U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Publishing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

95–851 PDF 2015

EXAMINING PUBLIC HEALTH LEGISLATION TO 

HELP PATIENTS AND LOCAL COMMUNITIES 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

JANUARY 27, 2015 

Serial No. 114–5 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

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 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

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 

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 

LOIS CAPPS, California 

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 LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CARDENAS, California 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

DORIS O. MATSUI, California 

BEN RAY LUJAN, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CARDENAS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

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

opening statement ................................................................................................ 3 

Prepared statement .......................................................................................... 4 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 6 

Prepared statement .......................................................................................... 7 

Hon. Joseph P. Kennedy, III, a Representative in Congress from the Commonwealth of Massachusetts, opening statement .................................................... 8 

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

New Jersey, prepared statement ........................................................................ 9 

WITNESSES

Ben Chlapek, Public Safety Training Coordinator, Mid-America Regional 

Council, on Behalf of the National Association of Emergency Medical Technicians ................................................................................................................... 11 

Prepared statement .......................................................................................... 13 

John L. Eadie, Director, Prescription Drug Monitoring Program Center of 

Excellence, Brandeis University ......................................................................... 20 

Prepared statement .......................................................................................... 22 

Blaine Enderson, M.D., Chairman, Trauma Center Association of America ..... 27 

Prepared statement .......................................................................................... 29 

Nathan B. Fountain, M.D., Chair, Professional Advisory Board, Epilepsy 

Foundation of America ........................................................................................ 37 

Prepared statement .......................................................................................... 40 

D. Linden Barber, Partner and Director, DEA Compliance Operations, 

Quarles & Brady, LLP ......................................................................................... 49 

Prepared statement .......................................................................................... 51 

Answers to submitted questions ...................................................................... 163 

SUBMITTED MATERIAL

Report of the Pew Charitable Trusts, ‘‘Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices,’’ September 20, 

2012, by Thomas Clark, et al., submitted by Mr. Guthrie 1 ............................. 83 

H.R. 235, the Veteran Emergency Medical Technician Support Act of 2013, 

submitted by Mr. Pitts ......................................................................................... 84 

H.R. ————, the National All Schedules Prescription Electronic Reporting 

Reauthorization Act of 2015, submitted by Mr. Pitts ....................................... 88 

H.R. ————, the Trauma Systems and Regionalization of Emergency Care 

Reauthorization Act, submitted by Mr. Pitts ..................................................... 99 

H.R. ————, the Access to Life-Saving Trauma Care for All Americans 

Act, submitted by Mr. Pitts ................................................................................. 103 

H.R. ————, the Ensuring Patient Access and Effective Drug Enforcement 

Act of 2015, submitted by Mr. Pitts ................................................................... 106 

H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, submitted by Mr. Pitts ......................................................................... 112 

1The information has been retained in committee files and also is available at http:// 

docs.house.gov/meetings/IF/IF14/20150127/102844/HMTG-114-IF14-20150127-SD054.pdf. 

Page

IV 

Statement of National Council for Prescription Drug Programs, January 27, 

2015, by Stephen C. Mullenix, Senior Vice President, Public Policy and 

Industry Relations. submitted by Mr. Whitfield ............................................... 117 

Report of the National Council for Prescription Drug Programs, ‘‘NCPDP 

Recommendations for Improving Prescription Drug Monitoring Programs,’’ 

March 2013, submitted by Mr. Whitfield ........................................................... 121 

Article of January 12, 2015, ‘‘The Prescription Opioid and Heroin Crisis: 

A Public Health Approach to an Epidemic of Addiction,’’ by Andrew 

Kolodny, et al., Annual Review of Public Health, submitted by Mr. Guthrie . 141 

Statement of the National Association of Chain Drug Stores, January 27, 

2015, submitted by Mrs. Blackburn ................................................................... 157 

Letter of January 22, 2015, from American Pharmacists Association, et al., 

to Mrs. Blackburn, et al., submitted by Mrs. Blackburn .................................. 161 

Letter of January 22, 2015, from John M. Gray, President and Chief Executive Officer, Healthcare Distribution Management Association, to Mrs. 

Blackburn, et al., submitted by Mrs. Blackburn ............................................... 162 

(1) 

EXAMINING PUBLIC HEALTH LEGISLATION 

TO HELP PATIENTS AND LOCAL COMMUNITIES 

TUESDAY, JANUARY 27, 2015 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 11:16 a.m., in room 

2322, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Guthrie, Whitfield, 

Shimkus, Blackburn, Griffith, Bilirakis, Long, Bucshon, Collins, 

Upton (ex officio), Green, Capps, Butterfield, Sarbanes, Matsui, 

Schrader, Kennedy, Cardenas, and Pallone (ex officio). 

Staff present: Brenda Destro, Professional Staff Member, Health; 

Andy Duberstein, Deputy Press Secretary; Carly McWilliams, Professional Staff Member, Health; Katie Novaria, Professional Staff 

Member, Health; Chris Sarley, Policy Coordinator, Environment 

and the Economy; Macey Sevcik, Press Assistant; Adrianna 

Simonelli, Legislative Associate, Health; Heidi Stirrup, Policy Coordinator, Health; John Stone, Counsel, Health; Ziky Ababiya, Democratic Policy Analyst; Jeff Carroll, Democratic Staff Director; Eric 

Flamm, Democratic FDA Detailee; Hannah Green, Democratic Policy Analyst; Tiffany Guarascio, Democratic Deputy Staff Director 

and Chief Health Advisor; and Meredith Jones, Democratic Director, Outreach and Member Services. 

Mr. PITTS. The subcommittee will come to order. The Chair will 

recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Today the subcommittee will consider some unfinished business 

from the last Congress in the form of six bills. 

The Veteran Emergency Medical Technician Support Act, sponsored by Representative Adam Kinzinger, would assist States in 

streamlining their certification requirements for those veterans 

with emergency medical technician training who want to work in 

the civilian workforce. 

The National All Schedules Prescription Electronic Reporting Reauthorization Act, or NASPER, sponsored by Representative Ed 

2 

Whitfield, would reauthorize the NASPER program to support 

State prescription drug monitoring programs. 

The Trauma Systems and Regionalization of Emergency Care Reauthorization Act, sponsored by Representative Burgess and Ranking Member Green, would reauthorize certain trauma care programs through fiscal year 2019. 

The Access to Life-Saving Trauma Care for All Americans Act, 

to be sponsored by Representative Burgess, Ranking Member 

Green, would reauthorize trauma care—centered care grants. 

H.R. 471, introduced by Representative Marino, Blackburn, 

Welch, and Chu, the Ensuring Patient Access and Effective Drug 

Enforcement Act of 2015, would improve law enforcement efforts 

regarding prescription drug diversion and abuse. 

And the Improving Regulatory Transparency for New Medical 

Therapies Act, which I introduced, along with Ranking Member 

Pallone, last Congress and will be reintroducing shortly, seeks to 

improve the transparency and consistency of the Drug Enforcement 

Agency’s scheduling of new FDA-approved drugs under the Controlled Substances Act. 

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

Mr. PITTS. I look forward to hearing the testimony of all of our 

witnesses today. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

Today, the subcommittee will consider some unfinished business from the last 

Congress, in the form of six bills. 

• The Veteran Emergency Medical Technician Support Act, sponsored by Rep. 

Adam Kinzinger, would assist States in streamlining their certification requirements for those veterans with emergency medical technician (EMT) training who 

want to work in the civilian workforce. 

• The National All Schedules Prescription Electronic Reporting Reauthorization 

Act, or NASPER, sponsored by Rep. Ed Whitfield, would reauthorize the NASPER 

program to support State prescription drug monitoring programs. 

• The Trauma Systems and Regionalization of Emergency Care Reauthorization 

Act, sponsored by Rep. Burgess and Ranking Member Green, would reauthorize certain trauma care programs through FY2019. 

• The Access to Life-Saving Trauma Care for All Americans Act, to be sponsored 

by Rep. Burgess and Ranking Member Green, would reauthorize trauma center care 

grants. 

• H.R. 471, introduced by Reps. Marino, Blackburn, Welch, and Chu, the Ensuring 

Patient Access and Effective Drug Enforcement Act of 2015, would improve law enforcement efforts regarding prescription drug diversion and abuse. 

• And, the Improving Regulatory Transparency for New Medical Therapies Act, 

which I introduced along with Ranking Member Pallone last Congress, and will be 

reintroducing shortly, seeks to improve the transparency and consistency of the 

Drug Enforcement Agency’s (DEA) scheduling of new FDA-approved drugs under 

the Controlled Substances Act (CSA). 

I look forward to the testimony of all of our witnesses today. 

Mr. PITTS. I yield the remainder of my time to Representative 

Whitfield. 

Mr. WHITFIELD. Well, Chairman Pitts, thank you very much for 

having this hearing today on the important topic of public health 

and for including the NASPER reauthorization draft as part of that 

discussion. 

3 

I am delighted that Mr. John Eadie is with us today, and we look 

forward to his testimony. He has 35 years or so of experience with 

the drug monitoring issues. 

And I look forward to your testimony. 

I might add that we have reached a point, unfortunately, in 

America today where more people are dying from drug overdoses 

than they—from prescription drug overdose than they are from 

automobile accidents. 

And I would just say that, back in 2001, the Appropriations Committee, without any authorization from the authorizing committee, 

started a drug monitoring program, which turned out to be a very 

good program. In 2005, this committee came back, through Congressman Pallone and Mr. Pitts and myself and others, and we authorized NASPER, a National All Prescription Drug Monitoring 

Program for the entire country. We had great difficulty obtaining 

funding for it because the appropriators always funneled the money 

through the drug monitoring program at the Department of Justice. NASPER was at HHS. And so, ever since 2005, we have had 

sort of two different programs. Unfortunately, the one at HHS was 

not getting any funding basically. 

Today, most States do have drug monitoring programs, but we 

still have these separate programs—one at DOJ and one at HHS. 

And so, hopefully, we tried to explore about a year ago a way to 

sort of combine these programs to just make it more efficient and 

more helpful to the American people. And I don’t think we have totally resolved that yet, but I do think it is important we reauthorize this program. 

And I look forward to maybe having some discussions with you, 

Mr. Eadie, and others that have an interest. And is there a way 

that we can still try to get these programs together? 

And, with that, I yield back the balance of my time. 

Mr. PITTS. The Chair thanks the gentleman. 

Now, recognize the ranking member of the subcommittee, Mr. 

Green, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman. 

And good morning to our witnesses for you all being here today. 

This hearing is called to examine six proposals which will 

strengthen public health, each which is the product of bipartisan 

efforts. 

I thank the chairman for having this hearing. It is not only an 

opportunity to further these important pieces of legislation. But it 

also serves as a reminder of the great work this committee can accomplish when we work together to advance our healthcare system. 

The Veteran Emergency Medical Technician Support Act, as led 

by Representatives Kinzinger and Capps, the legislation will save 

lives—will help States utilize the skills of our Nation’s veterans 

and address emergency medical technician shortages by streamlining the certification and licensure requirements of returning veterans who have completed military EMT training. 

4 

The Improving Regulatory Transparency for New Medical Therapies Act—that is the last time I will say that—provides a solution 

to current delays experienced by patients in need. 

The amount of time the DEA has asked before acting on FDA 

recommendations has lengthened in recent years, delaying the 

availability of new therapies. Led by Chairman Pitts and Ranking 

Member Pallone, this legislation will improve patient access by 

bringing clarity and transparency to the process of scheduling new 

FDA-approved therapy. 

Representatives Marino, Welch, Blackburn, and Chu introduced 

the Ensuring Patient Access and Effective Drug Enforcement Act. 

This legislation would promote patient access to medically necessary controlled substances and, with the DEA’s authority, to suspend a DEA registrant acting in a manner that puts public health 

and safety at risk. 

The National All Schedules Prescription Electronic Reporting or 

NASPER Reauthorization Act, by our Ranking Member Pallone 

and Representative Whitfield, will reauthorize the improved prescription drug monitoring programs—are essential to part of our 

Nation’s effort to combat the epidemic of prescription drug and 

opioid overdose. The reauthorization of NASPER will help States 

implement and improve their PDMs, which improve clinical decisionmaking and reduce diversion. 

The final two bills that are being considered today are the Trauma Systems and Regionalization of Emergency Care Authorization 

Act and the Access to Life-Saving Trauma Care for All Americans 

Act. My good friend and fellow Texan Dr. Mike Burgess—I wish 

Mike was here to hear me brag about him—and I have led these 

legislative efforts. I thank him and his staff for their continued 

dedication and hard work. Both bills will reauthorize important 

programs that are designed to ensure that availability and effectiveness of effective use of trauma care. Trauma is the leading 

cause of death under age 44. Federal investments in trauma centers and systems will save lives, improve patient outcomes, and 

provide downstream cost savings to the healthcare system. 

Again, I want to thank Dr. Burgess for his partnership on this 

issue and the chairman for bringing these legislative proposals before the committee today. I thank my colleagues on both sides of 

the aisle for their thoughtful and worthy proposals and their commitment to improving access and delivery of health care. 

I look forward to working on a bipartisan manner on many 

issues before our subcommittee, including our solutions with the 

expiration of the Health Centers Fund in September. Unless we 

take action, community health centers will reduce an immediate 60 

to 70 percent funding cut. Health centers alone are bipartisan. And 

letting the fund expire without a solution in place will severely 

limit patient access to the cost effective primary and preventive 

care that is provided to millions of Americans. 

[The prepared statement of Mr. Green follows:] 

PREPARED STATEMENT OF HON. GENE GREEN

Good morning and thank you all for being here. This hearing was called to examine six proposals that will strengthen public health, each of which is the product 

of bipartisan effort. 

5 

I thank the chairman for having this hearing. It is not only an opportunity to further these important pieces of legislation, but it also serves as a reminder of the 

great work this committee can accomplish when we work together to advance our 

health care system. 

The Veteran Emergency Medical Technician Support Act is led by Representatives 

Kinzinger and Capps. This legislation will help States utilize the skills of our Nation’s veterans and address emergency medical technician shortages by streamlining 

the certification and licensure requirements for returning veterans who have completed military EMT training. 

The Improving Regulatory Transparency for New Medical Therapies Act provides 

a solution to current delays experienced by patients in need. The amount of time 

the DEA has taken before acting on FDA recommendations has lengthened in recent 

years, delaying the availability of new therapies. Led by Chairman Pitts and Ranking Member Pallone, this legislation will improve patient access by bringing clarity 

and transparency to the process of scheduling a new FDA-approved therapy. 

Representatives Marino, Welch, Blackburn, and Chu introduced the Ensuring Patient Access and Effective Drug Enforcement Act. This legislation will promote patient access to medically necessary controlled substances and protects DEA’s authority to suspend a DEA registrant acting in a manner that puts public health and 

safety at risk. 

The National All Schedules Prescription Electronic Reporting, or NASPER Reauthorization Act, led by Ranking Member Pallone and Representative Whitfield, will 

reauthorize and improve prescription drug monitoring programs. PDMPs are an essential part of our Nation’s effort to combat the epidemic of prescription drug abuse 

and opioid overdose. The reauthorization of NASPER will help States implement 

and improve their PDMPs, which improve clinical decisionmaking and reduce diversion. 

The final two bills being considered today are the Trauma Systems and Regionalization of Emergency Care Reauthorization Act and the Access to Life-Saving Trauma Care for All Americans Act. My good friend and fellow Texan Dr. Mike Burgess 

and I have led these legislative efforts. I thank him and his staff for their continued 

dedication and hard work. 

Both bills will reauthorize important programs that are designed to ensure the 

availability and effective use of trauma care. Trauma is the leading cause of death 

under age 44. Federal investments in trauma centers and systems will save lives, 

improve patient outcomes, and provide downstream cost savings to the health care 

system. Thank you again to Dr. Burgess for your partnership on this issue and to 

Mr. Chairman for bringing these legislative proposals before the committee today. 

I thank all of my colleagues from both sides of the aisle for putting forward these 

thoughtful and worthy proposals, and for their commitment to improving access and 

delivery of health care. 

I look forward to continuing to work in a bipartisan manner on the many issues 

before our subcommittee, including on a solution to the expiration of the Health 

Centers Fund in September. Unless we take action, community health centers will 

experience an immediate 60-70 percent funding cut. 

Health centers have a long history of bipartisan support, and letting the fund expire without a solution in place will severely limit patient access to the cost-effective 

primary and preventive care they provide to millions of Americans. 

Thank you, and I yield the remainder of my time to the Congresswoman from 

California, Lois Capps. 

Mr. GREEN. With that, Mr. Chairman, I would like to yield the 

remainder of my time to my colleague from California, Lois Capps. 

Mrs. CAPPS. I thank the ranking member for yielding. 

And, Mr. Chairman, thank you for holding this important hearing today. 

I am pleased to, again, be working with Representative 

Kinzinger to introduce the Veteran Emergency Medical Technician 

Support Act, as we did in the past two Congresses, to see it up for 

discussion today. 

While our military men and women receive some of the best technical training in emergency medicine anywhere, when they return 

home, they are often required to start back at square one to receive 

the same certification for civilian jobs. At the same time, military 

6 

medics with civilian credentials often must let these civilians certificates lapse while they are defending our country. Either way, 

this keeps our veterans out of the civilian workforce and withholds 

valuable medical personnel from our communities. 

Vets EMT is a small but straightforward bipartisan bill to help 

States streamline their certification processes to take military 

medic training into account for civilian licensure. I look forward to 

testimony today about the training these men and women have already received, the need for this bill, and the impact it could have 

as written or if expanded. 

I, also, must again plug my Emergency Medic Transition Act, a 

more comprehensive bill to help develop appropriate fast-track 

military-to-community programs which also deserves a hearing. I 

am hopeful we can continue to work together in a bipartisan way 

to move these important pieces of legislation out of the committee 

so that we can help these talented professionals join our healthcare 

workforce and improve the care in our communities. 

And I am out of time. 

I will yield back and thank my colleague for yielding to me. 

Mr. PITTS. The Chair thanks the gentlelady. 

I now recognize the chairman of the full committee, Mr. Upton, 

for 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman. 

In the last Congress, this committee established an impressive 

record of success with 51 bipartisan bills signed into law, many of 

which are now helping improve public health. 

Families in local communities expect us to work together to solve 

problems, and we look forward to using our prior success as a 

springboard to further boost the public health that this new—in 

this new Congress. Today, we are going to examine a half a dozen 

bills that collectively will help our Nation’s veterans; address the 

prescription drug abuse crisis; secure access to trauma systems; 

and, yes, improve the Controlled Substances Act. 

First, we are going to hear testimony on our bill authored by Mr. 

Kinzinger, the Veteran Emergency Medical Technician Support 

Act, passed by the full House in February of 2013, which would 

help military medics in those States with a shortage of emergency 

medical technicians. 

We will also discussed the National All Schedules Prescription 

Electronic Reporting Reauthorization Act led by Mr. Whitfield to 

help address the prescription drug crisis here. 

We are also going to hear testimony on two trauma bills, led by 

Dr. Burgess and Ranking Member Green. The Trauma Systems 

and Regionalization of Emergency Care Reauthorization Act, which 

was passed to the full House in June of last year, would help support State and rural development trauma systems. 

The second bill will reauthorize language from the Public Health 

Service Act to fund trauma care centers. 

And, finally, the subcommittee will hear about two bills related 

to the Controlled Substances Act: Improving Regulatory Transparency for New Medical Therapies Act, led by Chairman Pitts and 

7 

Ranking Member Pallone, which would amend the CSA to improve 

and streamline the DEA’s process for scheduling new drugs approved by the FDA; ensuring Patient Access and Effective Drug 

Enforcement Act, led by Vice Chair Blackburn and Reps Marino, 

Welch and Chu, would help prevent prescription drug abuse, establish clear and consistent enforcement standards, and ensure that 

patients have access to medications by promoting collaboration 

among Government agencies, patients, industries, stakeholders. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

In the 113th Congress, the Energy and Commerce Committee established an impressive Record of Success with 51 bipartisan bills signed into law, many of which 

are now helping improve public health. Families and local communities expect us 

to work together to solve problems, and we look forward to using our prior success 

as a springboard to further boost the public health this new Congress. Today we 

will examine a half dozen bills that collectively will help our Nation’s veterans, address the prescription drug abuse crisis, secure access to trauma systems, and improve the Controlled Substances Act. 

First, we will hear testimony on a bill authored by Mr. Kinzinger. The Veteran 

Emergency Medical Technician Support Act, passed by the full House in February 

2013, would help military medics and those States with a shortage of Emergency 

Medical Technicians. 

We also will discuss the National All Schedules Prescription Electronic Reporting 

Reauthorization Act led by Mr. Whitfield to help address the prescription drug 

abuse crisis. 

We will hear testimony on two trauma bills led by Dr. Burgess and Ranking 

Member Green. The Trauma Systems and Regionalization of Emergency Care Reauthorization Act was passed through the full House in June 2014 and would help 

support State and rural development of trauma systems. The second bill will reauthorize language from the Public Health Service Act to fund trauma care centers. 

Finally, the subcommittee will hear about two bills related to the Controlled Substances Act. The Improving Regulatory Transparency for New Medical Therapies 

Act, led by Chairman Pitts and full committee Ranking Member Pallone, would 

amend the CSA to improve and streamline the Drug Enforcement Agency’s process 

for scheduling new drugs approved by the Food and Drug Administration. 

The Ensuring Patient Access and Effective Drug Enforcement Act, led by Vice 

Chairman Blackburn and Reps. Marino, Welch, and Chu would help prevent prescription drug abuse, establish clear and consistent enforcement standards, and ensure patients have access to medications by promoting collaboration among Government agencies, patients, and industry stakeholders. 

I thank the witnesses for attending today’s hearing, and I look forward to their 

testimony and recommendations as we begin to build upon our strong record of bipartisan success. 

Mr. UPTON. Thank you all for being here, and I yield to Mr. 

Whitfield. 

Mr. WHITFIELD. Thank you very much. 

I would like to ask unanimous consent to set in the record a 

statement from the National Council for Prescription Drug Programs and a white paper on recommendations for improving prescription drug monitoring programs. 

Mr. PITTS. Without objection, so ordered. 

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

Mr. WHITFIELD. Thank you. 

Mr. PITTS. All right. The gentlemen yields back. 

I would like to ask unanimous consent—since the ranking member, Mr. Pallone, is not here—to yield his time to Representative 

Kennedy. 

8 

Without objection, Mr. Kennedy is recognized for 5 minutes for 

an opening statement. 

OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, III, A 

REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF MASSACHUSETTS 

Mr. KENNEDY. Thank you, Mr. Chairman. I will take about 30 

seconds, I hope. But thank you for yielding and recognizing me. 

I want to thank the witnesses for their testimony today and Mr. 

Whitfield and Mr. Pallone for their work on the NASPER reauthorization. 

This is an issue that is of particular importance for me back in 

my home district. At the end of 2014, there were about 209 heroin 

overdoses in Taunton, Massachusetts, alone. In less than 20 days 

into 2015, there have already been 10 suspected overdoses. 

We can often trace the origin of those overdoses back to opioid 

addiction and prescription drug abuse. Tufts Health Care Institute’s Program on Opioid Risk Management released a report in 

2011 with some alarming findings. They estimated that the societal 

cost of opioid abuse in the U.S. are substantial, with total societal 

costs being $55.7 billion and healthcare costs about $25 billion. The 

annual cost per patient diagnosed with opiate abuse dependance 

and misuse are considerably higher than those with patients without such diagnoses. 

I was a prosecutor for several years before running for Congress. 

I saw the effects of opioid addiction every single day in the courtroom through property crimes, breaking and entering, larcenies, 

and other such crimes that would end up—this addiction would 

drive people to such lengths to break the law to try to continue to 

feed an addiction. 

Prescription drug abuse programs and prescription monitoring 

programs are an absolutely critical part to trying to come up with 

a comprehensive plan to combat this epidemic. And I applaud Mr. 

Pallone and Mr. Whitfield for their efforts on this. 

And I would like to yield 1 minute of my time back to Mr. 

Butterfield. 

Mr. BUTTERFIELD. Thank you very much, Mr. Kennedy, for yielding. 

And thank you, Mr. Chairman, and the ranking member for the 

opportunity to sit in Mr. Pallone’s seat for just a few minutes and 

to claim some of his time this morning. 

But, Frank, I will be moving on in just a minute. I have got one 

or two other places to go. 

But, Mr. Chairman, I appreciate the opportunity to discuss a 

number of bipartisan bills that many of us have worked on in the 

past. In particular, I was a supporter of the Trauma Systems and 

Regionalization of Emergency Care, the reauthorization act, and 

the Regulatory Transparency for New Medical Therapies Act that 

we handled in the 113th Congress. Finding innovative ways to improve access to care in rural communities, particularly ones like 

mine in eastern North Carolina, can mean the difference between 

life and death. The ACA went a long way. It went a long way toward improving rural health care and created or reauthorized the 

four programs included in the Trauma Systems Act. We must reauVerDate Mar 15 2010 15:23 Aug 17, 2015 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_5PHS LEGISLATION\114-5 PHSA LEGISLATION PENDING W
9 

thorize this program and put our money where our mouths are by 

fully funding these programs. 

Furthermore, the New Medical Therapies Act would improve access to care by accelerating the process to help patients access important medicines. 

I thank you, Mr. Kennedy. 

I yield back to you, sir. 

Mr. KENNEDY. Thank you, Mr. Butterfield. 

I think I yield my time, which was Mr. Pallone’s time, back to 

Mr. Pallone. 

Mr. PITTS. Mr. Pallone, you have 2 minutes left. 

Mr. PALLONE. All right. Thank you, Mr. Chairman. 

I just wanted to say briefly that I think that these six public 

health bills are important. They all aim to address important public health issues within our communities. I am not going to go into 

all the details about them. 

The first two, the Improving Regulatory Transparency Act, 

speeds up Drug Enforcement Administration decisions on scheduling of new FDA-approved drugs with regard to controlled substance. 

And the second one, Ensuring Patient Access and Effective Drug 

Enforcement, adds two definitions to controlled substances. The 

goal of that bill is to help drug distributors, pharmacies, and others 

work with DEA to achieve the difficult balance between keeping 

controlled substance prescription drugs away from drug abusers 

but not from patients who need them. 

The next bill, the veterans bill, authorizes a demonstration grant 

programs for States to streamline certification and licensure requirements for returning veterans to become emergency medical 

technicians. We had some great good hearings with this. 

And I want to thank Congresswoman Capps for her work on this 

issue. 

And then we have the two bills reauthorizing a number of trauma programs, which are very important, because traumatic injury 

is the leading cause of death for children and adults under the age 

of 45. And it is critical that States are equipped to deliver these 

medical services. 

And the last one the subcommittee will review is the NASPER 

bill, which I coauthored with my colleague from Kentucky, Mr. 

Whitfield. And this legislation helps States establish and maintain 

prescription drug monitoring programs in order to combat drug 

abuses, which is an epidemic in the United States. So it is critical 

that we continue to support a program like this through Federal 

funding. 

Many of these bills passed our committee in the House last Congress with broad bipartisan support, as you know, Mr. Chairman. 

And I look forward to working with my colleagues to do the same 

this year. Thanks. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you, Chairman Pitts, for holding this hearing on the six public health bills 

before us today. All of the bills aim to address important public health issues within 

our communities. 

10 

The Improving Regulatory Transparency for New Medical Therapies Act would 

speed up Drug Enforcement Administration (DEA) decisions on scheduling of new 

FDA-approved drugs containing controlled substances, so that they could get to patients more quickly. It also would speed up the DEA registration process allowing 

the manufacture and distribution of controlled substances for use only in clinical 

trials. The bill aims to ensure that there are not unnecessary delays of medicines 

getting to patients in need. I want to thank Chairman Pitts for working with me 

on this bill last Congress and committing to move forward early this Congress. 

The Ensuring Patient Access and Effective Drug Enforcement Act would add two 

definitions to the Controlled Substances Act to better focus DEA’s enforcement activities. It also would require DEA to provide registrants an opportunity to submit 

an action plan to correct any violations for which DEA is considering revoking or 

suspending their controlled substance registration. The goal of the bill is to help 

drug distributors, pharmacies, and others work with DEA to achieve the difficult 

balance between keeping controlled substance prescription drugs away from drug 

abusers but not from patients who need them. I thank Representatives Blackburn, 

Marino, Welch, and Chu for introducing this legislation. 

The next bill, the Veterans Emergency Medical Technician Support Act, authorizes a demonstration grant program for states to streamline the certification and licensure requirements for returning veterans to become emergency medical technicians. Returning vets have important skills and experiences that make them highly 

qualified for jobs in health care and particularly in emergency medicine. This bill 

passed both the committee and the House last Congress, and I want to thank Congresswoman Capps for her work on this issue. 

We are also considering two bills reauthorizing a number of trauma programs. 

The Trauma Systems and Regionalization of Emergency Care Reauthorization Act, 

which passed the House last year, is aimed at planning and implementing trauma 

care systems in the States and establishing pilot projects for innovative models of 

regionalized trauma care. The second bill, the Access to Life-Saving Trauma Care 

for All Americans Act, reauthorizes two additional trauma programs that expire this 

year that aim to increase the availability of trauma services, as well as an interagency program for basic and clinical research on trauma. Traumatic injury is the 

leading cause of death for children and adults under the age of 45, and it is critical 

that States are equipped to deliver these medical services. I would again like to 

thank Mr. Green and Mr. Burgess, who are both leaders on trauma care, for their 

work on these bills. 

Finally, the subcommittee will review the National All Schedules Prescription 

Electronic Reporting Reauthorization Act, which I coauthored with my colleague 

from Kentucky, Mr. Whitfield, during the last Congress. This legislation helps 

States establish and maintain prescription drug monitoring programs in order to 

combat prescription drug abuse, an epidemic in the United States. It is critical that 

we continue support for this program through Federal funding. 

Many of these bills passed our committee and the House last Congress with broad 

bipartisan support. I look forward to working with my colleagues to do the same 

this year. 

Mr. PITTS. The Chair thanks the gentlemen. 

That concludes the opening statement of the Members. As usual, 

all Members’ written statements—opening statements will be made 

a part of the record. 

I would like to thank the witnesses for the efforts they made to 

be a part of the hearing today, especially in light of the hazardous 

travel conditions due to wintry weather. Since we announced a 1- 

hour delay in the start of our hearing today, one of our witnesses, 

Mr. John Eadie, has informed that he may need to leave early because of travel constraints. But thank you for all the effort that you 

made to get here. 

I want my colleagues to be aware of this so they can form their 

questions with this in mind. So thank you. 

On our panel today, we have five witnesses: Mr. Ben Chlapek, 

deputy director of Central Jackson County Fire in Blue Springs, 

Missouri; Mr. John Eadie, director of Prescription Drug Monitoring 

Program Center of Excellence at Brandeis University; Dr. Blaine 

11 

Enderson from the Department of Surgery at the University of 

Tennessee Medical Center; Dr. Nathan Fountain, professor of neurology and director of the F.E. Dreifuss Comprehensive Epilepsy 

Program here on behalf of the Epilepsy Foundation; and Mr. Linden Barber, partner and director of DEA Compliance Operations at 

Quarles & Brady. 

Thank you for coming today. Your written testimony will be 

made a part of the record. You will be each given 5 minutes to 

summarize your testimony. 

And, Mr. Chlapek, we will begin you. You are recognized for 5 

minutes for your summary. 

STATEMENTS OF BEN CHLAPEK, PUBLIC SAFETY TRAINING 

COORDINATOR, MID–AMERICA REGIONAL COUNCIL, ON BEHALF OF THE NATIONAL ASSOCIATION OF EMERGENCY 

MEDICAL TECHNICIANS; JOHN L. EADIE, DIRECTOR, PRESCRIPTION DRUG MONITORING PROGRAM CENTER OF EXCELLENCE, BRANDEIS UNIVERSITY; BLAINE ENDERSON, 

M.D., CHAIRMAN, TRAUMA CENTER ASSOCIATION OF AMERICA; NATHAN B. FOUNTAIN, M.D., CHAIR, PROFESSIONAL ADVISORY BOARD, EPILEPSY FOUNDATION OF AMERICA; AND 

D. LINDEN BARBER, PARTNER AND DIRECTOR, DEA COMPLIANCE OPERATIONS, QUARLES & BRADY, LLP 

STATEMENT OF BEN CHLAPEK 

Mr. CHLAPEK. Thank you, Chairman Pitts, Vice Chairman Guthrie, and Mr. Green, and members of the subcommittee. My name 

is Ben Chlapek, and I am here to discuss the issue of military medics veterans who are honorable transitioning into the civilian EMS 

field. I am representing the National Association of Emergency 

Medical Technicians that represents roughly 40,000-plus EMTs, 

paramedics, and first responders of all delivery models, fire-based, 

hospital-based, privates, third services, industrial, and military 

medics. 

I currently serve on the Board of Directors and as the chair of 

the Military Relations Committee; recently retired as the deputy 

chief of Central Jackson County Fire; and have been a registered 

paramedic, nationally registered, for over 30 years. Also, recently 

retired from the United States Army as Lieutenant Colonel and 

have 36 years of service in the Army, starting in 1975, with one 

small break. 

Bottom line up front is we have an obstacle course when a military medic transitions from the military and tries to get a civilian 

EMS license. Currently, the Army and Air Force graduate their 

medics at the Joint Training Facility in San Antonio with a National Registry EMT card. The Navy does not. They almost meet 

the criteria, but the medics split off at one point and get their specialty training or specialized training. 

We have a lot of people who are helping us with this. And when 

they have to repeat it, it is a waste of their skills. They are doing 

the same thing over and over. In addition, a lot of military medics 

gain advanced skills, such as suturing and doing other forms of advanced medicine that civilian medics don’t. 

12 

One of the biggest concerns—and it is voiced by Sergeant Major 

Harold Montgomery, the senior medical enlisted advisor of Special 

Operations Command at MacDill Air Force Base in Tampa, Florida, his biggest concern is that we lose the knowledge and advances 

we have gained in Iraq and Afghanistan and Kosovo and don’t use 

those, don’t learn from them, and they will be lost. These military 

medics that are transitioning have that ability. For example, many 

law enforcement agencies across the country now carry combat 

tourniquets and hemostatic agents, which have saved some lives. 

It has been documented by the first responders, the officers being 

able to use these skills. 

There is a shortage in rural America of paramedics. And when 

these medics get out, even as EMTs, they need to advance to paramedic. We have gone the gap analysis. We know what needs to be 

done. And House Bill 235 is a great, big jump in getting that 

achieved. 

It won’t solve all the issues. But we have done the gap analysis. 

There are many States now passing legislation—over 30 at this 

point—to help veterans and streamline the process to become civilian medics because the State licensing procedures differ. They 

aren’t the same. 

Another thing we have done is written an interstate compact, 

and that is being presented to the States now. 

We need a common registry. The Senate bill would help make a 

solid jump to get this achieved. This is near and dear to my heart. 

I have deployed with fire department medics, with private medics 

who have gone back and tried to integrate back into their services. 

Some have. Some haven’t. The National Registry of EMTs has gone 

a long way toward helping. The National Association of EMTs has 

led this charge. I had 40 medics and EMTs on one tour and worked 

very hard for them to keep their certification. 

I suffered a traumatic brain injury in 2008 in Afghanistan. It 

was moderate, and I still receive therapy today at the Kansas City 

VA, who does a great job. This—this initiative is near and dear to 

my heart, and I thank you for letting me speak today. God bless. 

Mr. PITTS. The Chair thanks the gentleman. 

[The prepared statement of Mr. Chlapek follows:] 

13 

14 

15 

16 

17 

18 

19 

20 

Mr. PITTS. Mr. Eadie, you are recognized for 5 minutes for your 

summary. 

STATEMENT OF JOHN L. EADIE 

Mr. EADIE. Thank you, Chairman Pitts, Ranking Member Green, 

and Representative Whitfield for providing this opportunity to testify regarding proposed legislation to help fund State prescription 

drug monitoring programs, PDMPs, through the National All 

Schedule Prescription Electronic Reporting Act, i.e., NASPER. 

I am John Eadie. I have worked on public health for 45 years 

and specifically on PDMPs for 30 years. I currently serve as director of the Prescription Drug Monitoring Program Center of Excellence at Brandeis University, where we identify what makes 

PDMPs effective and help them reach their full potential. For example, through a partnership with Pew Charitable Trust and support from BJA, we have published a white paper on PDMP best 

practices. 

PDMPs are operating in 49 States and Guam with another authorized for the District of Columbia. They are essential ingredients in the Nation’s effort to reverse the epidemic of prescription 

opioid overdoses and deaths and rising heroin abuse. The health 

and safety of families across America depend on PDMPs being as 

effective as possible. 

The Center of Excellence reviews PDMP’s performance and has 

found that they improve clinical decisionmaking and patient care 

by prescribers and pharmacies; identify and reduce doctor shopping; impact on controlled substances availability and prescribing; 

help improve health outcomes; reduce drug and medical costs related to inappropriate prescribing; reduce diversion into illegal use; 

and assist drug investigations; monitor compliance in drug abstinence; assist in substance abuse treatment and medical examiner 

practices; assist in drug abuse prevention and surveillance efforts. 

Some Sates have recently issued broad mandates on prescribers 

to obtain and review PDMP data prior to issuing the first scheduled controlled substance to each patient and periodically thereafter, for example, every 3 months. Kentucky, Tennessee, and New 

York report rapid increases in prescribers registering for PDMP 

use, increases in requests for PDMP data—over a 300 percent increase in Tennessee, over 500 percent in Kentucky, and over 10,000 

percent in New York—decreases in the prescribing of some commonly abused controlled substances and decreases in doctor shopping. 

Florida, in 2011, implemented its PDMP and other initiatives. 

The Florida Medical Examiner has just reported for 2013 that 

there was an 8.3 percent decrease in 1 year in the number of 

deaths in which 1 or more controlled substance prescription was 

identified as the primary cause, while oxycodone deaths declined by 

27.3 percent. 

Further developments are needed. One example, after proactively 

analyzing their data, PDMPs should proactively send out unsolicited reports to prescribers, pharmacists, healthcare professional licensing boards, and law enforcement. This is one of the most effective best practices. But more than two-thirds of PDMPs still need 

to fully implement that. 

21 

A second example. Medicaid/Medicare, workers compensation, 

and other third-party payers need to protect their enrolled patients’ 

health and safety and do so by helping prescribers and pharmacists 

avoid issuing and dispensing prescriptions that will cause harm to 

their patients. But this can only be done by PDMPs providing secure patient data access to third-party payers. And this is not a 

common practice today. 

In order to reduce the opioid epidemic, PDMPs need to adopt the 

most effective practices, and this requires money. But the cost is 

miniscule compared to the price in lives and dollars if PDMPs do 

not rise to their full potential. 

The reauthorization of NASPER, with proposed changes, will assist States by adding important funds that complement other initiatives. States need NASPER to encourage the technological development of PDMPs’ interoperability with electronic health records 

and health information exchanges. 

This development will allow PDMP data to reach prescribers and 

pharmacists in their normal workflow, increase clinicians’ ability to 

properly treat their patients and avoid prescribing or dispensing to 

doctor shoppers or persons counterfeiting or forging prescriptions. 

Importantly, NASPER can help States sustain critical PDMP operations. 

I thank the bill sponsors for their efforts to improve NASPER 

and encourage the Subcommittee on Health to approve it. 

Mr. PITTS. The Chair thanks the gentlemen. 

[The prepared statement of Mr. Eadie follows:] 

22 

23 

24 

25 

26 

27 

Mr. PITTS. Dr. Enderson, you are recognized for 5 minutes for 

summary. 

STATEMENT OF BLAINE ENDERSON 

Dr. ENDERSON. Chairman Pitts, Ranking Member Green, and 

members of the committee, thank you for holding this hearing on 

examining public health legislation to help patients in local communities and for inviting the Trauma Center Association of American, TCAA, to speak. 

TCAA is a nonprofit 501(c)(6) association representing trauma 

centers and systems across the country and is committed to ensuring access to lifesaving trauma services. 

TCAA, along with our advocacy partners—the American Trauma 

Society, the American Association for the Surgery of Trauma, the 

American College of Surgeons, the American College of Emergency 

Physicians, the American Burn Association, the American Association of Neurological Surgeons, the College of Neurological Surgeons, the Emergency Nurses Association, the Society of Trauma 

Nurses, the American Academy of Orthopedic Surgeons, and the 

Eastern Association for the Surgery of Trauma—are on the forefront of providing trauma and emergency care to millions of Americans. And it is out of that commitment that we submit these comments for your consideration. 

As organizations that care deeply about access to trauma and 

emergency care, we would like to thank you for passing the Trauma Systems and Regionalization of Emergency Care Reauthorization Act, H.R. 4080, last session and express our strong support for 

the passage of this vital legislation again this session. 

We would also like to thank Dr. Burgess and Representative 

Green for their continued leadership and recognize the importance 

of these systems of care in saving lives. 

Trauma is a major public health issue, as we have heard. In the 

United States, approximately 35 million are treated every year for 

traumatic injury. It is the leading cause of death under age 44. And 

at an annual cost of $67.3 billion, trauma is the third most expensive medical condition. 

The value proposition for trauma care is well documented. The 

care provided by trauma centers, including specialist physicians, 

nurses, and their entire trauma team, has a dramatic and cost-effective impact on a patient’s subsequent quality of life. In fact, 

trauma care is more cost effective than many other interventions, 

including dialysis for kidney failure. 

Victims of traumatic injury treated at a level 1 trauma center 

are 25 percent more likely to survive than those treated at a general hospital. Unfortunately, 45 million Americans lack access to 

major trauma centers. And if they are taken to nontrauma centers, 

the risk of death increases to 30 percent within 48 hours. 

The Trauma Systems and Regionalization of Emergency Care Reauthorization Act would reauthorize two important grant mechanisms: The Trauma Care Systems Planning Grants Program and 

the Regionalization of Emergency Care Pilots Program, each authorized at $12 million per year. 

The Trauma Care Systems Planning Grant supports State and 

rural development of trauma systems. The Regionalization of 

28 

Emergency Care Pilots Program funds pilot programs to design, 

implement, and evaluate innovate models of regionalized emergency care. 

Unfortunately, in 2015, we still lack effective regionalized care 

systems for infectious diseases, like Ebola, or even for cardiac or 

stroke patients. The vast majority of hospitals addressing patients 

with these conditions also serve as our Nation’s regional trauma 

centers. These hospitals must have the tools and capabilities to 

care for all of these patients with emergent, time-sensitive, and 

life-threatening conditions, whether it is trauma, stroke, or Ebola. 

The funding to support these hospitals must follow and support 

their willingness to provide care to the sickest Americans in the 

greatest hour of need. 

In addition to the Trauma Care Systems Planning Grant and Regionalization of Emergency Care Pilots, there are two other programs contained in the Public Health Service Act, said to expire 

this year, which need to be addressed by Congress. The Access to 

Life-Saving Trauma Care For All Americans Act would reauthorize 

these vital programs to prevent more closures and improve access 

to trauma care. 

The Trauma Care Center Grants are authorized at $100 million 

per year in an effort to prevent more trauma center closures by 

supporting their core missions, curtailing losses from uncompensated care, and providing emergency award to centers at risk of 

closing. Also, the Trauma Service Availability Grants, authorized 

at $100 million per year, are channelled through the States to address shortfalls in trauma service and improve access to and the 

availability of trauma care in underserved areas. 

In addition, the Interagency Program for Trauma Research is in 

need of reauthorization. This program is designed to facilitate collaboration across the National Institutes of Health on trauma research. 

All the programs are designed to ensure the availability and effective use of trauma care to save lives, cost, and improve patient 

outcomes. Trauma can happen to anyone any time and anywhere, 

as demonstrated by the Boston Marathon bombing and other recent 

casualties. And yet trauma care is not available for millions of 

Americans, especially in rural areas. 

We would encourage the Congress to reauthorize these vital programs to maintain trauma services for Americans in the United 

States. And if there are any questions, please feel free to contact 

the Trauma Center Association of America. Thank you. 

Mr. PITTS. The Chair thanks the gentlemen. 

[The prepared statement of Dr. Enderson follows:] 

29 

30 

31 

32 

33 

34 

35 

36 

37 

Mr. PITTS. Dr. Fountain, you are recognized for 5 minutes for 

your summary. 

STATEMENT OF NATHAN B. FOUNTAIN 

Dr. FOUNTAIN. Thank you, Chairman Pitts and Ranking Member 

Green, for allowing me to testify on behalf of the more than 2.8 

millions Americans living with epilepsy and, of course, their families. 

As chair of the Epilepsy Foundation’s Professional Advisory 

Board, I am here to support a legislative initiative that I know is 

important to the committee. The reintroduction of and passage of 

last year’s Improving Regulatory Transparency for New Medical 

Therapies Act. The Epilepsy Foundation is extremely grateful for 

the committee’s leadership for what we believe is an important 

problem that has a reasonable and workable legislative solution. 

The most important thing I can tell you today is that the delay 

caused by the lack of a timeline for the Drug Enforcement Agency 

in making FDA-approved drugs available to patients threatens the 

lives and health of Americans. The magnitude of the problem is astounding by every reasonable measure. 

The timeline for DEA approval has increased significantly, when 

comparing the era of the late 1990s. So if you look at the period 

from 1997 to 1999, compared to late 2000—so 2009 through 2013— 

the average time between FDA approval and then DEA final scheduling of a controlled substance has increased substantially. If we 

look at the late 1990s, it was 49.3 days. And it increased, then, in 

the most recent era, to 237 days. So many days—it is probably 

more appropriate to look at it in months. So from 49 days to almost 

8 months. 

There is a particular anti-epileptic drug called Fycompa that was 

approved by the FDA in 2012, but the final scheduling by the DEA 

occurred almost 400 days later. Now, we have to talk in terms of 

years instead of months or days. 

The delay in drug approval by the DEA, as addressed by this legislation, is particularly important to people with epilepsy because 

epilepsy is common; it causes serious problems, including death; 

and previously approved epilepsy drugs that are scheduled by the 

DEA are not subject to abuse by any major we can identify. So it 

appears that there is a delay of potentially lifesaving treatments 

without a compelling reason. 

And, of course, this applies equally to people with other conditions that might very well die while waiting for new drugs to be 

approved. So you can imagine how this would apply to someone 

with cancer or heart disease that is advancing while waiting for a 

drug to be approved. 

But, today, I will specifically address this issue as a representative of the Epilepsy Foundation, which is the leading national voluntary health organization that speaks on behalf of the 2.8 million 

Americans with epilepsy. I serve as chair of our medical advisors, 

but I am also a practicing neurologist at the University of Virginia 

and director of a large epilepsy program, where I have firsthand 

experience with the problems caused by the delays in drug approval. I would like to share information about epilepsy so that you 

38 

can better understand why our organization is steadfast in support 

of this bill. 

Epilepsy is any condition of the brain that causes seizures. So 

you can imagine it has diverse causes; acquired things like head 

trauma or stroke, or you can be born with a genetic predisposition 

and otherwise be perfectly normal. Approximately 1 in 26 people 

will develop epilepsy. That is a lot of people; 1 in 26 people develop 

epilepsy at some point in their lives. The onset is greatest in childhood and in older adults. That is why epilepsy is the fourth most 

common neurological condition—after migraine, stroke and Alzheimer’s disease, then comes epilepsy. So that might beg the question, ‘‘What is a seizure,’’ for your own curiosity. 

A seizure is an electrical storm of the brain. The storm can be 

confined to just one small area of the brain and cause something 

as isolated as just staring and responsiveness or jerking of one 

arm, or it can involve the whole brain. 

The type of seizure most people are familiar with is a generalized 

tonic-clonic or grand mal seizure, during which the whole brain is 

involved. The person becomes stiff, straightens out, falls to the 

ground, is unconscious and jerks all over for a few minutes. Afterwards, their brain is entirely exhausted and so is the person. They 

are unresponsive, but then they recover to normal over the course 

of typically about an hour. 

You can understand that this can cause injury from falling, choking, crashing a car, drowning. Even milder seizures that consist 

only of staring and confusion can cause serious problems. During 

confusion, people may put their hand into boiling water, thinking 

they are stirring it with their arm, for instance; pick up an iron by 

the hot face and not realize it; or be chopping vegetables and not 

realize it becomes part of them that they are cutting. 

In addition to the direct injury that seizures can cause, it can 

also result in the tragic circumstance of sudden, unexpected death 

in epilepsy or SUDEP, S–U-D–E-P, sudden unexpected death in 

epilepsy, which is the most common cause of epilepsy-related 

death. 

SUDEP occurs when someone with epilepsy dies for no obvious 

reason. That is, there may be evidence of a typical seizure, a seizure like they have had a hundred or a thousand times before, for 

instance, but there is no evidence of choking; there is no evidence 

of trauma or prolonged seizure. 

In my last testimony to this committee, I related a story of Matthew, a delightful, young engineering college student, who was very 

much like my own son, who is a college student. Matthew died 

from SUDEP during the time that Fycompa was waiting to be 

scheduled by the DEA. It had been approved by the FDA, had already been suggested, had been scheduled, and DEA was waiting 

its approval. 2,800 Americans die from SUDEP each year. For people like Matthew, waiting a year to get an effective drug to treat 

their seizures, is not acceptable since the drug could be lifesaving. 

It is troubling, as a patient advocacy organization as well, that 

we can’t offer a clear explanation of why the delay occurs at the 

DEA, since the DEA review has never made a change to the drug 

schedule recommended by the FDA. They have always followed 

FDA recommendations. Nor can we offer an explanation of why 

39 

there is no timeline for DEA approval. After all, the FDA drug review process is largely transparent with predictable timelines. And 

our committee wonders why the DEA approval process doesn’t have 

a similar timeline or transparency requirement. 

The current delays discouraging innovation in epilepsy therapy 

development, the unpredictable delay at the DEA means companies 

cannot accurately predict the amount of time they will have left on 

their drug patent or exclusivity. This bill proposes a simple solution to the problem and will ensure that drugs will not sit idly 

waiting to be scheduled while patients wait for potentially lifesaving drugs. 

We urge all members to consider full support of this legislation. 

Predictable and timely access to new therapies would be a phenomenal accomplishment for epilepsy patients and all Americans 

suffering from conditions like epilepsy. I thank the committee for 

its time and attention today. 

Mr. PITTS. The Chair thanks the gentleman. 

[The prepared statement of Dr. Fountain follows:] 

40 

41 

42 

43 

44 

45 

46 

47 

48 

49 

Mr. PITTS. Now recognizes Mr. Barber, 5 minutes for an opening 

statement. 

STATEMENT OF D. LINDEN BARBER 

Mr. BARBER. Good morning, Mr. Chairman, Ranking Member 

Green, members of the subcommittee. 

For the last 3 and a half years as the director of the DEA compliance and litigation practice at Quarles & Brady, I have dealt with 

registrants on a daily basis. But, prior to that, I was the associate 

chief counsel at DEA. I worked at the agency for 12 years. And 

there I was the associate chief counsel in charge of the litigation 

section that took administrative actions against registrants. 

Over these last 15 years, we have seen a chain of well-intentioned actions and reactions by DEA and by the industry that have 

unintentional consequences, consequences that undermine the ability of DEA and industry to address the issue of prescription drug 

abuse while ensuring that there is adequate supply of controlled 

substances to meet the legitimate medical needs of the United 

States. 

These unintended consequences are produced, in large part, by a 

lack of clarity in the law and the uncertainty produced in the regulatory environment. Ensuring Patient Access and Effective Drug 

Enforcement Act of 2015 provides much needed clarity in the Controlled Substances Act. Consider the unintended consequences that 

have occurred as a result of the lack of clarity. Communication between DEA and members of industry is thwarted. And communication is the cornerstone of a regulatory environment that promotes 

compliance and collaboration, particularly in an area like prescription drug abuse, an area that changes frequently and is difficult for 

DEA and industry to detect those who are attempting to obtain 

controlled substances for an illicit purpose. 

This breakdown has led to a lack of access to controlled substances for certain patients. It has altered the ordering patterns of 

pharmacies, making it more difficult for DEA and members of the 

supply chain to detect suspicious orders. And there is growing evidence to suggest that these actions and reactions are contributing 

to the rise in heroin use. 

When patients with chronic pain are forced to go from pharmacy 

to pharmacy in search of a pharmacist who will dispense a controlled substance that the patient has taken for years to control legitimate pain, we have a problem. When a pharmacist fears that 

filling such a prescription will result in being second-guessed by 

DEA and having their DEA registration suspended, we have a 

problem. When wholesale distributors decide to limit the supply of 

narcotics to pharmacies simply to avoid the risk of regulatory action, we have a problem. And certainly, if the lack of supply of controlled substances leads some people to use heroin, as some of the 

recent evidence suggests, we have a problem. That is why clarity 

in the law is so important. 

H.R. 471 provides clarity in a way that will allow DEA and industry to address these unintended consequences. While addressing 

these unintended consequences is essential, it is also important to 

preserve DEA’s ability to issue immediate suspensions to address 

imminent danger to public health and safety. The lack of clarity 

50 

and an inconsistent approach to immediate suspensions over the 

last 40 years has led to judicial challenges of DEA’s authority. 

In 2006, when I was the associate chief counsel at DEA, the 

agency stopped issuing immediate suspensions because of a Federal 

court ruling that found that the DEA had—its process for immediate suspensions was unconstitutional. During an 8-month period 

while the Internet pharmacies were out of control, fueling prescription drug abuse, the agency issued no immediate suspensions. That 

is Exhibit A for why clarity in the law and protecting DEA’s authority is so important. 

Clarity also promotes access to controlled medications for patients. Without clarity, registrants often act to reduce perceived 

regulatory risk. A pharmacist refuses to fill legitimate prescriptions 

for narcotics simply because dispensing a high volume of narcotics 

brings scrutiny from DEA and from the wholesale distributor. No 

one wants cancer patients, wounded veterans, those in chronic pain 

to go without medication, but restricting access is an unintended 

consequence of a regulatory environment that lacks clarity. 

The Ensuring Patient Access and Effective Drug Enforcement 

Act of 2015 holds the promise of fulfilling its name. By defining key 

terms in the CSA, the regulatory and enforcement environment 

will be clarified. Communication between DEA and registrants will 

be enhanced. Registrants will be less likely to restrict access to legitimate patients out of a fear that they may be second-guessed by 

DEA. Registrants will also be encouraged to assist DEA in detecting controlled substance diversion. And DEA’s authority to issue 

immediate suspensions will be protected from judicial curtailment 

because there will be a clear, legal standard. 

I thank the chairman and the committee. 

Mr. PITTS. The Chair thanks the gentleman. 

[The prepared statement of Mr. Barber follows:] 

51 

52 

53 

54 

55 

56 

57 

58 

59 

60 

61 

62 

63 

64 

65 

66 

67 

68 

Mr. PITTS. I will begin questioning and recognize myself 5 minutes for that purpose. 

Dr. Fountain, in your testimony, you mention that the DEA has 

no set timeline or transparency requirements when making scheduling determinations. How does this impact patients, particularly 

those who have not benefited from currently available therapies? 

Dr. FOUNTAIN. About one-third of people with epilepsy will continue to have seizures, despite available treatments. For those 

third of patients, every new therapy is vitally important. Because 

the incidence of SUDEP, sudden unexplained death in epilepsy, 

seems to be related to the number of seizures, logically. So for 

those patients who are most severely affected, they are in most 

need of new therapies. And those new—the sooner those new therapies are available, the sooner that their seizures can be reduced in 

frequency; the less likely they are going to die as well as suffer 

those other consequences. 

So, of course, the epilepsy community, the Epilepsy Foundation 

wants to have safe and effective drugs. That is paramount. But if 

the FDA has already determined them to be safe and effective, 

then, for our community, it is difficult to understand why it would 

be delayed at the FDA—I mean, at the DEA while waiting to be 

scheduled. So it can impact patients very directly. 

Mr. PITTS. Now, give me the length of time, the longest time patients have had to wait on DEA after FDA has conducted its own 

detailed abuse liability analysis and approved a new therapy. 

Dr. FOUNTAIN. I think, based on the analysis that has been done 

in the published literature, the drug I mentioned before, Fycompa, 

I think, is the longest time. And it was 400 days. So 400 days after 

FDA approval was when the drug was finally made available, 

scheduled, and finally scheduled by the DEA. So approximately 400 

days, more than a year. 

Mr. PITTS. Do you know of any widespread abuse or criminal diversion of epilepsy treatments? 

Dr. FOUNTAIN. I am not aware of a single case report. So I have 

done my own literature search of the medical literature. And I am 

not aware of even a single case report of abuse of what we would 

consider standard epilepsy drugs. It is true in epilepsy, we sometimes, in special circumstances, use other drugs that might be subject to control, the so-called benzodiazepines, that have a different 

role. But for normal epilepsy drugs, the ones that have been approved in the recent many decades, I am not aware of any actual 

abuse. 

Mr. PITTS. Mr. Chlapek, both the GAO and the IOM have addressed the need of the EMS system in the U.S. Two of the areas 

of need, personnel and training, were highlighted. Since those reports were issued, there have been several events that have reinforced the need for a highly trained effective responsive EMS system—terrorist attacks, natural disasters, pandemics. Do you see 

this bill as another way of improving preparedness? 

Mr. CHLAPEK. Chairman Pitts, absolutely. 

This bill will help take a trained and—a trained group of medics 

and transition them so they take care of the shortfall. They are 

more able to help in disasters. They are more able to help with proVerDate Mar 15 2010 15:23 Aug 17, 2015 Jkt 037690 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_5PHS LEGISLATION\114-5 PHSA LEGISLATION PENDING W
69 

tection of a license or certification in incidents like Boston or 

Katrina and can go from State to State. 

Mr. PITTS. Now, if you were making recommendations to the 

States to streamline the process for veterans to become EMTs, 

what would you focus on? 

Mr. CHLAPEK. Approving education programs, the training centers and education facilities to offer something similar to Lansing 

Community College in Michigan, that sits down with the veteran 

and looks at their electronic military training record and gives 

them credit—transcripts credit—for that at no cost and then fills 

the gap and gets them out within a few weeks or a weekend. 

Mr. PITTS. OK. 

Mr. Eadie, you have mentioned that there is a white paper that 

describes best practices PDMPs need to adopt. 

Mr. EADIE. Yes, sir. It is available on our—the Web site of the— 

at PDMPexcellence.org. And it is the—that is the Web site for the 

PDMP Center of Excellence at Brandeis University. Yes. 

Mr. PITTS. Could you highlight a few of the practices you think 

are important to improve PDMPs. 

Mr. EADIE. Absolutely. I would first comment that there are 35 

best practices listed, so it comes—deals with everything from the 

way data is collected from pharmacies right through how the data 

is used. 

In terms of the data use, the recent advent of the mandated use 

of the systems by prescribers has certainly proven to be very effective in the States that have already initiated that, and I mentioned 

the examples of that in my earlier comments. 

The major one that has yet to be fully implemented is the use 

of unsolicited reporting or proactive reporting called both— 

proactively States analyze the data that is in their system and then 

share it with those people who need to see it based upon what the 

analysis shows. To date, only about a third of States are covering 

that—doing that adequately. And so there is a great deal of room 

there. 

There are other things, like, the—the excellent effort that is underway to allow data to be shared through electronic health records 

and health information exchanges that is a technological fix, so to 

speak, that will allow the prescribers and pharmacists to get data 

faster and right within their normal workflow so they can review 

it more readily. 

Mr. PITTS. Thank you. My time has expired. 

The Chair recognizes the ranking member, Mr. Green, 5 minutes 

for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

And I am going to focus my questions on the two trauma-related 

bills that Dr. Burgess and I have introduced. And Dr. Burgess is 

actually chairing another subcommittee of our full Energy and 

Commerce Committee downstairs. 

Both bills will reauthorize a number of important programs 

aimed at strengthening trauma systems, developing regionalized 

systems of care, and improving availability of high-level trauma 

services. 

Dr. Enderson, it is a disappointing fact that 44 million Americans currently lack access to the major trauma centers within the 

70 

golden hour of the injury, the time period when the chances of survival are greatest. Can you elaborate on the issue of access and 

why timely and appropriate care within the first hour of injury is 

so critical? 

Dr. ENDERSON. Traumatic injury is a surgical disease. Basically 

the injuries that kill patients when they are injured are—frequently, they are bleeding to death and they need access to surgical 

care within that time to stop the dying process while they are 

bleeding. 

The access problems occur commonly in the United States in 

rural areas, but we also have access problems in some of our major 

cities where there is a maldistribution of level 1 trauma centers. 

So someone who is injured on one side of the city has problems getting transported to that trauma center in the length of time before 

they bleed to death. And if they are taken to a hospital that is not 

part of the system, that delays the care until they reach that definitive surgical care. 

Mr. GREEN. Thank you. 

I represent Houston, Texas. And I first became involved in this 

issue when hurricane Allison—or Tropical Storm Allison flooded 

our two level 1 trauma centers in our Medical Center and the area 

was under water. While tropical storms and hurricanes are not 

typically the greatest threat to trauma centers’ operations, cost 

pressures, providers shortages have caused many trauma centers 

to close and many more are struggling to maintain operations. 

As you mentioned in your testimony, from 1990 to 2005, 30 percent of our trauma centers closed their doors. Can you discuss why 

access to trauma care is threatened by losses associated with the 

high cost of treating severely injured patients, a problem compounded by uncompensated care and the growing shortage of trauma-related physicians? 

Dr. ENDERSON. The cost does keep going up. The demands on 

providers are increasing. And if we close down trauma centers, that 

just puts a further strain on the system. In many areas, such as 

our area, we are the only trauma center in our area. And we don’t 

have any backup. And the fewer trauma centers you have, they are 

more likely to get overloaded with all of the patients so that, when 

they are needed for critical events, they can’t provide care for their 

patients. 

So it is nice to have some redundancy in that system, but that 

redundancy has to make sense. It has to be in places where they 

can work with the higher level trauma centers where they can take 

care of their patients and provide the care that is needed in that 

region and for those injured patients. 

Mr. GREEN. And I want to point out that some of these programs 

have not received funding for several years. 

Dr. ENDERSON. They have not. They have been authorized, but 

they have not had appropriations. 

Mr. GREEN. Dr. Enderson, what can you talk about the value of 

investing in trauma centers and trauma care programs like these? 

Dr. ENDERSON. We have heard that trauma is the leading cause 

of death in patients under the age of 44. If you have young patients 

who are injured and you treat them and get them back to normal 

life, they can return to a long working life for society. 

71 

As an example, we recently had a young man. He was at work. 

He got ill. He was driving home, and he had a bad wreck. He had 

terrible injuries. He had a ruptured thoracic aorta. He had extremity fractures. He had a head injury. And yet, by getting brought 

quickly to our trauma center, we were able to treat those injuries 

over a period of time, and in 6 months, he was back working and 

back with his family. 

Mr. GREEN. Well—and, Mr. Chairman, I realize a lot of us have 

been to both Iraq and Afghanistan. And that was the same goal 

that we had for our military, to make sure that there was a—within that hour period, they could reach a trauma center, whether it 

be in Kabul, Kandahar in Afghanistan, or in Baghdad, or Balad in 

Iraq. 

Mr. Enderson, can you talk about the value of investing in trauma systems and trauma care programs like these? 

Dr. ENDERSON. I think the value is simply what you pointed out. 

So, in the military, they have a great regionalized system where 

they provide lifesaving care at the screen. They quickly transport 

to a place for more definitive care. And then they transfer them 

back to the United States for rehabilitation. 

What we need is a system that involves all levels of trauma care 

so that we can take our young people and return them to a normal 

life. 

Mr. GREEN. Thank you, Mr. Chairman, again. 

I will yield back my time, except I want to thank Dr. Burgess 

for his partnership and leadership. 

And I also thank the Trauma Coalition, who has worked hard on 

the of reauthorization of these programs. 

And I yield back. 

Mr. GUTHRIE [presiding]. Thank you. 

The gentleman yields back, and I will recognize myself for 5 minutes for questioning 

Mr. Eadie, I am from Kentucky, and we have been very active 

in this area. According to the Department of Health and Human 

Services, as of July 2013, 47 States had operational prescription 

drug monitoring plans or PDMPs. However, they are significantly 

underutilized by providers. A number of factors contribute to this 

underutilization, including the cumbersome nature of accessing 

current systems and privacy concerns. Would you elaborate on 

some of the factors that may lead to underutilization of PDMPs? 

Mr. EADIE. Certainly, I am happy to do that, and I want to acknowledge Kentucky’s leadership for the country on many issues, 

including this one. 

In many cases, the cumbersome nature of this process as you describe it is correct. Doctors have to take the time to do it. Recent 

developments in Kentucky and other States has been actually to 

allow the physicians to delegate the responsibility to a subordinate 

person in the practice, with the prescriber keeping responsibility. 

That is also a practical thing that can be done, and we encourage 

every State to look at that. And in fact, those States that have 

mandated use have found it essential because of the increased 

workload of having to pull up the data. 

Mr. GUTHRIE. I want to ask you, on the mandate, do you think 

that is the right approach, to mandate the use? Kentucky and I 

72 

think New York—I know my State has and also the State of New 

York. 

Mr. EADIE. Yes. 

Mr. GUTHRIE. Will you elaborate on mandating? 

Mr. EADIE. Yes. What those mandates—there are multiple types 

of mandates out there, some, like the State of Nevada, which mandates the prescribers use the system but only when they have a 

reason to believe that the patient in front of them is not there for 

legitimate medical purposes. Such States have not significantly increased their use of the data by prescribers with that kind of a 

mandate. But Kentucky, New York, and Tennessee have pioneered 

a new one in which basically every patient is required, with a few 

logical exceptions, before the first prescription is issued and then 

periodically thereafter. And, in the case of Kentucky, it is at least 

every 3 months, they have to check before issuing an additional 

prescription beyond 3 months. What that does is it allows a prescriber in each case to check. 

We know from work that we did with the State of Massachusetts 

that in that State, when these unsolicited reports I talked about 

were sent out and they sent to prescribers and then we, with them, 

did a survey, found that only 8 percent of the prescribers acknowledged after receiving those reports that they had known about the 

multiple doctor episodes or doctor shopping that was going on by 

their patients. Putting it the other way, more than 90 percent of 

the prescribers did not know what was going on and, therefore, 

would not have asked for the data had it not been sent to them. 

Or, in the case of a mandate, they have to look, which is why they 

are effective. 

And we have seen in Kentucky and, frankly, in all three of those 

States, that medical opposition at first to being required to use the 

system has modified itself after implementation. 

Mr. GUTHRIE. I am going to try to get another question in from 

another panelist. 

Mr. EADIE. Please. 

Mr. GUTHRIE. That was very helpful. I appreciate what you were 

saying. 

Mr. Chlapek, when you were talking about the situation, you 

said there were a lot of people helping and involved and working 

in this, and so I have two questions really I will ask you because 

we have a minute and a half. Who were the stakeholders that 

should be addressing this and giving us information for policy questions? And you also said H.R. 235 will address issues, but there is 

still a lot of other issues to be addressed. You talk about State licensing, and I understand how that, you know, with each State 

having its own and us reluctant to get into that because that is a 

States issue would be a problem. What other issues besides the 

State licensing do you think maybe other legislation would help? So 

who are the stakeholders, and what other issues need to be addressed? 

Mr. CHLAPEK. Vice Chairman Guthrie, other issues are standardization of training at the Joint Services Medical Training Facility 

in San Antonio. If we could get all of those folks with a National 

Registry EMT card, that would really help as they try to transition 

out. 

73 

Other issues, H.R. 235 mainly helps with providing some funds 

for educational facilities to develop their transition program, especially in the rural or shortage areas. Other issues are standardization of State licenses. If there was a National Registry, that would 

really help us. Many States accept the registry now, but all don’t. 

Mr. GUTHRIE. I used to be a State legislator. It probably would 

be easy for States to adopt rules if it came out with a standard uniform service. As you said, if the uniform services would have a 

standard training program with a standard card or standard criteria, then it would be easy for States to—so maybe that is where 

to start. 

But my time is actually expired. I appreciate you doing so. 

I would like to recognize Mr. Schrader from Oregon for 5 minutes 

of questioning. 

Mr. SCHRADER. Thank you, Mr. Chairman. 

I appreciate the opportunity. First question for Mr. Eadie. I am 

curious, as you have heard testified by Mr. Whitfield that we currently have a program, a registry, if you will, that is operated out 

of the DOJ unit and wondered what the advantages of or need for 

the unit out of HHS would be and why that is critical for making 

this program work effectively? 

Mr. EADIE. I appreciate your question. It is my experience that 

both law enforcement and the public health professions have to be 

involved in addressing these issues. Neither one can address it. I 

mean, a fundamental thing is that prescriptions are issued by 

healthcare professionals. And the entire system of delivery of 

opioids, for example, are through the health care system. So a public health involvement and regulatory involvement involving health 

care is essential. At the same time, as long as we have had these 

types of drugs available for medical use, which is so important, 

they have also had the risk of making people addicted. And when 

that happens, people move into all sorts of illegal and criminal behavior patterns, including forgeries, counterfeitings, organized 

rings of drug shoppers, et cetera, and pill mills. Those are outside 

the realm that can be dealt with and addressed effectively by traditional public health entities. 

And I give you simply the examples. Public health, if you look 

at seatbelts, that is a triumph basically of both public health and 

law enforcement working together. The simple thing of people 

being quarantined in a public health emergency and an epidemic, 

public health orders it; law enforcement enforces it. And I could go 

on. 

But my point is that both aspects are essential, and we cannot 

hope to solve this epidemic if we don’t keep both parts working together. 

Mr. SCHRADER. Very good. Thank you. 

Mr. Barber, I was wondering if you could elaborate a little bit on 

the lack of clarity in the DEA guidelines, particularly as it affects 

distributors, and talk about why the definition of ‘‘imminent danger’’ is so important, and modifying the corrective action is important also? 

Mr. BARBER. Yes, sir. The statute currently does not have a definition for ‘‘imminent danger,’’ unlike other Federal statutes designed to protect public health and safety, such as the Mines Safety 

74 

Act. When an attorney, when an agent for DEA is faced with making a decision about whether or not, prior to a hearing, to issue an 

immediate suspension, which brings due process rights to bear, the 

question is, what constitutes an imminent danger? In my written 

testimony, I cite an example where DEA has issued a suspension 

for conduct that they knew had ceased for months. So it is those 

types of scenarios that create a lack of clarity about what the 

standard is that will lead to an immediate suspension, and that is 

why courts have at times intervened. 

And going back to the year after DEA was created in 1974, all 

the way to as recently as 2013, courts have questioned and in 

many cases overturned suspensions issued by the agency because 

of that lack of clarity. As far as the corrective action plan, that is 

an important piece of the legislation in that it provides an assurance to a registrant who has taken corrective action that that will 

be taken into account, thereby enhancing collaboration and communication with the agency. There are times where registrants get it 

wrong, and the agency needs to take action. But if the registrant 

has taken corrective action, it is appropriate for the agency to consider that. 

Mr. SCHRADER. Very good. Thank you. 

Mr. Enderson, could you talk very briefly about what the benefits 

are with regard to regionalization. What does that translate into? 

What does that really mean? 

Dr. ENDERSON. What regionalization really means is that all of 

the parts of a system work together, and it may be under one head. 

So you have a Level 1 trauma center. You may have other trauma 

centers. You have other hospitals, but there is a system set up to 

ensure that the right patient gets to the right place at the right 

time, and they all work together. In the past, we have talked about 

exclusive trauma systems where you just have one center. Now we 

talk about inclusive trauma centers. You want everyone involved so 

that they know what their role is in making sure that the patient 

gets to the right pace. 

Mr. SCHRADER. So they can get the immediate care they need no 

matter what. 

Dr. ENDERSON. The immediate care. So there is not delays. If 

they are closer to another hospital, there is not a delay there. 

There are ways set up to automatically get the patient to where 

they need to be. 

Mr. SCHRADER. Thank you. 

I yield back. 

Mr. GUTHRIE. The gentleman yields back. 

Recognizes Mr. Griffith of Virginia for 5 minutes of questioning. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

Dr. Fountain, if you could talk a little bit about where you think 

we ought to go in regard to the DEA and how we can better improve that process. I know the bills that we have here today, but 

are there other things that we can be doing as a committee to assist in making sure that we get some action on those things that 

have already been approved by the DEA or maybe even some research into things that we know might help epileptic patients that 

we are not able to do studies on yet? 

75 

Dr. FOUNTAIN. I guess there are two other DEA-related issues 

that are important to the epilepsy community and to Americans in 

general. One of them peculiar to epilepsy drugs is that although 

they are scheduled by the FDA, they are scheduled at a low level. 

And for administrative reasons, they have been scheduled because 

the FDA, when it makes a recommendation to the DEA, follows 

eight specific criteria, and if these eight specific criteria boxes are 

checked off, then it requires DEA to schedule it. But those boxes— 

while they are perfectly reasonable, for instance, if the drug is approved in a class in which that class of drugs is already regulated, 

then the DEA is forced to schedule it. Well, for epilepsy drugs, because of historical reasons, they are in those classes, so they end 

up getting scheduled by the DEA. But from a medical perspective, 

it sort of somewhere between unbelievable and comical because 

they aren’t the kind of drugs that you would typically regulate like 

that. So the physicians who are not epilepsy physicians always ask 

the question, Well, why is that a regulated drug? 

So specifically for our community and maybe for other drugs regulated by the DEA, especially given the burden that the DEA has 

of dealing with these specific and important issues that we have 

been addressing, it might be reasonable to revisit for epilepsy 

drugs but perhaps other drugs, speaking for myself, that don’t necessarily need to be regulated by the DEA. 

Mr. GRIFFITH. And there may be some drugs that do need to be 

regulated by the DEA, but maybe we need to take a look at how 

they are regulated. Currently I am working on some language with 

the epilepsy folks in regard to figuring out a way that we can use 

the cannabinoid oil from the marijuana plant. Of course, it is hard 

to figure out how much cannabinoid oil and how much THC you 

need to make it work for the children who apparently—at least 

anecdotally, it appears that is a treatment plan for some patients. 

But we haven’t had a lot of studies done over the years by the 

DEA. Would you agree? 

Dr. FOUNTAIN. That is right. So the other issue relevant to the 

epilepsy community and to those with severe medical conditions is 

regulation of cannabis derivatives and cannabidiol, which is one derivative of marijuana that doesn’t cause a high, doesn’t cause euphoria or anything like that, seems to have some effectiveness in 

treating seizures and a few other medical conditions and is not the 

part of the plant or the compound that typically is associated with 

drug abuse. THC is, and so, consequently, for the epilepsy community, we would like to find a way to have cannabidiol oil available, 

first of all, to be studied and have research to know it is safe and 

effective; but then, beyond that, to make it available to people with 

the most severe epilepsies in certain circumstances. 

Mr. GRIFFITH. And we definitely want to go in that direction but 

also make sure—because clearly that is a drug that can be 

abused—and we want to make sure that we don’t overlook that 

when we go down that path. 

Mr. Barber, I know you sometimes get on the hot seat in here 

because we are trying to get things accomplished and get new 

treatments out there at the same time you are trying to make sure 

we don’t have a lot of abuse of drugs. When last we were here and 

discussing these items, I had a situation where a small town pharVerDate Mar 15 2010 15:23 Aug 17, 2015 Jkt 037690 PO 00000 Frm 00079 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_5PHS LEGISLATION\114-5 PHSA LEGISLATION PENDING W
76 

macy couldn’t do what they can do. You mentioned that in your 

opening statement, and I appreciate that. You felt like we needed 

to try to make a better system so that we didn’t have those problems where small town pharmacies with one supplier might have 

these issues. Do you have any suggestions that you can think of 

that we can do to be of assistance in that? Is there legislation that 

we need to pass that we haven’t thought of yet or aren’t moving 

on? 

Mr. BARBER. I believe the Ensuring Patient Access and Effective 

Drug Enforcement Act of 2015 is a great step in the right direction. 

I do think that there are certainly oversight roles that committees 

such as this can play. For example, DEA’s regulation calls on distributors to detect and report suspicious orders to DEA. Those are, 

according to the regulations, orders of unusual size, unusual frequency, or those that deviate substantially from a normal ordering 

pattern. What is unusual depends on the context of the ordering 

pharmacy. What deviates substantially is somewhat amorphous, 

and so if there is greater clarity around regulatory obligations like 

that, it will help pharmacies who now find themselves oftentimes 

not having sufficient drug supply to meet the needs of their patients. 

Mr. GRIFFITH. If I can take just a minute, Mr. Chairman, and 

just say I understand what he is saying. If I am translating it correctly, what that means is if you have a pharmacy that serves a 

lot of older people who are more likely to have pain needs, a senior 

population, than a pharmacy that serves a younger, you can’t have 

a one-size-fits-all for the pharmacy that is in a community that is 

younger and a pharmacy that is in a community that is substantially older and is going to have more pain issues. Is that a fair 

translation? 

Mr. BARBER. That is a fair translation. Context always matters, 

both in the law enforcement and healthcare arena. 

Mr. GRIFFITH. I appreciate it, and I appreciate the panel being 

here today. 

Thank you, Mr. Chairman. I yield back. 

Mr. GUTHRIE. Thank you. The gentleman’s time is expired. 

The Chair recognizes Mr. Sarbanes from Maryland for 5 minutes 

for questioning. 

Mr. SARBANES. Thank you, Mr. Chairman. I won’t take 5 minutes. 

Most of you have come from great distances to share your expertise with us, and it is deeply appreciated by the committee. 

Mr. Chlapek, is that how I pronounce it? 

Mr. CHLAPEK. It is Chlapek, sir. 

Mr. SARBANES. Chlapek, sorry. I gather you were here to testify 

primarily with respect to the helping veterans with emergency 

medical training proposal—— 

Mr. CHLAPEK. Yes, sir. 

Mr. SARBANES. Which I think is a terrific opportunity to showcase how we can streamline bringing providers of all kinds, frankly, more quickly into the healthcare workforce. I have been working 

for many years on this idea of looking in nontraditional places for 

people that can help meet some of the shortages we have, whether 

that is physicians or nurses or, in this case, EMTs. In looking at 

77 

military medics, who obviously come with a vast amount of experience, for that resource makes a tremendous amount of sense, and 

seeing if there is ways that we can streamline the process for actually getting them deployed here in the homeland to help respond 

to these emergencies makes a lot of sense. 

So this demonstration project that Adam Kinzinger and Congresswoman Capps have proposed I think could make a tremendous amount of difference. 

I was just curious whether you have had the opportunity—I 

imagine you have—to work with some EMT professionals who are 

former military medics and what your observation has been as to 

the kind of expertise and experience that they bring to the job? 

Mr. CHLAPEK. It depends, sir. You have the Special Forces or 

SEAL or PJ medic that is deployed forward that does a whole lot 

of different things—puts chest tubes in, uses conscious sedation, 

and some other adjuncts. These folks can come out and go—they 

should be able to challenge the paramedic test right away. And I 

will get phone calls that ask, What can I do, from these medics, 

and so I try to link them up with an educational institution that 

will let them do a weekend refresher and then challenge the test 

through their institution. 

Mr. SARBANES. Excellent. Excellent. Well, that is a good perspective, and I think what they can bring to a team, to an EMT team 

on the ground, given their experience and perspective, is incredibly 

valuable. In other words, it is not just another source of finding 

people for this job. It is finding people that are particularly qualified in certain respects for the job, and that is why I support this 

bill in particular. Thank you very much for your testimony. Appreciate it. 

And all of you. 

Mr. GUTHRIE. The gentleman yields back. 

The next recognized is Mr. Long from Missouri for 5 minutes for 

questions. 

Mr. LONG. Thank you, Mr. Chairman. 

Mr. Chlapek, number one, it is nice to have a fellow Missourian 

here, so welcome. Can you kind of walk us through the traditional 

State credentialing or licensing process for EMTs? 

Mr. CHLAPEK. Yes, sir. The military EMTs or the civilian EMTs, 

Mr. Long? 

Mr. LONG. Well, the traditional—just the civilian is what I am 

getting at. 

Mr. CHLAPEK. Civilian EMTs, normally for the basic course, go 

through a one-semester or roughly 6-month time period with two 

clinical shifts and then take the test. The State of Missouri, for example, as well as about 40 other States, have adopted the National 

Registry exam because it takes a lot of pressure off of them. It is 

standardized. It is vetted, and they will take that exam and then 

receive a license. For paramedics, they go anywhere from two to 

three semesters and do an excess of 600 to 700 clinical hours, both 

in a hospital and in an ambulance. And then, once they do a certain number of skills, they are allowed to move on. 

Mr. LONG. OK. Can you kind of juxtapose that with the military 

training? For someone with previous training, such as a military 

78 

medic in Missouri, would they be qualified as EMT basic or EMT 

intermediate or EMT paramedic? 

Mr. CHLAPEK. The military medics, for the most part, that go 

through the program at San Antonio at the Joint Training Facility 

qualify; if they are in the Army or the Air Force, they will have 

a National Registry card. They present that to most States, and 

they are handed a State license to work within that State. 

The Special Forces medics come in, and they are expected—they 

have done everything to qualify to test for a paramedic level card. 

Sometimes they do, and sometimes they don’t. It depends. A Navy 

SEAL medic retired after 22 years and went to LA County Fire, 

and he wound up going through their whole paramedic course 

again. But it was one of the few things he could do that really satisfied him after the job he had been doing. 

Mr. LONG. I know there are EMT shortages, and would you characterize that problem—is it a problem of recruitment or a problem 

of retention or both? 

Mr. CHLAPEK. Both, along with pay. EMS is severely underfunded, especially in rural areas, and some of these folks either volunteer or work for about $15,000 a year. If they are paramedic 

level, they can make 50 to 60 or a little more. There is a huge difference, and it is underfunded. 

Mr. LONG. I was going to ask how you think that State 

healthcare systems could keep qualified EMTs working in the field, 

but I think you kind of answered that. 

Mr. CHLAPEK. Yes, sir. 

Mr. LONG. With that, Mr. Chairman, I yield back. 

Mr. CHLAPEK. Thank you. 

Mr. GUTHRIE. The gentleman yields back. 

The next recognized is Mr. Bucshon of Indiana for 5 minutes of 

questions. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

Prior to coming to Congress, I was a cardiovascular and thoracic 

surgeon for 15 years, so I am pretty familiar with the subject matter, especially as it relates to trauma and really all the medical 

issues, including EMT and how you deal with pharmacies and what 

the process is. And I just would like to say at the top that this is 

a huge problem. My law enforcement in my community, in Evansville, Indiana, recently told me that prescription drug issues have 

overtaken methamphetamine as a community health problem in 

our county. And that I think is probably widespread across the 

country. 

Mr. Eadie, your comments about combining law enforcement and 

medical are very critical. I can tell you, as a practicing physician, 

one of the issues is time and the information in an expedient manner. Most physicians, as you know, 99.9 percent don’t want to prescribe narcotics to people that are doctor shopping, but available 

information quickly is so critical if we can provide that. 

As a surgeon, of course, I provided acute medical care and acute 

pain management, which is a completely different area than our 

primary care physicians or neurologists and others have to deal 

with, so maybe you can expand further on how you think—I mean, 

getting the information from medical records, for example, the two 

major hospital systems in Evansville have two EMR systems that 

79 

don’t communicate with each other. And some of the medical practices have EMR systems that don’t communicate with either hospital. How do we make progress in that area, because I know that 

there is a lot of smart IT professionals that can probably fix this 

problem overnight. Right? But it is about proprietary information. 

It is about economics. It is about profit for different systems, and 

I totally understand that. But how do we get past that and get the 

physicians the information immediately so that they, on the prescribing side, we don’t overprescribe? 

Mr. EADIE. I thank you for your question, and I want to also acknowledge that I would be happy to put you in contact with the 

people in Indiana who are experimenting with this. There is a trial 

underway in Indiana. You are one of the 16 States where there is 

an effort being made to translate PDMP data directly into the existing systems of electronic health records and health information 

exchanges. The details of that, they would have to provide to you, 

but it is important work. And that is why we support the NASPER. 

It is one of the major reasons we support NASPER, is that—and 

feel it is so important—is that we have seen the value and importance of doing exactly what you are talking about. And these 16 

States have started, but that is not nearly enough, and they have 

got a long way to go. They are just experimenting. NASPER funding has, in its refocused form, in the redrafted legislation would 

really encourage this. It would provide funding to support States 

to do the necessary work. And it is going to take time. The complications of proprietary systems, multiple systems in each State, 

it is going to take a while to overcome those barriers and hurdles 

that have been put in place by multiple systems, but it is doable. 

And there is a real national effort underway, and in fact, the 

Substance Abuse and Mental Health Services, or SAMHSA, is the 

one that is spearheading this effort with the office from the White 

House on technological developments for health care. There is a lot 

of work that has been done, and I would be very happy to put you 

in touch with them to learn about that. 

Mr. BUCSHON. That would be great. 

And, of course, the medical systems need to be able to communicate with pharmacies and, honestly, with law enforcement also in 

some way. So it is a complicated problem. But my wife is a anesthesiologist—still practicing—so she tells me every day the number 

of patients that come to the hospital for other procedures that are 

on, have been taking narcotics or, honestly, benzodiazepines for 

many, many years. This is really an epidemic problem. It is across 

socioeconomic class. It is something I have been working on since 

I have been in Congress in the State, on the methamphetamine 

issue, trying to solve that. But now the prescription drug issue is, 

it has been and is surpassing that. 

So I can tell you firsthand, you know, the significance. And I appreciate all your testimony and everyone working towards solutions 

to solve the problem. 

And on the EMT side, quickly, Mr. Chairman, the last Congress, 

we were able to get legislation passed on commercial driver’s license for veterans who had driving experience in the military, 

making that a streamlined process so that they could get a commercial driver’s license to drive a semi, for example, across the 

80 

country because of their military experience. So I do think there is 

a good chance that this legislation will move forward and become 

law, and I hope it does. 

So I yield back. 

Mr. GUTHRIE. The gentleman yields back. 

And I ask unanimous consent to enter into the record a report, 

‘‘The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction.’’ 

Without objection, so ordered. 

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

Mr. GUTHRIE. The Chair now recognized Mr. Collins of New York 

for 5 minutes of questions. 

Mr. COLLINS. Thank you, Mr. Chairman. This has been a great 

hearing. 

I think, first of all, Mr. Chlapek, we all agree: Anything we can 

do help our vets coming back, we want to do. And while this may 

not be a lot of money per year—a couple hundred thousand per 

year I understand is what has been requested—do you know how 

many States have this issue? I mean, one of the requirements is 

the State claim a shortage of EMTs, and there is a need. Do you 

happen to know, is this 2 or 3 States or 10 or 15? How great is 

the need for what we are proposing here? 

Mr. CHLAPEK. Nearly every State that has a rural area has a 

shortage in those areas. They are currently served by volunteers, 

but as more and more folks go back into the city for work and both 

members of the household work and requirements keep increasing 

for the mobile healthcare providers, the folks on the street, EMS 

professionals, they can’t keep people at all. And veterans are coming out. They know how to be on time for work. They know how 

to follow orders, and they just need help with the license. 

Illinois is a prime example. And Carle out in Champaign-Urbana, has a conference every year on rural health care. EMS is the 

big thing. 

Mr. COLLINS. I know this has bipartisan support, and we won’t 

know until we get this approved and appropriated just how many 

folks are going to apply for it, but certainly a worthy objective. And 

thank you for bringing that up. 

My other question really is for Dr. Enderson on the trauma 

piece. First of all, I am just curious, do we know, since this one is 

a reauthorization, in the last couple of years, how many hospitals 

have applied? And what is the average amount of money they are 

getting? And have we seen a report that tracks how this money has 

allowed us to either get new trauma centers or keep trauma centers open? In other words, what are the metrics coming back at us? 

Dr. ENDERSON. Well, sir, unfortunately, these have been authorized over the past several years, but there have been no appropriations for that. 

Mr. COLLINS. I am glad you brought that up as well. As an authorizing committee but not the appropriators, that is information 

I didn’t know as a new Member, and I am glad to know that so 

we can move forward. Certainly the access to trauma, as we talked 

about, that golden hour is critical. I represent the western New 

York area, and Erie County Medical Center has one of the best 

Level 1 trauma centers in the country. And it is quite expensive 

81 

to set that up, and I know it is always the issue with the county 

government and others, tight budget times deciding where this 

money goes; but it is a lifesaver quite literally, whether it is the 

ski resorts that are 60 miles away and the incidents there, which 

tend to be head trauma and the like, that access has saved many 

lives in western New York, and I know we are blessed to have that. 

I know it is very much of a cost burden, but we have decided as 

a community it is worth that money. 

Would you see that in something like I am explaining—they are 

existing, they are there, the community is behind them—would 

they qualify for one of these grants, or is this really more focused 

on, assuming it is appropriated, those areas that don’t have one 

now? 

Dr. ENDERSON. Both. So part of it applies to trauma centers that 

exist, especially trauma centers that are having significant difficulties and are in danger of closing, we are trying to prevent that, but 

we are also trying to help States look at the models of trauma care 

that they have and make sure that they are allocating the resources the way that make sense. So, in a regionalized system, 

these, as you pointed out, are very expensive resources. You don’t 

want every hospital duplicating those resources. You have to understand how it works best in a system, know how it works, and 

how that system can work together to take care of their patients. 

Mr. COLLINS. Yes. I mean, the good news for our area is we did 

designate the Erie County Medical Center as the Level 1 trauma 

center. The other hospitals recognize that. It is also the regional 

arm, and in many cases, that 1 hour works with our mercy flight, 

the helicopters coming in. I suspect we are probably an example of 

best practices, both in the type of facility and also the way the 

other hospitals recognize that that is our designated trauma center. 

Dr. ENDERSON. Absolutely. 

Mr. COLLINS. So, again, very important issue. Thank you for your 

testimony. 

Mr. Chairman, I yield back my remaining 5 seconds. 

Mr. GUTHRIE. The gentleman yields back. 

The gentlelady from Tennessee is recognized for 5 minutes for 

questions. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

I want to thank you all for being here, especially Dr. Enderson, 

my fellow Tennessean, and we are delighted to have him here and 

with us today. 

Mr. Chairman, I have got some things to submit for the record. 

First of all, the statement of the National Association of Chain 

Drug Stores on today’s hearing. 

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

Mrs. BLACKBURN. And, secondly, letters of support for the Ensuring Patient Access and Effective Drug Enforcement Act of 2015, 

which is the work product of Ms. Chu, Mr. Welch, Mr. Marino, and 

I. These are from the American Pharmacists Association, the 

Healthcare Distribution Management Association, the National Association of Chain Drug Stores, and the National Community Pharmacists Association. 

Mr. GUTHRIE. Seeing no objection, so ordered. 

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

82 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

Very quickly as we wrap up, I did have a couple of questions on 

H.R. 471, which is the Ensuring Patient Access and Effective Drug 

Enforcement Act. 

Mr. Barber, you mentioned in your remarks to one of the questions that context matters, and I appreciate hearing that. So I 

wanted to go back to your testimony. You said that little has 

changed in the past year in regard to the issue of dealing with 

DEA and guidance. And I want to know, has there been any improvement in the guidance the DEA is giving to distributors and 

pharmacists on this issue? 

Mr. BARBER. It hasn’t changed, so I would say there has been no 

improvement or any decrement. It is unchanged. 

Mrs. BLACKBURN. Well, I was hoping there was a sliver of a right 

step in the right direction, but I guess not, and it shows why we 

need to go ahead and get this bill passed. 

I wanted to also ask you, we hear some discussion about whether 

or not to define ‘‘imminent danger,’’ and I would like for you briefly 

to touch on why giving definition to ‘‘imminent danger’’ would benefit the DEA? 

Mr. BARBER. Well, as a former counsel who appeared in Federal 

courts, assisted U.S. Attorney’s Office in defending the suspension 

power of the agency, having a clear legal standard is always best. 

There are Federal statutes that were passed around the same time 

as the CSA that contain a definition of ‘‘imminent danger,’’ and 

rather than having it undefined and having courts second-guess 

the agency’s important power, to me it seems like if Congress gave 

a clear standard in the law, then the agency could enforce it and 

courts would not be left to second-guess DEA. 

Mrs. BLACKBURN. OK. So you would say the harm comes in having no definition of ‘‘imminent danger’’? 

Mr. BARBER. I believe that is the harm. It is a harm both to the 

agency and to the regulated community, who doesn’t know where 

the lines are, and we have those unintended consequences I mentioned in my testimony. 

Mrs. BLACKBURN. Thank you. 

And, Mr. Chairman, just for the record, we are speaking in reference to the Controlled Substance Act. 

Well, I know you all are ready to step away from the desk. And 

we are appreciative that you are here. 

And, Mr. Chairman, in the interest of time and ending the hearing, I will yield back my time. 

Mr. GUTHRIE. Thank you. The gentlelady yields back her time. 

All Members have been recognized. I remind Members that they 

have 10 business days to submit questions for the record, and I ask 

that the witnesses respond to the questions promptly. Members 

should submit their questions by the close of business on Tuesday, 

February 10. 

Without objection, we have one more. We have a unanimous consent request for ‘‘Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices’’ for the record. 

83 

1The information has been retained in committee files and also is available at http:// 

docs.house.gov/meetings/IF/IF14/20150127/102844/HMTG-114-IF14-20150127-SD054.pdf. 

Without objection, so ordered. 1

Without objection, the subcommittee is adjourned. 

[Whereupon, at 12:52 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

84 

85 

86 

87 

88 

89 

90 

91 

92 

93 

94 

95 

96 

97 

98 

99 

100 

101 

102 

103 

104 

105 

106 

107 

108 

109 

110 

111 

112 

113 

114 

115 

116 

117 

118 

119 

120 

121 

122 

123 

124 

125 

126 

127 

128 

129 

130 

131 

132 

133 

134 

135 

136 

137 

138 

139 

140 

141 

142 

143 

144 

145 

146 

147 

148 

149 

150 

151 

152 

153 

154 

155 

156 

157 

158 

159 

160 

161 

162 

163 

164 

165 

166 

167 

Æ