on this. 

Ms. GIBSON. Thank you. 

Mr. HUDSON. OK. And with that, Mr. Chairman, I will yield 

back. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. The Chair recognizes the gentleman from Virginia, Mr. 

Griffith, for 5 minutes for questions, please. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate it very 

much. I appreciate you being here with us today. 

So I have heard a lot of comments from my colleagues on both 

sides of the aisle about concerns about doing research with different—and I don’t know what the right word is—but when you 

change the formula a little bit on fentanyl, and they are concerned 

about, we don’t want this stuff on the street, but what about research because it may be helpful, the drug might, if you change it 

a little bit, it might actually have some positive impacts. And you 

responded that you have 600 folks working on THC and 

cannabidiol. 

My concern is, and I think probably where this concern has come 

from other folks is, is that this has been a long standing complaint 

with the DEA on substances that are either unscheduled or Schedule I, such as marijuana. You mentioned THC and cannabidiol. Virginia had the first medical marijuana law in the United States 

passed in 1979 by former Congressman Rick Boucher when he was 

in the State Senate, and member of the House of Delegates, the 

late Chip Woodrum. 

And from 1979 to 1998, there wasn’t a whole lot going on, because in 1998, somebody tried to take that law off the books. That 

is when I got involved in this issue. And what we heard at that 

time in Virginia was, yes, they say they are doing research at the 

DEA, but we have a hard time getting approval. 

And I note with some interest that in our next panel, we have 

a witness, Dr.Beardsley, who in his written testimony, tells us that 

in one instance, it took over 4 months to get cannabidiol added to 

my Schedule I registration. And this drug has no abuse potential 

and no street value, so I think it is pretty much accurate. 

So I want to work with you to get the language right. I don’t 

want this stuff on the street. But I also want to make sure that 

we don’t have a repeat of the past, and then once it gets put into 

a Schedule I or Schedule A, as the Katko bill would have it do, that 

we not just immediately take all those substances off the table for 

research. Because if we don’t continue to look at all the possibilities 

for all kinds of treatments, we may not know what we are missing, 

and we may have some value in that. 

57 

Will you agree to work with me on that and others to get this 

language right so that we can do the research while trying to give 

you the power to get the nasty stuff off of the streets that we don’t 

want our kids using, but knowing that sometimes a little poison 

can be a medicine? 

Ms. GIBSON. Sir, I appreciate your concern about research, and 

it is my concern, too. And I will be more than happy to work with 

you regarding research. If we can streamline the process, if we can 

get the right people to do—— 

Mr. GRIFFITH. What I want is not just the research. I want your 

folks and your legal team to help our legal team come up with language that allows us to do both. To make it improper to have it 

on the streets, but still to allow our research universities and our 

folks and our doctors and our medical community who are doing research, to look for those miracle cures, even if one of those may 

have some component that is a fentanyl derivative. 

Ms. GIBSON. Sir, I will be more than happy to work with you. 

Mr. GRIFFITH. On getting that language down? 

Ms. GIBSON. Yes, sir. 

Mr. GRIFFITH. Excellent. Thank you. 

Also, Mr. Beardsley’s written testimony mentions a policy change 

made a few years ago that now requires a researcher to have a separate control substance registrations for each building that they 

conduct research in. 

So he goes through a system, and he says, I used to have one 

person who could be in charge of it, now I have to have 20 people. 

And some of those people have to have four different registrations 

because they work in four different buildings. And he is at MCV, 

Medical College in Virginia, VCUs medical school. And it is in 

downtown Richmond, and they do stuff in lots of different buildings, four for research, apparently. 

I am just wondering why that policy change was made and if we 

couldn’t change it back? 

Ms. GIBSON. Sir, again—— 

Mr. GRIFFITH. You have been here a month-and-a-half and you 

don’t know the answer to that one. Can you research that and get 

it for me? 

Ms. GIBSON. But I want to find the answer for you. 

Mr. GRIFFITH. Yes, ma’am. 

Ms. GIBSON. I am sitting here and I want to find the answer for 

you. And I definitely want to work with you regarding this, because 

I believe research is very important. 

Mr. GRIFFITH. Yes. And I understand that. That is a reasonable 

answer in light of the fact you have been there 6 weeks. 

Have you all released any updated regulations or guidance to 

pharmacists or other healthcare professionals and/or patients regarding the implementation of Section 702 of CARA, which allows 

prescribers and patients to request a partial fill of Schedule II control substances. And if yes, where can that information be found. 

And if not, why? 

Ms. GIBSON. Sir, I believe that is still in my regulations department, still being drafted. And we are trying to get that language 

right, but is it definitely part of the CARA bill, and we are definitely working on it. 

58 

Mr. GRIFFITH. Well, and I would hope that, and I appreciate that 

you all worked hard to get the fentanyls rescheduled or scheduled 

in 2 months, but this would cut down on supply out there on the 

street and would really appreciate if your department that handles 

that could get that done expeditiously. 

With that, I have to yield back because my time is up and I 

thank you much. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. The chair recognizes the gentleman from Georgia, Mr. 

Carter, 5 minutes for questions, please. 

Mr. CARTER. Thank you, Mr. Chairman. Thank you, Ms. Gibson, 

for being here. I appreciate it very much. We talked earlier today, 

you had a question from another member about a bill that I am 

cosponsoring along with one of my Democratic colleagues, the Special Registration For Telemedicine Clarification Act of 2018. 

And you mentioned that it is available now that through telemedicine you can get a waiver in order to write a prescription for 

an opioid for pain medication without seeing the patient but seeing 

them through telehealth. Is that right? 

Ms. GIBSON. It is not a special waiver, from what I understand. 

Telemedicine under the Ryan Haight Act—— 

Mr. CARTER. Right. 

Ms. GIBSON [continuing]. Has been outlined as far as there are 

certain situations that you can follow and you can engage in telemedicine. 

Mr. CARTER. But the Ryan Haight Act limits that. Nevertheless, 

the intent of this bill that we are cosponsoring, Representative 

Bustos and myself, is to allow or to direct the agency to come up 

with and to promulgate the rules so that we can do this, so that 

it can happen. Because this is extremely important, particularly in 

rural areas where telemedicine is vital, and particularly for patients who need that pain medication who may not have access to 

a professional at that time. 

Ms. GIBSON. I agree that telemedicine is definitely needed. But, 

again, when I put my regulatory hat on and my main concern is 

diversion. 

Mr. CARTER. I understand. Do you feel like this is something that 

you can do? Because what we say in this legislation is to direct the 

agency to come up to DEA to promulgate the rules within 30 days 

of the passage of the law. 

Ms. GIBSON. I understand. 

Mr. CARTER. OK. Well, I just want to make sure. And certainly, 

we are concerned about the fraudulent use of it as well. So another 

bill that I am cosponsoring, again, along with one of my Democrat 

colleagues Representative Mark DeSaulnier, is Empowering Pharmacists in the Fight Against Opioid Abuse Act. And that, of course, 

is for the DEA to help pharmacists to identify fraudulent prescriptions. And that is something that is very important. For your information, currently I am the only pharmacist serving in Congress. I 

practiced for over 30 years. And I have to tell you that this is something we do need help with, and we welcome this help. We want 

to have the ability to identify fraudulent prescriptions. 

However, you have to keep in mind that we are not law enforcement officers. The only thing worse, I think, for myself as a pracVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
59 

ticing pharmacist, the only thing worse than dispensing medication 

that would be opioids, in particular, that would be for abuse and 

for diversion, would have been to deny a prescription to a person 

who truly needed it. That is very difficult. 

I don’t want to have to profile. It is unfair for you to expect me 

to have a patient come in and for me to make a decision by looking 

at that patient and saying that they don’t look like they need this, 

that I am supposed to keep them from having it. That is simply 

not right. And something that I am not trained in. So I hope you 

will keep that in mind during the time that you are looking at it. 

Another thing I wanted to touch on was what we did in CARA, 

the Comprehensive Addiction Recovery Act, to allow 3 prescriptions 

for a 30-day supply to be written. One of the things that has been 

suggested, and it was just mentioned, was the fact that possibly allowing physicians to have a refill on a prescription, in a smaller 

amount. 

All of us in pharmacy have experienced getting a prescription for 

simply a dental procedure for 30 oxycodone. And that is something 

we hate to see. 

So I hope that the Department will look at possibly allowing for 

a smaller quantity with perhaps just one refill that has to be filled 

within a certain time period. That is something that I had hope 

you will look at as well. 

Mr. CARTER. One of the things that concerns me is—look, there 

are rogue practitioners in every profession, every profession, including the medical profession, and practitioners. And one of the things 

that concerns me is that I have never had a doctor who said: I 

didn’t know opioids were addictive. 

Physicians are smart people. They are intelligent people. They 

have gone through intensive training. They understand it. They do 

need to have continuing education with it. 

But it does concern me, and it concerns me how long it takes for 

the DEA to respond to some of these rogue doctors. Sometime I 

hope you will look at that. 

The last think I wanted to touch on is, when I was a member 

of the Georgia State legislature, every year, we have a dangerous 

drug act, and we include drugs into the Schedule I classifications 

in our State. I did that on numerous occasions. It is very difficult. 

It is going to be very difficult with you with the synthetic drugs. 

I know how they get around it. 

I just want to ask you. After it becomes a Schedule I drug, a 

state can’t overrule you and say that that could be legal, can they? 

You know where I am going. 

Ms. GIBSON. I know where you are going. 

Mr. CARTER. OK. Yes or no. 

Ms. GIBSON. And if Federal law identifies a substance to be 

Schedule I, it is Schedule I. 

Mr. CARTER. Can I ask you one question? 

Ms. GIBSON. Yes, sir. 

Mr. CARTER. What is marijuana? 

Ms. GIBSON. Schedule I. 

Mr. CARTER. Thank you very much. 

Mr. Chairman, I yield. 

60 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. 

The chair recognizes the gentleman from Kentucky, Mr. Guthrie, 

the vice chairman of the subcommittee. You are recognized for 5 

minutes for questions. 

Mr. GUTHRIE. Thank you for being here today. In your testimony, 

you mentioned AlphaBay, a criminal marketplace website operated 

for over 2 years. I understand it took a lot of national and even 

international resources to take them down. 

Can you please tell me if there is now a timely process in place 

should another AlphaBay surface again? 

Ms. GIBSON. Sir, I appreciate your questioning because these 

cases are difficult. These cases are labor intensive to include diversion cases. Going after physicians, it is incumbent that we use 

every tool in our toolbox to go after them, to include working with 

our state. So, yes, they are labor intensive, but we get it done, and 

that is why I am proud of the DEA, because no matter what the 

task is in front of us, we figure it out, how to do it, and we get 

it done. 

Mr. GUTHRIE. I understand that, and I agree. But if there is 

something unique like website—this new website that came on 

board, you went through a 2-year process, and you did, there had 

to be lessons learned, to say, well, this is something that we could 

have done differently, done better that would have sped up the 

process again or sped up the process, and hopefully that is more 

adopted into plans? 

Ms. GIBSON. Sir, I am a fairly aggressive human being, and I believe that we learn from anything that we do, and we make it better. And that being said, anything that we can improve upon to get 

these bad actors out there in handcuffs, I am all for. Anybody who 

violates the CSA intentionally, they will be in handcuffs, if it is up 

to me. 

If it is a distributor and if I have a criminal case that I can make 

against them, they will be in handcuffs, I promise you. 

Mr. GUTHRIE. Thank you, I appreciate that. And also, yesterday, 

Attorney General Sessions announced the formation of the new 

Prescription Interdiction & Litigation Task Force at DOJ. I was 

very pleased to hear about this. And can you please speak to the 

DEA’s role in this task force and how the DOJ task force will work 

with the DEA Special Operations Division on heroin/fentanyl task 

force. 

Ms. GIBSON. Sir, I appreciate your question, and that is a new 

endeavor. And we are working with our counterparts at the Department of Justice right now to understand our role. So I would 

have to get back with you regarding your answer. 

Mr. GUTHRIE. OK. Thank you. 

Also, I know several people, Ms. DeGette and Mr. Hudson and 

others, have mentioned the National Drug Take Back Initiative. I 

think several of us have asked about that. It has been effective, but 

we can do more. I know that Mr. Walberg, who is probably going 

to go in a couple of minutes, has a bill addressing unused opioid 

disposal for hospice. I won’t get into his area, but I know he is 

going to talk about that. 

61 

But would you just kind of speak to safe disposal and what options do we have, and what you would like to see Congress do in 

that respect? 

Ms. GIBSON. Sir, I appreciate that concern because it is a concern 

of mine, because once we can get these drugs off the street in the 

prescription pill form, we have to make sure that they are not diverted again. So that requires guidelines. That requires policy. And 

we would be more than happy to work with any entity out there 

to come up with a game plan so that when we get those pills off 

the street and we can get them into a safe location and they remain in custody to be disposed of, that is our ultimate goal. 

Mr. GUTHRIE. OK. Thank you. And that finishes my questions. 

I yield back a minute 26. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. I think we have accommodated all the members of the 

subcommittee, and I am now pleased to recognize Mr. Walberg, 

who is a member of the full committee, 5 minutes for your questions. 

Mr. WALBERG. I thank the chairman for your hospitality and allowing me to sit with this panel today. 

And, Ms. Gibson, thank you for the work that you do, and thank 

you for being here. 

In Mr. Mulder’s testimony to come, it expresses support for H.R. 

5041, a bill that I have sponsored along with a couple of other 

members of our committee. He expressed the support of it being expanded to authorize hospice personnel to dispose of unused medication when a living patient undergoes a medication change. Would 

the DEA have concerns with that proposal? 

Ms. GIBSON. Sir, we definitely want to work with you and the 

committee to make sure that we get the language right and we get 

the process right, because we want to make sure that we get those 

drugs into the hands of an entity that can secure them and prevent 

them from being diverted. 

Mr. WALBERG. Well, I think that would be the concern of the hospice personnel as well at this point, plus making sure that there 

isn’t a temptation by leaving those in the medicine cabinets or— 

we look forward to working on that. 

Would the DEA be supportive of language being included in the 

bill to add additional reporting requirements? For example, a notation on the patient’s record that state the date the medication was 

destroyed, the dosage, and who destroyed the medication, could 

that alleviate concerns? 

Ms. GIBSON. That is definitely language that we can talk about 

and add. Absolutely, it would be a mechanism that would we could 

use. 

Mr. WALBERG. Thank you. I won’t wear out my welcome. Those 

were two questions I had. I yield back. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. I believe that has accommodated everyone who had 

questions. 

Mr. Green, do you have a followup? 

Mr. GREEN. No. 

Mr. BURGESS. Neither do I. We are going to take the briefest of 

recesses while we transition the panel. 

62 

Ms. Gibson, I want to thank you for your participation today. I 

expect we will have an opportunity to talk about all of these things 

in more detail as your tenure in the agency increases. So thank you 

for being here today. 

Ms. GIBSON. I look forward to it. Thank you. 

[Recess.] 

Mr. BURGESS. I think we have almost successfully transitioned. 

We still have a couple of vacant chairs. There we go. Well, I think 

we have transitioned to our second panel today, and we want to 

thank our witnesses for being here and taking the time to testify 

before the subcommittee. 

Once again, each witness will have the opportunity to give an 

opening statement, and that will be followed by rounds of questions 

from members. So, today, this afternoon, in the second panel, we 

are going to hear from Mr. Frank Fowler, Chief of Police, Syracuse 

Police Department; Dr. Patrick Beardsley, Professor, Department 

of Pharmacology and Toxicology, Virginia Commonwealth University; Dr. John Mulder—I have got you out of order—Dr. Mulder, 

John Mulder, Director, Trillium Institute; Dr. Ponni Subbiah, Chief 

Medical Officer, Indivior; Dr. David Kan, President, California Society of Addiction Medicine; Richard Nance, Director, Utah County 

Department of Drug and Alcohol Prevention and Treatment; Thomas Cosgrove, Partner, Covington and Burling, LLP; Dr. Andrew 

Kolodny, Codirector, Opioid Policy Research, Brandeis University; 

and Richard Logan, owner of L&S Pharmacy. 

We appreciate each of you being here today and, again, are 

grateful for your forbearance in what has been a long afternoon. 

Chief Fowler, you are recognized for 5 minutes to give a summary 

of your opening statement. 

And, chief, make sure your microphone is on. 

STATEMENTS OF FRANK L. FOWLER, CHIEF OF POLICE, SYRACUSE POLICE DEPARTMENT; PATRICK M. BEARDSLEY, PH.D., 

PROFESSOR, DEPARTMENT OF PHARMACOLOGY AND TOXICOLOGY, VIRGINIA COMMONWEALTH UNIVERSITY; JOHN 

MULDER, M.D., FAAHPM, HMDC, DIRECTOR, TRILLIUM INSTITUTE; PONNI SUBBIAH, M.D., CHIEF MEDICAL OFFICER, 

INDIVIOR PLC; DAVID Y. KAN, M.D., PRESIDENT, CALIFORNIA 

SOCIETY OF ADDICTION MEDICINE; RICHARD J. NANCE, 

LCSW, DIRECTOR, UTAH COUNTY DEPARTMENT OF DRUG 

AND ALCOHOL PREVENTION AND TREATMENT; THOMAS J. 

COSGROVE, PARTNER, COVINGTON AND BURLING LLP; ANDREW KOLODNY, M.D., CODIRECTOR, OPIOID POLICY RESEARCH, BRANDEIS UNIVERSITY; AND RICHARD N. LOGAN, 

JR., PHARM.D., OWNER, L&S PHARMACY. 

STATEMENT OF FRANK L. FOWLER 

Chief FOWLER. Thank you. Thank you, Chairman Burgess, Ranking Member Green, and the distinguished members of the Committee on Energy and Commerce. I am here today to make an effort to paint a picture of a community that has been ravaged by 

synthetic drug abuse. Beginning in 2013, the Syracuse Police Department responded to an increase in the use and subsequent overdose of synthetic marijuana known as Spike. The Syracuse Police 

63 

Department implemented various means of tracking the problem in 

addition to our law enforcement efforts. 

In 2015, the Syracuse Police Department saw its largest number 

of overdoses from the use of synthetic marijuana, the largest number of overall cause for services related to overall overdoses and 

persons down, and also made the largest number of arrests related 

to this substance. While the department took steps to get these 

drugs off the streets, new chemical formations of Spike were beginning to be put into circulation. 

In addition to all of the Syracuse Police Department’s efforts, the 

only thing that we could charge a person with was a local law violation, issuing them an appearance ticket and releasing them. This 

is just one example of the dangerous synthetic compounds that are 

flooding our streets. Toxic synthetic drugs are designed to mimic 

drugs like marijuana, LSD, cocaine, ecstasy, and other hard drugs. 

They could be more potent than the real thing, and oftentimes are 

more deadly. 

In addition, these drugs are not simply affecting the users, my 

officers and other first responders are put in harm’s way simply by 

coming in contact with these often lethal substances. 

As a local law enforcement official, we need H.R. 2851, the 

SITSA Act, which was introduced by Congressman Katko. This bill 

takes a big step towards eradicating these harmful substances and 

protecting our community. SITSA will give my officers the tools 

they need to target synthetic substance and the criminals who distribute and traffic them. 

Under this bill, a drug such as Spike could be temporarily or permanently added to the new schedule under the Controlled Substances Act in as little as 30 days after the chemical compound has 

been identified. The abusers of these synthetic drugs are not simply confined to my jurisdiction. Colleagues of mine from across the 

country are dealing with the same issues and have expressed a 

need for a solution. H.R. 2851 is that solution. 

I urge this committee to pass this bill and to give us the tools 

we need to combat this deadly epidemic. Thank you again for this 

opportunity and I welcome your questions. 

[The prepared statement of Chief Fowler follows:] 

64 


30411.016

Testimony 

Chief Frank Fowler 

Committee on Energy and Commerce 

2/28/2018 

Thank you Chairman Walden, Ranking Member Pallone, and 

distinguished Members ofthe Committee on Energy and Commerce. 

am here today to paint you a picture of community that has been 

ravaged by synthetic drug abuse. Beginning in 2013, the Syracuse 

Police Department (SPD) responded to an increase in the use and 

subsequent overdoses of synthetic marijuana (spike). SPD 

implemented various means of tracking the problem in addition to the 

police enforcement efforts. In 2015, Syracuse saw the largest number 

of overdoses from use of synthetic marijuana; the largest number of 

overall calls for service, calls for service related to overall overdoses 

and persons down; and also made the largest number of arrests related 

to this substance. While the department took steps to get these drugs 

off the street, new chemical formulations of "spike" were being put in 
65 


30411.017

circulation. In addition, all the SPD could do to someone selling this 

dangerous drug was to give them an appearance ticket for local law 

violation. 

This is just one example of the dangerous synthetic compounds 

that are flooding our streets. Toxic, synthetic drugs are designed to 

mimic street drugs like marijuana, LSD, cocaine, ecstasy and other hard 

drugs. They can be more potent than the real thing and often times are 

more deadly. In addition, these drugs are not simply effecting the 

users. My officers and other first responders are put in harm's way 

simply by coming in contact with these often lethal substances. As a 

local law enforcement official, we need H.R. 2851, the SITSA Act, 

introduced by Congressman John Katko. This bill takes a big step 

towards eradicating these harmful substances and protecting our 

communities. 

SITSA will give my officers the tools they need to target synthetic 

substances and the criminals who distribute and traffic them. Under 

this bill, a drug such as "spike" could be temporarily or permanently 
66 


30411.018

added to a new schedule under the Controlled Substances Act in as 

little as 30 days after the chemical compound has been identified. 

The abuses of synthetic drugs are not simply confined to my 

jurisdiction. Colleagues of mine from across the country are dealing 

with the same issues and have expressed the need for a solution. H.R. 

2851 is that solution. I urge this committee to pass this bill and give us 

the tools we need to combat this deadly epidemic. 

Thank you again for the opportunity be here] I welcome your 

questions. 
67 

Mr. BURGESS. Thank you, Chief Fowler. 

Dr. Beardsley, you are recognized for 5 minutes, please. 

STATEMENT OF PATRICK M. BEARDSLEY, PH.D. 

Mr. BEARDSLEY. I am Dr. Patrick Beardsley, a professor of pharmacology and toxicology at the Virginia Commonwealth University. 

In addition to my faculty appointment, I am a member of the Expert Committee on Drug Dependence for the World Health Organization, a committee that is the first step for processing drugs for 

their international control. 

Thank you for the opportunity to be here today to discuss SITSA, 

H.R. 2851. We are all dedicated to finding paths to take us away 

from our present opioid crisis. I believe one path will be through 

research. There is a perpetual need to strike a balance between 

regulatory control of drugs to ensure public safely and the necessity 

for researchers to have access to controlled drugs to further science. 

The Controlled Substances Act, the CSA, explicitly recognizes 

both those needs, and I am personally sympathetic to both needs. 

As a researcher of the drugs of abuse, however, I have concerns 

that SITSA upsets that balance. I would like to take the next few 

minutes of your time to identify my concerns. 

It is my opinion that the Attorney General has already been able 

to effectively regulate all synthetic opioids that are known to be a 

current problem via the present CSA. Effective February 6 of this 

month, the DEA issued a scheduling order that included all 

fentanyl-related substances that are not currently scheduled to be 

included in Schedule I. 

Fentanyls constitute the greatest portion of all synthetic opioids 

abused. A few non-fentanyl synthetic opioids that have been identified as abused have previously been scheduled. Because most, if not 

all, currently abused synthetic opioids are currently scheduled 

under the CSA, it is unclear of the introduction of Schedule A by 

SITSA to help address the current problems with abused synthetic 

opioids. 

Considering 13 fentanyls are exclusively identified in SITSA to 

be included in Schedule A, it is likely all will eventually be transferred. How public health would be enhanced transferring these 

compounds from Schedule I to Schedule A conditions is also unclear. The addition of another category of drugs by SITSA to the 

CSA is problematic. In so doing, it adds another level of costly bureaucracy to researchers who work with drugs of abuse. 

Registrants with only a Schedule II to V registration will have 

to obtain a Schedule A registration. All registrants, whether they 

hold a Schedule I or a Schedule A registration, will have to submit 

protocols to the Attorney General for his approval to justify the use 

of each drug in Schedule A. Functionally, this arrangement is very 

similar to how research with Schedule I drugs are now handled. It 

can take a year or longer to obtain a Schedule I registration, and 

it can require many months to have a new drug added to one’s existing Schedule I registration. With similar delays that are now impeding research with Schedule I drugs transferred to Schedule A 

drugs, SITSA will provide nothing to the research that will has 

hasten our understanding of synthetic opioids through science and 

will likely only impede that progress. This problem is compounded 

68 

by an absence of a mechanism in SITSA for removing a drug from 

Schedule A once it is scheduled. 

Under SITSA, the Attorney General has the power to place a 

compound in Schedule A based upon a drug structure. And in the 

absence of additional scientific information, commonly provided by 

HHS and NIDA, the National Institute of Drug Abuse, this can result in misclassifications of drugs and missed opportunities for discovering medications we need to confront the opioid crisis with. 

Determining scheduling driven by chemical structure can be misleading. For example, the chemical structures of morphine and 

naloxone are very similar, yet one is highly abused and the other 

is an antagonist that is an antidote to the effects of the other. Adding a compound just based upon structural similarity to an abused 

compound may inadvertently ban an antidote to the abused compound. 

In addition to my concerns regarding SITSA, I do have suggestions that would make conducting research with synthetic opioids 

and controlled substances in general more efficient, far less costly, 

and bring much relief from the bureaucratic burden of conducting 

research with them. My statement time doesn’t permit me to enumerate them, but my suggestions can be found in my written statement, and I would be happy to discuss them later, if asked. 

I have tried to identify a few concerns I have with SITSA as a 

researcher, and I welcome any questions you may have. Thank you. 

[The prepared statement of Mr. Beardsley follows:] 

69 


30411.019

STATEMENT 

OF 

PATRICK M. BEARDSLEY, PH.D. 

PROFESSOR, 

DEPARTMENT OF PHARMACOLOGY & TOXICOLOGY 

VIRGINIA COMMONWEALTH UNIVERSITY 

RICHMOND, VA 

BEFORE THE 

SUBCOMMITIEE ON HEALTH OF THE 

COMMITIEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

II 

"COMBATIING THE OPIOID CRISIS: 

HELPING COMMUNITIES BALANCE ENFORCEMENT AND PATIENT 

SAFETY" 

FEBRUARY 28, 2018 

1 
70 


30411.020

Mr. Chairman and Members of the Health Subcommittee, I am Dr. Patrick 

Beardsley, a professor of Pharmacology and Toxicology at the Virginia 

Commonwealth University. In addition to my faculty appointment, I am a 

member of the Expert Committee on Drug Dependence for the World Health 

Organization, a committee that is the first step for processing drugs for their 

international control. Thank you for the opportunity to be here today to discuss 

SITSA, H.R. 2851. 

We are all dedicated to finding paths to take us away from our present opioid 

crisis. I believe one path will be through research. There is a perpetual need to 

strike a balance between the regulatory control of drugs to insure public safety, 

and the necessity for researchers to have access to controlled drugs to further 

science. The Controlled Substances Act explicitly recognizes both those needs, 

and I am personally sympathetic to both needs. As a researcher of the drugs of 

abuse, however, I have concerns that SITSA upsets that balance. I would like to 

take the next few minutes of your time to identify my concerns. I would also like 

to end my statement by identifying a few ways that would enable research with 

synthetic opioids, and drugs of abuse more generally, to be more efficient, far 

2 
71 


30411.021

less costly, and bring much relief from the bureaucratic burden of conducting 

research with them. 

It is my opinion that the Attorney General has been able to effectively regulate 

all synthetic opioids that are known to be a current problem via the historical 

process identified by the Controlled Substances Act (the CSA). Effective February 

6, 2018, the DEA issued a scheduling order that included all fentanyl-related 

substances that are not currently scheduled, to be included in Schedule I. 

Fentanyls constitute the greatest portion of all synthetic opioids abused. The few 

non-fentanyl synthetic opioids that have been identified as abused in recent 

years have been previously included in Schedule I. Because most, if not all 

currently abused synthetic opioids are currently scheduled under the CSA, it is 

unclear how the introduction of Schedule A will help address the current 

problems with abused synthetic opioids. 

Regarding the fentanyls that have now all been included in Schedule I, it is 

unclear whether they will be transferred into Schedule A if SITSA is passed. 

Considering 13 fentanyls are explicitly identified in SITSA to be included in 

3 
72 


30411.022

Schedule A, this appears to be the likely outcome. How would public health be 

enhanced transferring these compounds from Schedule I conditions to Schedule 

A conditions? 

SITSA also adds yet another level of bureaucracy to researchers who work 

with drugs of abuse by the addition of yet another category of drugs, Schedule 

A, and the associated requirements in order to study them. SITSA indicates that a 

separate registration for engaging in research with a Schedule A substance shall 

not be required for researchers who hold Schedule I registrations. Registrants 

with only a schedule II-V registration will have to obtain a Schedule A 

registration. All registrants, whether they hold a Schedule I or a Schedule A 

registration, will have to submit protocols to the Attorney General for his 

approval to justify the use of each Schedule A substance. Functionally, this 

arrangement is very similar to how research with Schedule I drugs are now 

handled. It can take a year or longer to obtain a Schedule I registration, and it can 

require many months to have a new drug added to one's existing Schedule I 

registration. If similar delays that are now impeding research with Schedule I 

drugs transfer to Schedule A drugs, SITSA provides nothing to the researcher 

4 
73 


30411.023

that will hasten our understanding of synthetic opioids through science, and will 

likely only impede that progress. 

Under SITSA, the Attorney General also has the power to place a compound 

in Schedule A based only upon a drug's structure, and in the absence of 

pharmacological information commonly provided by HHS and NIDA. This can 

result in misclassifications of drugs and missed opportunities for discovering 

medications we need for confronting the opioid crisis. Determining scheduling 

solely by chemical structure can be misleading. For example, the chemical 

structures of morphine and naloxone are very similar, yet one is highly abused, 

and the other is an antagonist, that is an antidote, to the effects of the other. 

Banning a compound just based upon structural similarity to an abused 

compound may inadvertently ban an antidote to the abused compound. 

Injudicious scheduling could be particularly counter-productive in the 

discovery of treatments for over-dose. There have been numerous reports that 

overdose with some fentanyls can be refractive to the ability of naloxone to 

revive respiration often requiring multiple initial and subsequent naloxone 

treatments. Just as naloxone is a particularly effective antagonist to morphine's 

5 
74 


30411.024

effects, perhaps an antagonist based upon fentanyl's structure would be more 

effective than naloxone. Research directed at that possibility will be chilled if 

potential antagonists are preemptively classified in Schedule A as abused drugs 

just based on structure. This problem is compounded by an absence of a 

mechanism in SITSA for removing a drug from Schedule A once it is scheduled. 

Several ways would make conducting research with synthetic opioids, and 

controlled substances in general, more efficient, far less costly, and bring much 

relief from the bureaucratic burden of conducting research with them. 

Requiring only one registration per researcher would greatly facilitate the 

research process with Schedule I drugs. In my district, multiple DEA 

registrations are now required for a researcher if he conducts research in more 

than one laboratory if the laboratories are in different buildings. This 

requirement only became policy about five years ago, and before then only a 

single registration was required. I conduct controlled substance research in four 

buildings that are close to each other on my campus. I am required to have 

separate controlled substance registrations for each building. That means I am 

6 
75 


30411.025

required to have four Schedule I, four Schedule II-V, and four Commonwealth of 

Virginia controlled substance registrations. The bureaucratic burden of 

maintaining location-specific records for one set of registrations is challenging, 

for four it makes research untenable. 

Allowing one registrant to supply controlled substances to an entire unit 

would maximize efficiency, minimize costs, and still insure public safety. For 

decades prior to 2013, it had been permitted that one person, the chair of my 

department, was allowed to dispense controlled substances to other faculty 

within the department. Requirements changed in 2013 that required all faculty 

that conducted research with controlled substances to obtain their own sets of 

registrations. In my department that meant over 20 faculty now had to obtain 

their own registrations, and for anyone who had multiple laboratories in 

different buildings, it required that they individually obtain multiple sets of 

registrations. This change involved an enormous cost of time and money, and it 

is elusive how public safety had been enhanced by it. 

Clarifying the registration application process, and setting limits to the 

duration of an application's review would facilitate and encourage more research 

with the drugs of abuse. The process for applying for a registration can be 

7 
76 


30411.026

confusing. In my state, the Commonwealth of Virginia, an applicant is instructed 

that he or she needs a federal registration before applying for a state registration, 

but DEA instructions indicate a state registration is needed before applying for a 

federal registration. It's only by trial-and-error that one learns that a state 

registration is needed before applying for a federal registration to conduct 

research with Schedule II-V drugs, but a federal registration is needed before 

applying for a state registration to conduct research with Schedule I drugs. Once 

a proper federal application is submitted, it can take a year or longer to obtain an 

approved registration. This confusion in the application process, and the delay in 

obtaining an approved registration, inhibits researchers, especially younger 

researchers, from commencing research with the drugs of abuse and from 

dedicating careers to their study. If law dictated a reasonable and maximal 

amount of time provided the DEA for the review process, timelier drug abuse 

research would be conducted and more researchers would be conducting drug 

abuse research. 

Shortening the delay between application and approval for adding a new 

drug to an existing Schedule I registration would eliminate the most inhibiting 

factor associated with conducting research with Schedule I drugs. It can take 

8 
77 


30411.027

over four months to add a new compound to a Schedule I registration. A 

protocol has to be written and submitted detailing the dose and number of 

doses to be administered and the quantity of drug needed. Drug needs are often 

impossible for a researcher to estimate. For instance, I conduct what is called 

drug self-administration research in which laboratory animals are allowed to 

self-dose themselves with a test substance. This procedure is the major procedure 

for pre-clinically assessing the abuse potential of a drug, and for evaluating 

medications for treating drug abuse disorders. The researcher doesn't know 

beforehand if the laboratory subject will self-administer the test drug or not, that 

is the objective of the test procedure. Consequentially, the researcher finds it 

impossible to estimate drug needs, proving extremely difficult to prepare the 

needed protocol. After the application and protocol is submitted, months can go 

by before being approved to use the drug. In one instance, it took over four 

months to get cannabidiol added to my Schedule I registration, and this drug has 

no abuse potential and no street value. 

Being able to add an entire class of drugs to a Schedule I registration 

would greatly benefit timely research, and minimize the costs and the 

unnecessary bureaucratic burden associated with adding individual drugs. I 

9 
78 


30411.028

thought this was going to be the case when all fentanyls (except those previously 

scheduled) were added to Schedule I on February 6, 2018. However, when I went 

to apply to add that category to my Schedule I registration, I was instructed that 

if I wanted to conduct research with any fentanyl previously scheduled, or one 

individually scheduled in the future, I had to go through the typical process of 

adding it to my registration as well. Therefore, adding fentanyls as a class would 

only give me rights to conduct research with unscheduled fentanyls, and I could 

be prosecuted if I conducted research with a fentanyl that had been individually 

listed, even if I had been approved for a "group fentanyl" category. If a researcher 

could be approved to conduct research with a class of compounds, especially 

considering that the DEA has now shown it can schedule entire classes of 

compounds, this would save thousands of dollars exhausted in the bureaucratic 

processing of individual drug applications, and more importantly, would inspire 

spontaneous and creative research. 

I have tried to identify a few concerns I have with SITS A as a researcher, and 

concluded with a few suggestions of how research with the synthetic opioids, 

and drugs of abuse more generally, can be facilitated. Thank you and I welcome 

10 
79 


30411.029

your questions. 

Sincerely, 

Patrick M. Beardsley, Ph.D. 

Professor, Dept of Pharmacology & Toxicology, 

Institute for Drug and Alcohol Studies, 

& Center for Biomarker Research and Personalized Medicine 

Virginia Commonwealth University 

410 N. 12th. St.; Smith Bld. Rm. #756 

Richmond, VA 23298-0613 

tel: 804 8285185 

11 
80 

Mr. BURGESS. Thank you, Dr. Beardsley. 

Dr. Mulder, you are recognized for 5 minutes, please. 

STATEMENT OF JOHN MULDER, M.D., FAAHPM, HMDC 

Dr. MULDER. Thank you, Chairman Burgess and members of the 

committee. We appreciate the opportunity to just share a few moments with you this afternoon. I am John Mulder. I am a physician 

who has been practicing in the field of hospice and palliative medicine for over 30 years and have cared for a lot of folks, thousands 

over that period of time. 

I am here in support of House bill 5041 and appreciate Representative Walberg, as well as Representative Dingell and Representative Hudson, for crafting and advancing this bill. It is pretty 

straightforward. This bill would allow licensed hospice personnel to 

destroy medication in the home that is left over after a patient 

dies, or in cases where someone is still living, but the medication 

has been changed, leaving excess medication in the house. It would 

allow for them to properly dispose of that. 

Every year in America, we care for between 1 1⁄2 and 2 million 

hospice patients, which means that those are the numbers of patients that are dying. And I would submit that virtually everyone 

has medication left over. We can’t predict when someone is going 

to die. Therefore, we prescribe medications, typically in small 

amounts, but they die, and medications are left over. 

So the mathematical extrapolation is pretty straightforward. We 

end up with tens of millions of doses of controlled substances that 

are left in the homes of our hospice patients every year. And at this 

point in time, our hospice personnel are not legally allowed to handle that. They can make recommendations, but as we have already 

heard in earlier testimony, the availability of take-back programs, 

the process of using the mail-in envelopes and other processes that 

are in place legally are sometimes onerous, and families typically 

don’t take advantage of that. That just leaves too many medications left on the shelf and ultimately potentially to be sometimes 

innocently, but sometimes nefariously, abused by family members 

or diverted. 

So, when we are talking about a quick and easy way to get rid 

of millions of doses of controlled substances off the streets—potentially off the streets—this is a very simple, and I would note, bipartisan effort that has—that to me makes an awful lot of sense. And 

that is it. That is it. 

The only thing I would add is—just the one thing I have noticed 

in a lot of legislation, both Federal as well as State, is that in the 

effort to push forward legislation, a lot of times the role of hospice 

in the care of the patients and the unique and special plight of hospice patients is sometimes overlooked, and sometimes the legislative burdens and barriers could have the potential of introducing 

preventable suffering for our hospice patients. 

So I would just ask that the committee and members be mindful 

of the unique nature of hospice concerns and to take advantage of 

the resources of the National Association of Home Care and Hospice as a resource for additional input. I as well am available to 

answer any questions or concerns that someone might have about 

this issue. 

81 

[The prepared statement of Dr. Mulder follows:] 


30411.030

NATIONAL ASSOCIATION FOR HOME CARE & HOSPICE Dmisr Sdwder. RN MSN NEA·OC 228 s._..,,suh !'itn;o.·t. St'-. Wmhilltrl<m, DC lO{IO;i • .;mlf.'i<l1·7424 • 2011~47·3~40. (u Wil.lWd. A. Dumbi, Eaq. C/h/iTHl<ll<l of r/N [il)llrtf f'mirJnlt 

TESTIMONY OF JOHN ADRIAN MULDER, MD, FAAHPM, HMDC 

Director, Trillium Institute 

Grand Rapids, MI 

before the 

House Committee on Energy and Commerce 

Subcommittee on Health 

at a hearing on 

"COMBATING THE OPIOID CRISIS: HELPING COMMUNITIES 

BALANCE ENFORCEMENT AND PATIENT SAFETY" 

February 28, 2018 

1 
82 


30411.031

Chairman Burgess, Ranking Member Green, and Members of the Committee: My name is John Adrian 

Mulder, MD, FAAHPM, HMDC. I am the Medical Director of the Trillium Institute in Grand Rapids, 

MI, which provides education on palliative care and end oflife issues to medical and lay communities, 

and navigation services to those dealing with advanced and terminal illnesses. I also serve as Chief 

Medical Consultant for Hospice and Palliative Care at Faith Hospice, which is part of Holland Home, also 

located in Grand Rapids. Holland Home is Michigan's largest non-profit provider of senior services and 

employs over 1,400 people who serve more than 4,000 individuals daily. 

Holland Home is an active member of the National Association for Home Care & Hospice (NAHC), the 

largest national organization representing home health, home care, and hospice organizations of all types; 

we are also active with the Michigan HomeCare & Hospice Association, which I serve as a board 

member. Trillium Institute is also a member of the American Academy of Hospice and Palliative 

Medicine, the National Hospice and Palliative Care Organization, the Center for the Advancement of 

Palliative Care, and the Coalition to Transform Advanced Care. 

As a hospice and palliative care physician who has been caring for patients at the end of life for over 30 

years, and on behalf ofNAHC, I am honored to present testimony in support of!-!.R. 5041, The Safe 

Disposal of Unused Medication Act, which would authorize employees of a hospice program to handle 

controlled substances in the residence of a deceased hospice patient in order to assist in their disposal. 

We thank Representative Walberg, as well as Representatives Dingell and Hudson, for their efforts to 

develop this legislation. I also bring thanks from the Michigan HomeCare & Hospice Association and its 

strong endorsement for your legislation. 

2 
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30411.032

Approximately 98 percent of hospice care days are provided in a patient's place of residence. A high 

proportion of patients are dispensed medications to address terminal, intractable pain. Most of these 

drugs are opioids or otherwise classified as controlled substances, and heavily regulated by the federal 

government. With some frequency, medications that were prescribed for use by a hospice patient will go 

unused. This can happen for a number of reasons, including when a patient dies or when the hospice 

initiates medication changes. 

In recent years, and particularly since the Drug Enforcement Administration's (DEA's) issuance affinal 

regulations implementing the Secure and Responsible Drug Disposal Act of 2010, many questions have 

arisen regarding the appropriate role of hospice professionals relative to destruction of controlled 

substances in patient's homes. Under current law, unless a state or locality has enacted legislation that 

otherwise allows hospices to dispose of unused medications, hospice staff may not handle or destroy such 

medications in the home. As a result, it is frequently the case that hospice home visiting staff-- who may 

be the last professional to visit the home in connection with a patient's death-- must leave dangerous 

medications with a high risk for diversion and misuse by those for whom the drug was never intended in 

the home environment. These circumstances create a significant challenge for hospice personnel. 

Strict adherence to existing federal law means that a hospice may only educate the patient or family in 

proper disposal methods and/or provide approved mail-back pouches, and supply information about 

community "drop boxes" or "drug take back" days. This presumes that a willing and able individual with 

proper authority to dispose of a patient's property is available. This is frequently not the case. Further, 

not all hospices have access to supplies of mail-back pouches, and public "drop boxes" and "take back" 

days are few and far between. Some have suggested that hospices call local authorities to come into the 

home to seize leftover medications. Hospice provider experience indicates that local police and sheriffs' 

offices are not sufficiently staffed to fulfill this function. 

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A moderate sized hospice caring for 2,000 patients a year will prescribe approximately I million pills per 

year, the majority of which will be controlled substances. These are typically prescribed in limited 

quantities- 7-14 day supply at a time- but since it is impossible to predict precisely when a hospice 

patient will die, there will always be medications left over when death occurs. Similarly, it is not always 

possible to predict how well a patient will tolerate a medication or dosage, so prescription changes 

frequently occur during the course of treatment. This yields potentially tens of thousands of pills in need 

of disposal, and at risk for misuse or diversion. 

It should be noted that hospice providers are extremely sensitive to the potential for diversion of 

medications intended for terminally ill patients. Hospice personnel keep close track of medication 

supplies in the home and where diversion by family members is suspected the hospice will frequently take 

steps to address the issue by reducing the amount of medication dispensed, providing lock boxes, alerting 

the pharmacy of their concern and, in some cases, the local authorities. 

Given the growing public health threat posed by widespread misuse of controlled substances, a number of 

states have enacted or are in the process of developing legislation that would permit hospice organizations 

to authorize certain home visiting staff to participate in the destruction of unused controlled medications. 

While these efforts are laudable, there is significant variation among these laws, which ultimately 

diminishes the ability of the federal government to oversee activities in this area, and does little to ensure 

that hospices nationwide adhere to a distinct set of standards for destruction of controlled substances in 

the home. 

It is for this reason that we applaud the introduction of H.R. 5041. Under this legislation, Medicarecertified hospice providers may authorize licensed employees that are acting within the scope of their 

employment to handle controlled substances for the purpose of disposal after the patient has died. In 

order to be qualified to authorize such destruction, hospices would be required to: 

4 
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Have in place written policies and procedures for assisting in the disposal of the controlled 

substances of the deceased individual 

Have provided a copy of those written policies and procedures to the patient or patient 

representative and family at the time that the medications are ordered 

Have discussed the policies and procedures with the patient or representative at the time that the 

medications are ordered and 

Have documented in the patient's clinical record that the written policies and procedures were 

provided and discussed. 

We are gratified to see that the legislation gives hospice providers the option to decide whether or not to 

authorize employees to assist in destruction of controlled substances in the home. Some hospices are 

concerned that requiring their staff to assist in the destruction of unused medications could pose a 

personal risk to those employees or a potential liability risk to the hospice, so we believe it is vital that 

hospices be given the opportunity to make that choice on behalf of their organizations. We also strongly 

support the bill's provision that exempts hospice employees from the Drug Enforcement Administration's 

registration requirements that would otherwise apply. These requirements are complex and would be 

prohibitively expensive for most community hospices to meet. 

We believe H.R. 5041 represents a common-sense, real-world approach to allowing hospice agencies to 

authorize their personnel to safely handle controlled substances in a patient's residence for the sole 

purpose of assisting in their proper disposal after a hospice patient's death. It is our belief that the 

legislation could be further strengthened by extending authority to destroy the medications to instances 

under which medications for a living patient have been changed (leaving unused medications in the home 

that could be diverted for misuse) and to specify the disciplines to which the authority would apply 

(including RNs, LPNs, social workers, physicians, nurse practitioners and physician assistants) so that 

5 
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there is no confusion over which personnel would be permitted to destroy the medications. We at NAHC, 

along with our associates at the National Hospice and Palliative Care Organization (NHPCO), have 

worked collaboratively with the sponsors of H.R. 5041 and we look forward to continuing discussions 

with you on these issues going forward. 

Additional Issues. 

While I have the opportunity, there are other issues related to prescribing of controlled substances that 

have emerged in a number of states that have serious implications for the comfort and relief of terminally 

ill patients and the practice of hospice and palliative medicine. One relates to drug shortages, including 

supplies of opioids and other pain medications. Throughout the nation, hospices are hearing from their 

supply houses that they should prepare for widespread shortages as the result of the temporary shutdown 

of production in Puerto Rico (as the result of Hurricane Maria) and the DEA's reduction in production 

quotas. We fully appreciate that a vital step in reducing the prevalence of opioid abuse is to reduce 

overproduction of these medications, thereby limiting the amount that may be available for diversion. 

However, hospice and hospital providers must have timely and affordable access to medications that are 

necessary to treat their patients effectively. A hallmark of palliative care is ensuring that we do all that 

we can to address unnecessary and debilitating pain, and many hospices are fearful that they will be 

unable to do that in future months. 

We would encourage the DEA and the Food and Drug Administration, and other appropriate federal 

agencies, to ensure that they have a process in place to closely track supply needs, anticipate potential 

shortages and quickly address them in a way that does not threaten continuity of care or increase the cost 

of effective care delivery. 

Further, many states have enacted, or are developing, legislation that would place additional limitations 

on prescribing practices for controlled substances. While we agree that these actions are warranted to 

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help address the growing opioid crisis, some states are placing limitations on the circumstances under 

which controlled substances can be prescribed without giving consideration to the special needs of 

terminally ill patients. Of particular concern are provisions that require a prescriber to have a "bona fide" 

relationship, and more specifically how they define such a relationship. Many of these emerging laws 

require that a complete history and physical be conducted prior to prescribing a controlled substance, and 

that the patient again be evaluated before dosing changes are made, or additional medications prescribed. 

While there may be clinical circumstances in non-terminal situations in which this may be appropriate, in 

hospice and palliative care, it is essential that patients have access to medications as quickly as possible in 

order to control pain and other symptoms that are frequently problematic at the end of life. Moreover, 

these patients have been heavily engaged in the healthcare system at the time of their hospice admission 

with complex regimens put in place by their physicians. To require additional hands-on physician 

intervention to simply maintain their current pain medications is onerous, time consuming, duplicative, 

and will delay the provision of care. There is no other area of medical practice in which patient care is as 

carefully scrutinized or monitored. Nurse case managers are in the home at the bedside, communicating 

with hospice physicians in real time, and facilitating the relationship that effectively manages the plan of 

care. 

In recent months there have been several states in which physicians and hospice providers have had to 

negotiate with state legislators and regulators to ensure that exceptions to these restrictive laws are 

enacted to allow effective care of hospice patients. While regulation of prescribing practices is, for the 

most part, the domain of the state, the issue has emerged with sufficient frequently that I believe it is 

useful for this committee to be aware of this concern. 

In a similar vein, many hospices are finding that in growing numbers community physicians are hesitant 

to prescribe pain medications for patients with advanced or terminal illness because of the intense 

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scrutiny that prescribing practices are receiving throughout the Nation. While I believe that these fears 

may not be well-founded- and clearly, it is not the intention of legislators that hospice patients sufferthis is an issue that is a growing concern in my field. I am very concerned that we could be facing the 

reality of dying patients being forced into situations of preventable suffering as a result of legislative 

efforts, that while reasonably conceived, will fail to protect the most vulnerable and prone to suffering. 

would also parenthetically note that it is not patients at the end of life, nor hospice physician prescribers, 

who have influenced the current opioid misuse and addiction issues. 

As indicated at the start of this testimony, I am appreciative of the opportunity to discuss these issues with 

you today. In the course of my palliative work, 15 years ago I was asked to consult with the DEA and the 

FBI in investigating opioid diversion cases and abuse cases. I have appreciated the opioid challenges that 

are permeating our communities, and yet understand the need to meet the pain needs of patients at the end 

of life. I would be pleased to answer any questions that you may have, and, along with representatives of 

the National Association for Home Care & Hospice (NAHC), welcome the opportunity to serve as a 

resource to members and staff of the committee. 

8 
89 

Mr. BURGESS. Thank you, Dr. Mulder. We appreciate your testimony. 

Dr. Subbiah, you are recognized for 5 minutes, please. 

STATEMENT OF PONNI SUBBIAH, M.D. 

Dr. SUBBIAH. Good afternoon. I am Dr. Ponni Subbiah. I am a 

neurologist and chief medical officer at Indivior, global specialty 

pharmaceutical company with a core focus on addiction medicine. 

We have a 20-year commitment to the vision that all patients have 

access to evidence-based treatments. We developed the first 

buprenorphine-based medication for treatment of opioid dependence in the U.S. 

Today, we have a portfolio of treatments for opioid addiction, as 

well as a pipeline of product candidates to address unmet patient 

needs for this and other disorders, including alcohol use disorder 

and schizophrenia. To address the opioid epidemic, it is important 

to understand the patient journey. It is complex and often misunderstood. 

Addiction is a brain disease and not a moral failure. However, social stigma, prejudice, and misconceptions about addiction coupled 

with feelings of guilt and shame often prevent people from seeking 

help. Even when people want help, cravings and withdrawal symptoms can be so intense that there is generally only a small window 

of time when a person can emotionally and physically pursue treatment. 

The healthcare system, however, does not always encourage 

treatment during that window due to structural barriers to care. 

This is one reason that many of those who need help go untreated. 

Any patient in need of treatment for opioid use disorder should 

have access to the medication-assisted treatment prescribed by 

their healthcare professional. 

Indivior’s focus on patient needs to drive decisions inspired the 

R&D team to develop Sublocade, which received FDA approval on 

November 30 of last year. Sublocade is the first once-monthly 

Schedule III buprenorphine extended release injection for subcutaneous use. In the face of this growing addiction crisis, FDA granted 

the product fast-track approval and priority review designation. 

Now, it is indicated for the treatment of moderate to severe 

opioid use disorder in patients as part of a complete treatment plan 

that includes counseling and psychosocial support. Sublocade uses 

the Atrigel delivery system, which allows for once-monthly dosing 

and is intended to be administered only by healthcare providers. 

Sublocade will be distributed through a restricted distribution system, which is part of a risk evaluation and mitigation strategy program. The goal of this program is to mitigate serious harm or 

death that could be result from intravenous administration, self-administration, by the patient. 

All healthcare settings and pharmacies that order and dispense 

Sublocade must be certified and establish procedures to verify that 

the medication is dispensed directly to a healthcare provider for administration by a healthcare provider only. As every patient’s journey toward recovery is different, access to all evidence-based treatment options is critical. Sublocade represents one such option. 

90 

Government policies impacting these treatments must adapt to 

ensure patients to have access to new innovative medical technologies. Historically, buprenorphine treatments have been daily 

oral medication, and the Controlled Substances Act allows for dispensing this medication directly to patients. However, Sublocade, 

as required by our FDA approved REMS can only be administered 

directly by the healthcare provider and cannot be dispensed directly to the patient. 

In recent years, the distribution of injectable products have 

evolved from a transitional buy and bill system where physician 

practices purchase drugs directly from a distributor to one that allows specialty pharmacies to ship a patient’s prescription directly 

to administering provider. For example, current long-acting 

injectable treatments used for schizophrenia utilized both these 

distribution methods to ensure optimal patient access to these 

medications. 

Current law, however, is ambiguous and could impede patient access to new treatment innovations. We agree with Representatives 

Costello and Nolan that the law needs to be clarified so that these 

next-generation buprenorphine products can be accessed directly by 

healthcare providers through a specialty pharmacy restricted delivery system, as well as a traditional buy-and-bill system. 

We support the proposed legislation to remove ambiguity in the 

current law to ensure that patients of opioid use disorder and their 

providers have the same level of access to these innovative treatments as they do to other injectable products. This technical clarification will ensure the safest distribution channels for these new 

medical technologies. 

Thank you again for the opportunity to address the committee. 

Together, we can transform addiction from a human crisis to a recognized treatable disease. Thank you. 

[The prepared statement of Dr. Subbiah follows:] 

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~~~~ INDIVIOR ~ ~ Focus on you. 

Dr. Ponni Subbiah, MD, MPH 

Chief Medical Officer, lndivior PLC 

Statement to the House Energy and Commerce Subcommittee on Health 

Hearing on 

Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Good morning. Thank you, Chairman Burgess and Ranking Member Green, for the privilege to 

address the Subcommittee and for recognizing the importance of combatting the current opioid 

crisis. I am Dr. Ponni Subbiah, a neurologist and Chief Medical Officer at lndivior. lndivior is a 

global specialty pharmaceutical company. Our core focus is addiction medicine. We have a 20-

year legacy of commitment to our vision that all patients have access to evidence-based 

treatment for the chronic condition and co-occurring disorders of addiction. We developed the 

first buprenorphine-based opioid use disorder treatment for patients in the United States. 

Today, we have a global portfolio of treatments for opioid addiction and a pipeline of product 

candidates to address unmet patient needs for this disorder and other chronic conditions, 

including alcohol use disorder and schizophrenia. 

To address the opioid epidemic, it is important to understand the patient journey. It is complex 

and often misunderstood. Addiction is a brain disease and not a moral failure. However, social 

stigma, prejudice and misconceptions about addiction, coupled with feelings of guilt and shame, 

often prevent people from seeking help. Addiction is often punished and criminalized. 

Even when people want to stop using illicit drugs, cravings and withdrawal symptoms can be so 

intense that generally there is only a small window of time when a person is emotionally and 

physically able to pursue treatment. The healthcare system, however, does not always encourage 
92 


30411.039

2 

treatment during that window due to structural barriers to care. This is one of many reasons that 

the majority of those who need help go untreated. For this reason, lndivior believes that any 

patient in need of approved treatments for opioid use disorder should have access to the 

medically-assisted treatment (MAT) prescribed by their health care professional. Several 

government agencies have noted that MAT has recognized track records of success. 

lndivior's core guiding principle- focus on patient needs to drive decisions- inspired our research 

and development team to develop SUBLOCADE'M which received FDA approval on November 30, 

2017. SUBLOCADE is the first once-monthly Schedule Ill buprenorphine extended-release 

injection for subcutaneous use. In the face of the growing addiction crisis, FDA granted the 

product Fast Track approval and Priority Review designation. It is indicated for the treatment of 

moderate to severe opioid use disorder in patients as part of a complete treatment plan that 

includes counselling and psychosocial support. SUBLOCADE uses the ATRIGEL'" delivery system 

which allows for once-monthly dosing and is intended to be administered only by healthcare 

providers. 

SUBLOCADE will be distributed through a restricted distribution system, which is part of a Risk 

Evaluation and Mitigation Strategy (REMS) program. The goal of the REMS is to mitigate serious 

harm or death that could result from intravenous self-administration by the patient. All 

healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified and 

establish processes and procedures to verify that the medication is dispensed directly to a 

healthcare provider for administration by a healthcare provider only. 

As every patient's journey towards recovery is different, access to additional treatment options 

is critical. SUBLOCADE represents one such option that we believe will be essential to addressing 

the needs of patients, families and communities battling the opioid epidemic. 
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3 

New innovations are expanding medication-assisted treatment options. Government policies 

impacting these treatments must adapt to ensure patients have access to all evidence-based 

treatment options. 

Historically, buprenorphine treatments have been daily, oral medications and the Controlled 

Substances Act allows for dispensing of these medications directly to patients. However, as 

stated earlier, SUBLOCADE, as required by our risk management program, can only be 

administered directly by the healthcare provider and cannot be dispensed directly to the patient. 

In recent years, the distribution of injectable products has evolved from a traditional buy-and-bill 

system, where physician practices purchase drugs directly from a distributor, to one that allows 

specialty pharmacies to ship a patient's prescription directly to the administering provider. For 

example, current long-acting injectable treatments used for schizophrenia utilize both these 

distribution methods to ensure optimal patient access to these medications. 

Based on this, we agree with Representatives Costello and Nolan, the sponsors of the Ensuring 

Patient Access to Substance Use Disorder Treatments Act of 2018, that the law needs to be 

clarified so that these next generation buprenorphine products can also be accessed directly by 

healthcare providers through a specialty pharmacy restricted delivery system as well as a 

traditional buy and bill system. 

We agree with the Committee that there is a role for Congress, and the Administration, to update 

laws to allow for new medical technologies. We support the proposed legislation to remove any 

ambiguity in the current law to ensure that patients with opioid use disorder and their providers 

have the same level of access to these innovative treatments as they do to other injectable 

products. We believe this technical clarification will ensure the safest distribution channels for 

these new treatments. 

Thank you again for the opportunity to address the Committee. 
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4 

All of us together can transform addiction from a human crisis to a recognized and highly treated 

disease. We stand ready to support the Committee's work however we can. I would be happy 

to answer any of your questions. Thank you for your leadership and consideration. 

-END 
95 

Mr. BURGESS. Thank you for your testimony. 

Dr. Kan, you are recognized for 5 minutes, please. 

STATEMENT OF DAVID Y. KAN, M.D. 

Dr. KAN. Chairman Burgess and Ranking Member Green, thank 

you for inviting me to participate in this hearing. Thank you to the 

subcommittee for your leadership in addressing our country’s opioid 

epidemic. 

My name is Dr. David Kan, and I am the president of the California Society of Addiction Medicine, a chapter of the American Society of Addiction Medicine, also known as ASAM. This testimony 

is offered on behalf of ASAM. Established in 1954, ASAM is a national medical specialty society of more than 5,000 physicians and 

allied health professionals whose mission is to increase access to 

high-quality addiction treatment. I am board certified in addiction 

medicine and psychiatry. I served 10 years in Federal service at a 

VA methadone program within the San Francisco VA Medical Center as medical director. I am the current medical director at Bright 

Heart Health, which provides telemedicine services in 21 states 

across the United States. 

My testimony today will focus on three facts. Number one, addiction involving opioid use is effectively treated with a combination 

of medications and psychosocial interventions. And ASAM has published guidelines that detail best practices for the use of these 

medications. 

Number two, there are significant barriers to accessing medications for addiction involving opioid use and a nationwide treatment 

gap. 

Number three, changes to the Controlled Substances Act to facilitate the use of telemedicine and new medication formulations can 

expand access to medications for addiction involving opioid use to 

close the gap. There are currently three medications—methadone, 

naltrexone, and buprenorphine—that are FDA approved and have 

substantial evidence for their effectiveness treating addiction involving opioid use. 

Given the bills being considered today, I will focus my remarks 

on the safely and effectiveness of buprenorphine. Compared to full 

opioid agonists like methadone, buprenorphine is much safer with 

significantly lowered overdose deaths and adverse events. The direct healthcare savings per treated opioid dependent patient per 

year exceed $20,000. ASAM has published clear standards of care 

for clinicians treating patients with addiction, as well as prescribing guidelines. 

Despite the strong evidence used for the use of buprenorphine, 

very few eligible patients are offered medications to help treat their 

disease. Studies have shown that 80 percent of patients with opioid 

addiction don’t receive any treatment, and the majority of States 

don’t have enough treatment providers to provide the capacity to 

meet the need. 

Other access barriers include transportation difficulties, limited 

hours of operation, and few prescribers who accept Medicaid or 

Medicare, often making access to treatment next to impossible. 

Making smart and targeted changes to the Controlled Substances 

Act to facilitate treatment of buprenorphine and for addiction inVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00101 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
96 

volving opioid use via telemedicine and the use of new 

buprenorphine formulations are steps this Congress should take to 

expand addiction treatment access. 

Telemedicine provides significant opportunities to reach more patients. The Ryan Haight Act limits the expansion of treatment with 

buprenorphine for addiction involving opioid use via telemedicine 

by generally requiring an in-person medical evaluation or the presence of the patient in a DEA-registered hospital or clinic. 

Consistent with ASAM’s standards of care and national practice 

guidelines, ASAM recommends that the requirement for an in-person physical exam by the prescribing clinician be revised to allow 

for a physical exam to be conducted by another appropriately licensed healthcare professional and documented in the patient’s 

medical record. 

Additionally, ASAM recommends limiting this exception to the 

in-person physical exam requirement only to those physicians who 

hold additional certification or who practice in a qualified practice 

setting per the definitions in the 2016 SAMHSA rule that raised 

the dated 2016 prescribing limit. These changes would increase access while ensuring high-quality care from competent healthcare 

providers and safety for the patients to reduce diversion. 

Secondly, ASAM encourages Congress to amend the Controlled 

Substances Act to allow for specialty pharmacies to deliver new 

injectable and implantable buprenorphine formulations directly to 

the administering clinician’s practice rather than relying on the 

buy-and-bill method for obtaining and being reimbursed for the 

medications. Such a change is not a new pathway for medication 

delivery; it would allow for these controlled substances to be delivered as many noncontrolled substances are already. It is a technical, commonsense fix that will expand treatment access while potentially reducing buprenorphine diversion. And ASAM urges this 

subcommittee to advance the bill to approve it. 

Thank you again for the opportunity to present here today. I look 

toward to your questions. 

[The prepared statement of Dr. Kan follows:] 

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AS A Mhe Voice of Addiction Medicine 

American Society of Addiction Medicine 

Testimony of David Kan, MD, DFASAM 

Before the Energy and Commerce Committee Subcommittee on Health 

February 28, 2018 

Executive Summary 

My name is Dr. David Kan, and I'm the President of the California Society of Addiction Medicine, 

a Chapter of the American Society of Addiction Medicine (ASAM), which represents more than 

5,000 of our nation's addiction specialist physicians and other clinicians. 

My testimony today will focus on the following facts: 

1. Addiction involving opioid use can be successfully treated with a combination of 

medications and psychosocial interventions, and we have published standards and 

guidelines that detail best practices for the use of these medications. 

2. There are significant barriers to access these effective medications, resulting in a 

significant addiction treatment gap in our country. 

3. Changes to the Controlled Substances Act to facilitate the use of telemedicine and new 

medication formulations can expand access to evidence-based treatment options and 

help close the addiction treatment gap. 

Opioid addiction is taking a devastating toll on our families, friends, and neighbors across the 

country, but there is hope when patients can access effective treatment services. ASAM is 

honored today to offer its thoughts and expertise on how we can close the treatment gap, 

improve the quality of care, and ultimately save lives. 

1 
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Introduction 

Chairman Burgess and Ranking Member Green, thank you very much for inviting me to 

participate in this important hearing. I'm grateful to you and the other Members of the 

Subcommittee for your leadership in addressing the epidemic of opioid addiction currently 

ravaging our country. 

My name is Dr. David Kan, and I am the President of the California Society of Addiction 

Medicine, a Chapter of the American Society of Addiction Medicine, also known as ASAM. This 

testimony is offered on behalf of ASAM, myself as a practicing addiction specialist physician, 

and my patients. I am board-certified in both Addiction Medicine and General and Forensic 

Psychiatry, and I'm the Medical Director of Bright Heart Health, which provides telemedicine 

addiction treatment services in 21 states across the United States, and of which I have a 3.5% 

ownership interest. I have dedicated my entire career to treating patients with opioid addiction 

and have spent more than a decade treating addiction at the Veterans Administration Medical 

Center in San Francisco, where I used telemedicine to treatment patients. I am also a faculty 

member at the UCSF Department of Psychiatry. 

Established in 1954, ASAM is a national medical specialty society of more than 5,000 

physicians and allied health professionals who specialize in the treatment of addiction. Its 

mission is to increase access to and improve the quality of addiction treatment; to educate 

physicians, other health care providers and the public; to support research and prevention; and 

to promote the appropriate role of the physician in the care of patients with addictive disorders. 
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My testimony today will focus on the following three facts: 

1. Addiction involving opioid use can be successfully treated with a combination of 

medications and psychosocial interventions, and we have published guidelines that 

detail best practices for the use of these medications. 

2. There are significant barriers to access these effective medications, resulting in a 

significant addiction treatment gap in our country. 

3. Changes to the Controlled Substances Act to facilitate the use of telemedicine and new 

medication formulations can expand access to evidence-based treatment options and 

help close the addiction treatment gap. 

Addiction Involving Opioid Use Can Be Treated Successfully 

The medical literature is clear, and as a practicing addiction specialist with more than a decade 

of experience I can confirm, that addiction involving opioid use can be treated successfully with 

a combination of medication and psychosocial interventions. 

There are currently three medications that are FDA-approved to treat opioid addiction: 

methadone, which has been used in highly regulated opioid treatment programs since the 

1960s; buprenorphine, which has been used since 2002 by specially trained physicians in their 

offices; and naltrexone, which is not a controlled substance and can be administered by any 

licensed prescriber. Given the bills being considered by the Subcommittee today, I will focus my 

remarks on the safety and effectiveness of buprenorphine, although it is important to note that 

all three medications have been proven to be safe and clinically effective for the treatment of 

addiction involving opioid use. 

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The benefits of buprenorphine in the treatment of opioid dependence and opioid use disorder 

are well documented. A 2013 review of the scientific literature found substantial, broad and 

conclusive evidence for the effectiveness of all three medications. 1 Several studies of officebased treatment with buprenorphine found it improves treatment engagement; reduces 

cravings, illicit opioid use, and mortality; and improves psychosocial outcomes. Compared to full 

opioid agonists like methadone, buprenorphine offers an improved safety profile, with 

significantly lower related overdose deaths and adverse events after treatment discharge. 2

•

3

•

4 

Moreover, the direct health care savings per opioid dependent patient per year exceed 

$20,000, 5 with total economic savings stretching beyond just health care costs to the 

criminal justice and social services sectors as well. 

Finally, we have clear standards of care for clinicians treating patients with addiction, as well as 

comprehensive guidelines for how to use medications effectively in the clinical care of persons 

with addiction involving opioid use. ASAM's Standards of Care for the Addiction Specialist 

Physician, which apply to any physician assuming the responsibility for caring for patients with 

addiction and related disorders, address expected physician competencies and actions with the 

ultimate purpose of improving patient outcomes. ASAM's National Practice Guideline for the 

Use of Medications in the Treatment of Addiction Involving Opioid Use was developed to 

promote evidence-based clinical treatment of opioid use disorder and to assist clinicians in the 

decision-making process for prescribing medications to patients with opioid use disorder. It 

offers specific clinical recommendations on the assessment and diagnosis of opioid use 

disorder, treatment options, managing withdrawal, initiating medication treatment, and 

psychosocial treatment. 51 will return to the Standards and the Guideline's recommendations 

shortly when I discuss the in-person physical examination requirement stipulated by the Ryan 

Haight Act. 

4 
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There are Significant Barriers to Access these Medications Leading to a Major Treatment 

Gap 

Despite the strong evidence base for the use of buprenorphine and the clinical guidance 

available, very few eligible patients are offered medication to help treat their disease. Indeed, a 

2015 study published in the Journal of the American Medical Association found that 80% of 

Americans with opioid addiction don't receive treatment. 7 Part of the treatment gap is 

attributable to lack of access to DATA-waived clinicians who can prescribe buprenorphine. A 

2015 study co-authored by the Assistant Secretary for Mental Health and Substance Use Dr. 

McCance-Katz that estimated national and state need and capacity for opioid agonist 

medication-assisted treatment (both methadone and buprenorphine) found that, "among states 

and the District of Columbia, 96% had opioid abuse or dependence rates higher than 

their buprenorphine treatment capacity rates." The authors concluded, "Significant gaps 

between treatment need and capacity exist at the state and national levels. Strategies to 

increase the number of [opioid agonist-MAn providers are needed."8 

Other barriers preventing patients from accessing this life-saving treatment include 

transportation difficulties, limited hours of operation, and few prescribers who accept Medicaid 

or Medicare. Individually, these barriers prevent access. However, patients often encounter 

multiple barriers making access to treatment next to impossible. 

Whether rural or urban, many individuals struggle with attending appointments due to 

functional ability and transportation issues related to bus schedules, costs of travel, and 

ability to adjust work and life schedules around appointments. 

Many providers only offer limited hours or weekday schedules. Many individuals 

seeking treatment for addiction involving opioid use are employed by retail, restaurant, 

5 
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construction, or similar industries with limited flexibility to attend frequent medication and 

behavioral health appointments in accordance to their treatment plan. 

Finally, the scarcity of Medicaid-eligible and enrolled practitioners and programs that 

could provide medications for the treatment of addiction involving opioid use to Medicaid 

patients limits geographic access for Medicaid beneficiaries with addiction involving 

opioid use, requiring long commutes and/or Medicaid-paid transportation, whose costs 

are rising substantially as a result. Many physicians choose to offer cash only practices, 

restricting access to care to only individuals who can pay out-of-pocket. 

Changes to the Controlled Substances Act to Facilitate Treatment Via Telemedicine and 

New Medication Formulations Can Help Close the Treatment Gap 

While not a silver bullet that will solve our current opioid addiction crisis or fully close the 

treatment gap, making smart and targeted changes to the Controlled Substances Act to 

facilitate treatment with buprenorphine for addiction involving opioid use via telemedicine and 

the use of new implantable and injectable buprenorphine formulations are steps this Congress 

should take to expand treatment access. 

Tefemedicine 

Telemedicine provides significant opportunities to reach more patients in urban, peri-urban, and 

rural communities. However, the current restrictions on internet prescribing under the Ryan 

Haight Act and the seven, specific "practice of telemedicine" exceptions it provides for are of 

limited utility for expanding access to treatment with buprenorphine for addiction involving opioid 

use via telemedicine. As you know, the Ryan Haight Act generally requires an "in-person 

medical evaluation" in the physical presence of the prescribing clinician for the prescription to be 

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considered valid. The "practice of telemedicine" exceptions to this requirement provide for 

circumstances in which the patient is being treated by, and physically located in, a DEAregistered hospital or clinic, or in which the patient is being treated by and in the physical 

presence of another DEA-registered practitioner. It generally does not allow for circumstances in 

which a patient may have received a medical evaluation by another qualified practitioner but is 

not physically present in a DEA-registered hospital or clinic or with another DEA-registered 

practitioner. 

ASAM's Standards of Care and National Practice Guideline make it clear that patients 

presenting for treatment of addiction involving opioid use should receive a physical examination 

by a qualified and appropriately licensed healthcare professional as part of a comprehensive 

assessment process. However, they specifically allow for this examination to be conducted by a 

health care professional other than the prescriber, as long as the prescriber "ensure[s] that a 

current physical examination is contained within the patient medical record before a patient is 

started on a new medication for the treatment of his/her addiction." 9 Accordingly, ASAM 

recommends that the requirement for an in-person physical exam by the prescribing 

clinician be revised to allow for the physical exam to be conducted by another 

appropriately licensed healthcare professional and documented in the patient's medical 

record. Completion of the patient's medical history should include screening for concomitant 

medical conditions, including infectious diseases (hepatitis, HIV, and tuberculosis [TB]), acute 

trauma, and pregnancy. Initial laboratory testing should also include a complete blood count and 

liver function tests. 

Additionally, ASAM recommends limiting this exception to the in-person physical exam 

requirement for patients who will be treated with buprenorphine for opioid addiction only to those 

physicians who hold "additional certification" or who practice in a "qualified practice setting" per 

7 
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the definitions in the 2016 SAMSHA rule that raised the DATA-2000 prescribing limit. 

Specifically, only physicians who hold board certification in addiction medicine or addiction 

psychiatry by the American Board of Addiction Medicine or the American Board of Medical 

Specialties, or certification by the American Society of Addiction Medicine, or those who practice 

in settings that provide professional coverage for patient medical emergencies when the 

practice is closed, provide access to case management services, are registered with their state 

POMP, and are able to accept third-party insurance, should be allowed to prescribe 

buprenorphine via telemedicine with an in-person evaluation conducted by another 

appropriately licensed healthcare professional and documented in the patient's medical record. 

These changes would allow for highly skilled addiction specialists to treat patients who might 

otherwise face insurmountable geographic, logistical, or financial barriers to in-person 

treatment, and would make progress toward closing the addiction treatment gap while still 

ensuring patients are receiving high-quality care from competent health care providers. 

New Formulations 

Secondly, ASAM encourages Congress to move expeditiously to amend the Controlled 

Substances Act to allow for specialty pharmacies to deliver new injectable and implantable 

buprenorphine formulations directly to the administering clinician's practice, rather than requiring 

the clinician to rely on the "buy and bill" method for obtaining and being reimbursed for the 

medications. 

Foremost to ASAM's mission is a goal to increase access to and improve the quality of addiction 

treatment. The introduction and use of novel addiction medications supports this goaL Addiction 

patients, like all patients, should have available to them a robust and varied array of treatment 

8 
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options, as no one treatment modality is appropriate or therapeutic for everyone. The recent 

approval of implantable and injectable buprenorphine formulations expands treatment options 

for patients. No product will be suitable for all patients, and many will still be best-served by oral 

formulations, other medications, or no medication at all, but they may help improve treatment 

adherence and reduce diversion among certain patients for whom they are indicated. 

However, these options are only valuable if patients can access them. A change to the 

Controlled Substances Act, as has been proposed in Senate bill 916, would facilitate access to 

these new products by allowing them to be delivered to administering practitioners on a patientby-patient basis rather than requiring the practitioners anticipate demand, buy the medication in 

advance, store it on site, and hope they estimated the correct number of doses needed to meet 

demand and avoid waste. This is not a new pathway for medication delivery but would allow for 

these controlled substances to be delivered as many non-controlled substances are already. It 

is a technical, common-sense fix to the law that will expand treatment access while potentially 

reducing the buprenorphine diversion, and ASAM urges this Subcommittee to advance a bill to 

approve it. 

Thank you, again, for the opportunity to present here today. ASAM looks forward to a continued 

collaboration on this and other addiction-related issues, and I look forward to your questions. 

### 

1 Chalk M, Alan is-Hirsch K, Woodworth A, Kemp J, and McClellan T. FDA Approved Medications for the Treatment 

of Opiate Dependence: literature Reviews on Effectiveness & Cost- Effectiveness. 2013. Available at: 

http://www.asam.org/docs/default-source/advocacy/aaam implications-for-opioid-addiction-treatment final 2 Schwartz RP, Gryczynski J, O'Grady KE, et al. Opioid Agonist Treatments and Heroin Overdose Deaths in 

Baltimore, Maryland, 1995-2009. American Journal of Public Health. 2013;103(5):917-922. 

d oi: 10.2105/ AJ PH .2012.301049. 3 Paone D, Tuazon E, Stajic M, et al. Buprenorphine infrequently found in fatal overdose in New York City. Drug 

Alcohol Depend. 2015 Oct 1; 155:298-301. doi: 10.1 016/j.drugalcdep.2015.08.007. Epub 2015 Aug 15. 

4 Bell JR, Butler B, Lawrence, A. et al. Comparing overdose mortality associated with methadone and 

buprenorphine treatment. Drug Alcohol Depend. 2009;104(1): 73-77. doi: 10.1016/j.drugalcdep.2009.03.020 

9 
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5 Tkacz J, Volpicelli J, Un H, and Ruetsch C. Relationship between buprenorphine adherence and health service 

utilization and costs among opioid dependent patients. J Subst Abuse Treat. 2014 Apr;46(4):456·62. doi: 

10.1016/j.jsa\.2013.10.014. Epub 2013 Nov 12. 6 Kampman K and Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use 

of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med 2015;9: 1-10. 

7 Saloner B and Karthikeyan S. Changes in Substance Abuse Treatment Use Among Individuals With Opioid Use 

Disorders in the United States, 2004-2013. JAMA. 2015;314(14):1515-1517. 

8 Jones CM, Campopiano M, Baldwin G, and McCance-Katz E. National and State Treatment Need and Capacity for 

Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 

10.2105/AJPH.2015.302664. Epub 2015 Jun 11. 9 Kampman K and Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use 

of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med 2015;9: 1-10. 

10 
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Appendix: ASAM Position on Other Bills under Consideration 

Bill ASAM Position 

H.R. 2063, the Opioid The dramatic increase in the prescription of opioid medications 

Preventing Abuse 

through Continuing has played a significant role in rise of opioid addiction and 

Education (PACE) Act of 

2017 development of the opioid overdose epidemic in the United 

States. To address this epidemic, we must take a 

comprehensive approach to strengthening treatment, 

prevention, and recovery services for patients with addiction, 

including strategies to ensure safe and responsible prescribing 

of opioids. This bill would help reduce unnecessary exposure 

to addictive medications by requiring prescribers to be 

educated on safe prescribing practices and 

addiction, and ASAM is pleased to endorse it. 

In addition, ASAM offers these additional recommendations for 

consideration: 

. Make the new training requirement a condition of 

registration to prescribe or dispense benzodiazepines in 

addition to opioids for the treatment of pain. 

. Streamline federal efforts to promote safe opioid 

prescribing by incorporating the recommendations 

included in the CDC Guideline for Prescribing Opioids 

for Chronic Pain. There is no need for duplicative 

federal recommendations on opioid prescribing; in fact, 

duplicative efforts may only confuse practitioners and 

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further clutter an already-crowded educational space on 

this topic. 

Offer a "test-out" option that would give practitioners the 

opportunity to demonstrate their knowledge and "testout" of this mandatory training requirement. 

12 
109 

Mr. BURGESS. Thank you, Dr. Kan. 

Mr. Nance, you are recognized for 5 minutes, please, for an opening statement. 

STATEMENT OF RICHARD J. NANCE 

Mr. NANCE. Thank you, Chairman Burgess, Ranking Member 

Green, and members of the committee, I appreciate the opportunity 

to testify on an issue that is impacting community-based addiction 

and mental health centers across the country. 

Thanks to Representatives Carter, Bustos, Harper, and Matsui 

for their leadership on the two discussion draft bills focused on the 

Ryan Haight Act. We appreciate your work. 

I am honored to be here today on behalf of the National Council 

for Behavioral Health, a national group that represents 2,900 

member centers who serve more than 8 million adults and children 

living with behavioral health disorders in the United States. Since 

1998, I have served as the director of Utah County’s Department 

of Drug and Alcohol Prevention and Treatment. I am a member of 

the National Council. I am also a licensed clinical social worker in 

the State of Utah. My department provides a comprehensive range 

of drug and alcohol prevention and treatment services, including 

medication-assisted treatment for opioid addiction and abuse. 

Over 40 percent of the people I have in treatment at my agency 

right now are there for an opiate issue, and over 30 percent of 

them are receiving medication-assisted treatment. That is nearly 

400 out of 850 clients I have in treatment today. 

I am here to discuss an issue that limits community addiction 

and mental health centers’ ability to provide patients access to 

treatment using telemedicine. Medically appropriate treatment for 

behavioral health conditions sometimes involves controlled substances. Unfortunately, today, thousands of centers across the 

country are unable to utilize telemedicine that results in a prescription for a controlled substance due to the DEA’s narrow interpretation of the Ryan Haight Act. 

In my remarks, I will explain why this is and why the MatsuiHarper bill provides the relief we need in order to be able to serve 

patients more effectively. Let me state upfront first, though, the 

National Council appreciates and affirms the importance of the 

Ryan Haight Act. As recent reports have shown, even with the act 

in place, it is still far too easy to go online and buy controlled substances without a valid prescription. 

In November of 2016, two junior high students in Park City, 

Utah, ordered a drug called U47700, a synthetic opiate analogue, 

sometimes referred to as Pink, took the drug and overdosed and 

died. These studies underscore the importance of the DEA’s vigilance over the online ecosystem and the rogue actors that claim to 

be doing telemedicine and operating an online pharmacy but, instead, are functionally pill mills. 

Our goal is to allow licensed, DEA-regulated, community addiction and mental health centers staffed by regulated and licensed 

professionals to be able to comply with the Ryan Haight Act in 

order to improve patients’ access to care. So what we are asking 

is that you regulate us. I don’t know too many people who would 

come in here and ask you to regulate us. 

110 

Here is how the situation plays out in Utah and illustrates the 

problem around the country. The act allows for a prescription of 

controlled substance without a prior in-person examination in limited circumstances, known as telemedicine exceptions. The most 

common way telemedicine is allowed is when the patient is located 

in a DEA-registered hospital or medical clinic and is being treated 

by a DEA-registered provider located offsite. The problem is DEA 

has interpreted the hospital and clinic exception so narrowly that 

it often does not apply to community-based addiction and mental 

health centers. 

For an example, one patient at one of the Utah’s community addiction and mental health centers is in crisis. I am giving you an 

example here. The patient may need addiction treatment involving 

medication-assisted treatment with a controlled substance like 

Suboxone. The center is staffed with the social workers, nurses, 

counselors, and other licensed mental health professionals, sometimes including physicians. Due to shortages of providers in parts 

of Utah, the center where our patient is located rarely has a DEAregistered doctor onsite. But the center does have the ability to 

connect the patient to a DEA-registered addictionologist using telemedicine technology. The problem is my center is licensed by the 

Utah Department of Human Services as a drug and alcohol treatment agency, not licensed as a hospital or medical clinic by the 

Utah Department of Health, as the DEA requires. 

As such, my licensed center is unable to register with the DEA 

and the hospital or clinic telemedicine exception in the Ryan 

Haight Act doesn’t apply. Accordingly, we can’t provide the needed 

care to patients using telemedicine. Instead, we must wait for a 

DEA-registered doctor to go on the road to do an in-person physical 

examination before the patient gets a prescription for Suboxone or 

another controlled substance to treat their opioid addiction. This is 

just one illustration of the problem. 

As discussed in my written statement, there are many other examples of how the DEA’s narrow interpretation of hospital or clinic 

is keeping legitimate centers from treating patients utilizing telemedicine when controlled substances are needed. The Harper-Matsui bill aims to remedy this. 

Finally, although the opioid epidemic is the subject of today’s 

hearing, it is critical that the DEA allow centers to use telemedicine to treat other mental health conditions, too. This is discussed 

also further in my written statements. 

Thank you very much. I appreciate the opportunity to be here, 

and I am also willing to take questions. 

[The prepared statement of Mr. Nance follows:] 

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Statement by Richard Nance, LCSW 

Director of Utah County's Department of Drug and Alcohol Prevention and Treatment 

on 

Combatting the Oploid Crisis: Helping Communities Balance Enforcement and Patient Safety 

before 

Summary 

Committee on Energy & Commerce, 

Subcommittee on Health 

U.S. House of Representatives 

February 28, 2018 

The National Council for Behavioral Health appreciates and affirms the importance of the Ryan Haight Act. 

This Act is as important today as it was when it was passed in 2008. Our goal is to enable regulated community 

mental health and drug and alcohol treatment centers- facilities that are staffed by regulated and licensed 

healthcare professionals -to be able to comply with the Ryan Haight Act and in order to provide care to 

patients in need. The issue is that DEA's narrow interpretation of the Ryan Haight Online Pharmacy Consumer 

Protection Act is limiting community mental health and addiction treatment centers' ability to provide patients 

speedy and safe treatments that involve controlled substances for substance use disorder {SUD) and mental 

health conditions by utilizing telemedicine. 

The reason is simple: Legitimate community mental health and addiction treatment centers are currently 

unable to register with DEA as a "hospital or clinic" as required by the Ryan Haight Act because DEA has 

interpreted "hospital or clinic" to mean a state-licensed medical facility. The problem is that many community 

mental health and addiction treatment centers are not licensed as state medical facilities as DEA's 

interpretation requires; instead these legitimate patient care centers may be state-licensed but county-run, 

county-licensed, or even run by/through the local government itself. To comply with the Ryan Haight Act, 

these centers are asking for additional regulation and oversight by DEA so they can provide Americans access 

to SUD and other mental health therapies via telemedicine, as medically appropriate. 
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The Harper/Matsui draft legislation does just that, enabling community mental health and addiction treatment 

centers to register with DEA to provide care via telemedicine. The Carter/Bustos draft also provides for a 

mechanism to expand access to telemedicine treatments and will have the most impact if enacted in 

conjunction with the Harper/Matsui draft. 

Statement 

Chairman Burgess, Ranking Member Green, and Members of the Health Subcommittee, thank you for the 

opportunity to testify on an issue that is impacting community addiction and mental health treatment centers' 

ability to provide patients speedy and safe treatments for substance use disorder (SUD) and mental health 

conditions by utilizing telemedicine. Medically appropriate treatment for SUD and mental health conditions 

sometimes involves controlled substances. Unfortunately, today thousands of community addiction and 

mental health treatment centers across the country are unable to use telemedicine that results in the issuance 

of a prescription for a controlled substance due to the DEA's narrow interpretation of the Ryan Haight Online 

Pharmacy Consumer Protection Act (Ryan Haight Act). 

I appreciate the opportunity to speak for the 2,900 National Council for Behavioral Health member 

organizations that provide front-line addiction and mental health treatment across the country. We deeply 

appreciate Congress's interest in creating a pathway to enable legitimate community addiction and mental 

health treatment centers to register with DEA such that they may provide treatment for Americans in need. 

About the National Council for Behavioral Health 

The National Council for Behavioral Health is the unifying voice of America's health care organizations that 

deliver mental health and addictions treatment and services. Together with our 2,900 member organizations 
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serving over 10 million adults, children and families living with mental illnesses and addictions, the National 

Council is committed to all Americans having access to comprehensive, high-quality care that affords every 

opportunity for recovery. 

I am a Licensed Clinical Social Worker in Utah, and have been Director of Utah County's Department of Drug 

and Alcohol Prevention and Treatment (UCaDDAPT) since 1998. UCaDDAPT provides a comprehensive range of 

drug and alcohol prevention and treatment services, including medication-assisted treatment for substance 

use disorders (SUD), such as opiate addiction and abuse, as well as for co-occurring SUD and mental health 

disorders. UCaDDAPT also contracts for methadone treatment services. Utah County has a population of over 

600,000, and UCaDDAPT serves over 2,000 people per year. Over 40% of these are now being seen for opiate 

use disorders, and at any given time about 30% of those are receiving MAT in addition to counseling services. 

LEGISLATION IS NEEDED TO ENABLE COMMUNITY ADDICTION AND MENTAL HEALTH TREATMENT CENTERS TO USE 

TELEMEDICINE TO PROVIDE TREATMENT INVOLVING CONTROLLED SUBSTANCES 

The Problem 

Thanks to ever-expanding technological advances, telemedicine has the potential to improve access to care, 

while reducing costs and increasing patient and provider convenience. Unfortunately, today my center and 

many other legitimate community addiction and mental health treatment centers are unable use 

telemedicine to connect patients in our center with DEA-registered doctors. Here is why: 

The Controlled Substances Act, as amended by the Ryan Haight Act, allows for the issuance of a prescription 

for a controlled substance without a prior in-person patient medical evaluation in limited circumstances, 

known as telemedicine exceptions. The most common way for such telemedicine to be permitted is when the 
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patient being treated is located in a DEA-registered hospital or clinic and is being treated by a DEA-registered 

provider located off-site. See 21 U.S.C. 829(e)(3)(A).In order to register, DEA requires that hospitals or clinics 

be licensed by a state. See Appendix A, DEA Registration Form 224, Section 4. The state licensure requirement 

is not in statute, rather is a result of DEA's administrative application of the Act. The problem is, many 

community addiction and mental health treatment centers are unable to use telemedicine that results in a 

prescription for a controlled substance because they are not "state-licensed" according to DEA's 

interpretation. Many community addiction and mental health centers are licensed, certified, or otherwise 

formally overseen and recognized by their state, county, or municipality but do not meet the DEA's narrow 

interpretation. 

The National Council believes community mental health or addiction treatment facilities that are licensed, 

operated, authorized, or otherwise recognized by a state, county or municipality should be able to register 

with DEA for purposes of complying with the Ryan Haight Act. 

Especially given the oploid epidemic, the National Council continues to believe remote prescribing of 

controlled substances without a prior in-person medical evaluation should be limited to patients located in a 

DEA-registered facility, including community addiction and mental health treatment centers registered 

under the two draft bills sponsored by Representatives Harper and Matsui and by Representatives Carter 

and Bustos. Our concerns with removing the registration requirement and/or allowing patients to receive 

prescriptions for controlled substances via telemedicine while at their home or otherwise not in a care setting 

as currently permitted under the Act are outlined later in this statement. 

About Community Addiction and Mental Health Treatment Centers 

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In general, community addiction and mental health treatment centers are facilities that treat patients for 

mental health, substance use disorder, and other behavioral health needs. These centers, for the most part, do 

not dispense controlled substances.' 

There is no federal definition of a community mental health center or of an addiction treatment center 

applicable in all 50 states to clinics that serve patients from all payer sources. Rather, states, counties, and in 

some cases municipalities determine what qualifies as a legitimate center and how to regulate them. 

Sometimes centers are required to have state licenses; sometimes states establish and run the centers 

themselves as parts of the government; in other cases, centers are regulated by county or municipal 

governments. For example: 

1. In Utah: Community mental health and addiction treatment (MH/SUD) centers are overseen by the 

State Department of Human Services Office of Licensing. Utah has a county government-based 

addiction and mental health system, which means addiction and mental health services are services 

are delivered directly by county government, or are contracted out to one or more MH/SUD providers 

that are also under the purview of the state licensing department and are overseen by governing 

boards comprised of elected county government officials. 

2. In Texas- Community mental health centers (known as Community Centers) are governmental 

entities authorized in Texas statute and required by Texas law to treat individuals with severe and 

persistent mental illness throughout Texas. In their capacity as units of Texas government they do not 

require any additional state license to perform their state-mandated tasks. These centers are a critical 

component of the Texas health care system and already meet the intent of registration by virtue of 

their statutory authorization to perform the functions of Community Mental Health Centers with 

1 While rare, we are aware of at least one center that does dispense: the Josephine County, Oregon Health Department is the local 

behavioral health authority, and they operate a licensed methadone program -thus dispense controlled substances. 
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regard to psychiatric medications. The Texas Council of Community Centers represents 39 centers 

across Texas that were established by Texas statute and has spent multiple years working with DEA on 

behalf of its membership to secure DEA registration, with no resolution to date. See Appendix B for a 

discussion of these efforts. 

3. In Georgia- Community mental health centers (known as Community Service Boards) are quasigovernmental entities authorized in Georgia statute and required by Georgia law to treat individuals 

with severe and persistent mental illness. In their capacity as instrumentalities of Georgia government, 

they do not require any additional state license to perform their state-mandated tasks. These centers 

are a critical component of the Georgia health care system and they are already registered under 

Georgia law with regard to controlled substances. The CSBs of the Georgia Association of Community 

Service Boards are concerned about access to vital psychiatric services in schools (as delivered by 

school-based clinics in partnership with Community Service Boards) and rural areas. 

4. In Missouri- Community mental health centers operate across 25 service areas reaching the entire 

state. These providers are non-profit entities serving in a quasi-governmental role as administrative 

agents of the state responsible for a comprehensive array of mental health and addiction services in 

their catchment area. Though these centers do not have a state licensure number, they are certified 

and monitored by the state, are subject to detailed administrative rules outlining their certification 

criteria and obligations, and are closely overseen by a system of regional managers. 

The authorizing governmental body (e.g. states, counties) can determine the scope of services that are able to 

be provided in these centers and the professional qualification requirements of the centers' on-site staff. 

1. Types of Providers On-Site in Centers: Community addiction and mental health treatment centers may 

not always have doctors or psychiatrists on-site at all times. In these cases, it is common for centers to 

be staffed by social workers, nurses, counselors and other state-licensed mental health or addiction 

professionals that do not have prescribing authority. Staff at community addiction and mental health 
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treatment facilities are regulated by state and local laws, including any requirements for licensure (e.g. 

state nursing licenses, social worker licenses), education, and professional conduct. 

2. Scope of Services Provided in Centers: The types of services provided by community addiction and 

mental health treatment centers vary, but we do know that roughly 75% of the National Council's 

2,900 member organizations offer addiction treatment services. The number of organizations that 

strictly provide mental health treatment services without any addiction services is very slim. 

For example, Hill Country MHDD Centers serve 19 Texas counties and provide mental health, individual 

developmental disability, substance use disorder, and early childhood intervention services. These 

centers need the ability to register with DEA such they can bring in an addictionologist, addiction 

psychiatrist or child psychiatrist via telemedicine to prescribe to a patient on-site, when medically 

appropriate. 

The Impact an Patients During the Dpiaid Epidemic and Beyand 

The inability of legitimate community addiction and mental health treatment centers to use telemedicine 

has a direct impact on the lives of Americans. As this Committee understands, the demand for addiction and 

mental health services far exceeds current system capacity to serve patients. Telemedicine is a vital 

opportunity to extend both addiction and mental health treatment services to more patients, particularly 

those living in rural and frontier areas that lack qualified providers. 

There are only four medications commonly used to treat opiate use disorders. One of these- naloxone is 

only used for emergency reversal of opiate overdoses. Naltrexone- in oral or long acting injection form works 

well for some patients, but not for all. The other two- methadone and buprenorphine (also delivered as 

Suboxone, a formulation that includes buprenorphine combined with naloxone)- are controlled substances 

and a form of opiate medication themselves. Methadone is the longstanding gold standard for opiate addiction 
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treatment, but methadone treatment programs are subject to tight licensing, accreditation, and DEA oversight 

standards. These standards make the establishment of methadone treatment programs in rural and frontier 

areas economically non-viable. Buprenorphine/Suboxone can be prescribed by DATA 2000 certified physicians, 

but for several reasons, there are few Suboxone prescribers in rural and frontier areas. In Utah, there are over 

400 Suboxone prescribers on the DEA's list, however, many of these are not actively prescribing Suboxone. Of 

the remainder, many choose not to solicit new Suboxone patients, but only use their certification to prescribe 

to existing patients in their own practices. There are 506 registered buprenorphine prescribers in Utah and 28 

American Board of Addiction Medicine (ABAM)-certified physicians in practice (however, some of these only 

do pain management). Only 72 Suboxone prescribers can be found on the Suboxone.com website for Utah. 

Here is a real-world example from my practice in Utah: A patient at one of our rural licensed community 

mental health or addiction treatment centers is in crisis and needs addiction treatment involving a prescription 

for a controlled substance as part of his/her medication-assisted treatment (MAT). MAT is a highly effective, 

evidence-based treatment for opioid addiction that combines the use of medication with counseling and 

mental therapies. 

As common with community addiction and mental health treatment centers, my center is staffed with social 

workers, nurses, counselors and other mental health professionals, including a full time ABAM certified 

addictionologist. Due to shortages of providers and the rural and frontier nature of most of the rest of the 

state, many other community addiction and mental health centers do not regularly have DEA-registered 

doctors or psychiatrists on site who are certified, competent, or willing to prescribe MAT for opiate use 

disorders. 
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But thanks to advances in technology, we do have the technical ability to connect the patient to a DEAregistered psychiatrist via telemedicine. The problem is that because my center is licensed by our state 

Department of Human Services (not licensed by our state Department of Health as DEA requires of medical 

clinics), we are unable to register with DEA such that the Ryan Haight Act's telemedicine exception for 

"treatment in a hospital or clinic" would apply. 

As such, we cannot provide the patient his/her needed care; rather we must wait for a DEA-registered doctor 

to "go on the road." If we take Bluff, Utah, as an example, it can take up to ten hours round-trip including an 

overnight stay- to do the required face-to-face physical evaluation of the patient prior to writing the 

prescription. If Suboxone treatment is indicated, this requires the patient to fill the prescription then return to 

the office for a medically supervised induction process that takes up to 4 hours. For Dr. Elina Chernyak in my 

office to provide this service, she must forego seeing up to 48-60 of our own patients to see one in the rural 

setting- if the patient actually keeps the appointment. People in active opiate addiction are often 

disorganized, physically ill, and cognitively impaired to the point that they may be unable to keep or even 

remember their appointment. 

In the context of the opioid epidemic, the costs of this inefficiency can tragically be measured in lives lost from 

speedy access to MAT. We can also measure the cost in terms of dollars, as just for my Utah center alone we 

estimate it costs $490 in travel, lodging, and per diem and $1,400 in physician time to have Dr. Chernyak drive 

out to the center to do an in-person patient medical evaluation, prescribing, and Suboxone induction. In the 

winter in Utah, this could easily double or even have to be cancelled for safety reasons depending on road 

conditions. This is to see perhaps one patient, versus the 48-60 that she could see if she stayed in her office 

in Provo. Continuing care could be conducted via telemedicine procedures. 
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If the law were changed to permit our clinics to register with DEA, instead of this inefficient and high-cost 

workaround, we could provide consumers with more responsive, timely access to care. Currently, to evaluate 

and initiate Suboxone treatment, Dr. Chernyak must drive often quite lengthy distances for the first face-toface visit, with continuing patient care and consulting with the clinical staff being done via a secure HIPAAcompliant telehealth platform called Zoom. 

In contrast, when Suboxone is prescribed via telemedicine, we would follow a version of Vermont's hub and 

spoke model. The hub would be our office in Provo where our DEA-certified addiction medicine doctor- Dr. 

Chernyak- has her full-time office. The spokes could be one or more rural or frontier community MH/SUD 

health center(s) or federally qualified health center sites. At present we have contracts with Northeastern 

Counseling Center and Mountainlands Community Health Center in Vernal and Roosevelt, Utah that could 

serve as the spokes in this model. In addition to counselors and therapists, both these centers employ nursing 

staff who can monitor patients' first use of the medication (known as "induction") and immediately address 

any adverse reactions in partnership with the prescribing physician via telemediclne. Having a medical 

professional in the room with the patient is the standard practice for first-time use, or induction, of Suboxone 

and is in accordance with national best practices and guidelines established by ASAM. This is the only way we 

would consider practicing addiction medicine using Suboxone. We would never consider it advisable to see a 

patient over a non-secure platform such as Facetime when the patient was using the Wi-Fi at Starbucks, for 

instance. 

National Council Support for Federal Legislation 

The National Council appreciates the efforts this Committee, including Representatives Carter, Harper and 

Matsui, for putting forward draft legislation that would support the ability of legitimate clinics to register with 

DEA for purposes of complying with the Ryan Haight Act. Benefits of this approach include: 

10 
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1. Giving DEA transparency into and jurisdiction over the practices of health care locations not otherwise 

registered with the DEA under Section 303(f) but which nonetheless have patients on-site that need 

treatment via telemedicine involving the issuance of a prescription for a controlled substance. 

2. Balancing the burden that is placed on the health care provider with a corresponding onus on the 

center where the patient is located. Providers already must be registered with DEA in order to 

prescribe controlled substances. 

3. Continuing DEA jurisdiction over both parts of the treatment- the provider and the center- which 

both benefits the Agency's enforcement abilities and is consistent with the Ryan Haight Act's "belt and 

suspenders" approach of allowing telemedicine treatment in a hospital or clinic registered with the 

DEA. 

As for how to accomplish this goal, we defer to Congressional leaders on the best approach but share some 

considerations: 

1. Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f) does not capture what community 

addiction and mental health treatment centers do. These centers typically do not dispense controlled 

substances and do not conduct research. Accordingly, we fear that the addition of community 

addiction and mental health treatment centers to Section 303(f) will not solve our problem. 

2. As an alternative, Paragraph (54) of section 102 of the Controlled Substances Act (21 U.S.C. 102) could 

be amended to make clear that legitimate community addiction and mental health treatment centers 

shall be eligible to register with DEA just like state licensed hospitals and clinics currently can. For 

example: 

"{i) while the patient is being treated by, and physically located in-

"(/) a hospital or clinic registered under section 303{f); or 

11 
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30411.065

"{II) a community mental health or addiction treatment center registered for purposes 

of this subparagraph." 

Plus at the end: 

"The Attorney General shall register community mental health or addiction treatment facilities 

that are licensed, operated, authorized, or otherwise recognized by a State, county, or 

municipal government for purposes of treatment via the practice of telemedicine as described 

in subparagraph (A)" 

3. We appreciate the draft Harper/Matsui bill allows centers to use telemedicine to treat patients for all 

types of addiction and mental health conditions, not just SUD. While the opioid epidemic is the 

nation's most pressing public health issue and the subject of this hearing, the National Council wishes 

to emphasize the importance of allowing community addiction and mental health treatment centers to 

use telemedicine to treat other mental health conditions too, not just SUD. There are two reasons for 

this: 

a. There is a legitimate public health need to improve access to mental health services generally. 

According to federal health authorities, there are roughly 4,000 areas nationwide where there 

is only one psychiatrist for every 30,000 patients. Further, the American Academy of Child and 

Adolescent Psychiatrists, (AACAP) reports there are approximately 8,300 practicing child and 

adolescent psychiatrists in the U.S. - and over 15 million youths in need of one. Telemedicine 

can be part of the solution to this provided shortage, but currently the Ryan Haight Act limits 

mental health providers' ability to treat mental illness because of restrictions on stimulants 

that are commonly used in psychiatric treatment for both children and adults. 

b. Many treatment centers provide both addiction and mental health services, and not all states 

certify, recognize or otherwise authorize addiction and mental health treatment centers in the 

same way. In some states there are two separate certifications (one for mental health 

12 
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30411.066

treatment services and another for addiction treatment services), while other states provide a 

single certification for community providers offering both types of services. Therefore, to be 

inclusive of the full universe of community providers who offer addiction treatment services, 

the legislation cannot narrow the scope to simply "addiction" providers as this would exclude 

many of the organizations who currently provide both addiction and mental health care. 

4. We also support the approach outlined in the Carter/Bustos draft, which requires DEA to act swiftly to 

implement a "special registration" and note that we continue to believe that the patient who is being 

treated by telemedicine should be located in a DEA-registered facility. It is our hope that such a special 

process would be inclusive enough to apply to community addiction and mental health treatment 

clinics, though we fear that if the registration process is implemented too narrowly it could continue to 

exclude these treatment providers. It is possible that DEA could implement the "special registration" in 

such a way as to still require "state licensure" of hospitals and clinics, or to otherwise draft regulations 

that would continue to exclude legitimate community addiction and mental health treatment centers 

from being able to use telemedicine for controlled substance treatment. If that were to occur, centers 

that are licensed, operated, authorized, or otherwise recognized by a State, county, or municipal 

government would still be shut out from being able to provide effective health care options to patients 

in need. The Carter/Bustos draft bill will have the most impact if enacted in conjunction with the 

Harper/Matsui draft bill that clearly specifies community mental health and addiction providers as a 

category of centers eligible to register with DEA. 

5. We support requiring patients to be treated via telemedicine while located in a DEA-registered 

location (hospital, clinic, center). The draft Harper-Matsui bill simply makes clear that legitimate 

community addiction and mental health treatment centers shall be eligible to register with DEA just 

like hospitals and clinics. 

13 
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30411.067

Allowing patients to receive prescriptions for controlled substances via telemedicine outside of a 

legitimate care setting would erode the Ryan Haight Act and invite rogue online pharmacies posing as 

telemedicine providers into the market. The National Council worries rogue actors would see this as a 

market opportunity to offer controlled substances based on a prescription issued via "telemedicine," 

but instead of providing real patient care, rogue sites would simply sell prescriptions on demand for 

controlled substances. Such a result is opposite of Congress's intent, of course, and contrary to the 

Ryan Haight Act itself, but a foreseeable consequence of allowing online prescribing of controlled 

substances to patients outside of legitimate care settings. As true when the Ryan Haight Act was 

passed in 2008, illegal online dispensing/prescribing of controlled substances is still a problem today: 

a. In February 2018 the National Association of Boards of Pharmacy (NABP) reported that 54% of 

the online pharmacy websites they surveyed were selling controlled substances. This is a 

substantial jump from the 13% of all sites NABP has reviewed and listed as "Not 

Recommended" in the past nine years that were selling controlled substances. 

b. The Alliance for Safe Online Pharmacies estimates that there are roughly 30,000 active online 

drug sellers operating at any one time. If NABP's finding that 54% of sites sell controlled 

substances holds true for the full online pharmacy market, that would mean more than 15,000 

sites offer controlled substances at any one time. 

c. The U.S. Senate Permanent Subcommittee on Investigations January 2018 report evidences 

how easy it is to buy illicit, mail-order opioids online. Investigators for the Subcommittee 

posed as would-be online buyers, entering terms like "fentanyl for sale" into Google and used 

payment information to track more than 500 US-lin ked transactions from these illegal sites. 

d. Just last week a group of Senators led by Ryan Haight Act sponsor Senator Feinstein and 

Judiciary Chairman Senator Grassley sent a letter to Go ogle, Microsoft, Pinterest and Yahoo 

discuss the rise illegal online sale of controlled substances. 

14 
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Therefore, the National Council urges Congress to not authorize online prescribing of controlled 

substances to patients not located in a DEA-registered facility-whether an existing DEA-registered 

facility or a center registered pursuant to the Harper/Matsui or Carter/Bustos bills-as such risks 

making the opioid epidemic worse. 

Conclusion 

Thank you again for considering my testimony in support of the draft Harper/Matsui and Carter/Bustos bills 

that would enable legitimate community addiction and mental health treatment centers to register with DEA 

to be able to use telemedicine that involves issuance of a prescription for a controlled substance. Changing this 

law will have immediate and measurable impact on the lives of countless Americans seeking treatment options 

for mental health conditions and substance use disorder. I appreciate your time and attention to this 

important public health issue. 

Appendices 

Appendix A: DEA Registration Form 224, for hospitals and clinics 

Appendix B: Memo from Texas Council of Community Centers describing previous efforts to register 

community mental health centers with DEA, drafted April 2016 

15 
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30411.162

Form-224 

MAIL-TO ADDRESS 

SECTION 2 BUSINESS ACTIVITY 

APPLICATION FOR REGISTRATION 

Under the Controlled Substances Act 

IMPORTANT DO NOT SEND THIS APPLICATION AND APPLY ON-LINE 

Please print mailing address changes to the right of the address in thls box 

National Provider Jdentiflcation 

l:C~I ~J:~:r ~ Practitioner 

APPROVED OMB NO 1117-0014 

FORM DEA-224 (04-12) 

FORM EXPIRES: 01/3112016 

Do you have other DEA registration numbers? 

Ll NO L'] YES 

-i'EE-FORTHREE-(3)-vEARs-iS-$7:iTFEE IS NON-REFUNDABLE 

{ODS, OMO, DO, DPM, DVM. or MD} 

irf~~~~~~,r D~~~~~ DVM, or MD) 

; Mid-level Practitioner (MLP) ' (DOM, HMO, MP, NO, NP, 00, PA, or RPH) 

FOR Automated Dispensrng System (ADS) ONLY 

DEA Registration # 

of Re.tail Pharmacy forth1sADS 

SECTION 3 DRUG SCHEDULES 

Checkallthatapply 

Schedule 2 Narcotic 

Schedule 2 Non-Narcotic (2N) Schedule 3 Non-Narcotic (3N) 

Check this box if you require official order forms- for purchase of schedule 2 controlled substances NEW -Pagel 
127 


30411.163

SECTION 4 

STATE LICENSE(S) 

MANDATORY 

Besuretomcludeboth 

statehcensenumbers 

SECTION 5 

State License Number 

State Controlled Substance License Number 

What state was this license issued in? 

Expiration 

Date 

Expiration 

Date 

LIABILITY 1, Has the applicant ever been convicted of a crime in 9(?nnE!ctiqn with C'?n!rolled substance(s) under state or federal law, or t;>een exc_luded or directed to be excluded from partiCipation 1n a medtcare or state health care program,or IS any such act1onpendmg? 

Date(s) of incident MM-DD-YYYY: 

IMPORTANT 2. Has ~he apphcan\ ever s.urrendered (fo~ cause) or had a federal controlled substance registration revoked, suspended, restncted, or demed, or 1s any such act1on pendmg? 

oate(s) of incident MM-DD-YYYY· :·.:~~'""" .••.• "'t" "' ,,:_,_:I""'C':":,~.,,, 3 Has the applicant ever surrendere~ (for cause) or had a sta~e prof~ssional license_ or controlled substance registration revoked, suspended, denied, restncted, or placed on probation, or 1s any such act1on pending? 

Date{s) of inc1dent MM-DD-YYYY: t:·~.:t:~ j-- ·" L.:J ~""'~I~J:.·.· ( "'·'l ~~~lr!~~~i~~~~~·~r,co~~rporation whose stock is owned and ~j ~~~~~~~~~{re';ilerr~~rf~~rc~~~~.c~ ded, restricte , d~nied, or ever had a state. profttsSIOnall spended, den1ed, restncted or placed on probat1on, or ts any such act1on pendmg? 

Date(s) of incident MM-DD-YYYY: 

EXPLANATION OF "YES" ANSWERS 

Applicants who have 

Liability question# __ 

answered "YES" to Nature of incident anyofthefourquestions 

above must provide a statement to explain each "YES" answer. 

Useth1sspace or attach a separate sheet and Disposition of incident: return with application 

SECTION 6 EXEMPTION FROM APPLICATION PSIS 

Location(s)ofin<:-idcnt: ______ :....,. ________ _ 

YES NO 

r· 1 

YES NO 

YES NO 

YES NO 

i,] Check this box if the applicant is a federBl,_state, or l!fcal government official or institution. Does not apply to contractor-operated institutions 

METHOD OF PAYMENT 

Checkoneformof 

payment only 

Signlfpayingby 

cred1tcard 

SECTION 8 

APPLICANT'S 

SIGNATURE 

S1gn 1n mk 

Sig,natur-e :of certifymg ofllclal (other than applicant) 

Signature of Card Holder 

Printed Name of Card Holder 

I certify that the foregoing information furnished on this application is true and correct 

Signature of applicant (sign in ink) 

Print or type name and t1t!e of applicant 

Date 

Teleph ne No. (reqUired lor venficat1on) 

Date 

Mail this form with payment to 

DEA Headquarter 

AITN: Registration Section/CDR 

P.O. Box 2639 

Springfield, VA 22152-2639 

FEE IS NON-REFUNDABLE 
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30411.164

Form- 224 APPLICATION FOR REGISTRATION SUPPLEMENTARY INSTRUCTIONS AND INFORMATION 

SECTION 1. APPLICANT IDENTIFICATION -Information must be typed or printed in the blocks provided to help reduce data entry errors. A physical address is required ir1 

address line 1: a post office box or continuatlon of address may be entered ir1 address line 2. Fee exempt applicant must list the address of the federal or state fee exempt 

institution. 

Applicant must enter a valid social security number (SSN), or a tax identification r~umber (TIN) if applying as a business entity. Debt collection information is mandatory 

pursuant to the Debt Collection Improvement Act of1996. 

The email address, point of contact, national provider id, date of birth, year graduated, and professional school are new data items that are used to facilitate communication 

or as required by inter-agency data sharing requirements. They are requested in order to facilitate communication or as required by inter·agency data sharing requirements. 

Practitioner must enter Ofle degree from this list: DDS, DMD. DO, DPM, DVM, or MD. 

Mid-level practitioner must enter one degree from this list DOM, HMO, MP, NO, NP, 00, PA, or RPH. 

SECTION 2. BUSINESS ACTIVITY ·Indicate or~ly one. Practitioner or mid-level practitioner must enter the degree conferred, and are requested to enter the last 

professional school of matriculatior~ and the year graduated 

Automated dispensing system (ADS) must provide current DEA registration number of parent retail pharmacy or hospital, and attach, a notarized affidavit in 

accordance with 21 CFR Part 1301.17. Affidavit must include: 

1 Name of parent retail pharmacy or hospital and complete address 

2. Name of long-term Care (l TC) facility and complete address 

3. Permit or license number(s) and date issued of State certification to operate ADS at named LTC facility 

4, 
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30411.165

Form· 224 APPLICATION FOR REGISTRATION 

·CONTINUED· 

SUPPLEMENTARY INSTRUCTIONS AND INFORMATION 

SECTION 4. STATE LICENSE(S) ·Federal registration by DEA is based upon the applicant's compliance with applicable state and local laws. Applicant should contact the 

local state licensing authority prior to completing this application. If your state requires a separate controlled substance number, provide that number on this application. 

SECTION 5. LIABILITY· Applicant must answer all four questions for the application to be accepted for processing. If you answer "Yes' to a question, provide an 

explanation in the space provided. If you answer 'Yes· to several of the questions, then you must provide a separate explanation describing the date, location, nature, and 

result of each incident. If additional space is required, you may attach a separate page, 

SECTION 6. EXEMPTION APPLICATION FEE • Exemption from payment of application fee is limited to federal, state or focal government official or institution. The 

applicant's superior or agency officer must certify exempt status. The signature, authority title, and telephone number of the certifying official (other than the applicant) must 

be provided. The address of the fee exempt institution must appear in Section 1. 

SECTION 7. METHOD OF PAYMENT -Indicate the desired method of payment. Make checks payable to 'Drug Enforcement Administration•. Third-party checks or checks 

drawn on foreign banks will not be accepted, FEES ARE NON-REFUNDABLE. 

Card holder signature in section7does not fulfill this 

Notice to Registrants Making Payment by Check 

Authorization to Convert Your Check: If you send us a check to make your payment, your check will be converted into an electronic fund transfer. "Electronic fund transfer" 

is the term used to refer to the process in which we electronically instruct your financial institution to transfer funds from your account to our account, rather than processing 

your check. By sending your completed, signed check to us, you authorize us to ~opy your check and to use the account informa!ion from yo~r check to_ make an electronic 

fund transfer from your account for the same amount as the check. If the electroniC fund transfer cannot be processed for technical rea?ons, you authonze us to process the 

copyofyourcheck 

Your Rights: You should contact your financial institution immediately if you believe that the electrOnic fund transfer reported on your account statement was not properly 

authorized or is otherwise incorrect. Consumers have protections under Federal law callaO the Electronic Fund Transfer Act for an unauthorized or incorrect electronic fund 

transfer. 

ADDITIONAL INFORMATION 

No registration will be issued unless a completed application has been received {21 CFR 1301.13), 

The Debt Collection Improvements Act of 1996 (31 U.S.C, §7701} requires !hat you furnish your Taxpayer Identification Number {TIN) or Social Security Number (SSN) on 

this application, This number is required for debt collection procedures if your fee is not collectible. 

PRIVACY ACT NOTICE: Providing information othe(th~n your SSN or TIN is voluntary; however, failure to furnish it will preclude processing of the application, The 

authorities for coHection4this information are §§302 and 303 of the Controlled Substances Act (CSA) (21 U.S,C. §§822 and 823). The principle purpose lor which the 

information wl!! be used ls to register app!lcant& pursuant to the CSA. The information may be disclosed to other Federal law enforcement and regulatory agencies for law 

enforcement and regulatory purposes, State and focal laW enforcement and regulatory agencies for law enforcement and regulatory purposes, and persons registered under 

the CSA for the purpose of verifying registration:,for further guidance regarding how your information may be used or disclosed, and a complete list of the routine uses of this 

collection, please see the DEA System of Records Notice 'Controlled Substances Act Registration Records' (DEA-005), 52 FR 47208, December 11, 1987, as modified. 

Your Local 

DEA Office 

CONTACT INFORMATION 

All offices are listed on web site 

{800,877,and888aretoH-free) 

INTERNET 

www,deadiversion.usdoj.gov 

TELEPHONE 

HQ Call Cenler (800) 882-9539 

WRITIEN INQUIRIES: 

DEA 

Attn: Registration Section/ODR 

P.O. Box2639 

Springfield, VA 22152-2639 
130 


30411.166

BACKGROUND HIGHLIGHTS 

On April15, 2014, the Texas Council was notified of an unfolding DEA issue at one of our Community 

Mental Health Centers (CMHCs) regarding a determination by a Drug Enforcement Agency (DEA) official 

that the Center's DEA registered psychiatrist was out of compliance with the Ryan Haight Act (RHA) 

relating to prescribing controlled substances via tete-medicine. This raised substantial concern not only 

for the cited CMHC, but for CMHCs across the state, the majority providing tete-psychiatry services. 

Several attorneys surrounding the situation determined this DEA determination was a misunderstanding 

or misinterpretation of the RHA, noting the act exempts prescribing via tete-medicine. However, Texas 

Council legal counsel ultimately advised Texas CMHCs to accept the DEA determination and move 

toward resolution. 

1. Following multiple communications and a June 24, 2014 meeting in East Texas with 

representatives from Texas CMHCs, Texas Department of Public Safety (TDPS) and the Drug 

Enforcement Agency (DEA), agreement was reached that Texas CMHCs should register their 

clinics with the DEA in order to realize the tete-medicine exemption cited in the RHA. 

NOTE: TDPS had previously determined that Texas CMHCs were exempt from registration 

requirements due to their governmental status, but in the course of deliberations with CMHCs 

and the DEA, they came to understand why the registration was necessary due to the negative 

impact on Texas tete-psychiatry practices as a result of the Ryan Haight Act. 

2. As the registering authority in Texas, TDPS agreed to expedite Texas CMHC registrations and 

instructed the initial Texas CMHCs to register as Hospitals/Clinics on Form 224. On June 30, 

2014, the first Texas CMHC submitted the registration as instructed by TDPS (see attached). In 

July, Mr. Richard Boyd, DEA Registration Section Chief, denied the registration with the stated 

reason that the "license" number provided on the application was "invalid and therefore DEA 

determined your application to be defective and is withdrawn. Please resubmit your application 

once you have the proper state authority". 

NOTE: the Texas Council was not able to obtain from DEA officials (or locate) a regulatory 

requirement for an entity to be licensed in order to receive DEA registration. In multiple 

exchanges with Mr. Boyd he referenced the need for evidence of "the state authority" for 

CMHCs. Texas Council legal counsel provided Mr. Boyd with the statutory authority ofTexas 

CMHCs and advised him that TDPS conveyed this authority to the DEA by registering the Texas 

CMHCs, but this was not accepted by Mr. Boyd. 

3. Another round of communications culminated in a September 9, 2014 meeting in Houston 

between Texas Council legal counsel, representatives ofthe Texas Health and Human Service 

Commission (HHSC), DEA representatives (Mr. Boyd joined by conference call) and other 

stakeholders impacted by the application of Ryan Haight Act on tete-psychiatry in Texas. From 

this meeting, Texas Council legal counsel understood the DEA would accept a letter from state 

officials describing the related authority of Texas CMHCs. Thus began a lengthy endeavor to 

8140 North Mopac Expressway, Westpark Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: 512.794.8280 Web: www.txcouncil.com 
131 


30411.167

obtain a state agency letter describing the authority of Texas CMHCs, an endeavor that began 

with an educational process with Health and Human Services Commissioner and Department of 

State Health Services attorneys (who initially believed a registration path could be identified). 

4. After several months of dialogue between Texas Council, HHSC officials, HHSC legal counsel 

(and, we understand, Mr. Boyd), on January 12, 2015 the HHSC Executive Commissioner issued a 

letter to the DEA describing the statutory authority of Texas CMHCs (see attached). 

Refe re need Statute: http://www .statutes .legis. state. tx. u s/Docs/H S/htm /H S. 534. h tm 11534.001 

5. The e-mail exchanges below, between Sonja Gaines, Texas HHSC Associate Commissioner for 

Mental Health Coordination, and Mr. Boyd, DEA Section Chief, begins with Mr. Boyd's response 

to the January 12, 20151etter from Texas HHSC Executive Commissioner. As per this exchange, 

Mr. Boyd indicates that evidence oft he "state authority" for Texas CMHC can only be met if the 

state puts in writing that Texas CMHCs are hospitals operating without a license (with licensure 

waived by the state). He would not accept that the Hospital/Clinic category was the closest 

category TOPS (as the DEA registering authority in Texas) had available in their on-line 

registration and that Texas CMHCs used this category to apply for registration of their telepsychiatry clinics at the instruction of TOPS. 

6. Although Mr. Boyd contends that he made clear all along that "state authority" meant licensed 

hospital, others involved in the various communications with Mr. Boyd never understood this 

was what he required in order to register the Texas CMHCs. This realization by the Texas 

Council effectively ended the quest for a letter from a state agency that would satisfy Mr. Boyd 

as the state agencies were clearly not in a legal position to state that Texas CMHCs are operating 

as "hospitals without licenses". This realization also effectively ended Texas Council hopes that 

we could register Texas CMHCs under current DEA regulations, as applied by Mr. Boyd. 

7. On July 20, 2015 the Texas Council was notified that the DEA issued a notice of intent (excerpted 

below) to amend registration requirements to permit a special registration for "Practice of 

Telemedicine". 

Title: •Special Registration to Engage in the Practice ofTelemedicine 

Abstract: 

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) (Pub. L. 11 0-425) was enacted on 

October 15. 2008, and amended the Controlled Substances Act by adding various provisions to prevent the illegal 

distribution and dispensing of controlled substances by means of the Internet. Among other things, the Act required 

an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by 

means of the Internet, except in the case of practitioners engaged in the practice of telemedicine. The definition of the 

"practice of telemedicine" includes seven distinct categories that involve circumstances in which the prescribing 

practitioner might be unable to satisfy the Act's in-person medical evaluation requirement yet nonetheless has 

sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course 

of professional practice. One specific category within the Act's definition of the "practice of telemedicine" includes "a 

practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831 (h)]." 21 

U.S.C. 802(54)(E). The Act also specifies certain criteria that DEA must consider when evaluating an application for 

such a registration. However, the Act contemplates that DEA must issue regulations to effectuate this special 

registration provision. The DEA proposes to amend the registration requirements to permit such a special registration. 

8140 North Mopac Expressway, Westpark Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: 512.794.8280 Web: www.txcouncil.com 
132 


30411.168

SELECT E-Mail Exchanges 

[Texas HHSC Associate Commissioner Sonja Gaines & DEA Section Chief, Richard Boyd] 

From: Gaines,Sonja (HHSC) [mailto:Sonja.Gaines@hhsc.state.tx.us] 

Sent: Friday, February 06, 2015 7:30PM 

To: Danette Castle <dcastle@txcouncil.com>; Carvan Adkins <cadkins@toase.com> 

Subject: Fwd: New Pending app W15007375B 

Mr. Boyd got back with me. The dialogue is very promising. HHSC attorneys are actively engaged and 

working through me to get to a resolution. You can see the dialogue about waiving centers as hospitals. 

That may not be viable- attorneys working on an alternative I can present to Boyd. 

More next week! 

SONJA GAINES,MBA I ASSOCIATE COMMISSIONER 

Mental Health Coordination 14900 N. Lamar Blvd. I Austin, Texas 78751 

Office: 512.487.3417 Cell: 512-720-20861 sonja.gaines@hhsc.state.tx.us 

From: "Gaines,Sonja (HHSC)" <Sonja.Gaines@hhsc.state.tx.us> 

Date: February 6, 2015 at 11:31:09 AM PST 

To: "Boyd, Richard A." <Richard.A.Boyd@usdoj.gov> 

Subject: Re: New Pending app W15007375B 

Great-we will work on a communication and hopefully get back with you by next week. Again, thank you 

so much for your clarification and assistance. 

You have been a huge help. 

SONJA GAINEs,MBA I ASSOCIATE COMMISSIONER 

Mental Health Coordination 14900 N. Lamar Blvd. I Austin, Texas 78751 

Office: 512.487.3417 Cell: 512-720-20861 sonja.gaines@hhsc.state.tx.us 

On Feb 6, 2015, at 11:27 AM, "Boyd, Richard A." <Richard.A.Boyd@usdoj.gov> wrote: 

Yes- we would be able to use that letter in lieu of state license for proof that the 

state understands they will be operating as a DEA registered hospital and the 

state license is waived. 

Richard Boyd 

Section Chief 

DEA Registration and Program Support 

8140 North Mopac Expressway, Westpark Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: S12.794.8280 Web: www.txcouncil.com 
133 


30411.169

From: Gaines,Sonja (HHSC) [mailto:Sonja.Gaines@hhsc.state.tx.us] 

Sent: Friday, February 06, 2015 2:24PM 

To: Boyd, Richard A. 

Subject: Re: New Pending app W15007375B 

Mr. Boyd, 

Thanks so much for your assistance and the clarification. 

Dr. Janek is the Executive Commissioner over DSHS as well as other state agencies. Would a 

communication from Dr .Janek regarding the referenced written waiver a a hospital ,meet the outcome 

you outlined below? 

SONJA GAINES,MBA I ASSOCIATE COMMISSIONER 

Mental Health Coordination 14900 N. Lamar Blvd. I Austin, Texas 78751 

Office: 512.487.3417 Cell: 512-720-20861 sonja.gaines@hhsc.state.tx.us 

On Feb 6, 2015, at 10:53 AM, "Boyd, Richard A." <Richard.A.Boyd@usdoj.gov> wrote: 

Ms.Gaines- thank you for your prompt response. 

DEA issues a DEA registration predicated upon state authority (21USC 823). For hospitals in TX that 

requires a DPS license and a license from DSHS and if they have a pharmacy on the premises, than a 

state license from the BOP. 

The Community Centers are attempting to register with DEA without the state licenses as state 

authorized hospitals in order to conduct telemedicine, which requires, as an exception to the initial face 

to face dr/patient consultation, for the telemedicine to be conducted in a DEA registered hospital. 

This was all explained to them in the Sept video conference we had and DEA even offered that if they 

get DSHS to provide DEA with written waiver for getting a DSHS license as a hospital, DEA can use that as 

the state authority. I hope that helps 

Richard Boyd 

Section Chief 

DEA Registration and Program Support 

8140 North Mopac Expressway, West park Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: 512.794.8280 Web: www.txcouncil.com 
134 


30411.170

-----Original Message-----

From: Gaines,Sonja (HHSC) [mailto:Sonja.Gaines@hhsc.state.tx.us] 

Sent: Thursday, February OS, 2015 10:00 PM 

To: Boyd, Richard A. 

Subject: Re: New Pending app W15007375B 

Mr. Boyd, 

Thank you for your communication. Texas HHSC is committed to working with DEA to solve this 

registration dilemma. I have no doubt that the Texas Community Centers should be registered with DEA 

just as they are already registered with the Texas Department of Public Safety. You are correct that they 

are not hospitals, however, it is my understanding that DPS instructed the community centers to check 

the hospital box on the DPS form as that is the closest business activity label available on the DPS 

application. 

These Community Centers are in fact governmental entities required by Texas law to treat individuals 

with severe and persistent mental illness throughout Texas. In their capacity as units of Texas 

government they do not require any additional state license in order to perform their state mandated 

tasks. These centers are a critical component of the Texas health care system and they are already 

registered under Texas law with regard to controlled substances. It is critical that they be registered 

with the DEA in order to comply with federal law. We just need to figure out how to make that happen. 

You stated in your email communication that Commissioner Janek did not mention a waiver from the 

Texas hospital licensing requirements. As these centers are not required to be licensed as hospitals 

there is nothing to be waived by HHSC. I am unclear regarding your request for language waiving a 

requirement that does not exist under Texas law. HHSC is committed to working with DEA toward a 

viable solution to this registration dilemma, but I need your help in understanding why Commissioner 

Janek's January 12, 2015 letter was not sufficient for your purposes. Your assistance with what the letter 

needs to say is appreciated. 

Thank you, 

SONJA GAINES,MBAI ASSOCIATE COMMISSIONER Mental Health Coordination 14900 N. Lamar Blvd. I 

Austin, Texas 78751 

Office: 512.487.3417 Cell: 512-720-20861 sonja.gaines@hhsc.state.tx.us 

8140 North Mopac Expressway, Westpark Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: 512.794.8280 Web: www.txcouncil.com 
135 


30411.171

-----Original Message-----

From: Boyd, Richard A. [mailto:Richard.A.Boyd@usdoj.gov] 

Sent: Thursday, February 5, 2015 9:59AM 

To: Gaines, Sonja (HHSC) 

Cc: Sullivan, Lisa D.; Carter, Ruth A.; Mullins, Robert E.; Giacoppo, Maureen; Adams, Carolyn B. 

Subject: FW: New Pending app W1500737SB 

Ms. Gaines- your name was listed on Dr Janek's letter as the POC for the attached issue. After reading 

the attached, I believe some pertinent facts were omitted in the discussion surrounding the issuance of 

a DEA registration for the state MH/MR facilities. 

Several MH/MR have submitted DEA applications as a hospital to obtain a DEA registration as a Texas 

hospital. All of these applications have been denied since there was no state licenses issued to those 

facilities by the DSHS, DPS and the BOP. All of the 1,378 hospitals in Texas have those licenses, including 

other state operated facilities. 

The federal Controlled Substance Act 21 USC 823 requires that the entity registering with the DEA, for a 

DEA registration. to obtain state authority before the DEA can issue a registration. Numerous 

discussions /email have reiterated this requirement to the MH/MR facilities and their attorney. To date 

these facilities have not properly registered with the Texas authorities to recognize their authority to 

operate as a hospital under Texas law. Since these facilities have no state licensure, DEA cannot issue a 

DEA registration for the MH/MR as hospitals. 

Dr Janek correctly pointed out that the MH/MR must comply with all applicable laws and regulatory 

requirements regarding controlled substances. To date MH/MR has failed to comply with both state and 

federal requirement to obtain a DEA registration. The attached letter contains no waiver of Texas 

requirements to be licensed as a hospital. 

Please let me know if you have any other questions. 

Richard Boyd 

Section Chief 

DEA Registration and Program Support 

8140 North Mopac Expressway, West park Building 3, Suite 240, Austin, Texas 78759 

Tel. 512.794.9268 Fax: 512.794.8280 Web: www.txcouncil.com 
136 

Mr. BURGESS. Thank you, Mr. Nance. 

Mr. Cosgrove, you are recognized for 5 minutes, please. 

STATEMENT OF THOMAS J. COSGROVE 

Mr. COSGROVE. Thank you, Chairman Burgess, Ranking Member 

Green, and members of the subcommittee, for the opportunity to 

testify today. My name is Tom Cosgrove. And until last year, I was 

an official at the Food and Drug Administration responsible for 

current good manufacturing practice enforcement and compliance 

within the Center for Drug Evaluation and Research, or CDER. 

In that role, I was responsible for ensuring manufacturing quality and compliance for the thousands of drug manufacturing facilities around the world that make medicines distributed in the 

United States. Since December of 2017, I have been a partner at 

the law firm of Covington & Burling here in Washington. Covington represents a number of clients in the food, drug, and cosmetics industries that use tableting and encapsulating machines. 

The subject of the draft bill under consideration, which is the 

Tableting and Encapsulating Machine Regulation Act of 2018, but 

the views expressed today here are my own. 

I share Congress’ and the public’s concern about the opioid abuse 

epidemic and am encouraged to see so much action in Congress and 

society at large aimed at ending the crisis. In my role at FDA, I 

was aware of the acute problem of the importation of illicit opioids, 

opioid analogues, and synthetic drugs from overseas from international mail facilities. This appears to be a different issue, however, than the use and regulation of tableting and encapsulating 

machines in the United States. 

Virtually all manufacturers of solid oral drugs in the United 

States use tableting or encapsulating machines in some form, at 

least as those terms are defined under the draft bill. This includes 

prescription, nonprescription, and many animal drugs covering everything from innovative new drugs to OTC products that people 

use daily. In addition, dietary supplement manufacturers commonly use tableting and encapsulating machines as part of their 

manufacturing processes. 

One need only walk down the health and wellness aisle of the 

local supermarket to get a sense of the ubiquity of products manufactured using tableting and encapsulating machines. Furthermore, 

tableting machines are often used in the manufacture of candy, cosmetics, and certain household products such as cleaning agents. 

Were the draft bill to be enacted as now written, lawful domestic 

manufacturers using tableting and encapsulating machines to 

produce legally marketed, noncontrolled products, including 

nondrug products, they would be subject to the CSA’s strict requirements for controlled substances. 

A straightforward reading of the draft bill at hand would appear 

to require manufacturers to register with the DEA and with state 

authorities in each location that they hold or operate a machine. 

Manufacturers apparently would need to store tableting and encapsulating machines in secured areas, such as the ones used to safeguard controlled substances themselves. This includes things like 

electronically-monitored safes, steel cages, or vaults that meet certain specifications. 

137 

Manufacturers hoping to dispose or replace malfunctioning machines could need to transfer machines to companies specifically 

registered by DEA to render those machines nonretrievable. In addition, manufacturers might need to comply with additional recordkeeping and paperwork requirements each time they move a machine. Such requirements, if enacted, could cause domestic manufacturers to incur direct costs of machine registration, recordkeeping, security, and disposal, and indirect costs from training, 

education, and audits to ensure compliance. 

We live in a time also where there is enormous pressure on drug 

manufacturers to move their operations overseas for cost reasons. 

In fact, one of FDA’s main challenges today is keeping up with the 

pace and explosion of drugs being manufactured overseas in places 

like India and China. 

Ironically, the draft bill would burden most of the companies that 

have nothing to do with opioids or other controlled substances because these companies would need to establish CSA compliance 

systems from scratch. Furthermore, Congress has already amended 

the CSA to give DEA special authority to regulate tableting and 

encapsulating machines. 

In 1988, Congress passed the Chemical Diversion and Trafficking 

Act, or the CDTA. That act is described in the written testimony 

of Ms. Gibson, who testified earlier today, and I won’t recap that 

here. 

If Congress decides that enhanced regulation of tableting and encapsulating machines is needed. I would encourage a more tailored 

approach that builds on existing authorities. First, I would want to 

better understand why DEA’s existing CDTA authorities are not 

sufficient. One potential further approach would be to consider 

amending the CDTA, such that companies would also register 

equipment with DEA beyond only reporting transactions. This 

could be tethered with an appropriately crafted exemption for firms 

regulated by FDA. This way, DEA could develop a more robust 

database of tableting and encapsulating machines so that perhaps 

thousands of companies around the United States would not suddenly be regulated as if they were holding controlled substances. 

If Congress decides to move forward on this or any similar proposal, I would be happy to serve as a resource in deliberations 

going forward. Thank you for the opportunity to testify today. I 

would be happy to take any questions. 

[The prepared statement of Mr. Cosgrove follows:] 

138 


30411.069

Testimony of Thomas Cosgrove. Covington & Burling LLP (Feb. 28. 2018) 

Before the House E&C Health Subcommittee on the "Tableting and Encapsulating 

Machine Regulation Act of 2018" 

Thank you to Chairman Burgess, Ranking Member Green and Members of the Subcommittee 

for the opportunity to testify today. My name is Thomas Cosgrove, and until late last year, I was 

an official at the Food and Drug Administration (FDA) responsible for Current Good 

Manufacturing Practices (CGMP) enforcement and compliance within the Center for Drug 

Evaluation and Research (CDER). In that role, I was responsible for ensuring manufacturing 

and quality compliance for the thousands of drug manufacturing facilities around the world that 

make medicines distributed in the United States. Since December of 2017, I have been a partner 

at the law firm of Covington & Burling LLP. Covington represents a number of clients in the 

food, drug, and cosmetics industries that use tableting and encapsulating machines, the subject 

of the draft bill under consideration, but the views expressed today are my own. 

I am here today to testify on what I think could be the unintended consequences of the draft bill, 

the "Tableting and Encapsulating Machine Regulation Act of 2018" and to suggest perhaps a 

more tailored approach. From my prior role as an FDA official, I have a perspective on the 

overlapping systems of regulation applicable to manufacturers of drugs, dietary supplements, 

and other products regulated by FDA. As the Director of the Office of Manufacturing Quality at 

FDA CDER, I supervised the review of FDA drug facility inspections and made decisions within 

CDER on whether to recommend administrative or civil enforcement actions in cases of 

significant regulatory violations. Many of the cases reviewed in the Office of Manufacturing 

Quality involved tableting or encapsulating operations in the United States and abroad. The 

Office of Manufacturing Quality was also responsible for enforcement decision making under 

the Food, Drug and Cosmetic Act (FDCA) in connection with manufacturers of approved and 

lawfully manufactured controlled substances. 

I share Congress and the public's concern about the opioid abuse epidemic and am encouraged 

to see so much action in Congress and society at large aimed at ending the crisis. In my role at 

FDA, I was aware of the acute problem of the importation of illicit opioids and opioid analogs 

from overseas through international mail facilities. This appears to be a different issue, 

however, than the use and regulation oftableting and encapsulating machines in the United 

States. 

The approach proposed in the draft bill is to regulate tableting and encapsulating machines the 

same as controlled substances. I am concerned that this approach would significantly and 

unnecessarily increase regulatory burdens on lawful U.S. manufacturers of tableted and 

encapsulated products. More importantly, it could harm patients and consumers by potentially 

disrupting the supply of medicines and other products, and at the very least it could increase 

consumer prices. I believe the Drug Enforcement Administration (DEA) should continue to 

investigate individuals who manufacture illicit substances using tableting machines and any 

future expansion ofthe regulation oftableting and encapsulating machines should be more 

narrowly tailored than the approach proposed in the draft bill. 

Virtually all manufacturers of "solid oral" drugs in the United States use tableting or 

encapsulating machines in some form. This includes prescription, nonprescription and many 

animal drugs, covering everything from innovative new drugs to OTC products that people use 

daily. In addition, dietary supplement manufacturers commonly use tableting and 

encapsulating machines as part of their manufacturing processes. For instance, the majority of 

vitamins sold in the United States are tableted or encapsulated. One need only to walk down the 
139 


30411.070

health and wellness aisle of a local supermarket to get a sense of the ubiquity of products 

manufactured using tableting and encapsulating machines. Furthermore, tableting machines 

are often used in the manufacture of candy, cosmetics and certain household products such as 

cleaning agents. The collective dollar value of these product sales in the United States is 

enormous and people use them every day. 

Tableting and encapsulating machines are essential to manufacture these products. A tableting 

machine operates by compressing a substance, generally a granulated powder mixture, using 

great force into the form of a solid tablet. An encapsulating machine is used to fill soft or hard 

gelatin capsules with a substance, generally granules, semi-solids or liquids. These machines 

are carefully designed to ensure that tablets and capsules are consistently the same size, shape, 

and weight. With respect to drugs, one of the jobs of FDA is to ensure through inspections that 

manufacturers making tablets and capsules are able to consistently deliver the same dose of 

drug to patients across the millions of unit doses they may manufacture. 

The Controlled Substances Act (CSA) and DEA's regulations have been carefully crafted to 

prevent controlled substances from being diverted for illegal activity while ensuring they remain 

available for legal medical and scientific uses. These laws designed to govern substances, 

however, may not be well suited to regulating tableting and encapsulating machines. The CSA 

requires sensible and careful control over controlled substances themselves throughout the drug 

manufacturing process, but it is unclear how such controls could sensibly apply to equipment 

used by countless U.S. manufacturers that supply necessary products to nearly all Americans. 

For example, were the draft bill to be enacted as now written, lawful domestic manufacturers 

using tableting and encapsulating machines to produce legally marketed, non-controlled 

products (including non-drug products) would be subject to the CSA's strict requirements for 

controlled substances. A straightforward reading of the draft bill at hand would appear to 

require manufacturers to register with the DEA and with state authorities in each location they 

hold or operate a machine. Manufacturers apparently would need to store tableting and 

encapsulating machines in secured areas such as the ones used to safeguard controlled 

substances themselves, such as electronically monitored safes, steel cages, or vaults that meet 

certain specifications. Manufacturers hoping to dispose of or replace malfunctioning machines 

could need to transfer machines to companies specifically registered by DEA to render the 

machines "non-retrievable." In addition, manufacturers might need to comply with additional 

recordkeeping and paperwork requirements each time they move a machine from one location 

to another, even between two company-owned properties within the same state. These 

requirements could be unworkable for manufacturers operating large industrial tableting and 

encapsulating machines integrated within production lines. 

Such requirements if enacted would greatly increase regulatory burdens for domestic 

manufacturers and make everyday products less available to consumers. For instance, although 

manufacturers of drugs and dietary supplements are already used to a high degree of regulation 

by FDA, additional requirements imposed by the draft bill could be costly and unwieldy. FDA 

inspects manufacturing facilities to ensure that equipment such as tableting machines are 

operating within the scope of Current Good Manufacturing Practices under applicable law and 

regulations. FDA does not, however, require registration of individual pieces of equipment. 

Drug, dietary supplement, and other manufacturers have a great deal of flexibility in selecting or 

changing out the equipment they use, which flexibility could disappear if this bill were enacted 

as drafted. 

2 
140 


30411.071

Regulating this equipment itself as a controlled substance could be a fundamental and expensive 

change. Domestic manufacturers could incur direct costs of machine registration, 

recordkeeping, security, and disposal and indirect costs from training, education, and audits to 

ensure compliance with the CSA. These additional burdens could increase the costs for 

manufacturers to produce their products in the United States compared to manufacturing their 

products abroad, where tableting and encapsulating machines would not be subject to the CSA's 

controlled substance requirements. We live in a time where there is already enormous pressure 

on drug manufactures to move their operations overseas for cost reasons. In fact, one of FDA's 

main challenges today is keeping up with the explosion of drugs manufactured overseas in 

places like India and China. 

Ironically, the draft bill would burden most the companies that have nothing to do with opioids 

or other controlled substances. Existing manufacturers of medicines that are controlled 

substances should already have systems in place to ensure that the controlled substances 

themselves are handled in accordance with DEA rules. Companies that have nothing to do with 

controlled substances now, which constitute the vast majority of companies that use tableting 

and encapsulating machines, would have to develop CSA-compliant systems from scratch. This 

could lead to higher costs to consumers and potentially even drug shortages. 

Furthermore, Congress has already amended the CSA to give DEA special authority to regulate 

tableting and encapsulating machines. In 1988, Congress passed the Chemical Diversion and 

Trafficking Act (CDTA). Under the CSA as amended by the CDTA, DEA already has a role in 

connection with the distribution, importation, or exportation of a tableting machine or 

encapsulating machine. Under existing law, each person selling a tableting or encapsulating 

machine must report the transaction to DEA. Each person must also file a report to DEA before 

importing or exporting a machine. DEA may deny entry to any unregistered shipment of 

tableting or encapsulating machines. 

The FDA also has broad powers to regulate drug manufacturing facilities using tableting and 

encapsulating machines under existing provisions of the FDCA. FDA regularly inspects 

manufacturing facilities to ensure that equipment, including tableting and encapsulating 

machines, is functioning properly and being used for legal activities. FDA has authority to take 

action if it encounters drugs being counterfeited, including counterfeited opioids and other 

controlled substances. From my own experience, I believe that FDA would be poised to take 

quick action in concert with DEA if it found a manufacturer under its jurisdiction illegally 

manufacturing a controlled substance. 

If Congress decides that enhanced regulation of tableting and encapsulating machines is needed, 

I would encourage a more tailored approach that builds on existing authorities. First, I would 

want to understand better why DEA's existing CDTA authorities are not sufficient. One 

potential further approach would be to consider amending the CDTA, such that companies 

would also register equipment with DEA beyond only reporting transactions. This could be 

tethered with an appropriately crafted exemption for firms regulated by FDA. This way, DEA 

could develop a more robust database of tableting and encapsulating machines, but perhaps 

thousands of companies around the United States would not suddenly be regulated as if they 

were holding controlled substances. If Congress decides to move forward on this or any similar 

proposal, I would be happy to serve as a resource in deliberations going forward. 

Thank you again for the opportunity to testify and I would be happy to take any questions. 

3 
141 

Mr. BURGESS. Thank you, Mr. Cosgrove. 

Dr. Kolodny, you are recognized for 5 minutes, please. 

STATEMENT OF ANDREW KOLODNY, M.D. 

Dr. KOLODNY. Thank you, Chairman Burgess, Ranking Member 

Green, and members of the Health Subcommittee, for the opportunity to testify today. And my name is Dr. Andrew Kolodny, and 

I am the Codirector of Opioid Policy Research at Brandeis University. I am also the Director of Physicians for Responsible Opioid 

Prescribing. My testimony today is on behalf of PROP, Physicians 

for Responsible Opioid Prescribing. 

As you all think about solutions to the opioid crisis, I think it is 

very important to frame the problem and to frame it the right way. 

I believe that the correct way to frame the opioid crisis is as an 

epidemic of opioid addiction. Not everyone who dies of an opioid 

overdose was suffering from opioid addiction, but the studies tell us 

that the vast majority of the people dying are opioid addicted. 

If we frame the problem the right way, as an epidemic of opioid 

addiction, the strategies, the big picture strategies, for bringing it 

under control become much more clearer. We really have to accomplish two things. We have to prevent more people from becoming 

opioid addicted, and we have to see that the people who are addicted are accessing effective treatment. 

When I say ‘‘epidemic,’’ I am not exaggerating. From 1997 to 

2011, there was a 900-percent increase in the number of people suffering from opioid addiction, and it is that increase in the number 

of Americans with opioid addiction that explains why we are experiencing record high levels of overdose deaths, why we are seeing 

a soaring increase in infants born opioid dependent, outbreaks of 

injection-related infectious diseases, and a flood of heroin and 

fentanyl into our communities. 

To bring the epidemic under control, we have to prevent new 

cases of the disease. That primarily is going to be through cautious 

prescribing. And I am going to focus the remainder of my statement on H.R. 2063, a bill to mandate prescriber education. 

Although I do not support the bill in its current form, I am 

strongly in favor of mandatory education for DEA registrants who 

intend to prescribe more than a 3-day supply of opioid analgesics. 

And I commend Representative Schneider and his cosponsors for 

introducing this legislation. The need for this law becomes clear 

when we look at the cause of our opioid addiction epidemic. And 

the CDC has been perfectly clear about why we are experiencing 

this epidemic. 

What the CDC has shown us—and we have got a slide up here. 

If you look at the slide, the green line at the top represents opioid 

consumption or prescribing in the United States. The red line represents deaths involving prescription opioids, and the blue line represents addiction involving prescription opioids. The CDC has really been saying that, as that green line went up, addiction and overdose deaths went up right along with it. As the prescribing increased, it has led to the epidemic that we have got today. 

The reason that that green line began to go up so rapidly, the 

reason the medical community began prescribing so aggressively is 

because we doctors were responding to a brilliant multifaceted 

142 

marketing campaign that changed the culture of opioid prescribing 

in the United States. Starting in the nineties, we began hearing 

that patients were suffering because we were too stingy with 

opioids. We began hearing that we should stop worrying about addiction, that even with long-term use, the risk of addiction was 

much less than 1 percent. 

We began hearing that opioids were safe and effective for conditions like low back pain, where the leading experts tell us they are 

neither safe nor effective. We would have been less gullible if we 

had just heard these messages directly from drug companies. But 

as we heard earlier, these messages came to the medical community from every different direction. In particular, we were hearing 

these messages from professional societies. 

The American Academy of Pain Medicine and the American Pain 

Society in 1997 put out a consensus statement calling for much 

greater use of opioids and claiming that the risk of addiction had 

been overblown, even that the risk of overdose deaths had been 

overblown. 

My greatest concern with H.R. 2063 is that it relies on these organizations and other professional groups with industry ties to provide the government-mandated prescriber education. One of the 

most important lessons from the crisis is the need for strict firewalls between pharmaceutical company marketing and medical 

education. Had marketing not been so cleverly disguised as education, we might not have an opioid addiction epidemic today. 

If we learn from our past mistakes, we will not rely on the same 

industry-funded professional societies that got us into this mess to 

provide the education we need to get out of it. It may be hard for 

you to believe that, in the midst of our opioid addiction epidemic, 

that doctors are still overprescribing, but we are. The United 

States continues to prescribe more opioids than any other country 

on Earth. 

Millions of dollars were spent misinforming the American medical community about opioids, but very little has been done to correct the record. That is why prescriber education must be made 

mandatory, and that is why the content for the education must be 

developed and administered by individuals and organizations who 

do not accept payments from pharmaceutical companies. Thank 

you. 

[The prepared statement of Dr. Kolodny follows:] 

143 


30411.072

Statement by Andrew Kolodny, MD 

Director, Physicians for Responsible Opioid Prescribing (PROP) 

Co-Director, Opioid Policy Research Collaborative, Brandeis University 

on 

Combatting the Opioid Crisis 

before 

Committee on Energy & Commerce, 

Subcommittee on Health 

U.S. House of Representatives 

February 28, 2018 

Chairman Burgess, Ranking Member Green, and Members of the Health Subcommittee, thank 

you for the opportunity to testify today on measures to address the opioid crisis. The opioid 

crisis is best understood as an epidemic of opioid addiction. When I use the term "epidemic" I 

am referring to the very sharp increase in the number of Americans suffering from opioid 

addiction that occurred over the past 20 years. From 1997 to 2011, there was a 900% increase 

in the number of Americans seeking treatment for addiction to prescription opioids. It is the 

increased prevalence of opioid addiction that explains why we are experiencing record high 

levels of opioid-related overdose deaths. It is the reason we are seeing heroin and fentanyl flood 

into our communities. It is the reason we have seen a soaring increase in infants bom opioid 

dependent and children entering the foster care system and outbreaks of injection-related 

infectious diseases and an impact on our workforce. 

When the opioid crisis is framed properly, as an epidemic of addiction, the strategies for 

bringing the epidemic to an end become clear. We must 1) prevent more Americans from 

becoming opioid addicted and 2) we must ensure easy access to effective addiction treatment. 

In particular, we must ensure that buprenorphine, the first-line treatment for opioid addiction, is 

easier to access than painkillers, heroin or fentanyl. At present access to buprenorphine is 

inadequate. Not enough doctors are able to prescribe it. And of those who do, very few accept 

commercial insurance or Medicaid. The patient's Medicaid or commercial insurance will pay for 

their buprenorphine prescription but patients must often pay out of their own pocket for the visit 

to the doctor. If we want more patients to seek treatment, it needs to cost less than a bag of 

heroin. Until that happens, I believe opioid overdose deaths will remain at historically high 

levels. 

I would like to focus the remainder of my statement on H.R. 2063 a bill to mandate prescriber 

education. Although I do not support the bill in its current form, I am strongly in favor of 

mandatory education for DEA registrants who intend to prescribe more than a 3-day supply of 

opioid analgesics and I commend Representative Schneider and his co-sponsors for introducing 

this legislation. 

The need for this law becomes clear when we look at the cause of our opioid addiction 

epidemic, a topic the Centers for Disease Control and Prevention (CDC) has been very clear 

about. The CDC has shown that a sharp increase in prescriptions for opioids resulted in a 

corresponding rise in addiction and overdose deaths. 
144 


30411.073

-Opioidsaleskg/10,000 

-Opioiddeaths/100,000 

- Opioid tre11tment admission.!/1 n,ooo 

1999 1000 2001 2001 2003 1004 2005 2006 2007 2008 2009 2010 

Yaar 

This is a CDC graph. The green line represents opioid prescribing, the red line represents opioid 

deaths, and the blue line represents opioid addiction. As the green line went up, as opioid 

prescriptions started to soar, it led to parallel increases in addiction and overdose deaths. 

The reason the green line began rising, the reason the medical community began prescribing so 

aggressively, is because we (doctors) were responding to a brilliant, multi-faceted marketing 

campaign that changed the culture of opioid prescribing. Starting in the 1990s, we began 

hearing that patients were suffering because we were too stingy with opioids. We began hearing 

that we should stop worrying about addiction. We began hearing that even with long-term use, 

the risk that a patient would get addicted was much less than 1%. We began hearing that 

opioids were safe and effective for chronic pain and that we could improve the quality of life in 

our patients if we prescribed more liberally. We began hearing that opioids are a gift from 

mother nature and should be used much more for just about any complaint of pain. 

We would have been less gullible if we were only hearing these messages from drug company 

sales reps. But we were hearing these messages from pain specialists eminent in the field of 

pain medicine, from the Joint Commission, which accredits our hospitals, and we were hearing 

these messages from our professional societies-all of whom had financial relationships with 

opioid manufacturers. More than any other organizations, it was efforts by American Pain 

Society and the American Academy of Pain Medicine that were most damaging. My greatest 

concern with H.R. 2063 is that it relies on these organizations and other professional societies 

with pharmaceutical company ties to provide mandatory prescriber education. 

One of the most important lessons from this crisis is the need for strict firewalls between 

pharmaceutical company marketing and medical education. Had pharmaceutical marketing not 

been so effectively disguised as education, we might not have an opioid addiction epidemic 

today. Professional societies with financial ties to pharmaceutical companies should not be 

offering government-mandated prescriber education. 

It may be hard for you to believe that in the midst of our opioid addiction epidemic, doctors are 

still overprescribing, but they are. The United States continues to prescribe far more opioids 

than any other country on earth. Millions of dollars were spent misinforming the American 

medical community about opioids. But very little has been invested in correcting the record. That 

is why prescriber education must be made mandatory. And that is why the content for the 

education must be developed and administered by individuals and organizations that do not 

accept funding from drug companies. 
145 

Mr. BURGESS. Thank you. 

Mr. Logan, you are recognized for 5 minutes, please. 

STATEMENT OF RICHARD N. LOGAN, JR. 

Mr. LOGAN. Chairman Burgess, Ranking Member Green, members of the subcommittee, thank you for holding this hearing on the 

opioid crisis. I am Dr. Richard Logan. I have been a community 

practice pharmacist since 1975 and currently own two pharmacies 

in southeastern Missouri. Oddly enough, in addition to my duties 

as a community practice pharmacist, I have spent the last 25 years 

as a Missouri certified police officer and am a recently retired prescription drug diversion investigator for the Mississippi County, 

Missouri, Sheriff’s Department. 

I am here today on behalf of the National Community Pharmacists Association to present some of my experiences and viewpoints focusing on viable solutions to prevent drug abuse and diversion while maintaining legitimate access of patients to needed 

medication. 

NCPA represents America’s community pharmacists, including 

owners of more than 22,000 independent community pharmacies 

just like mine. Our job as healthcare professionals is to help patients safely navigate medication-related treatment across multiple 

disease states. We are focused on positive outcomes and safe medication usage. 

Yet, as pharmacists, we struggle to meet these goals in the midst 

of an opioid epidemic that kills hundreds of people daily and over 

200,000 Americans since 1999. My flagship pharmacy is in Missouri. It is the first pharmacy across the Mississippi River on I-57 

and Highway 60 from Illinois, Tennessee, and Kentucky. My State 

has no adequate functioning PDMP and, as such, is a magnet for 

those who would abuse prescription opioids. 

It is not unusual for travelers to drive hundreds of miles from 

eastern Kentucky, Ohio, or other areas distant to me to visit a pill 

mill in Georgia or Florida and end up at my prescription counter 

with prescriptions for narcotics, lots of narcotics. Common sense 

tells me that somewhere between Kentucky, Florida, and Missouri, 

those folks have passed a pharmacy, but they end up at mine. 

I once investigated a traveler who had driven U.S. Highway 60 

across just southern Missouri, had seen eight physicians and visited 18 pharmacies in search of opioids. I served on many search 

warrant teams, made many arrests, some at my own prescription 

counter, had lots of convictions, dodged bullets in the line of duty, 

spent nearly 25 years fighting drug abuse, was responsible for putting together a bicounty prescription drug task force that led to 

many arrests, and still I feel like I have done nothing to stem the 

tide. It is just that overwhelming. 

All the while, as a practicing pharmacist, I go to bat for my legitimate patients who need opioid therapy so they can lead a productive life and not be denied therapy or declined therapy due to 

the stigma attached to opioid abuse. As the final checkpoint in the 

system of checks and balances, pharmacists play a vital role in ensuring all medications, including controlled substances, are appropriate for their patients. 

146 

Pharmacists are often the last professional an opioid patient sees 

and the first professional to realize that a patient is slipping into 

an abusive pattern. Pharmacists must monitor their patients and 

work in collaboration with other healthcare providers, understand 

the risks and benefits of opioid therapy, and keep the best interest 

of the patient at the center of all decisions. 

There are promising policies that Congress or the administration 

could move forward that would have a positive impact on mitigating or preventing abuse. One such policy is included in H.R. 

4275, the Empowering Pharmacists in the Fight Against Opioid 

Abuse Act, to provide for the development and dissemination of 

programs and materials for training pharmacists, healthcare providers, and patients on indicators that a prescription is fraudulent, 

forged, or otherwise indicative of abuse or diversion. This is not 

only a commonsense policy; it is one that fits in well with the DEA 

360 strategy to engage all of those involved with opioid treatment. 

NCPA supports such efforts to bring greater diversity and education to other healthcare providers and patients regarding a pharmacist declining to fill a controlled substance. NCPA offers itself as 

a resource, if necessary. Thank you. 

[The prepared statement of Mr. Logan follows:] 

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30411.074

United States House of Representatives Energy and Commerce Committee 

Subcommittee on Health Hearing 

"Combating the Opioid Crisis: Helping Communities Balance Enforcement ond Patient Safety" 

Written Testimony of: 

Richard N. Logan, Jr., PharmD, Pharmacist/Owner, Logan+ Seiler, Inc. 

Drug Diversion Investigator (Retired), Mississippi County Sheriff's Department, Charleston, Missonri 

On Behalf of the National Community Pharmacists Association (NCPA) 

February 28, 2018 

Chairman Burgess, Ranking Member Green and Members of the Subcommittee: 

Thank you for conducting this hearing on the opioid crisis and providing me the opportunity to share my views and 

personal experiences. My name is Richard Logan and I have been a community practice pharmacist since 1975, 

owning two pharmacies in Southeast Missouri. Additionally, I am a recently retired drug diversion investigator for 

the Mississippi County, Missouri Sheriff's Department. I have taught officers techniques of drug diversion 

investigation and have strived to raise awareness of prescription drug abuse in Missouri. 

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148 


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Page 2 

I am a member of the National Community Pharmacists Association (NCPA) and have been awarded the NCPA 

Prescription Drug Safety Award in recognition of my work in educating my community on the beneftis of the 

correct use of prescription drug products and the hazards associated with their misuse. 

NCPA represents America's community pharmacists, including the owners of more than 22,000 independent 

community pharmacies. Together they represent an $80 billion health care marketplace and employ more than 

250,000 individuals on a full or part-time basis. I am here today as a healthcare provider, small business owner and 

retired drug diversion investigator to present some of my experiences and viewpoints, focusing on viable solutions 

to prevent drug abuse and diversion while maintaining legitimate patient access, 

In this statement, NCPA would like to present thoughts on important issues surrounding the opioid epidemic and 

appreciates the opportunity to offer recommendations that should be considered to respond to the nation's opioid 

crisis. Independent community pharmacies play a critical role in ensuring patients have immediate access to 

medications. Our members have extensive knowledge and experience in caring for patients with chronic pain as 

well as those in their communities with substance use disorders. 

NCPA is committed to working collaboratively with Members of Congress, the Administration, and other 

stakeholders in adopting viable solutions to prevent drug abuse and diversion. Pharmacists ensure proper 

medication use and abide by the rules contained in the Controlled Substances Act. Pharmacists perform their due 

diligence each time they fill a prescription and have a corresponding duty of care as does the prescriber. 
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As the final check-point in the system of checks and balances, pharmacists play a vital role in ensuring all 

medications, including controlled substances, are appropriate for their patients, Community pharmacists play an 

increasingly important role in monitoring for signs of prescription drug abuse and criminal activity, and must 

separate prescription drug use, misuse, abuse, and criminal behavior. Most importantly, pharmacists must monitor 

all their patients and work in collaboration with other health care providers, keeping the best interest of the patient 

at the center of all decisions. 

Professional collaboration is key to ensure controlled substances are being prescribed and dispensed and used 

correctly. It may be the case where a prescriber is unaware of other controlled substance prescriptions a patient is 

taking and pharmacists need to communicate any concerns to the prescriber. 

NCPA participated several years ago in a coalition of stakeholder organizations representing the medical, 

pharmacist, and supply chain spectrum highlighting the challenges and "red flag" warning signs related to 

prescribing and dispensing controlled substance prescriptions. A consensus document was released with the goal 

of providing health care practitioners with an understanding of their shared responsibility to ensure that all 

controlled substances are prescribed and dispensed for a legitimate medical purpose, as well as to provide guidance 

on which red flag warning signs warrant further scrutiny. 

The consensus document is a good tool for healthcare providers, but at the end of the day pharmacists are not law 

enforcement officers. Criminals who engage in drug seeking behavior can be dangerous and it's important that 

pharmacists develop a relationship with local law enforcement and alert them when appropriate. 
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NCPA believes there are efforts in the marketplace that are currently making a difference in the battle against opioid 

abuse and are scalable. Also, there are promising policies that Congress or the Administration could move forward 

that would have a positive impact on mitigating or preventing abuse, without compromising legitimate patient 

access to needed pain medications. 

One such policy is included in H.R. 4275, the Empowering Pharmacists in the Fight Against Opioid Abuse Act, 

introduced by Representatives Mark DeSaulnier (D-Calif.) and Buddy Carter (R-Ga.), to provide for development 

and dissemination of programs and materials for training pharmacists, health care providers, and patients on 

indicators that a prescription is fraudulent, forged, or otherwise indicative of abuse or diversion. 

H.R. 4275 requires the Administrator of the Drug Enforcement Administration (DEA) work in consultation with 

the Secretary of Health and Human Services (HHS), the Commissioner of Food and Drugs (FDA), the Director of 

the Centers for Disease Control and Prevention (CDC), and the Assistant Secretary for Mental Health and Substance 

Use (SAMHSA), to develop and disseminate programs and materials for training pharmacists, health care providers 

and patients. The training programs and materials would discuss circumstances under which a pharmacist may 

decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, 

forged, or otherwise indicative of abuse or diversion. In developing the training programs and materials the DEA 

Administrator must seek input from relevant national, state, and local associations, boards of pharmacy, medical 

societies, licensing boards, health care practitioners, and patients. 
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NCP A supports such an effort to bring greater clarity and education to other health care providers and patients 

regarding a pharmacist declining to fill a controlled substance. Even though pharmacists currently have the right to 

decline filling any controlled substance as part of their corresponding responsibility per the Controlled Substances 

Act, it is important to educate patients and entities such as insurance companies and pharmacy benefit managers on 

such circumstances. 

It is also important for the DEA to provide greater clarity and update its regulations and guidance surrounding laws 

currently in place, such as Section 702 of the Comprehensive Addiction and Recovery Act (CARA), which amended 

the Controlled Substances Act to enable patients or physicians to request a "partial fill" of any Schedule II 

medication. However, it is our understanding that to date DEA has provided no clarity, updated regulations or 

guidance surrounding this provision. 

NCPA's other recommendations for solutions to address the opioid crisis include the following: 

Expand Consumer Access to Naloxone: NCPA supports and advocates for pharmacists to participate in wider 

distribution of naloxone under pathways approved by state regulatory boards. The least restrictive means to 

increasing access to naloxone is to allow pharmacists to directly prescribe. 

Establish Limits on Maximum Day Supply for Certain Controlled Substances: Federal or state based policies 

to limit initial fills of opioids should be standardized for consistent implementation, taking into consideration certain 

patient populations, such as hospice patients and those residing in skilled nursing facilities. 
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Any policy to limit initial fills of opioids should include a list of circumstances in which a prescriber be allowed to 

deviate from the mandate. 

Prohibit Certain Controlled Substances from Being Delivered to Patients via Physician Offices or via Mail: 

Prohibiting delivery of controlled substances to patients via physician offices or the mail is another policy that can 

have a positive impact on mitigating or preventing abuse by offering added assurances against diversion. Utilizing 

the triad of care between a prescriber, pharmacist and patient is vital with opioid therapies. 

Expand Electronic Prescribing of Controlled Substances: NCPA also supports expanding electronic prescribing 

of controlled substances via requiring prescriptions for controlled substances to be electronically prescribed where 

feasible. 

Enhance Prescription Drug Monitoring Programs: We also support enhancing prescription drug monitoring 

programs by increasing operability of robust electronic databases to track all prescriptions for controlled substances. 

National standards to provide timely, reliable information at point of prescribing and dispensing should also be 

leveraged. 

Increase Health Care Provider Education: Increasing health care provider education should be a priority. For 

any required prescriber education program, a verification infrastructure with minimal administrative burden should 

be considered. 
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For example, automatic checks related to prescriber status on completion of educational requirements prior to 

transmission of impacted prescriptions and mechanisms for pharmacists to be informed about the requirements of 

the program must be considered. We would offer the Transmucosal Immediate Release Fentanyl (TIRF) REMS 

program as an example. The pharmacist's role is to provide continuity of education and monitoring. 

Increase Use and Access to Medication Assisted Treatment: NCPA supports expanding practitioner eligibility 

for DATA waivers, including pharmacists. Advancement of the pharmacist's role in MAT for opioid use disorders 

can help improve access and outcomes, while reducing the risk of relapse. Pharmacists are already partnering with 

physicians to provide MAT. When such relationships form, pharmacists have taken the lead in developing treatment 

plans, communicating with patients, improving adherence, monitoring patients, identifying treatment options and 

performing tasks to alleviate the physician' burden. Thus, pharmacists have both the knowledge and experience to 

provide MAT but treatment is limited because of regulatory barriers. 

Expand the Ability of Pharmacies to Identify Individuals with Substance Use Disorders: Pharmacists should 

be allowed to participate in SBIRT or Screening, Brief, Intervention and Referral to Treatment activities. For 

example, Virginia Medicaid's Addiction Recovery Treatment Services (ARTS) is a transformative new benefit 

being offered for Medicaid patients. The benefit includes coverage for SBIRT provided by pharmacies. The purpose 

of SBIRT is to identify individuals who may have alcohol and/or other substance use problems. Following 

screening, a brief intervention is provided to educate individuals about their use, alert them to possible consequences 

and, if needed, begin to motivate them to take steps to change their behavior. 
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Conclusion 

NCPA greatly appreciates the opportunity to share our recommendations on ways to respond to the nation's opioid 

crisis. NCPA stands ready to work with all stakeholders to stem the growing tide of opioid abuse and overdose. 
155 

Mr. BURGESS. Thank you, Mr. Logan. 

And thanks to all of our witnesses for your testimony. It has certainly been insightful. 

At this time, I would like to yield to the gentleman from Oregon, 

the chairman of the full committee, for your questions. 

Mr. WALDEN. Thanks, again, Mr. Chairman, for your leadership 

on this issue and your subcommittee’s good work. 

And to all our witnesses, thank you for your testimony, it is very, 

very helpful in our work. 

I want to ask Chief Fowler, you provided a crime analysis report 

as part of your written testimony. The primary focus of the report 

is overdoses related to Spike or synthetic marijuana. Have you seen 

other synthetic drugs on the streets in your community? What has 

been the impact of these substances? And is synthetic marijuana 

the worst analogue drug on the streets of Syracuse, or do you have 

data that fentanyl and other opioids are worst? 

Chief FOWLER. So, currently, Spike, the one that I spoke about, 

is the one that we are having the most problem with. But fentanyl 

is certainly a tremendous problem, and it ranks second. 

Mr. WALDEN. Which is the most deadly? 

Chief FOWLER. Fentanyl is indeed the most deadly. We see the 

most deaths associated with overdoses with fentanyl. 

Mr. WALDEN. What is the practical effect with Spike? What happens when you come on a scene? 

Chief FOWLER. It is marketed as a synthetic marijuana, but it 

has a hallucinogenic effect. And what we see is people in what I 

could best term as psychosis. They are acting out in a very bizarre 

fashion, oftentimes violent, incoherent. And then they exhibit a 

number of medical issues in which they have to be addressed at the 

local hospital. 

Mr. WALDEN. Such as? 

Chief FOWLER. Rapid breathing. Some even pass right out after 

they have exhausted themselves from running around and acting 

in a very bizarre way. Sweating profusely. And I am not a medical 

expert—— 

Mr. WALDEN. Right. 

Chief FOWLER. I would imagine that everything that a company—a person’s heart rate rising, their blood pressure rising, I 

would imagine that that has some type of medical effects on a person, but I am not a medical expert, so I can’t tell you what those 

are. But the bizarre behavior and the violent behavior, that is 

something that I can really identify with. 

Mr. WALDEN. What is the youngest age that you have seen either—— 

Chief FOWLER. Quite young. 

Mr. WALDEN. What is that? 

Chief FOWLER. When this first came on the scene, what we discovered was that it was sitting right on the shelf in the local convenience stores. 

Mr. WALDEN. Now, wait a minute. It was what? 

Chief FOWLER. When it first came on the scene, it was sitting 

right on the shelf of local convenience stores in these very colorful 

packages, and I personally overheard a couple of high school students talking about why it is that they would choose to use Spike 

156 

over marijuana; it is because they happen to be on probation, and 

if they were to have to give a urinalysis test, that this substance 

would not appear. And so they were using this to get away with 

a probation violation. 

So our young people started to use this substance, and they were 

experiencing the same things that everyone else was, these episodes of psychosis there in the schools, on the streets. So we see 

all ages. 

Mr. WALDEN. So the legislation Mr. Katko brought to our attention and worked hard on is very focused on the fentanyl analogues? 

Mr. NANCE. Sure. 

Mr. WALDEN. In your police department’s experience, what other 

synthetic drugs do you think we should be addressing comprehensively by class? What else should we be looking at here? 

Chief FOWLER. Well, I think that all of the synthetic drugs that 

we can identify, we need to take a look at them because what is 

happening is, is that they are all appearing on our streets. The 

minute that we bring one substance under control, a different or 

another substance will pop up. And we have a simultaneous problem with Spike and fentanyl right now. 

Mr. WALDEN. And so, broadly speaking, do you feel like your department has the tools you need when your team comes across illicit synthetic drugs? The goal here is we want to get this right 

when we put this legislation together. So what are we missing here 

that would be helpful in your efforts? 

Chief FOWLER. Sure. Law enforcement is only as effective as the 

laws that we enforce. 

Mr. WALDEN. Right. 

Chief FOWLER. Let’s take Spike, for example, because that is 

what I have talked about the most. Right now, it is not scheduled. 

And the only thing that we can do is give people an appearance 

ticket for a local law violation for—— 

Mr. WALDEN. What does that mean, a local law enforcement violation? 

Chief FOWLER. Well, we went to our local legislators and had 

them enact a local ordinance to—— 

Mr. WALDEN. Against Spike? 

Chief FOWLER. Excuse me? 

Mr. WALDEN. Against Spike. 

Chief FOWLER. Yes. To make the substance illegal. And that is 

the charge that we utilize. 

Mr. WALDEN. What is the penalty? 

Chief FOWLER. It is a violation, so—— 

Mr. WALDEN. Oh, it is a traffic ticket, in effect. 

Chief FOWLER. Basically, sir. 

Mr. WALDEN. So it is not a deterrent, to speak of? 

Chief FOWLER. Not at all. Not at all. 

Mr. WALDEN. Thank you. 

And thanks again to the whole panel. You all have been most 

helpful in our work, and we are going to continue down this path, 

and we are going to get it right, and we are going to pass new laws 

so you have the tools you need to stop this to the best of your ability. But we need your input, so thank you very much. 

Chief FOWLER. Thank you, sir. 

157 

Mr. GUTHRIE [presiding]. Thank you. The chairman yields back. 

And the chair will recognize Ms. Castor from Florida for 5 minutes. 

Ms. CASTOR. Thank you very much, Mr. Chairman. And thank 

you to all the witnesses for being here this afternoon. 

Dr. Kan, in your testimony, you talk about the significant barriers to access for folks who are suffering from opioid addiction. 

And you call it, you say we have a significant addiction treatment 

gap in America. You cite the journal of the American Medical Association, a report in 2015 that says 80 percent of Americans with 

opioid addiction do not receive treatment. 

And a lot of you here have recommended some ways to tackle the 

problem. It seems like it is so piecemeal, though. These recommendations are good, to do a little more in telemedicine and 

buprenorphine formulations and distribution, but this is a public 

health crisis. And what I am hearing at home from parents and 

others, there is just no capacity out there. There is just no, even 

in the Affordable Care Act now, we have new requirements that insurance cover essential health benefits, including mental health. 

Under Medicaid, yes, you have some treatment options, but it is 

just not happening on the ground. So what else can you recommend 

to us to help improve the long-term treatment that so many Americans are going to need to tackle their addiction? 

Dr. KAN. Thank you for that question. I think telemedicine is one 

piece of the entire puzzle. There is a much broader puzzle when it 

comes to reducing stigma around the illness, that is part of the effect in this telemedicine, in that people don’t have to walk into a 

clinic and be publicly identified as being treated. 

In addition to that, we need to expand access to all forms of 

treatment, both different formulations and different avenues in 

which people can get that type of treatment. If I think about opioid 

use disorder as a physician, about 80 percent of the side effects is 

predicted by medications alone. Meaning that with medications, 

you can effectively reduce the risk for accidental overdose, and 

counseling is significant. It is incredibly important in changing people’s lives, but we need to create expanded access. We need to keep 

people alive. 

This is a position that has been considered the American Society 

of Addiction Medicine, and it is certainly a position that ASAM has 

taken in that we need to reach out to patients that we do not see. 

I don’t worry about the patient that is in my practice. I don’t worry 

about the patient that I am treating because they are in front of 

me, and I can monitor them and give them appropriate treatment. 

However, the person who leaves my practice or they disappear 

from care, I worry about because I know they are not receiving 

care. 

Ms. CASTOR. So Mr. Nance, you are on the ground doing this. 

What is it going to take for us, really, to make sure that the folks 

who need long-term treatment, receive that long-term treatment. 

Mr. NANCE. Well, Dr. Kan is right. The biggest problem we face 

is capacity. You mentioned this yourself, that was the beginning of 

your question. We have got the capacity in Utah to treat less than 

20 percent of the people that need drug and alcohol treatment. So 

workforce is a huge factor. If we don’t have the staff to deliver the 

services, we can’t provide the treatment. 

158 

Effective evidence-based treatments are important as well. And 

we strive very hard to identify those that we can afford, implement 

them, train our staff to implement them to fidelity—— 

Ms. CASTOR. So you are recommending to offset, we need to do 

more in workforce training for doctors, nurses, counselors? Is that 

part of it? 

Mr. NANCE. Yes, we need to provide more primary behavioral 

health staff, but other specialties that don’t deal primarily with 

drug and alcohol prevention and treatment services need more 

training and education on how to identify and refer someone to 

treatment and provide some of those treatments themselves. 

Ms. CASTOR. And Dr.Kolodny, you have cited some very stark 

statistics that we are now— what are your recommendations to 

really tackle the barriers to access for—JAMA says 80 percent of 

Americans with opioid addiction don’t receive any treatment. How 

do we get to that? 

Dr. KOLODNY. I very much appreciate that question. I think the 

only way we are going to get there is with a massive Federal investment in the billions. We have to create a treatment system 

that doesn’t really exist yet. 

The majority of the State-licensed drug and alcohol treatment 

programs don’t offer buprenorphine. Many of them don’t even have 

enough physician time to be able to prescribe buprenorphine. 

Among people who are getting it right now, even people with good 

insurance often have to pay out of their own pocket for the doctor’s 

visit, their Medicaid or their commercial insurance is only paying 

for the prescription. 

If we really want to see deaths start to come down, it has to be 

easier to get treatment than it is to get a bag of dope. If someone 

who is opioid-addicted when they wake up in the morning, they are 

going to need to use. Many people will have something by the bedside because they are going to be feeling very sick when they start 

to wake up. If they have got $20 in their pocket and they know 

where they can go get heroin, even if it has got fentanyl in it, that 

is what they are going to do. And if finding a doctor is more expensive and more difficult, we are not going to start to see overdose 

deaths start to come down. 

So we really have to build out a system that doesn’t exist, and 

I don’t see any other way other than investing billions for that system. 

Ms. CASTOR. Thank you very much. I yield back my time. 

Mr. BURGESS [presiding]. The chair thanks the gentlelady. The 

gentlelady yields back. The chair recognizes the gentleman from 

Kentucky, Mr. Guthrie, 5 minutes for questions, please. 

Mr. GUTHRIE. Thank you very much, Mr. Chairman. And thank 

you all for being here. This is very informative. 

And, Dr. Kan, I have a question for you. Thank you for your insightful testimony. Knowing that you have firsthand experience 

treating patients with opioid addiction, as well as utilizing telemedicine builds your credibility both as a practitioner and a witness. 

My questions will be two. When using medication-assisted treatment, how common is it for you to pair this medicine with cognitive 

behavioral therapy? And is it important that any changes to the 

159 

Ryan Haight that increases access to medicated-assisted treatment 

not be so tailored that the result unintentionally cuts off behavioral 

therapy? 

Dr. KAN. Thank you for those questions. So the answer to your 

first question, how often do I combine treatment with therapy, and 

you mention cognitive behavioral therapy, which is a very specific 

type of therapy, but we use multi-modal therapies that we pick because of the patient assessment, what is it that they need? And 

within my practices, within the VA, within my company, it is 100 

percent. One hundred percent of patients receive psychotherapeutic 

intervention. 

The second question—I am sorry, I forgot the second question at 

this point. 

Mr. GUTHRIE. The second question, is it important that any 

changes to Ryan Haight that increase access to medicated-assisted 

treatment not be so tailored that the result unintentionally cuts off 

behavioral therapy? 

Dr. KAN. I think that the room for psychotherapeutic intervention should always be available. And when we talk about the qualified practice setting within the data—2016 amendment, it does 

cover those things that the people have the capacity to provide the 

therapy, if it is indicated. 

Mr. GUTHRIE. Thank you. And I have a question for Dr.Mulder. 

Thank you for your testimony and for the Michigan Home Care 

Hospice Association support for the Safe Disposal of Unused Medication Act. 

In your testimony, you note that roughly 98 percent of hospice 

care days are provided in a patient’s residence. You go on to explain that at a moderate-sized hospice care with 2,000 patients per 

year, approximately 1 million pills will be prescribed per year. 

So a series of questions: If 98 percent of these prescriptions, 

roughly 1 million pills are going into homes, isn’t this statistic 

alone enough to validate the need for safe disposal? Is it your belief 

that safe disposal would reduce the likelihood of misuse or diversion? And are you able to give some examples of safe disposal that 

hospice workers have used in the past or currently use in States 

that allow this type of—— 

Dr. MULDER. Yes. Yes. And I will give you some examples. 

Mr. GUTHRIE. Perfect. 

Dr. MULDER. So going back a few years, as I mentioned, I have 

had the privilege of working in the hospice industry for over 30 

years. And so we have seen, it is very, very common in past years, 

a nurse would come out, she would declare the death, she would 

sit and work with the bereaved family. And then with a witness, 

she would either crush and flush the pills, or in case of liquid 

opioids, just put them down the sink and turn the faucet on. That 

is what they did. 

In later years, when they said, oh, maybe we shouldn’t be doing 

the flush thing, that they would, most of the nurses would carry 

kitty litter in their trunk, and they would bring in some of that. 

They would crush the pills and the liquid and just mix them with 

kitty litter, take it back and dispose of it back at the office. I suppose it ended up in a landfill somewhere, but I don’t really know. 

But that is how they did it in the past. Since I had—— 

160 

Mr. BURGESS. Will the gentleman yield for 1 minute. 

Mr. GUTHRIE. Yes, I will yield. 

Mr. BURGESS. We also have the EPA under our jurisdiction. Be 

careful. They might be watching. 

Dr. MULDER. I understand. 

Mr. BURGESS. I yield back. 

Dr. MULDER. You didn’t hear that from me. 

But, again, that is in the past. That is in the past. And I think 

some of the more recent strategies are simply because of that. 

They just didn’t want opioids winding up in our water supply 

and our landfills. And so, more recently when the laws were 

amended and changed and introduced, that restricted the personnel, who could really take back medications, that really put the 

hands off. And I want to say that goes back to about 2013 or 2014, 

2013 or 2014. I don’t remember the exact dates of the legislation, 

so that is how they did it in the past. 

I don’t know how they are doing it in States that they currently 

allow that but now—and there has also been another trend that we 

saw developing, where patients families would say, oh, you can’t 

touch that, that is mine now. He died, but I inherit everything that 

was his. And so those are my pills, and you may not touch them. 

Mr. GUTHRIE. Well, thank you for your testimony. And it is certainly an area, when you start looking at the volume, that we have 

to address. And so I appreciate my friends from Michigan for bringing this forward. 

Dr. MULDER. Thank you. 

Mr. GUTHRIE. And I yield back my time. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. The chair recognizes the gentlelady from California, 

Ms. Matsui, 5 minutes for questions. 

Ms. MATSUI. Thank you, Mr. Chairman. As I mentioned in my 

question to DEA, the purpose of the discussion draft I am working 

on with Representative Harper is to expand access to treatment 

where it is not currently available. We are seeking to do this within the current Ryan Haight telemedicine prescribing framework. 

Mr. Nance, you are familiar with the community behavior health 

clinic system in Utah and see a need for additional access to remote prescribing for the patients you serve. Can you expand upon 

the need that you see for more access to medication-assisted treatment and the challenges that clinics and their patients face? 

Mr. NANCE. Sure. Here is a visual representation of one of the 

challenges. This is a pretty good shot of the road from Moab down 

to Blanding, Utah. From my office to Blanding is about a 300-mile 

drive. There are about 4,000 people that live in Blanding. If someone down there has an opioid addiction problem and rural and 

frontier areas have a higher rate than the rest of the country in 

general for opioid addiction problems, their access to treatment is 

very, very limited. 

So I kind of hang out with some farmers from time to time. 

Ms. MATSUI. OK. 

Mr. NANCE. And one of the funny things I have heard one of 

them say was, the darn beavers can irrigate better than I can, but 

the water has got to the end of the row. So we need to have access 

to telehealth treatment so that if a client shows up in the commuVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00166 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
161 

nity behavioral health center in Blanding and needs opioid addiction treatment, that that can be provided for them through a physician that may be located in Provo or Salt Lake, or some other place 

along the Wasatch front where the majority of the population of the 

State lives. 

If we can’t do that, we are going to have a higher death rate than 

we already do. We had 600 last year in the State of Utah, 187 of 

those were heroin, and all the rest were preparation opioids. So we 

need to be able to have qualified, certified license addiction medicine professionals to be able to provide services in those small outlying towns across the country, not just in Utah. 

Ms. MATSUI. So you are dealing with putting doctors on the road 

to do in-person exams, is that right? 

Mr. NANCE. Yes, I am sorry to interrupt you. If my 

addictionologist was to drive to Blanding, it would take her 2 days 

away from the office to possibly see one patient, if that patient 

showed up. People with opioid disorders typically are sick and disorganized and cognitively impaired. They have a difficult time 

keeping appointments. That would take the ability away for her to 

see somewhere between 48 and 60 patients in my own office and 

would cost us close to $2,000 in her time and travel time and overnight stay to be the able to see that one patient. 

Ms. MATSUI. So you mentioned it is important for the committee 

to allow telemedicine to be used for mental health treatments as 

well, not just substance use disorder. Why is that? 

Mr. NANCE. Same thing. In rural Utah, there aren’t that many 

psychiatrists to go around. Right now we have been doing telehealth through Project Echo with the University of Utah as kind 

of a platform to do that. The same thing happens in New Mexico. 

And it is pretty easy for a child psychiatrist, for instance, and there 

are even fewer of those than there are addictionologists in the 

State, to be able to use telehealth technology to evaluate a patient 

at that remote site. 

But if they are going to write a prescription for a controlled substance, like a benzodiazapine for an anxiety disorder, or ADHD for 

attention deficit and hyperactivity disorder, that face-to-face issue 

still exists under the Ryan Haight Act. 

Ms. MATSUI. OK. Could I just address some concerns that have 

been expressed? 

Now, you expressed strong support for preventing fraudulent remote prescribing. Obviously, they all do. There may be concerns 

that opening a new pathway to registration for non-DEA-registered 

clinics may lead to fraudulent prescribing. We need to ensure that 

there are sufficient requirements on both the clinic with a patient 

present and a doctor doing the prescribing remotely. For clinics you 

represent, how are the authorized, and what is the regulatory oversight they undergo? 

Mr. NANCE. That is a very good question, too. We are licensed 

by the Utah State Department of Human Services. We have a licensing inspection every year. We also get an inspection from the 

Utah Medicaid program. We also get a contract compliance audit 

from the Utah Department of Human Services, and a peer-review 

visit. We get at least 3 or 4 oversight visits every year. 

162 

So our centers are licensed, our staff are licensed. And what I am 

proposing we do is kind of an agency-to-agency practice model. It 

is very similar to the Vermont hub and spoke model. You may be 

familiar with that. If you are not, you ought to look that up. 

Ms. MATSUI. OK. 

Mr. NANCE. It is on addictionpolicy.org, I believe, website. And 

Vermont is kind of small. I think the furthest distance between one 

side and another might be 100 to 150 miles. It is a lot further than 

states on the left. 

Ms. MATSUI. Well, I have a lot of questions, but I also know we 

will be working on discussion drafts, so I will be hopefully conferring with you and others on the committee. So thank you very 

much for that. 

Mr. NANCE. And the National Council staff will be happy to be 

a resource for you as well. 

Ms. MATSUI. Thank you. 

Mr. NANCE. It is just up on K street. 

Mr. BURGESS. The gentlelady yields back. The chair would observe that Project Echo was a product of the Energy and Commerce 

Committee. 

The chair now recognizes Dr.Bucshon from Indiana, 5 minutes 

for questions, please. 

Mr. BUCSHON. Thank you, Mr. Chairman. Dr.Kan, Section 303 of 

CARA, the Comprehensive Addiction Recovery Act was something 

that meant to expand available treatment and give patients information basically on what their treatment options are. It also included requirements for individual treatment plans and other 

things. How is SAMHSA doing with implementing, you know, the 

new, some of the changes that were made in CARA? 

Dr. KAN. I probably couldn’t comment on how SAMHSA is doing. 

I think Dr. McCants Kats could probably provide some of that testimony, but my understanding, is that they are making affirmative—— 

Mr. BUCSHON. I have already asked her so. 

Dr. KAN. OK. I would defer to her on the answer. 

Mr. BUCSHON. All right. OK. I didn’t like her answer, but that 

is OK. 

Mr. Nance. 

Mr. NANCE. You want me to answer the same question? 

Mr. BUCSHON. Yes. 

Mr. NANCE. Well, this has been a great thing—— 

Mr. BUCSHON. I mean, are you getting good guidance from 

SAMHSA after CARA was—— 

Mr. NANCE. Yes, what SAMHSA has done is transmitted the 

guidance to the Utah State Department of Substance Abuse and 

Mental Health. 

We had several meetings back in the spring of 2017. The funding 

was made available to us. We had to write applications for that 

that complied with what the State guidance was. 

Mr. BUCSHON. Yes. 

Mr. NANCE. So it has been really helpful. I had 10 hours a week 

of physician prescriber prior to the CARA Act and the 21st Century 

Cures Act. Now I have her full time. The physician I had on contract with before would not prescribe buprenorphine for me. Now, 

163 

I have a full-time physician that will prescribe buprenorphine and 

that we can make available to other parts of the State. 

Mr. BUCSHON. OK. Now, HHS would increase the therapy—the 

number of people. Has that been implemented? I mean from 100 

to any practice to HHS—— 

Dr. KAN. Yes, that has. Both on an ongoing basis for people who 

are qualified but also in emergent circumstances when people 

reach 100 patient cap. 

Mr. BUCSHON. OK. That is good to hear. Doctor—yes go ahead. 

Dr. SUBBIAH. I would just add something to that. I think the caps 

have been increased, but if you look at the physicians or healthcare 

providers who have been waivered, not many of them are prescribing up to capacity. Because it is not only stigma of disease, we 

have to overcome also stigma of treatment—— 

Mr. BUCSHON. Understood. 

Dr. SUBBIAH [continuing]. And taking care of these patients. 

Mr. BUCSHON. Yes, I agree. In fact, this next question is for you. 

For long-acting buprenorphine, are insurance companies and CMS 

paying for this? 

Dr. SUBBIAH. This product, Sublocade, just got approved at the 

end of last year and it is going to be on the market in March. 

Mr. BUCSHON. It got approved by FDA, right? 

Dr. SUBBIAH. FDA. 

Mr. BUCSHON. Yes, that is different than CMS? 

Dr. SUBBIAH. Yes. So it is not, right now, in the market yet. It 

will be in the market starting in March. 

Mr. BUCSHON. Yes, I am just asking, did CMS give a coverage 

decision on it? 

Dr. SUBBIAH. Not yet. 

Mr. BUCSHON. Not yet. Because what we are finding in a lot of 

areas in healthcare right now as we get FDA-approved products, 

both drugs and devices, and then we get delayed payment decisions 

from CMS, which is preventing access to patients. So that is a big 

problem. If that is the case, I would appreciate knowing about that 

because we try to have some impact on that. 

Dr. Kolodny, I was interested in your testimony talking about 

continuing education for physicians. Is there anything the Federal 

Government can do to encourage, maybe, what I would call groundlevel training, which is not after people who are already out of 

medical school and practicing, but I have been talking with the Association of American Medical Colleges, for example, about implementing more training programs for assessing pain and properly 

treating pain in medical schools, and then certainly residency programs. 

I mean, do you have any thoughts on that? 

Dr. KOLODNY. You know, I think the bigger problem are the older 

doctors, not the docs coming out of training. Doctors who are in 

their 20s and 30s, they have come of age during our opioid addiction epidemic. Many have lost friends to opioid overdoses. They are 

much less likely to fall for the nonsense that you can prescribe 

long-term and a patient won’t get addicted. 

The bigger problem are doctors my age and older—— 

Mr. BUCSHON [continuing]. Who had it drilled into them for 15 

years that we need to prescribe more and more. 

164 

Mr. BUCSHON. Right. And I commented on that during the testimony from the DEA. I am in that boat. I went into practice in 

1995. We all understood that. 

Dr. Kan, last question real quick. The existing laws in-person 

medical evaluation as well as allowable exemptions, you explained 

in your testimony that the in-person evaluation committee excepted 

if a patient is being treated by and physically located in a DEAregistered hospital or clinic or a patient is being treated by and in 

the physical presence of another DEA-registered practitioner, does 

this narrow exception cause geographic access problems—and you 

may have answered this in part—particularly for patients in rural 

areas that cannot physically get to a DEA-registered hospital or 

clinic or a DEA-registered practitioner? 

Dr. KAN. I am speaking on behalf of ASAM. So ASAM does not 

have a position on this specific issue. I will say in my practice, we 

lose 20 percent of our patients because we can’t get a physician to 

them between the time that they call and our 72 hours that we set 

out the goal to meet with them. And we send the physicians to the 

patients. We don’t require the patients to travel to us. 

Mr. BUCSHON. Understood. Thank you. I yield back, Mr. Chairman. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. The chair recognizes the gentleman from Texas, Mr. 

Green, 5 minutes for questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. Cosgrove, your testimony was basically not to make it harder 

to import these pieces of equipment that make pills is that correct? 

Mr. COSGOVE. Well, I don’t think it is necessarily that. I think 

my testimony really is focused on making sure that legitimate 

users of tableting and encapsulating machines are not suddenly 

stuck with the requirements of the CSA, the Controlled Substances 

Act. 

Mr. GREEN. OK. 

Mr. COSGROVE. I think there can be ways for importation to be 

monitored and blocked in appropriate circumstances, but what we 

don’t want is thousands of facilities around the country to suddenly 

have controlled substances within their walls. 

Mr. GREEN. Well, for example, I assume some company in the 

United States actually produces these machines also? 

Mr. COSGROVE. I believe that is correct. I think some of them are 

also imported from Germany and other countries. 

Mr. GREEN. OK. Dr.Beardsley, I want to thank you for sharing 

your experience as a researcher because this is the Health Subcommittee, and we are proud of our efforts to try and plus up NIH 

funding. 

You noted in your testimony, it will take over a year to obtain 

a Schedule I registration. I heard from others that the requirements associated with Schedule I substances such as storage and 

security requirements can be cost prohibitive, in some instances, be 

a disincentive for researchers to examine these substances for their 

therapeutic value. 

You note in your testimony the confusion in the application process and delay in obtaining an approved registration inhibits reVerDate Nov 24 2008 12:03 Jan 30, 2019 Jkt 037690 PO 00000 Frm 00170 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-103 CHRIS
165 

searchers, especially young researchers, from commencing research 

with drugs of abuse and from dedicating their careers to study. 

To what extent does this confusion in the process and other hurdles you mentioned, protocols, registration, costs, obtaining institutional support, inhibit researchers and institutions from taking up 

projects with Schedule I substances? 

Mr. BEARDSLEY. Well, thank you for that question. There is a 

huge hurdle in becoming a Schedule I registrant, for instance. The 

application process entails submitting security requirements, detailing how much drug you will be using in your protocol. In my 

case, I work with laboratory animals. I have to identify how many 

doses I will be giving each animal and what routes of administration. I have to estimate the amount of drug I will be administering 

to be approved with the protocol. 

And just that point is particularly difficult to estimate the 

amount of drug one needs to do research. 

Mr. GREEN. Well, I only have 5 minutes. 

Mr. BEARDSLEY. Oh, I am sorry. 

Mr. GREEN. We heard from HHS, however, that H.R. 2851 attempts to streamline the researcher registration process. But we 

heard from HHS that there may still be, constitute a barrier to research that may have negative impact on drug development. 

Could you reiterate why you think this and what steps we can 

to remove those hurdles, and clearly getting bumped between Virginia and the DEA on which one registration you get first. That 

seems pretty silly. We ought to be able to deal with that. 

Mr. BEARDSLEY. Right. First off, with SITSA, a drug can be put 

into Schedule A only based upon structure. That is problematic because there are many drugs that have similar structures, some of 

which are drugs of abuse, some of which are antidotes to those 

drugs of abuse. 

So if a drug is scheduled, it is really a disincentive for a researcher to begin conducting research with that drug. If the drug 

is in the schedule for no other reasons than its structure, we will 

never know whether it is a drug of abuse or a breakthrough medication. So that is one instance in which scheduling a drug just 

based on structure can be a disincentive for conducting research 

with these drugs. 

And for younger researchers to go through the hurdles of obtaining the Schedule I registration, for instance, that is yet another 

hurdle. 

Mr. GREEN. Well, we don’t want to do anything that would eliminate the potential for research, because that is the other thing that 

we want to do. But be that as it may, we will see what we can do. 

Dr. Kolodny, do you believe requiring 12 hours of continuing education every 3 years is a practical requirement for healthcare practitioners to prescribe opioids? 

Dr. KOLODNY. I do think that we should be mandating prescriber 

education. I think that we should allow doctors who don’t intend 

to prescribe more than a 3-day supply of opioids to opt out. If we 

had an opt out, then you are not making people take training irrelevant to their practice. Many doctors would opt out, because 3 days 

is more than enough. You would reduce the number of doctors able 

166 

to prescribe aggressively. And for doctors who do major surgery or 

treat cancer, they would take the training. 

I think that is the way to go. I would like to point out that for 

buprenorphine, a medicine much safer than drugs like oxycodone, 

we have an 8-hour training requirement, and then we limit the 

number of patients the doctor can treat. Whereas, for the drugs 

that are causing addiction, causing overdose deaths, we have no 

training requirement and we have no caps on the number of patients that they can prescribe to. 

Mr. GREEN. OK. Thank you. I yield back, Mr. Chairman. 

Mr. BURGESS. The chair thanks the gentleman. The gentleman 

yields back. The chair recognizes the gentlelady from Indiana, Mrs. 

Brooks, 5 minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman. Dr. Kolodny, I am 

going to follow up. And I assume you heard from the last panel, 

from DEA, that I, too, am working on a bill, but slightly different. 

While fewer hours, it comes in part from the President’s Commission on Combating Drug Addiction Opioid Crisis, and it was top 

recommendation that all prescribers should be required to have 

some continuing medical education. I know you agree with that. 

Ours calls for 3 hours, but it is not just about preventing the 

overdose, it is also about education on physicians and other practitioners, learning how to detect of their own patient base that they 

already have, not just the prevention of the addiction, but also, how 

they can learn more about just addiction writ large. 

Do you believe that state licensing agencies are equipped to 

produce and manage education programs of this type? Because I 

know you are not in favor of other organizations producing that 

training. What about state licensing or agencies, possibly in conjunction with working with best practices from HHS? 

Dr. KOLODNY. It took a while for policymakers on a State and 

Federal level to recognize that the opioid addiction epidemic was 

being fueled by very aggressive prescribing, that the medical community really needed to change course. And many State legislators 

have responded by passing laws mandating prescriber education on 

a State level. I don’t believe those systems are working. 

The way they typically work is that every doctor in the State 

who has a registration, whether or not they ever intend to prescribe an opioid, has to take a course on pain treatment. It is usually online. The content for these courses is awful. In many cases, 

the courses are taught by the same doctors who were teaching the 

courses that really got us into this mess. 

I don’t think that is the way to go. I think this should be done 

on a Federal level linked to DEA registration with an opt-out for 

doctors who don’t want to prescribe more than 3 days, let them opt 

out. But then they are not allowed to prescribe more than 3 days. 

That would overnight shrink the pool of doctors capable of prescribing aggressively. I like that you are thinking about addiction 

and we really do want to teach more than just how to prescribe 

these medicines. We need to also be teaching people who prescribe 

addictive drugs about addiction. 

Mrs. BROOKS. And I will probably be submitting for the record, 

because I have a couple other questions for another panelist about 

167 

other model programs or ideas you might have on the specific types 

of courses and so forth. 

Dr. Kan, my concern, and you have testified about the fact that 

so few people receive treatment but yet many people have medical 

professionals in their lives or they do see medical professionals. 

Would you say it is uncommon for primary care physicians or the 

physician that has prescribed the opioids to detect and to diagnose 

an addiction? 

Dr. KAN. I would say that it is quite common. Dr. Kolodny made 

a comment earlier that I agreed with, that the change in opioids 

is going to cost in the billions of dollars. But the changes that we 

can have now is we need to educate the prescribers on how to identify problematic use. 

For example, we know that anywhere from 15 to 45 percent of 

patients who are taking prescribed opioids for chronic pain demonstrate aberrant behavior, meaning that they have a urine drug 

screen that is negative for the opioid. They may have something 

else in the drug screen or there is other problems. 

I think that treating the opioid epidemic, one of the main emphases that we see is that primary care needs to be taught how to do 

it. I think of buprenorphine a lot like insulin. If you look at the 

Type 2 diabetes disease model, it is almost a perfect analogue for 

opioid use disorder. I think of opioid use disorder with chronic exposure, whether for recreation or medication, changes the brain. 

And for some patients they need buprenorphine, just as some people who suffer from diabetes need insulin. 

And I would argue to you that insulin is far more dangerous 

than buprenorphine. 

Mrs. BROOKS. Would you please share with me, though, aside 

from continuing the medical education, which is what I have been 

focused on in crafting a bill, what else can we do to better equip 

physicians, primary care, who are not trained addiction specialists 

as to what they should be doing? 

Dr. KAN. I think what we need to equip them with is the access 

to the specialist. The greatest difficulty that a primary care provider sees, they don’t know who to send the person to, because the 

addiction specialist they referred them to may be a cash practitioner or they may not have access to treatment. 

So we need to educate a workforce that once the primary care 

provider identifies the person, then they can be sent to the specialist. This is the Vermont hub and spoke model. Because they 

have hubs that are specially trained clinics, and when they stabilize, they go back to their primary care provider. It is a model 

that has been used in the city and county of San Francisco where 

I work part-time. 

I already had my DEA x-waiver, but I was required to get it because the model that they use is they have extensive treatment 

and then goes back to the primary care provider once somebody is 

stabilized. As they destabilize, go back to the hub. 

Mrs. BROOKS. Thank you. My time is up. I yield back. Thank you 

all for your work. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. The chair recognizes the gentleman from Virginia, Mr. 

Griffith, 5 minutes for questions, please. 

168 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. Mr. Nance, 

let me just say thank you for your testimony that you have given 

thus far on telemedicine. It is a very important field for us to get 

in and explore. 

My district is in the east, but it is a very rural district. And 

while we don’t have the miles that you have, sometimes getting 

around the mountain, particularly when the weather is not the 

best or when people are having problems to begin with, as you 

pointed out, can be a problem. And so I agree with many of the 

things that you say and appreciate your testimony here today on 

that. I appreciate everybody’s testimony today. It has been very informative. 

Dr. Beardsley, if I might just briefly. You talk about drugs and 

compounds may be structurally similar. And we heard some comments earlier today about the long history of opioids, and sometimes we treat one opioid with another opioid. And so I am just 

kind of curious, the naloxone, are you absolutely certain that that 

doesn’t have an addictive problem down the road? Do you think 

that works for us no matter what? 

Mr. BEARDSLEY. I am absolutely certain that naloxone does not 

have addictive properties. 

Mr. GRIFFITH. Because it is the antidote, as you said earlier. 

Mr. BEARDSLEY. It is an antagonist, right, to opioids that are 

abused. That is an antidote, more or less it reverses their effects. 

Mr. GRIFFITH. Yes. I appreciate it. That takes me to you, Mr. 

Logan, if I might. One of your recommendations is to allow pharmacists to prescribe naloxone. 

Can you explain the differences you have seen in terms of access 

to reversal drugs in the States that currently allow this compared 

to those that do not. And how has increased access improved patient treatment? 

Mr. LOGAN. There is a long answer to that question. 

Mr. GRIFFITH. Can I get a shorter one? 

Mr. LOGAN. You can. 

Mr. GRIFFITH. You can send a longer written one, if you would 

like. 

Mr. LOGAN. Naloxone is a life-saving drug. When it is used, it is 

in a life or death situation. If it is not used there is no treatment 

thereafter. In that instance, the more we distribute the easier it is 

to get, whether provided by a healthcare professional, an EMS, or 

a family member. It doesn’t matter. We have got to get it in the 

hands of the people who need it. And as of now, if I am not mistaken, naloxone is available through pharmacies in every State. 

Mr. GRIFFITH. OK. You referenced a Virginia program, Virginia’s 

Medicaid Addiction Recovering Treatment Services has a new benefit for Medicaid patients which includes coverage for SBRT (ph) 

provided by pharmacies. And I wrote that down. I am bad with all 

those names, too. But could you explain how that program works 

and specifically, how it has worked in Virginia and what good that 

does? 

Mr. LOGAN. I am going to defer to NCPA for that answer. I can 

tell you about what is happening in Missouri. 

Mr. GRIFFITH. All right. Tell me what is happening in Missouri. 

Mr. LOGAN. Not much. 

169 

Mr. GRIFFITH. OK. But it seems like what they are looking for 

is giving the pharmacists the authority to—and they will send me 

a written response—but giving the pharmacists the authority to 

say, ‘‘Hey, we think this person might have a problem.’’ And instead of having law enforcement swoop in, have some education 

and try to get treatment for that individual first. Is that your understanding of the program? 

Mr. LOGAN. The whole goal of the program is to keep addiction 

addiction and not make addiction criminal. We don’t want a person 

who is ill being treated in the legal system. From both sides of my 

life, my pharmacy healthcare side and my law enforcement side, we 

want those people properly assigned and properly treated. 

Mr. GRIFFITH. Absolutely. And so do we. And I appreciate you on 

that. 

Dr. Beardsley, back to you. I know earlier you were scratching 

your head a little bit. That is what us lawyers call conditional relevancy. I was setting up his question but asking you something. 

And you were like, why is he asking me that. 

But now I am going to ask questions directly to you and that is, 

you talked about how adding a new drug to your existing Schedule 

I registration may take months. Now for the folks back home who 

are watching this in the middle of the night or right now, you have 

to get permission to do—you do Schedule I registration, to do research on some of the more dangerous drugs, or at least the ones 

that are on Schedule I, isn’t that correct? 

Mr. BEARDSLEY. That is correct. 

Mr. GRIFFITH. And so could you tell us how, so we can all better 

understand, how taking months to get the Schedule I registration 

for a researcher can gum up the process. 

Mr. BEARDSLEY. Well, it interrupts the research process if you 

have to wait for months in order to get approved for using a drug. 

The initial process for even applying to have a Schedule I drug 

added to your registration is lengthy for the researcher himself. It 

takes several hours to prepare a protocol. And that also has research costs in terms of downtime. In my case, I do research in four 

laboratories—buildings are very close together. And yet I have to 

have four Schedule I registrations, four Schedule II to V registrations, and four commonwealth of Virginia registrations to do that 

research. That all adds cost and hampers research. 

Mr. GRIFFITH. Cost, time, and makes it harder to come up with 

good results, isn’t that correct? 

Mr. BEARDSLEY. Well, it ends up creating a bureaucratic morass 

that can almost make research untenable. 

Mr. GRIFFITH. Well, I appreciate that. My time is up and I appreciate all of you. And I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. The chair recognizes the gentleman from Georgia, Mr. 

Carter, 5 minutes for questions, please. 

Mr. CARTER. Thank you, Mr. Chairman. Mr. Chairman, before I 

start, I want to compliment you and staff. This is an outstanding 

panel. Seriously, we got boots on the ground. So often, with all due 

respect, we only have people from academia. But this is truly boots 

on the ground. And I just can’t tell you, I am so impressed. I am 

170 

sorry I had to leave a little earlier to go meet with another group, 

but let me get started because I have a lot I want to go through. 

I am going to start with you, Dr. Kan. I want to ask you, because 

telemedicine—I have got a bill that we are considering with telemedicine—but specifically with the Ryan Haight Act, it limits expanded access to buprenorphine. And I am just wondering if you 

can speak to that, very quickly, about how we could do away with 

that so that we could be able to prescribe it, if we needed to, but 

because of this act, as I understand it, we are not able to? 

Dr. KAN. If we amend it to the recommendation that we can rely 

on another provider, that would be extremely helpful. With my 

company, we rely on emergency department physicians. We pair 

with emergency departments to identify, get them started on 

buprenorphine and quickly matriculate into care. 

The short version of it is that the drug dealers are open 24/7. 

Mr. CARTER. Right. 

Dr. KAN. We need to be ready to do the same. 

Mr. CARTER. Right. Mr. Nance, you mentioned this also in your 

testimony, about the limitations that Ryan Haight Act is causing 

us on that. Can you comment on that very quickly? 

Mr. NANCE. Can you ask me a more specific question? 

Mr. CARTER. Particularly, as I understand it, it limits the expanded access to treatment with some of the drugs that we need 

to be treating this opioid addiction with, like buprenorphine. 

Mr. NANCE. Yes, the whole point of my testimony is that, especially in rural and frontier areas—— 

Mr. CARTER. Absolutely. 

Mr. NANCE [continuing]. You have very, very few licensed providers who will actually be willing to provide buprenorphine. My 

friend at the DEA in Utah says we have 503 licensed trained 

buprenorphine prescribers. Only 125 of them are actually practicing and prescribing buprenorphine. But if you go on the 

buprenorphine treatment binder on their website, there are only 

about 70 listed. 

Mr. CARTER. Right. 

Mr. NANCE. So you have got a huge potential labor pool out there 

but they are just reluctant to do it because they are not familiar 

with—— 

Mr. CARTER. But specifically with telemedicine, if we were able 

to have the physician be able to prescribe it then, as I understand 

it, and they can’t because of the Ryan Haight Act. 

Mr. NANCE. Right. It is very, very difficult. You have to have 

that first face-to-face. If we can get the community behavioral 

health centers included as a kind of separate definition inside the 

Ryan Haight Act, then we can open up a lot of potential 

buprenorphine services to the patients in those extreme—— 

Mr. CARTER. OK. Let me move on. Mr. Logan, I wanted to ask 

you. Did you all ever get the PDMP in Missouri? 

Mr. LOGAN. I keep getting asked these questions with long answers. 

Mr. CARTER. OK. I need you to make it real quick. Yes or no. 

Mr. LOGAN. We have an executive order signed that examines 

prescriptions written and adjudicated through a third-party insurance. 

171 

Mr. CARTER. OK. 

Mr. LOGAN. And prescribes blame to over-prescribers. 

Mr. CARTER. OK. For a long time 49 out of 50 States had it. Missouri was the only one who didn’t have it. And it needs to go across 

State lines. As you pointed out earlier in your testimony, you are 

right on the State line. And you are going to get prescriptions as 

I did, in my pharmacy from many States. So that is why it is so 

very important. 

I wanted to mention just a couple of other things. Mr. Cosgrove, 

you mentioned a number of companies, pharmaceutical manufacturers are moving overseas. Is that because of our tax laws? We 

changed that just recently, so I hope that we have resolved that. 

Mr. COSGROVE. Well, I am not an expert in tax law. 

Mr. CARTER. Right. 

Mr. COSGROVE. I do know that the manufacturing costs overseas 

for a number of reasons—— 

Mr. CARTER. OK. 

Mr. COSGROVE [continuing]. Are dramatically lower than—— 

Mr. CARTER. Well, if it is because of manufacturing costs. But if 

it is because of the tax problems, then we have resolved that problem with the Tax Cuts and Jobs Act. So I want to make sure we 

understand that. 

Dr. Subbiah, you mentioned about the new drug that you had. 

I just wanted to ask you very quickly. You haven’t used specialty 

pharmacies, only practitioners can be injected. Was that mandated 

by the FDA or did the company decide that is the way that you 

wanted to go? Because access is a big problem when we are talking 

about these kinds of drugs, and obviously, that is going to limit access there. 

Dr. SUBBIAH. So this was in discussion with the FDA. It is part 

of our risk evaluation mitigation strategy program. 

Mr. CARTER. OK. 

Dr. SUBBIAH. Because a lot of doctors, some of them do not want 

to do the buy-in bill, and so there had to be another way in a restricted distribution system. So if a doctor in Utah wanted to prescribe Sublocade, they can contact one of the specialty pharmacists 

that we are working with. 

Mr. CARTER. Right. 

Dr. SUBBIAH. And they will get a named patient for prescription 

that will be sent to that doctor for use only in that patient. 

Mr. CARTER. OK. And one last thing. Dr. Mulder, thank you. I 

was a hospice consultant pharmacist for many years. And quite 

often in Congress, we have the tendency to overreact and overdo 

it. And you pointed out something that is very important. There 

are people out there who truly need these drugs. We need to make 

sure that they are going to be able to get them and have access 

to them. So thank you for pointing that out. 

Mr. MULDER. Amen. 

Mr. CARTER. Yes. Thank you, Mr. Chairman. I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. And does the gentleman from Michigan wish to be recognized for questions? 

Mr. WALBERG. Yes, Mr. Chairman. 

Mr. BURGESS. You are recognized for 5 minutes. 

172 

Mr. WALBERG. Thank you. Thanks again for letting me sit in this 

panel. And specifically, I would add to my colleagues’ comments— 

and compliments to you, Dr. Mulder. It is a tough field that you 

are in. And it is a compassion field, and we want to make sure that 

we do things right. But I am delighted that you are also thinking 

along the lines of how do we carry on our impact with end-of-life 

issues, with human beings in need, but also make sure that what 

we use and use appropriately, doesn’t end up causing problems for 

others down the road. 

In our home State of Michigan, Mr. Mulder, we have seen real 

challenges with diversion and misuse of leftover medications that 

have contributed to the opioid crisis. Hospices and hospice personnel could play a key role in helping ensure these drugs are 

properly disposed of, but current DEA regulations appear to pose 

an obstacle. 

Could you please describe the current challenge that hospice personnel face when an individual passes away and there is remaining 

unused medication? How does the current law specifically prevent 

hospice personnel from destroying this unused medication to ensure that it is not diverted to another purpose? 

Dr. MULDER. Well, it somewhat has to do with the take-back provisions in which, if they are going to receive these medications, 

whether for the purpose of distributing them somewhere else or to, 

of destroying them, it is a reverse distributor process. And they 

have to be licensed by the DEA as a reverse distributor to be able 

to take those medications in. I think I am using the right terminology. The pharmacists can correct me if I am not. 

But when that came into effect then, they, by law, can’t take 

those medications. They really are not allowed to do anything with 

that. And that is the primary limitation. 

Mr. WALBERG. Is that the same problem in an actual physical 

hospice facility? 

Mr. MULDER. No, it really isn’t. And part of that has to do with 

how those facilities are licensed. And that may vary from State to 

State but that does not exist, for example, we have a, our hospice 

operates in a facility. We do not have that same restriction. 

Mr. WALBERG. OK. In your opinion, what type of licensing should 

a hospice worker have to be able to destroy unused medication? Is 

that something that needs to be further clarified in my bill, H.R. 

5041? 

Mr. MULDER. Yes. Well, for sure, physicians, physician assistants, nurse practitioners, and registered nurses, I would put at the 

top of my list as those who already have licensure and could, I 

think, very logically be certified to be able to manage that process. 

Mr. WALBERG. So they have the background, they have the training, they have the certification. If indeed they are retired and volunteer services, would that carry over? 

Mr. MULDER. I probably would not extend that to volunteers. 

Volunteers, although they function in many capacities as a kind of 

a surrogate employee at the hospice, the relationship is different, 

the financial relationship is different, the regulatory relationship is 

different. And I probably would be reluctant to subscribe that particular task. That is my own personal view, though, to a volunteer. 

173 

Mr. WALBERG. OK. Well thank you. I appreciate the entire panel 

and sitting in, but appreciate, Dr. Mulder, your points. I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. The Chair would observe that I had delayed my questioning to allow other members to pose their questions and then 

catch planes, or trains, or automobiles, whatever they needed to do. 

Dr. Mulder, I really was encouraged to hear you use the term, 

we are going to miss some episodes of preventable suffering. And 

it worries me, too. 

Mr. MULDER. Thank you. 

Mr. BURGESS. One of my very first hearings in this committee, 

and it was a long time ago, but it is why doctors are not prescribing enough pain medicine to the point that some others have 

made on this panel. I have seen the pendulum swing both ways. 

And I do worry that we live in the land of unintended consequences 

here in the United States House of Representatives. 

So it worries me that some of the things that we are perhaps 

contemplating today are going to put more people into the realm 

of preventable suffering that is not prevented, and I worry about 

that. So thank you for what you do in bringing that to our attention as well. 

Mr. MULDER. Well, thank you for your comments and we will be 

looking forward to the diligence of this committee to make sure 

that doesn’t happen. 

Mr. BURGESS. Yes, ever hopeful. 

Mr. Logan, first off, I want you to know that in the appropriations bill for Labor, Health and Human Services that the House of 

Representatives passed in September—now, the Senate has never 

taken any action, so it hasn’t become law—but the bill that we 

passed in September actually did carve up some dollars for people 

who don’t have a PDMD available so that it would be available. 

I am a big believer in PDMPs. I think they are useful. I worry 

about burdening people with too many inputs that they have to put 

in their electronic health record but at the same time—or too many 

queries of a database, but still, this is one that I think can be very 

useful. 

But let me just ask you. You described a situation where your 

pharmacy is, and you are on a big highway, that is the crossroads 

of the Nation and people come from all over the country with prescriptions they have received somewhere else and then they 

present them to you. Did I understand that correctly? 

Mr. LOGAN. Yes, you did. 

Mr. BURGESS. And I got the impression, I may have been overcalling it, but I got the impression that you felt that sometimes— 

I don’t want to infer anything. Do you feel that sometimes the prescription perhaps is overly generous with the amount of medication 

that is dispensed? 

Mr. LOGAN. Any time I see multiple prescriptions for multiple 

people in one vehicle in quantities of excess of 180 oxycodone, I 

think that is excessive, yes. 

Mr. BURGESS. So with your keen powers of observation, you are 

able to deduce that that may be an overprescribing situation? 

Mr. LOGAN. Thank God it don’t take no rocket scientist. 

174 

Mr. BURGESS. And that is the point. Our representative from the 

agency, from the DEA, I don’t think is here any longer, but I was 

under the impression every time I wrote a triplicate prescription 

for a controlled substance that it goes into—whether I had a PDMP 

or not—it goes into a database. Somebody is monitoring that. 

Maybe someone at my State level, maybe someone at the Federal 

level. 

So it is not a surprise that these prescriptions are going out the 

doors or the pills are going out the doors. I had this very conversation with Secretary Azar 2 weeks ago when he was here. CMS has 

a lot of data at its disposal. It knows who under their care, in 

Medicare or Medicaid, is receiving an untoward number of pills. 

And it also knows the pharmacies to which it is reimbursing payment where an untoward number of pills are going out. Is that not 

recently to assume? 

Mr. LOGAN. An inordinate number of these prescriptions are 

cash. There is no claim generated for them. So what you deal with 

at a payor level is paid claims. PDEs we call them. If there is no 

cash claim, if there is no PDMP, it never happened. 

Mr. BURGESS. Well, back to the point of the PDMP, why I 

thought it was important to put the money forward on that. This 

committee actually authorized a bill, it was called NASPER well 

over 10 years ago, that was to provide that type of help. It got tied 

up in the appropriations process, and although it was authorized 

on several occasions, it was never funded. So I tried to correct that 

last September so that it would be funded. 

But I guess the point I am getting at is it is not a surprise that 

there are some people who are overprescribing, and you can know 

who they are. You have brought up a point that I had not actually 

considered, which was the cash transaction, but still, the pharmacy 

has a record of the pills that they—are you not required to account 

for every controlled substance dose that comes through your 

shelves? 

Mr. LOGAN. Absolutely. The pharmacist’s duty of care is to determine the legality of the prescription. Are all the numbers on it? Is 

it filled out correctly? But also the legitimacy of the prescription. 

Is there a valid prescriber-patient relationship? Have there been diagnostic tests done to justify what we are talking about? A lot of 

times, the pharmacist has to go on gut feeling on the legitimacy. 

And the independent pharmacist is in a unique position. We determine our own destiny. 

We can say yes, we will fill it. No, we won’t. We are where the 

buck stops. There are people who work for companies that may not 

have the discretion to determine the legality and legitimacy and go 

strictly on the legality of the prescription. 

Mr. BURGESS. And I guess the point I was getting at, at some 

level, that data is available, because whether it be an independent 

pharmacist or a chain pharmacy, all of those dosages of those controlled substances have to be accounted for somewhere. 

Mr. LOGAN. In either controlled substance inventory mandated 

by DEA or purchases through wholesalers. 

Mr. BURGESS. Correct. So it is knowable if a location is receiving 

an unusual or an untoward amount of product, is that—— 

Mr. LOGAN. Absolutely. 

175 

Mr. BURGESS. And Dr. Kolodny, obviously you and I do see 

things a little bit differently on some of the approaches, but I will 

say this: I look at our doctors as our allies in this, not our adversaries. I think if we treat our doctors as allies, they will be our allies. If we treat them as adversaries, they will be our adversaries. 

We, I think, sometimes unnecessarily complicate the lives of our 

physicians to the point where some of them will just give up and 

we will have preventable pain that doesn’t get prevented or that 

doesn’t get treated. So I just worry that putting the onus on a practicing physician to do some mandatory training, I don’t know that 

that is going to solve the problem when the problem is as big as 

what Dr. Logan describes at his crossroads pharmacy. And yet, 

that data is known. Somebody knows that those bills are going out 

the door, right? 

Dr. KOLODNY. Yes. And I think we do agree that doctors are not 

to blame. I think that doctors were responding to brilliant marketing. And that is why we are seeing litigation from counties and 

States across the country and why the Department of Justice and 

Attorney General Sessions announced yesterday that the Federal 

Government is going to be helping out. There is an understanding 

that the medical community has been deceived about the risks and 

benefits of these drugs. 

The pill mill doctors, we have to try and stop them because they 

are killing a lot of people, but they are really not the root of the 

problem. The bigger problem is the well-meaning doctors and dentists who are inadvertently creating customers for these doctors. 

We have to stop those doctors because they kill people. But this 

epidemic will not end unless we prevent more people from becoming opioid-addicted. 

Mr. BURGESS. And here is where we disagree. I practiced in the 

1980s and 1990s. I can rarely remember writing a prescription for 

more than 12 doses of a controlled substance. I had a surgical practice, and someone who was operated on was going to need pain relief. I recognized that. It did seem like in the old days we could 

allow for a refill on a prescription. And that may be a State function in Texas, but it seems like that went away at some point. And 

I don’t know if that led to the conclusion that people are going to 

write larger numbers of pills so they don’t get a telephone call on 

the weekend. I don’t know. I am inferring that. I have no data to 

back that up. 

But it just seems like the world changed somewhere between the 

late 1990s and the end of the first decade of the 21st century. 

Dr. KOLODNY. You are absolutely right. In fact we know exactly 

what year the prescribing began to take off. It happened in 1996. 

And it wasn’t just OxyContin that starts to take off in 1996. 

Hydrocodone, hydromorphone, morphine, the fentanyl patch. Starting in 1996 is when the prescribing really begins to explode. 

In 2014, the fall 2014, we put Vicodin into a more restrictive category where it couldn’t be phoned in easily and where you couldn’t 

write refills. And that may have had an influence on the quantity 

in a prescription, but the overall impact of that change was a dramatic reduction in the number of hydrocodone pills that were prescribed. 

176 

So I think the bigger part of the problem was starting in 1996, 

a multifaceted campaign that was very effective that told doctors 

that we need to prescribe more. And many doctors are still very 

badly misinformed. I think in an ideal world we would not have to 

make doctors take a training course. We could rely on doctors. But 

in this situation, doctors are not able to accurately weigh the risks 

versus the benefit for the patient in front of them. 

Mr. BURGESS. I disagree with that. That is our job. That is what 

we do. That is what we were trained to do. So you and I are going 

to fundamentally disagree on that. I will just conclude with the observation, I have gone way over time, but since I am the chairman, 

I can do that. 

I don’t know that any of the doctors who are writing those prescriptions that Mr. Logan gets presented with at 2:00 or 3:00 in the 

morning, I don’t know if—you may force them to take a continuing 

education course, but I don’t think it is going to alter their behavior in the least. 

And I also agree with you that some of the courses that are 

available, I, in fact, took for my CME last August, I did an online 

course on opiate use and proper prescribing. One thing I have 

learned to do over the years is how to take a test. I disagreed with 

the philosophic premise that was coming out of this large medical 

school in the east, but I was able to answer the questions the way 

they wanted and got what my goal was, which was my continuing 

education hours. 

You all have been very generous with your time today and I do 

appreciate it. 

Mr. Green, do you have a followup? 

Mr. GREEN. Yes, Mr. Chairman. I am not going to ask for the full 

6 minutes that you took but I just want to ask, is anybody—— 

Mr. BURGESS. You see, I aggregated all of the extra time that 

was taken on your side of the dais. 

Mr. GREEN. Well, I just want to ask other witnesses, if you have 

any short statements in response to the chair or any of the stuff 

we did, because our efforts are to try a find a solution, and the balance, what we can do. Because we know we have an epidemic, but 

I have also seen overkill and that is what some of the testimony 

is, but we also know we need to deal with this issue. And does anybody have anything else for what the Chair responded to? 

Yes, Doctor. 

Dr. SUBBIAH. I think the main thing you heard from all of us is 

that it requires a multi-pronged approach. It is going to require the 

treatment, it is going to require telemedicine. It is going to require 

education. And I think all of those are going to be very important. 

It is very encouraging today that you did allow all of us to give 

those different perspectives. So thank you. 

Mr. BURGESS. That is what a hearing is all about. 

Mr. GREEN. Yes. One thing. I had a constituent in our district 

who worked for many years in construction and he needed an 

opioid. And one of the chain drug stores, Walgreens that I work 

with all the time, because they help do immunizations in my area. 

The independent pharmacist has the right to decide that. And so 

I asked the regional director, I said, well, could this fellow go to 

another Walgreens? He said well, that pharmacist might decide not 

177 

to. We ended up finding his medication, probably not at the most 

reputable pharmacy that we should have. 

So there is an issue about people who really need it just to survive because of their lifestyle or their work. As we get older, we 

find out that where we fell down and we are 30 years, when you 

are 65 you all of a sudden say, hey, that hurts. So, but anyway, 

thank you, Mr. Chairman. 

Mr. BURGESS. The Chair will not refer to you as an enabler. 

I do want to thank all our witnesses again for being here today, 

and for the time you have invested. As you can see, this is an important topic. And as the Chairman said we are going to have multiple hearing on this. 

I would like to submit statements from the following for the 

record: Congressman David Kustoff, Prime Therapeutics, National 

Association of Chain Drug Stores, the University of Texas, Johns 

Hopkins University, CVS Health, Braeburn. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. Pursuant to committee rules, I remind members 

they have 10 business days to submit additional questions for the 

record, and I ask the witnesses to submit those responses within 

10 business days upon receipt of said questions. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 5:12 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

178 


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UNIVERSITY OF CALIFORNIA, SAN DIEGO UCSD 

BERKELEY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO SANTA BARBARA • SANTA CRUZ 

ADAM L. HALBERSTADT, Ph.D. 

ASSISTANT PROFESSOR 

February 27, 2018 

RE: Comments on the SITSA Act 

DEPARTMENT OF PSYCHIATRY 

UNIVERSITY OF CALIFORNIA, SAN DIEGO 

9500 GILMAN DRIVE 

LA JOLLA, CALIFORNIA 92093-0804 

TELEPHONE: (412) 608-4960 

FAX: (619) 543-2493 

Email: ahalbers@ucsd.edu 

Our nation is facing an unprecedented epidemic of opioid abuse. Nevertheless, while I 

appreciate the attention Congress is giving to this issue, I am concerned that the SITSA Act will have 

unintended consequences for scientific research and drug discovery. 

The SITSA Act allows substance to be controlled based on their structural similarity to 

controlled substances or their predicted pharmacological properties. Unfortunately, it is not always 

possible to reliably predict the pharmacological properties of new substances based solely on their 

structural features. Although structure-activity relationships have been defined for many drug classes, 

it is often the case that pharmacologists do not fully understand the molecular interactions between 

drugs and their biological targets, meaning that predictions about the pharmacology of novel 

substances must be confirmed empirically through experimental testing. Slight changes in the 

molecular structure of a drug can potentially markedly alter its pharmacological properties, often in 

unexpected or novel ways. 

There are many controlled substance analogs that have been discovered to have unexpected, 

therapeutically useful pharmacological properties, demonstrating why it is necessary to confirm 

pharmacological predictions with biological testing. The following examples are illustrative: 

(1) 3-Fiuorofentanyl. It was recently reported in the journal Science that 3-fluorofentanyl is a 

potential non-addictive painkiller. Although 3-fluorofentanyl binds to the same primary target as the 

narcotic fentanyl- a protein known as the mu opioid receptor- it does so in a manner that restricts 

the interaction to injured tissues. Experimental testing indicates that 3-fluorofentanyllacks abuse 

potential in rodents. Nevertheless, in the absence of experimental data, 3-fluorofentanyl and similar 

substances would likely be scheduled as controlled substance analogs under the regulations 

promulgated by the SITSA Act. 

(2) UWA-101. UWA-101, a close structural analog of the Schedule I substance MDMA 

(Ecstasy), was recently developed as a potential treatment for Parkinson's disease. Testing has 

confirmed that UWA-101 does not produce MDMA-Iike effects in rodents, meaning that it is unlikely to 

have abuse potential in humans. Nevertheless, UWA-1 01 has pharmacological properties that are 

similar to those of MDMA. so the possibility exists that UWA-101 could be controlled as an MDMA 

analog under the SISTA Act. The case of UWA-101 is another example that shows why biological 

testing is necessary in order for the government to make accurate and informed scheduling decisions. 

(3) Lisuride. Lisuride is a structural analog of LSD and these two drugs have virtually identical 

pharmacological properties. Nevertheless, lisuride does not produce hallucinogenic effects in humans 

and has actually been used in some countries as a treatment for Parkinson's disease and migraine. 

Although lisuride and LSD interact with the same primary target in the brain (the 5-HT 2A receptor), 

evidence indicates that they do so in subtly different ways, potentially explaining why lisuride does not 

produce hallucinogenic effects. Unfortunately, scientists are just beginning to understand how LSD 

interacts with the 5-HT 2A receptor and not enough is known about these interactions at the molecular 

level to reliably predict whether a new analog in this structural class will produce hallucinogenic 

effects or will mimic the effects of lisuride. 
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(4) BOL-148. Similar to lisuride, an analog of LSD known as BOL-148 (2-bromo-LSD) 

interacts with the 5-HT2A receptor but does not produce hallucinogenic effects. Case reports 

published in the journal Cephalagia in 2010 indicate that BOL-148 may be an effective treatment for 

cluster headaches, which is an extremely debilitating medical condition. 

(5) DOl. DOl is a structural analog of several hallucinogens regulated as Schedule I 

substances, including 4-methyl-2,5-dimethoxyamphetamine (DOM). According to recent reports in 

the scientific literature, DOl has potent anti-inflammatory effects, potentially making it a useful 

treatment for arthritis and asthma. The anti-inflammatory effects of DOl were discovered 

serendipitously- DOl happened to be available in the laboratory conducting this research and it was 

tested based on a hunch. At that time, there was no other evidence that DOl has anti-inflammatory 

effects and other chemicals in this class do not produce this effect. It is unlikely that this effect of DOl 

would have been discovered if it had been scheduled as a controlled substance analog. 

(6) Loperamide. The anti-diarrhealloperamide, which is marketed over the counter in the USA 

under the brand name lmodiumrM, is an analog of diphenoxylate (a Schedule II narcotic) and 

diphenoxin (a Schedule I narcotic). Loperamide is a potent agonist at the mu opioid receptor but has 

little abuse potential because it is actively removed from the brain by a transport protein. Loperamide 

is yet another example that shows how structural features are not always a reliable predictor of abuse 

potential. 

I am concerned about the repercussions of loosening the criteria for scheduling analogs of 

controlled substances. To date, several substances that have undergone emergency scheduling 

were later determined to have no abuse potential. Examples include benzylfentanyl and 

thenylfentanyl, which were emergency scheduled by the DEA in November 1985, and 

trifluoromethylphenylpiperazine, which was emergency scheduled in September 2002. Although such 

erroneous emergency scheduling actions have been rare, the changes to the GSA proposed in the 

SITSA Act will greatly increase the likelihood that substances lacking abuse potential are erroneously 

scheduled. 

Unfortunately, erroneous scheduling actions have detrimental consequences for science and 

medicine. Scheduling all compounds that are even remotely related to drugs of abuse as controlled 

substance analogs will hinder promising research efforts to discover new therapeutic agents. 

Furthermore, many important "tool compounds" that are routinely used by scientific researchers to 

study drug responses are structurally related to controlled substances. Although these compounds 

lack abuse potential, I fear that the availability and use of many of these important tools will be 

restricted under the regulatory regime proposed in the SITSA Act. The SITSA Act does contain a 

research exemption, but it does not make sense, in my opinion, to place restrictions on research with 

these substances unless they actually have abuse potential. 

Another aspect of the SIT SA Act that would likely harm scientific research is the provision 

requiring researchers to register as manufacturers in order to distribute Schedule A compounds for 

use by collaborators at other research institutions. Currently, Schedule 1 researchers are not required 

to register as manufacturers in order to distribute these substances to collaborators who are licensed 

by the DEA to work with the same substances. Under the GSA, manufacturers have very 

burdensome security requirements because they often work with substances in bulk quantities; by 

contrast, it is not practical for researchers to register as manufacturers in order to synthesize and 

distribute small quantities of scheduled substances to collaborators. This particular regulation would 

likely limit the availability of Schedule A substances for research. Although some researchers will be 

able to synthesize the substances themselves or obtain them from colleagues at the same institution, 

neither of those options will be feasible for most investigators. 

In summary, I am concerned that legitimate research will be hindered by scheduling all 

compounds that are structurally related to drugs of abuse. Furthermore, it is not clear that new 

legislation is necessary in light of the recent emergency scheduling action by the DEA to control an 

entire structural class of fentanyl analogs. Thank you for considering my thoughts on this important 

issue. If you would like to discuss this matter further, please feel free to contact me. 

Sincerely, 

Adam 

~~ L. Halberstadt, Ph.D. 
180 


30411.084

THE COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, INC. 

3420 N. Broad Street, Room 324, Philadelphia, PA 19140-5104 

Telephone: 215-707-3242 • Fax: 215-707-1904 • Website: http://www.cpdd.org 

Executive Officer: 

Loretta P. Finnegan, MD 

E-mail: finnega1337@aol.com 

Director, Executive Office: 

Ellen B. Geller, MA 

215-707-5307 

E-mail: gellerellen@gmail.com 

Board of Directors: 

Alan J Budney, PhD, President 

Leonard Howell, PhD, Past~President 

Margaret Haney, PhD, President~Elect 

Jack Bergman, PhD, Treasurer 

Patrick M Beardsley, PhD 

Kathleen M Carroll, PhD 

Marilyn E Carroll, PhD 

Howard D Chilcoat, SeD 

Timothy P Condon, PhD 

Sarah H Heil, PhD 

Amy C Janes, PhD 

Geoffrey K Mumford, PhD 

Thomas E Prisinzano, PhD 

Beatriz Rocha, MD, PhD 

Stacey C Sigmon, PhD 

Mark A Smith, PhD 

William Stoops, PhD 

Jennifer W Tidey, PhD 

Elise M Weerts, PhD 

June 23, 2017 

Representatives Robert Goodlatte and John Conyers 

House Judiciary Committee 

2138 Rayburn House Office Building 

Washington, DC 20515 

On behalf of the College on Problems of Drug Dependence (CPDD), 

we are writing to express our views on H.R. 2851, Stop the Importation 

and Trafficking of Synthetic Analogues (SITSA) Act of 2017. CPDD is 

the longest standing scholarly society in the United States that is 

devoted to issues surrounding substance use disorders. The College 

has over 1000 members, and serves as an interface among 

governmental, industry, and academic communities maintaining 

liaisons with regulatory and research agencies as well as educational, 

treatment, and prevention facilities in the drug abuse field. 

We share the concerns of the Committee and sponsors of H.R. 2851 

about the opioid epidemic and its devastating consequences for 

millions of Americans, their families, and their communities. According 

to a recent New York Times article, an estimated 59,000 Americans 

died in 2016 of drug overdoses, the largest annual jump in deaths ever 

recorded in the United States. One of the main reasons for that 

dramatic and disturbing increase is the spread of fentanyl, a synthetic 

opioid that is inexpensive and potent. The College supports robust, 

science-based efforts to curb the sale and use of synthetic analogues. 

While CPDD agrees with the spirit of H.R. 2851, we believe that 

legislation to enhance the Justice Department's efforts to temporarily 

schedule new synthetic compounds must institutionalize a more 

enhanced role of the Department of Health and Human Services' science-based agencies, specifically the 

National Institute on Drug Abuse and the Food and Drug Administration. The current version of H.R. 2851 

gives the Attorney General blanket authority to temporarily schedule a substance, and the AG is only 

required to provide a 30-day public notice of pending scheduling action and "take into consideration any 

comments" from HHS on proposed orders to temporarily schedule a compound. The temporary scheduling 

process for synthetic analogues bypasses the current process that requires the AG to conduct a three-factor 

analysis before temporary scheduling can proceed. 

Moreover, to permanently schedule a compound, current law requires the AG to obtain an eight-factor 

analysis by FDA and a recommendation from HHS on a permanent scheduling action. For synthetic 

analogues, H.R. 2851 enables the Attorney General to bypass the current role of science-based agencies in 

reviewing what compounds should be scheduled. 

We seek to ensure that science-based Federal agencies, including FDA and NIDA, are involved in 

decisions regarding temporary scheduling of synthetic analogues, rather than the current version of H.R. 

2851, which merely requires that HHS be informed of the AG's intent to schedule such compounds. 
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If the intent of the legislation is to enable the "scientific and research communities to develop information on 

these newly-invented substances," then the research exemption written into the current version of H.R. 

2851 needs to be enhanced significantly. The bill provides that researchers who already have a Schedule I 

license will not need an additional one, except to review protocols for research on these targeted 

substances. This exemption applies to only a small subset of potential scientists who could and should 

research potential treatments to the targeted synthetic compounds but who will be discouraged from doing 

this research by the burdens and lengthy regulatory burdens and time required to gain approval of a 

Schedule I license. CPDD encourages the Committee to consider an expanded exemption that would 

enable researchers with Schedule I, II, Ill, IV and V licenses to conduct research on those synthetic 

analogues that will be temporarily scheduled under terms of this legislation. 

Respectively 

Alan Budney, PhD 

President, The College on Problems of Drug Dependence 
182 


30411.086

House Energy and Commerce Committee, Health Subcommittee 

Testimony of Congressman Brad Schneider (IL-10) 

February 28, 2018 

Thank you, Chairman Burgess, Ranking Member Green, and the Health Subcommittee for 

considering this legislation. 

Across the country, American families and our communities are suffering under a crisis of opioid 

addiction and misuse. This insidious epidemic does not discriminate based on political party, 

geography, economic status, gender, or age. Every day it claims more than 115 lives. 

This is a multi-faceted problem and addressing it will require a multi-faceted approach. I thank 

my colleagues on the Bipartisan Heroin Task Force for their work across the aisle to find 

solutions. 

One important action we can take is ensuring our doctors are up-to-date with the most current 

best practices and research for preventing, identifying and treating the disease of addiction. 

The H.R. 2063, the Preventing Opioid Abuse Through Continuing Education (or Opioid 

PACE) Act would require providers who treat patients with prescription opioids for pain 

management to complete 12 hours of continuing medical education (CME) every three years. 

The CME would focus on pain management treatment guidelines and best practices (including 

non-opiate alternatives), early detection of opioid use disorder, and the treatment and 

management of patients with opioid use disorder. 

The bill would link completion of the CME requirements to the renewal of the provider's Drug 

Enforcement Agency (DEA) license. 

Many states already see the value of continuing education for prescribers of opioids. A 2017 

study in the Journal of Medical Regulation found 29 of 50 states have pain 
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management/controlled substance prescribing continuing education requirements for at least 

some physicians, and 10 have requirements tied to license renewal. 

Equipping the prescribers of opioids with the training to better decide when opioid medications 

are best indicated will help limit these drugs to only patients who will benefit from them, and 

prevent overprescribing when other, non-opioid treatment methods may be more effective. 

Reducing over-prescription will be an important factor in curbing the epidemic. According to the 

Centers for Disease Control (CDC), sales of prescription opioids in the United States nearly 

quadrupled from 1999 to 2014, but there has not been an overall change in the amount of pain 

Americans report. During this time period, prescription opioid overdose deaths increased 

similarly. 

A modified version of this bill addressing only Department of Defense medical professionals 

passed the House in 2017 as an amendment to the National Defense Authorization Act. 

Our men and women in uniform are not immune from the epidemic of opioid addiction and 

abuse. In fact, the National Institute of Health reports rates of prescription opioid misuse are 

higher among service members than among civilians due to the use of these drugs to treat the 

symptoms ofPTSD and chronic pain. 

I thank my colleagues for their consideration of the Opioid PACE Act and urge them to support 

this measure to help equip medical professionals with the training and best practices needed to 

address this epidemic. 
184 


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December 18, 2017 

The Honorable Lamar Alexander 

Chairman 

Committee on Health, Education, Labor 

and Pensions 

United States Senate 

Washington, DC 20210 

Dear Chairman Alexander and Senator Murray: 

The Honorable Patty Murray 

Ranking Member 

Committee on Health, Education, Labor 

and Pensions 

United States Senate 

Washington, D.C. 20210 

We, the under-signed organizations, write to indicate our continued support for passage of 

Section 3 of S. 916, the Protecting Patient Access to Emergency Medications Act of 2017, which 

was approved by your Committee in April of this year. This legislation will greatly benefit patients 

who wish to use innovative new forms of medication-assisted treatment (MAT) as part of their 

recovery. 

As you are aware, recent advances in medical technology have made development of new 

medications to treat addiction possible. These products promise to greatly enhance patient 

compliance to treatment because they are substantially longer acting than previous therapies. As 

they are administered directly by a provider to a patient, they also greatly reduce the opportunity 

for illegal diversion, misuse and accidently pediatric exposure. 

The Controlled Substances Act is silent on whether such products can be delivered directly to the 

administering provider, rather than directly to the patient. This is how non-controlled, provideradministered medications are distributed. Section 3 of S. 916, the Protecting Patient Access to 

Emergency Medications Act of 2017, would address this inequity. It clarifies that controlled 

substances may be delivered to prescribing or administering practitioners, including medications 

that are administered by implantation, injection, or through the use of an intrathecal pump, for 

maintenance or detoxification treatment of addiction. 

It is important that opioid use disorder patients have the same access to the full range of Food 

and Drug Administration approved treatment options as any other patient would. The approval 

last year of an implantable buprenorphine product, and the anticipated approval in the next few 

months of long-acting injectable formulations, provide much-needed new treatment options for 

patients and allow health care providers and patients the choice of selecting a treatment that is 

most appropriate for their needs. 

We appreciate your leadership in recognizing the necessity for this small-but-important change to 

the Controlled Substances Act. This correction will allow the right treatment to get to the right 

patient at the right time by increasing access to lifesaving treatments for opioid use disorder. 

Every day, according to the CDC, 91 people die of an opioid overdose. Congress clearly has a vital 

role to play in combatting the current the opioid crisis, and we strongly support swift passage of 

this critical piece of legislation so patients and providers will have access to these important, new 

treatments. 
185 


30411.089

We urge that you act quickly to see that this legislation is approved by the Senate and moved to 

the House of Representatives for passage. It is a small change in the law, but one which will 

greatly benefit patients. The opioid overdose epidemic has already affected too many Americans. 

Now is the time to act -let's give health care professionals on the front line of this crisis the tools 

they need to save lives. We urge you to pass S. 916. 

Sincerely, 

Advocates for Opioid Recovery 

Breaking Barriers - Hope Is Alive 

Community Pharmacies of Indiana 

Cover2 Resources 

Daniel's Story 

Family Advocates Coalition to End Addiction in Maryland (F.A.C.E. Addiction Maryland) 

Heroin Action Coalition 

Indiana Pharmacists Association 

Maryland Heroin Awareness Advocates 

Ohio Society of Addiction Medicine 

Prevention Action Alliance 

Robby's Voice 

Savannah Harm Reduction Coalition 

Shatterproof 

The Addicts Parents United 

The Indiana Academy of Physician Assistants 

Tyler's light 

Watauga Recovery Center 

Young People in Recovery 
186 


30411.090

OFFICERS 

Presldent 

Kelly J. Clllrk, MD, MBA. DFASAM 

Pres1denHied: 

Paul H. Earley, MD, OFASAM 

VkaPresident 

Margatet JaTVis, MD, OFASAM 

Secretary 

Yngvild Olsen, MD, MPH. FASAM 

Treasurer 

Brian Hurley, MD, MBA, FASAM 

Immediate Past President 

R. Jeffrey Goldsmith, MD, OLFAPA. DFA.SAM 

BOARD OF DIRECTORS 

DirKtors~at·Large 

Anthony Albanese. MD, DFASAM 

Marc Galanter, MD, DFASA.M 

William F. Haning. Ill, MD, DFAPA. DFASAM 

Petros Levounls, MD, MA, DFASAM 

Edwin A. Salsitz, MD, DfASAM 

John C Tanner, 00, OFASAM 

Reglonal Directors 

Reg ton I IHred:or 

Jeff Selzer, MD, OFASAM 

Region II Director 

Murtuza Ghadiali, MD 

fte.!:JI"'" Ill Director 

Ke:· Freedman, MD, MS, MBA, FACP, AGAF, 

oF,_, .. v1 

Region IV Director 

Mkha~ Shore, MD, DFASAM, DlFAPA 

Reglon V Direttor 

Anika Atvanzo, MD, MS, FACP, FASAM 

Regfon VI Director 

Gavin Bart, MD, PhD, DFASAM 

Re-gion VII Director 

A Kennison Roy, 1!1, MD, DLFAPA, DFASAM 

Reglon Vtll Director 

Miriam Komaromy, MD, FACP, FASAM 

Regfon IX Director' 

Peter Selby, MBBS, CCFP, FCFP. MHSt, 

DFASAM 

Reglon X Dlrettor 

Scott Teitelbaum, MD, DFASAM 

Ex·Offfdo 

Stuart Git!ow, MD, MPH, MBA DFAPA. DFASAM 

Randolph P. Holmes, MD, FASAM 

T01;!d Kammeu.ell, MD, Ff\SAM 

Mich~Re tofwa!!, MD, FASAM 

Penny~ Milts. MBA 

Ale~sanclra Zgiersli.a, MD, PhD 

FOUNDING PRE510£NT 

Ruth fo~ MD 

!895-1969 

American Society of 

Addiction Medicine 

September 21, 2017 

The Honorable Bill Cassidy 

United States Senate 

520 Hart Senate Office Building 

Washington DC 20510 

The Honorable Roy Blunt 

United States Senate 

260 Russell Senate Office Building 

Washington DC 20510 

The Honorable Michael Bennet 

United States Senate 

261 Russell Senate Off1ce 

Building Washington DC 20510 

The Honorable AI Franken 

United States Senate 

309 Hart Senate Office Building 

Washington DC i0510 

Dear Senators Cassidy, Blunt, Bennet, and Franken: 

On behalf of the American Society of Addiction Medicine (ASAM), a 

national medical specialty representing more than 5,000 physicians and 

allied health professionals who specialize in the treatment of addiction, I 

am writing to express our support for Section 3 of your bill, S. 916, the 

Protecting Patient Access to Emergency Medications Act of 2017, which 

would allow pharmacies to deliver controlled substances to prescribing 

or administering practitioners, including medications that are 

administered by implantation, injection, or through the use of an 

intrathecal pump for maintenance or detoxification treatment of 

addiction. 

Foremost to ASAM's mission is a goal to increase access to and improve 

the quality of addiction treatment. The introduction and use of novel 

addiction pharmacotherapies supports this goal. Addiction patients, like 

all patients, should have available to them a robust and varied array of 

treatment options, as no one treatment modality is appropriate or 

therapeutic for everyone. The recent approval of an implantable 

buprenorphine product, and the anticipated approval of two injectable 

buprenorphine formulations, expands treatment options for patients. 

No product will be suitable for all patients, and many will still be bestserved by oral formulations, other medications, or no medication at all, 

but they may help improve treatment adherence and reduce diversion 

among certain patients for whom they are indicated. 

11400 Ruckvme Pi!.::e Suite zoo RoCkville, MD :WB51 

Phone: 30Hi56--3920 I fax: 30L656.381S 

www.ASAM.org 
187 


30411.091

However, these options are only valuable if patients can access them. S. 916 would facilitate 

access to these new products by allowing them to be delivered to administering practitioners 

on a patient-by-patient basis rather than requiring the practitioners anticipate demand, buy the 

medication in advance, store it on site, and hope they estimated the correct number of doses 

needed to meet demand and avoid waste. This is not a new pathway for medication delivery, 

but would allow for these controlled substances to be delivered as many non-controlled 

substances are already. 

ASAM appreciates your attention to this technical.detail and your leadership In championing 

legislation that will promote patient access to new addiction treatment options. We look 

forward to working with you to ensure your bill's passage. 

Sincerely, 

Kelly J. Clark, MD, MBA, DFASAM 

President, American Society of Addiction Medicine 

CC: The Honorable lamar Alexander 

The Honorable Patty Murray 
188 


30411.092

CLAAD Center for Lawful Access 

and Abuse Deterrence 

November 22, 20 17 

The Honorable Lamar Alexander 

Chairman 

Committee on Health, Education, Labor 

and Pensions 

United States Senate 

Washington, DC 20210 

Dear Chairman Alexander and Senator Murray: 

The Honorable Patty MutTay 

Ranking Member 

Committee on Health, Education, Labor 

and Pensions 

United States Senate 

Washington, DC 20210 

On behalf of the Center for Lawful Access and Abuse Deterrence {CLAAD), I would like to submit this 

letter to support the passage of Section 3 of S. 916 to allow pharmacies to dispense controlled substances that 

are administered by a health care practitioner directly to the health care practitioner. 

CLAAD is a tax-exempt, not-for-profit organization working to improve health and safety. We recommend 

consensus-based solutions to the nation's drug overdose epidemic. All such efforts must revolve around 

individualized health care. 

As you are aware, we are facing an opioid overdose epidemic. Ninety-one Americans die every day from an 

opioid related overdose.' With such alarming rates of overdose, regulators and policymakers should be 

developing policies that encourage access to treatment with effective medications approved by the FDA that 

enhance adherence to treatment and reduce the likelihood of diversion. 

Practitioner-administered buprenorphine products inherently increase treatment adherence and reduce post 

dispensing diversion. Yet, current law makes it difficult for a practitioner to administer these products. 

Under current law, a pharmacy cannot dispense these medications directly to a practitioner. Therefore, if a 

practitioner wants to treat a patient with a practitioner-administered buprenorphine product, the practitioner 

has to {I) purchase the product and have it shipped directly to his or her office, {2) administer the product to 

the patient, and then (3) bill the patient or the patient's insurer for payment. This process is known as "buy 

and bill." Buy and bill can be burdensome for some practitioners because of the upfront cost of the 

medication and the uncertainty regarding whether they will get paid. These burdens may deter practitioners 

from prescribing these medications, and therefore, thereby limiting patient access to these medications. 

Therefore, we urge Congress to pass Section 3 ofS. 916to enable pharmacies to dispense practitioneradministered controlled substances directly to the practitioner. Passage ofthis section will improve 

access to adherence enhancing and diversion resistant medications. We appreciate your consideration of 

our comments and would be pleased to discuss this matter in greater detail with you. 

Sincerely, 

/~-t!fit~7=+ -- Nellie Wild 

Senior Policy Advisor 

1 https:/ /www .cdc.gov/drugoverdose/epidemic/indcx.html 

Center for lawful Access and Abuse Deterrence 

3000 K Street, NW. Suite 270 · Washington, DC 20007 · 202-599-8435 · www.claad.org · @claad_coalition 
189 


30411.093

Catalent 

14 Schoolhouse Rood 

Somerset, NJ 06673 

catale11t.oom 

Comel! Stamoran, Ph.D. 

Vice President, Corporate StrateQY 

and Government Affairs 

T +1~732.-537-6408 

E cornel!.st:amoran@Catalent.com 

February 27, 2018 

The Honorable Mike Burgess 

Chairman 

Subcommittee on Health of the 

Committee on Energy & Commerce 

United States House of Representatives 

2336 Rayburn House Office Building 

Washington, DC 20510 

The Honorable Gene Green 

Ranking Member 

Subcommittee on Health of the 

Committee on Energy & Commerce 

United States House of Representatives 

2470 Rayburn House Office Building 

Washington, DC 20510 

Re: H.R. __,The Tableting and Encapsulating Machine Regulation Act of 2018 

Dear Chairman Burgess and Ranking Member Green: 

I write you today on behalf of Catalent, Inc., a NYSE-IIsted advanced dosage form provider and contract 

development and manufacturing company, with global headquarters in Somerset, New Jersey, We produce 

more than 72 billion doses of prescription and consumer health products annually across more than 7,000 

products on behalf of our customers, and for patients around the world. 

we applaud the comprehensive approach to addressing the Illicit use of opioids represented by the eight 

draft bills to be discussed during the Combating the Opioid Crisis hearing planned for this Wednesday, 

February 28, 2018. 

We are reaching out to express some concerns regarding provisions of the initial draft of one of those bills, 

The Tableting and Encapsulating Machine Regulation Act of 2018 (the "Tableting Regulation Bill" or 

the "Bill"). We recognize that testimony by the Drug Enforcement Administration (the "DEA") at 2016 

hearings of the Committee of Energy & Commerce Indicated a growing use of imported tablet presses and 

encapsulating machines to supply illicit drug markets in the United States. we also note that, in response to 

this activity, in late 2016, the DEA established expanded reporting requirements for all import, export, and 

domestic transactions involving such equipment, which were implemented In mid-2017.1 

The initial draft of the Tableting Regulation Bill would reclassify every machine that produces either tablets 

or capsules in any domestic facility as a controlled substance, and thus subject to DEA oversight, 

recordkeeping, security, and other requirements-the same standards that apply to narcotic bulk drugs and 

finished doses. These new requirements are imposed without regard to whether any such machine is sited 

at a facility that Is already governed by the Food, Drug & Cosmetic Act (the "FD&C Act"), or is already 

regulated by the Food & Drug Administration, nor does the legislation recognize the Inherent differences 

between machinery and the sorts of controlled substances that are already regulated by the Controlled 

Substances Act. 

1 See https :/ /www .deadiversion. usdoj .gov /fed_regs/rules/20 16/fr1230. pdf. 
190 


30411.094

Catalent 

February 27, 2018 

Page 2 

While all the implications of the Bill's reclassification are not fully clear, the Bill is likely to impose substantial 

new regulatory oversight burdens on legitimate, law-abiding manufacturers of both prescription and nonprescription products, most of which are not producing opioids or other controlled substances. 

Further, the bill would drive significant additional costs for reporting, compliance management, and security, 

directly reducing funds currently used to Invest in growth, expand employment, and drive Innovation. 

Finally, we believe that the application of such provisions to production sites already regulated by the FDA 

will yield limited added enforcement value above that provided by the expanded transaction reporting 

requirements only recently Implemented by the DEA. 

Despite these significant concerns, we appreciate the enforcement benefits to be realized by applying such a 

status change to tableting and encapsulating production equipment that is not sited in facilities otherwise 

regulated by the FDA or subject to the FD&C Act. We believe that there are several possible approaches to 

modify the draft Bill to mitigate such concerns from regulated industry. In one such example, the 

application of such a reclassification might specifically exclude equipment in sites regulated by the FDA 

under existing sections of the FD&C Act, including but not limited to those relevant to producers of clinical 

and/or commercial supplies of prescription pharmaceuticals, over-the-counter monograph products, dietary 

supplements, and veterinary drugs. There are alternative approaches that we are discussing with Industry 

trade associations and other companies, which we have agreed to review with the Subcommittee staff in 

upcoming weeks. 

In closing, we reiterate our support for the efforts of the Subcommittee to address the challenges facing our 

country as a result of the Illicit use of oplolds. We recognize the difficult task before you and appreciate 

your consideration of our concerns and ideas to address them. For additional information, please contact 

either Com ell Stamoran (ccrnell.stamoran@catalent.com, 732-537-6408) or Steven Fasman 

(steven.fasman@catalent.com, 732-537-5956). 

Sincerely yours, 

Cornell 

c~ Stamoran 

Vice President, Corporate Strategy 

and Government Affairs 

cc: Steven Fasman 

Senior Vice President & General Counsel 

Catalent, Inc. 
191 


30411.095

-,a]_ 

0 •• } PHARMA t; 8/0PHARMA ~~ OUTSOURCING ASSOCIATION 

February 26, 2018 

The Honorable Michael c. Burgess 

Chairman 

Subcommittee on Health 

House Committee on Energy and Commerce 

United States House of Representatives 

2336 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Gene Green 

Ranking Member 

Subcommittee on Health 

House Committee on Energy and Commerce 

United States House of Representatives 

2470 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Burgess and Ranking Member Green, 

I am writing you today on behalf of the Pharma & Biopharma Outsourcing Association 

(PBOA), a trade association representing Contract Manufacturing Organizations and 

Contract Development & Manufacturing Organizations (collectively described as CDMOs for 

purposes of this letter). PBOA members provide the technologies and services that help the 

pharma and biopharma Industry develop and manufacture drugs, biologics, vaccines, and 

other treatments safely and cost effectively. Our members represent more than 20,000 

domestic manufacturing jobs, and overall manufacture more than 220 billion doses 

annually. CDMOs produce between 30% and 40% of all dosages consumed by patients In 

the U.S. 

We applaud your ongoing commitment to comprehensively addressing the Illicit use of 

opioids and combating this deadly epidemic unfolding in communities across America. With 

the enactment of the Comprehensive Addiction and Recovery Act In 2016, and through the 

Energy and Commerce Committee's ongoing consideration of additional policy proposals, 

you are truly leading the charge and we support your efforts. 

We are, however, concerned about one of the proposals being considered at the Health 

Subcommittee hearing on February 28, 2018: The Tableting and Encapsulating Machine 

Regulation Act of 2018. We recognize from testimony provided to the Subcommittee by 

the Drug Enforcement Administration (''DEA") in 2016 that there are legitimate concerns 

about the illicit use of Imported tablet presses and encapsulating machines, and we agree 

that there is an acute need to curb these practices. We also note that, In response to this 

activity, In late 2016 the DEA established expanded reporting requirements for all import, 

export, and domestic transactions Involving such equipment, which were implemented in 

mld-2017.1 

The legislation being, considered on February 28 would reclassify every machine that 

produces either tablets or capsules in any domestic facility as a controlled substance, and 

thus subject to DEA oversight, recordkeeping, security, and other requirements- the same 

standards that apply to narcotic bulk drugs and finished doses. These new requirements 

1 See https://www.deadiversion.usdoj.gov/fed_regs/rules/2016/fr1230.pdf 

PBOA • 10 Alta Vista Dr. Ringwood, NJ 07 456 • 201-788-7994 • pharma-bio.org 
192 


30411.096

PHARMA ~ BIOPHARMA OUTSOURCING ASSOCIATION 

would be Imposed without regard to whether any such machine is sited at a facility that Is 

already regulated by the Food and Drug Administration ("FDA"), 

While all the Implications of such a reclassification are not fully clear, this legislation, if 

enacted in its current form, would likely Impose substantial new regulatory oversight 

burdens on manufacturers of both prescription and non-prescription products, most of which 

are not producing oplolds or other controlled substances. Further, the bill would drive 

significant additional costs for reporting, compliance management, and security, directly 

reducing funds currently used to Invest in growth, expand employment and drive 

Innovation. An ally, we believe that the application of such provisions to production sites 

already overseen by the FDA will yield limited added enforcement value above that provided 

by the expanded transaction reporting requirements only recently Implemented by the DEA. 

We do understand and appreciate the need to more stringently oversee the acquisition and 

use of such production equipment that Is not sited In facilities otherwise regulated by the 

FDA. We believe that there are several possible approaches to modify the legislation to 

mitigate our concerns. For example, you could specifically exclude equipment in sites 

regulated by the FDA under existing sections of the Food, Drug and Cosmetic, Including but 

not limited to those relevant to producers of clinical and/or commercial supplies of 

prescription pharmaceuticals, over-the-counter monograph products, dietary supplements, 

and veterinary drugs. There are alternative approaches that we are discussing with Industry 

trade associations and other companies, which we have agreed to review with the 

Committee staff In upcoming weeks. 

In closing, we reiterate our support for the efforts of the Committee to address the 

challenges facing our country related to the Illicit use of opiolds. We recognize the difficult 

task before you, appreciate your consideration of our concerns and Ideas, and restate our 

commitment to working constructively with you to address legitimate concerns about the 

Illicit use of this type of the equipment without Imposing Inappropriate burdens on legitimate 

manufacturers. 

Sincerely, 

Gil Roth 

President 

Pharma & Biopharma Outsourcing Association 

PBOA • I 0 Alta Vista Dr, Ringwood, NJ 07456 • 201-788-7994 • pharma-bio.org 
193 


30411.097

~~~1--PH_A_.R_M_A_t;_B_/0-P-HARMA 0 B OUTSOURCING ASSOCIATION 

PBOA Member Companies 

3M Drug Delivery 

Afton Scientific 

Alcaml 

Althea CMO 

Avid Bioservices 

Avlsta Pharma Services 

Baxter Biopharma Solutions 

Berkshire Sterile 

catalent Pharma Solutions 

CMIC CMO USA 

Coating Place 

CPC - Contract Pharmacal Corp. 

OPT, a division of Mylan 

Emergent BioSolutions 

Grand River Aseptic Manufacturing 

Groupe PARIMA 

Halo Pharma 

IDT Blologlka 

Jubilant HolllsterStier 

LSNE - Lyo Services of New England 

Metrics Contract Services 

Mission Pharmacal 

Particle Sciences, a Lubrlzol Company 

Patheon, a part of Thermo Fisher 

PCI Pharma Services 

Pfizer CentreOne 

Pharma Packaging Solutions 

Piramal Pharma Solutions 

Renaissance Lakewood 

Tapemark 

Thera pure 

WellSpring Pharma Services 

PBOA • 10 Alto V!•ta Dr. Ringwood, NJ 07456 • 201-788-7994 • phorma-blo.org 
194 


30411.098

THE COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, INC. 

3420 N. Broad Street, Room 324, Philadelphia, PA 19140-5104 

Telephone: 215-707-3242 • Fax: 215-707-1904 • Website: http://www.cpdd.org 

Executive Officer: 

Loretta P. Finnegan, MD 

E-mail: finnegal337@aol.com 

Director, Executive Office: 

Ellen B. Geller, MA 

215-707-5307 

E-mail: gellerellen@gmail.com 

Board of Directors: 

Alan J Budney, PhD, President 

Leonard Howell, PhD, Past-President 

Margaret Haney, PhD, President-Elect 

Jack Bergman, PhD, Treasurer 

Patrick M Beardsley, PhD 

Kathleen M Carroll, PhD 

Marilyn E Carroll, PhD 

Howard D Chilcoat, SeD 

Timothy P Condon, PhD 

Sarah H Heil, PhD 

Amy C Janes, PhD 

Geoffrey K Mumford, PhD 

Thomas E Prisinzano, PhD 

Beatriz Rocha, MD, PhD 

Stacey C Sigmon, PhD 

Mark A Smith, PhD 

William Stoops, PhD 

Jennifer W Tidey, PhD 

Elise M Weerts, PhD 

June 23, 2017 

Representatives Robert Goodlatte and John Conyers 

House Judiciary Committee 

2138 Rayburn House Office Building 

Washington, DC 20515 

On behalf of the College on Problems of Drug Dependence (CPDD), 

we are writing to express our views on H.R. 2851, Stop the Importation 

and Trafficking of Synthetic Analogues (SITSA) Act of 2017. CPDD is 

the longest standing scholarly society in the United States that is 

devoted to issues surrounding substance use disorders. The College 

has over 1000 members, and serves as an interface among 

governmental, industry, and academic communities maintaining 

liaisons with regulatory and research agencies as well as educational, 

treatment, and prevention facilities in the drug abuse field. 

We share the concerns of the Committee and sponsors of H.R. 2851 

about the opioid epidemic and its devastating consequences for 

millions of Americans, their families, and their communities. According 

to a recent New York Times article, an estimated 59,000 Americans 

died in 2016 of drug overdoses, the largest annual jump in deaths ever 

recorded in the United States. One of the main reasons for that 

dramatic and disturbing increase is the spread of fentanyl, a synthetic 

opioid that is inexpensive and potent. The College supports robust, 

science-based efforts to curb the sale and use of synthetic analogues. 

While CPDD agrees with the spirit of H.R. 2851, we believe that 

legislation to enhance the Justice Department's efforts to temporarily 

schedule new synthetic compounds must institutionalize a more 

enhanced role of the Department of Health and Human Services' science-based agencies, specifically the 

National Institute on Drug Abuse and the Food and Drug Administration. The current version of H.R. 2851 

gives the Attorney General blanket authority to temporarily schedule a substance, and the AG is only 

required to provide a 30-day public notice of pending scheduling action and "take into consideration any 

comments" from HHS on proposed orders to temporarily schedule a compound. The temporary scheduling 

process for synthetic analogues bypasses the current process that requires the AG to conduct a three-factor 

analysis before temporary scheduling can proceed. 

Moreover, to permanently schedule a compound, current law requires the AG to obtain an eight-factor 

analysis by FDA and a recommendation from HHS on a permanent scheduling action. For synthetic 

analogues, H.R. 2851 enables the Attorney General to bypass the current role of science-based agencies in 

reviewing what compounds should be scheduled. 

We seek to ensure that science-based Federal agencies, including FDA and NIDA, are involved in 

decisions regarding temporary scheduling of synthetic analogues, rather than the current version of H.R. 

2851, which merely requires that HHS be informed of the AG's intent to schedule such compounds. 
195 


30411.099

If the intent of the legislation is to enable the "scientific and research communities to develop information on 

these newly-invented substances," then the research exemption written into the current version of H.R 

2851 needs to be enhanced significantly. The bill provides that researchers who already have a Schedule I 

license will not need an additional one, except to review protocols for research on these targeted 

substances. This exemption applies to only a small subset of potential scientists who could and should 

research potential treatments to the targeted synthetic compounds but who will be discouraged from doing 

this research by the burdens and lengthy regulatory burdens and time required to gain approval of a 

Schedule I license. CPDD encourages the Committee to consider an expanded exemption that would 

enable researchers with Schedule I, II, Ill, IV and V licenses to conduct research on those synthetic 

analogues that will be temporarily scheduled under terms of this legislation. 

Respectively 

Alan Budney, PhD 

President, The College on Problems of Drug Dependence 
196 


30411.172

Center on 

Budget 

and Policy Priorities 

h.:hru;try 2H, 201 H 

820 First Sttt'Ct NE, Suiw 510 

\X';\shingwn, DC 20002 

Tel' 202-408-1080 

Fax: 202~4fl8~Hl56 

Ct.'nter(g'cbpp.org 

W'\VV>'.cbpp.org 

Medicaid Expansion Dramatically Increased Coverage 

for People with Opioid-Use Disorders, 

Latest Data Show 

By Matt Broaddus, Peggy Jlailey, and A viva A ron-Dine 

The latest data from the federal Agency for Healthcare Research and Quality highlight the 

importance of the Affordable Care Act's (ACA) !vfedicaid expansion in increasing insurance 

coverage among people with opioid-usc disorders (OUD).' Our analysis of these data, which offer a 

comprehensive picture of opioid-related hospitalizations around the country, finds that the share of 

hospitalizations in which the pat:Jent was uninsured fcH dramatically in states that expanded 

Medicaid: from 13.4 percent in 2013 (the year before expansion took effect) to just 2.9 percent two 

years later. This steep decline indicates that many uninsured people coping with OUDs hav:_g.~m d 

coverage through Medicaid expansion. (See Figure 1.) 

-.__/ 

In addition, the data rebut claims that Medicaid expansion contributed to the opioid crisis. 

Opioid-related hospitalizations were higher in expansion than non-expansion states as early as 2011, 

three years before l\1edicaid expansion took effect, and have been growing at roughly the same rate 

in expansion and non-expansion states since expansion took effect. I'vledicaid is part of the solution 

to the opioid crisis, not a cause. 

Medicaid Expansion Increased Coverage and Access to Treatment 

The need for substance usc disorder (SUD) treatment, particularly as related to OUDs, is acute, A 

record 63,600 people died of drug overdoses in 2016, with 42,200 due to opioid use. Drug overdose 

death rates rose by statistically significant amounts in 27 states between 2013 and 2015 and in 34 

states between 2013 and 2016, according to the Centers for Disease Control and Prevention. 2 

By itself, having a SUD isn't considered a disabling condition under !v[cclicaid rules, so before the 

t\CA expanded Medicaid, low-income adults with SUDs generally didn't qualify for Medicaid unless 

they also had a physical or mental health disability. States' recent Medicaid expansions under the 

1 Healthcare Cost and Utilization Project Fast Star:;, Agcncr for Healthcarc Research and Quality, December 2017 

update, htq.w I /www hcup~us.ahrq.gnv /f;:,srstats/landing isp. 

2 Centers for Disea~e Control and Prevention, ''Drug Overdose Death Data: 2015-2016 Death Increases," 

https: II 'WY..rw.cdc.rov I drug-overdose/ data /smtedeaths.html. 
197 


30411.173

ACA allow adults witb incomes below 138 percent of the poverty line to enroll reh>atdless of 

disability, opening the door tn cm•er~ge for far more adults wirh SUDs. 

Recently rdeased data from the Hea!thcare Cost and Utilization Project (HCUP) at the Agency 

for Hea!thcare Research and Quality shed new light on how expansion affects coverage for people 

with OUDs. For states with available data, the HCUP provides a complete picture of opioid-userelated hospitalizations, including whether the patient was covered by Medicaid, Medicare, or private 

insurance or was uninsured. \'{1

e analyzed these data for the states with data available from 2011 

through 2015, and which either expanded Medicaid in january 2014 or had not expanded by the end 

of 2015. (See the methods note for derails.) 

In Medicaid expansion states, the uninsured rate for opioid-related hospitalizations plummeted by 

79 percent, from 13.4 percent in 2013 (the year before expansion implementation) to 2.9 percent in 

2015. The decline in non-expansion states was a much more modest 5 percent, from 17.3 percent in 

2013 to 16.4 percent in 2015 (see Figure 1). \Xl1ile hath expansion and non-expansion states saw 

siz<~bk declines in their overall uninsured rates during this period, Medicaid expansion appears to 

have been especially critical for expanding coverage to those with Ol1Ds.3 

The expansion states with the largest drops in the uninsured rate for opioid-related 

hospitalizations were Kentucky (90 percent), Oregon (89 percent), West Virginia (86 percent), 

Arizona (84 percent), and Illinois (83 percent).' (See Appendix Table 1 for additional state-level 

data.) 

These data are consistent with other evidence that Medicaid expansion is improving access ro care 

for people with opioid use and other substance use disorders. Medicaid makes medications like 

huprenorphine and naloxone, which are prescribed to combat opioid use disorders, affordable for 

beneticiaries. Medicaid spending on prescription drug treatment for opioid use disorders more than 

doubled between 2011 and 2016, from $394 million to $930 million. Five states with particularly 

high overdose mortaUt:y rates- West Virginia, lvfassachusetts, Ohio, Rhode Island, and Ken rocky 

-have also seen especially rapid growth in Medicaid spending for these drugs; all of these states are 

Medicaid expansion states.5 Evidence also suggests that Medicaid expansion improved acce.'5 ro 

substance use treatment services more broadly. After expanding Medicaid, Kentucky experienced a 

3 Since the fuU implementation of the- AC1Vs health insutance cov~rnge provisions at the beginning of2014-, ovcraU 

uninsuted r-ates have de dined significantly both in states that adopted the ACA's Mcdicnid e>:p:msion and those that did 

not, hut expansion s~ates have setn a larger de din~: fmrn I 2.9 pc:rc~::nt in 2013 to 6.5 percent in 2016, versus a drop from 

17.0 percent w 11.7 percent in non-expansion states. Sec _Matr Bronddus, ~'Census D<Jra; St«tcs. Not ExptUldlttg 

.Medicaid Lag F-urther on He:ahh Coverage;~ Center on Budger and Polky Priorltics, Scptcmbc r 12, 2017 ~ 

hrrps://www.cbpp.otg/blog/£.~nsus~ct..a.tHU!te.~~~xp3~.m~d..:-lag-futthcr-on-he-alrll-C'~vcragc. 

"'Some of these newly eligible. adults likely (;mollcd when they were hospit;>.!izcd. The ACA allows hosp-itals to provide 

presumptive ctigibility to people like!)' to be 1lcdicaid digiblc. Those found ctigiblc after they complete the cligibilit)' 

process cao receive folJ0\1,H.~p treatment (Section 1902(a)(47)(b) of the Sod:1l SL~cnrity Act). 

5 Lis(! Clemmons-Cope) 1\·brni Epstein1 ;md Genevieve Kenney, ''Tb.pkl GrO\vth in !vkdicaid Spending on ?vkdications 

to Trcar Opiokl Usc Disorder and Ovcrdos.c/, Urban Institute, June 28.2017, 

http5: I I 1.\'W\\'. urban.org-frr:SL"1lrChLpuhlktl.rinn/.--!£!l?iQ .:.l~XP~b..:..t:!l~if.3i9_;.f:U£Oding- medications- tre;~t-npigid-usc-disordcrnnd-m·crdo-sc. 

2 
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700 percent increase in i\Iedicaid beneficiaries using substance use treatment services." Use of 

tre~tment services rose nationally as well; one study found that expanding Medicaid reduced the 

Lmmet need for substance usc treatment by 18.3 percent. 7 

ACA Medicaid Expansion Reduced Share of 

Opioid-Related Hospitalizations in Which 

Patient Was Uninsured 

Medlcmd expansion states Non-expansion states 

20% 

15 

10 

Quarter before expansion' 

5 

0 2011 2011 2012 2012 2013 2013 2014 2014 2015 2015 

01 03 01 03 01 03 01 03 01 03 

It· .,r', ',d ll\ ., I ·.:rl. 1

1lz 

" "!.i " 1.1 .. , J:)l'. >I. ' I''• ,. ~ , · I :I ', ,•f' I I· It tj 

., . 11·J·;,x1 .. ·'· I. t.t I> j,·j ' .~·, j< I• I• 

' . ' ~ ' .. l· t~l ,, /l·! 1 !! ,·l!\ l '·1··1 I 

'" ' l ~ ' . 

Moreover, substance usc disorders usual!y don't occur in isolation; people with SUDs also need 

access to physical and mental health services. Medicaid expansion has been shown to help people 

get these services, too. For example, an Ohio study found that 59 percent of people with opioid.-usc 

disorders who had gained Medicaid coverage under expansion reported improved access to mental 

health care.' Nationwide, the share of people forgoing mental health care due to cost fell by about 

(,"Subst-ance Use and the 1\CA in Kenrucky," Four1dation for a Healthy Kentucky, Dccemb~r 2016, 

https://www hea1thr~k\·.org/rcs/im~wes/rt.s.cmrc~.;:./1~ullwSub5tance-( lse~Brief~Fin~t! 12 l6-002r.pdf. 

Hefe1 \V'cn, Benjamin Druss, and Janet Cummings, "Effect ofMcdicatd E~p:tnsions on Health Insutance CovertJ.ge and 

Acce~s to Care Among Low-Income Adults with Bcha:~:ioral Health Condidons," I-fealtb SrrJiiccJ 1\tJMrciJ, December 2015, 

bltps: I f.,.>~w.ocbi.olm.nih.)~>V /pmc /wicle,/PM!,46938S} /. 

~"'Ohio Medicaid Group VIfi Assessment: A Report to the Ohio General Assembly," Ohio Department ofMcdica..id. 

December 2016, htr!2l.L.Lmcdk:-aicl.ohio.gov /portals /0 /rcsou rccs /report:> /annu:tl/ group~ viti ~assc:ssmcnt.tlli.f. 

3 
199 


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one-third as the ACA, including Medicaid expansion, took effect. 9 And more generally, studies find 

that Jlleclicaid expansion bas increased access to primary and preventiYe care, increased the share of 

people r,ctting regular care for chronic conditions, and reduced the share of people forgoing needed 

care due to cost."' 

Research Also Refutes Claims That Expansion Is Driving Opioid Crisis 

At a recent hearing of the Senate Homeland Security and Government Reform Committee, 11 

Chairman Ron Johnson claimed that Medicaid expansion contributed to the opioid crisis. 12 But the 

evidence doesn't support this claim; to rhe contrary, as discussed above, the expansion has increased 

access to treatment. And the HCUP data show that opioid-related hospitalizations have been 

growing·- since before the expansion took effect- in both expansion and non-expansion states, 

and at roughly the same rate. 

The HCUP data show that opioid-relatecl hospitalizations are increasing across the nation, 

regardless of Medicaid expansion. They are more prevalent in Medicaid expansion states, reflecting 

the fact that man)' of the northeastern and midwestern states at the epicenter of the crisis opted to 

expand. But these rates were higher as early as 2011 -well before expansion took effect. Aftet 

expansion, hospitalization rates rose at similar rates in expansion and non-expansion states. 

Nationally, opioid-relatcd hospimlizations rose by 11 percent between 2013 and 2015, from 208 to 

231 per 100,000 people. !\Iedicaid expansion states saw a 12 percent increase, from 241 to 270 per 

100,000 people. Non-expansion states saw a lO percent increase, from 169 to 185 per 100,000 

people. (See Figure 2.) 

9 .Assist<1nt Secretary for Planning and Evaluation, "Continui.ng Progress on the Opjoid Epidemic: the Role of the 

Affordable Care Act," J•n""'T 11, 2lll7, https://nspc hhs.goy /syitcmlfiks/pdf/255456/ACAOpioid.pdf. 

10 Sec for example Beniamin D. Sommers eta!., <~Changt:l' in Utili;:.ation and Health Among Lmv-lncome Adults After 

!\Iedicaid Expansiun or Expanded Priv:uc Insurance/' joJtrnal of !he Atllenl:an Afr:t!ical A.rsoa~:i//(;.11, October 

2016, http:/ /iamanet\votkcnmnmrn,.ls/j:tmainternalmcdicinc/artici<.·-abstract/2542421), For 'J revie-.v of the literature, 

sec Assistant Sccrct;:trr for Planning- and Evaluation. "Medicaid Expnn~lon lrnpacts on Insur;o.ncc Cm.·,~ragc and Access 

to Cnrc," Department of Health and Humnn Servu::c.s, updated Januaq· 18, 

2017, https: I (.,po.hhs.g<ltisystem/filcs/pdf /255516/medicaidexpansinn.pdf. 

11 "Unintended Consequence$: Medicaid a.nd the Opioid Epidemic," Se-nate Committee on Homeland Security and 

Governn1ental Affairs, January l7t 2018) https:/ /u..-..V\v.hs~r-ac.senate.t~ovlhC'arinfslunintcndcd~cons~.q1LGfu:~.~.:ill.C.di.g_tid.: 

~nd-thc-opioid-epidcmic. 

12 l3Hl Gb.ubet·, ... Ron Johnson l.inks i\iedica.ld to Opioid Crisis During Heari11g," J1ilwaokrt']otmMI Jmtind,]'Jnuary 27, 

2018, ht!;ps-: I /"\"-\'\l.¥.is.on1inc.corn /story /news /politics /2018/01/17/ron-johnson-lgnd-hcRrin~-explorc-if-mcdica.id-play:-­

role-opillkt-:rcris!s/ 1038376001/. The cornmittce 1

S Republican staff released a report titled "Drugs for DoHan;; How 

lv{edicaid Help'S Fud the Opioitl Epldemk," 

4 
200 


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Opioid·Related Hospitalizations Aren't Rising More 

in ACA Medicaid Expansion States than Other States 

Rise in hospitalizatrons per 100,000 people since fu-st quarter of 2011 

Medicaid exp<Jnsion states Non-expansion states 

35% 

30 

25 

20 

15 

10 

5 

Quarter before expansion' 

0 2011 

01 

l'.· ,, 

2011 

03 

'I 

l:• ,,, 

2012 

01 

' I<, ( \ 

·:r·.!•r. 

•'!1 . ·~ !, y 

., 'I ~ ' Ill . ~ • 

• 1•' 1 ·!·· ·F 

2012 2013 

03 

I'-

01 

,·>,(, .. •., 

"' "' •.trk 

;'l j•.l!,f, 

, .. 1 ·! r.~ , d 

2013 2014 2014 2015 

03 01 03 01 

1 '! .:.!'.',:!; .) !' _,,, 

'J "·'·'',.r1.1 

!l! ·ll'; ,., 

}>'I•J';.>.•Jl. •i 1'1i1, !• • 

2015 

03 

. (!. 

t. t 

These results, which belie claims that Medicaid expansion has caused a disproportionate increase 

in OUDs, are consistent with other researchers' analysis of dmg overdose rates." They arc also 

consistent with new research from the Oregon Health Insurance Experiment In 2008, prior tO the 

ACA, Oregon undertook its own expansion of Medicaid to low-income adults. But because of 

limited funding, Oregon assigned Medicaid slots by lottery, which researchers have used as a 

randomized experiment to evalLrate the impact of Medicaid coverage. A new study finds that those 

enrolled in Oregon's Medicaid expansion program were no more likely to be prescribed opioids -

or to be prescribed rrtore opioids ~ than low-income adults not enrolled in fvledicaid. However, 

Medicaid enrollees were almosr twice as likely to be t=>tescribcd treatment medications for opioid use 

disorder as those not enrolled, although this tinding falls just short of statistical significance dne to a 

small sample size. 

Furthermore, virtually no Medicaid enrollees in Oregon possessed prescription drugs not 

originally prescribed to them." This is an important finding, given the serious health risks associated 

n Andrew Goodman-Bacon and .Emma Sandoe, "Did ~lcdicnid Expansion Cause the Opioid Epidemic? There's Little 

Evidenc~:: That It Did/1 Hra/tl; ~~1j]airJ1 Aut,'l15t 23, 20 17, 

https://\ww.hoalrh"ffairs.or~/do/lll1377/hblo~201708231l6 1040/full/. 

l·l Katherine Baickcr rt ttl., "The Effect of ~fcdicaid on l\-lt!dicadon Use Among Poot Aduhs; Evidence from Oregon," 

Hta/1/i ."1f];,i,, December 2017, https:l/w>I'\Y.hcalthaffair~,_Qr)(/doi/pdf/IJL1}77/blrhaf(2.Q17J)91_~--
201 


30411.177

·with prescription medication sharing; and it is especially significant in relation to opioids, given the 

concern that opioid prescription sharing is prevalent.'; 

Of course, some people enrolled in Medicaid have received inappropriate opioid prescriptions. 

But tl1e problem of people receiving inappropriate opioid prescriptions is not unique to Medicaid. 1t 

also exists with private insurers and Medicare, which experience the same challenges in 

implementing solutions such as improving prescription tracking, identifying providers who 

overprescribe medications, and researching non-opioid inten•entions for pain." It is also important 

to understand that the rise in opioid-related overdose deaths is now largely due to non-prescription 

drugs like heroin and fentanyL,-

States Are Using Medicaid to Help Address Opioid Crisis 

Now that more people with SUDs are eligible for Medicaid, states can significantly improve 

treatment for people with SUDs by improving Medicaid-covered services. Medicaid can be a 

sustainable funding source for providers, as opposed to capped, shon-rerm grant funding, and states 

like California, Kentucky, Maryland, Massachusetts, New Hampshire, New Jersey, and West Virginia 

have new 1\1edicaid initiatives for people with SUDs underway. These states are providing services 

such as inpatient treatment or short-term residential treatment and innovative evidence-based 

serYices like peer suppons; they also are providing wraparound supports such as housing and 

employment to increase the impact of treatment. Other states, including Illinois, North Carolina, 

and New Mexico, are seeking federal approval for similar proposals." 

Among a panel of experts dealing directly with the opioid crisis- public health and law 

enforcement officials, policymakers, and policy experts -Medicaid expansion was among the 

policies consistently named as most critical for addressing the crisis.,. Claims that l\Iedicaid coverage 

has worsened the epidemic aren't supported by the available evidence and shouldn't deter states th.'lt 

have not yet expanded Medicaid from taking adl'antagc of the opportunity to improve coverage and 

treatment for people struggling with opioid usc and other substance usc disorders. 

1

·

1 Kebede Berene}]llnic Shcridan 1 and Trudi Aspdcr., >(Prescription Medication Sharing: A Systematic Rcviev..· of rbc 

Lit~rature,'' A111etitmt ]afm]{J} tJ{Publir Hrnltb, April 2014, hups://\~'\V\v.nr:bi.nlm.nih.goy{ptnc/article~/PMC402!i682/; 

Alene Kennedy~ Hendricks, Andrea Gielen, and Eileen ~kDona1d, "M<..>-dic9.tion Sharing, Storage, and. Dispos-al Pmctices 

for Opioid Mcd.ications Amohg US Adu!ts/' jolimlll qf thr> Amrrkt1nAffdiml As.rocialiM, July 2016, 

htrps: // jru nanef\\"0 rk.com ljOIJ ro~ls /j:::~:m~jntcrna!me:dicinc/ fullarricle/2 S2? 388. 

\(

1 For cxampl~, for ~n analysis of high rates of opioid us.c and long-term opioid usc among people enrolled in 

commercial covcmgc, sec Blue Cross Blue Shield Association, "America's oploid epidemic and its effect on the natlon's 

commcrciallr~insured population," June 29,2017, hnps://\v·w'-\'.bchs.com/thc-health~of~amcric:lhcports/am~.:;. 

Ql'!i.Qid-epidemic-and-i[s.-effcct~nn-the-nations-cornm~rciully-insured. 

1'7 N<'clia Koummg, ''25()/l') of aU overdoses arc from heroin,'' CNNl February 24,2017, 

https: II W\\".v. cnn.com /2017 /02/24 /hcalrh /heroin-overdose-study/. 

~ Peggy B~iley, "Building on ACA's Sm;:cess \X101.1ld Help i\Ullions with Subsrance C$e Disorders/, Center on Budget 

ttnd Policr Priorities, Aptill !, 2017, https:/ /\,-._,.,,._chpp.org/rc~carch/heaith.Lh.4ildini.,._on-a.c,'l.s .. succcss-would-hdp~ 

milli{lqs-with~i;lubsmnr.:c-u~c-dbt)rde~. 

J'> Josh K~t7., "How u Police Chief, a Governor ~nd a Sociologist \\'ould Spend Sl 0{) Bil!ion to Solve the Opioid Crisis,11 

l'.lm' Yoli~ Times, February 14, 2018, h.np!>://\t'\.\"\.\" m·tirni?S:,comlinteractivc/2018/02/14/upshot/opintd-ciisisS<lludons.hnnL 

6 
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30411.178

Methods Note 

The Agency for Hea!thcare Research and Quality developed the Health care Cost and Utilization Project 

(HCUP) through a collabOration with states and health industl)' representatives. The result is the nation's 

most comprehensive source of hospital care data. We use the most recent available HCUP data, released in 

December 2017, which include consistent quarterly data for 44 states and the District of Columbia (DC) 

from the first quarter of 2011 through the third quarter of 2015. Revisions to data classification were made 

in the fourth quarter of 2015, so data after this revision are not comparable to earlier data. 

First, we identified states with HCUP data for the entire study period. Data are available for 32 states and 

DC on the share oftotal opioid-related hospitalizations by patients without health coverage, and for 40 

states and DC on the number of opioid-related hospitalizations per 100,000 people in the state. 

Then we classified those states with available data based on their Affordable Care Act Medicaid expansion 

status. States that expanded in January 2014 compose the "Medicaid expansion group," and states that 

had not expanded by October 2015 compose the "non-expansion group." For our main analysis, we 

excluded states that expanded Medicaid either before January 2014 or between January 2014 and October 

2015: Alaska, California, Connecticut, DC, Indiana, Minnesota, New Jersey, Pennsylvania, and Washington. 

(Data for some of these states are included in Appendix Table 1.) 

Finally, we aggregated and compared relevant quarterly data over the study period for the expansion and 

non-expansion groups. Our analysis of insurance coverage status of patients hospitalized for opioid·related 

conditions included 13 states in each group. our analysis of opioid-related hospitalizations per 100,000 

people included 19 expansion states and 16 non-expansion states. (Because this analysis does not require 

data dis aggregated by payer, data are available for more states.) 

7 
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Share of Opioid-Related Hospitalizations by Uninsured Patients, for Medicaid 

Expansion States 

State 2013,% uninsured 2015,% uninsured %Change 

Arizona 16.7% 2.7% -84% 

Arkansas 17.2% 4.2% -75% 

Colorado 13.8% 3.9% -72% 

Illinois 15.6% 2.6% -83% 

Kentucky 27.6% 2.8% -90% 

Maryland 23.0% 5.8% -75% 

Massachusetts 6TQ% 1.5% -75% 

Michigan 8.5% 1.1% -80% 

Nevada 20.3% 3.7% -82% 

New York 5.7% 2.7% -53% 

Ohio 20.2% 3.4% ·83% 

Oregon B.2% 1.4% -89% 

West Virginia 21.1% 3.0% ·86% 

Expanded in 2015 

Indiana 16.1% 8.6% -47% 

Pennsylvania 7.5% 3.4% -54% 

8 
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311/2018 The Opiold Eplderric: A Crisis Years In the Ma!dng- The New York limes 

€be ~e\tJ §ork€imes 

The Opioid Epidemic: A Crisis Years in the 

Making 

By Maya Salam (https://www.nytlmes.com/by /maya-sal am) Oct. 26, 2017 

Examining the body of a woman who died of an overdose in August. 

Todd Heisler/The New York Times 

The current opioid epidemic is the deadliest drug crisis in American history. 

Overdoses, fueled by opioids, are the leading cause of death for Americans under 

50 years old- killing roughly 64,000 people last year, more than guns or car 

accidents, and doing so at a pace faster than the H.I.V. epidemic did at its peak. 

President Trump declared the opioid crisis a "public health emerg~y,: 

.(!illp..s.;/./~ytirnes.com/.1Ql7/JQ/--2§/.llli/.Rl!lim/_trymll:Qpioid-crjsis,htrnl). on 

Thursday, though he did not release additional funding to address it. Had he 

declared it a "national emergency;' as he promised to do in August, it would have 

led to the quick allocation of federal funds. 

https:/f.mmi'r')(lmes.ccm'201711012&'usfC4)ioid-crisis-public-heBith-emarget"C):html 1/9 
205 


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311/2018 The Opioid Epidemic: A Cr!sls Years in the Making~ The NewYotkTlmes 

The New York Times has been covering the outbreak- from when it started 

bubbling up in towns around the United States years ago to now, as it decimates 

communities and families. 

Here is a roundup of our best reporting on the epidemic, including short answers 

.(lill!1s..:/./.IDTI£J1ytimes.com~interactive/.2lll7/J!B/.QJ/JJ.p..ID21!SJ.!l.i2ki:.drng: 

overdose-epidemic.htm!). to hard questions about it. 

Snapshots of a Public Health Crisis 

A team of reporters went inside the epidemic, from New England to "safe 

injection" areas in the Pacific Northwest, to explore the experiences of addicts 

and those trying to stem the tide. "I don't know how I'm alive, honestly;• one 

Massachusetts woman said. Here are their stories 

.(!illPE/./.IDTI£J1ytimes com/.2lll7/.ill/.ilil/JJJ;/sJ_l!ioid-crisis-epidemic.htmi).. 

Even babies are affected by the crisis, with a surge of newborns dependent on opioids. 

Ty Wright for The New York Times 

The youngest members of society have not been exempt from the crisis. Toddlers 

and young children are increasing!y...Qeing found unconscious or dead 

.(lillPE/./.IDTI£J1YJ.imes.com/.2lll7/.M/.lQLus/s!_l!ioid-deaths-children.html). after 

htlps:llwMv.n~mes.co.-rl2017/1012&us/opioid-cris1s~pub!ic--health-omergency:hlni 
206 


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l/112016 The Opldd Epidemic: A Crisis Years in tha Making- The NewYorknmes 

consuming an adult's drugs, and a surge of ll!lli!il!:l1l:P.endent newborns has 

forced doctors to rethink treatment 

.(http~/./.www.nY.times.com/.2QTI/.07 f.n/..!llilltl!/.QP.ioid-addiction-babies.html) .. 

You have 4 free articles remaining. 

Subscribe to The Times 

(https:/ /www.nytlmes.com/ subscrlption/multiproduct/lp8HYKU.html7 

campaignld=6YH9R&return_url=https%3A%2F"A.2Fwww.nytlmes.com%2F2017%2F10%2F26%2Fu 

crisls-public-health-emergency.html) 

The Numbers 

Our reporters have been deciphering and providing context to masses of data 

about the many and varied ways opioids are affecting Americans. 

How overdose deaths rippled across the United States. 

Haeyoun Park and Matthew Bloch/The New York Times 

Illustrated in a series of rna~ 

.(lillP~/./.www.nyJ;imes.com/.interactive!.2Qll1/..Ql/.07 (.us!.Qrug-overdose-cteaths-inthe-us.html), here's how overdose deaths rippled across the United States from 

319 
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31112018 The Opioid Epidemic; A Crisis Years ln the Mal4ng -The New York. Times 

1999 to 2014, along with a breakdown of the large concentration of deaths in 

regions like Appalachia and the Southwest. 

This interactive guiz 

.(l:Jllp..s.;,Uwww.nYJ;imes.com/.interactive!JJJJ1/.04illLllP.mml;/Jill!g-overdoseJ::~Y.OU·draw-it.html? _r.::..!l). aims to provide a deeper understanding of the 

mounting toll by asking readers to compare drug overdose deaths with other 

causes of death. 

U.S. ByYousur AI-Hiou, Josh Katz a... 2:03 

Here are the facts on the deadly ... 

It's the deadliest drug crisis in American history. It kills about 90 Americans everyday. Here 

are answers to some key questions about the crisis. 

Oct. 26,2017 Image by Michael Bryant/The Philadelphia Inquirer, via Associated Press 

The government's account of drug deaths in 2016 was the first national data to 

break down the growth by drug and by state, which revealed that deaths 

involving synthetic opioids, mostly fentanyls, ha~p~j~ 

y~(l:!llm;/.~ytimes comf.interactive/.2017 /Jm/.illl/..Y~Lfen1lmyl:drng: 

overdose-deaths.html) .. 

While Mr. Trump fulfilled his vow to add urgency to the rapidly escalating opioid 

problem, his declaration falls short of the national emergency declaration he had 

pledged. These are the 28 currently actiye national emerg!llQes 

.(l:!llm;UIDYW.DYJ;imes.comLinteractive/.lQIZLilll/~/Jl~/Jlpioid-crisisnational-emergll!ll;yl!tml).. 

Health Care llttps:llwNw.r¥imes.ccm'2017/10'2&us/opioid-crisis~public-health-emergencyhtm 
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31112018 The Opioid Epidemic: A Crlsls Years !n the Making- The NewYork11mes 

Drug companies and doctors have been accused of fueling the opioid crisis, but 

insurers may also be playing a role by making it easier to get opioids than the 

drugs that treat addiction to them. Here are the findings of our analysis 

.(lillPEL~Y.times.com/.1!111~1l7Lhealth/.Qpiml:l:P.ainki!!ers-insurancemP.anies.html).. ) 

A patient had to begin taking a hydrocodone, 

an opioid, to treat her pain after her insurer 

changed what it covered. 

Kevin D. Liles for The New York Times 

With the soaring death toll, routine autopsies are overwhelming medical 

examiners everywhere. ~P.oke to Dr. Thomas A. Andrew 

.(hll~/./~Y.times.com/.1!111/JQL07j_usLQ!:yg-oyerctose-medicalexaminer.html). of New Hampshire, which had more deaths per capita from 

synthetic opioids than any other state. Dr. Andrew decided to stop practicing 

medicine and instead minister to the living about the dangers of drugs. "I'm not 

an alarmist by nature, but this is not overhyped;' he said. 

The Upshot reported on prescription drug monitoring programs, a tool that could 

be more wide!y~g!lt9P.ioid abuse 

.(hllRS..:.L/~Y.times.com/.1!111/Jl.Jl/llL!JP.ffilll:/~pful-tool-to-combat-theQP.ioid-crisis.htlnl) .. 

Jails and Justice 

Heroin users are filling the country's jails, but recovering addicts are almost 

always cut off from their medication while incarcerated. Connecticut, though, is 

trying something new: a methadone treatment program to help inmates 

successfully re-enter society. We looked at the conundrums detention centers are 

fl!&ing_(btlRS..;.i/:Jf:!!Yf,JJ,Y.times.com/.1!111/.ill!/JHLus/heroin-addjctjon-jlli!§: 

methadone-suboxone-treatment,html) .. 

https://W.wr.t'1}4imes.corrv'2017/10/26fus/opioid--crisis-pub!ic-health-errergency:htm! 519 
209 


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l-'112018 TheOpioid Epidenic: A Crisis Years In the Maloing- TheNewYorkTlmes 

V.S. By Kassle Bracken 3:41 

• t 

Watch: What Happens After Pri. .. 

The Times, in collaboration with the PBS series "Frontline;• followed 10 recently released 

inmates struggling to succeed on the outside. July 16, 2017 

On Staten Island, prosecutors are leaping into largely uncharted legal terrain to 

fight the scourge: ~ging dealers in overdose deaths 

.(!J.t1p_a;/./~Y..tinles.com/.1lll7/..QZ/.23/JlYEgi..Qil/.new-tactic-in-war-on-Q~ 

~ging-dea)ers-in-oyerdose;!eaths.html) .. And a New York Times Magazine 

writer traye!ed to a small tqwn in New Ham~ 

.(!ill!l£1./~ytimes com/.2QlZ/J!1/.!2/Jllllg~/a-small-tQWn-police-officerg. 

war-on-drug~)., where one police officer has been trying to curb the rash of 

opioid overdoses. 

Dealing in the Digital Age 

The internet is proving to be a grim tool in the opioid drug trade. 

On Reddit, one of the world's largest online communities, qgioid forums have 

~place to buy...dD!gs..(!ill!l£/./.mY.YWytinles.com/.2QlZ/J!1/..2!.l/..illi/.ll!llilk!: 

reddit html). and find solace for people like Rachel Frazier, who posted on Reddit 

regularly and dipped into drug-related communities such as "opiates!' She died 

two weeks after seeking drugs in a forum. 

hHps:/N.o..\w.n:,tlrM$.com'2017110126'us/opioid-crlsis-publlc-health-emerg~htn1 6/9 
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m1201a The Opioid Epidenic: A Crisis Years In the Mailing· The New York Times 

Rachel Frazier 

Between2012 and 2016, Rache!Frazierposted onReddit regularly as rachell787, occasionally dipping into 

drug-related communities such as "opiates." Two weeks befure she was funod dead of an overdose, she posted in 

''opiaterolk:all" fur the first time, apparently hoping to obtain drugs using the furunis coded language. 

POSf ON OPIATEROLLCALL POSf ON OPIATES POSf ELSEWHERE ON REDD!T 

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Dealers are embracing the dark web 

.(!m!l§..;/.~ytimes.com/_l!UZ~/.10~~/.Qpioid-dark-webID:!Jg-over!lose htin!). to anonymously send powerful synthetic opioids such as 

fentanyl to nearly every region of the country. Despite dozens of arrests, new 

merchants- many of them based in Asia - quickly pop up to fill the void. 

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3'112018 The Oplold Epidenlc; A Crisis Years in lhe Ma!Qng -The New YorkTlmes 

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Widow of Pulse Nightclub Killer Goes on Trial, a Challenge for 

Prosecutors 

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Lies That Worlt Die: 'Outside Agitator' and Paid 

'Actor' 

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Her Backpack Has a Bullet Hole in It, but She Went • 

to School ·· " 

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l/112018 The Oploid Epidemic: A Crisis Years in !he MaiQng- The NewYorkllmes 

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31112016 !nsldetheStoryof Arrerica's 19\h-CenturyOplateAddcUon I History! Smithsonian 

~g)(~~.Yml!~ 

~Sli!l!l TrayelWithUs ~ &lQn: ~~Arts & Culture lm'&) At the Smjthsonian ~ ~ 

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Smlthsonlan.com 

~ ~y_fQ!i!;Y. Term; ofUse 

Inside the Story of America's 19th-Century Opiate 

Addiction 

Doctors then, as now, overprescribed the painkiller to patients in need, and 

then, as now, government policy had a distinct bias 

This cartoon from Harper's Weeko/ depicts how opiates were used in the 19th century to help babies cope with 

teething. (Harpers Weekly) 

By~Y. 

smit:monian.com 

January4,2018 

The man was bk:eding, wounded in a bar fight, half-conscious. Charles Schuppert, aNew Orleans surgeon, was surnrmned to help. 

lt was the late 1870s, and Schuppert, like thousands of American doctors ofhis era, turned to the m>st effuctive drug in his kit '1 

gave him an injection ofm>rphine subcutaneously ofY, grain," Schuppert wrote in his casebook 'This acted like a chanu, as he 

came to in a minute from the stupor he was in and rested very easily." 

Physicians like Schuppert used m>rphine as a new-fungled wonder drug. h1iected with a hypodermic syringe, the medication 

relieved pain. asthrm, headaches, alcoholics' delirium tremens. gastrointestinal diseases and menstrual cralll's. ''Doctors were really 

impressed by the speedy resuhs they got," says David T Courtwright, author of Dark Pqradi!e' A History_gf_f)pjate Addiction in 

~. '1t's almost as if someone had handed them a magic wand." 

By 1895, m>rphine and opimn powders, like OX)Contin and other prescription opioids today, had k:d to an addiction epidemic that 

affucted roughly I in 200 Americans. Befure 1900, the typical opiate addict in America was an upper-class or middk:-class white 

woman. Today, doctors are re-learning lessons their predecessors learned IIlOre than a lili:tiroo ago. 

Opium's history in the United States is as old as the nation itself During the Amerioan Revolution, the Continental and Brifuh annies 

used opimn to treat sick and wounded soldiers. Benjamin Franklin 122k.2l!iYm late in lili: to cope with severe pain from a bladder 

stone. A doctor gave laudanwn, a tincture of opimn mixed with aleohol to Ak:xander Hamilton after his futal duel with Aaron Burr. 

The Civil War helped set off America's opiate epidemic. The Uninn Army akme issued nearly 10 million opium pill<; to its soldiers, 

plus 2,8 million ounces ofopimn powders and tioctures. An unknown number of soldiers returned home addicted, or with war 

wounds that opimnrelieved. "Even if a disabled soldier survived the war without becoming addicted, there was a good chance he 

would later xreet up with a hypodermic-wielding physician," Com1right wrote. The hypodermic syringe, introduced to the United 

States in 1856 and widely used to deliver II10rphine by the 1870s, played an even greater role, argued Courtwright in Dark 

Paradise. 'Though it could cure little, it could relieve anything." he wrote. ''Doctors and patients alike were tempted to oveiU'ie." 

Opiates made up 15 percent of all prescriptions dispensed in Boston in 1888, according to a survey of the city's drug stores. '1n 

1890, opiates were sold in an unregulated xredicalrmrketplace," wrote Caroline Jean Acker in her 2002 book, Creating the 

American Junkie: Addiction Research in the Classic Era of Narcotic Control. "Physicians prescribed them fur a wide range of 

indications, and pharmacists sold them to individuals medicatiog themselves fur physical and mental discomfOrts." 

htlpsJiwHN.smithsonlanmag .cOI'll'listor(!nside-story-arnericas·19th-c~ntLny·oplate-addictim-1809676731 &18 
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3'112018 Inside lhe Story of Arrer!ca's 19th-Century Opiate AddicHon 1 History I Sml.thsallan 

Male doctors turned to m:>rphine to relieve many female patients' menstrual cramps, "diseases of a nervous character," and even 

DDrning sickness. Overuse led to addiction. By the late 1800s, women made up DDre lllan 60 percent of opium addicts. "Uterine 

and ovarian complications cause rrore ladies to full into the [opium] habit, than all other diseases conhined," M!lll; Dr. Frederick 

Heman Hubbard in bis 1881 book, The Opium Habit and Alcoholism. 

Throughout the 1870s and 1880s, medicJ journals filled with warnings about the danger of =rphine addiction. But many doctors 

were slow to heed them, because ofinadiljuate medical education and a shortage of other lrea!Irents. "In the 19th century, when a 

physician decided to recoiil!OOnd or prescnbe an opiate fur a patient, the physician did not have a lot ofakernatives," said 

Courtwright in a recent interview. Financial pressures mattered too: demand fur IIDrphine from well-off patients, competition from 

other doctors and pharmacies willing to supply narcoties. 

Only aronnd 1895, at the peak of the epidemic, did doctors begin to slow and reverse the overuse of opiates. Advances in medicine 

and public heakb played a role: acceptance of the genn theory of disease, vaccines, x-rays, and the debut of new pain relievers, 

such as aspirin in 1899. Better sanitation meant fewer patients contracting dysentery or other gastrointestinal diseases, then turning 

to opiates fur the~ constipating and pain-relieving effi:c1s. 

Educating doctors was key to fighting the epidemic. Medical instructors and textbooks from the 1890s regularly delivered strong 

warnings against overusing opium "By the late 19th cenlllry, [if] you pick up a medical journal ahnut tmrpbine addiction," says 

Courtwrigh~ ''you'll very comrronly enccunter a sentence like this: 'Doctors who resort too quickly to the needle are lazy, they're 

incompetent, they're poorly trained, they're behind the times."'New regulations also helped: state laws passed between 1895 and 

1915 restricted the sale of opiates to patients with a valid prescription, ending their availability as over-the-counter dmgs. 

AB doctors led fewer patients to addiction, another kind of user emerged as the new fuce of the addict Opium s~roking spread 

across the United States from the 1870s into lhe 1910s, with Chinese immigrants operating opium dens in JDJSt major cities and 

Western towns. They attracted bolh indentured Chinese immigrant workers and white Americans, especially 'lower-class urban 

males, often neophyte members of the nnderworkl," according to Dark Paradise. '!t's a poor town now-a-days that has not a 

Chinese laundry,'' a white opiunrSJroker said in 1883, "and nearly every one of these has its hyout"- an opium pipe and 

accessories. 

That shift created a politieal opening fur prohibition. 'fu the late 19th centuiy, as long as the rrost comrronkind of11arcotic addict 

was a sick old lady, a ~rorphine or opium user, people weren't really interested in throwing them in jail," Courtwright says. "That 

was a bad problem, that was a scandal, but it wasn't a crime." 

That changed in the 191 Os and 1920s, he says. "When the typical drug user was a young tough on a street comer, hanging out with 

his friends and snorting heroin, that's a very diffi:rent and less sympathetic picture of 11an:otie addiction" 

The fuderal government's effurts to ban opium grew out of its new colonialist ambitions in the Pacific. The Philippines were then a 

territory under American control and the opium trade there raised significant concerns. President Theodore Roosevek called fur an 

inteTlllltiolllll opium commission to meet in Shanghai at the urging ofahrmed American missionaries stationed in the region. "U.S. 

delegates/' wrote Acker in Creating the American Junkie, '\vere in a poor position to advocate refbnn elsewhere when their o\'Vtl 

countrY lack natio11allegishtion regulating the opium trade." Secretary ofState Elihu Root submitted a draft bill to Congress that 

would ban the ~ort of opium prepared fur smoking and punish possession of it wkb up to two years in prison. "Since SIIDking 

opium was identilied with Chinese, garublers, and prostitutes," Courtwright wrote, "little opposition was anticipated." 

The law, passed in February 1909, limited supply and drove prices up. One New York City addict interviewed fur a stndy quoted 

in Acker's book said the price of"a can ofhop" jumped fiom $4 to $50. That pushed addicts toward rrore potent opiates, 

especially rrorphine and heroin. 

The subsequent Harrison Narcotic Act of 1914, originally intended as a regulation of medical opimn, became a near-prolubition. 

President Woodrow Wilson's Treasury Department used the act to stamp out many doctors' practice of prescribing opiates to 

"maintain" an addict's habit. After the U.S. Supreme Court endorsed this interpretation of the law in 1919, cities across the 11ation 

opened narcotic clinics fur the addicted- a precursor to modem methadone treatm:nt. The clinics were short-lived; the Treasury 

Department's N arcotie Division succeeded in closing nearly all of them by 1921. But those that ibcused on long-term mainte11ance 

and older, sicker addic1s- such as Dr Willis Butler's clinic in Shrevepo~ Louisiana- showed good resuks, says Courtwright "One 

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215 


30411.111

311/2018 inside the Sloryof Arrerlca's 19th-Century Opiate Addiction I History! Snithsonlan 

of the lessons of the 20th-century treat:rrent saga," he says, 'ls that long term maintenance can work, and work vecy well, for some 

patients." 

Courtwright, a IJiWry_Jlrofussor at the UniversityofNorth Florida, wrote Dark Paradise in 1982, then updated it in 2001 to 

include post-World War II heroin addiction and the Reagan-era war on drugs. Since then, he's been thinking a lot about the 

similarities and differences between America's two major opiate ep.idemics, 120 years apart. Modem doctors have a lotm::~re 

trealmlnt 

that pressed 

options 

them 

than 

to prescnbe 

their 19th-century 

new opi:Jids 

counterparts, 

such as OxyContin 

he says, but 

"The 

they 

wave 

experienced 

of medical 

a 

opiate 

much nme 

addiction 

~ 

in the 19th century was 

trore accidental" says Couttwright '1n the late 20th and early 21st centuries, there's more of a sinister conm:rcial elerrent to it." 

In 1982, Couttwright wrote, ''What we think about addiction very nnx:h depends on who is addicted." That holds true today, he 

says. ''You don't see a lot of people advocating a 1980s-style draconian drug polioy with mandatory minimum sentences in 

respome to this epidemic," he says. 

Class and race play a role in that, he acknowledges. "A lot of new addicts are small-town white Arrerieans: fuotball players who get 

their knees rressed up in high school or college, older people who have a variety of chronic degenerative diseases." Reversing the 

trend of I 00 years agn, drug policy is turning less punitive as addiction spreads among middle-class, white Arrerieans. 

Now, Courtwright says, the country may be heading toward a wiser policy that blends drug interdiction with trealmlnt and 

preventive education. "An effective drug policy is coneemed with both supply reduction and demand reduction," he says. '1f you 

can make it mere dif!icuh and expensive to get supply, at the same tiJre thet you make treatment on demand available to people, 

then that's a gnod strategy" 

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About Erldr: 1Htkey 

Erick Trickey is a writer in Boston, covering politics, history, cities, arts, and science. He has written fur POUTICO Magazine, 

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Questions for the Record: 

Submitted by Congressman David Kustoff (R-TN) 

Energy and Commerce Subcommittee on Health 

Hearing: "Combating the Opioid Crisis: Helping Communities Balance 

Enforcement and Patient Safety" 

Questions to Mr. Thomas Cosgrove, Partner, Covington & Burling, LLP.: 

I. In your written testimony, you note that the Drug Enforcement Administration already 

has a role in connection with the distribution, importation, and exportation of a tableting 

machine or encapsulating machine." While ultimately, this is true with the legitimate 

users ofthese machines, evidence suggests that those engaging in the illicit distribution of 

narcotics would likely not report their tableting or encapsulating machines to the DEA. 

The intent ofthis draft legislation is not to harm or overregulate those companies using 

tableting machines or encapsulating machine for legitimate purposes but rather, it is 

designed to give DEA the ability to prosecute those using the machines to produce illegal 

narcotics. With that in mind, can you provide specific details as to how you would best 

tailor this legislation to achieve the goal of reducing illegal pill presses on the street while 

preserving the ability for legitimate companies to avoid onerous regulations? 

2. You mentioned that one possibility would be to amend the Chemical Diversion and 

Trafficking Act to give DEA broader authority under the provision. How would you 

amend this provision to effectively limit the illicit use ofthese machines? 

3. In your best estimation, which countries do most of these encapsulating and tableting 

machines originate prior to being imported to the United States? Can you estimate as to 

how many ofthese machines are produced domestically? 

4. It is understood that legitimate actors using encapsulating machines and tableting 

machines would register the device with the Drug Enforcement Administration. With 

that, it is believed that DEA can maintain a database of these machines, which they can 

monitor regularly. However, in an effort to prevent these machines from being used to 

produce illicit narcotics, how would you propose the DEA develop a more robust 

database to prevent these machines from ending up in the hands of bad actors? 

Questions to Ms. Susan Gibson, Deputy Assistant Attorney, Diversion Control, Drug 

Enforcement Administration: 

I. According to the written testimony of Mr. Thomas Cosgrove, the Drug Enforcement 

Administration currently has a "role in connection with the distribution, importation, and 

exportation of a tableting machine or encapsulating machine." Could you describe DEA's 

role in enforcing the distribution, importation, and exportation of a tableting or 

encapsulating machine? 
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30411.113

2. How does DEA currently oversee the use of these machines and how regularly does this 

oversight occur? Is there any coordination between the DEA and other agencies to ensure 

that those machines currently registered with the DEA are used for legitimate purposes? 

3. Of the number of registrants that DEA monitors allowing for the importation, 

exportation, and distribution of a tableting or encapsulating machine, is it safe to presume 

that those engaging in illicit activity through the use of these machines would avoid the 

registration process with the DEA? If so, what are the current penalties that a person 

could face if he or she is caught with an encapsulating or tableting machine that was not 

registered with the Drug Enforcement Administration? 

4. From an importation standpoint, can DEA offer specifics to as where most of these 

devices originate? In your best estimation, what percentage of these tableting or 

encapsulating machines were registered with DEA? 

5. How many legitimate shipments oftableting and encapsulating machines entered the 

United States? Which countries were the source ofthese shipments? 
218 


30411.114

STATEMENT FOR THE RECORD 

House Energy and Commerce, Subcommittee on Health 

Hearing 

T H E R A P E U T! C s• 

"Combating the Opioid Crisis: Helping Communities Balance Enforcement 

and Patient Safety" 

February 28, 2018 

On behalf of Prime Therapeutics (Prime), a pharmacy benefit manager serving more than 27 million members across 

the country and headquartered in Eagan, Minnesota, we would like to thank the Subcommittee for your efforts to 

address our nation's opioid epidemic and alert you to Prime's efforts to address the crisis. 

Prime has been working to reduce controlled substance misuse for more than a decade. Our pharmacists created a 

controlled substance score- an algorithm to identify people who are at risk for controlled substance abuse. We 

shared this tool publicly in the hopes that our peer-reviewed tool would be adopted by other health organizations so 

they, too, could help identify people who may need help in their own populations. This controlled substance score is 

the foundation to Prime's comprehensive Controlled Substance Management Program (overview attached), a 

program built on the recommendations of the Centers for Disease Control and Prevention (CDC). 

As part of our Controlled Substance Management Program we conduct prescriber outreach, which alerts prescribers 

to patients who have a high controlled substance score. A point-of-sale alert is then applied which notifies 

pharmacists of potential concerns with controlled substance prescriptions. They then can intervene directly with 

members. If appropriate, and to increase safety, we may enroll members who are at risk in a "pharmacy home" or 

single prescriber for obtaining their controlled substance medicines. 

Through these efforts, our program is helping produce positive outcomes. In the past five years, Prime has seen a 

71 percent decline in the number of high-risk opioid users and a 16 percent reduction in opioid claims among its 

commercial membership. 

Furthermore, our pharmacists have served on the Phannacy Quality Alliance to develop "double threat" guidelines to 

help physicians prevent prescribing of opioids and benzodiazepines which, when combined, may lead to death. 

Prime also participated in the Institute for Clinical and Economic Review's (ICER's) evaluation of abuse-deterrent 

formulations (ADFs) where evidence was not sufficient to show a reduced risk of abuse for patients being prescribed 

ADF opioids and, at current prices, ADFs would need to undergo significant cost reductions to achieve cost 

neutrality. We've also collaborated with health organizations to advocate for a nationwide prescription drug 

monitoring program (PDMPs) to prevent "doctor shopping". We actively work with law enforcement agencies to 

prevent fraud, waste and abuse. 

We are also focused on safe disposal of medicines. According to a Q.Ublic opinion survey Prime commissioned, we 

found that few Americans safely dispose of unused medicine. We need to do what we can to keep these dangerous 

medicines from falling into the wrong hands. That is why Prime joined with Walgreens and several other health care 

organizations to announce an expanded safe medication disposal effort. This program is bringing "take back" kiosks 
219 


30411.115

to an additional 900 Walgreens stores- adding to the 600 kiosks in existence -in areas where the opioid epidemic 

has challenged communities. 

Our public opinion survey results also revealed that many people aren't told about the dangers of opioids. This 

signals that many tools aimed at combatting the opioid crisis may be underused. That's alarming knowing how many 

resources are already being put into existing tools that may not be used to their fullest potential. A recent Clinton 

Foundation/Johns Hopkins Bloomberg School of Public Health report- which included extensive contributions from 

one of Prime's clinical pharmacists- shared similar information and recommendations for action to address the 

epidemic. It's this kind of collaborative work that will help move the needle to end the epidemic. 

Our work is far from over. Prime is now developing a predictive modeling tool so opioid misuse can be avoided 

before it ever starts. This tool will enable us to identify individuals who are early in their opioid use and have 

characteristics matching those who use opioids at unsafe levels. We can then work with prescribers to help educate 

members on the dangers of controlled substances and prescribe other pain management treatments. Preventing 

misuse is key to slowing and eventually ending this epidemic. 

In the realm of public policy, we believe there are several policies that would help address the opioid epidemic. First, 

we support requiring prescriber use of interoperable PDMPs. While not all states allow managed care plans and 

PBMs to access PDMPs, where state laws do permit such access, PBMs like Prime are able to obtain complete 

claims history for covered members. Such access enables improvements in current controlled substances 

interventions that have been shown to positively influence controlled substances utilization. The literature supports 

the benefrts of PDMPs. For instance, a 2016 study in Health Affairs found that the implementation of a POMP 

program was associated with more than a 30 percent reduction in the rate of prescribing of Schedule II 

opioids. Another 2016 Health Affairs study found that implementation of stale PDMPs was associated with the 

prevention of one opioid-related overdose death every two hours on average nationwide. 

Second, greater adoption of a-prescribing for controlled substances (EPCS) reduces diversion. For instance, since 

New York State's EPCS mandate took effect in March 2016, there has been a 70 percent reduction in the loss and 

theft of prescription forms. 

Third, Prime also strongly supports the CDC's guidelines for prescribing opioids for chronic pain and believes that 

greater adherence to them would help reduce inappropriate prescribing. Further, provisions in the Comprehensive 

Addiction and Recovery Act (CARA)- to "lock-in" Medicare beneficiaries who may be misusing opioids to a 

pharmacy home or single prescriber- will help complement similar efforts in the Medicaid population and should 

reduce the incidence of addiction in seniors. 

Prime believes this epidemic deserves action on multiple fronts- from pharmacy benefit managers, as well as 

pharmacies, providers, pharmaceutical manufacturers, government and law enforcement agencies, and many other 

organizations. Together we have great influence over finding solutions made for those affected by this alarming 

public health issue. 

Prime is proud of what we have accomplished with our controlled substance programs and partnerships over the last 

decade. Should you have any questions, please do not hesitate to contact Julie Cantor-Weinberg in Prime's Office of 

Government Affairs at Julie.Cantor-Weinberg@primetherapeutics.com. 

2 
220 


30411.116

NACDS NATIONAL ASSOCIATION OF 

CHAIN DRUG STORES 

Statement 

Of 

The National Association of Chain Drug Stores 

For 

United States House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

On 

"Combating the Opioid Crisis: 

Helping Communities Balance Enforcement and Patient Safety" 

February 28, 2018 

10:00 a.m. 

2123 Rayburn House Office Building 

National Association of Chain Drug Stores (NACDS) 

1776 Wilson Blvd., Suite 200 

Arlington, VA 22209 

703-549-3001 

www .nacds.org 
221 


30411.117

Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Page 1 

Introduction 

The National Association of Chain Drug Stores (NACDS) thanks Chairman Burgess, Ranking 

Member Greene and the members of the Subcommittee on Health for your leadership and 

commitment to finding and implementing policy changes to address the opioid crisis. NACDS 

and our members remain committed to partnering with policymakers, law enforcement, and 

others to work on viable strategies to prevent prescription opioid diversion and abuse. Chain 

pharmacies engage daily in activities with the goal of preventing the diversion and abuse of all 

prescription medications, including opioids. We thank you for the opportunity to provide 

recommendations on policy changes to help curb the opioid crisis. 

NACDS represents traditional drug stores and supermarkets and mass merchants with 

pharmacies. Chains operate more than 40,000 pharmacies, and NACDS' chain member 

companies include regional chains, with a minimum of four stores, and national companies. 

Chains employ more than 3.2 million individuals, including 179,000 pharmacists. They fill 

over 2.9 billion prescriptions yearly, and help patients use medicines correctly and safely, 

while offering innovative services that improve patient health and healthcare affordability. 

NACDS members also include more than 850 supplier partners and over 60 international 

members representing 22 countries. For more information, visit www.NACDS.org. 

NACDS Key Policy Initiatives to Help Curb Prescription Opioid Abuse 

As public health authorities have indicated, face-to-face interactions between pharmacists and 

patients have made pharmacists keenly aware ofthe extreme challenges and complexities 

associated with the opioid abuse epidemic. 

Pharmacists and pharmacies fully understand that controlled substances are subject to abuse by a 

minority of individuals who improperly obtain controlled substance prescriptions from 

physicians and other prescribers. Pharmacists and pharmacies strive to treat medical conditions 

and ease patients' pain while simultaneously guarding against the abuse of controlled substances. 

The key is to guard against abuse without impeding our primary goal of assisting patients who 

need pharmacy services. 

Based on our experiences, NACDS is pursuing four public policy solutions to complement 

pharmacy's collaboration with other stakeholders including healthcare professionals and law 

enforcement to address prescription opioid abuse in communities across the country. 

I. Require Prescriptions to Be Issued Electronically 

Chain pharmacy supports policies that promote the use of electronic prescribing to transmit 

prescription information between prescribers and pharmacists. For controlled substances in 

particular, use of this technology adds new dimensions of safety and security in the 

prescribing process. Data from self-reported drug abusers suggest that between 3% and 9% 
222 


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Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Page2 

of diverted opioid prescriptions are tied to forged prescriptions. 1

·

2 Electronic controlled 

substance prescriptions serve to reduce the likelihood of diversion in this manner, as 

electronic controlled substance prescriptions cannot be altered, cannot be copied, and are 

electronically trackable. Furthermore, the federal DEA rules for electronic controlled 

substances prescriptions establish strict security measures, such as two-factor authentication, 

that reduce the likelihood of fraudulent prescribing. Notably, the state of New York saw a 

70% reduction in the rate of lost or stolen prescription forms after implementing its own 

mandatory electronic prescribing law. 3 

The rate of electronic prescribing has increased significantly in recent years. In 2008, there 

were about 68 million electronic prescriptions.4 As of2016, over 1.6 billion prescriptions 

were issued electronically, including approximately 45.3 million controlled substance 

prescriptions. 5 Still, there is room for further improvement, particularly with controlled 

substances prescriptions which lag behind in overall adoption rates. While 90% of all 

pharmacies are enabled to receive electronic prescriptions, only 17% of prescribers have 

systems that can send electronic prescriptions for controlled substances.6 

To enhance healthcare providers' utilization of this technology and to foster prescriber adoption, 

chain pharmacy urges the adoption of policies to require that all prescriptions be issued 

electronically, with limited exceptions for situations in which issuing an electronic prescription 

may not be feasible. We support the Every Prescription Conveyed Securely Act (H.R. 3528), 

legislation that requires electronic prescribing for controlled substances in Medicare Part D. 

We thank Representative Mullin as an original cosponsor of this legislation and we ask that 

the Subcommittee work to pass this necessary legislation. 

IL Nationwide Prescription Drug Monitoring Program 

NACDS supports the important role of prescription drug monitoring programs (PDMPs) in 

helping to prevent drug abuse and diversion. Over the years, PDMPs have been established 

throughout the country as tools to curb diversion and abuse of controlled substance prescriptions. 

At this time, nearly every state has implemented their own program designed to assist in the 

identification and prevention of drug abuse and diversion at the prescriber, pharmacy, and patient 

levels. However, there are significant variances across state programs, which altogether, impede 

optimal use of PDMPs to their fullest extent. 

NACDS is calling upon stakeholders to work together to develop and implement a nationwide 

PDMP solution to harmonize state requirements for reporting and accessing PDMP data. Our 

goal is to establish one system with unified expectations for appropriate use of PDMP data by 

1 Rosenblum, Andrew, et al., "Prescription Opioid Abuse Among Enrollees into Methadone Maintenance 

Treatment," Drug and Alcohol Dependence, 90.1 (2007): 64-71. 2 Inciardi, James A., et al., "The 'Black Box' of Prescription Drug Diversion," Journal of Addictive Diseases, 28.4 

(2009): 332-347. 3 Remarks of Anita Murray, Deputy Director, New York State Department of Health at the Harold Rogers 

Prescription Drug Monitoring Program National Meeting [September 6, 2017). 4 Surescripts National Progress Report for 2012. 5 Surescripts National Progress Report for 20 I 6. 6 Ibid. 
223 


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Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Page3 

prescribers, pharmacies, law enforcement, and others. Such a system would leverage electronic 

prescribing systems to provide timely, in-workflow analyses of real-time data with actionable 

point-of-care guidance for prescribers and dispensers. We urge the participation of 

policymakers, like the Office of the National Coordinator, other healthcare providers, law 

enforcement, and other stakeholders on this important initiative to create a national PDMP 

solution. 

III. Take Back and Disposal of Consumer's Unused Controlled Substances 

Chain pharmacies are committed to creating programs that provide patients with safe and 

effective ways to dispose of unwanted controlled substances. To this end, NACDS supports 

policies that accommodate pharmacy participation in a variety of DEA authorized options for 

controlled substance drug disposal programs. These options include, but are not limited to: 

take-back kiosks in pharmacies, mail-back envelopes made available by manufacturers or 

pharmacies, community drug take-back events hosted at pharmacies, in-home disposal 

products, take-back kiosks at law enforcement locations, and vouchers to patients to obtain 

mail-back envelopes from manufacturers or pharmacies. Of greatest importance, pharmacies 

must be offered a variety of program options, so that they can choose which consumer 

controlled substance drug disposal program best fits their patients' needs and is best suited 

for the community that they serve. 

As highlighted in the above examples of drug disposal options, pharmacies alone are not the 

solution to the safe and effective disposal of unwanted controlled substances. Combating 

prescription drug abuse requires collaboration across the supply chain. Chain pharmacy 

seeks collaborative efforts, including working with manufacturers to help customers safely 

and effectively dispose of their unwanted opioid drugs. Accordingly, we support programs 

that require manufacturers to fund and make mail-back envelopes available to pharmacies to 

distribute to patients, upon request, when those patients fill opioid prescriptions. A program 

of manufacturer-funded mail-back envelopes for unused opioid drugs recognizes that the 

entire drug supply chain has a role in drug disposal. 

Earlier this month, the FDA provided a policy document to the Energy and Commerce 

Committee in which FDA called upon manufacturers to establish programs for the return or 

destruction of unused opioids. 7 NACDS fully supports FDA's policy position and we 

applaud FDA for recognizing the supply chain team effort required for effective consumer 

controlled substance disposal. Accordingly, we urge the Subcommittee to also support 

FDA's policy position, as well. 

Beyond the development and implementation of a variety of consumer controlled substance 

disposal programs, NACDS also supports patient education programs on consumer 

controlled substance disposal programs. To promote public awareness and use of the 

available disposal options, we encourage federal and state government and/or pharmaceutical 

7 "FDA Asks E&C For New Authority On Opioid Evaluation, Seizure; Suggests Requirements On Manufacturers;" 

Inside Health Policy, https:ffinsidehealthoolicy.com/daily-newsffda-asks-ec-new-authority-opioid-evaluationseizure-suggests-reguirements-manufacturers, accessed February 9, 2018; Referencing FDA policy document 

provided to the House Energy and Commerce Committee. 
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Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Page4 

manufacturer stewardship organizations to develop and provide drug disposal educational 

materials to consumers. Ideally, such materials should focus upon controlled substances, 

including the dangers of misuse and the potential for addiction to prescription controlled 

substances, treatment resources available, and the proper way to dispose of unused 

prescription controlled substances. These educational materials should be posted on 

government websites and be made available to pharmacies to provide to customers filling 

controlled substance prescriptions, with each pharmacy determining the best method for 

making those materials available to its patient population in a written and/or electronic 

format. 

IV. 7-Day Supply Limit for Initial Opioid Prescriptions Issued for Acute Pain 

NACDS supports policies establishing a 7-day supply limit for initial opioid prescriptions written 

for acute pain. This policy aligns with the Guideline for Prescribing Opioids for Chronic Pain 

developed by the Centers for Disease Control and Prevention (CDC) and serves to reduce the 

incidence of misuse, abuse, and overdose of these drugs. 8 

A clinical evidence review performed by the CDC revealed that a greater amount of early opioid 

exposure is associated with a greater risk for long-term use and addiction.9 Notably, the average 

day supply per opioid prescription has increased in recent years, growing from 13.3 to 18.1 days 

per prescription between 2006 and 2016. 10 Considering this trend and the risk of early exposure 

to higher amounts of opioids, it is imperative that lawmakers adopt policies to promote careful 

prescribing practices for prescription opioids. 

So far, over 20 states have adopted laws or other policies limiting the maximum day supply 

that can be authorized on an initial opioid prescription for acute pain (with appropriate 

exemptions, such as patients with pain due to cancer, hospice, or other end-of-life care, etc.) 

Chain pharmacy encourages Congress to enact legislation that is standardized across the 

nation to promote consistent patient care and implementation across the country. NACDS 

would support federal legislation that preempts individual state variations. 

)> Limiting Opioid Prescriptions 

Health plans and their pharmacy benefit managers are also altering health plan designs to 

cover less than prescribed amounts of opioids. However, existing federal and state standards 

may complicate efforts by pharmacies to dispense less than prescribed amounts of opioids. 

Several states have laws or rules that can be read to require pharmacies to dispense 

medications as prescribed. Section 702 of the Comprehensive Addiction and Recovery Act 

of 2016 allows pharmacies to dispense less than prescribed amounts of opioids, but only as 

allowed by DEA rules or when "requested by the patient or the practitioner that wrote the 

'Centers for Disease Control and Prevention, CDC Guideline for Prescribing Opioidsjor Chronic Pain. CDC.gov. 

https:/lwww.cdc.gov/drugoverdose/prescribing/guideline.html. 

9 Ibid. 

1

° Centers for Disease Control and Prevention, Annual Sun•eillance Repon of Drug-Related Risks and Outcomes. 

United States, 2017. https ://www. cdc. gov /drugoverdose/pdf/pubs/20 17 -cdc-drug-surveillance-report.pdf 
225 


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Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety 

February 28, 2018 

Page 5 

prescription." A DEA rule also raises questions regarding the ability of pharmacies to 

dispense less than prescribed amounts of opioids. The rule provides that a pharmacist may 

partially fill a prescription for a Schedule II opioid only if the pharmacist is "unable" to 

dispense the full amount prescribed. 11 NACDS and others have asked DEA to clarify when 

pharmacies may dispense less than prescribed amounts of opioids. 

In the absence of DEA action to clarify these matters, NACDS would support federal 

legislation to clarify federal policy regarding when pharmacies may dispense less than 

prescribed amounts of opioids. 

Practitioner Education 

As the Subcommittee considers H.R. 2063, legislation to amend the Controlled Substances 

Act to require certain practitioner education as a condition of registration to prescribe or 

dispense opioids for the treatment of pain or pain management, we ask the Subcommittee to 

consider expanding this education requirement beyond opioids to include all controlled 

substances in Schedules II-V. 

As currently drafted, H.R. 2063 requires that as a condition of obtaining and maintaining DEA 

registration, prescribers who prescribe or dispense opioids must complete twelve hours of 

continuing education on pain management treatment guidelines and best practices, early 

detection of opioid addiction, and the treatment and management of opioid-dependent patients. 

However, there are non-opioid controlled substance medications that can be abused individually, 

by their very nature, and/or concurrently with opioids as potentiators of the desired illicit effect 

(e.g., the so-called "Holy Trinity" of opioids, benzodiazepines, and carisoprodol). 

Given that all controlled substances can potentially be abused as well as the increased risk of 

overdose with concurrent use of opioids and other controlled substances in particular, prescribers 

of all controlled substance medications should be educated on pain management treatment 

guidelines and best practices, early detection of controlled substance medication addiction, and 

the treatment and management of patients that are addicted to controlled substance medications. 

Accordingly, NACDS recommends that H.R. 2063 be amended to ensure that all prescribers of 

controlled substances complete the required continuing education as a condition of maintaining 

their DEA registration. 

Conclusion 

NACDS thanks the Subcommittee for consideration of our comments. We look forward to 

working with policymakers and stakeholders on these important issues. 

"21 CFR §1306.!3(a). 
226 


30411.122

27 February 2018 

To Whom It May Concern: 

I am Professor of Pharmacology and Psychiatry and the Robert A Welch Distinguished University Chair in 

Chemistry at the University ofTexas Health Science Center in San Antonio, Texas. I have conducted drug abuse 

research for more 40 years, and I have held US Drug Enforcement Administration (DEA) Schedule I and 

Schedule 11-V registrations for 28 years, in addition to State of Louisiana and State of Texas registrations. 

As a scientist who has dedicated his entire career to studying drug abuse, I am keenly aware of the need to 

strike a balance between regulatory control of drugs to protect the public and the freedom for researchers to 

study drugs in order to advance our understanding of drug abuse and develop new treatments. My research 

program has three major goals: 1) understand the factors that cause drug abuse; 2) evaluate the abuse potential 

of new chemicals (largely for the pharmaceutical industry and regulatory agencies); and 3) develop new 

treatments for drug abuse. The success of each of these activities depends upon the availability of a wide variety 

of drugs - the primary tools that we use to study the brain and addiction - including controlled substances. 

Scientists need the freedom to pursue lines of research that they, the experts, deem important; for that to occur, 

they need to have access to drugs. 

Current regulatory oversight of scientists working with controlled substances is a significant impediment to 

research, and further regulatory oversight, as would likely result from the Stop the Importation and Trafficking of 

Synthetic Analogues Act of 2017 (SITSA), would worsen this situation. Separate storage and record keeping 

that is currently required of anyone working with Schedule I compounds is a burden for many researchers and 

institutions that is not clearly reduced with the new Schedule A; moreover, it is unclear whether the new schedule 

A would facilitate better access to research tools for scientists. Despite having a DEA Schedule I registration for 

nearly 30 years without incident, when I want to study a Schedule I compound that is not already on my 

registration, I have to submit volumes of paperwork (much of it redundant with previous requests) as part of a 

request evaluated by the DEA and others. Decisions on my most recent requests have taken many months; 

those delays impede research and prevent scientists like me from responding quickly to public health issues 

(e.g., emergence of a new drug of abuse) that demand systematic study. Increased regulatory oversight of 

researchers regarding controlled substances would have no obvious impact in protecting public health while 

significantly decreasing the productivity of scientists. 

Rational decisions as to whether a drug should be scheduled or whether it might be a useful medicine can 

be made only with solid scientific data, and those data can be collected only if scientists have appropriate access 

to drugs for their experiments. The scheduling of compounds based strictly on chemical structure is a concern 

since drugs that are nearly identical in structure can have dramatically different effects. For example, some 

drugs contributing to the current opioid epidemic and overdose crisis (e.g., heroin) are structurally very similar to 

the drugs used to treat opioid abuse (naltrexone) or rescue patients from opioid overdose (naloxone). Similarly, 

there is evidence that the toxic effects of some fentanyl derivatives are relatively insensitive to reversal by the 

only drug (naloxone) that is available for rescue from overdose; however, most researchers do not have a 

Schedule I registration so they cannot investigate this important question. Schedule A would add another 

category of registration, but would not improve access to important tools for scientists because under SITSA all 

Schedule I and Schedule A registrants would be required to submit requests to the Attorney General. 

Additional regulatory oversight and scheduling of compounds without solid scientific evidence will not 

improve public health but will further impede the already difficult job of dedicated addiction researchers. 

Respectfully, 

t/f~ Charles P France 

Charles P France, PhD I Robert A Welch Distinguished University Chair in Chemistry 

Department of Pharmacology I Mail Code 7764 I 7703 Floyd Curl Drive I San Antonio, Texas 78229-3900 USA 

Voice: 210.567.6969 I Fax: 210.567,0104 I Email: france@uthscsa.edu 
227 


30411.123

Catherine M. Davis. Ph.D. 

Assistant Professor 

Department of Psychiatry and Behavioral Sciences 

Division of Behavioral Biology 

Hopkins Bayview Medical Center 

5510 Nathan Shock Drive I BBRC 3000 

Baltimore, MD 21224-6823 

410-550-2775 T 

410-550-2780 F 

cdavis91 @jhmi.edu 

Comments of Catherine M. Davis, PhD 

Health Subcommittee of the Committee on Energy ft Commerce 

Wednesday, February 28, 2018 

Combating the Opioid Crisis: Helping Communities Balance Enforcement and 

Patient Safety 

Performing research with compounds on Schedules 1-V creates hurdles for researchers that 

must be met before state and federal licenses will be issued, including how they store the 

compounds, in addition to how the compounds are distributed, tracked, and wasted within 

the laboratory. These are not trivial concerns and require specialized equipment (e.g., certain 

type of safe) and inspections (from the DEA, but also from each researcher's institution -

which can be more variable and restrictive in their requirements than the DEA). A researcher 

who has completed and received his/her Schedule I and/or 11-V licenses has shown the state 

and federal governments that they have the necessary facilities and personnel in place to 

safely use this compounds with minimal risk of diversion. Adding another schedule to this 

structure would increase the burden already placed on these researchers, slow the progress 

made in researching these substances, and possibly turn away new (and more senior) 

investigators from researching these substances due to the regulatory and financial burdens of 

maintaining these various state and federal licenses. 

Given that the DEA's emergency scheduling ability, it is not clear exactly what schedule A will 

do that emergency scheduling to schedule I would be unable to achieve. The creation of 

Schedule A creates another regulatory burden for researchers, such that they may need to 

apply for an additional license in the future or have this sub-schedule added to their current 

licenses, even though they already have both Schedule I and/or 11-V licenses and thus have 

the appropriate facilities in place to receive, store, handle, and dispose of Schedule 1-V 

substances. Further, this bill could limit the research completed on these compounds by 

making them harder to acquire at a time when it is imperative that we understand the abuse 

liability of various opioids and their analogues. It is unclear how the creation of this new 

schedule or sub-schedule will actually decrease abuse of these compounds. As written, this 

legislation does not differ substantially from Schedule I or II, such that without this 

legislation, these compounds would go unscheduled. 

Finally, this new legislation removes scientific input from the discussion regarding the 

scheduling associated with a specific compound or class of compounds. With no input from 

scientists and pubic health officials this legislation would provide the Justice Department a 

method to put almost any substance in the Schedule A category, even if the scientific 

evidence for such a classification is limited or lacking. This fact could potentially place many 

compounds on Schedule A due to their similarities in chemical structure without sufficient 

evidence from the scientific community to support their possible abuse. 
228 


30411.124

Catherine M. Davis, Ph.D. 
229 


30411.125

~CVSHealth Statement for the Record 

House Energy and Commerce Subcommittee on Health 

February 28, 2018 

CVS Health's mission is based on the simple premise that health is everything, and we 

believe our role is to help people on their path to better health. This belief guides every 

decision we make. Every day, in countless ways, our teams of expert clinicians, 

pharmacists, and nurses work hard to care for patients. 

We share the House Energy and Commerce Committee's concern that across the 

country, many lives in the communities we serve are being disrupted by the opioid 

abuse epidemic. The problem is a complex one with many causes and challenges. 

Defeating the epidemic of opioid abuse requires the active involvement of stakeholders 

throughout the health care community, as well as law enforcement and regulatory 

agencies, and CVS Health is committed to being part of the solution. 

While CVS Health has developed and implemented numerous programs and initiatives 

aimed at combating opioid abuse across our company, we understand the Committee is 

interested in obtaining additional recommendations regarding policy and regulatory 

changes that could be made to help align and leverage the full range of clinical assets 

offered across the heath care payor and provider continuum. 

As Congress considers new initiatives to address the epidemic, we strongly encourage 

consideration of the following: 

Reducing Quantities of Opioids Prescribed 

In 2016, the Centers for Disease Control and Prevention (CDC) released a prescribing 

guideline to promote medically appropriate use of prescription painkillers. The 

recommendations in the guideline are intended to assist primary care providers make 

informed prescribing decisions and improve patient care for those with pain while 

reducing the number of people who misuse, abuse or overdose from these drugs. 

CVS Health has created a program for our clients that incorporates the 2016 CDC 

recommendations into the utilization management programs for prescriptions 

adjudicated through CVS Caremark, our pharmacy benefits manager. We have 

encouraged our clients to adopt this program, and if they do, we limit the quantities of 

opioids covered to a seven-day supply for most acute conditions. Our initial findings 

indicate employers, unions, and health plans that implemented our opioid utilization 

management program in 2017 experienced a 70 percent decrease in the number of 

patients new to opioid therapy with an acute condition who received more than sevenday supply of an opioid. For those plans, the number of patients new to opioid therapy 

who now receive a seven-day supply or less is nearly 94 percent. 
230 


30411.126

We believe, however, more can be done at the federal and state level to reduce the 

risks of inappropriate use and to limit unnecessary supply. The CDC guideline advises 

there is rarely a need for more than seven days of opioids for acute conditions. Based 

on this recommendation, at least 18 states have established prescribing limits for acute 

pain at seven days or less. CVS Health supports these quantity restrictions and 

believes Congress should take action to amend the Controlled Substances Act to 

establish similar prescribing limits at the federal level and to expand the circumstances 

under which a pharmacy could provide a partial fill of a Cll opioid medication. 

E-Prescribing of Controlled Substances 

CVS Health supports electronic prescribing of prescription drugs. Electronic prescribing 

has proven effective in reducing drug diversion and fraud, as it makes it easier to track 

prescriptions and more difficult to alter them. We believe Congress should move to 

require electronic prescribing in Medicare as would be required under H.R. 3528, The 

Every Prescription Conveyed Securely Act, introduced by Congressman Markwayne 

Mullin (R-OK) and Congresswoman Katherine Clark (D-MA). Enactment of this legislation 

would be a significant step to improve patient outcomes, increase drug security, and limit 

the inappropriate use of opioids. 

Support for Prescription Drug Take-Back Programs 

For several years, CVS Health has supported the Medication Disposal for Safer 

Communities Program, which provides police departments across the United States 

with an easy way to obtain a drug collection unit for their locations. Through this 

program, created with the Partnership for Drug-Free Kids, CVS Health has donated 

more than 860 medication disposal units to local police departments in 43 states, 

collecting more than 140 metric tons of unwanted medication. Beginning in 2017, CVS 

Health expanded its total disposal units to 1 ,550 kiosks, including the phase-in of 750 

additional disposal units in CVS Pharmacy locations across the country. 

We believe these kinds of programs provide a valuable resource to public health and 

law enforcement organizations in securing unwanted medications. As Congress 

considers additional funding to address the opioid abuse epidemic, we encourage 

members to support financial assistance for community drug take-back programs, which 

have demonstrated a meaningful impact on reducing drug diversion and abuse across 

the United States. Additionally, we believe Congress could provide a review of current 

drug take-back and disposal regulations in an effort to limit costs and to ensure as many 

providers as possible are able to participate in these important community take-back 

initiatives. 

CVS Health appreciates the opportunity to offer our recommendations to the 

Committee. We look forward to working with you further as you consider solutions to 

address this public health crisis. 
231 


30411.127

brae burn 47 Huffish St, Suite 441 

Prim~eton, NJ 08642 

28 February 2018 

Hon. Greg Walden 

Chairman 

2125 Rayburn HOB 

Washington, DC 20515 

Hon. Frank Pallone 

Ranking Member 

2322A Rayburn HOB 

Washington, DC 20515 

Dear Chairman Walden & Ranking Member PalloneOn behalf of Braeburn, I am writing to thank you for your leadership on 

the Ensuring Patient Access to Substance Use Disorder Treatments Act 

of 2018, which will make long overdue updates to federal law to improve 

the dispensing of implantable and injectable therapies. We share your 

goal of expanding access to treatments for patients with Opioid Use 

Disorder, and applaud your efforts to make abuse, misuse and diversion 

more difficult. 

Braeburn is dedicated to developing evidence-based treatments to help 

stop the opioid epidemic and save American lives. Braeburn provides the 

health care provider with a platform of addiction treatment medications 

that help promote adherence and are expected to be less prone to abuse 

and diversion than daily addiction treatments. 

The Ensuring Patient Access to Substance Use Disorder Treatments 

Act will expand access to practitioner-administered treatments, which 

will help to ensure proper delivery and medication adherence, while 

potentially minimizing risks of diversion, misuse and accidental pediatric 

exposure. 

The Controlled Substances Act, when originally enacted, did not foresee 

these innovative new products, and requires that a product must be 

dispensed to the patient for whom it was written. This requirement 

creates an unnecessary barrier to next generation treatments. 

We thank you again for your leadership on this critical issue. 

Best, 

Mike 

\\rtf:;~ Derkacz 

President & CEO 
232 


30411.128

American 

~ Hospital 

Association. 

February 28, 2018 

The Honorable Michael Burgess, M.D. 

Chairman 

Subcommittee on Health 

House Committee on Energy and Commerce 

United States House of Representatives 

Washington, DC 20515 

The Honorable Gene Green 

Ranking Member 

Subcommittee on Health 

!Dl1001 Street. NW Two CityCenter, Suite 400 Washingtnn, DC 20011~ 

I202I631H100 Phone WVWI!'.aha.org 

House Committee on Energy and Commerce 

United States House of Representatives 

Washington, DC 20515 

Dear Chairman Burgess and Ranking Member Green: 

On behalf of our nearly 5,000 member hospitals, health systems and other health care 

organizations, and our clinician partners- including more than 270,000 affiliated physicians, 

2 million nurses and other caregivers- and the 43,00 health care leaders who belong to our 

professional membership groups, the American Hospital Association (AHA) thanks you for your 

leadership on addressing the opioid crisis. 

Every day, hospitals witness the devastating effects of opioids on the patients, families and 

communities we serve. Prescription opioids can be a safe and necessary element of pain 

management for those who have experienced trauma or are suffering from cancer, sickle cell 

disease or other diseases that cause debilitating pain. On the other hand, opioids carry significant 

risk for misuse, addiction, overdose and death, and must be used judiciously. 

To prevent addiction and misuse, hospitals and health systems are working to reduce patients' 

exposure to opioids by making other types of pain control more readily available. They are 

implementing standard, evidence-based protocols for prescribing limited amounts of opioids to 

patients, and they are safeguarding prescription drugs from diversion. Our members are using 

state prescription drug monitoring programs and working to link them to their electronic health 

records to ensure that a seamless and accurate flow of information regarding the patient's 

prescriptions is available. 

When patients are diagnosed with substance use disorder, hospitals are offering treatment or 

referrals, as appropriate, and integrating physical and behavioral health care. They are training 

first responders to use naloxone and, in some cases, equipping them with this overdose antidote. 
233 


30411.129

The Honorable Michael Burgess, M.D. 

The Honorable Gene Green 

February 28,2018 

Page 2 of2 

We have, along with the Centers for Disease Control and Prevention, developed a resource for 

patients in hospitals to educate them about the appropriate use of opioids, and we have produced 

a toolkit for our 5.000 member hospitals to help them provide optimal care to patients. But we 

are fully aware that the size and scope of this epidemic require collaboration between federal, 

state, and local governments, and the private sector, and resources that only the federal 

government is able to provide. 

The AHA is gratified to see the Subcommittee on Health begin to receive testimony on specific 

legislative approaches to solving this crisis. Our membership is evaluating the potential 

implications of the many bills that have been referred to the Subcommittee this year, and we look 

forward to working with you and your staff in the coming weeks to shape legislation affecting 

hospitals and health systems. As you work through the various issues in the Subcommittee's 

jurisdiction, we ask you to consider the policy priorities in the attached letter, which we 

submitted to the Senate Committee on Finance earlier this month. 

71~'· 'JLto ~sP.Nckels Executive V ce President 

Attachment 
234 


30411.130

American 

~ Hospital 

Association. 

February 16,2018 

The Honorable Orrin G. Hatch, Chairman 

The Honorable Ron Wyden, Ranking Member 

Senate Committee on Finance 

United States Senate 

Washington, DC 2051 0-6200 

Transmitted via email: Opioids@finance.senate.gov 

lmllllhS111let,NW 

Two CilyCenter, Suits 400 

Washingtorl, CC 200l1-«f (202) 6JB..1100 Phone 

INIM'V.aha.org 

Re: Request for Recommendations for Policy Actions to Address the Opioid Epidemic 

Dear Chairman Hatch and Ranking Member Wyden: 

As the nation continues to struggle with the devastating public health crisis created by the opioid 

epidemic, it is encouraging to see the Senate Finance Committee exploring how changes in 

public policy and the Medicare and Medicaid programs can help in the fight. We appreciate your 

interest and commitment and welcome this opportunity to continue to work with you. On behalf 

of our nearly 5,000 member hospitals, health systems and other health care organizations, and 

our clinician partners- including more than 270,000 affiliated physicians, 2 million nurses and 

other caregivers- and the 43,00 health care leaders who belong to our professional membership 

groups, the American Hospital Association (AHA) thanks you for addressing the nation's opioid 

epidemic. 

HOSPITALS AND HEALTH SYSTEMS ARE ALREADY TAKING ACTION 

Every day, hospitals witness the devastating effects of the opioid epidemic on the patients, 

families, and communities we serve. Prescription opioids can be a safe and necessary element of 

pain management for those who have experienced trauma or are suffering from cancer, sickle 

cell disease or other diseases that cause debilitating pain. On the other hand, opioids carry 

significant risk for misuse, addiction, overdose and death, and must be used judiciously. 

To prevent addiction and misuse, hospitals and health systems are working to reduce patients' 

exposure to opioids by making other types of pain control more readily available. They are 

implementing standard, evidence-based protocols for prescribing limited amounts of opioids to 

patients, and they are safeguarding prescription drugs from diversion. Our members are using 

state prescription drug monitoring programs and working to link them to their electronic health 
235 


30411.131

Senate Committee on Finance 

February 16,2018 

Page 2 of 4 

records (EHRs) to ensure that a seamless and accurate flow of information regarding the 

patient's prescriptions is available. 

When patients are diagnosed with substance use disorder (SUD), hospitals are offering treatment 

or referrals, as appropriate, and integrating physical and behavioral health care. They are training 

first responders to use naloxone and, in some cases, equipping them with this overdose antidote. 

However, hospitals are aware that this epidemic cannot be successfully dealt with by health care 

providers working independently. They are collaborating with their communities to create 

coordinated responses. They are forming partnerships with other health care providers, state and 

local departments of health, law enforcement, schools, community organizations and others. 

Through these collaborations, we have seen hospitals engage recovery specialists to help patients 

admitted for drug overdose enter treatment, expand SUD treatment services, join with law 

enforcement to facilitate access to treatment, fund public education programs, educate 

community clinicians about prescribing practices, and more. But much remains to be done. 

There are five policy issues of paramount importance to enable this work to address 

opioids to continue. 

1) Preserve and Protect Health Insurance Coverage, Including Medicaid. We urge the 

Committee to ensure that coverage through the health insurance exchanges and through 

Medicaid, which provide a substantial number of Americans with benefits for substance use 

disorder treatment, be preserved. In addition, the Senate Finance Committee has the opportunity 

to ensure that Medicaid programs adequately cover SUD treatment, and an essential step in that 

effort is to eliminate the Institutions for Mental Disease (!MD) exclusion. This exclusion 

prohibits Medicaid from paying for care for patients between ages 21 and 64 who are 

hospitalized in inpatient psychiatric hospitals, thus making it extremely challenging for those of 

limited means to receive effective treatment for substance use disorders. Prohibiting payment for 

SUD treatment in freestanding psychiatric facilities seems to further stigmatize and blame 

victims for their illness. 

IMDs could expand access to services for patients with SUDs if the exclusion were eliminated. 

Addressing this exclusion would be particularly helpful in improving access to treatment for 

those with severe or more complex SUDs. It also could reduce wait times, and possibly the 

occurrence of emergency department boarding, for patients with both substance use and mental 

health disorders who would benefit from inpatient treatment. We urge the Committee to report 

out legislation to end the IMD exclusion. 

2) Enhance Parity Enforcement. The Mental Health Parity and Addiction Equity Act 

(MHPAEA) gave the Department of Labor responsibility for enforcing parity in health coverage. 

Our members and the patients they serve continue to face obstacles in securing coverage and 

payment as intended by the parity law. More must be done to enhance parity compliance, 

including ensuring that parity provisions included in the 21st Century Cures Act are carried out. 

New guidance for health plans, improved transparency of benefit information, and additional 

parity compliance analysis tools can all support better adherence to MHPAEA provisions. 
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Senate Committee on Finance 

February 16, 20 18 

Page 3 of4 

Federal agencies, and especially the Department of Labor, must make parity enforcement a 

priority. We urge the Committee to clearly communicate this expectation to the Secretary of 

Labor. 

3) Make Critical Information Readily Available to All Clinicians Treating Patients with 

SUD. Clinicians treating patients, for any condition, need information on their substance use 

disorder to ensure their patients' safety. The partitioning of a patient's medical record to keep 

SUD diagnoses and treatments hidden from most clinicians who will treat the patient is 

dangerous for the patient, burdensome for providers and contributes to the stigmatization of 

mental/behavioral health diseases. Too many patients who suffer from an SUD have stories of 

how a well-intentioned emergency room physician or other clinician working on physical health 

issues nearly prescribed them an opioid or another drug that would have endangered their life or 

sobriety. Such incidents happen because the clinician cannot access information on the patient's 

SUD and treatment plan unless the patient gives consent. The prevalence of SUD in the 

population requires that hospitals have access to complete information about the patient's 

medical history, including information about substance use disorders. 

Finally, providers go to extraordinary lengths to comply with the requirements of 42CFR Part 2. 

For example, we have spoken to obstetricians who specialize in treating pregnant women with 

SUD diagnoses and other clinicians who treat both the physical and SUD diagnoses of patients. 

To ensure compliance with 42CFR Part 2, as currently written, these clinicians have to have two 

separate computers and two separate medical records. This adds burden and expense, with no 

benefit to patients. 

Recent revisions made by the Substance Abuse and Mental Health Services Administration to 

the Part 2 regulations are not a significant improvement over the previous requirements and do 

little to eliminate the regulation's barriers that impede the robust sharing of patient information 

necessary for effective clinical integration and quality improvement. Complete alignment of 

Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy 

rule will require statutory changes. We urge the members of the Committee to support 

S. 1850, the Protecting Jessica Grubb's Legacy Act, introduced by Sens. Joe Man chin (DWV) and Shelley Moore Capito (R-WV), which would mandate that 42 CFR Part 2 be 

brought into alignment with HIPAA. This alignment would protect patients from 

inappropriate disclosure of their health information while enabling clinicians to more 

safely treat those with SUD. Further, while that bill is under consideration, we urge the 

Committee to encourage the Centers for Medicare & Medicaid Services to include information 

for beneficiaries in the Medicare & You handbook and in public service announcements to alert 

patients and their families that clinicians other than those caring for behavioral health issues will 

not be able to access information about their prescriptions or treatment plan for SUD without 

their express permission, and explain why it is important for the patients' safety that their 

clinicians know about their diagnoses. 

4) Enhance Medication-assisted Treatment (MAT). A recent report from the National 

Academies of Sciences, Engineering and Medicine underscores the gaps in availability of MAT 

in the U.S. The AHA has previously supported efforts to increase patient limits for 
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Senate Committee on Finance 

February 16, 2018 

Page 4 of4 

buprenorphine prescribing. The federal government should continue to incentivize adequate 

access to MAT. That starts with having enough clinicians with specialized training. Among the 

key challenges for health systems in offering SUD services is finding trained providers. 

Medicare should incentivize providers to get this training by providing an increase in payment to 

those who have completed the training or by recognizing the acquisition of such skills as a 

quality improvement activity under the Merit-based Incentive Payment System. 

5) Promote Interstate Data Sharing Among Prescription Drug Monitoring Programs 

(PDMPs). The AHA also supports efforts to ensure that POMP information is shared across state 

lines. State PDMPs are an important tool in fighting the epidemic, and Congress should seek 

ways to maximize the capacity of this technology to help clinicians avoid unnecessary or 

potentially harmful opioid prescriptions. We understand that most PDMPs already engage in 

some level of information sharing, especially with their neighboring states. To enhance these 

efforts, certified EHRs can be used to improve knowledge about a patient's medications- active 

and prior. The best approach would be to ensure the inclusion of POMP information in the 

certified EHR in a timely and efficient manner in the course of the clinical workflow, which 

requires improved interoperability. We urge the Committee to consider dedicated funding to 

promote improved interoperability between health care providers and PDMPs, and among 

PDMPs in different states. 

Thank you for this opportunity to comment. If you have questions or need further information, 

please feel free to contact me or have a member of the Committee staff reach out to Priscilla 

Ross, senior associate director of federal relations, at pross@aha.org or 202-626-2677. 

~y, ;ft. 

~asP. ickels 

Executive ice President 

Government Relations and Public Policy 
238 


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February 28, 2018 

The Honorable Michael Burgess 

US House of Representatives 

2336 Rayburn HOB 

Washington, D.C. 20515 

The Honorable Gene Green 

US House ofRepresentatives 

2470 Rayburn HOB 

Washington, D.C. 20515 

Dear Chairman Burgess and Ranking Member Green, 

The Drug Policy Alliance appreciates the opportunity to submit testimony for consideration of 

HR 2851, the "Stop Importation and Trafficking of Synthetic Analogues Act of2017" during 

today's hearing titled "Combating the Opioid Crisis: Helping Communities Balance Enforcement 

and Patient Safety." 

The Drug Policy Alliance (DPA) works to increase the degree to which problematic drug use is 

treated as a health issue and advances evidence-based drug policy grounded in compassion and 

human rights. We accordingly oppose policies that predominantly rely on the criminal justice 

system to address drug use. Congress has recognized the failings of harsh sentences for drugs 

like heroin and crack and held hearings in recent years to reduce such penalties. DPA believes 

that we can best protect the public's health, not through relying on punitive approaches to drugs, 

but by focusing on the underlying reasons for their demand and offering evidence-based 

strategies for preventing their use, reducing their harm, and treating those who are using them 

problematically. 

In recent years, a bipartisan consensus has emerged in Congress that urgent action is needed to 

address the opioid overdose crisis. Both parties have come together to pass measures such as the 

Comprehensive Addiction and Recovery Act and 21 ''Century CURES Act that treat the opioid 

overdose crisis as a public health not enforcement- challenge. Most recently Congress 

approved six billion dollars in new funding to address this crisis. This Committee has held 

numerous hearings that have explored evidence-based and health-based solutions to the opioid 

overdose crisis. Although there is still a tremendous amount of work to be done, Congress has 

made important progress toward the goal of addressing the opioid overdose crisis. We are very 

disappointed then to see the Committee take up HR 2851. 

SITSA is a counterproductive approach to the opioid overdose crisis that would greatly expand 

the penalties for drug offenses and enable the Attorney General to ban hundreds of substances 

and prosecute people with long federal prison terms in violation of the new drug laws. The 

Attorney General already has authority granted by Congress to use emergency scheduling 

powers, as well as the ability to concurrently pursue permanent rule making authority for 

substances that have been emergency scheduled. A heavy reliance on law enforcement and the 

criminal justice system to prevent addiction has failed to reduce rates of opioid use and overdose. 

HR 2851 will similarly not deter the use or sale of fentanyl and other synthetic analogues. 

We know that synthetic analogues are often manufactured outside the country. This is also the 

case with fentanyl and fentanyl analogues. In June 2016, the head of the DEA Chuck Rosenberg 

testified before the Senate Judiciary Committee that, "Illicit fentanyl, fentanyl derivatives, and 

Drug Policy Alliance I 1620 I Street NW, Suite 925, Washington, DC 20006 

212.683.2030 voice I 202.216.0803 fax I www.drugpolicy.org 
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30411.135

their immediate precursors are often produced in China." Buyers and sellers in the United States 

are often unaware ofthe composition and potency of the drugs. However, users and sellers 

would face heightened penalties under the bill regardless of their knowledge of the presence or 

potency of these substances. Individuals with unmet overdose prevention and treatment needs are 

not being served or protected by supply-side strategies. Policies formulated to address the opioid 

crisis must effectively mitigate risks associated with use, dependence and overdose. 

We are also very concerned that SITSA would establish a mechanism by which the Attorney 

General can add synthetic compounds to the new "Schedule A" for analogues without consent 

from the Department of Health and Human Services, or input from scientific experts in the 

relevant fields. Most substances that are permanently scheduled must undergo an administrative 

rulemaking process that has been in place more than 40 years. 

This longstanding process under the federal controlled substances law (21 USC 811) requires 

that the Department of Health and Human Services analyze scientific and medical information 

about the substance and give the green light to schedule before the Attorney General can proceed 

with permanent scheduling. Each agency has equal weight when making decisions. Under this 

proposal, the public health role is circumvented, leaving the Attorney General with unilateral 

power to decide which drugs are scheduled and thus how the ensuing penalties are applied. 

This is true even in cases where the Department of Health and Human Services would otherwise 

determine a substance should not be scheduled. This potentially means that thousands of 

synthetic compounds could be scheduled, including substances that pose no known health risk. 

Individuals could be subjected to long prison terms for possessing substances that have not even 

been scientifically evaluated for abuse potential. This makes no sense and provides no benefit to 

public health and safety but only wastes limited resources that should be prioritized toward 

interventions such as medication-assisted treatment and health services proven to help reduce 

overdose and problematic substance use. 

We are also concerned about provisions in SITSA that mandate that the United States Sentencing 

Commission follow the Attorney General's guidance when creating drug equivalency tables for 

synthetic drugs. The U.S. Sentencing Commission is already studying the issue of synthetic 

drugs and penalties. They have held hearings on the issue and heard testimony from a variety of 

law enforcement and public health officials as they seek to find solutions to this complex topic. 

The expertise and information gathered by the Commission is important to review and consider 

before this Committee moves forward with legislation in this area. 

Thank you for considering our views, 

Grant Smith 

Deputy Director 

Office ofNational Affairs 

Drug Policy Alliance 
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February 28, 2018 

The Honorable Michael Burgess 

US House of Representatives 

2336 Rayburn HOB 

Washington, D.C. 20515 

Columbia University IN THE CITY OF NEW YORK 

Department of Chemistry 

The Honorable Gene Green 

US House of Representatives 

2470 Rayburn HOB 

Washington, D.C. 20515 

Dear Chairman Burgess and Ranking Member Green, 

I am writing to express my concerns in regard to the "Stop the Importation and Trafficking of 

Synthetic Analogues Act of2017" ("SITSA Act"; H.R. 2851) and respectfully offer my recommendations 

for improving this proposed legislation. I am a medicinal chemist by training and serve as an Associate 

Research Scientist at Columbia University, where I pursue multiple lines of research in the broad areas of 

neuroscience and psychoactive drugs, with a specific focus on the design, synthesis, and study of novel 

opioid receptor modulators. Myself and colleagues pursue the key long-term goal of applying our work in 

studying such chemical compounds to positively affect human health, including through the development 

of new therapeutics for treating psychiatric and physical pain disorders. 

To achieve this goal, we also collaborate with scientists across the United States and internationally 

and thus, have broad exposure to the promise and challenges of this exciting research area. I also serve as 

CEO and co-founder of a small startup company working to translate our discoveries from the laboratory 

bench to the doctor's toolbox. The nature of our work often requires the study of controlled substances, 

whether as controls in experiments, starting points for modification and improvement, or potential 

therapeutics in their own right. Accordingly, I feel I am well qualified to speak on both the promise and 

importance of my chosen field's work and also the challenges that regulatory controls often place in the 

path of these pursuits. 

Before proceeding with a specific discussion of the SITSA Act and its negative implications for 

scientific research as currently written, I feel it is important to review the history ofthese issues and existing 

problems with the regulatory framework around controlled substances. As the members of the committee 

are aware, the Controlled Substances Act (CSA) currently regulates a number of psychoactive compounds 

as Schedule I drugs. This most restrictive schedule of the act places severe compliance burdens on 

legitimate researchers who seek to study these substances and unlock their medicinal potential. 

For example, prospective Schedule I licensees must submit detailed research plans, permit 

inspections of their facilities, and obtain specialized storage equipment (lockboxes and the like, in some 

cases with direct alarms to local law enforcement), often at significant cost. Such burdens are often further 

complicated by state and local licensing requirements. Further, the existing compliance requirements also 

dramatically curtail scientific collaboration because most laboratories or commercial vendors with which a 

Schedule I licensee may wish to collaborate, will not hold the necessary licenses, nor will they be willing 

or able to obtain them. This problem has become particularly acute in the increasingly interdisciplinary 

world of modern biomedical research, where collaborative teams are essential to major discoveries. These 

many challenges have historically resulted in very few researchers being able or willing to obtain such 

Schedule I licensing. The resulting chilling effect on basic and translational research with Schedule I 

substances has been dramatic and long lasting and cannot be understated. 

Further, the current regulatory requirements do not make sense from a practical perspective and do 

not serve the purpose of the CSA, ostensibly to protect the public from exposure to harmful psychoactive 

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Columbia University 

1:'\ THE CITY OF NEW YOHK 

Department of Chemistry 

substances. The requirements for Schedule I licensing are significantly more stringent than those for 

substances in Schedules II-V, despite the fact that many substances in these less restrictive schedules have 

a potential for abuse and diversion as great, or greater than, many substances listed in Schedule I. It should 

further be noted that although stringent precautions are certainly warranted for commercial facilities 

manufacturing or distributing large quantities of controlled substances, it is my respectful opinion that they 

go above and beyond what is necessary in the context of basic research, where the quantities of material 

required are extremely limited. Research with cells and/or animals typically requires a quantity of material 

far below that which could be credibly claimed to have a risk for diversion to the illicit market. In fact, the 

quantity of material required is in many cases too little to have a measurable effect on even a single human 

being. Conside~ing this extremely limited risk of diversion or exposure to the public via legitimate scientific 

research channels, it seems unreasonable to impose restrictions which unnecessarily undermine the ability 

of the scientific community to study Schedule I compounds. 

Lastly, we must consider the immense potential benefits that research on Schedule I substances 

may ultimately have for medicine, particularly in the area of mental health. Simply because a compound is 

currently found in Schedule I does not mean it can never be found to have medical benefits when used 

appropriately and with care. Despite the challenges of working with Schedule I substances, some in the 

research community have persisted and are demonstrating exciting efficacy for Schedule I drugs in treating 

a number of serious and underserved medical disorders. 

For example, MDMA, the active component of"ecstasy", is currently in Phase Ill clinical trials for 

the treatment of post-traumatic stress disorder and has been granted Breakthrough Therapy Designation by 

the Food and Drug Administration (FDA). Likewise, psilocybin, the active component of "magic 

mushrooms", has demonstrated efficacy in treating cancer-associated depression, and a little-known 

compound derived from an African plant, ibogaine, has shown great promise in treating drug addiction (in 

trials outside the US due largely to regulatory challenges). Further, it should be remembered that even 

heroin is an effective and safe analgesic for severe pain when used under a doctor's care, and in fact has 

been used in the United Kingdom for this purpose for decades. Accordingly, a substance's inclusion in 

Schedule I should not immediately dismiss it as a potential therapeutic. 

I am hopeful that the members of the committee will agree that scientific research with such 

substances must be allowed to continue with limited obstruction when at all possible, such that new 

medicines may one day be delivered to patients. Although progress has been made, it has been dramatically 

slowed due largely to our existing regulatory framework and the negative stigma automatically associated 

with compounds placed in Schedule I. 

Given these existing challenges with research on Schedule I compounds, the SITSA Act as written 

is particularly concerning, as it presents new barriers to scientific research with controlled substances and 

continues the trend of ignoring the input of the scientific community in regulatory decisions. 

First, the SITSA Act creates a new drug schedule, Schedule A, to which compounds may be added 

with no well-defined evidentiary standard. Specifically, the act requires that a substance to be added to 

Schedule A have (I) a chemical structure that is substantially similar to the chemical structure of a 

controlled substance in any existing schedule and (2) an actual or predicted stimulant, depressant, or 

hallucinogenic effect on the central nervous system (emphasis mine). 

From the expert perspective of a chemist or pharmacologist, both of these requirements are 

excessively ambiguous. It is not clear how much deviation in chemical structure is required before a 

Havcmeyer Hall Columbia University ChcmistiT 3000 Broadway New York, NY 10027 
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Columbia University IN THE CITY OF NEW YORK 

Department of Chemistry 

chemical compound is no longer "substantially similar", nor could such a requirement be clearly defined 

and applied generally across all possible cases given the vast structural variability of drug-like compounds. 

This is well evidenced by the observation that the concept of "structural similarity" is frequently litigated 

in US courts in the context of pharmaceutical patent disputes, where each case must be carefully considered 

by experts and decided on its individual merits. 

Similarly, the ability to predict a psychoactive effect of a given chemical compound based solely 

on its chemical structure, is extremely limited. It is well known to a practicing medicinal chemist that even 

small changes to the structure of a chemical compound, in some cases as small as the addition or removal 

of a single atom, can change the potency of that compound's effect by 100-fold or more. Accordingly, an 

unstudied compound, although appearing largely similar in chemical structure to a known psychoactive 

drug, may in fact be completely inactive. Thus, to place regulatory controls on a substance based merely 

on predicted effect is unwarranted at best, and at worst, scientifically negligent. 

Second, the SITSA Act specifies that the listing of a substance in Schedule A (either temporary or 

permanent) is at the sole discretion of the Attorney General and requires no input from the scientific 

community at large, nor the leading federal agency dedicated to the study of drug abuse issues, the National 

Institute on Drug Abuse (NIDA). Further, temporary scheduling orders under this new statute would not be 

subject to judicial review. It is unsettling that a law enforcement agency (the Department of Justice) would 

be solely entrusted to make a complex regulatory decision requiring careful and complex scientific analysis, 

and having far-reaching consequences for not only scientific research, but public health and criminal justice, 

without the input of all stakeholders. 

Further, the proposed definition of Schedule A and procedures for listing in said schedule largely 

circumvent and render meaningless the existing regulatory framework and controls of the CSA. Because 

the SITSA Act would allow the Attorney General to unilaterally place new substances into Schedule A with 

little if any evidentiary standard, including both temporary and permanent scheduling actions, which can 

be initiated simultaneously, there is no longer any reason to utilize the existing (if imperfect) scheduling 

procedures of the CSA. Existing procedures at least require presentation of some evidence demonstrating 

abuse liability, extent of abuse, or adverse public health consequences for a proposed controlled substance 

(e.g. 8-factor analysis) and include clear pathways for input from federal agencies with specialized 

medicinal and scientific expertise (e.g. the FDA and NIDA). !fa new, easier, and unilateral pathway is now 

available, there will be no incentive for the Attorney General to proceed through the more rigorous 

scheduling procedures currently codified in the CSA. 

Lastly, the SIT SA Act imposes substantially the same regulatory requirements upon legitimate use 

(e.g. scientific research) of Schedule A substances as those currently imposed for Schedule I substances. 

Thus, placement of a substance into Schedule A is likely to have a chilling effect on scientific research with 

said substance identical to that of placing it in Schedule I, which I hope the members of the committee will 

agree, has historically been substantial. This is unreasonable given both I) the substantially lower standard 

for placing a new chemical substance into Schedule A as compared to Schedule I and 2) as noted above, 

the high possibility which exists for substances to be placed into Schedule A without any actual evidence 

of abuse liability or danger to public health. 

The danger to the scientific enterprise is further exacerbated by the observation that given the lower 

evidentiary standard of Schedule A listing, as discussed above, such procedures are likely to be the most 

frequently utilized for scheduling of new substances from this point forward, and therefore preclude an 

ever-growing list of biologically interesting compounds from scientific study. Further, although I note that 

Havcmcyer Hall Columbia University Chemistry 3000 Broadw<ty New York, NY !0027 
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Columbia University 

!:\'THE CITY OF :"'EW YORK 

Department of Chemistry 

the legislation has admirably precluded individuals merely in possession of Schedule A controlled 

substances from criminal and civil sanctions, this exemption will not be expected to protect many scientific 

researchers. Given that most substances to be listed under Schedule A are expected to be novel compounds 

with little history of use or study, it is likely that they will not be commercially available to researchers for 

purchase (especially given the new regulatory requirements for commercial manufacturers). Accordingly, 

chemists will need to synthesize these compounds in the laboratory (in limited quantities) to permit study 

and thereby, the activities in many research laboratories would by necessity extend beyond simple 

possession. Thus, a "possession exemption" as written is not enough to protect the scientific enterprise. 

Such regulatory policies are unfortunate not only in their long-term negative implications for 

development of new therapeutics, but also for their immediate negative consequences for our understanding 

of little-studied chemical entities. If the Attorney General or another regulatory agency genuinely believes 

that a new substance, which in many cases has never been the subject of rigorous scientific study, poses a 

danger to the public, then research must be allowed to continue such that the effects and risks of said 

substance may be understood. As the committee is well aware, legislation is unlikely to entirely remove 

any controlled substance from the illicit market or completely prevent its exposure to the public. 

Accordingly, the physiological and behavioral effects of new and emerging drugs of abuse must be studied 

to provide reliable information to physicians and public health agencies attempting to cope with the realworld consequences of their use. 

In light of the above concerns with the SITS A Act as written, I would like to respectfully propose 

practical solutions that would provide greater scientific rigor in the evaluation of proposed controlled 

substances and limit the regulatory burden for legitimate scientific researchers intending to study such 

substances, while concurrently having little or no impact on the effectiveness of the proposed act to serve 

its intended purpose. It is my understanding that such intent is to improve the ability oflaw enforcement to 

respond rapidly to newly identified harmful substances on the illicit market, with a particular emphasis on 

interdiction of illegally imported substances and disruption of moderate- or large-scale domestic and 

international drug trafficking operations. Accordingly, the following recommendations should be 

considered in the context of this goal and it should be recognized that they will present little or no 

impediment to its achievement. 

First, the SITSA Act should require better evidentiary standards to establish that a proposed 

controlled substance has an actual, not merely predicted, psychoactive effect before scheduling can 

proceed. Such standards might include, at a minimum, I) radioligand binding studies and functional assays 

in cells to demonstrate that a given compound has an effect on a central nervous system receptor activated 

or blocked by known scheduled substances and a potency similar to or higher than compounds having 

known effects in humans and 2) effects in classical rodent assays of abuse liability like conditioned place 

preference or self-administration, again with a potency similar to or higher than compounds having 

established effects in man. Federal scientific agencies (e.g. NIDA) already maintain laboratories or contract 

with academic institutions capable of quickly and easily performing such studies, so lack of resources 

should not be an excuse for more rigorous profiling of unknown substances before regulatory action is 

taken. For example, the Psychoactive Drug Screening Program funded by the National Institute of Mental 

Health provides rapid screening for binding and functional activity of novel compounds at central nervous 

system receptors. 

Second, the SITSA Act should require the concurrence of both federal scientific (e.g. NIDA) and 

medical agencies (e.g. FDA), or an independent scientific body, that a proposed substance meets the 

standards for Schedule A control (ideally amended as above). 

Have meyer Hall Columbia University Chemistry 3000 Broadway New York, NY !0027 
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Columbia University IN THE CITY OF NEW YORK 

Department of Chemistry 

Third, the SITSA Act could greatly minimize the impact on the scientific research community 

through two mechanisms, I) making the regulatory requirements for the use and handling of Schedule A 

substances more consistent with those for substances in Schedules II-V, which are less onerous, and 2) 

instituting exempt quantities below which regulatory requirements would not apply. Such exemption 

amounts (the maximum to be possessed/used/manufactured by a given laboratory/individual at any given 

time) would protect in a clearly defined way not just possession, but also laboratory scale manufacturing, 

structural modification, or other uses provided that the total quantity at issue was below the exemption 

amount. 

For substances of well-defined potency, an exempt quantity could be set at some small multiple 

(e.g. 10-fold) of the dose required (or reasonably expected) to elicit an observable psychoactive effect in a 

human being. For substances where there is no or little information about their pharmacology or potency, 

a default exempt quantity could apply until such information was obtained. Exempting such limited 

quantities would permit the vast majority of early stage research in cells and animals to continue 

unhindered, while presenting extremely limited risk of diversion to illicit markets or risk to public safety. 

It cannot reasonably be argued that a handful of scientific laboratories across the entire country, each 

possessing at most a few human-equivalent doses of a Schedule A substance at any given time, could 

reasonably serve as a viable illicit market for such substances or expose the general public to any 

appreciable risk of exposure. Further, the existence of such exempt quantities would not interfere with the 

broader intent of the act whatsoever, especially considering that the act already exempts possession of 

Schedule A substances from regulatory control, clearly signaling its intent to focus on disruption of 

moderate- or large-scale drug trafficking operations. 

It is my hope that through the above discussion you will understand the challenges the research 

community has faced both historically and will face in the future, with regard to regulation of controlled 

substances. I hope you will also agree that careful, legitimate research on controlled psychoactive 

substances holds great promise for improving human health, particularly in the area of mental health, where 

improvements to the standard of care are so desperately needed. In light of this, I respectfully ask that you 

consider my proposals for improving the SITSA Act to limit its detrimental affect on scientific research. 

0Lp~ Associate Research Scientist 

Columbia University 

New York, NY 10027 

Havemeyer Hall Columbia University Chemistry 3000 Broadway New York, NY 10027 
245 


30411.141

The Honorable Mark DeSaulnier (CA-ll) 

Committee on Energy and Commerce 

Subcommittee on Health 

Statement for the Record 

February 28,2018 

Deaths from drug overdoses have risen in nearly every county across the United States, with 

47,055lives lost each year due to overdose, the equivalent of about 125 people every day. 1 At 

the same time, more prescription opioids are being dispensed than ever before. In 2010, 

prescription opioid use in the U.S. translated into 693 mg of morphine per person, nearly doubled 

from 2007. 2 

The people on the front lines of the abuse of prescription pain killers are pharmacists. 3 Under 

current law, pharmacists are required to exercise sound professional judgment when making a 

determination about the legitimacy of a controlled substance prescription. The responsibility to 

validate the prescription for a specific set of criteria is done with great care and professionalism 

by hundreds of thousands of pharmacists every year. 

The Empowering Pharmacists in the Fight Against Opioid Abuse Act would require the 

Department of Health and Human Services, the Drug Enforcement Administration, and other 

federal agencies responsible for combatting the opioid epidemic to produce and disseminate 

materials to pharmacists, medical professionals, and patients that provide additional guidance on 

when and how to refuse to fill a prescription that the pharmacist believes to be fraudulent. It 

simply clarifies the tools that pharmacists already are empowered with and ensures that 

information about the rules surrounding denying to fill a prescription are readily available for 

any professional or patient who may need it. 

Pharmacists have a difficult job made even more taxing by the rise of this epidemic. This 

bipartisan, commonsense legislation will help improve the last line of defense against 

prescription drug abuse in our communities and could have a meaningful impact in combatting 

the opioid epidemic. 

1 http:/lblogs.cdc.gov/nchs-data-visualization/drug-poisoning-mortality/ 

2 http://www.painpolicy.wisc.edu/opioid-consumption-data 

3 http://www.deadiversion.usdoi.gov/mtgs/pharm awareness/conf 20 !3/august 2013/prevoznik.pdf 
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30411.142

GREG WALDEN, OREGON 

CHAIRMAN 

Ms. Susan Gibson 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

Ql:ongre9'9' of tbe Wnfteb ~tateS' 

~ou~e of 1\epre~entatibe~ 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority (202)225-2927 

Minority i202)225-3641 

AprilS, 2018 

Deputy Assistant Administrator 

Diversion Control Division 

Drug Enforcement Administration 

700 Army Navy Drive 

Arlington, VA 22202 

Dear Ms. Gibson: 

Thank you for appearing before the Subcommittee on Health on February 28,2018, to 

testify at the hearing entitled "Combatting the Opioid Crisis: Helping Communities Balance 

Enforcement and Patient Safety." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record 

remains open for ten business days to permit Members to submit additional questions for the 

record, which are attached. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on Aprill9, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
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30411.143

Office of the Assistant Attorney General 

The Honorable Michael C. Burgess, M.D. 

Chairman 

Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, DC 20515 

Dear Mr. Chairman: 

U.S. Department of Justice 

Office of Legislative Affairs 

Washington, D.C. 20530 

AUG 2 4 2018 

Enclosed please find responses to questions for the record arising from the appearance of 

Susan A. Gibson, Deputy Assistant Administrator for the Office of Diversion Control 

Regulatory, Diversion Control Division, Drug Enforcement Administration, before the House 

Energy and Commerce Subcommittee on Health on February 28, 2018, at a hearing entitled 

"Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety." 

We hope that this information is of assistance to the Committee. 

The Office of Management and Budget has advised us that there is no objection to 

submission of this letter from the perspective of the Administration's program. Please do not 

hesitate to contact this office if we can be of additional assistance regarding this or any other 

matter. 

Enclosure 

cc: The Honorable Gene Green 

Ranking Member 

Sincerely, 

Prim 

"W~f~ F. Escalona 

Principal Deputy Assistant Attorney General 
248 


30411.144

Questions for the Record 

Drug Enforcement Administration 

Before the Subcommittee on Health 

Energy and Commerce Committee 

U.S. House of Representatives 

For a Hearing Entitled 

"Combating the Opioid Crisis: Helping Communities Balance Enforcement and 

Patient Safety" 

February 28, 2018 

The Honorable Michael C. Buaess. M.D. 

1. Ms. Gibson, in your testimony, you state that manufacturers and distributors 

will keep one step ahead of government action by introducing and repackaging 

new synthetic products that are not listed as controlled substances. The 

distribution and use of these synthetic opioids have wreaked havoc on our 

nation's public health, and we have convened this hearing to analyze and 

develop legislation that will prevent further spread of the opioid epidemic. 

• In what ways can the Special Operations Division Heroin/Fentanyl Task 

Force Working Group bridge the gaps between agencies so that there's a 

united enforcement effort to prohibit crafty manufacturers and 

distributors from exploiting the cracks in our system? 

RESPONSE: The shared goal of neutralizing criminal networks that threaten our national 

security as well as our partner nations is what bridges the gaps between agencies. The 

Drug Enforcement Administration's (DBA) Special Operations Division (SOD) 

Heroin/Fentanyl Task Force Working Group works in a complementary and 

comprehensive manner in our approach. This focus, in effect, is about the quality and 

nature of our relationships that make SOD successful as part of the whole-of-government 

approach to combat these persistent threats. 

Through a "top-down/bottom-up approach," SOD analyzes field inputs and applies 

its specialized capabilities to identify connections between domestic and foreign networks. 

This unique approach enables SOD to leverage the authorities, capabilities, and resources 

ofits partners to energize joint operations and satisfy intelligence requirements in support 

of national coordination strategies. This approach allows SOD to work across Department 

lines as a powerful resource that coordinates national and international efforts to combat 

fentanyl, fentanyl related compounds, precursor chemicals, money laundering, and 

synthetic opioid networks. 
249 


30411.145

HEROIN/FENTANYL TASK FORCE: In 2014, the SOD prioritized operations that 

targeted major international and domestic heroin/fentanyl distributors and threat streams, 

and created the SOD Heroin/Fentanyl Task Force (HFTF). The HFTF improved 

information sharing between U.S. law enforcement agencies, to include DEA, Homeland 

Security Investigations (HSI), the Federal Bureau ofinvestigation (FBI), the U.S. Customs 

and Border Protection (CBP), the U.S. Postal Inspection Service (USPIS), as well as the 

DEA Special Testing and Research Laboratory (STRL). These agencies collaborate 

closely by refmed information sharing mechanisms established at SOD with the 

Department of Defense Narcotics and Transnational Crime Support Center, the National 

Targeting Center, and the Joint Interagency Task Force West to develop actionable lead 

packages on potential fentanyl/synthetics distributors, which are actioned domestically and 

internationally in various field offices. 

The HFTF collaborates with the STRL regarding large seizures that test positive for 

fentanyl. The HFTF utilizes the information from the STRL as a pointer system to connect 

fentanyl networks, regionally and internationally. 

EXAMPLE OF SOD-HFTF COORDINATION SUCCESS: Since May 2013, law 

enforcement agencies, working together under the Attorney General's Organized Crime 

Drug Enforcement Task Forces (OCDETF) Program, have been investigating the drug 

trafficking activities of Chinese national Jian Zhang and his criminal organization based in 

Shandong Province, China. OCDETF used various techniques during the investigation of 

Zhang, which included judicial wire intercepts of electronic communications by the United 

States and China, undercover transactions by federal agents, collaboration with the private 

sector, and debriefing of confidential sources and cooperating defendants. Zhang's 

criminal organization utilizes the internet to advertise the sale of his controlled substances 

distributed by various manufacturing laboratories in mainland China. Zhang was 

responsible in recruiting, teaching and organizing U.S. and Canada based regional 

distributors to purchase and manufacture his synthetic opioids into counterfeit pills such as 

30 mg oxycodone. 

SOD-HFTF SUPPORT TO COMBAT CHINESE TCOs: Under these SOD-supported 

operations, HFTF was able to identify, interdict, and successfully indict Zhang, who was 

purchasing raw materials from China chemical suppliers for the purpose of synthesizing, 

producing, and distributing dangerous narcotics through the United States and Canada. 

The illicit drugs Zhang trafficked into Canada and the United States were linked and 

directly responsible for multiple overdose deaths and serious injuries across the nation. 

RESULTS AND IMPACT: On September 21,2017, Zhang was indicted in North Dakota 

on five separate counts to include conspiracy to possess with the intent to distribute the 

fentanyl resulting in serious bodily injury and death. In addition to the investigation clearly 

establishing that Zhang was the source of supply for the fentanyl and fentanyl analogues 

that supplied a Canadian re-distributor, Zhang was also found to be the source of narcotics 

for eight other federal investigations across the United States. As a result of SOD and 

OCDETF coordinated enforcement operations, U.S.law enforcement agencies arrested 56 

drug traffickers, seized in excess of 1,000 kilograms of drugs of various types, $1 million 

in currency, and other assets totaling over $450,000 in U.S currency. Each were connected 

to investigations under SOD Operation Deadly Merchant, Operation Denial, and Operation 

2 
250 


30411.146

Slippery Pete. These actions represent a significant milestone in denying the illicit 

trafficking offentanyl in the United States and international markets, as well as sending a 

clear message of future unified efforts to combat these threats from SOD and its partners. 

These examples of SOD supported operations are representative of increasing multijurisdictional success stories that arise from cooperation and superbly coordinated 

interagency efforts from dozens offederal, state, and local agencies spanning both regional 

and international borders. 

2. You also state in your testimony that there was an exponential increase in the 

number of fentanyl reports from 2013 to 2016. This statistic suggests that 

fentanyl has become more accessible, which implies that trafficking of illegal 

fentanyl, and other synthetic opioids, has increased. ' 

• Mr. Katko's bill aims to modernize scheduling guidelines so that your 

agency can keep up with the rapidly changing nature of synthetic drugs. 

Can you comment on the importance of working with the Food and Drug 

Administration in your efforts to discover and schedule these new drugs in 

a timely manner? 

RESPONSE: The Department of Justice (Department) and DEA have worked with the 

Department of Health and Human Services, and its appropriate components, including 

the Food and Drug Administration (FDA), to provide extensive technical assistance to 

both the House and the Senate on H.R. 2851 and S. 1327, the "Stop the Importation and 

Trafficking of Synthetic Analogues Act of2017," or the SITS A Act. The rapidity and 

ease with which dangerous synthetic drugs are manufactured and introduced into the 

illicit market make control through law enforcement responses extremely challenging. 

Additional tools are needed to reduce the threat these substances pose, including a more 

expeditious pathway to schedule such substances under the Controlled Substances Act 

(CSA). DEA has engaged extensively with FDA and the National Institute on Drug 

Abuse on ways to streamline the current scheduling framework, without impeding bona 

fide scientific and medical research. 

DEA agrees that it is important for the research community to have access to 

psychoactive substances for licit research and DEA strongly supports research on 

controlled substances, including those in Schedule I of the CSA. Recognizing that the 

process of obtaining a DEA registration may result in significant delays, DEA has taken 

steps to improve the process. One example is the new electronic system through which 

applications can be submitted. DEA also understands the significant role FDA plays in 

both the scheduling and registration process for controlled substances. SITSA would: 

provide DEA with a critical tool enabling it to be proactive in combating the influx of 

synthetic drugs that are causing great harm to the public; preserve an appropriate role for 

the FDA in the scheduling process; and ensure adequate access to imalogues of 

controlled substances for licit research. 

3. Ms. Gibson, in your testimony, you talk about fentanyl and fentanyl analogues 

coming into the United States from China to be mixed with heroin and 

cocaine, or pressed into a pill form. You say, and I quote, "In some cases, 

3 
251 


30411.147

traffickers have industrial pill presses shipped into the United States directly 

from China and operate illegal fentanyl pill press mills domestically." 

• What is the DEA doing to stop pill presses from being used for criminal 

activity? 

Response: All regulated persons are required to submit in advance the notification of an 

import or export of a tableting or an encapsulating machine. The advance notification 

must contain the information described in 21 CFR 1310.06 (e)(1) and (e )(2). DEA 

would pursue enforcement action as it receives information from CBP about illegal 

imports oftableting or encapsulating machines. 

4. I agree that the current pill press proposal- in discussion draft form- needs to 

be more narrowly tailored. This concept was raised in the President's 

Commission made this recommendation- it's number 25. The intent of this 

legislation is to capture criminal practices of pill presses being used to produce 

counterfeit drugs and not create a burden on legitimate industries. 

• Do you have any creative ways we could do this without causing 

unnecessary harm on legitimate industries, like over-the-counter products 

or dietary supplements? 

Response: DEA is willing to work with the Committee by providing technical 

assistance on any legislation that will address the criminal practices of pill presses 

being imported and used to produce counterfeit drugs, while also allowing legitimate 

industries to continue to operate within the confines of the law. 

4 
252 


30411.148

The Honorable Susan W. Brooks 

5. One commonly referenced method of reducing opioid overdoses is to reduce 

opioid prescriptions. As you know, a DEA registration is required for 

practitioners to be able to prescribe controlled substances. I would like to focus 

my questions today on the importance of prescriber education in reducing the 

number of prescriptions. I am working on a bill that will require prescribers to 

complete continuing medical education (CME) prior to receiving a DEA 

registration. 

• In what ways does DEA monitor prescribing practices? Have there 

been any changes related to prescribers that DEA has implemented 

in response to the current opioid epidemic? 

Response: DEA does not have the statutory authority to monitor the prescribing practices 

ofDEA-registered prescribers. As you know, prescription drug monitoring programs 

(PDMPs) are state-run electronic database systems used by practitioners, pharmacists, 

medical and pharmacy boards, and, where permitted, law enforcement. Federal law 

enforcement access to a state's PDMP is limited and access varies according to state law. 

It is usually only granted when a prescriber is under a federal investigation. These 

programs are established through state legislation and are tailored to the specific needs of 

each state. DEA strongly supports robust PDMPs and encourages medical professionals to 

use this important tool to detect and prevent doctor shopping and other forms of diversion. 

Currently, 49 states have an operatiqnal PDMP. If funded, Missouri would become the 

50th, pursuant to the Governor's Executive Order in July 2017. 1 As ofJanuary 2018, 40 of 

these 49 states with operational PDMPs require controlled substance prescribers to use the 

state's PDMP prior to prescribing a controlled substance in certain circumstances as 

mandated by each state's legislation.2 DBA encourages all practitioners and pharmacists to 

use their state PDMPs. 

PDMPs are valuable tools for prescribers, pharmacists, and law enforcement 

agencies to identify, detect, and prevent nonmedical prescription drug use and diversion. 

Law enforcement ability to request, view, and utilize PDMP data in support of ongoing 

investigations in a manner that protects patient privacy is vital. Access to information in 

support of active state and federal investigations varies widely from state to state, with 

some states requiring a court order for law enforcement to obtain data. Some requirements 

can hinder DBA's investigations of those who are operating outside of the CSA and impact 

DEA's ability to effectively protect the public health and safety. 

In May 2018, DBA initiated a nationwide program to offer training to all DEAregistered prescribers. This program is designed to train DBA-registered prescribers on 

how to detect and guard against diversion activities in response to the current opioid 

1 The Missouri statewide PDM.P has not been funded and is not operational. Please note that the county of St. Louis~ Missouri. instituted 

its own operational PDMP in April2017. This PDMP is open to participation from additional jurisdictions outside of St. Louis County. 

As of February 2018, there are 58 jurisdictions participating in the PDMP. These 58 jurisdictions cover 79% of the state population and 

92% ofli.ea1thcare providers. 2 PDMP Center of Excellence, Brandeis University. http://www.pdmpassist.org/pdf7Mandatory Query Conditions 20180 I 02 pdf 

retrieved March 6, 2018. 

5 
253 


30411.149

epidemic. In addition to the training opportunities offered to registrants, DEA has also 

begun a program to proactively send targeted email messages to various segments of its 

registrant population on matters of mutual interest. For example, in February 2018, DEA 

sent correspondence to 1.3 million doctors nationwide alerting them of the Centers for 

Disease Control and Prevention's (CDC) recommendations for the prescribing of opioids 

for acute pain and advising practitioners of a free training webinar available from CDC. In 

the coming months, DEA will send targeted messages to certain practitioners on how they 

may utilize telemedicine to treat opioid use disorder. 

Much like the recommendations of the President's Commission on Combating Drug 

Addiction and the Opioid Crisis, DEA recognizes the importance of fostering training 

amongst prescribers about the risks and benefits of opioid therapy. DEA supports the 

recommendation made by the Commission to require new and existing practitioners to 

demonstrate that they have received continuing medical education when applying for or 

renewing their DEA license. In order to better inform the Department on how many 

prescribers are taking training in this area, on February 7, 2018, DEA began to ask each 

individual practitioner, at the time of their application or renewal, whether they have 

received training regarding the prescribing or dispensing of opioids. Since deployment, 83 

percent of the respondents have affirmatively stated that they have taken such training. 

6 
254 


30411.150

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. DavidKan 

President 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congre5'5' of tbc Wnttcb $tatc1i 

1!}omie of l\epresentatibes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majori1y (202.}225--2927 

Minority (202)225-3641 

AprilS, 2018 

California Society of Addiction Medicine 

575 Market Street; Suite 2125 

San Francisco, CA 94105 

Dear Dr. Kan: 

Thank you for appearing before the Subcommittee on Health on February 28, 2018, to 

testifY at the hearing entitled "Combatting the Opioid Crisis: Helping Communities Balance 

Enforcement and Patient Safety." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record 

remains open for ten business days to permit Members to submit additional questions for the 

record, which are attached. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on April19, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
255 


30411.151

OFFICERS 

President 

Kelly J. Clark, MD, MBA, DFAPA, DFASAM 

President-Elect 

Paul H. Earley, MD, DFASAM 

Vice President 

Margaret Jarvis, MD, DFASAM 

Secretary 

Yngvild Olsen, MD, MPH,DFASAM 

Treasurer 

Brian Hurley, MD, MBA, FASAM 

Immediate Past President 

R. Jeffrey Goldsmith, MD, DLFAPA, DFASAM 

BOARD OF DIRECTORS 

Directors-at-Large 

Anthony Albanese, MD, DFASAM 

Marc Galanter, MD, DFASAM 

William F. Haning, Ill, MD, DFAPA, DFASAM 

Petros levounis, MD, MA, DFASAM 

John C. Tanner, DO, DFASAM 

Reglona!Directors 

RegioniDlrector 

Jeff Seizer, MD, DFASAM 

Region I! Director 

MurtuzaGhadiali, MD 

Region I!! Director 

Kenneth Freedman, MD, MS, MBA, FACP, AGAF, 

DFASAM 

Reg1oniVDlrector 

Michael Shore, MD, DFASAM, DLFAPA 

RegionVDlrectOI' 

Anika A!vanzo, MD, MS, FACP, FASAM 

Region VI Director 

Gavin Bart, MD, PhD, DFASAM 

Region VI! Director 

A. Kenison Roy, Ill, MD, DLFAPA, DFASAM 

Region VII! Director 

Minam Komaromy, MD, FACP, DFASAM 

Reglo11IXDirector 

PeterSelby,MB9S,CCFP,FCfP,MHSc, 

DFASAM 

Region X Director 

Scott Teitelbaum, MD, DFASAM 

Ex-Officio 

Stuart G!tlow, MD, MPH, MBA, DFAPA, DFASAM 

Randolph P. Holmes, MD, FASAM 

Michelle lofwal!, MD, FASAM 

PennyS.Mil!s,MBA 

AleksandraZglerska, MD, PhD 

FOUNDING PRESIDENT 

Ruth Fox, MD 

1895-1989 

ASAM 

April19, 2018 

Zach Dareshori 

Legislative Clerk 

American Society of 

Addiction Medicine 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Re: Questions for the record of the hearing entitled "Combatting the 

Opioid Crisis: Helping Communities Balance Enforcement and Patient 

Safety" 

Dear Mr. Dareshori, 

It was my pleasure to appear before the Subcommittee on Health on 

February 28, 2018 to testify at the hearing entitled "Combatting the 

Opioid Crisis: Helping Communities Balance Enforcement and Patient 

Safety." Please find below my responses to the additional questions for 

the record submitted by Members. 

The Honorable Susan W. Brooks 

1. Would you say it is uncommon for a primary care physician or the 

physician prescribing opioids to detect and diagnose addiction? 

A: Yes. Given that most clinicians receive no or minimal training on 

diagnosing or treating addiction in their clinical training programs, 

most ore not equipped to recognize the signs and symptoms of 

addiction or diagnose it. Primary care physicians are especially pressed 

for time with patients, and likely do not have the time to screen or 

assess patients for addiction during a typical visit. 

Even if a primary care physician has the time and training ta detect and 

diagnose addiction in a patient, tao often the patient is not offered or 

engaged in evidence-based treatment for their disease. Diagnosing 

without intervening in o positive manner is not useful. A patient with 

suspected opioid use disorder should receive a comprehensive 

assessment with a biopsychosocial approach that comports with the 

ASAM Criteria to determine the type and intensity of treatment that the 

patient needs. The clinician should then discuss and offer to the patient 

all therapeutic options, including all FDA-approved medications for 

11400 Rockville Pike, Suit~ 200, Rockville, MD 20852 

Phone: 301.656.3920 l Fax: 301.656.3815 

www.ASAM.org 
256 


30411.152

opioid use disorder unless clinically contraindicated. The patient and treating clinician should 

decide together the best treatment options and individualized treatment plan. 

2. Aside from Continuing Medical Education, what can be done to better equip physicians who 

may not be addiction specialists to detect addiction while evaluating their patents? 

A: Prescription drug monitoring programs (POMPs) are valuable tools that can help inform safe 

prescribing and alert clinicians to possible substance misuse by a patient. However, the quality 

and timeliness of POMP data varies by state, and many POMP programs are not integrated into 

normal clinician workflow, making it more difficult far clinicians to check the reports. Additional 

federal investments to help stotes improve the quality and timeliness of their POMP data and 

better integrate their systems with clinician workflow and electronic medical records could 

increase their use and usefulness. Additionally, helping states to make their POMPs 

interoperable with neighboring states will give clinicians a more complete picture of their 

patient's prescription history. 

In addition to investments in POMPs, the federal government should invest in improved 

healthcare professional curricula to ensure the next generation of healthcare professionals is 

better equipped to diagnose and treat addiction omong its patients. These investments could 

come in the form of grants to healthcare professional schools to support the revision or 

expansion of their curricula to include enhanced training on diagnosing and treating addiction 

as well as managing patients with chronic pain. 

Again, it is important to stress that detecting addiction without intervening to engage the 

patient in treatment is unproductive. While clinicians needs to be better trained and have better 

tools at their disposal to detect and diagnose addiction among their patients, they must also be 

able to engage patients in evidence-based treatment, whether they treat the patient 

themselves or refer the patient to a qualified specialist. 

3. Are there best practices or education techniques that you know of to help communities and 

local law enforcement combat addiction by teaching individuals to detect addiction in loved 

ones? 

A: As with any medical condition, addiction should be diagnosed by a trained and licensed 

medical professional. However, community members and law enforcement officials can play an 

important role in supporting those with addiction in their treatment and recovery, providing 

emergency medical help to individuals who have experienced an overdose, and connecting 

persons with addiction to community-based resources for assessment and treatment. There are 

best practices for community programs to prevent addiction, training for the use of naloxone in 

the event of an overdose, and law enforcement-assisted diversion to redirect persons with 

addiction from the criminal justice system into treatment. The Substance Abuse and Mental 

Health Services Administration (SAMHSA} oversees programs in all three of these areas and 

would be best suited to discuss further the role of community members and law enforcement 

officers in responding to the opioid crisis. 

Naloxone access, as recently recommended by the Surgeon General, for people suffering from 

addiction, their families, and the community are critical to prevent and reverse fatal overdoses. 

50% of people who overdose currently do so in their own home. Encouraging co-prescribing of 

naloxone with high risk opioid regimens would increase access to naloxone. Many states have 

state standing orders for naloxone that all citizens can access. 
257 


30411.153

Amendment of telemedicine laws consistent with my prior testimony would allow for more 

rapid access to treatment. 

Initiation of Medication for Addiction Treatment such as buprenorphine or long-acting 

injectable naltrexone in Emergency Departments, inpatient hospitals, and correctional facilities 

would reduce the high risk of fatal overdose associated with discharge from criminal justice. 

Coalition building is critical as there is no one place that can identify all of the patients. 

Supporting community opioid safety coalitions would be a valuable role. 

Spreading a message of universal precautions to patients, their families, and their doctors 

around opioids is critical in preventing new inappropriate opioid medication starts. Universal 

precautions like with bodily fluids recognizes that the medication carries risks and the risks 

should be mitigated. Risk assessment is a great concept; however, we know that even low risk 

individuals can become physically dependent and/or addicted. 

The Honorable Dianna DeGette 

Opioids play an important role in pain management, but when they are prescribed in excess 

quantities they increase the risk for misuse and abuse. This past decade the United States 

experienced a parallel increase in opioid prescriptions and the incidence of opioid use disorders 

among pain patients. Reducing opioid prescriptions should be one part of the federal 

government's response to the drug epidemic. This goal can be partially achieved by educating 

providers on safe opioid prescribing practices. Congressman Schneider's bill, the Opioid 

Preventing Abuse through Continuing Education (PACE) Act, would require physicians to 

complete a yearly four-hour course on the use of opioid therapy in pain management. Do you 

believe that the training proposed under the PACE Act is a reasonable requirement for 

physicians who prescribe opioids? 

A: Yes. ASAM has long endorsed mandatory education for prescribers of controlled substances 

as a condition of obtaining or renewing a registration to prescribe or dispense controlled 

substances, including opioids. ASAM is pleased to endorse the PACE Act, as we believe it would 

help reduce unnecessary exposure to can trolled medications by requiring prescribers ta be 

educated on safe prescribing practices and addiction. Still, ASAM has offered the following 

recommendations to strengthen the bill, ensure it is streamlined with federal efforts already 

underway to inform safe prescribing, and minimize its burden on prescribers who are already 

well-versed on issues related to pain management and addiction: 

• Make the new training requirement a condition of registration to prescribe or dispense 

benzodiazepines in addition to opioids for the treatment of pain. 

• Streamline federal efforts to promote safe opioid prescribing by incorporating the 

recommendations included in the CDC Guideline for Prescribing Opioids for Chronic Pain. 

There is no need for duplicative federal recommendations on opioid prescribing; in fact, 

duplicative efforts may only confuse practitioners and further clutter an alreadycrowded educational space on this topic. 

• Offer a "test-out" option that would give practitioners the opportunity to demonstrate 

their knowledge and "test-out" of this mandatory training requirement. 
258 


30411.154

Thank you again for the opportunity to provide testimony to the Subcommittee. If ASAM can 

be of further assistance to the Committee as it considers addiction-related legislation, please 

don't hesitate to contact ASAM's birector of Advocacy and Government Relations, Kelt'y 

Corredor, at kcorredor@asam.org or 301-547-4111. 

Sincerely, 

David Kan, MD 
259 


30411.155

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

((ongre~~ of tbt Wnittb i>tate~ 

j!)ou£le of ~epre£lentatibe£1 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Mr. Thomas Cosgrove 

Partner 

Covington & Burling LLP 

860 lOth Street, N.W. 

Washington, DC 20001 

Dear Mr. Cosgrove: 

Majority (202)225-29:<7 

Minority (202}225-3641 

AprilS, 2018 

Thank you for appearing before the Subcommittee on Health on February 28,2018, to 

testify at the hearing entitled "Combatting the Opioid Crisis: Helping Communities Balance 

Enforcement and Patient Safety." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record 

remains open for ten business days to permit Members to submit additional questions for the 

record, which are attached. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on April19, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

A'll tl>j haer~M.D. irma€} - __ 

Subcommittee on Health 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
260 


30411.156

Attachment- Additional Questions for the Record 

The Honorable Michael C. Burgess, M.D. 

I agree that the current pill press proposal- in discussion draft form- needs to be more narrowly 

tailored. This concept was raised in the President's Commission as a recommendation- it's 

number 25. Here's what it says: "The importation oftableting machines (pill presses) is 

regulated by DEA. DEA has recently enhanced importation regulations by replacing paper 

reporting with an electronic process. However, the active use of pill presses remains 

unregulated." 

While DEA currently can inspect a registrant's usc of controlled substances in their usable form 

to verify they are properly stored and used for their stated, registered purposes, the DEA 

currently cannot inspect pill presses to verify that the equipment is not being used to produce 

counterfeit drugs. 

The intent of the draft legislation (the Tableting and Encapsulating Machine Regulation Act of 

20 18) is to capture criminal practices of pill presses being used to produce counterfeit drugs and 

not create a burden on legitimate industries. 

1. Do you have any creative ways we could do this without causing unnecessary harm on 

legitimate industries, like over-the-counter products or dietary supplements? 

You point out that under existing law, each person selling a tableting or encapsulating machine 

must report the transaction to DEA. A quick search on eBay yesterday produced 572 results. 

Some of these machines can produce 5,000 pills per hour. 

2. Is the DEA requiring transaction reports on these products? 

3. What is the difference in a pill press bought on eBay to tablet or encapsulate illicit 

synthetic fentanyl versus one used by a legitimate licensed manufacturer? 

You also note that existing manufacturers of controlled substances have systems in place be sure 

they're in compliance with DEA standards and rules. But this proposal is targeting illicit drugs. 

4. Do you have any suggestions on how we can differentiate between the legitimate and 

counterfeit use of these machines? 
261 


30411.157

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congre~~ of tbe Wniteb fS>tate~ 

l!}ouse of l\epresentntibes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515--6115 Majority !202)225-2927 

Minarlty 1202)225--3641 

AprilS, 2018 

Dr. Andrew Kolodny 

Co-Director, Opioid Policy Research Collaborative 

The Heller School for Policy and Management 

Brandeis University 

415 South Street 

Waltham, MA 02453 

Dear Dr. Kolodny: 

Thank you for appearing before the Subcommittee on Health on February 28,2018, to 

testify at the hearing entitled "Combatting the Opioid Crisis: Helping Communities Balance 

Enforcement and Patient Safety." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record 

remains open for ten business days to permit Members to submit additional questions for the 

record, which are attached. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on April19, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
262 


30411.158

PROP 

Physicians for Responsible 

Opioid Prescribing 

April23, 2018 

By Email 

The Hon. Michael C. Burgess, M.D. 

Chair, Subcommittee on Health 

The Hon. Susan W. Brooks 

Member, Subcommittee on Health 

c/o Zack Dareshori, Legislative Clerk 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Email: zack.dareshori@mail.house.gov 

Re: Additional Questions for the Record 

Dear Chairman Burgess: 

Physicians for Responsible Opioid Prescribing 

12800 Whitewater Drive, Suite 100 

Minnetonka, MN 55343 

www.supportprop.org 

T952 943 3937 

Thank you for the opportunity to supplement my testimony at the recent hearing entitled 

"Combatting the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety." 

Your and Congresswoman Brooks's follow-up questions raise critically important issues that I 

am pleased to address. 

Enclosed please find my additional testimony for the hearing record in response to your 

questions. As requested, I have sent a Word version of the document to the e-mail address 

provided in your letter. Please note that because you and Congresswoman Brooks posed the 

same questions, I am providing a combined response. 

Please do not hesitate to contact me with further questions. Your subcommittee's focus on these 

issues is essential to bringing the country's opioid addiction epidemic under control. 

Sincerely, 

Andrew Kolodny, M.D. 

Director, Opioid Policy Research Collaborative 

Co-Founder, Physicians for Responsible Opioid Prescribing 

Enclosure 
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Supplemental Testimony of Dr. Andrew Kolodny 

Responding to Additional Questions for the Record From 

Congressman Michael C. Burgess and Congresswoman Susan W. Brooks 

1. Could you discuss your insight on how you arrived at your conclusion that requiring 

physicians additional CME on opioids would contribute to resolving the public 

health crisis before us today? 

Our opioid addiction epidemic- now the worst drug epidemic in U.S. history- was caused by a 

significant change in the way the medical community prescribes opioid analgesics. 

Specifically, in the mid-1990s, we began prescribing opioids at increasingly higher rates, and we 

began prescribing these medicines for more conditions. No longer were opioid medications 

reserved for short-term, painful conditions like pain after major surgery or to ease suffering at the 

end of life. Physicians began prescribing opioid medications for common moderately painful 

conditions such as low-back pain, arthritis and fibromyalgia. 

Opioid medications are highly addictive. Consequently, as the number of prescriptions for opioid 

medications skyrocketed, we saw parallel increases in the number of people suffering from 

opioid addiction, opioid overdoses, and deaths. 

I do not blame doctors for overprescribing. We became more aggressive in our use of opioids 

because we were responding to a multi-faceted marketing campaign. Enlightened medical 

providers, we were told, should not allow patients to suffer needlessly. We should recognize 

pain as a "fifth vital sign" and think of opioids as a "gift from mother nature" to deliver 

compassionate care. The campaign exaggerated the benefits of opioids and minimized the risks 

of long-tenn usc, especially the risk of addiction. 

We might have been less gullible if we had only heard these messages from advertisements or 

pharmaceutical sales reps. But we also heard these messages from physicians eminent in the 

field of pain medicine, from the Joint Commission, and even from state medical boards. Only 

now is the public learning about the role opioid manufacturers played in coopting these 

authorities in their campaign to increase opioid prescribing. 

I firmly agree that doctors are necessary allies. If we want to bring our country's opioid 

addiction epidemic under control, we need them to prescribe opioids more cautiously. That 

requires prescribers to better understand the risks and benefits of opioid medications. Indeed, for 

precisely this reason, I joined with leading experts in field of pain management and addiction in 

2010 to create Physicians for Responsible Opioid Prescribing (PROP) an organization devoted 

to correcting the widespread misconceptions about opioid medications. 

While I firmly believe that the medical community needs better education about the risks and 

benefits of opioid medications, I share your concerns about the current mandatory Continuing 

Medical Education (CME) strategies being pursued in several states. I, too, have spoken to 

physicians who are frustrated with these programs. The problem with these programs, however, 

can be fixed. 

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First, prescribers should have the right to opt-out of mandatory CMEs that are not relevant to 

their practices. Medical professionals are busy, and our priority should be caring for patients. 

Clinicians who intend to limit their prescribing to 3 days or less should be permitted to opt out. 

The vast majority of clinicians only prescribe opioids for acute pain, conditions that typically 

require 3 days or less of opioid use. Accordingly, the ability of such medical providers to "optout" will alleviate complaints that mandatory CMEs impose "undue" burdens. It will also ensure 

that the education is reaching clinicians who prescribe opioids to patients likely to become 

physiologically dependent (physiological dependence starts setting in after 5 days of opioid use). 

Second, the content of mandatory CMEs should be scrutinized to ensure that medical 

professionals are receiving accurate, up-to-date information about the risks and benefits of opioid 

medications. The content of any CMEs should be free of industry bias, and the faculty should be 

independent as well. 

If these modest steps are taken, I am confident that mandatory CMEs will not create a barrier to 

the compassionate treatment of patients with chronic pain. To the contrary, it will help ensure 

that physicians are caring for patients with chronic pain responsibly and not putting patients at 

risk of opioid addiction based upon the outdated and inaccurate information that fueled a public 

health catastrophe. 

2. Do you think there would be a better way to address your concerns regarding the 

overprescribing of opioids other than potentially burdening well-intentioned doctors 

further? 

For the reasons explained above, I believe that mandatory Continuing Medical Education (CME) 

is a necessary intervention to bring the opioid addiction epidemic under control, and I am 

confident that mandatory CMEs will not burden doctors unnecessarily- especially if those who 

intend to prescribe these medications only for 3 days or less are allowed to op.t out. 

Your concern for well-intentioned doctors, however, raises another issue. It is important to 

recognize the role that well-intentioned doctors have played in the opioid addiction crisis. The 

medical community overprescribed opioid medications not because we were indifferent or set 

out to harm patients. Rather, the manufacturers of opioid medications targeted well-intentioned 

doctors and persuaded the medical community that we were allowing pain patients to suffer 

needlessly and opioids were the answer. As a result, millions of pain patients became addicted to 

opioids- often by using opioid medications exactly as prescribed. 

I admire your desire to see that well-intentioned doctors are not unduly burdened, but there is a 

more pressing target for those concerns: the extensive and unnecessary burdens on the 

prescription ofbuprenorphine (Suboxone). 

Buprenorphine is the first-line treatment for opioid addiction. With the help of this medication, 

many people who are addicted to opioids can once again lead fully productive lives. 

Unfortunately millions of people who could benefit from buprenorphine do not have access to 

this medication because there are numerous barriers to treatment. For example, a doctor who 

wants to prescribe buprenophine must take an 8-hour training course, and after completing the 

course, that doctor is capped in terms of the number of patients he or she can treat. 

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It makes no sense to require doctors to take a full day of additional training to prescrib~ a 

medicine to treat opioid addiction when no extra training is required for physicians who want to 

prescribe opioids like OxyContin that are far more addictive and potentially dangerous .. It is 

similarly incongruous to cap the number of patients that a doctor can treat with Buprenorphine 

when no limits exist on the number of patients who may be prescribed opioids or the amount or 

dosage of opioids patients can receive. 

Thank you again for the opportunity to testify and for your leadership on this critically important 

issue.