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85–445 2014

EXAMINING THE FEDERAL GOVERNMENT’S 

RESPONSE TO THE PRESCRIPTION DRUG 

ABUSE CRISIS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

JUNE 14, 2013 

Serial No. 113–55 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

FRANK PALLONE, JR., New Jersey 

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 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(V) 

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 .......................................................................................... 3 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, prepared statement ........................................................................... 4 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 5 

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

Texas, opening statement .................................................................................... 6 

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

New Jersey, prepared statement ........................................................................ 67 

WITNESSES

R. Gil Kerlikowske, Director, Office of National Drug Control Policy, Executive Office of the President .................................................................................. 8 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ...................................................................... 79 

Doug Throckmorton, Deputy Director for Regulatory Programs, Center for 

Drug Evaluation and Research, U.S. Food and Drug Administration ............ 19 

Prepared statement .......................................................................................... 21 

Answers to submitted questions ...................................................................... 101 

H. Westley Clark, Director, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration .............................. 32 

Prepared statement .......................................................................................... 34 

Answers to submitted questions ...................................................................... 108 

SUBMITTED MATERIAL

Statement of National Association of Chain Drug Stores, submitted by Mr. 

Pitts ....................................................................................................................... 68

(1) 

EXAMINING THE FEDERAL GOVERNMENT’S 

RESPONSE TO THE PRESCRIPTION DRUG 

ABUSE CRISIS 

FRIDAY, JUNE 14, 2013 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 9:32 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Joe Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Whitfield, Rogers, Murphy, Gingrey, Cassidy, Guthrie, Griffith, Bilirakis, 

Ellmers, Capps, Schakowsky, Green, Butterfield, and Castor. 

Staff present: Clay Alspach, Chief Counsel, Health; Gary Andres, 

Staff Director; Sean Bonyun, Communications Director; Matt 

Bravo, Professional Staff Member; Paul Edattel, Professional Staff 

Member, Health; Brad Grantz, Policy Coordinator, O&I; Sydne 

Harwick, Legislative Clerk; Carly McWilliams, Professional Staff 

Member, Health; Katie Novaria, Professional Staff Member, 

Health; Andrew Powaleny, Deputy Press Secretary; Chris Sarley, 

Policy Coordinator, Environment and the Economy; Heidi Stirrup, 

Health Policy Coordinator; Alli Corr, Democratic Policy Analyst; 

Eric Flamm, Democratic FDA Detailee; Elizabeth Letter, Democratic Assistant Press Secretary; Karen Lightfoot, Democratic Communications Director and Senior Policy Advisor; Anne Morris Reid, 

Democratic Professional Staff Member; and Rachel Sher, Democratic Senior Counsel. 

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

OF PENNSYLVANIA 

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

recognize himself for an opening statement. 

Today’s hearing is the first in a series of hearings this subcommittee will hold on the subject of prescription drug abuse, 

which has been described by the Centers for Disease Control and 

Prevention as an epidemic in the United States. 

In 2010, 7 million individuals aged 1.2 or older—that is 2.7 percent of this population—were current nonmedical users of prescription, or psychotherapeutic, drugs, and over one million emergency 

department visits that year involved nonmedical use of pharmaVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
2 

ceuticals. Nearly all of these drugs were originally prescribed by a 

physician. 

According to the National Institute on Drug Abuse, prescription 

drug abuse is most prominent among young adults age 18 to 25. 

NIDA also reports that in 2010, almost 3,000 young adults died 

from prescription drug—mainly opioid—overdoses, which is more 

than the total number of people that died from overdoses of any 

other drug, including heroin and cocaine combined. 

Opioid pain relievers, such as Vicodin and OxyContin, are the 

largest class of abused prescription drugs, followed by stimulants 

for treating attention deficit hyperactivity disorder—ADHD—such 

as Adderall or Ritalin, and central nervous system depressants for 

relieving anxiety, such as Valium and Xanax. 

According to the National Survey on Drug Use and Health, published by the Substance Abuse and Mental Health Services Administration (SAMHSA), of those individuals who used prescription 

painkillers non-medically in 2010 and 2011, nearly 3⁄4 received the 

drugs from a friend or relative, either for free, that is 54.2 percent; 

through a purchase, that is 12.2 percent; or by stealing the drugs, 

4.4 percent. 

Today’s hearing focuses on the Federal Government’s response to 

the prescription drug abuse epidemic. It should be noted that this 

committee has played a key role in facilitating Prescription Drug 

Monitoring Programs by authorizing the National All Schedules 

Prescription Electronic Reporting Act (NASPER), co-sponsored by 

Representative Whitfield and Ranking Member Pallone. NASPER, 

which is housed at the Department of Health and Human Services, 

was signed into law on August 11, 2005, to assist States in combating prescription drug abuse of controlled substances through the 

PDMP. 

It provides grants to set up or improve state systems that meet 

basic standards of information collection and privacy protections 

that will make it easier for States to share information. PDMPs enable authorities to identify prescription drug abusers, as well as 

the ‘‘problem doctors’’ who either overprescribe or incorrectly prescribe prescription drugs. 

While NASPER is an excellent step in the right direction, the 

program has not been funded since fiscal year 2010, although HHS 

continues to fund state PDMPs through grants to support interstate interoperability and integration of PDMPs with electronic 

health records and to improve the timeliness of access to PDMP 

data. 

It is abundantly clear that the prescription drug abuse epidemic 

is a crisis in the U.S. However, while we discuss this complicated 

and dynamic issue we need to keep in mind that many of these 

medications that so many are abusing are critical for many patients living with chronic pain. 

The Institute of Medicine estimates that there are more than 100 

million adults in the U.S. living with chronic pain. It is critical as 

we move forward that we remember that these medications are 

vital for many Americans experiencing such pain. 

This hearing will help us better understand and define the various components of the issues and the challenges we face. In addiVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
3 

tion, this subcommittee will learn about the programs we currently 

have in place and their level of effectiveness. 

Today’s witnesses represent the Office of National Drug Control 

Policy, the FDA, and the Substance Abuse and Mental Health 

Services Administration. I look forward to hearing their testimony. 

Thank you. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The Subcommittee will come to order. 

The Chair will recognize himself for an opening statement.Today’s hearing is the 

first in a series of hearings this Subcommittee will hold on the subject of prescription drug abuse, which has been described by the Centers for Disease Control and 

Prevention (CDC) as an epidemic in the United States. 

In 2010, seven million individuals aged 12 or older (2.7% of this population) were 

current nonmedical users of prescription-or psychotherapeutic-drugs, and over 1 million emergency department visits that year involved nonmedical use of pharmaceuticals. 

Nearly all of these drugs were originally prescribed by a physician. 

According to the National Institute on Drug Abuse (NIDA), prescription drug 

abuse is most prominent among young adults (age 18 to 25). 

NIDA also reports that in 2010, almost 3,000 young adults died from prescription 

drug (mainly opioid) overdoses-which is more than the total number of people that 

died from overdoses of any other drug, including heroin and cocaine combined. 

Opioid pain relievers, such as Vicodin or Oxycontin, are the largest class of 

abused prescription drugs, followed by stimulants for treating Attention Deficit Hyperactivity Disorder (ADHD), such as Adderall or Ritalin, and central nervous system depressants for relieving anxiety, such as Valium or Xanax. 

According to the National Survey on Drug Use and Health, published by the Substance Abuse and Mental Health Services Administration (SAMHSA), of those individuals who used prescription painkillers non-medically in 2010 and 2011, nearly 

three-quarters received the drugs from a friend or relative-either for free (54.2%), 

through a purchase (12.2%), or via stealing the drugs (4.4%). 

Today’s hearing focuses on the federal government’s response to the prescription 

drug abuse epidemic. 

It should be noted that this Committee has played a key role in facilitating prescription drug monitoring programs (PDMPs), by authorizing the National All 

Schedules Prescription Electronic Reporting Act (NASPER), co-sponsored by Rep 

Whitfield and Ranking Member Pallone. 

NASPER, which is housed at the Department of Health and Human Services, was 

signed into law on August 11, 2005, to assist states in combating prescription drug 

abuse of controlled substances through a PDMP. 

It provides grants to set up or improve state systems that meet basic standards 

of information collection and privacy protections that will make it easier for states 

to share information. PDMPs enable authorities to identify prescription drug abusers, as well as the ‘‘problem doctors’’ who either over-prescribe or incorrectly prescribe prescription drugs. 

While NASPER is an excellent step in the right direction, the program has not 

been funded since FY2010, although HHS continues to fund state PDMPs through 

grants to support interstate interoperability and integration of PDMPs with electronic health records and to improve the timeliness of access to PDMP data. 

It is abundantly clear that the prescription drug abuse epidemic is a crisis in the 

U.S. However, while we discuss this complicated and dynamic issue we need to keep 

in mind that many of these medications that so many are abusing are critical for 

many patients living with chronic pain. 

The Institute of Medicine estimates that there are more than 100 million adults 

in the US living with chronic pain. It is critical as we move forward that we remember that these medications are vital for many Americans experiencing such pain. 

This hearing will help us better understand and define the various components 

of the issues and the challenges we face. In addition, this Subcommittee will learn 

about the programs we currently have in place and their level of effectiveness. 

Today’s witnesses represent the Office of National Drug Control Policy, the FDA, 

and the Substance Abuse and Mental Health Services Administration, and I look 

forward to their testimony. 

4 

Thank you, and I yield the balance of my time to Rep. 

——————————————————. 

Mr. PITTS. And does anyone seek time? I guess I don’t have time. 

Thank you. I yield the balance of my time and now recognize the 

gentlelady Ms. Schakowsky for 5 minutes for an opening statement. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

First, I would like to ask if I could put the opening statement of 

Mr. Waxman into the record. 

Mr. PITTS. Without objection, so ordered. 

[The prepared statement of Mr. Waxman follows:] 

PREPARED STATEMENT OF HON. HENRY A. WAXMAN

Prescription drug abuse is a serious and growing problem in America. The number of deaths due to unintentional overdoses with prescription drugs dwarfs the 

number of deaths from illegal drugs, and almost doubled between 2000 and 2007. 

According to the Centers for Disease Control and Prevention, there were over 16,650 

deaths in 2010 due to overdose with prescription painkillers. 

Although these drugs can cause harm if abused, they can also offer tremendous 

relief to patients, such as those with cancer or with chronic pain that responds poorly to other medications. The challenge, then, is to identify the means to prevent 

abuse while preserving access to these drugs by those who truly need them. I hope 

our witnesses today will provide information that can help us meet this challenge. 

Clearly, there is no silver bullet, or any single simple approach that will solve the 

problem. However, there are a number of avenues that may be worth pursuing, 

many of which are reflected in the Administration’s prescription drug abuse plan. 

First: Providers should be better educated on the use and potential abuse of these 

drugs, so they can be more effective in recognizing developing problems of abuse, 

and, in turn, more effective in educating and treating their patients. Studies show 

that even brief interventions by health care providers can be successful in reducing 

or eliminating substance abuse by patients who have begun abusing prescription 

opioids but have not yet become addicted to them. 

There are a number of potential mechanisms that could enhance provider education. For example, Congress or possibly the Drug Enforcement Administration 

could include among the eligibility standards for DEA registration, a requirement 

that physicians receive adequate and appropriate training in the prescribing and 

use of controlled substances. FDA could also require that pharmaceutical companies 

develop educational materials and physician training programs as part of a Risk 

Evaluation and Mitigation Strategy (REMS) tied to opioid drug approval. 

Second: We must educate patients on the risks of abuse of these drugs, and the 

need to properly store and dispose of them. According to a 2009 national survey by 

the Substance Abuse and Mental Health Services Administration, over 70% of people who abused these drugs got them from friends or relatives, rather than from 

drug dealers or over the internet. If we can reduce inappropriate access to these 

drugs, we can also reduce the incidence of their abuse. 

A third approach involves efforts of drug companies to develop abuse-deterrent 

formulations of controlled drugs—making them difficult or impossible to crush or 

dissolve, for example, so they cannot be taken by inhalation or injection for an enhanced effect. FDA is supportive of such activities, and recently released a draft 

guidance to assist industry in developing new formulations of opioid drugs with 

abuse-deterrent properties. The guidance describes FDA’s current thinking about 

the studies companies would be expected to conduct to demonstrate the abuse-deterrent properties of a specific formulation, including the process by which FDA would 

evaluate such studies as well as the labeling claims FDA might approve based on 

the results. 

This is a positive development and I applaud FDA for making this guidance a top 

priority. But I am concerned about the increasing evidence that brand companies 

are using abuse-deterrent technologies as a tool to thwart generic competition. 

Indeed, the brand manufacturers of opioid drugs appear to be timing the release 

of their new abuse-deterrent formulations to coincide with the expiration of their 

patents and periods of marketing exclusivity. Upon FDA approval of the new formulations, the companies remove the old formulations from the market, claiming that 

they are no longer safe. If FDA agrees the brand formulations were removed for 

5 

safety reasons, FDA is precluded from approving generic competitors without comparable abuse-deterrent formulations. 

When a brand manufacturer’s new formulation truly deters abuse, there is no 

question FDA should not approve a generic version without comparable abuse-deterrent properties. In making that evaluation, however, FDA must be careful to ensure 

that the claimed abuse-deterrent properties are effective enough to justify a decision 

that the original version is no longer an acceptably-safe product. 

To be clear: Abuse deterrence should not become a new ‘‘work-around’’ through 

which brand companies avoid generic competition. Instead drug manufacturers 

should engage in this area in accordance with both the letter and the spirit of the 

law. Towards that end, FDA should also provide guidance to companies on what 

they are expected to do to obtain approval of abuse-deterrent generic formulations. 

No doubt, we need to address the growing problem of prescription drug abuse in 

this country. But we must do so through means that recognize and preserve the critical role opioid pain medications play in improving the quality of life of those with 

otherwise intractable and chronic pain. I hope our hearing today will enable us to 

make progress towards this goal. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you. 

I am happy that we are having this hearing on drug abuse in the 

United States and I am glad that we can work together in a bipartisan manner to tackle this problem. I want to welcome all of our 

witnesses today. 

This hearing provides an opportunity to raise awareness and discuss action that we can take to end a crisis that is truly destroying 

lives, hurting families and communities across the country. 

My constituent, Peter Jackson, tragically lost his 18-year-old 

daughter Emily to this epidemic. While visiting family, Emily’s 

cousin offered her an OxyContin tablet that had belonged to her 

uncle, who had recently died of cancer. After taking the OxyContin 

tablet while drinking, Emily went to sleep and never woke up. She 

died from respiratory depression; she stopped breathing. 

While Emily’s story of dying after taking a single un-prescribed 

OxyContin tablet may be extremely rare, death from the abuse and 

misuse of prescription opioid drugs are not. Prescription opioid 

drugs were involved in 16,650 overdose deaths in 2010, accounting 

for more deaths than from overdoses of heroin and cocaine combined. This represents a 313 percent increase in deaths over the 

past decade. 

In addition to those tragic deaths, there are other negative 

health consequences that result from prescription drug abuse. For 

every overdose death in 2010 there were an additional 10 abuse 

treatment admissions, 26 emergency department visits, 108 people 

with abuse or dependence, and 733 nonmedical users of those 

drugs. 

In addition to the human toll, there are financial costs associated 

with prescription drug abuse that our health care system simply 

cannot afford. The direct health care cost of prescription drug 

abuse exceeds $70 billion each year. Research has found that, on 

average, opioid abusers generate direct costs 8.7 times higher than 

non-abusers each year. It is a national imperative that we work to 

end this crisis. Reducing the prevalence of prescription drug abuse 

will save lives and save money. 

6 

There are actions underway that are helping to combat this problem at the federal level. Last year, we passed several provisions as 

part of the Food and Drug Administration’s Safety and Innovation 

Act to combat prescription drug abuse, including a requirement 

that the FDA hold a public meeting on the scheduling of 

hydrocodone and issue guidance on developing abuse-deterrent 

products. Federal agencies are also operating programs to combat 

prescription drug abuse, including developing and supporting efforts to educate providers and populations at risk for prescription 

drug abuse. 

While federal efforts are critical, we must partner with States if 

we are to be successful in ending prescription drug abuse due to 

States’ responsibility to license and train the health care professionals that prescribe and dispense these drugs. We must also 

build on current efforts by identifying additional steps that we can 

take to tackle such abuse. We must make drugs containing 

hydrocodone schedule II drugs. While it will be important to take 

steps to ensure this change does not limit access to patients with 

legitimate medical needs, this change is needed to adequately reflect the potential risk these drugs pose to public health. 

We should also take steps necessary to restrict the use of 

oxycodone pain relievers to severe pain, rather than moderate to 

severe pain, in order to prevent the overprescribing of these powerful medications. 

I look forward to hearing from our witnesses about the Federal 

Government’s efforts to combat prescription drug abuse, to learn 

additional steps we can take to stop the abuse and misuse of opioid 

drugs, and I would appreciate any comment on the suggestions 

that I made it my testimony. 

And I yield back. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the vice chairman of the subcommittee, Dr. Burgess, for 5 minutes 

for an opening statement. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the Chairman for the recognition. 

Now, the fact of the matter is that we lose more people in this 

country to the drug overdoses than we do to automobile accidents. 

And of those drug overdoses, 2⁄3 of them are prescription drug 

overdoses. So we have got a plenty big problem. The good news is 

there is plenty we can do about it. But unfortunately, the agencies 

and lawmakers have, so far, not taking anything other than a 

short-term approach. We really need a broad-based, comprehensive 

strategy that is focused on going after the bad actors. 

So to start we could go after the pill mills. They may be hard to 

find, but maybe not. They advertise, so we are very fortunate. They 

tell us where they are, what their hours are, they tell us their 

charges. So if I can find them, how come the Board of Pharmacy 

can’t? How come law enforcement can’t? And take a hard look at 

this. 

Look, I ran a medical practice for 25 years, never once did I advertise a free initial visit, dispensing onsite, discounts off meds, 

7 

coupon included. This warrants a hard look. It just doesn’t fit a 

normal type of medical practice. 

We should reauthorize and fight to fund NASPER. This committee reauthorized it in the past. It is the only authorizing legislation that encourages state Prescription Drug Monitoring Programs. 

NASPER was a product of this committee, bipartisan, drafted with 

medical providers, States and patients in mind. 

We should encourage qualitative drug screening and reject contrary Medicare policies. We should encourage abuse deterrent formulations and reward investment in these technologies. We might 

also work with Canada to align our policies in approving and reimbursing these technologies. We should look at and examine the personal use exemption to see if it encourages bringing controlled substances into the country. We should do more to shutdown the rogue 

internet pharmacies at home and abroad. 

It boils down to this: right now, you can go to a publication; you 

could go on the internet and buy a controlled substance by pointing 

and clicking at two things, two statements you have to make: one, 

I need the drug; and two, I ain’t lying. Most people can meet that 

bar. 

I am open to discussing provider education if it does not subvert 

medical judgment. We have allowed a few bad actors to jeopardize 

a doctor’s ability to offer pain care and care for the patients out of 

fear for patient abuse and diversion. And this is an important 

point. Being someone who has written prescriptions, I do have a 

perspective on this that says we have got to stop the diversion but 

we also need to be careful that our—whatever we do is not so prescriptive that it prevents people who have a legitimate need and 

use of this medication to not obtain it. 

So pain costs are estimated at more than $100 billion yearly and 

they are the cause of 25 percent of sick days. Prescription medications may be an important part of pain therapy. If we don’t stop 

the bad actors, we are going to hurt the people who have legitimate 

uses for these medications. The bad actors cannot be allowed to 

jeopardize a doctor’s ability to alleviate human suffering. 

Again, there is much we should do. I understand why this may 

be a series of hearings and, Mr. Chairman, obviously I look forward 

to working with you. We need to involve doctors; we need to involve 

patients as witnesses. 

Thank you, Mr. Chairman, for the consideration and I will yield 

the balance of the time to Dr. Gingrey. 

Mr. GINGREY. I appreciate my OB/GYN colleague from Texas for 

yielding to me because I agree with so much of what he said. 

You know, the problem is a huge problem in not only the cost 

of the legal dispensation or prescribing of these types of medications, pain medications, anxiolytics, antidepressants, whatever. 

But, just think about the cost of decreasing productivity in individuals that maybe are a little bit, just a little bit overmedicated. You 

know, this might sound a little harsh, but honestly, I think maybe 

a little pain or a little anxiety in our lives is a good thing. It can 

be a productive thing and make you appreciate that you have to 

work through that. And that if you try to completely eliminate each 

of those things, then that is where you get to the dependency, the 

addiction, the decreased productivity, or the cost to society. 

8 

So I think physicians have a big role to play in this, and even 

the ones that are prescribing legally. And I am not talking here 

about the pill mills. The State’s doing, I think, a good job of trying 

to crack down on that. 

But finally, we must take a close look at how we as a society support treatment and recovery for patients struggling to overcome addiction. We must look for new and innovative treatment plans 

which treat this dependence and leave the abuser without new addictions, where they are on some other medication that is supposedly helping them and they are almost just as addicted as they 

were before. 

Mr. Chairman, I yield back and I thank you for the time. 

Mr. PITTS. The chair thanks the gentleman. 

That concludes the opening statements. The Committee has one 

panel before us today and I will introduce those members at this 

time: Mr. Gil Kerlikowske, Director, Office of National Drug Control Policy is with us; secondly, Dr. Throckmorton, Deputy Director 

of Regulatory Programs, Center for Drugs Evaluation and Research, U.S. Food and Drug Administration; finally, Dr. Westley 

Clark, Director, Center for Substance Abuse Treatment, Substance 

Abuse and Mental Health Services Administration. 

Thank you for coming. Your written testimony will be made part 

of the record. You will be each given 5 minutes to summarize your 

testimony. 

Mr. Kerlikowske, you are recognized for 5 minutes for your opening statement. 

STATEMENTS OF R. GIL KERLIKOWSKE, DIRECTOR, OFFICE OF 

NATIONAL DRUG CONTROL POLICY, EXECUTIVE OFFICE OF 

THE PRESIDENT; DR. DOUG THROCKMORTON, DEPUTY DIRECTOR FOR REGULATORY PROGRAMS, CENTER FOR DRUG 

EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION; AND DR. H. WESTLEY CLARK, DIRECTOR, CENTER FOR SUBSTANCE ABUSE TREATMENT, SUBSTANCE 

ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION 

STATEMENT OF R. GIL KERLIKOWSKE 

Mr. KERLIKOWSKE. Thank you, Chairman Pitts and representative Schakowsky and members of the subcommittee, and thank you 

for the opportunity to address the important issue of prescription 

drug abuse in this country. 

Preventing prescription drug abuse has been a major focus of our 

office since my confirmation now 4 years ago. We have worked very 

collaboratively with a number of federal agencies throughout government to address what the CDC has rightly termed an epidemic. 

My position allows me to raise the public awareness and take action on drug issues that affect the Nation, and the Administration 

recognizes that addiction is a disease, that prevention, treatment, 

and smart law enforcement all have to play a part of a comprehensive strategy to reduce drug use, to give help to those who need it, 

and to ensure public health and safety. 

And we are here today because the prescription drug abuse as 

a devastating consequences for public health and safety in the 

country. Increases in treatment admissions for substance use disVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
9 

orders, emergency department visits, and, sadly, the deaths that 

are attributable to prescription drug overdoses place an enormous 

burden upon communities across the country. 

In 2010 alone, more than 38,000 Americans died from a drug 

overdose; 22,000 of those overdose deaths were attributable to prescription medications; and most of those deaths, almost 17,000, 

were attributable to prescription painkillers. And in response the 

Administration released a comprehensive program called Prescription Drug Abuse Prevention Plan. 

The plan brings together a variety of federal, state, local, and 

tribal partners to focus on the four major priority areas dealing 

with this: education, monitoring, proper disposal, and enforcement, 

and the plan promotes mandatory education and safe prescribing 

and addiction practices for prescribers and dispensers. 

Current training for health care providers on safe opioid prescribing and addiction can be an adequate and inconsistent. Medical school students receive an average of only 11 hours of training 

on pain education. Most schools do not offer specific training on 

opioids at all. Several States including Iowa, Massachusetts, and 

Utah passed mandatory prescriber education legislation. And we 

have come a long way in educating the general public about prescription drug abuse. We have worked with a wide array of state 

government leaders, medical associations, public health and safety 

organizations to prioritize prescription drug abuse and overdose 

prevention. 

The second pillar of the plan focuses on strengthening the Prescription Drug Monitoring Programs. In 2006, only 20 States had 

PDMPs. Today, 49 States have authorized legislation, 46 States 

have operational PDMPs. There are currently 14 States that are 

able now to share data across state lines and we are supporting 

that expanded interoperability. 

The Administration has worked with Congress to allow the Department of Veterans Affairs to share prescription drug data with 

PDMPs and we are pleased to say that the VA’s rulemaking process is nearing completion, and VA has authorized its health care 

providers to access those state PDMPs when consistent with state 

laws. 

And third, the Administration has continued to expand safe and 

proper disposal of unused and expired medication. Since 2010, the 

Drug Enforcement Administration has partnered with thousands of 

local law enforcement agencies and our Drug-Free Communities 

coalitions to hold six national take-back days collectively, safely 

disposing of over 2.8 million pounds of unused medication. 

Lastly, the Administration plan focuses on improving law enforcement capabilities to reduce diversion. The National Methamphetamine and Pharmaceutical Initiative, funded through our 

office of high intensity truck trafficking areas, has trained more 

than 2,500 law enforcement and criminal justice professionals on 

pharmaceutical crime investigations and prosecutions. The federal 

law enforcement continues to partner with state and local agencies 

around the country to reduce the pill mills and prosecute those 

that are responsible for improper or illegal prescribing. 

The Administration is working to expand access to naloxone, an 

emergency overdose reversal medication for first responders who 

10 

may encounter overdose victims and can help prevent a fatal opioid 

overdose. And we are also addressing many of the other consequences of the epidemic, including the emerging issues like neonatal abstinence syndrome and indications of increased heroin use 

in other places throughout the country. 

In closing, let me recognize that none of these things would be 

possible if my executive branch colleagues and I want to accomplish for this Nation without the ongoing support of Members of 

Congress. And thank you for the opportunity to testify. 

[The prepared statement of Mr. Kerlikowske follows:] 

11 


85445.001

EXECCTfVE OFFICE OF THE PRESIDE:'\-r Ol'TICE OF :;:ArlO"AL DRL:G CO~lROL POUCY 

"Examining the Federal Government's 

Response to the Prescription Drug Abuse 

Crisis" 

Committee on Energy and Commerce 

Subcommittee on Health 

United States House of Representatives 

Friday, June 14,2013 

9:30 a.m. 

2123 Rayburn House Office Building 

Statement 

of 

R. Gil Kerlikowske 

Director of National Drug Control 
12 


85445.002

Chainnan Pitts. Ranking Member Pallone, and distinguished members of the Subcommittee. 

thank you for this opportunity to address prescription drug abuse in our country. The Office of 

National Drug Control Policy (ONDCP) was established by Congress with the principal purpose 

of reducing illicit drug use. manufacturing. and trafficking; drug-related crime and violence; and 

drug-related health consequences. As a component of the Executive Office of the President, Our 

office establishes policies. priorities, and objectives for the Nation's drug policies. We also 

evaluate, coordinate, and oversee the international and domestic anti-drug efforts of Executive 

Branch agencies and ensure such efforts sustain and complement statc and local drug policy 

activities. 

As Director of National Drug Control Policy and chief advisor to the President on drug poliey 

matters, I am charged Vvith producing the National Drug Control Strategy, the Administration's 

primary blueprint for dlUg policy, along with a national drug control budget and guidelines for 

cooperation among Federal, state, locaL and tribal entities. My position allows me to raise public 

awareness and to take action on drug issues affecting our Nation. The Obama Administration 

recognizes thar addiction is a disease, and that we need an evidence-based public health and 

safety approach to reduce drug use and its consequences. 

The Administration'5 :20 13 National Dru;; Control Strategy represents a 21st century approach to 

drug policy. This science-based plan. guided by the latest research on substance use and 

substance use disorders, contains more than 100 specific actions to support our work to protect 

public health and safety in America. The Strategy contains a specific policy focus area devoted 

to preventing prescription drug abuse, which has been a signature initiative of my tenure as 

Director of National Drug Control Policy. 

The considerable public health and safety consequences of prescription dlUg abuse underscore 

the need for action, which is why the Administration released its comprehensive Prescription 

Drug Abuse Prevention Plan (Planj in 1011. The Plan, a companion to the National Drug 

Control Strategy, brings together a Vvide range of stakeholders to reduce diversion and abuse of 

prescription drugs while also ensuring legitimate access. The Plan focuses on four major pillars, 

each desil;,'TIed to intervene at a critical juncture in the process of diversion and abuse: education 

for prescribers. patients, and parents; prescription drug monitoring programs; proper medication 

disposal; and effective enforcement. 

There are signs that the national effort to reduce and prevent prescription drug abuse is working. 

The latest survey data show the number of people 12 and older currently abusing prescription 

drugs has decreased significantly from 7.0 lnillion in 2010 to 6.1 million in 20] 1, a 11 percent 

decrease,l We also know that pa.~t month non-medical use of prescription drugs among young 

adults ages 18 to 25 was significantly lower in 101] (5.0 percent) compared to just one year 

, Substance Attuse and Mental Iiea!th Se:-vi.ces Administratle')fl. Resultsfrom the 201 I ,National SurV(;:r on Drug Usc and Health: Summary of 

Xu/wnel FIndings, l:.S, Ix..partment nfHcalth and Human Services, [September 2012J. Available: 

hupJ/w\yw sa,fnhs~.l!ov!da1a.'t\SDl TH '2k 1 ! Resu1tsl!{SDlHifb.'1''y'!!?2011.!llm#Fi~~~ 

1 
13 


85445.003

earlier percent), a trend that is also true for the abuse of pain relievers among this age 

group. However, while these trends are promising. we know there is much more to do. 

The Epidemic of .Preseriptioll Drug Abuse 

The misuse and abuse of prescription medications have taken a devastating toll on the public 

health and safety of our Kation. Increases in substance abuse treatment admissions, emergency 

department visits. and, most disturbingl!: overdose deaths attri~~~ble to prescription drug abusc 

place enormous burdens upon commurutles across the country:·· .. So pronounced are these 

consequences that the Centers for Disease Control and Prevention (CDC) has characterized 

prescription drug overdose as a public health epidemic," a label 1:.1at furti1cr underscorcs the need 

for urgent policy. progranl. aild community-led responses. 

The numbers paint a grave picture. In 2010 alone, more than 38.000 Americans died from drug 

overdose. Drug overdose deaths have become the leading cause of death due to injury in the 

United States, with drug overdose deaths outl1umbering both motor vehicle (35,000) and firealTIl 

(31,000) deaths in the United States in 2010. 7 This means that on average more than 100 

Americans die from drug overdoses every day in this country. 

Just over 22,000 of these overdose deaths were attributable to prescription medications, and most 

of those deaths - almost 17.000 [16.651]·- were attributable to prescription opioids - nearly four 

times the number just a decade earlier. Opioid pain relievers are now involved in far more 

overdose deaths than heroin and cocaine combined.8 

The abuse of prescription opiates also is associated vvith increased morbidity. In 201] alone, 1.2 

million emergency department visits involved the non-medical use of prescription drugs-more 

than double the estimate from 7 years earlier and about equaling the number of visits involving 

all mher illicit drugs combined (1.2 million vs. 1.3 million).9 Data also show a nearly six-fold 

Use and Health: Summary of 

Sllbstancc Ahuse and Mental Health S~rvices Administration, Treaunent Episode Data Sct (TEDS) 1999<2009, 'K"ationa! Admissions to 

Substance Abuse Treatmem Services. 'U.S. Departml!l1t of Ilealth and Ifumar! Services. f20l11. Ayailab1c: 

~':"'''Emhsa,gnv/d.ill.?,_~~12f1Ji!)5_f.m . ..Q:t{;)'EDS2C 1 (l~\Veh.vdf 

.1, Suhs:ancc Ahuse ~ . .nd ~1-cntal Health Services Administration. Highlights (If the 2010 Drug Abuse Warning Network (DAWK) Findings on 

Drug-Related Emergency Department Visits. U.s. DeparLl1l,mt of Health and Human Services. puly .2012j. Available: 

20t33 (2): 231-23i. 

eM (."t ai. Pharmac(.."Uticai Overdose Dcains, United States. 2010. J}\J\.{4. 20B:309(7}:657-659. 

Sl.:nSlaDCe Abus:c ;md Mental Health Sen.'lccs AdmlnistratiofL ltighiights of the 20 i 0 Drug. Abuse Waming. ~ctwork CDA W1'-i) Findings on 

Drug~Rdatcd Emerg,;ncy Department Visits. U.s. Dcparu'11cnt {}fBcalth and Human Services. puly 2012]. Available: 

http://\\'',,,'W.~'t.b~.vl.4?:at2k".l~12!..\.\YSJLt.{i[,)R~196EPlIi!lhjighls2010.pdf 

2 
14 


85445.004

increase in addiction treatment admissions for individuals primarily abusing prescription pain 

relievers from 2000 to 2010. 10 

The ease of access to prescription drugs, combined with a low perception of risk, make reducing 

prescription drug abuse especially difficull particularly among youth. We all recognize that 

these drugs can be just as dangerous and deadly as illicit substances when misused or abused. 

The Federal Response 

Two years ago, 'With input fTOm our partners in the Federal Government, including the Food and 

Drug Administration and the Substance Abuse and Mental Health Services Administration 

(SAMHSA) of the Department of Health and Human Services (HHS), who are represented here 

today, the Obama Administration released the first comprehensive action plan to combat the 

prescription drug abuse epidemic, the Prescription Drug Abuse Prevention Plan. 

The first pillar of the Plan outlines the Administration's support for expanded education for the 

public, patients, and prescribers. As many health care providers would agree. managing a 

patient's pain is a crucial and often very ditllcult task. However, research indicates that students 

in medical school reccive on average only II hours of training on pain and pain management, 

and most schools do not offer specific training on opioids, substance abuse and addiction, or 

clinical decision making.: 1 A 2011 Government Accountability Office report on education 

efforts related to prescription pain reliever abuse found that "most prescribers receive little 

training on the importance of appropriate prescribing and dispensing of prescription E,ain 

relievers. on how to recognize substance abuse in their patients. or on treating pain." " It is clear 

that training can prepare our health care providers to adequately address pain management, 

substance abuse, alld responsible prescribing practices. 

For these reasons, the Plan includes a core action to promote mandatory education on proper 

prescribing and addiction potential for prescribers and dispensers of these controlled substances. 

Training is an important public health measure, and the Administration continues to support 

mfmdatory education for prescribers, as reiterated in the 2013. National Drug Conlrol Stralegy. 

Several states, including Iowa,13 Massachusetts,J4 and Utah,J, have passed legislation requiring 

prescriber education on this subject. 

)El Substance Abuse and Mental Health Servict!s Administ.'1ltion. Treatment Episode Data Set (l'£DSj Subslance Abuse Treatment Admissions by 

Primary SubSTance qf Ahuse. According 10 Sf/X. Age Group. Race, and Ethnicity. Untted States 1200n and 2010 tabJes]. U.s. Department of 

llealth and Human Serri ... 'Cs. !201:l Availablt!: h!-.mJf~yt\ygp;tl;:;A!?mi).~.!l,g('~~~~~r;.4,'~~:£Rtl?.D_Y~?lIo£llQ.Ql!..U:~<iL..!!.t,:1L~1sG~~1,a..l,=-LS. 

l! Me:r.ci. L, ci aL Pain Education in Nor:.h American Medica! Schools. The Journal cJPain. 12(l2):11.99~I2(J8. :Wl1. 

!~ i ~S Guvcrnmcnt Accountability Office. Prescription Pain RelwvL'r Abuse. fDe~mbt.'r }Oll]. Available: 

Dt.ttjl~T.::.\t,giE?,.g~;y./.?S!f.~1~2.9..QL?~lM.,pjl 

(~ h)wa B·oard of Medicinc. "New rules require physicians 10 complete training on chronic pain. cnd~of-lije care:' State: of Jowa, [August 2011J, 

.\vailable: 
15 


85445.005

ONDCP worked \\ith the National Institute on Drug Abuse at the IIBS National Institutes of 

Health to develop two free online continuing education training tools for health care 

professionals who prescribe opioid analgesics. Since these tools became available in October 

2012. ciinicians have completed nearly 50,000 hours of continuing medical education courses on 

the abuse potential of these medications and management of patients to whom they are 

prescribed. 

We are also working to educate the general public. ONDCP's National Youth Anti-Drug Media 

Canlpaign provides teen exposure to anti-drug messages through a combination of advertising 

(e.g., social media., Internet, and cinema) and public communications. The Media Campaign's 

"Above the Influence" brand (\\fww.abovetheinfluence.com), which is being transitioned to the 

Partnership at DrugfrL'C.org. is an important national tool for educating young people and their 

parents about the dfuigers of prescription drug abuse, among its many other drug prevention 

messages. ONDCP also manages the Drug Free Communities (DFC) Support Program, which 

provides grants to nearly 700 loeal drug·free community coalitions, enabling them to increase 

collaboration anlOng community partners, including local youth, parent, business. reiigious, 

civic, law enforcement, and other groups, to prevent and reduce youth substance use, including 

prescription drug abuse and misuse. Since DFC coalitions have identified preseription drug 

abuse as a growing problem and a priority for their communities, the DFC Program recently 

modified its four core measures to include prescription drug abuse prevention. Through 

prevention strategies. DFC coalitions use comprehensive approaches to address prescription drug 

abuse. such as raising awareness for preseribers, parents, and youth: organizing prescription drug 

disposal events: and developing systems for safe disposal of prescription drugs. 

The second pillar of the Plan focuses on strengthening Prescription Drug Monitoring Programs 

(PDMPs), state-administered databases that monitor the prescribing and dispensing of controlled 

substances. Infonnation contained in PDMPs may be used by prescribers and phannacists to 

identify patients who may be doctor shopping (seeing multiple doctors to obtain prescriptions), 

need substance abuse treatment, or are at risk for overdose. In accordance ,vith. state laws, PDMP 

infonnation may also be used by state regulatory and law enforcement officials to pursue cases 

involving "pill mills," prescribers or phannacists operating outside the bounds of proper practice, 

and other sources of diversion. In 2006, only 20 states had PDMPs. Today, 49 states have laws 

authorizing PDMPs; only Missouri and the District of Columbia are without legislation 

authorizing PDMPs, and 46 states have operational programs. 

But these important programs can function more effectively. For example, as of today. only 14 

state PDMJ's can share data with other PDMPs. We are working with our Federal partners to 

make these systems more user-friendly, so physicians and pharmacists can aceess them quickly 

and easily. For instance, SAMHSA and the HBS Office of the National Coordinator for Health 

lnfoIDlation Technology worked with health care facilities across the country to better integrate 

PDMPs into provider workflow, making these critical tools more accessible to tllose who need 

them. Ongoing support from the Bureau of Justice Assistanee at the Department of Justice, 

through thc Harold Rogers PDMP Program, is faeilitating ongoing efforts to enhanee 

interoperability anlong state systems. 

4 
16 


85445.006

These systems must continue to mature, and the Administration continues to invest and focus on 

expanding interstate data sharing, streamlining PDMP operations, and ensuring that data from 

prescribers in Federal agencies, such as the Department of Defense, Department of Veterans 

Affairs, and the Indian Health Service, are shared with state PDMPs. 

The third pillar of our plan focuses on safe disposal of unused and expired medications. 

Research shows that over 70 percent of people misusing prescription pain relievers in the past 

year report getting them from a friend or relative the last time they abused them. 16 Safe and 

proper disposal prograllls allow individuals to dispose of unneeded or expired medications in a 

safe, timely, and environmentally responsible manner. 

Since September 2010. Ule Drug Enforcement Administration (DEA) has partnered with 

hundreds of state and local law enforcement agencies and community coalitions, as well as other 

Federal agencies, to hold six ~ational Take-Back Days. Through these events, DEA has 

collected and safely disposed of more than 2.8 million pounds of unneeded or expired 

medications. As part of the Secure and Responsible Drug Disposal Act of 20] O. DEA recently 

published proposed regulations that, once finalized, will expand the safe and effective disposal of 

prescription drugs nationwide. ONDCP will work vvith Federal, state, local, and tribal 

stakeholders to identify ways to establish disposal programs in their communities upon 

completion of the rulemaking process, 

The final pillar of the Administration's plan focuses on improving law enforcement capabilities 

to reduce diversion. Federal law enforcement is partnering with state and local agencies across 

the country to reduce pill mills and prosecute those responsible for improper or illegal 

prescribing practices. The National Metha.-nphetamine and Pharmaceuticals Initiative G'JMPI), 

funded through ONDCP's High Intensity Drug Trafficking Areas (HIDTA) prof,'Tlill1, provides 

critical training on pharmaceutical crime investigations to law enforcement agencies across the 

country. rn FY 2012 alone, >JMPI provided training to nearly 6,600 law enforcement and 

criminal justice professionals. Also in 2012, NMPI helped convene five statewide prescription 

drug summits. These efforts disseminate critical knowledge to law enforcement and criminal 

justice professionals. 

Collaboration on this issue has included a broad range of stakeholders. We have worked with a 

number of associations and groups. including the National Governors Association, the National 

Association of Atiorneys General, the American Medical Association, the American Dental 

Association. Ule National Safety Council, the >Jational Conference of State Legislatures, the 

>Jational Association of Boards of Pharmacy, the Association of State and Territorial Health 

Officials, state medical boards, and countless community groups in states. localities. and tribes 

across the country. 

1(> Substance Abuse ?..nd Mem~i Health Services Administratkm, Results./rom the 201} A'ational Sun'e)' on Drug Use and Health: Summary of 

Available: 

5 
17 


85445.007

All of these groups and the constituencies they represent have recognized the urgency ofthi5 

national problem and are helping to bring about the changes we need to prevent more abuse, 

more arrests, and more deaths. 

There are signs that the national effort to reduce and prevent prescription drug abuse is working. 

The latest survey data show the number ofpeopJe 12 and older currently abusing prescription 

drugs has decreased significantly from 7.0 million in2010 to 6.1 million in2011, a 12 percent 

decrease. 1 i We also know that past month non-medical use of prescription drugs among young 

adults ages 18 to 25 was significantly lower in 2011 (5.0 percent) compared to just one year 

earlier (5.9 percent), a trend that is also true for the abuse of pain relievers among this age 

groUp.18 However, while these trends are promising, we know there is much more to do, 

particularly to address increasing rates of chronic nonmedical use of pain relievers. The 

frequency of chronic nonmedical use of pain relievers (nonmedical use of 200 days or more in 

the past year) among all users in the past year increased roughly 75 percent between 2002-2003 

and 2009-2010. This equates to almost I million people in the United States who reported using 

opioid analgesics nonmedically each year. 19 

The Administration is focused on addressing some oflhe most pronounced consequences of this 

epidemic, including overdose deaths and emerging issues like maternal addiction and neonatal 

abstinence syndrome (withdrawal symptoms due to a mother's substance use). The need for 

further partnerships on overdose prevention is underscored by evidence of increased heroin use 

in some areas of the country and increasing heroin treatment admissions among 18- to 25-yearolds (from approximately 43,000 in 2000 to approximately 68,000 in 2010).20 

With the recent rise in overdose deaths across the country,21 it is increasingly important that we 

make eertain everyone know overdoses can be prevented and that deaths can be avoided. We are 

working to expand access to naloxone, an emergency overdose reversal medication, for first 

responders who encounter overdose victims. 

For example, the Police Department in Quincy, Massachusetts, has partnered with that State's 

health department to train and equip police officers to resuscitate overdose victims using 

naloxone. Since October 2010, officers in Quincy have administered naloxone in more than 160 

overdose events. almo~'1: all of them resulting in successful overdose reversals.22 

;\faloxone is only one element in the broad range of overdose prevention efforts. The odds of 

surviving an overdose, much like the odds of surviving a heart attack, depend on ho\;; quickly the 

victim receives treatment. \Ve are also closely examining Good Samaritan laws, which immunize 

17 Substance Abuse and Mcntaf Health Services Administration, ResultsJrom [he 20111./a[ionai Survey on Drug V:,e cmd Health: Summary oI 

,\':aticmai Findings, (J.S, Department of Health and Huma.'1 Serviccs. [September 20 i2J. A vailab1e: 

htiJ1.;ibD~~",sifmh:-a POy!q.~~!.tiSl)lll:!!'6kJ1R~\,11t,'ilN .. s.LUJare;;ult~.J..,h1.mtf~ 

11< Suhstance Abuse fu1.d 1\:1cntal Health Seryices Ad. .. ninistratjon, Results/rom the 20] 1 j\;ational SWW!)' 011 Drug (/:te and Heaith: Summary q( 

Nationa! Fmdmgs. LI.S. Department of Hcaltb and Human Services, (September 20l2}. Available: 

h.tm;iL\\'\\'v.-.samfis?JW,1i@l&tNSDUIl/1kJ 1 Rcsult')f'NSDmJr;:i1J!Th:;',.Q..UJumll.~ 

,<> Jone~ eM, FrC'-qualcy of prescription pain reliever nonmedical use: 2002-:W03 and 2009-2010, Arch Intern Med, 2012~172( 16): 1265·1267 

~\l j(me!' eM Heroin use and ht."roir. use risk behaviors among nonmedical users of prescription opioid pain relievers -t initcd Statt"S_100:!-2004 

and 2008-20 I O. Drug Alcohol Dopend. 2013 Feb I L pii: S0376-8716fl3 )0\10 19-7. doi: !OJ 0 16!j.drugalcdcp.20133l I .iJm. ~! jOO¢$ eM et at Pharmaceutical Overdose Deaths, United Statcs_ 2010. JAMA 2013;309(7):65i-659. 

1.:: Quincy (\1A) Poil;:;L' D(~partment Reporting 

6 
18 


85445.008

from criminal prosecution individuals who arc overdosing and \,imesses on the scene who seek 

medical aid for t.l}ese individuals. These laws eliminate any potential fear of prosecution for drug 

use and thus facilitate seeking prompt medical attention if an individual is overdosing. Several 

states-including California. :s Illinois,24 and New Mexic025···-have passed Good Samaritan laws. 

As these laws are implemented. the Administration will carefully monitor their effect on public 

health and public safety. 

The Administration also recognizes that people who need treatment should have timely access to 

a broad array of services. especiaJly access to medication assisted treatments for opioid 

addiction. Fortunately. we have an array of proven interventions and medications to treat 

addiction. 

The Affordable Care Act ,,,,ill also help expand treatment services. The Affordable Care Act ",ill 

extend access to and parity for mental health and substance use disorder benefits for an estimated 

62 million Americans and help integrate substance use treatment into mainstream health care.26 

The health care law. therefore, gives many more Americans in need an opportunity to be treated. 

Conclusion 

We continue to work with our Federal. state, local, and tribal partners to accomplish all the goals 

of the Prescripiiol1 Drug Abuse Prevention Plan and address other emerging issues, such as the 

transition from prescription drugs to heroin. ensuring treatment for opioid abuse and misuse for 

pregnant women, and neonatal abstinence syndrome. 

Together with aU of yon. we are committed partners, working to reduce the prevalence of 

substance use disorders through preventioll, increasing access to treatment, and helping 

individuals recover from the disease of addiction. 

Thank you for the opportunity to testify here today, and for your ongoing commitment to this 

issue. I look fOf\vard to continuing to work willi you on this pressing public health matter. 

Affordable Care Act WlJI Expand Mental Health and Substance lise Disorder Benefits 

Research Brief. AssisJ.al'lt SecretUl"'Y for Planning and Evaluation !A.'lPE}. Washington. DC 

{Citation: AOSti4.ct (If the Brief found at b'ttp://aspe.hhs.gov/healthlreporl<;;'2{) 13!mentailrb _ mentatcfm) 

7 
19 

Mr. PITTS. The chair thanks the gentleman. 

Dr. Throckmorton, you are recognized for 5 minutes for an opening statement. 

STATEMENT OF DOUG THROCKMORTON 

Dr. THROCKMORTON. Mr. Chairman and members of the subcommittee, I am Dr. Douglas Throckmorton, Deputy Director for 

Regulatory Programs in the Center for Drug Evaluation and Research at the FDA. Thank you for your opportunity to be here 

today to discuss the misuse and abuse of prescription drugs, especially prescription opioids. 

The importance of this problem is hard to overstate. Beyond the 

sobering statistics are individuals and their families whose lives 

have been shattered by prescription opioid misuse, abuse, and addiction. It is a crisis that affects us all, and meaningful and enduring solutions will require all of our collective efforts. 

Balancing the needs of patients suffering from pain with the 

need to combat opioid misuse, abuse, and addiction is a priority for 

the FDA and for me personally. In seeking this balance, FDA has 

pursued a targeted, science-based approach aimed at critical points 

in the development and use of opiod medications. While additional 

work remains to be done, I would like to mention some of the activities FDA is doing now. 

First, we are a science-based agency and are focusing on improving the safe use of pain medicines. These activities include recent 

work we have done to encourage the development of abuse-deterrent drug formulations for opioids. The FDA believes the development of these new formulations to successfully deter abuse is an 

important part of our efforts to improve their safe use. 

For example, in January of this year, the FDA issued a draft 

guidance document for industry outlining the development of 

abuse-deterrent opioid drug products. And in the fall, the FDA will 

participate in a public meeting to discuss the issues addressed in 

that draft guidance, as well as issues surrounding the development 

of abuse-deterrent formulations for generic drug products. 

In addition, the FDA has taken recent regulatory actions concerning two opioid products, OxyContin and Opana ER, that were 

reformulated with the intention of making the products more difficult to manipulate and abuse. The data for these two products 

were reviewed carefully and independently by FDA scientists and 

resulted in a change in the labeling for OxyContin. Our decisions 

relied on the totality of the evidence for the particular drug at 

hand, and given where we are in the evolving science of abuse deterrence, were made on a case-by-case basis. 

A second critical area where we have devoted time and resources 

is the development of effective patient and prescriber education. 

The interaction between prescribers and patients plays a critical 

role in improving the safe use of these drugs and the FDA has 

taken a number of steps to improve the educational materials that 

are available for patients and prescribers. 

For example, in July of 2012 we approved a risk evaluation and 

mitigation strategy, known as REMS, for manufacturers of over 20 

extended-release and long-acting opioids. Under this REMS, manufacturers are required to support the development of effective preVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
20 

scriber training programs offered by accredited continuing education providers and to make them available at little or no cost to 

health care professionals. The training is based on a syllabus developed by the FDA with input from other stakeholders. We are currently posting those educational materials on our Web site to make 

them easier for prescribers to find and make use of. 

A third critical area where we have devoted time and resources 

is on ways to prevent the overdose deaths associated with prescription opioids by improving the treatment of overdose. Naloxone is an 

injectable medication that is the standard treatment to rapidly reverse the overdose of either prescription or illicit opioid. And when 

given quickly, it can and does save lives. 

At a public meeting the FDA convened last year with several 

other parts of the Federal Government, stakeholders encouraged 

the exploration of new ways to administer naloxone that may be 

easier than currently available, such as auto-injectors or via 

intranasal administration. In this area, FDA is working to provide 

regulatory priority assistance to manufacturers, who are working 

on assessing these new ways to give naloxone. 

To finish my remarks, our society faces two important challenges. We must balance efforts to address the misuse, abuse, and 

addiction that harms our families and communities and the need 

for appropriate access to pain medications for patients that need 

them. There can be no doubt there is much to be done and that 

we must act now. These are not simple issues and there are no 

easy answers. Given the complexity of the issues surrounding this 

problem, real and enduring progress will require a multifaceted approach combined with the dedication, persistence, and full engagement of all parties. 

FDA continues to prioritize our efforts in this area to combat this 

significant public health crisis. We welcome the opportunity to 

work with Congress, our federal partners, the medical community, 

advocacy organizations, patients, and families to turn the tide on 

this devastating epidemic. 

Thank you for your continued interest in this important topic 

and for the opportunity to testify regarding FDA’s contributions on 

this issue. I am happy to answer any questions you have. 

[The prepared statement of Dr. Throckmorton follows:] 

21 


85445.009

rtU~~", (:::!f.. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

STATEMENT 

OF 

Food and Drug Administration 

Silver Spring, MD 20993 

DOUGLAS C. THROCKMORTON, M.D. 

DEPUTY DIRECTOR FOR REGULATORY PROGRAMS 

CENTER FOR DRUG EV ALUA TION AND RESEARCH 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

"EXAMINING THE FEDERAL GOVERNMENT'S RESPONSE TO THE 

PRESCRIPTION DRUG ABUSE CRISIS" 

June 14,2013 

RELEASE ONLY UPON DELIVERY 
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INTRODUCTION 

Mr. Chairman, Ranking Member Pallone, and Members of the Subcommittee, I am 

Dr. Douglas Throckmorton, Deputy Director for Regulatory Programs in the Center for Drug 

Evaluation and Research at the Food and Drug Administration (FDA or the Agency), which is 

part of the Department of Health and Human Services (HHS). Thank you for the opportunity 

to be here today to discuss the epidemic of misuse, abuse, and diversion of prescription drugs, 

especially prescription opioids, in the United States. 

This is a problem that has cast a terrible shadow across our nation and led to a public 

health crisis of devastating proportions. It is a crisis that has affected us all, and meaningful 

and enduring solutions will require all of our collective efforts. 

Many of us are all too familiar with the numbers associated with this epidemic. 

According to the latest estimates from the Centers for Disease Control and Prevention (CDC), 

in 2010, prescription opioid drugs were involved in 16,650 overdose deaths, a 313 percent 

increase over the past decade. And the Substance Abuse and Mental Health Services 

Administration (SAMHSA) reports that for each death, there are an additional nine treatment 

admissions,l 32 emergency department visits, 2 and 734 non-medical users of these drugs. 3 

Although the problem partly is attributable to inappropriate or illicit use, such as sharing 

1 Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and 

Quality. Treatment Episode Data Set (TEDS): 2000-2010. National Admissions to Substance Abuse Treatment 

Services. DASIS Series S-61, HHS Publication No. (SMA) 12-4701. Rockville, MD: Substance Abuse and 

Mental Health Services Administration, 2012. 

2 Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and 

Quality, SAMHSA, Drug Abuse Warning Network, 2010 available at 

http://11'ww.samhsa.g01:·dataidmrn/nalions!Nalion_20II .. AIIMA.xls. 

3 Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and 

Quality. Results from the 2011 National Survey on Drug Use and Health: detailed table 1.1 A (HHS Publication 

No. SMA 12-4713, NSDUH Series H-44). Rockville, MD: Substance Abuse and Mental Health Services 

Administration, 2012. 

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medication with family and friends or theft of the drug from home medicine cabinets, 

legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, 

and death for some patients. Beyond these grim statistics, we find individuals and their 

families whose lives have been shattered by prescription opioid abuse, misuse, and addiction. 

We playa critical role in the development, review, and approval of drugs. FDA reviews 

applications for opioid medical products, requires accurate drug prescribing information, and 

monitors how these products are used once they go to market-and a balance must be struck 

between their benefit in treating patients and the risks associated with misuse, abuse, and 

addiction to those patients and to others. 

Combating opioid misuse, abuse, and addiction has long been a priority for the Agency, 

and FDA has taken many steps to address this problem over the last few decades. We have 

taken action to build upon existing initiatives and develop new ones, including establishing a 

task force to focus on this critical issue. 

Over the last decade or so, FDA has worked to pursue a targeted, science-based, multipronged approach that addresses misuse, abuse, and addiction at critical points in the 

development of an opioid product and in its use throughout the health care system. This 

comprehensive approach includes five broad areas: 

• Encouraging scientific work into the development of safe and effective treatments for 

pain and into the most appropriate uses of pain medicines; 

• Encouraging the development of abuse-deterrent drug formulations for opioids; 

• Working to improve the appropriate use of opioids to treat pain through prescriber and 

patient education; 

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• Evaluating opioid labeling, and 

• Improving the availability of products that treat abuse and overdose. 

Research, Scientific, and Development Needs 

As a scientific and public health regulatory agency, FDA's approach to regulation of 

prescription opioids must be grounded in science; specifically, we must bring to bear the best 

available knowledge and understanding concerning both the treatment of pain and potential 

adverse consequences of opioid use. FDA has long been committed to obtaining the best 

information possible about the appropriate and safe use of opioid drugs in pain management. 

For example, we held ajoint meeting with the National Institutes of Health last May on what 

is known scientifically about the efficacy of opioids in treating chronic non-cancer pain. And 

we are continuing to work with academics and other scientists to ensure that we have reliable 

data to guide FDA's decision-making on these complex and challenging issues. 

The Food and Drug Administration Safety and Innovation Act (FDASIA, Pub. Law 

112-144) required FDA to "hold a public meeting to solicit advice and recommendations to 

assist in conducting a scientific and medical evaluation in connection with a scheduling 

recommendation to the Drug Enforcement Administration (DEA) regarding drug products 

containing hydrocodone, combined with other analgesics or as an antitussive." That meeting 

took place on January 24-25,2013. The Advisory Committee was provided data and heard 

presentations from various experts, and then the majority of the Committee voted to 

recommend rescheduling hydrocodone combination products from Schedule III to Schedule 

II. 

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FDA also received and is in the process of reviewing 768 comments from the publicpatients, parents, and health care professionals such as dentists, nurse practitioners, 

ophthalmologists and physicians-expressing their views on rescheduling. The data provided 

at the meeting, public comments, and the Committee's recommendation will help inform 

FDA's scheduling recommendation. 

Abuse-deterrent Formulations 

The continued development of opioids that are specifically formulated to deter abuse 

is an important component of our twin goals of minimizing abuse and misuse of prescription 

opioids while maintaining and improving access to these medications for patients who need 

them. Abuse-deterrent formulations target known or expected routes of abuse, such as 

crushing the product or extracting the active ingredient from the product to facilitate rapid 

release of the opioid following swallowing, snorting, or injection. 

FDA is working to encourage the development of abuse-deterrent forms of opioid 

medicines. First, in January of this year, FDA issued a draft guidance document on the 

development of abuse-deterrent opioid drug products, as required by FDASIA. The draft 

guidance sets forth FDA's current thinking regarding the studies that should be conducted to 

demonstrate that a given formulation has abuse-deterrent properties, how those studies will be 

evaluated by FDA, and what labeling claims may be approved based on the results of those 

studies. FDA will participate in an upcoming public meeting to discuss the issues addressed 

in the draft guidance on September 30 and October 1,2013. 

FDA has also recently taken regulatory actions regarding two opioid productsOxyContin and Opana ER-that were reformulated with the intention of making the products 
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more difficult to manipulate for purposes of abuse. The regulatory implications have been the 

subject of independent, extensive consideration by FDA experts over the course of many 

months. Our decisions took into account the totality of the evidence for the particular drug at 

issue and were made on a case-by-case basis. 

First, on April 16,2013, FDA approved updated labeling for Purdue Pharma L.P.'s 

reformulated OxyContin that describes its abuse-deterrent properties; specifically, the new 

labeling indicates that the product has physical and chemical properties that are expected to 

make abuse via injection difficult and reduce abuse via the intranasal route (snorting). The 

Agency also decided that the company's original formulation had been withdrawn for safety 

or effectiveness reasons, because it posed an increased potential for abuse by snorting and 

injecting, compared to reformulated OxyContin. As a result, FDA will not approve any 

generic versions of the original formulation ofOxyContin. 

Second, on May 10,2013, FDA determined that the original formulation ofOpana ER 

was not removed from the market for safety or effectiveness reasons, because the available 

evidence was insufficient to conclude that the original formulation had an increased potential 

for abuse compared to reformulated Opana ER. While there is an increased ability of the 

reformulated Opana ER to resist crushing relative to the original formulation, study data show 

that the reformulated version's extended-release features can be compromised when subjected 

to other forms of manipulation, such as cutting, grinding, or chewing, followed by 

swallowing. As a result, FDA will not take steps to remove existing generic versions of the 

original formulation from the market and will continue to approve such generics, so long as 

they meet all applicable requirements. 

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Although these actions had different outcomes based on the science presented, they 

demonstrate that FDA can and will act in this area to exercise our regulatory authority to 

protect the public health. While we intend to take a flexible, adaptive approach to the 

evaluation and labeling of potentially abuse-deterrent products, we will be driven by science 

and the data presented to us for each product to ensure that products that claim to be abusedeterrent actually deter abuse. 

While we recognize that abuse-deterrent formulations are not a panacea, they are an 

important part of a multi-faceted approach to the epidemic of prescription drug abuse. 

Prescriber and Patient Education 

Prescribers and patients both playa critical role in preventing the abuse and misuse of 

opioids, and FDA has taken a number of steps to educate these groups. On March I, 2013, 

FDA issued an open letter asking all prescribers of opioids to ensure that they have a thorough 

knowledge of the FDA-approved product labeling for the opioids they prescribe and to ensure 

that they have adequate training in opioid therapy. The letter was supported by the American 

Medical Association, American Academy of Family Physicians, and other leading health 

professional groups. 

The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug 

Administration Amendments Act of2007, authorizes FDA to require sponsors to develop and 

comply with risk evaluation and mitigation strategies (REMS) when necessary to ensure that 

the benefits of a drug outweigh the risks. In July 2012, after a three-year effort, FDA 

approved a REMS for manufacturers of over 20 extended-release and long-acting (ERlLA) 

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opioids. This REMS acknowledges that our nation's front-line health care professionals play 

an important role in efforts to reduce the abuse and misuse of opioids. 

It is also critically important to improve prescribers' knowledge about the best uses of 

opioids, including knowing when these products should be used and by which patients. Thus 

prescriber education is an important element of this REMS for ERILA opioids. Under the 

ERILA opioid REMS, manufacturers are required to ensure that prescriber training 

programs-offered by accredited continuing education providers-are made available for all 

U.S.-licensed prescribers, using a syllabus developed by FDA with input from many 

stakeholders. As a part of our assessment of this REMS, these courses will be audited to 

ensure that they are unbiased and accurate. 

The first of these voluntary prescriber training programs was rolled out on March 1, 

2013, and others will soon follow. Training is an important public health measure, and the 

Administration continues to support mandatory education for prescribers, as called for in the 

2013 National Drug Control Strategy. 

Finally, FDA tries to use its platform as a public health agency to educate patients and 

prescribers about the appropriate use and potential risks of drugs. In addition to training for 

prescribers, patients also need access to educational materials to help guide the use of opioid 

medicines. Under the REMS for ERILA opioids, manufacturers have developed a patientfriendly counseling tool for prescribers to give to every patient, when they write a prescription 

for an ERILA opioid. The REMS also includes a product-specific Medication Guide to be 

provided to the patient when they pick up their prescription. Included in these materials is 

information on how to safely store medications, while it is still in use, and what to do with the 

leftover supply, when it is no longer needed. Given the importance of educating patients, we 

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are also partnering with other groups. For instance, FDA and SAMHSA are working with the 

National Council on Patient Information and Education in a patient education campaign 

aimed at teenagers and college students. 

Opioid Labeling 

The primary tool that FDA uses to inform prescribers about the approved uses of 

medications is the approved product labeling (or package insert). The approved information 

is based on scientific and clinical information gathered about the drug, including clinical 

pharmacology studies, animal studies, clinical studies and post-market experience. It is 

important to note that FDA does not regulate the practice of medicine, and how an opioid 

product is prescribed is dependent on the prescriber's assessment of the benefits and risks to a 

particular patient based on factors, including the patient's pain management needs. 

Over the past several years, FDA has made many changes to opioid product labeling 

in an effort to improve their proper use and to reduce their misuse and abuse. Today these 

labels have some of the most restrictive language that can be found in drug labeling, including 

a boxed warning about their potential for abuse, which calls attention to serious or lifethreatening risks. In response to calls to further restrict the indications for these products and 

make changes to the labeling, we have held public meetings as recently as February of this 

year to get input on opioid labeling and identify what data exist that could inform further 

review of the labeling. We are currently reviewing that information and comments from 

stakeholders to determine whether additional changes are appropriate. 

Finally, with regard to improving the labeling for opioids, FDA agrees that opioid 

exposure from misuse or abuse can create significant problems for mothers and infants and 

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that the labeling needs to be accurate. Current FDA-approved labeling for opioid medications 

addresses the effects of in utero exposure on neonates and advises against the use of opioids 

in women during and immediately prior to labor and delivery. Labeling also addresses the 

effects of opioid exposure to newborns of mothers who continue to use opioids while nursing. 

Recently, the dangers of opioid withdrawal in infants born to mothers who were using opioids 

have been raised, and FDA is reviewing the labeling of opioids to ensure that it accurately 

reflects the available data on the effects of opioid exposure in pregnant and nursing women 

and their infants. 

Products to Treat Overdose and Abuse 

Finally, FDA has been working with many other stakeholders to explore the best ways 

to treat overdoses of opioids, including overdoses of FDA-approved opioid medications. In 

2009 and 20 I 0, over 15,000 people died from an overdose involving opioid medications. 

Naloxone is an injectable medication that is the standard treatment to rapidly reverse the 

overdose of either prescription (e.g., oxycodone) or illicit (e.g., heroin) opioids. Naloxone is 

most commonly used by trained medical personnel in emergency departments and on 

ambulances. There is a growing interest by prescribers and patients in exploring the broader 

uses of naloxone, including its use in non-medical settings such as nursing homes. 

FDA, working with other parts of the Federal Government, is looking at how naloxone 

may be delivered safely in ways that are potentially easier to use and do not require needles or 

syringes. Any such product would be subject to FDA review. FDA is providing priority 

regulatory assistance to manufacturers who are working on new ways of giving naloxone, 

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using auto injectors or intra-nasally, that would be easier to use in non-medical settings. FDA 

approval would be contingent on the safety and effectiveness ofthe new product. 

CONCLUSION 

In summary, we face an ongoing challenge and a dual responsibility-we must 

balance efforts to address misuse, abuse, and addiction that harm our families and 

communities against the need for appropriate access and the pain management needs of 

patients who rely on these important medications. There can be no doubt that there is much to 

be done--and we must act now. In my testimony I have discussed some of the many 

activities that FDA is working on in this area. These are not simple issues and there are no 

easy answers. Given the complexity of the issues surrounding the abuse, misuse, and 

addiction to prescription painkillers, real and enduring progress will require a multi-faceted 

approach combined with the dedication, persistence, and full engagement of all parties. We 

welcome the opportunity to work with Congress, our Federal partners, the medical 

community, advocacy organizations, and the multitude of interested communities and families 

to tum the tide on this devastating epidemic. 

Thank you for your continued interest in this important topic and for the opportunity 

to testifY regarding FDA's contributions to progress on this issue. I am happy to answer any 

questions you may have. 

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Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman, Dr. Clark, for 5 minutes for an opening statement. 

STATEMENT OF H. WESTLEY CLARK 

Dr. CLARK. Good morning, Chairman Pitts, Congresswoman 

Schakowsky, and members of the subcommittee. I am Dr. H. 

Westley Clark, and I am the director of the Center for Substance 

Abuse Treatment within the Substance Abuse and Mental Health 

Services Administration. Thank you for inviting me to testify today 

regarding SAMHSA’s role in preventing non-medical use of prescription drugs and treating individuals who abuse those drugs. 

SAMHSA’s mission is to reduce the impact of substance abuse 

and mental illness on America’s communities. We envision a nation 

that acts on the knowledge that behavioral health is essential for 

our health, prevention works, treatment is effective, and people recover. 

The challenge of prescription drug misuse and abuse is a complex 

issue that requires epidemiological surveillance, interventions, prescriber education, access to effective treatment services, and continued research by the private and public sectors. SAMHSA’s strategy 

to reduce prescription drug misuse and abuse aligns with the fourpart strategy of ONDCP. We work across the U.S. Department of 

Health and Human Services by participating in the Behavioral 

Health Coordinating Committee’s Prescription Drug Abuse Subcommittee. We are in active partnerships with the CDC, the FDA, 

the Office of the National Coordinator of Health Information Technology (NIH), and others aimed at preventing and treating prescription drug misuse and abuse. 

According to our 2011 National Survey on Drug Use and Health, 

nonmedical use of prescription drug ranks as the second-most common illicit class of drugs in the United States. You have mentioned 

these data and there is no need for me to repeat it, but it is important to know that there was a slight decline in nonmedical use between 2010 and 2011, which suggests that the national, state, and 

local efforts to reduce prescription drug misuse may be having an 

impact, but there is still much work to be done. 

State Prescription Drug Monitoring Programs, or PDMPs, are an 

important component in government efforts to prevent and reduce 

drug diversion and abuse. PDMPs monitor and analyze scheduled 

prescription drugs with the goal of preventing prescription drug 

misuse and abuse, as well as illegal diversion. 

In 2005, the National All Schedules Prescription Electronic Reporting Act, or NASPER, created a Department of Health and 

Human Services grant program administered by SAMHSA for 

States to implement or enhance PDMPs. NASPER received funding 

from Congress in fiscal years 2009 and 2010, which resulted in 

SAMHSA providing 26 grants to 14 States. However, in fiscal years 

2011 and ’12, Congress did not appropriate funding for the 

NASPER program. 

In 2011, SAMHSA funded the enhanced access to PDMPs 

through Health IT Project which was managed by ONC in collaboration with SAMHSA’s CDC and ONDCP. The project was unlike 

the NASPER grants in that its purpose was to use health IT to increase timely access to PDMP data. 

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In 2012, the PDMP Electronic Health Record Integration and 

Interoperability Expansion program was funded by SAMHSA. This 

program complements existing federal efforts by improving realtime access to PDMP data through the integration of PDMPs into 

existing technologies such as electronic health records. 

SAMHSA has also engaged in the efforts to prevent and treat 

prescription drug misuse and abuse through education programs 

for prescribers and future prescribers, prevention and early intervention programs, treatment of prescription drug abuse, as well as 

through regulation. We support the education of current prescribers through continuing medical education courses and other 

less formal efforts such as webinars. 

The Screening, Brief Intervention, and Referral to Treatment 

program is an important tool for the early identification of persons 

who might be at risk for opioid abuse and other substance use. 

SAMHSA provides grants to States, territories, and tribal organizations to implement SBIRT for adults in primary care. We have a 

residency grant program through SBIRT to address future prescribers and include screening for prescription drugs. 

We support prevention and early intervention through several 

other grant programs. Our block grant program is targeted toward 

funding to States and territories for their prevention and treatment 

and services efforts. The Strategic Prevention Framework Partnerships for Success program is designed to address two of the Nation’s top substance abuse prevention priorities, including underage 

drinking and prescription drug misuse and abuse among persons 

aged 12 to 25. 

We work with ONDCP on our Drug-Free Communities efforts in 

collaboration to make sure that communities can prioritize prescription drug abuse. We are working with other federal agencies 

to explore telemedicine to address the need for increased access in 

rural settings. Our strategy to reduce prescription drug misuse includes the expansion of improved access to treatment, the Drug Addiction Treatment Act of 2000 permits qualified physicians to prescribe certain medications for the treatment of opioid addiction in 

outpatient settings. 

We also regulate opioid treatment programs that use methadone 

and buprenorphine approved by FDA to treat patients with opioid 

dependence. We are working in collaboration with the DEA. 

Through these and other efforts, SAMHSA is working daily to 

address the issue in order to reduce the significant long-term impacts of this serious public health problem. Thank you for the opportunity to testify regarding SAMHSA’s efforts in this area and I 

welcome any questions that you might have. 

[The prepared statement of Dr. Clark follows:] 

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85445.020

Testimony Before the 

The Energy and Commerce Subcommittee on Health 

on Prescription Drug Abuse 

June 14,2013 

Statement ofH. Westley Clark, M.D., J.D., MPH 

Director, Center for Substance Abuse Treatment 

Substance Abuse and Mental Health Services Administration 

U.S. Department of Healtb and Human Services 
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Good morning Chairman Pitts, Ranking Member Pallone, and Members of the Subcommittee. 

My name is Dr. H. Westley Clark, and I am the Director of the Center for Substance Abuse 

Treatment within the Substance Abuse and Mental Health Services Administration (SAMHSA), 

an agency ofthe Department of Health and Human Services (HHS). I am pleased to address 

SAMHSA's role in preventing non-medical use of prescription drugs, and treating individuals 

who abuse prescription drugs. 

SAMHSA's Role 

SAMHSA was established in 1992 and is directed by Congress to effectively target substance 

abuse and mental health services to the people most in need of them, and to translate research in 

these areas more effectively and more rapidly into the general health care system. SAMHSA's 

mission is to reduce the impact of substance abuse and mental illness on America's communities. 

SAMHSA strives to create awareness that: 

• Behavioral health is essential for health; 

• Prevention works; 

• Treatment is effective; and 

• People recover from mental and substance use disorders. 

SAMHSA serves as a national voice on mental health and mental illness, substance abuse, and 

behavioral health systems of care. It coordinates behavioral health surveillance to better 

understand the impact of substance abuse and mental illness on children, adults, and families, as 

well as the costs associated with treatment. SAMHSA helps to ensure dollars are invested in 

evidence-based and data-driven programs and initiatives that result in improved health and 

resilience. 

The challenge of prescription drug misuse and abuse is a complex issue that requires 

epidemiological surveillance, distribution chain integrity, interventions, prescriber education, 

access to effective treatment services, and more research by the private and public sectors. Thus, 

no organization or agency can address the problem alone; a coordinated response is required. 

The Federal Government, medical partners, public health administrators, state governments, and 

international organizations all are needed to implement educational outreach and intervention 

strategies targeted to a range of discrete audiences, including physicians, pharmacists, patients, 

educators, parents, high school and college students, adults at high risk, older adults, and many 

others. Outreach to physicians as well as pharmacists needs to be complemented by education, 

screening, intervention, and treatment services for those misusing or abusing prescription drugs. 

SAMHSA's strategy to reduce prescription drug abuse and assist individuals who misuse or 

abuse prescription drugs is in alignment with the Office of National Drug Control 

Policy's (ONDCP) four-part strategy: education for prescribers, patients, and the public; 

prescription monitoring; safe drug disposal; and effective enforcement. SAMHSA works across 

the Department of Health and Human Services through the Behavioral Health Coordinating 

Committee's (BHCC) Prescription Drug Abuse Subcommittee. As a result, SAMHSA has 

partnerships with the Centers for Disease Control and Prevention (CDC), the Food and Drug 

Administration (FDA), the National Institutes of Health, the Centers for Medicare & 

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Medicaid Services, the Office of the National Coordinator for Health Information 

Technology (ONC), the Office of the Assistant Secretary for Health, and the Office of the 

Assistant Secretary for Planning and Evaluation aimed at preventing and treating prescription 

drug misuse and abuse. SAMHSA is represented on the ONDCP Interagency Workgroup on 

Prescription Drugs. 

Prevalence of Non-medical Prescription Drug Use 

SAMHSA's National Survey on Drug Use and Health (NSDUH) is an integral part of our 

national surveillance of non-medical use of prescription drugs. According to 2011 NSDUH data, 

nonmedical prescription drug use ranks as the second most common class of illicit drug use in 

the United States.! The NSDUH found that in 2011, 1.9 million persons aged 12 or older 

initiated non-medical use of prescription pain relievers in the preceding year. Marijuana was the 

only illicit drug with more initiates in 2011.2 The 2011 NSDUH also found that males were 

more likely than females to report non-medical prescription pain reliever use in the preceding 

year, and young adults (18 to 25) had the highest rate of reported prior-year non-medical use.3 

The 2011 NSDUH also revealed that an estimated 54 percent of the prior-year non-medical 

users of prescription pain relievers obtained the drugs for free from a friend or relative. The 

next most common source was a single doctor (18 percent), followed by individuals who bought 

or took drugs from a relative or friend (17 percent). Other less-frequent sources included buying 

drugs from a drug dealer or other stranger, obtaining them from more than one doctor, and less 

than one percent reported getting them from the internet.4 

Recent data indicate that the rate of non-medical use declined slightly between 20 \0 and 20115 

and suggest that national, state, and local efforts to reduce prescription drug misuse may be 

beginning to have an impact. However, with an annual average of 15.7 million people aged 12 or 

older having misused prescription drugs between 2005 and 2011, there is still much work left to 

be done. 

State Prescription Drug Monitoring Programs 

State prescription drug monitoring programs (PDMPs) are an important component of 

government efforts to prevent and reduce controlled substance diversion and abuse. State 

PDMPs collect, monitor, and analyze scheduled or controlled prescription drugs, with the goal of 

preventing prescription drug misuse and abuse and illegal diversion. Forty-six states operate 

PDMPs; three states (Georgia, New Hampshire, and Maryland) have enacted PDMP-establishing 

ICenter for Behavioral Health Statistics and Quality. (2012). Resultsfrom the 2011 National Survey on Drug Use 

and Health: Summary of national findings (HHS Publication No. SMA 12-4713, NSDUH Series H-44). Rockville, 

MD: Substance Abuse and Mental Health Services Administration. The survey defined "non-medical use" as use 

without a prescription of the individual's own or use simply for the experience or feeling the drugs caused. 

'Id. 

'Id. 

'Id. 

'id. 

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legislation but do not yet operate PDMPs; and one state (Missouri) and the District of Columbia 

have not enacted legislation.6 

The National All-Schedules Prescription Electronic Reporting Act of2005 (NASPER) created a 

grant program administered by SAMHSA for states to implement or enhance PDMPs. 

SAMHSA received NASPER funding from Congress in Fiscal Year (FY) 2009 and FY 2010, 

and provided 26 grants to 14 states. In FYs 2011 and 2012, Congress did not appropriate 

funding for NASPER. 

In FY 201 I, SAMHSA also funded the Enhancing Access To PDMPs Through Health 

Information Technology Project, which was managed by ONC in collaboration with SAMHSA, 

CDC, and ONDCP. This project stems from joint efforts of public sector and private industry 

experts that participated in the White House Roundtable on Health Information Technology and 

Prescription Drug Abuse in June 20 II. In turn, the BHCC Prescription Drug Abuse and Health 

Information Technology Subcommittees created the "Action Plan for Improving Access to 

Prescription Drug Monitoring Programs through Health Information Technology.,,7 The 

project's purpose is to use health information technology (health IT) to increase timely access to 

PDMP data for three types of medical professionals within a variety of care settings: 

• Ambulatory clinic healthcare providers (e.g., physicians, nurses, nurse practitioners); 

• Emergency Department physicians; and 

• Dispensing pharmacists. 

The project set out to investigate and develop the standards necessary to utilize existing 

technologies, the health information exchanges, and the PDMPs to improve, with appropriate 

privacy protections, the tracking of opioid use by implementing pilot studies and establishing 

work groups. The first part of the project involving the work groups was completed, and a report 

was published summarizing the work groups' findings, in August 2012. 8 The second part of the 

project identified, developed, and implemented six pilots that tested new technology that links 

state PDMPs and providers' electronic health record (EHR) systems. The results demonstrated 

the value-add of increased access to state PDMP data at the point of care. For example, , pilot 

participants reported that the functionality streamlined their clinical workflows, made PDMP 

data easier to access, and helped better inform clinical decisionmaking. 

In FY 2012, SAMHSA and ONe extended the project, scaled up some of the existing pilots (i.e., 

increased the number of pilot sites or of states supplying PDMP data), and launched new pilots 

to test new types of data integration. In total, seven pilots were launched or expanded. 

Additionally, a website, "PDMPConnect" was developed that will serve as a nexus of resources 

for prescribers, dispensers, health IT developers, and PDMP-related organizations. 

PDMPConnect will be launched in the near future to provide ongoing information to the 

prescriber and dispenser communities about the types of data connectivity programs underway, 

identifY and provide the resources needed to create PDMPlhealth IT connections, and provide 

6 Status of Prescription Drug Monitoring Programs (PDMPs), PDMP Training & Technical Assistance Center, 

available at http://pdmpassist.org/pdf/pmpprogramstatus2013.pdf (last revised June 5, 2013). 

7 http://w\Vw.healthit.govlshesl defaultlfi leslrules-regulationl0630 12-final-action-plan-clearance.pdf. 

8 http://'Www.healthit.gov/sites/default/files/rules-regulationI063012-final-action-plan-clearance.pdf. 

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video stories, articles, and news flashes to educate and build awareness about the field. 

Moreover, the technical framework for POMP integration is being examined to address 

challenges in interoperability through the Standards and Interoperability Framework. 

In FY 2012, SAMHSA established the POMP Electronic Health Record Integration and 

Interoperability Expansion program, with $4 million in funding from the Prevention and Public 

Health Fund. Working collaboratively with the Harold Rogers Prescription Orug Monitoring 

National Training and Technical Assistance Program at the Oepartment of Justice (OOJ), this 

program complements existing Federal efforts by improving real-time access to POMP data 

through integration into existing technologies, like EHRs, to improve the ability of state POMPs 

to reduce the nature, scope, and extent of misuse. The program also strengthens currentlyoperational state POMPs by providing resources to make the changes necessary to increase the 

POMPs' interoperability. Nine states received funding to allow for system modifications to 

expand interoperabiJity; EHR and pharmacy system enhancement; adoption of specifications for 

exchanging POMP reports; and modification ofEHR and pharmacy systems to permit new 

linkages. COC will evaluate the program and report on the best practices developed and how 

they can be utilized by other states working to link POMPs to other health IT systems. 

In FY 2013, SAMHSA, using budget authority, anticipates awarding up to eight grants for EHR 

and POMP data integration. Unlike the FY 2012 grants, the FY 2013 program will not focus on 

state-to-state interoperability. The purpose of this program is to reduce prescription drug misuse 

and abuse by providing healthcare providers with access to POMP data to make sound clinical 

decisions without disturbing their regular clinical workflow. 

Finally, SAMHSA staff participates in projects with other agencies to increase PDMP use to 

identify emerging prescription drug abuse problems. 

Additional Efforts in Preventing and Treating Prescription Drug Misuse and Abuse 

Education 

Current prescribers: SAMHSA supports the education of prescribers through formal continuing 

medical education courses and other less formal efforts, e.g., webinars hosted by SAMHSA's 

opioid prescriber clinical support system (PCSS) grantee (the American Academy of Addiction 

Psychiatry). SAMHSA has prioritized these prescribing courses for states with the highest rates 

of opioid-related mortality (e.g., New Mexico, West Virginia). The PCSS-Opioids is a national 

mentoring network offering support (e.g., clinical updates, evidence-based outcomes, and 

training) to physicians and other medical professionals in the appropriate use of methadone and 

other opioids for the treatment of chronic pain and opioid addiction. This program also addresses 

the nation's rise in opioid-associated morbidity and mortality that has been spurred by 

misuse/abuse, and fatal drug interactions involving methadone and other prescription 

medications, over-the-counter medications, and illicit drugs. 

SAMHSA also supports the Medical Education and Supporting Services for Opioid Treatment 

Program to educate and prepare opioid treatment programs (OTPs) to achieve accreditation by 

SAMHSA ' s approved accreditation organizations. Accreditation has been shown to improve 

treatment outcomes and access to treatment for patients and provides the opportunity for OTPs to 

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incorporate best practices in their treatment programs. Other goals include improving OTP 

administration and management, increasing staff retention, providing more OTP staff training, 

increasing availability of comprehensive services and emergency services, and improving patient 

outcomes. 

SAMHSA also works with ONDep to provide outreach and disseminate educational materials to 

various sectors of our society that encounter this class of drugs. 

Educating future prescription drug prescribers: SAMHSA's Screening, BriefIntervention, 

Referral to Treatment (SBIRT) program is an important tool for early identification of persons 

who might be at risk for opioid dependency and other substance use disorders. SAMHSA's 

SBIRT Residency grant program addresses future prescribers and includes screening for 

prescription drug abuse, and more recently has emphasized the use of state PDMPs. 

The SBIRT program was established to engage health professionals in the identification, 

counseling, referral, and ongoing medical management of persons with substance use disorders. 

Through SBIRT, states, territories, and tribal organizations are eligible to receive grants to 

implement screening, brief intervention and referral to treatment services for adults in primary 

care and community health settings, for substance misuse and substance use disorders. This 

program is based on research showing that by simply asking questions regarding unhealthy 

behavior and conducting brief interventions, patients are more likely to avoid the behavior in the 

future and seek help if they believe they have a problem. In 2011, over 213,000 clients were 

served by the SBIRT Program. The percentage of clients reporting abstinence at follow-up 

tripled compared to the percentage reporting abstinence at baseline. 

Prevention and Early Intervention 

Substance Abuse Prevention and Treatment Block Grant Prevention Set-Aside: 

The Substance Abuse Prevention and Treatment Block Grant (SABG) is a formula-based grant 

provided to states and territories to provide financial support for its prevention and treatment 

programs and services. Federal statute requires states and territories to direct at least 20 percent 

of the SABG toward substance abuse prevention services. For many states and territories, this 

funding represents the vast mlYority of their substance abuse prevention budget. Under the 

SABG states are requested to identify the categories of substances, including prescription drugs, 

they intend to address with the 20 percent set-aside for prevention based on data collected and 

analyzed from statewide and local needs assessments. 

Strategic Prevention FrameworkIPartnerships for Success: The Strategic Prevention 

FrameworklPartnerships for Success (SPF/PFS) is designed to address two of the nation's top 

substance abuse prevention priorities, including underage drinking and prescription drug misuse 

and abuse among persons aged 12 to 25. Under this program, states and jurisdictions are funded 

to implement a strategic planning process and to use data to identify which of the two priorities 

will be addressed with this grant's funding. The majority (85 percent) of grant funding must be 

allocated to communities of high need, which then use the funds to enhance their communitylevel infrastructures using the strategic planning process; leverage, redistribute, and/or realign 

funds for prevention activities; implement a comprehensive prevention approach, including a 

mix of evidence-based programs, policies, and practices that best address selected prevention 

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priorities; identify technical assistance and training needs and develop responsive activities; and 

collect and report community-level data. The program is based on the premise that changes at 

the community level will, over time, lead to measurable changes at the state level. By working 

together to foster change, states and their SPF/PFS funded communities of high need can more 

effectively begin to overcome the challenges underlying their substance abuse prevention 

priorities and achieve the goals of the SPF/PFS. 

Drug-Free Communities: The Drug-Free Communities (DFC) program is a collaborative effort 

directed by ONDCP and administered by SAMHSA. DFC has two goals: 

I. Establish and strengthen collaboration among communities, public and private non-profit 

agencies, and Federal, state, local, and tribal governments to support the efforts of 

community coalitions working to prevent and reduce substance use among youth. 

2. Reduce substance use among youth and, over time, reduce substance abuse among adults 

by addressing the factors in a community that increase the risk of substance abuse and 

promoting the factors that minimize the risk of substance abuse. 

Grantees funded under DFC target prescription drug misuse and abuse if the data collected and 

analyzed in their respective communities indicate it is a problem that needs to be addressed. 

Prevention of Prescription Drug Abuse in the Workplace Technical Assistance: The Prevention 

of Prescription Drug Abuse in the Workplace (PAW) program provides technical assistance to 

SAMHSA grantees, employers, unions, and other communities and collaborates with partner 

organizations. PAW educational/technical assistance resources include fact sheets, online 

products, occupational-specific screening and assessment tools, presentations, trainings, and 

literature reviews. Topics such as developing specific workplace prescription drug abuse 

policies; integrating prescription abuse messaging into current programs and community 

outreach activities; and prescription drug abuse evaluation activities and metrics are addressed. 

Tribal Prescription Drug Summit: In response to tribal leaders' concerns about an increase in the 

use and abuse of prescription drugs in American Indian communities, SAMHSA co-sponsored a 

Tribal Prescription Drug Abuse Summit in June 2012. The summit brought together tribal 

leaders and representatives of the Health Resources and Services Administration, SAMHSA, 

area Indian Health Service providers, behavioral health directors, and representatives of the 

Great Lakes and National American Indian and Alaska Native Addiction Technology Transfer 

Centers. The goal of the summit was to discuss the tribal perspective on prescription drug abuse 

and the Federal efforts and programs to address the issue and to create an action plan to move 

forward. Topics focused on four pillars of the action plan: education, monitoring, disposal, and 

enforcement. Participants continue to assess the effectiveness of the four pillars of the action 

plan against prescription drug abuse. 

Prescription Drug Abuse Treatment 

Treatment of opioid dependence/addiction is a critical element ofSAMHSA's strategy and 

includes psychotherapeutic approaches such as cognitive behavioral therapy, as well as 

expanding and improving access to the three FDA-approved medical treatments: (I) methadone, 

7 
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which is regulated by FDA, SAMHSA, and DOl's Drug Enforcement Administration (DEA); 

(2) buprenorphine, for which SAMHSA and DEA together process waivers enabling physicians 

in outpatient settings to prescribe products for opioid dependence; and (3) oral and extendedrelease injectable naltrexone. SAMHSA also has been working with other Federal agencies to 

explore "telemedicine" enabling treatment in rural settings. SAMHSA is continuously educating 

providers and consumers about these medical treatments through educational efforts, the PCSS 

model referenced above, and interactions with provider communities. SAMHSA works with the 

FDA to ensure that the safety of these medications is continuously monitored and analyzed. For 

example, SAMHSA convened expert panels and work groups with the FDA to assess 

methadone's safety for cardiac health; methadone-overdose-related mortality; the risk of pediatric 

exposure to buprenorphine; and diversion of these medications for illicit or inappropriate use. 

SAMHSA convened a similar meeting to develop guidelines for the medicine Vivitrol, an 

injectable medicine indicated for monthly administration to treat opioid dependence. 

SAMHSA provides direct funding for the treatment of substance abuse, including prescription 

drug abuse. The SABG is the largest program; the President's FY 2014 Budget includes 

$1.8 billion for this program, of which 80 percent is for treatment (the other 20 percent is 

directed to prevention). 

Regulation and Certification 

SAMHSA regulates OTPs that use methadone and buprenorphine products approved by FDA to 

treat patients with opioid dependence (42 CFR Part 8). SAMHSA carries out this responsibility 

in coordination with DEA, states, the District of Columbia, and territories by enforcing 

regulations that established an accreditation-based system. 

The Drug Addiction Treatment Act of2000 (DATA) permits qualified physicians to prescribe 

certain opioid treatment medications for the treatment of opioid addiction in the outpatient 

setting. Under DATA, qualifYing physicians are "certified" to obtain waivers from the 

requirement under 21 U.S.C. § 823(g) to obtain approval from SAMHSA as OTPs. As of 

June 1,2013, there are 23,000 active DATA-certified doctors eligible to prescribe buprenorphine 

products, and 6,440 active physicians may prescribe for up to 100 patients. 

Conclusion 

As I stated earlier in my testimony, prescription drug misuse and abuse is a complex issue. It 

requires a concerted effort by many. SAMHSA's prevention and treatment strategies to address 

drug misuse and abuse are both targeted specifically to the prescription drugs themselves and to 

programs that support prevention, intervention, and treatment of addictions, which can have a 

significant long-term impact on this serious public health problem. 

Thank you for this opportunity. I welcome any questions that you may have. 

8 
42 

Mr. PITTS. The chair thanks the gentleman. The chair apologizes; 

we are trying to get the jackhammer to stop, but until that time, 

if you will please speak directly into the mike, we would appreciate 

it. 

Thank you for your testimony. I will begin the questioning and 

recognize myself for 5 minutes for that purpose. 

Director Kerlikowske, the ONDCP oversees and coordinates the 

many agencies involved in prescription drug abuse. Please describe 

the advantages and challenges that come with having so many 

agencies and departments involved in the fight against prescription 

drug abuse. 

Mr. KERLIKOWSKE. Congress clearly recognized the need for coordination, the fact that there are 15 primary federal agencies that 

all have a role in the drug issue. I don’t think anything is more 

complex or challenging than the prescription drugs. It is not like 

an issue where it is coming across the border; it is coming right out 

of our own medicine cabinets. The mere fact that it was not recognized as a significant problem except by subject matter experts in 

the health field, people that ran treatment programs, but generally, 

the public did not even begin to understand the magnitude of the 

prescription drug problem. 

We worked to bring everybody together to sit at the table and to 

develop a plan knowing that any one component, whether it was 

the law enforcement agencies, whether it was the regulatory agencies, that any one component would not be able to solve or at least 

significantly reduce this problem. 

Our partners, two of which are here, but a number of them are 

out as part of our program, all came together with one goal, and 

that is to reduce this tragedy not only in the loss of life but the 

expense, so we couldn’t be more pleased with 1) their cooperation, 

and 2) at least the inkling, as Dr. Clark said, of some success in 

this area. 

Mr. PITTS. Thank you. Dr. Throckmorton, generic versions of 

long-acting opioids without abuse-deterrent properties entered the 

market in January of this year. Does the Agency intend to monitor 

real-time data in order to evaluate whether such entry affects 

opioid abuse and how well real-time data like this will be utilized 

by the Agency now and in the future when the FDA is evaluating 

the science regarding claims of abuse deterrents? 

Dr. THROCKMORTON. Mr. Chairman, the goal that our agency has 

set is to incentivize the development of successful abuse-deterrent 

formulations and find ways to move them onto the market. Our intent is to set forth a roadmap that makes that successful, makes 

that happen in good time. Following up on that, we need to work 

to develop ways to move generics that also have abuse-deterrent 

technologies, make them possible to come onto the market as well. 

You asked about monitoring of the response of the marketplace 

to those sorts of decisions. We do watch that information. We have 

an Office of Epidemiology that focuses on marketing issues, as well 

as post-marketing safety issues. We use that information as we 

look at individual decisions to understand the impact that a decision that ours might have with regard to the use of products in the 

market. 

43 

Mr. PITTS. And to follow up, the FDA has committed, through the 

user fee process, to increase transparency and predictability around 

the drug review and approval process. Earlier this week, we wrote 

to DEA regarding delays in reviewing FDA scheduling recommendations for new drug approvals containing controlled substances. Does the Agency have recommendations on improving this 

process to address the issue of DEA delays? 

Dr. THROCKMORTON. It is an important question that we make 

sure that we have timely access to new medicines that are recommended for controlling, but we need to remember that the final 

decision about the controlling is made by the Drug Enforcement 

Administration under the Controlled Substances Act. My focus in 

the Center for Drugs has been to make certain that there is a timely scientific assessment from the FDA that can in fact work to inform that decision by the Drug Enforcement Administration. So 

what we have been doing is looking back at our process to make 

sure that it is as efficient and timely and scientific as possible so 

we get our recommendations in good order to the Drug Enforcement Administration through our Office of Assistant Secretary for 

Health, which is at the Health and Human Services level. 

Mr. PITTS. Thank you. Dr. Clark, can you discuss your relationship with the 46 States that operate Prescription Drug Monitoring 

Programs? 

Dr. CLARK. We are working in concert with the Department of 

Justice, the Harold Rogers program. We have, through our special 

initiatives, reached out to as many jurisdictions as possible so that 

we can link the PDMPs with electronic health records. 

As you know, as I mentioned, the NASPER program, which was 

targeted toward grants to States, has not been funded, so we have 

shifted our focus from that effort to looking at other technologies 

so that we can address the public health aspect of this by linking 

electronic health records to PDMPs so that we can have real-time 

data so that the practitioner in the clinic or in the emergency room 

has access to information about the client sooner than some of the 

delays associated with current State PDMP programs. 

We can’t wait 2 weeks to inform the clinician. We would like to 

be able to get that clinician real-time access to information so that 

they can make appropriate decisions about the care. Sometimes, it 

is someone who is running a scam on the doctor; sometimes, it is 

a patient who is having a reaction to the medication. So it is really 

useful to have real-time access to the clinical context of using prescription drugs. 

Mr. PITTS. The chair thanks the gentleman. My time is expired. 

And the chair recognizes the gentlelady from California, Mrs. 

Capps, for 5 minutes for questions. 

Mrs. CAPPS. Thank you, Mr. Chairman. 

And I am so glad we are here today having a hearing on an issue 

that really clearly cuts across party lines. 

Prescription drug abuse is a real and pervasive problem, and 

while it clearly impacts families and communities across our Nation, it also affects our health care system. However, I want to 

make sure that efforts to address this issue, important as they are, 

do not cause other problems, especially those regarding people with 

chronic pain. This is a delicate balancing act in a way. 

44 

Americans’ struggle with pain has been an important issue for 

me for many years. In 2007, I introduced the National Pain Care 

Policy Act and was pleased to see the part of it was included with 

the Affordable Care Act. As a result, the Institute of Medicine was 

directed to do a study on pain, and what they found is that pain 

is the most common reason people seek medical care. Over 160 million US adults suffer from chronic pain. The severity, duration, and 

disabling consequences of pain vary from person to person, as does 

the response to treatment. But pain accompanies a range of other 

clinical conditions, as all of you know, including cancer, diabetes, 

arthritis, and on and on. Access to medications is critical for these 

patients and survivors in order to complete other prescribed treatments and maintain other activities of daily living. And many 

medications prescribed to patients for acute pain, as well as chronic 

pain contain hydrocodone. So Dr. Throckmorton, as FDA reviews 

the potential rescheduling of hydrocodone-containing medications, 

does sufficient data and analysis exists about the potential impacts 

rescheduling could have on patient access to hydrocodone-containing medications? 

Dr. THROCKMORTON. Thank you, Congresswoman. First, let me 

say I agree with you. Finding a balance between the necessary access for pain medicines for patients that require them and addressing this crisis of abuse is absolutely essential, something that the 

FDA keeps in mind as we are thinking about our regulatory activities. With regard to assessing access to pain medicines, it is something we have worked on internally; it is something I have discussed with outside groups extensively. I know there are a number 

of people looking at better ways to measure that. 

There is a part of our REMS implementation that we put in 

place last year. For instance, we required to the manufacturers to 

assess the impact of that REMS on access to pain medications because we understand that it is an important aspect of our regulatory activities and whatever we end up deciding to do in the future. 

With regards to hydrocodone, Congress, in the recent Food and 

Drug Administration Safety and Innovation Act directed us to hold 

public hearing on hydrocodone and up-scheduling, and in that direction included language directing us to talk to patients and 

groups that had experience on the impact that this might have 

with regards to the up-scheduling of hydrocodone. We held that 

meeting. We have over 700 comments to the docket about that 

meeting that we are currently looking at. A large number of them 

comment on the effects that different activities might have as regards to access, something that we are reviewing as we think about 

making our decisions. 

Mrs. CAPPS. Thank you. And if there are access problems, could 

you elaborate—I know there is not much time left—but on the 

process available to individuals who are rightfully prescribed these 

medications but encounter problems accessing them? 

Dr. THROCKMORTON. The reason why they are having trouble getting the medicine would be important to understand. So if there is 

a drug shortage, for instance, and their challenge is getting a drug 

that is not available anywhere in their area, FDA has a drug shortage staff that I supervise, and we would love to hear from you. We 

45 

have a Web site. We would want to work with you to find other 

ways to make that pain medicine available to you. 

If it is due to lack of availability at a pharmacy or pharmacies 

near you, you know, because of concerns over scheduling or something like that, those things I would have a less clear answer on 

but I would suggest the Boards of Pharmacy or other local area 

groups like that might be somewhere to talk to. 

Mrs. CAPPS. Thank you. And, Mr. Chairman, I am about out of 

time and I didn’t even get to ask the other 2 members of the panel. 

This is such an important topic I think for us to be discussing, and 

I would certainly hope that this is just one hearing, that we have 

many more because I wanted to get into prevention, and that is a 

whole other topic and involved may be some other people, too, but 

you certainly are experts on this. We could certainly use some more 

hearings on this topic in my opinion. So thank you very much for 

scheduling this one. 

Mr. PITTS. The chair thanks the gentlelady, and this is just the 

first in a series of hearings we plan. 

The chair now recognizes the vice chairman of the Subcommittee, 

Dr. Burgess, for 5 minutes for questions. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And Mr. Kerlikowske, you sent a letter—you heard me reference 

the alignment of our policies with those to our neighbor to the 

north and you sent a letter about this. And you got Dr. 

Throckmorton over there diligently working on abuse deterrents 

and OxyContin, but how do we align our policies with Canada to 

prevent the older generic form from coming across the border? Because I, probably as we speak about this, I can see someone developing a business plan that would involve the importation of large 

amounts of generic OxyContin that didn’t have an abuse deterrent. 

Mr. KERLIKOWSKE. It is an important issue because the United 

States has done a lot to reduce the easy availability and also the 

fact that the opiod prescription painkillers here are not as easily 

manipulated, but the fact that Canada has that was of great concern to us. So early on, before they hit the market, we had written 

to the Health Minister. The Health Minister from Canada replied 

that she actually didn’t have the authorities within Canadian law 

to limit this, but she had not only heard from us; she had also 

heard from the provinces who were also concerned that this would 

be widely and easily available within the provinces. 

So we notified Customs and Border Protection first to identify 

and be aware of this in case they see these coming through. So far 

in Milwaukee that is the only location that we have received a report of seeing some of these, and it was not a great number of 

them. 

We have a meeting scheduled in July with our Canadian counterparts who will be here in Washington, D.C., and I will be traveling 

to Ottawa hopefully with a colleague from the Food and Drug Administration to also work with them. 

Mr. BURGESS. So you will be monitoring it? 

Mr. KERLIKOWSKE. Absolutely. 

Mr. BURGESS. And would you be averse to providing periodic reports to the staff of this committee—— 

Mr. KERLIKOWSKE. I would be happy to. 

46 

Mr. BURGESS [continuing]. About that ongoing effort? You know, 

let me just ask you on your four pillars in your testimony you 

talked about, the last pillar was the enforcement piece. And despite 

the salacious nature of the covers of this magazine, I submit to you 

that I can help you locate the bad actors. They advertise and it is 

not hard to pick them out of a crowd. So I hope you are focusing 

some efforts on disrupting the supply chain because, again, these 

people are not shy about telling you who they are and where they 

are and their hours of operation, their prices, and a discount coupon. 

Mr. KERLIKOWSKE. You can see certainly Broward County, Florida, was the kind of epicenter of this. They had 90 of the top 100 

prescribing and dispensing—— 

Mr. BURGESS. This magazine is from Broward County—— 

Mr. KERLIKOWSKE [continuing]. Opioids. 

Mr. BURGESS [continuing]. So I wasn’t going to identify the location, but since you did—Dr. Throckmorton, let me just ask you. Are 

there any efforts at the FDA to make naloxone an over-the-counter 

preparation like an inhaler or an autopen? 

Dr. THROCKMORTON. We think it is important to first understand 

how best to use the naloxone, so we are working as a part of a 

much larger group of federal agencies to understand the best uses 

of naloxone. As a regulator, my job in that discussion is not to decide as a policy how naloxone should be used, and instead, it is to 

lay out the regulatory pathway should a firm be interested in developing one of those products. So we have met regularly with the 

makers of autoinjector products, makers of inhalational products to 

lay out the pathways that are necessary for them to get approval 

as prescription products. 

At the meeting that we held last year, attended by NIDA, attended by the Office of National Drug Control Policy and SAMHSA, 

we heard loud and clear that there was a broad interest in moving 

naloxone to over-the-counter status. 

Mr. BURGESS. Yes, let me just interrupt you. I am not sure I 

agree with that, but we live in a world where levonorgestrel now 

is available over-the-counter with the Tootsie Rolls and Snickers 

bars. If interdiction and abstinence is not going to work in other 

areas, you know, maybe this is something that needs to be looked 

at because anyone who has ever seen the dramatic reversal of an 

amp of NARCAN on an opiate overdose will understand that you 

go from crisis to normal in the space of 26 seconds, and it is dramatic. 

Again, I am not saying that I advocate that, but I just wonder 

in this brave new world that we have entered, is that a consideration? So I hear that you are in fact entertaining that. 

Mr. Kerlikowske, I also have to mention about drug diversion, 

and you mentioned the 11 hours in medical school. You do learn 

a lot in your very first years in residency and practice, and I just 

recall very vividly when I was a resident at Parkland Hospital 

moonlighting at community hospitals, and someone would come in 

with a textbook description—in fact, they probably memorized the 

textbook—but a textbook description of renal pain—renal colic pain 

and were savvy enough to bite their lip and spit in the cup before 

they collected a specimen for you so they had blood in their urine 

47 

and fit the bill pretty quickly. And I know what it is, Doctor; I have 

an appointment with my urologist. I just need something to get me 

through the night. And about the fourth time you hear that story, 

you think, there is something fishy here. 

Of course, doctor shopping is a big problem and the doctors who 

are just leaving training and getting into practice, this is where a 

lot of that educational activity could do a lot to prevent diversion. 

Thank you, Mr. Chairman. I will yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from Florida, Ms. Castor, for 5 minutes for questions. 

Ms. CASTOR. Thank you, Mr. Chairman. 

And thank you, gentlemen, very much. I am especially grateful 

to Director Kerlikowske because you have given us such great guidance in the State of Florida where, colleagues, it has been a horrendous problem in the State of Florida. You would not believe, you 

could drive by some of these pain management clinics and see lines 

of people early in the morning, and we would often hear from our 

colleagues in Kentucky, in Virginia, in Tennessee about how folks 

would just travel down to Florida, find a pain management clinic 

that would prescribe, give them onsite hundreds of pills, go back. 

And this pipeline, fortunately, has been squeezed now. Florida finally adopted a prescription drug database. We have some stops 

and starts with that. I am concerned their physicians and pharmacists are not using it; it is voluntary. I am a little bit concerned 

the State hasn’t provided a long-term commitment to make it work, 

and I would like you all to address that. 

But local law enforcement, they are seeing some improvements 

from where we would have at least one death per day in our community from prescription drug abuse. They say now with county ordinances on these pain management clinics new requirements to go 

after the docs, arrests of doctors and prosecutions. But I know local 

law enforcement can’t do it all. 

Can you all tell how is the State of Florida doing because I know 

it has been, unfortunately, one of the worst in the country? And 

then at the federal level what can we do to provide greater tools 

to local law enforcement? And then one of my local sheriffs says it 

is not up to local law enforcement; this is an addiction and we have 

go to do more. 

Director? 

Mr. KERLIKOWSKE. As a graduate of the University of South Florida, I had a special affinity for the problems in Florida in particular. But I can tell you that Florida is doing markedly, remarkably better. The leadership of the attorney general, Pam Bondi, on 

this issue has been very good. We have worked hard with a number of groups there and Florida has actually reduced the problem 

I think from seven overdose deaths a day. They have been able to 

make progress. 

I think from the federal government’s standpoint what we need 

to be able to do is to make sure that these prescription drug monitoring plans are interoperable. Fourteen States now can share data 

but we saw a moment of some of the physicians that were suspect, 

as the vice chair mentioned, from Florida to other States, and so 

48 

that information needs to be done. So that is one thing the federal 

government can continue to do. 

Ms. CASTOR. You know, our database is voluntary and it hasn’t 

been up and running for very long, but still, there is some frustration that you only have 10 percent of pharmacists that are using 

it and not many doctors. So if we have interoperability between 

States, that still doesn’t get to the problem of incentivizing pharmacists and doctors, prescribers to use that. How do we better 

incentivize the use of the database? 

Mr. KERLIKOWSKE. And we are actually seeing significant improvements. One is that the electronic health records system, 

which eventually will be compatible with these kind of systems so 

that you don’t have one PDMP standalone system, and then you 

have got your other electronic health records. 

The other is the e-prescribing that has taken hold. Physicians 

are not very happy about being able to prescribe electronically a 

large number of different types of drugs, but when it comes to controlled substances, they go back to paper and pencil. All of these 

things are kind of underway, but I think the amount of education 

and information that is being made to the physicians is a result of 

using a PDMP and the stories that they have told and the fact that 

we are strongly encouraging mandatory prescriber education will 

be helpful. Thank you. 

Ms. CASTOR. OK. And, gentlemen, can you all tell me—I am a 

cosponsor of a bill, H.R. 1285 by Congressman Buchanan from the 

Sarasota area and Congressman Markey from the Energy and 

Commerce Committee. It would amend the Controlled Substances 

Act to make any substance containing hydrocodone a schedule II 

drug. Do you all support that? Could you just say yes or no because 

my time is limited? 

Mr. KERLIKOWSKE. I don’t believe the Administration has taken 

a position and we have strongly encouraged the science-based evaluation for the scheduling. So I wouldn’t be able to tell you right 

now. 

Ms. CASTOR. OK. Doctor? 

Dr. THROCKMORTON. He is speaking for the Administration. 

Ms. CASTOR. OK. And same answer, Dr. Clark? 

Dr. CLARK. Speaks for the Administration. 

Ms. CASTOR. OK. Thank you all very much for your efforts in this 

area. 

Mr. PITTS. The gentlelady’s time is expired. 

At this time I request unanimous consent to include a statement 

from the National Association of Chain Drug Stores into the record. 

Without objection, so ordered. 

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

Mr. PITTS. The chair now recognizes the gentleman from Illinois, 

Mr. Shimkus, for 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. And I just have two 

brief questions. 

One is I understand in Europe 85 percent of their prescription 

drugs is in blister packaging. Whether that is correct or not, that 

is what I have been informed. Do you think that would have any 

positive effect on some of these specific prescription type drugs, especially for those that might be going to, you know, families or 

49 

families who are taking care of seniors and really the accountability and the inability to really just disburse that without breaking up the package? 

Dr. THROCKMORTON. I think it is a very good question, and the 

use of innovative packaging and storage techniques to make a difference in this particular crisis, one of the things that we have not 

had an opportunity to think through as fully as we would like to. 

I have formed a group within the FDA to start looking at these 

issues. I have a part of my center that focuses on packaging and 

labeling and those things, and I have asked them to look at issues 

like this. 

One of the challenges about requiring blister packs for one kind 

of drug is that it spills over to requiring blister packs potentially 

for other kinds of drugs that have similar kinds of dangers, and 

there is a concern about access and impact in other ways on health 

care system. So we need to look broadly at how these packaging 

more creatively than we have, I believe. 

Mr. SHIMKUS. Anyone else want to add? No. We were talking 

about some of the—and I am not a medical doctor so I don’t remember all the names and stuff of the various drugs or the drugs 

to remediate the drug effect, but I am curious as to how much coordination there is between each of you when there is a development of a promising treatment which could help address the national priority of abating the drug abuse crisis? And I do know the 

FDA really has the approval though, but are you all involved with 

them, especially in this case, Dr. Clark? 

Dr. CLARK. Yes, not only the FDA has the leadership in that but 

we work in collaboration with ONDCP, NIH, and others, as the literature, which as Dr. Throckmorton mentioned, that the sciencebased literature produces new ideas. We have this ongoing dialogue. We have working groups that are multiagency, multi-department to examine the implications. We also work with the organized 

medicine and the various medical societies to address these issues. 

We try to track these developments so that we can decide whether 

they can be moved into clinical practice. 

Mr. KERLIKOWSKE. We spend more time with each other than our 

family. 

Mr. SHIMKUS. That is true up here, too, many times, unfortunately. 

So, Mr. Chairman, that is all I have. I yield back the balance of 

my time. Thank you. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from Illinois, Ms. Schakowsky, for 5 minutes for 

questions. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. I wanted to also 

reinforce my view. I think I do have something as a comment that 

is already in the record, and when it comes to the changing the 

scheduling of hydrocodone from its current schedule III to schedule 

II of the Controlled Substance Act, that was one of the suggestions 

that came from my constituent who lost his daughter. 

The other was he suggested—and I don’t know if this is under 

consideration—take steps necessary to restrict the use of oxycodone 

pain relievers to severe pain rather than moderate to severe pain, 

so that would change the packaging in order to prevent the overVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
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prescribing of these powerful medications. I wonder if any—actually, whoever knows best. 

Dr. THROCKMORTON. Yes, that is something that I can comment 

on. There are citizens’ petitions, there are requests for action before 

my agency about the changes in labeling that you are referring to, 

so I won’t be able to talk in great specific about the changes in 

what is called the moderate-to-severe language that is in current 

opioid indications. 

I mean I will say, however, that the FDA has always had an interest in making sure that our labels are accurate and fair and include all of the information that we know to be scientific. 

I had a public meeting earlier in this year where I posted a series of questions to academics, advocates, family members asking 

for their help in understanding how our current labeling for opioids 

might be improved, in general asking them for suggestions, and we 

got a number of comments and we are in the process of looking at 

those comments, looking at other ways to make sure those labels 

say what they need to. We believe educating prescribers begins 

with the approved labeling, which outlines how the products are 

best used based on our scientific judgment, and we need to make 

those as fully accurate as we can. 

Ms. SCHAKOWSKY. I wonder if part of the customer, the consumer 

education includes encouraging families with children between 12 

and 18 to have a lockbox for certain drugs so that they keep them 

out of the hands of children, Dr. Clark? 

Dr. CLARK. Yes, we do believe that prescription drugs should be 

treated very carefully. Lockboxes are good ideas. As Chairman 

Pitts pointed out, a lot of prescription drugs are shared between 

friends and family, so you have got this cultural dynamic that we 

also have to deal with. So consumers and family members need to 

be brought in. 

And our prevention efforts include not only take-back programs 

that Mr. Kerlikowske mentioned but the idea of promoting of the 

appropriate management of description drugs in the home. So 

lockboxes is our one strategy; making sure we have an informed 

consumer, another strategy; making sure that the delivery system 

educates the consumer about the potential risk of misuse and diversion of the medications, yet another strategy. 

And, as was pointed out, we need to reach out to consumer 

groups and parent groups and consumer coalitions so that we can 

promote this cultural shift in attitudes about these medications. 

Ms. SCHAKOWSKY. OK. I have one more question. It appears 

there is a new trend of manufacturers seeking approval of new 

abuse-deterrent formulations near the time of the expiration of 

their patents and marketing exclusivity, so they then withdraw the 

original formulation from the market claiming it is no longer safe 

in light of the availability of the abuse-deterrent formulations. And 

if the FDA agrees that the original formulation was removed for 

safety reasons, then the FDA is precluded from approving generic 

competitors without comparable abuse-deterrent formulations. And 

in the absence of generic versions, then patients are forced to pay 

higher monopoly prices for extended time periods, which in turn 

has the potential to decrease patient access to these drugs. Have 

you heard about this? 

51 

Dr. THROCKMORTON. Yes. And this is back to the discussion of 

the balances, you know, that need to be kept in mind as we think 

about addressing this abuse crisis. So in this case we have the necessary balance between incentivizing the development of abuse-deterrent formulations that work. We want to have opioids in formulations that deter abuse. I believe that is in everyone’s best interest 

to find a way to incentivize that while at the same time recognizing 

the impact and importance of the generics in the U.S. market, currently well more than 75 percent of the total prescriptions, et 

cetera. 

Accomplishing that balance is something that the FDA is thinking and working very hard on. Our first action was earlier in the 

year when we put out the guidance laying out how we would try 

to incentivize the development of new formulations. Following up 

on that, we are now thinking about ways to develop guidance on 

abuse deterrent formulations to generics to allow them to come on 

the market as well. 

In other places and in this place I would expect our focus would 

be on the performance of those generics and not on the technology 

that was used to make that generic. So we would require that the 

generics demonstrate they are abuse-deterrent, the thing that we 

would all want to have rather than that they used the same technology. We think that would incentivize the development of appropriate generics, generics that work, while recognizing the important role that the innovator plays here in terms of developing new 

innovative products. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentleman from Louisiana, Dr. Cassidy, for 5 minutes for questions. 

Mr. CASSIDY. Thank you, Mr. Chairman. 

Mr. Kerlikowske, what percent of docs write what percent of narcotics? 

Mr. KERLIKOWSKE. Congressman, I actually don’t know. I know 

that the information about the doctors said to prescribe, for instance, oncologists write a large number of the—— 

Mr. CASSIDY. So oncologists, pain doctors? 

Mr. KERLIKOWSKE. The pain doctors, et cetera. And I think Dr. 

Throckmorton probably can also help me. I just play a doctor on 

TV. I am with a real doctor. 

Dr. THROCKMORTON. And I won’t be able to give you specific 

numbers; we can certainly get that. The majority of pain medications are actually written by primary care doctors and—— 

Mr. CASSIDY. No, that is the majority—— 

Dr. THROCKMORTON. Yes. 

Mr. CASSIDY. But if we look at those who write an extraordinary 

amount, those that are two standard deviations out, by definition 

if you are two standard deviations out, you are 5 percent, right? So 

intuitively, if we are looking at the folks who we are concerned 

about, I am suspecting that it is going to be a small percent writing 

a lot of the inappropriate prescriptions. You are nodding your head. 

Do you think that intuition is correct? 

Dr. THROCKMORTON. It depends on where you cut that line off is 

5 percent or it is something like that. But there is clearly a minorVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
52 

ity of physicians that are writing for large amounts of these 

opioids. I agree with that. 

Mr. CASSIDY. Now, I am not sure to whom this would go; I think 

one of the two of you because I am not sure this is SAMHSA’s gig, 

but I know if you got 46 States that have a Prescription Drug Monitoring Program, I am a doc; I have a DEA number. Every time I 

write that number it a goes into a database and they know if I 

have written an prescription. I think, although I was not able to 

confirm, these databases and likewise have patient information. 

Now, I keep on wondering if our goal is to find that small percent 

of docs who are writing inappropriately and we have a unique identifier for whom that doc is and we can look up in the phone book 

and see where their practice is, why don’t we just turn it over to 

Google and let them data mine and tell us who are the crooks? Do 

you follow what I am saying? 

Aside from being tongue-in-cheek, if we have all these unique 

identifiers and all these databases are real-time data, what is the 

challenge in figuring out which docs are the bad actors? 

Mr. KERLIKOWSKE. There are a couple challenges that really do 

come up. One is that things can change, particularly in rural areas, 

pretty dramatically if a physician leaves a practice and is gone and 

suddenly that physician taking his or her place has to write a lot 

more prescriptions because they have actually taken over. 

Mr. CASSIDY. But as we look at the data, I mean knowing that 

the urban setting is where most of this is happening, but even if 

it is rural, what you describe is a little kind of codicil that is still 

broad sweep. It seems as if we have got a unique identifier, you 

have got a real-time database, and you have got 46 States with it; 

it doesn’t seem like this should be such a challenge. 

Mr. KERLIKOWSKE. You are right, but also the real devastation 

has been in the rural areas. Kentucky, southern Ohio—— 

Mr. CASSIDY. I will accept that as well, but again, you have got 

a unique identifier, you have got a real-time database; what is the 

great challenge? 

Mr. KERLIKOWSKE. I think the other challenge is that because 

these are individual state programs, some are within the law enforcement component, some are within the medical practice component, and each State uses those individually to determine—— 

Mr. CASSIDY. So does DOJ have access to these Prescription Drug 

Monitoring Programs? 

Mr. KERLIKOWSKE. Those who have access? 

Mr. CASSIDY. Department of Justice or do you or does the executive branch? 

Mr. KERLIKOWSKE. No. 

Mr. CASSIDY. So it is entirely state jurisdiction? 

Mr. KERLIKOWSKE. Exactly. 

Mr. CASSIDY. Now, we mentioned interstate compacts. I presume 

in these interstate compacts the States are communicating one to 

the other as to, listen, this fellow just dropped out; he moved to 

your State. He is someone you should watch for. Dr. Clark, do you 

have a thought? 

Dr. CLARK. Well, we are moving toward that position. It is really 

important to recognize that the electronic health record integration 

and interoperability activity is moving toward that position. Some 

53 

jurisdictions are in fact trying to come up with algorithms where 

you can identify the outliers in terms of pain medication—— 

Mr. CASSIDY. Well, it just seems like a sort. 

Dr. CLARK. It is a little more complicated than that, as Dr. 

Throckmorton pointed out, in part because you do in fact pull in 

the cancer doctors or the arthritis doctors—— 

Mr. CASSIDY. But I know that. But you know who the cancer doctors are. If there are 100,000 docs, there is going to be 5,000 who 

are cancer and 5,000 who are legitimate pain docs, and then there 

is going to be somebody who you know just moved to this state 

from that state to the state. 

Dr. CLARK. Indeed. And that is what the electronic health 

records and interoperability—— 

Mr. CASSIDY. Now, see, it concerns me that your electronic medical record, because really I don’t want the government snooping in 

my electronic medical record. On the other hand, if we have a realtime database your Prescription Drug Monitoring Program, that is 

the subset of folks who are writing prescriptions and it is centered 

upon the physician, and you can look and see here is my top thousand writers, 500 are oncologists or pain docs or ortho, and here 

is—do you see what I am saying? 

Dr. CLARK. Yes, well, HHS has actually done a survey looking at 

part D programs and it discovered it was a little more complicated 

because indeed trying to pigeonhole a practice isn’t as simple as all 

that. But you are right with the advent of increasing monitoring 

capability and big data, we will be able to make some kind of reasonable assessment of a practitioner and at least explore that practitioner, what he or she is doing. 

Mr. CASSIDY. OK. I yield back. Thank you. 

Mr. PITTS. I thank the gentleman and now recognize the gentleman from North Carolina, Mr. Butterfield, for 5 minutes for 

questions. 

Mr. BUTTERFIELD. Thank you so very much, Mr. Chairman, and 

thank you for convening this hearing and thank the three witnesses for their testimony here today. 

Prescription drug abuse is certainly a serious problem that impacts an estimated 12 1⁄2 million Americans and now is considered 

a health epidemic by the Centers for Disease Control. And so it is 

a serious problem. This hearing today is very appropriate. This is 

a conversation that we must have and we must do something about 

it if we can. 

In the last Congress I served as ranking member of the Commerce, Manufacturing, and Trade Subcommittee under the thenleadership of Chairwoman Mary Bono. The issue of prescription 

drug abuse is one that was and continues to be very important to 

her and to me. Our subcommittee held several hearings on prescription drug abuse last Congress, and so I have a somewhat keen 

understanding and interest in stemming the growing problem. 

The chair then and I shared a deep concern for individuals’ wellbeing, especially young people who gain access to an abuse prescription drugs. The multiple hearings that we had on this issue 

during the last Congress made very clear to me that drug manufacturers and the drug supply chain are not the problem. With Purdue 

Pharma developing next-generation crush-resistant drugs, the inVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00059 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
54 

dustry is playing an increasing role in stopping illicit use. Nefarious black markets and drug diversion at the end-user stage are 

the problem. 

And so the question is how do we address this problem while 

avoiding burdensome regulations on your manufacturers and others along the supply chain? 

And so I just want to follow up just a bit on Ms. Schakowsky’s 

line of questioning a few moments ago. Abuse-deterrent drugs are 

a fairly new addition to the market, and so what impact have 

abuse-deterrent drugs had on the illegal and illicit use of prescription drugs? And so just thinking out loud, I would just imagine 

that if one drug is made abuse-deterrent, the person would just 

find another drug that is not abuse-deterrent that produces a similar result, shifting but not reducing the abuse. 

And I guess I can go to Dr. Throckmorton on this one. Should 

the FDA remove roadblocks to manufacturers who want to produce 

abuse-deterrent drugs so that they can speed the new formula to 

market to reduce overall abuse? 

Dr. THROCKMORTON. Yes, we should. And we are working to do 

exactly that. I view the development of abuse-deterrent technologies and encouraging their use in opioids as an incremental 

process. We are beginning now to walk a road where I had hoped 

to see a broad majority of opioids in abuse-deterrent formulations. 

That is going to help address your concern, the squeezing the balloon if you will, people moving from abuse-deterrent formulations 

to another formulation that is easier to abuse. 

In the short-term here, I think we would be fooling ourselves if 

you imagine that wasn’t going to happen, so my job—I think our 

agency’s job is to incentivize the development of those new technologies broadly and to make certain that those technologies demonstrate that they work. So we should be developing abuse-deterrent formulations that successfully reduce abuse through reviewing 

of the data—I believe the FDA plays a critical role there—and then 

rewarding those new formulations in labeling, rewarding them in 

ways that will encourage their use by physicians and by patients 

with a long-term goal of having a broad range of opioids that are 

in abuse-deterrent formulations. 

Mr. BUTTERFIELD. Let me now go to Dr. Clark if I can. 

Dr. Clark, how can we educate health care providers to spot the 

warning signs of frequent flyers who might not have a legitimate 

need for powerful prescription drugs? Do you think the implementation of interoperable electronic medical records—you mentioned 

that earlier—would help to flag these individuals who are doctorsurfing only to get more and more prescriptions that they need to 

sell? 

Dr. CLARK. Indeed. We think that the interoperability between 

electronic health records and the prescribing is very important. We 

are working with the Office of the National Coordinator for Health 

Information Technology to achieve that. We think that educating 

practitioners is important. We work with the FDA and the National Institute of Drug Abuse. We both have training programs, 

NIDAMED for the National Institute of Drug Abuse and SAMHSA 

has a training program associated with Boston University. We 

have trained over 13,000 prescribers. We work with state medical 

55 

societies. SAMHSA sponsors state medical society training, and we 

have, as a result of this broader effort that the Congress has mobilized, we are fighting. 

More and more practitioners are showing up at our conferences 

to listen and learn about prescription drug abuse, to listen and 

learn about adequate pain management strategies, to listen and 

learn how to monitor for deviant behaviors and also while maintaining a good balance of care because indeed pain is a problem. 

So we want to continue that effort here and we think that is a useful effort. 

Mr. BUTTERFIELD. Thank you, Dr. Clark. My time is expired. 

I didn’t get to Mr. Kerlikowske and I spent considerable time rehearsing your name and I won’t be able to use it. But I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Virginia, Mr. Griffith, for 5 minutes for questions. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate it. 

Dr. Throckmorton, can you please update the Committee as to 

where the Agency stands related to requirements of the Food and 

Drug Administration’s Safety and Innovation Act pertaining to 

public meetings surrounding the scheduling of combination 

hydrocodone products? Now, I know you mentioned in your testimony that a public meeting had been held and I think in one of 

the answers to the earlier questions you said you all were relying 

on science instead of going straight to rescheduling some of the 

drugs. 

But can you tell us, you know, what you hope for or we are hoping for an update on what you think is the process going forward 

on this rescheduling? 

Dr. THROCKMORTON. Sure. I won’t be able to talk in any detail 

because we have not yet formed a recommendation about what, you 

know, the matter. Our task was to respond both to the science, the 

request from the Drug Enforcement Administration to reconsider 

our recommendation from 2008, as well as respond to the language 

that Congress gave us in FDASIA directing us to hold the meeting 

that included membership to solicit input on things like the impact 

of up-scheduling. We are taking those two things very seriously. 

As I mentioned previously, that meeting elicited 760 some comments, over 100 of them making specific recommendations for us 

to consider instead of up-scheduling, so making recommendations 

for other activities. We are trying to work through all of those to 

form the best science-based recommendations—— 

Mr. GRIFFITH. Any idea of a timeline on when you think something might come out? 

Dr. THROCKMORTON. I am afraid I can’t give you a timeline. I can 

tell you that I understand your frustration. I understand that this 

is an important issue that we want to move forward. My people are 

doing everything that we possibly can to do it right. 

Mr. GRIFFITH. I appreciate that. Thank you. 

Now, it may come as a surprise to some of you all that Virginia 

actually has the oldest medicinal marijuana law on the books dating back to the 1979 act. That was, however, unlike some of those 

States that have said, you know, if it makes you feel good, do it. 

56 

Virginia actually requires that there be a medical reason and there 

be a prescription, which is not currently allowed. 

Wouldn’t you agree with me, Dr. Throckmorton, that we need to 

have a discussion about the legitimate uses of medicinal marijuana 

and freeing it up so that Virginia can exercise its will so that doctors can actually prescribe it in those areas that are authorized by 

the Virginia law? 

Dr. THROCKMORTON. My own personal views aside, the FDA 

would not have a clear role in responding to issues around medicinal marijuana. We do have a role in the scheduling of marijuana 

in a somewhat similar fashion that we have a role to play in 

hydrocodone. So there is a recommendation process that the DEA 

requests of us. That is regarding the development of marijuana-related drugs. 

Mr. GRIFFITH. But you would agree that we probably ought to be 

having a public discussion about legitimate medicinal marijuana 

usage? 

Dr. THROCKMORTON. I think I am not going to be able to comment on that, sir. 

Mr. GRIFFITH. All right. I appreciate that. 

The Center for Substance Abuse Treatment recently released an 

RFA for Physician Clinical Support System, Medication-Assisted 

Treatment to support physician educational on the use of medications to treat opioid addiction. My understanding is that a number 

of treatments have been approved by the FDA to directly treat 

opioid abuse. One such drug that I am aware of is—and I am probably going to mispronounce it—Vivitrol. How does CSAT plan to 

expand its efforts to increase awareness and knowledge about these 

new medications, Doctor—or either one of you? 

Dr. CLARK. One of the things that we are doing is working with 

medical societies, working with the treatment programs so that 

they are very much aware of the existence of medication. We have 

promulgated advisories so that people can understand them and we 

are also meeting with the manufacturers so that we have a better 

understanding of what their strategies are. So we think this is an 

important issue. 

We work with the FDA and ONDCP so that we can promulgate 

increased access to treatment because that is one of our concerns, 

making sure that people have access to new treatments as they develop and the consumers have access to those. 

Mr. GRIFFITH. I thank you. 

I would point out, Mr. Chairman, that I have heard a lot today 

about electronic medical records, and Dr. Cassidy issued a concern, 

a warning, a broad interpretation of the Smith v. Maryland case 

upon which the NSA relies on in its current standing would say 

that if you shared your medical records with a third party insurance company, you may also not require—I don’t agree with that 

interpretation, but you may also not require a search warrant to 

get those records. I don’t think that is right but that is another 

day. 

Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Pennsylvania, Dr. Murphy, for 5 minutes for 

questions. 

57 

Mr. MURPHY. Thank you, Mr. Chairman. I appreciate the panel 

being here. 

I want to follow up on some of the questions here about drugs 

used to treat opioid addiction. The current published information 

published by the FDA—and I address this to Dr. Throckmorton and 

Clark—allows for the use of generic buprenorphine, which is 

Suboxone, in the context of the doctor-patient joint decision. However, there is a concern from psychiatrists who treat persons with 

addictions that the published indications are vague enough to allow 

for misinterpretation. Now, I have heard from doctors in my district that there is misinformation about when a doctor can prescribe generic buprenorphine versus the branded Suboxone strip. 

And so it is leading to access issues because pharmacists are concerned about prescribing the generic. 

Are any of you aware of a problem with this issue? And if not, 

is that something you can get back to me on or we can communicate on later? I am not trying to trip you up. I am just trying 

to see if we can start a dialogue on that. 

Dr. THROCKMORTON. It would probably be better if we had a little 

bit more specifics about that one. 

Mr. MURPHY. Thank you. 

Dr. THROCKMORTON. There were recent issues about generic and 

innovator Suboxone. There was a citizens’ petition that was submitted to our agency that we responded to. I am not sure if that 

is exactly it but we would be happy to follow up and—— 

Mr. MURPHY. I would appreciate it if we can talk directly. 

Let me also ask about this. Now, we are aware of all the 

overdoses and how much they have killed with prescription painkillers. We know that States are collecting information on prescriptions but how this helps is still a concern. One person can go to 

10 different pharmacies with 10 different prescriptions and collect 

those, and the States can sometimes then pick up if it is the same 

person. But, of course, John Doe can also say, oh, I am filling a prescription for my grandmother, my aunt, and other things, and the 

question is can we find that person in the current system who may 

be using legitimate prescriptions or the next step is false names, 

et cetera? 

How does this collecting information by the States help us in 

finding such persons? Could some of you comment on that? Yes, sir. 

Mr. KERLIKOWSKE. Congressman, the two important parts of 

these PDMPs, which are then run by the state Boards of Licensure, 

one is that a physician can have that instant access to, say, to a 

new patient or, you know, the number of doctors that that patient 

has also seen because these require, when they fill these prescriptions, identification. The other is that a Board of Licensure and the 

States regulate medicine, not the Federal Government, can use 

that to identify a prescriber who may be above and beyond and 

then take appropriate steps for inquiry. 

I think that people do look at innovative ways around this but 

the States—and I would recognize Kentucky as an example—that 

have the most knowledgeable people running their PDMPs have 

been pretty successful in bringing this down. And of course the 

other part of that goal then is to get somebody into treatment to 

reduce the problem. 

58 

Mr. MURPHY. Well, let me add another element to this. A couple 

years ago Congress passed a law saying that people were picking 

up Sudafed had to show a photo ID, et cetera. 

Mr. KERLIKOWSKE. Right. 

Mr. MURPHY. And our concern is in terms of what you understand very well, for all of you, is that one person picking up multiple prescriptions for themselves we can pretty much identify that 

may be an abuse and that person can be picked up by the PDMPs, 

et cetera. One person who may be legitimately gathering prescriptions to pick them up for other family members we have to somehow identify who is a person with the problem, who is not. Can any 

of you comment on the concept of perhaps extending that, that requiring a photo ID so that person’s name could also be checked if 

they are picking up more? 

Mr. KERLIKOWSKE. I would certainly be happy to tell you what 

the state PDMPs are seeing as a result of that question. I would 

be glad to do that. 

Mr. MURPHY. Any others have any comments on thoughts that 

agencies may have about extending that? 

Dr. THROCKMORTON. Well, one agency that is not here would be 

the Drug Enforcement Agency, and I think there are limitations on 

how people can fill prescriptions that are not written directly to 

them. And it would be important just to look into that. And I don’t 

know those details so wouldn’t want to, you know, try to answer. 

Mr. MURPHY. Dr. Clark, do you have any comments? 

Dr. CLARK. And while we are thinking about this in a more formal way, I do know that many pharmacies, especially the chain 

pharmacies, are requiring photo ID on presentation even for the 

person for whom the prescription is written, and whoever picks up 

the drug, the photo ID is required. So I know that people are concerned about the issue. 

Mr. MURPHY. And I understand the chain drugstores then, they 

will begin to raise questions themselves by contacting the doctor, 

and obviously, we want to stop the illegality of this and we want 

to help the people in need. So I hope that is an area where we can 

move toward some—this is a concrete action that Congress can 

take on this and I look forward to talking with you more about 

that. 

Thank you very much, Mr. Chairman. I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Texas, Mr. Green, for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman, and thank you for having 

the hearing today. 

Dr. Clark, you spoke about SAMHSA’s effort to prevent prescription drug abuse in the first place and you have also described 

SAMHSA’s treatment activities when addiction disorders rise. 

Treatment of addiction to prescription drugs is crucial in importance and, as we all know, promising behavioral and medical approaches exist to treat this form of addiction. 

The Affordable Care Act builds on bipartisan legislation cosponsored and supported by many members of this committee, the Mental Health Parity and Addiction Equity Act of 2008, to ensure that 

more individuals suffering from substance abuse use disorders receive the care they need. 

59 

My first question is how do you anticipate the Affordable Care 

Act will impact access to services for people who are addicted to 

prescription drugs or have other substance use disorders? 

Dr. CLARK. One of the things that is in the Affordable Care Act 

is in fact the provision of services for mental health and substance 

use disorders, which means that individuals who have no coverage 

currently and that has been one of the barriers for people seeking 

treatment, that barrier would be removed. So the Affordable Care 

Act will allow health coverage for individuals who cannot afford the 

cost of care and therefore would be able to engage in care. 

It will also allow for a broader reach for using the structures like 

Accountable Care Organizations so that we can identify individuals 

early before they develop full-blown addiction issues, risky behavior 

if you will, so that we will be able to intervene at an earlier point 

in time. 

Mr. GREEN. So Medicaid and the marketplace exchanges, whether they are state or national exchanges, will expand the population 

for those who receive substance abuse treatment? 

Dr. CLARK. Indeed. 

Mr. GREEN. OK. It is clear from your comments the Affordable 

Care Act made it possible for many people with substance use disorders, whether it is addiction to prescription drugs or illicit drugs, 

to access treatment. 

Mr. Chairman, I know we have had differences over the Affordable Care Act but I hope we all share the goal of providing more 

robust treatment to those who are working to overcome prescription drugs. 

Director Kerlikowske—close enough, I hope—with your name 

like Green it is not hard to pronounce—how do you track the 

progress in completing action items identified in the Administration’s plan in meeting the goals you have set? 

Mr. KERLIKOWSKE. When we put together the prescription drug 

plan, we brought everyone to the table for a number of months, 

and all of the agreements that are in there continue into an interagency work group. So we set some specific goals and then we 

bring that where those people that are closest to the problem and 

on the ground and had a responsibility for each of their agencies 

together on a quarterly basis to go over their progress. 

So we are starting to see—and I come from a profession that isn’t 

known for its optimism in law enforcement, but I can tell you that 

seeing the changes that Dr. Clark and the chairman talked about 

from 2010 to 2011, I think we are starting to turn the corner on 

this prescription drug problem. 

Mr. GREEN. Good. Dr. Clark, I am interested in hearing more 

about SAMHSA’s coordination with the Centers for Disease Control 

and Prevention on surveillance activities. For example, you testified that SAMHSA funds the annual national survey on drug use 

and health which collects data on nonmedical use of prescription 

drugs, among other things. SAMHSA also oversees Drug Abuse 

Warning Network, or DAWN, surveillance activities of drug-related 

emergency department visits and drug deaths. Is that partnership 

going to continue and if you have any more to share with the Committee on that partnership because obviously we like agencies to 

work together? 

60 

Dr. CLARK. And indeed we are working together. I think the Assistant Secretary for Health Howard Koh and my immediate boss 

Pamela Hyde chairing the Behavioral Health Coordinated Committee, the objective is to make sure that we are working together, 

and Ms. Hyde works very closely with the director of the CDC to 

make sure that there is no duplication of effort but there is collaboration and coordination. 

And we have our data teams working together. The director of 

the Center for Behavioral Health Statistics and Quality, Dr. Pete 

Delaney, is working with the National Center for Health Statistics 

to make sure that we get the best data possible dealing with the 

epidemiology of substance abuse. 

Mr. GREEN. Thank you. Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Kentucky, Mr. Guthrie, for 5 minutes for questions. 

Mr. GUTHRIE. Thank you, Mr. Chair. And I thank you all for 

coming. 

These first couple of questions are for Dr. Throckmorton. And I 

have been a strong proponent—I am from Kentucky and we have 

been real aggressive with trying to deal with the drug problem in 

our area, prescription drug problem. And the tamper-resistant 

technology has been important. In your written testimony you 

talked about there were two recent determinations from the FDA 

on different formulations for OxyContin and for Opana ER, and can 

you take a minute to explain why there were two different determinations of those two cases about the drug-resistant technology? 

Dr. THROCKMORTON. Sure. I will speak in general terms. In both 

cases we looked at the available data on that product and specific 

the new formulation and then looked at it in comparison with the 

earlier formulation, the formulation that had been originally developed and asked questions about whether or not the new technology 

promised to reduce abuse. We think it is terribly important that 

this bar, this bar of concluding something is abuse-deterrent be 

high enough to be worth developing, make it an incentive, make it 

something that we can reward in labeling terms to make those 

products attractive for manufacturers to take the time and money 

to develop. 

In the case of OxyContin when we looked at the data, there were 

important aspects of the new formulation that really did predict it 

was going to be harder to abuse. One particular one is when people 

tried to make it ready to inject, it turns into a gel that is just physically impossible to inject into someone’s arm. You know, some of 

that testing involved using people who are addicts trying to, you 

know, do things that, you know, that would allow this to be used 

and they were unable to do it. 

Now, so those sorts of evidence strongly suggest that a product 

with those formulation characteristics is going to have reduced 

attractiveness to abusers in the real world. We are tracking that 

real-world experience now going forward. On the other hand, when 

we looked at the totality of the data around the Opana ER product, 

we didn’t see data of that same kind, data that suggested that that 

product was really going to be meaningfully harder to abuse, meaningfully meaning we would see less abuse—— 

61 

Mr. GUTHRIE. I want to ask you another one and I got one more 

that I want to ask, but thank you for that. And on Capitol Hill 

there has been a lot of discussion about whether generic prescription opioids must have identical abuse-deterrent technology or 

whether it must simply be comparable or meet or exceed of the 

other drug. Can you discuss your perspective on this debate and 

what you are doing to ensure the process remains science-based 

and technology-neutral? 

Dr. THROCKMORTON. Absolutely. And I think it is a very important question. We are going to be talking about—we are working 

internally on and we are planning on talking about it at a public 

meeting at the end of September and early October. What I anticipate is that we are going to rely on the generics demonstrating 

they are abuse-deterrent, not that they use the same technology. 

That would be the approach that we have used in other places. 

And so the testing that we will lay out, the testing that we will 

develop will be to decide whether or not the new formulation, however it is made, is abuse-deterrent to the level that it needs to be 

compared with the innovator, not that it used the same technology. 

Mr. GUTHRIE. Because I would like to ask Mr. Kerlikowske a 

question or just bring this up. A very good friend of mine—his 

name is Tommy Loving—he is head of our drug task force. Do you 

know Tommy? And very aggressive in this and we get together 

quite—I will see him in the morning actually for coffee probably. 

And he brought it to me a few months ago that heroin has really 

shown itself in an alarming statistic. And I said why is that kind 

of—you know, heroin, that seems like something that was 1970s, 

I guess? He said because our legislature has been so aggressive 

with the pharmacies, with the tamper-resistant, so now the prescription drugs are more difficult to get than heroin. 

And I just want to see—I know you are aware of that, just the 

strategy with that. The prescription drug abusers are now finding 

an outlet easier to get heroin than prescription drugs because we 

have been so good in our State of trying to control it. 

Dr. THROCKMORTON. And that has been going on for a while. The 

anecdotal evidence across the country is that there is an increase 

in heroin and some of the survey instruments are also showing 

that we have a younger population. 

There is another component about this, too, and that is that 

young people are heroin-naı ̈ve. Older people really have an understanding of the dangers of heroin. Young people believe that it is 

not that powerful, that as long as they smoke it or snort it that 

they won’t become an injecting drug user, and of course within a 

few weeks they do become an injecting drug user at the same time 

that prescription drugs are being made less available through all 

of the things that you have heard about today and the cost. And 

heroin is much less costly. So we have some real concerns about 

the heroin issue, and I couldn’t agree with the drug task force commander more. 

Mr. GUTHRIE. Thank you and I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Kentucky, Mr. Whitfield, for 5 minutes for 

questions. 

62 

Mr. WHITFIELD. Thank you, Mr. Chairman. And thank you all for 

being with us today. 

I want to give a little bit of historical perspective on the Prescription Drug Monitoring Program, and since my facts are oftentimes 

wrong, if I am wrong, you all can correct me. And then I want to 

just ask a couple of questions. 

Kentucky, as my understanding in 1998, started a Prescription 

Drug Monitoring Program. In 2002, Hal Rogers started the Prescription Drug Monitoring National Training and Technical Assistance Program at the Department of Justice. Now, that was an unauthorized program because this committee has the jurisdiction. Since that time, it has received an average of 7 or $8 million a 

year, and we all acknowledge and say that it has been an effective 

program. I don’t think anyone would dispute that. But in 2005, this 

committee that does have jurisdiction recognizing the success of 

that program initiated NASPER. Now, the only difference is that 

the Hal Rogers program was centered at the Department of Justice 

and NASPER was over at HHS. 

NASPER received funding in 2011, and ’12 I believe did not get 

funding. And, as a matter of fact, someone at the Appropriations 

Committee in the report language in the Omnibus Bill even specifically said no money will be spent on NASPER, which I thought was 

a little bit mean-spirited myself. 

But regardless of that, you three fellows are the experts in the 

area and I would ask you the question, do we need NASPER anymore? Maybe we should just eliminate NASPER and let’s just focus 

on the Hal Rogers program. Or should we try to combine them? Or 

should we try to reauthorize NASPER? 

You know, I think a lot of the problems we have in the Federal 

Government on a lot of programs is that Congress does not have 

a coherent, organized approach to dealing with the problem. So 

would you all just give us—because I mean our committee does 

have jurisdiction. Maybe we should reauthorize it and try to start 

over, but I would just ask for your guidance on this issue. And if 

each one of you would comment, I would appreciate it. 

Mr. KERLIKOWSKE. I know that NASPER was designed to have 

a bit of a different take on the program versus the high technology 

of the Hal Rogers PDMPs. We are pleased that there is still money, 

as you said 7 to $8 million each year that is made available to the 

States to start up these PDMPs. And I would be happy to sit down 

with not only representatives from Congress but also some of these 

inner-agency people and provide some level of our expertise and 

what we have seen as to NASPER. We would be glad to do that. 

Dr. CLARK. I agree with Director Kerlikowske. There needs to be, 

shall we say, a convening of minds to look at what it is that we 

are trying to achieve and how best can we achieve it. The specific 

program may not be the issue; it is the technologies that exist and 

it is bridging some of the limitations. And it is also dealing with 

some of the conflicting imperatives associated with both programs. 

So our focus on linking Prescription Drug Monitoring Programs 

with electronic health records, working with the Office of National 

Coordinated Health Information Technology and with the support 

of ONDCP in order to give practitioners real-time access, the 

amount of money and PDMPs just hasn’t been a large amount of 

63 

money in the first place, so the strategy might be how do we best 

use limited resources to enhance our efforts to deal with the prescription drug abuse problem without compromising the health of 

people who suffer from pain or other conditions requiring controlled 

substances. 

Mr. WHITFIELD. Yes. Now, Mr. Chairman, I might just suggest 

that—and maybe in a private setting—some of our staff could work 

with these three gentlemen and their staff to determine what can 

we do to make this program even more effective? I mean maybe all 

of the effort should be generated that the Hal Rogers program or 

maybe that there would be a combination or maybe there is something we can do. But since our program has expired, looking at reauthorization, I think it would be helpful to have these discussions. 

Thank you. 

Mr. PITTS. We will pursue that. Thank you. 

The chair now recognizes the gentlelady from North Carolina, 

Mrs. Ellmers, for 5 minutes for questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. And thank you for 

holding this subcommittee hearing. Thank you to our panel. 

I have a couple of questions in regard to patient safety for those 

who truly are in need of pain medication and how, as we are trying 

to make the system more effective for, you know, identifying abusers and how to use and work on that problem, how do we protect 

those patients as well? 

You know, the first thing that comes to my mind is the Sudafed 

issue and how an individual has to basically show their license, 

their identification, and I know why that has been put in place. I 

am curious as to why that approach was taken. Is it because it was 

an over-the-counter drug initially, and because it is used to formulate other drugs? Dr. Throckmorton, can you tell us a little bit 

about that approach? Because I am concerned that we might take 

an approach like that into the future with others. 

Dr. THROCKMORTON. I want to make sure that I understand the 

question you are asking. So with pseudoephedrine—Sudafed itself 

is not abused. It is—— 

Mrs. ELLMERS. Correct. 

Dr. THROCKMORTON [continuing]. Obviously, what it is being 

used to create—— 

Mrs. ELLMERS. Correct. 

Dr. THROCKMORTON [continuing]. Highly dangerous, you know, 

methamphetamine. And, you are right, it was over-the-counter and, 

you know, Congress felt that there were additional restrictions that 

were necessary to ensure the safe use of that product. 

That is different than the conversation we are having around 

hydrocodone where—— 

Mrs. ELLMERS. Right. 

Dr. THROCKMORTON [continuing]. It in and of itself is a product 

that has the potential for abuse—— 

Mrs. ELLMERS. Addictive abuse. 

Dr. THROCKMORTON [continuing]. One that is already under some 

control for the Drug Enforcement Administration, the schedule III 

already has a—— 

Mrs. ELLMERS. So basically, the difference being that the 

Sudafed was an agent that was used to—— 

64 

Dr. THROCKMORTON. Create. 

Mrs. ELLMERS [continuing]. Create another, and so therefore—— 

Dr. THROCKMORTON. That is the—— 

Mrs. ELLMERS [continuing]. The idea was to find out who was— 

make sure that those individuals who were actually purchasing it 

were identified. 

The other issue is what other protections is the FDA putting in 

place to ensure that patients who really are in need of those critical 

pain medications for, whether it be chronic pain or acute pain, 

what protections are in place so that again we might—I hate when 

the pendulum swings one way when really what we need to do is 

kind of come up with a real balance. 

Dr. THROCKMORTON. Well, we think there are several things to 

do. So first and foremost, we have been listening carefully. So I 

have been now working on the opioids and, you know, for a substantial fraction of my time for the last several years. And I have 

had the opportunity to sit down with hospice care workers. I have 

sat down with cancer survivors. I have sat down with groups to see 

the need for access to pain medicines for patients that need them. 

I have also sat down with groups, you know, that see the cost that 

prescription drug abuse is, you know, having in America. So to 

fully understand sort of the broad spectrum of views, we are trying 

to listen as carefully as we can. 

At the end of the day, one of the things that we concluded was 

the better educated people were about how best to use these medicines—and that means both the prescribers and the patients—the 

more comfortable we believed they would be in making the right 

choices. And the right choices here could be not prescribing an 

opioid to avoid abuse, avoid misuse, or it could be to make a choice 

to prescribe it because they are now educated well enough to know 

how to do it well, how to monitor that patient well, how to spot the 

signs of abuse—— 

Mrs. ELLMERS. Sure. 

Dr. THROCKMORTON [continuing]. And so they are not scared to 

use a word—— 

Mrs. ELLMERS. OK. 

Dr. THROCKMORTON [continuing]. To use the opiates right. 

Mrs. ELLMERS. And thank you because I think that is the best 

approach as well. 

But if there is an individual right now—and I appreciate especially working with hospice and certainly that is an area where 

those medications are used and I can see that issue occurring—but 

if there is an individual who feels that their pain, for whatever 

purpose, whatever reason, has an issue with access and feels that 

they are having difficulty obtaining, is there a phone number? Is 

there a way—who does that individual reach out to? And any of 

you can comment on any of these things. 

Dr. THROCKMORTON. Partly, it will depend on what the source of 

not being able to get the medicine is. So if it is a drug shortage, 

for instance, that the drug is not available the way, you know, 

sometimes drugs have gone into shortage recently and we have 

shortages with fentanyl, for instance, periodically or whatever, that 

is absolutely something the FDA wants to hear about. I have a 

staff that work on that 24/7 trying to understand, prevent, miniVerDate Nov 24 2008 15:36 Mar 04, 2014 Jkt 037690 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-55 CHRIS
65 

mize those shortages. And we have a Web site at the FDA to allow 

people to report. 

If it is a pharmacy not carrying the drug, those are decisions that 

the FDA doesn’t have a clear role in and I would suggest Boards 

of Pharmacy or some other local authorities would be the place to 

talk to. 

Mrs. ELLMERS. Thank you. Thank you. I apologize, Mr. Chairman. My time ran over. Thank you very much. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentleman from Florida, Mr. Bilirakis, for 5 minutes for questions. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate it very 

much. And thank you for holding this hearing. And I thank the 

panel for their testimony. 

Along with many Floridians, I am concerned about the alarming 

increase in prescription drug abuse and illegal sales of prescription 

medications. I believe that issues concerning both overprescribing 

and the illegal use and sale of these drugs should be addressed. 

Prescription drug abuse is both a federal and state issue, and I 

have worked with both local and federal officials to take on this 

issue. 

In my district, Pasco and Pinellas Counties have had some of the 

highest oxycodone causes of death with 197. Hillsborough County, 

this is in the Tampa Bay area, was fourth in Florida with 128 

deaths from oxycodone. Sadly, Pasco and Pinellas Counties also led 

the state in methadone deaths and hydrocodone deaths. The number of ER-related visits from misuse or abuse of prescription drugs 

has nearly doubled in the past 5 years. 

Recently, there was a drug summit in Pasco County where both 

health officials discussed the growing problem of babies born addicted to prescription drugs. Pinellas County ranks first in the 

state for babies born addicted. Florida has taken some positive 

steps to fight prescription drug abuse such as legislation to eliminate pill mills in 2011. 

Florida currently runs four drug tracking programs in addition 

to the Controlled Substance Reporting System. The number of doctors on the DEA’s list of top 100 purchasers of oxycodone declined 

by 97 percent in a single year and pain management clinic registration decreased by 36 percent. This is a good start but there is 

much more work to be done. I am sure you will agree. That is why 

I have instructed my office to look into issues of prescription drug 

abuse and developing, of course, future legislation. And again, Mr. 

Chairman, I really appreciate you holding this hearing. 

I have a couple questions. Mr. Kerlikowske, I talked a bit about 

this of course, the growing problem of babies born addicted to prescription drugs such as oxycodone. This is a serious problem in our 

communities. I would like to have you come down if you will to the 

Tampa Bay area and meet some of the local officials, the health officials and providers who are dealing with this growing problem. 

I want to ask you a question. Are there any funds or programs 

available for the local community to tap into to help with the problem either on the prevention or treatment side? And I also want 

to ask Dr. Clark, are there resources for my community, of course, 

from SAMHSA? So those are the questions. 

66 

Mr. KERLIKOWSKE. Congressman, we fund the Drug-Free Communities program, these grassroots communities programs that do 

prevention, and of course oftentimes that local voice is more powerful and more important to people about prevention. And we have 

worked with them to help them understand and become more 

knowledgeable. 

We fund almost 700 of them around the country to become more 

knowledgeable about this neonatal abstinence syndrome because 

we are seeing in a number of States, Florida, who is—and I attended the first meeting of the advisory committee that has worked 

so hard under the Attorney General to reduce that problem. It is 

a complex problem because there are women in pain that are also 

pregnant and are being treated. There are women in drug programs at the same time, and so there has to be a very careful balance. 

But I would also tell you I would be happy to visit the Tampa 

Bay area with you and examine this more closely. 

Mr. BILIRAKIS. Well, thank you very much. I appreciate that. I 

welcome that. 

Anyone else wish to comment on the panel? 

Dr. CLARK. We have Targeted Capacity Expansion grants that 

are available to the States so the States can use their block grants 

to help promote education. We are developing an internal strategy 

to deal with NES. We recognize it is much broader than the prescription opioids. It involves heroin. But, as you know, that any 

time a woman has to take medication while she is pregnant, there 

is some associated risk for the neonate, and so what we will try to 

do is promote adequate education of consumers and practitioners so 

that we can address these issues. 

We have a Pregnant and Postpartum Women’s program that allows women who have addiction problems to get into treatment. 

During the time that they are pregnant and when they deliver, we 

can deal with both the mom and the child. And the data do show 

that the outcomes of the birth are much more positive when we 

have those kinds of programs. 

But the most important thing is having this concerted effort involving multiple layers at the State level, at the local level, community level involving practitioners as well as consumers. 

Mr. BILIRAKIS. Thank you. Thank you very much. I yield back, 

Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman. 

The House is voting on the floor. There are less than 10 minutes 

left to vote. 

That concludes the questions from the members. There might be 

other questions. We will submit those to you in writing if you 

would please respond promptly. And members should submit their 

questions by the close of business on Friday, June 28. 

So thank you very much to the witnesses, to the members for attending. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 11:23 a.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

67 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

According to the Centers for Disease Control and Prevention, prescription drug 

abuse is an epidemic. And unfortunately it is a growing problem that is affecting 

too many American families. 

Data from the National Survey on Drug Use and Health (NSDUH) show that 

about 15.7 million people aged 12 or older used prescription-type drugs non-medically in the past year, and that 2.5 million of these individuals reported using prescription-type drugs non-medically for the first time. 

Particularly alarming is the fact that many people, especially teenagers, believe 

prescription drugs are safer than illegal drugs because they are prescribed by a 

healthcare professional and dispensed by a pharmacist. But with more than 20,000 

deaths occurring each year due to the misuse and abuse of prescription drugs, we 

must ensure that our research, education, and prevention efforts are addressing this 

major public health and safety concern. 

The federal government has undertaken a number of positive initiatives. The National All-Schedules Prescription Electronic Reporting Act (NASPER), which I coauthored with my colleague Ed Whitfield from Kentucky, was enacted in 2005 to provide grants to states to establish prescription drug monitoring programs, so that 

these potentially dangerous substances are used only for intended purposes with legitimate prescriptions. The program, administered by the Substance Abuse and 

Mental Health Services Administration (SAMHSA), helped ramp up state efforts to 

reduce abuse and diversion of prescription drugs. It is critical that we continue to 

support this program through federal funding. 

There is also a great deal of work being done right now by the Food and Drug 

Administration (FDA) to implement provisions related to prescription drug abuse 

that were included in the Food and Drug Administration Safety and Innovation Act 

(FDASIA), which Congress passed last summer. FDA has been tasked with thoroughly reviewing all Federal programs regarding prescription drug abuse and treatments for those with prescription drug dependence and identifying any gaps. That 

report is due out this summer and I think will be useful in the work of this Subcommittee. In addition, as we will hear from FDA today, they have issued guidance 

on developing abuse-deterrent products. 

The Administration has also made prescription drug abuse a priority, setting out 

a plan to address this health epidemic. I support those efforts, but it is clear that 

we still have an unsolved problem that needs further attention. 

I hope our witnesses today can help us navigate how we can find innovative approaches to combating prescription drug abuse while recognizing the critical use 

that many of these drugs have for patients across the country. 

Thank you. 

68 


85445.028

NATIONAL ASSOCIATION OF 

CHAIN DRUG STORES 

Statement 

Of 

The National Association 

of Chain Drug Stores 

For 

U.S. House of Representatives 

Energy and Commerce Committee 

Subcommittee on Health 

Hearing on: 

"Examining the Federal Government's 

Response to the Prescription Drug Abuse 

Crisis" 

June 14,2013 

9:30 a.m. 

2123 Rayburn House Office Building 

National Association of Chain Drug Stores (NACDS) 

1776 Wilson Blvd, Suite 200 

Arlington, VA 22209 

703-549-3001 

www.nacds.org 
69 


85445.029

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14,2013 

Page 2 ofll 

Introduction 

The National Association of Chain Drug Stores (NACDS) thanks the Subcommittee on 

Health for the opportunity to submit a statement for the hearing on "Examining the 

Federal Government's Response to the Prescription Drug Abuse Crisis." NACDS and 

the chain pharmacy industry are committed to partnering with federal and state agencies, 

law enforcement agencies, policymakers, and others to work on viable strategies to 

prevent prescription drug abuse, Our members are engaged daily in activities with the 

goal of preventing drug abuse. 

NACDS represents traditional drug stores, supermarkets, and mass merchants with 

pharmacies - from regional chains with four stores to national companies. Chains 

operate more than 41,000 pharmacies and employ more than 3.8 million employees, 

including 132,000 pharmacists. They fill over 2,7 billion prescriptions annually, which is 

more than 72 percent of annual prescriptions in the United States. The total economic 

impact of all retail stores with pharmacies transcends their over $1 trillion in annual sales. 

Every $1 spent in these stores creates a ripple effect of$1.81 in other industries, for a 

total economic impact of$1.81 trillion, equal to 12 percent ofGDP, For more 

information about NACDS, visit www.NACDS.org. 

NACDS and the chain pharmacy industry share the Subcommittee's concerns with the 

problem of prescription drug abuse. We believe that there are a variety of ways to help 
70 


85445.030

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Govermnent's Response to the Prescription Drug Crisis" 

June 14, 2013 

Page3ofl1 

curb prescription drug abuse, and chain pharmacies actively work on many initiatives to 

reduce this problem. 

Background 

First enacted in 1970, the federal Controlled Substances Act (CSA) regulates the 

manufacture, importation, possession, use, and distribution of prescription drugs that 

have a potential for diversion, addiction and abuse, known as "controlled substances." 

The CSA creates a closed system of distribution for controlled substances; DEA often 

refers to this as "cradle-to-grave" control over controlled substances. DEA has 

implemented a very tight and comprehensive regulatory regime pursuant to the CSA. 

States have followed this lead and have implemented similar, sometimes duplicative 

regimes. This matrix of regulation has created a multi-layered system of checks and 

balances to protect Americans from the dangers of prescription drug diversion and abuse. 

Pharmacists and other pharmacy personnel are all trained to understand and comply with 

this complex regulatory matrix. 

Chain Pharmacy Initiatives 

To comply with DEA's "cradle to grave" regulatory regime, chain pharmacies have 

created a variety of loss prevention and internal security systems that are in place from 

our prescription drug distribution centers right down to the point of dispensing to the 

patient. We undertake initiatives to ensure that prescription drugs are accounted for in 

every step along the way. Some of those initiatives could include conducting background 

checks before hiring personnel who have access to prescription drugs, training about 
71 


85445.031

NACDS Statement for the record to the U.S. House Energy and Commerce Committee. 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14. 2013 

Page 4 of II 

controlled substance laws and regulations within 30 days of hire, and maintaining 

electronic inventories of controlled substances and conducting random audits. The tools 

we utilize to secure our facilities and operations can include camera surveillance, heavy 

duty safes, secure cages, and complex alarm systems. We work closely with law 

enforcement to see that perpetrators are brought to justice. 

Specifically, at the pharmacy level, examples of the initiatives our members have 

undertaken include training pharmacy personnel on how to handle suspect prescription 

drug orders, and exception reporting, in which exceptionally large or unusual orders of 

controlled substances will trigger an internal investigation. Chain pharmacies also may 

maintain perpetual inventories of controlled substances that are randomly audited by 

internal security personnel. Pursuant to DEA and state regulations, every pharmacy is 

highly secured with physical barriers and complex alarm systems. Some pharmacies also 

utilize cameras and closed-circuit television to ensure compliance with policies and 

procedures. Some pharmacies require employees to read and sign "codes of conduct," 

which commits them to compliance. Some member pharmacies will conduct drug 

testing, including random, for cause, and pre-employment. 

In addition to developing, implementing, and maintaining our own policies and 

procedures, we support numerous other initiatives to mitigate and reduce prescription 

drug abuse. Chain pharmacies participate in state controlled substance prescription drug 

monitoring programs. NACDS and our member companies support policies that work to 

prevent illegitimate Internet drug sellers from selling or offering to sell drugs to U.S. 
72 


85445.032

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Govermnent's Response to the Prescription Drug Crisis" 

June 14,2013 

PageS of II 

consumers in violation offederal and state laws. We also support efforts to provide 

patients with means for disposal of their unwanted medications in ways that are 

authorized by law enforcement. 

The Role of FDA 

Six years ago, Congress passed the Food and Drug Administration Amendments Act of 

2007 (FDAAA), which provided the FDA the authority to impose risk management plans 

on prescription drugs, known as Risk Evaluation and Mitigation Strategies (REMS). A 

REMS will be imposed if FDA finds that a REMS is necessary to ensure that the benefits 

of a drug product outweigh the risks of the drug product. Among the numerous REMS 

that FDA has implemented is a REMS for long-acting and extended release opioid 

products ("LAIER opioid drugs"). These are pain relieving medications that have an 

elevated potential for abuse. The central component of this "Opioid REMS" is an 

education program for prescribers (e.g., physicians, nurse practitioners, physician 

assistants) so that LAIER opioid drugs can be prescribed and used safely. NACDS 

agrees that prescribers should be properly educated about the risks and benefits of 

prescription drugs, including those that have elevated abuse potential like LA/ER opioid 

drugs. It is critical that all prescribers understand the nature of addiction and abuse 

before issuing prescriptions for these medications. NACDS supports FDA's Opioid 

REMS. 

In addition, FDA recently implemented a REMS for another class of drugs with elevated 

abuse potential: transmucosal immediate-release fentanyl (TIRF) products. NACDS and 
73 


85445.033

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14, 2013 

Page 6 of 11 

other industry stakeholders have worked closely with FDA over the past few years to 

design and implement this REMS. We are appreciative ofthis collaborative effort 

spearheaded by FDA. If this REMS proves successful, we are hopeful that it could serve 

as a model for future REMS for products similar to TIRF products. 

As we pursue solutions to the problem of prescription drug abuse, it is critical that we do 

not place undue burdens on legitimate patients who require prescription medications. As 

FDA has recognized through the REMS program, the risks of medications must be 

mitigated relative to their benefits. However, we cannot mitigate risks to the point that 

legitimate patients cannot receive medications' benefits. We believe that FDA has struck 

a proper balance thus far. 

Controlled Prescription Monitoring Programs 

NACDS and chain pharmacies support controlled substance prescription monitoring 

programs to help combat prescription drug abuse. Currently, about 44 states have 

operational monitoring programs and another five states are in various stages of program 

implementation. Recognizing the important role these programs have in helping to 

prevent drug abuse and diversion, chain pharmacies actively support these programs. 

Pharmacies submit information on the controlled substances they dispense monthly, 

weekly, and daily depending on the particular state's program requirements. This 

information includes information on the patient, prescribed drug dosage and quantity, and 

the prescriber. This information allows the state to conduct confidential reviews to 

determine any patterns of potential abuse or diversion. 
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NACDS Statement for the record to the U.S. House Energy and Commerce Committee. 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14. 2013 

Page 70/11 

These monitoring programs offer many benefits to aid in curbing prescription drug abuse. 

For example, they aid in identifying, deterring, or preventing drug diversion and abuse. 

These programs encourage appropriate intervention to determine if a person may have a 

drug addiction, so that treatment may be facilitated. The programs also provide public 

information on trends in drug abuse and diversion. 

NACDS and chain pharmacies support these programs as one of many strategies to help 

curb prescription drug abuse and diversion. We believe that these programs have proven 

useful in preventing drug abuse and diversion at the prescriber, pharmacy and patient 

levels. 

Law Enforcement Authorized Programs for Return and Disposal of Unwanted 

Prescription Drugs 

Another important strategy to curb drug diversion and abuse is to provide consumers with 

appropriate means to return unwanted prescription drugs for disposal. 

Finding a workable law enforcement-authorized means for consumer disposal of unused 

and expired drug products is critical to reducing drug abuse. While varying policy 

options have been proposed, NACDS supports the following principles for proper return 

and disposal of consumers' unwanted medications. These include protecting patient 

health and safety by maintaining a physical separation between pharmacies and locations 

that take back consumers' unwanted drugs. For example, drug take-back events 
75 


85445.035

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14.2013 

Page 8 of 11 

sponsored by DEA provide for such separation and avoid the potential for returned 

medications to re-enter the drug distribution supply chain. In addition, we support 

policies where consumers have a reliable and readily available means to return their 

unwanted medications such as mail-back envelope programs that are sanctioned by law 

enforcement or the DEA. The state of Maine has operated a DEA-authorized drug mailback program, funded through federal grants, where consumers are provided with prepaid, mail-back envelopes distributed at pharmacies and other locations, to mail in their 

unwanted medications. In addition, at various locations across the U.S., law enforcement 

partners with pharmacies to provide drug take-back events to give consumers means to 

return their unwanted medications. These programs help prevent teens and others from 

accessing and using prescription drugs in dangerous and potentially deadly ways. We 

commented on DEA's proposed regulations to allow consumers to properly dispose of 

unused, unwanted prescription drugs, and look forward to DEA's final rule. 

The Role of DE A 

DEA holds the primary authority to implement and enforce the CSA. NACDS and our 

members vigorously support the mission and efforts ofDEA. We seek to work with 

DEA and other law enforcement bodies on a routine basis. 

Pharmacies understand that controlled substances are subject to abuse by a minority of 

individuals who improperly obtain controlled substance prescriptions from physicians 

and other prescribers. Pharmacies must treat medical conditions and ease patients' pain 

while simultaneously guarding against the abuse of controlled substances. The key is to 
76 


85445.036

NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14, 2013 

Page 90/11 

guard against abuse while still achieving our primary goal of assisting patients who need 

pharmacy services, 

DEA regulations provide that physicians and other prescribers are responsible for 

ensuring that prescriptions for controlled substances are issued for legitimate medical 

purposes within the prescribers' usual course of professional practice. According to DEA 

regulations, the responsibility for the proper prescribing and dispensing of controlled 

substances is upon the prescribing practitioner, but a corresponding responsibility rests 

with the pharmacist who fills the prescription. An order purporting to be a prescription 

issued not in the usual course of professional treatment is not a prescription within the 

meaning and intent of section 309 of the CSA (21 U.S.c. 829) and the person knowingly 

filling such a purported prescription, as well as the person issuing it, is subject to the 

penalties provided for violations of the CSA. 

In the recent past, it is our understanding that DEA has been taking a harder look at the 

problem of prescription drug abuse in the U.S. DEA has placed increased scrutiny on 

both wholesale distributors and pharmacies. Since the mid-2000's, DEA has taken action 

against wholesale distributors that it deems are inappropriately distributing controlled 

substances to pharmacies, including shutting down a number of their wholesale 

distribution centers. More recently, DEA has focused its attention on chain pharmacies, 

shutting down such chain pharmacy distribution centers that it deems are distributing 

controlled substances inappropriately, as well as shutting down a number of chain 

pharmacies that it believes are dispensing medications to patients inappropriately. 
77 


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NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14,2013 

Page 100f11 

In addition, DEA has been visiting states nationwide and providing day-long 

presentations to pharmacists to apprise them of DE A's expectations. 

Better Focusing Government Resources 

Unfortunately, DEA's enforcement actions are causing problems with patients' ability to 

access much needed prescription pain medications. To better focus government 

resources on solving the problem of prescription drug abuse, NACDS urges Congress to 

create a commission or advisory group to bring together all stakeholders to address the 

problems of prescription drug diversion and abuse. The activities and recommendations 

of the advisory group should be broad in scope; however the recommendations should 

include specific direction for federal agencies to carry out. Most importantly, there 

should be an agreement from all participants to support this collaborative result. 

The appropriate participants include key government agencies, patient groups, pharmacy 

groups, prescriber and other provider groups, prescription drug wholesaler groups, 

pharmaceutical companies, public policy experts, state attorneys general, and law 

enforcement officials including groups representing local law enforcement. 

The policy areas that should be reviewed include: 

• Improving controlled substance monitoring programs to avoid duplication and 

provide access to all relevant stakeholders 

• Shutting down illegal Internet prescription drug sites 

• Shutting down "pill mills" 
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NACDS Statement for the record to the U.S. House Energy and Commerce Committee, 

Subcommittee on Health 

"Examining the Federal Government's Response to the Prescription Drug Crisis" 

June 14. 2013 

Page 11 0/11 

• Facilitating proper disposal of prescription drugs through take-back programs 

• Identifying hot spots of prescription drug abuse 

• Better collaboration among federal agencies, especially FDA and DEA, on drug 

abuse issues to suggest guidelines for DEA action 

• More resources for law enforcement 

• Better education of providers, patients, parents and youth 

• Development of abuse-resistant products 

• Recommendations for reducing robberies, burglaries, and cargo theft 

• The recommendations should be broken down by state and federal recommendations 

with respect to what is appropriate federally versus the individual states 

We believe that bringing together stakeholders to address the problems of prescription 

drug abuse in this manner would provide better solutions than have been developed to 

date. Improved collaboration and coordination among federal agencies and other 

stakeholders would benefit all, including the patient, whose access to critical medication 

must be preserved in order for any potential solution to be successful. 

Conclusion 

NACDS thanks the Subcommittee for consideration of our comments on efforts to 

address the problem of drug abuse. We are committed to the health and welfare of our 

patients, as well as all Americans, including ensuring that they can still access critical 

pain medications while we tackle the problem of prescription drug abuse. 
79 


85445.039

FRED UPTON, MICHIGAN 

CHlIIRMAN 

HENRY A. WAXMAN, CALIfORNIA 

R/,NKING MEMBER 

ONE HUNDRED THIRTEENTH CONGRESS 

([ongre~~ of tue Wniteb 

:J!}OU5C of 1,cpnsentatib1'5 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HOUSE OFfiCE BUILDING 

WASH1NGTON, DC 20515-.s115 

The Honorable R, Gil Kerlikowske 

Director 

Office of National Drug Control Pol icy 

Executive omcc of tile President 

750 17th Street, N,W, 

Washington, D,C, 20503 

DcarMr. Kcrlikowske: 

July 9, 2013 

Thank you for appearing before the Subcommitrce on Health on Friday, .lune J 4,2013, to testify 

at the hearing entitled "Examining the Federal Government's Response to the Prescription Drug Abuse 

Crisis," 

Pursuant to the Rules of the Committee Oil Energy and Commerce, the hearing record remains 

open for len business days to pemlit Members to submit additional questions for the record, which are 

auached. The fonnat of your responses to these questions should be as follows: (I) the name of the 

Mt'mber whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions by the close of 

business on Tuesday, July 23, :W 13, Your responses should be mailed to Sydnc Harwick, Legislative 

Clerk, Commitree on Energy and Commerce, 2125 Rayburn House Office Building, Washington, D.C. 

20515 and e-mailed in Word format to Svdne.HarwicMi)mail,house.go\,. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee, 

cc: The Honorable Frank Pallone, Jr., Ranking Member, Subcommittee on llealth 

Attachment 
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85445.040

RESPONSES TO 

QUESTIONS SUBMITTED FOR THE RECORD TO 

R. GIL KERLIKOWSKE 

DIRECTOR 

OFFICE OF NATIONAL DRUG CONTROL POLICY 

FOLLOWING JUNE 14,2013, HEARING ENTITLED, 

"EXAMINING THE FEDERAL GOVERNMENT'S RESPONSE TO THE PRESCRIPTION 

DRUG ABUSE CRISIS" 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

UNITED STATES HOUSE OF REPRESENTATIVES 

The Honorable Joseph R. Pitts 

1. In 2012, the FDA, in partnership with other regulatory and law enforcement agencies, 

undertook Operation Pangea V and took action against more than 4,100 internet 

pharmacies. Operation Pangea V resulted in the shutdown of more than 18,000 illegal 

pharmacy websites and seized approximately $10.5 million worth of pharmaceuticals 

worldwide. This operation illustrates the magnitude ofthe internet pharmacy problem. 

Online Pharmacies have proven to be very problematic and dangerous as they often do not 

require any prescription. How is ONDCP combating online pharmacies? 

ANSWER: While research shows that less than one percent of individuals abusing or misusing 

prescription drugs obtain them from Internet sales, the Federal Government has taken steps to 

reduce the role of illegal Internet pharmacies in diversion ofopioid pharmaceuticals!. The Ryan 

Haight Online Pharmacy Consumer Protection Act requires Internet pharmacies dispensing 

controlled substances to obtain a special Drug Enforcement Administration (DEA) registration 

and report monthly to DEA, to disclose detailed information on their home page, and to not 

provide such pharmaceuticals to individuals who have not had at least one face-to-face 

evaluation by a prescribing medical practitioner, subject to limited exceptions for telemedicine 

practice. It is designed to allow DEA to better monitor unlawful Internet pharmacy operations, 

and reduces the number of Internet pharmacies distributing controlled substances illegally. 

Pharmacies that are lawfully registered with DEA and whose dispensing of controlled substances 

via the Internet consists of filling or refilling prescriptions for Schedule III-V controlled 

substances (as specified in 21 U.S.C. § 802(55) and (56)) are exempt from the Ryan Haight Act 

definition of "online pharmacy." Those online pharmacies and websites that continue to 

unlawfully sell opioid pharmaceuticals and other controlled substances are typically located 

outside the United States, and to date, DEA has not registered any online pharmacies pursuant to 

the Ryan Haight Act. 

I Substance Abuse and Mental Health Services Administration. Results/rom the 2011 National Survey on Drug Use 

and Health: Summary a/National Findings. U.S. Department of Health and Human Services. [September 2012]. 

Available: http://www.samhsa.gov/dataJNSDUH/2kIIResultsINSDUHresults2011.htm#2.16 
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85445.041

Within the Office of National Drug Control Policy (ONDCP), the High Intensity Drug 

Trafficking Areas (HIDT A) program provides designated areas around the country with funds to 

establish mUlti-agency task forces to address drug enforcement issues within their respective 

areas. Of the 28 HIDTAs, 19 (including 4 of the 5 regions comprising the Southwest Border 

HIDT A) have identified Internet pharmacies as a growing threat to their area. 

Most investigations conducted by HIDTA task forces focus on poly-drug organizations and not 

specifically on Internet sales of illegal drugs. Given the role the Internet has played in the illegal 

distribution of pharmaceuticals, however, some HIDTAs have specifically targeted them. 

For example, the Nevada HIDT A funds a task force called Pharm-Net that specifically targets 

pharmaceuticals purchased over the Internet. This unique task force has been in place since 

2006. The Pharm-Net task force focuses on sources of supply, including on-line pharmacies, and 

drug trafficking organizations that divert pharmaceutical controlled substances. Many of the 

targeted organizations involve medical professionals such as doctors, pharmacists or other health 

care workers with access to controlled substances or prescriptions to obtain controlled 

substances. 

ONDCP will continue to work with DEA, the Food and Drug Administration (FDA), and other 

agencies to address online operations illegally diverting these medications and will continue to 

partner with international, state, and local law enforcement agencies to further suppress illegal 

online sources of prescription drug diversion. 

2. How does the ONDCP allocate its funds to address prescription drug abuse? 

ANSWER: ONDCP partners with several agencies to coordinate funding for the action items 

listed in the 20 II Prescription Drug Abuse Prevention Plan (Plan) under the National Drug 

Control Budget. For example: 

The Administration has requested $7 million in FY 2014 for the Prescription Drug 

Monitoring Program of the Department of Justice's Office of Justice Programs to 

enhance the capacity of regulatory agencies and health care providers to collect and 

analyze controlled substance prescription data; 

The DEA's Diversion Control Program (DCP), with a request of$360.9 million in FY 

2014, aids in preventing the diversion of pharmaceutical controlled substances; 

The National Institute on Drug Abuse (NIDA) supports research to better understand the 

patterns and motivations underlying prescription drug abuse, the development and testing 

of prevention programs, pain medications with reduced abuse potential, and treatments 

for prescription drug abuse and opioid overdose. NIDA released findings in 2013 in the 

following areas: Problem Behaviors Can Signal Risk in Prescribing Opioids to Teens; 

Preclinical trials of an Oxycodone Vaccine successful; Thoughts of Suicide May Persist 

Among Nonmedical Prescription Opiate Users; and Few Teens With Prescription Opioid 

Use Disorders Receive Treatment; and 

The Substance Abuse and Mental Health Services Administration (SAMHSA) is 

reviewing applications for up to approximately $2.8 million in Cooperative Agreements 

2 
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85445.042

for Electronic Health Record and Prescription Drug Monitoring Program Data Integration 

grants. SAMHSA is also awarding up to $750,000 to help enable opioid treatment 

programs to develop electronic health record systems. 

In FY 2012, ONDCP spent $1 million from HIDTA's discretionary funding to support 

investigations to disrupt and dismantle drug trafficking organizations suspected of violating 

Federal, state, or local statutes pertaining to the diversion of licit pharmaceutical controlled 

substances. The investigations also targeted rogue pain clinics, physicians who prescribe 

scheduled drugs without a valid medical reason, and pharmacies that illegally dispense or divert 

controlled drugs. 

With a request of$85.6 million in FY 2014, ONDCP also funds nearly 700 Drug Free 

Communities (DFC) Support Program coalitions across the country. Many of these community 

coalitions have prevention initiatives geared toward reducing prescription drug abuse and 

misuse. Coalitions supported by the DFC program, which is administered by SAMHSA, work 

with youth, parents, schools, law enforcement, business professionals, media, local, state and 

tribal government, and other community members to identifY and address local youth substance 

use problems and create sustainable community-level change. Through the use of environmental 

prevention strategies, DFC coalitions use comprehensive approaches to address prescription drug 

abuse such as raising awareness for prescribers, parents, and youth; organizing prescription drug 

take-back events; and developing systems for safe disposal of prescription drugs. DFC grantees 

have identified prescription drug abuse as a priority for their coalitions. 

3. How does the CDC, FDA and ONDCP work together during the development of a 

promising treatment which could help address the national priority of abating the drug 

abuse crisis? While obviously approval of any new medication is under the purview of the 

FDA, I'd like to know more about the extent to which each of your agencies provide your 

expertise to one another when a therapy with this potential is under review. 

ANSWER: As acknowledged, there are very strict rules governing the review and approval of 

medications, including restrictions on the role Federal agencies outside the FDA can play in 

these processes. However, as part of the overall effort to curb prescription drug diversion and 

abuse, the Administration has established clear objectives to promote the development of 

promising treatments. 

One aspect ofthe Administration's Plan relates to the development of abuse deterrent 

formulations of opioids. The Plan has two specific action items to advance this work. The first 

item, led by the Department of Health and Human Services (HHS), calls for expediting research 

through grants, partnerships with academic institutions, and priority New Drug Application 

review by the FDA to develop treatments for pain with no abuse potential as well as the 

development of abuse-deterrent formulations of opioid medications and other drugs with abuse 

potential. NIDA is funding grants for the development of such medications. 

The second action item, also led by HHS, cal1s for providing guidance to the pharmaceutical 

industry on developing abuse-deterrent drug formulations and on post-market assessment of their 

3 
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85445.043

performance. In January 2013, FDA issued draft guidance on the development of abusedeterrent opioid drug products, as required by the Food and Drug Administration Safety and 

Innovation Act. Recent actions by FDA concerning abuse-deterrent formulations of well-known 

prescription opioid drugs demonstrate that FDA is using the available scientific information to 

make its determinations concerning the marketing by drug manufacturers of purported abusedeterrent formulations. 

NIDA has prioritized the development of medications to treat substance use disorders. To 

accelerate the progress of medications development, NIDA has increased collaboration with 

pharmaceutical industry and biotech companies, is evaluating compounds with relevant 

mechanisms that have been "de-risked", awarding larger grants for shorter duration to obtain 

quicker results, and having the flexibility to prioritize projects as needed. NIDA is also funding a 

promising approach to treat substance use disorders that uses anti-drug enzymes or antibodies to 

neutralize the substance while it is still in the bloodstream, keeping it from entering the brain. 

NIDA scientists also review the eight factor evaluation of abuse liability required under the 

Controlled Substances Act (CSA) for scheduling of medications, once the evaluations are 

performed by the FDA. 

The Centers for Disease Control and Prevention (CDC) regularly works with FDA on efforts to 

improve understanding of abuse and overdose risks, public health implications of abuse, and how 

safer products or those with abuse-deterrent properties might impact the public health burden. 

CDC is also engaged with FDA to improve surveillance capacity to better evaluate the impact or 

potential impact of products under development. 

One other aspect of sharing between FDA, CDC and ONDCP that has been valuable has been 

exchange of information about prescription drug use and misuse. Both FDA and CDC scientists 

are working hard to track this epidemic and share this information where possible and needed 

with ONDCP and other parts of the Federal Government. While new medications continue to be 

developed, broader adoption of existing medicines to manage substance use disorders is 

necessary. In one important step, working with interagency partners, the Department of Defense 

is currently working on rulemaking to allow for TRICARE coverage of treatment of substance 

use disorders through medication-assisted treatment, such as methadone or buprenorphine. 

ONDCP will continue to work with NIDA, FDA, CDC, and other Federal interagency partners to 

help ensure innovative treatments are developed and tested safely and efficiently, and that 

existing treatment modalities are widely available to those that need them. There is significant 

potential in medication-assisted treatment, and we must ensure that these options are widely 

available, particularly in underserved communities in rural and other areas with limited treatment 

infrastructure. ONDCP continues to urge the medical research and substance abuse treatment 

fields to develop new therapies and more fully incorporate existing, evidence-based treatment 

modalities into health care. 

Full implementation of the Affordable Care Act includes treatment for substance use disorders as 

one of the ten Essential Health Benefits, as well as application of the Mental Health Parity and 

Addiction Equity Act of 2008 to these benefits, so that substance use disorders are treated the 

same as other chronic health disorders. ONDCP continues to work with its Federal partners to 

4 
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85445.044

ensure that clinically effective and cost effective substance use disorder services are integrated 

into the U.S. healthcare system. 

4. How do you measure the success ofthe Prescription Drug Abuse Prevention Plan? 

ANSWER: The Administration has established a number of specific goals to help gauge 

success of the Plan and ongoing efforts to reduce and prevent abuse of prescription drugs. The 

overarching five-year goal, as outlined in the National Drug Control Strategy, is a 15 percent 

reduction in non-medical use of prescription-type psychotherapeutic drugs in the past year among people 

12 years of age and older. 

ONDCP has established a multi-pronged approach to assess progress on these goals. From a 

strategic level, the Performance Reporting System (PRS) is a monitoring system that assesses 

interagency progress toward achieving the Goals and Objectives of the Strategy. The Strategy 

addresses the importance of both prevention and early intervention. Three PRS measures address 

non-medical use of prescription drugs: (1) percent of respondents in the past year using 

prescription-type drugs non-medically, age 12 - 17; (2) percent of respondents in the past year 

using prescription-type drugs non-medically, age 18 - 25; and (3) and percent of respondents in 

the past year using prescription-type drugs non-medically, age 26+. From an operational 

perspective, the ONDCP Delivery Unit tracks progress on action items that support achieving the 

Goals of the Strategy, including supplemental strategies such as the Prescription Drug Abuse 

Action Plan. 

Historic strides have been made in preventing doctor shopping by working with states to expand 

the use of prescription drug monitoring programs (PDMPs). In 2006, only 20 states had PDMPs. 

Today, 49 states have laws authorizing these databases, and 47 states have operational programs. 

Each day, these programs are helping to rein in the diversion of prescription drugs for nonmedical use by enhancing the ability of prescribers, pharmacists, and state authorities to prevent 

abuse. 

ONDCP has worked extensively with medical professionals to provide training on how to 

properly prescribe painkillers. In conjunction with NIDA, ONDCP has made available two free 

online training tools for healthcare professionals who prescribe these powerful drugs. Already, 

nearly 60,000 clinicians have completed these training courses in less than a year. Moreover, 

FDA now requires manufacturers of extended-release and long-acting painkillers to make 

available free or low-cost continuing education to prescribers under the Risk Evaluation and 

Mitigation Strategy for extended-release and long-acting (ERfLA) opioid analgesic drugs 

(ERfLA Opioid Analgesic REMS). The FDA expects companies to train at least 60 percent of 

the approximately 320,000 prescribers of these drugs within the next four years. 

Through support ofDEA's National Prescription Drug Take-Back Day initiatives, communities 

have reasonable ways to dispose of unneeded or expired medications languishing in home 

medicine cabinets. These events have already collected and safety disposed of almost three 

million pounds of medications, draining a key source of drugs that are often diverted for abuse. 

5 
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85445.045

Progress has been made under all four pillars, and there are signs in recent years that this national 

effort is working. One example is non-medical prescription drug use among young adults. The 

rate of non-medical use of prescription drugs among young adults (18 to 25 years old) in 2012 

was 5.3 percent. While this rate is similar to rates seen in 2010 and 2012, it is lower than the rate 

in the years 2003 through 2007 and 2009 (which ranged from 5.9 to 6.5 percent).2 While not 

definitive, these new data underscore the need for ongoing focus on reducing and preventing 

prescription drug abuse. 

5. Why has ONDCP prioritized reauthorizing NASPER? 

ANSWER: When the Administration released the Plan in 20 II, the number of states that had 

PDMPs was significantly less than today, and those PDMPs were only beginning to commence 

operation, let alone work with each other. At that time, there were two Federal programs: the 

Harold Rogers Prescription Drug Monitoring Program (HRPDMP) grants, administrated by the 

Bureau of Justice Assistance (BJA) in the Department of Justice; and the National All Schedules 

Prescription Electronic Reporting (NASPER) program, administered by the Substance Abuse 

and Mental Health Services Administration (SAMHSA) within HHS. As originally conceived, 

HRPDMP grants could be used to plan a state PDMP, but to be eligible for a NASPER grant a 

state needed to have PDMP legislation in place. During the initial years ofNASPER's 

authorization, there was still a need to support widespread establishment and implementation of 

PDMPs, as well as ensuring that states would make their PDMPs more interoperable and use 

them as a public health tool, not primarily a law enforcement tool. 

Given that 49 states now have legislation authorizing PDMPs and 47 states have operational 

programs, the focus in supporting PDMPs has shifted from getting PDMPs started to improving 

the utility of existing PDMPs and enhancing their interoperability, both with other state PDMPs 

and with other health information technology systems. 

We are committed to working with SAMHSA and BJA to ensure a streamlined Federal approach 

to provide support for state PDMPs. We continue to support both BJA's efforts to fund and 

enhance PDMPs through the HRPDMP and SAMHSA's efforts through its PDMP and EHR 

Integration grants. 

6. Are you investigating a strategy involving drug packaging? 

ANSWER: In April 2013, FDA announced approval of updated labeling for reformulated 

OxyContin® (oxycodone hydrochloride) stating that the product has physiochemical properties 

that are expected to make abuse via injection difficult and are expected to reduce abuse via the 

intranasal route (snorting). This is the first time that FDA has approved labeling that 

2 Substance Abuse and Mental Health Services Administration. Results from the 2012 National Survey on Drug Use 

and Health: Summary a/National Findings. U.S. Department of Health and Human Services. [September 2013]. 

Available: 

http://www.samhsa.gov/datalNSDUHI2012SummNatFindDetTableslNationaIFindingsINSDUHresults2012.htm#ch2 

J. 

6 
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characterizes a product's abuse-deterrent properties. Including information about a product's 

abuse-deterrent properties in labeling is important to inform health care providers, patients, and 

the public about the product's predicted or actual abuse potential. FDA continues to encourage 

pharmaceutical manufacturers to seek approval of proposed product labeling that highlights 

product safety and other properties and appropriately characterizes the abuse-deterrent properties 

of a product. The FDA's guidance around such labeling notes that labeling language regarding 

abuse deterrence should describe the drug's specific abuse-deterrent properties, as well as the 

specific routes of abuse that the drug has been developed to deter. 

7. In the document Epidemic: Respondil1g to America's Prescriptiol1 Drug Abuse Crisis, one 

of the primary action items is educating prescribers. You note that you would like to 

amend Federal law to require the training. In conjunction with this legislative approach 

has your agency talked to medical, nursing, and pharmaceutical schools about including 

this in the curriculum? 

ANSWER: Yes, the Administration is working with a number of health care practitioner 

organizations and associations, as well as medical colleges and faculty to promote the 

widespread adoption of this safe prescribing and substance abuse content by medical educators. 

For example, ONDCP is working with the American Dental Association to ensure that safe 

prescribing education is properly tailored to dental students and professionals. Additionally, 

ONDCP leadership has met with a host of medical and pharmacy school deans and faculty, 

including a keynote address and a private meeting at the 2012 American Association of Colleges 

of Pharmacy Annual Meeting in Orlando, FL, and staff-level engagements with the Association 

of American Medical Colleges, encouraging these associations and their members to strengthen 

and expand curricula around safe prescribing, abuse-potential of medications, and recognizing 

the signs and intervening with patients with substance use disorders. These messages are 

reinforced in work with state Medical and Pharmacy Boards, as well as their national 

counterparts. All of these efforts inform education, not only in medical, nursing, dental, and 

pharmacy schools, but also continuing education over the course of health care professional 

careers. 

In 2011, ONDCP convened a meeting with leaders in pharmacy education to encourage 

pharmacy schools to expand educational offerings. The Administration has also taken a number 

of steps to promote expanded continuing medical education for prescribers, so that current 

prescribers receive further training in prescribing controlled substances, particularly opioid pain 

relievers. The Administration is committed to making convenient, free or low-cost tools and 

training available to a broad spectrum of prescribers and dispensers of these controlled 

substances. 

ONDCP worked with NIDA to develop two free online continuing education training tools for 

healthcare professionals who prescribe opioid analgesics. Since these tools became available in 

October 2012, nearly 60,000 clinicians (primarily physicians and nurses) have completed 

coursework eligible for continuing medical education credit-as well as training on the abuse 

potential of these medications and management of patients to whom they are prescribed. 

7 
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SAMHSA is providing training on prescription drug abuse for physicians and other health 

professionals both online and in-person in 20 states with particularly high rates of opioid 

dispensing. In addition, the FDA has developed a Risk Evaluation and Mitigation Strategy for 

ERiLA opioids analgesics. Approved in July 2012, the ERiLA Opioid Analgesic REMS requires 

all manufacturers ofERILA opioids to make available training for prescribers of these 

medications.3 The training must include information that prescribers can use when counseling 

patients about the risks and benefits of opioid use. The FDA expects the training to be provided 

free or at low-cost by continuing education providers and at least 60 percent of the 

approximately 320,000 active prescribers ofERILA opioids to be trained within four years from 

when training is available.4 A number of these education programs are already available or will 

be available to health care providers in the near future. 

8. It is clear that the prescription drug abuse crisis is extremely complicated and constantly 

changing. Has the ONDCP altered the prescription drug abuse plan to accommodate for 

the evolving epidemic? If so, how has the plan changed? 

a. What caused the changes in strategy? 

b. What have been the strongest and most effective parts of the strategy? 

ANSWER: ONDCP regularly engages with partners at the Federal, state, and local levels to 

adapt and respond to emerging issues related to prescription drug diversion and abuse. ONDCP 

also works with interagency partners to examine the latest research and data to better inform 

ongoing work to reduce prescription drug abuse and its consequences. The Administration is 

focused on addressing some of the most pronounced consequences of this epidemic, including 

overdose deaths and emerging issues like heroin use as well as neonatal abstinence syndrome 

and maternal addiction. 

With recent rises in overdose deaths across the country,5 ONDCP has increased its focus on 

comprehensive overdose prevention, recognizing that overdoses can be prevented, antidotes are 

available, and treatment is imperative. ONDCP is working with Federal partners and state and 

local authorities to expand access to naloxone, an emergency opioid overdose reversal 

medication, for first responders who encounter overdose victims. The agency is also closely 

examining Good Samaritan laws, which provide limited protections for individuals who call 911 

in overdose situations, to remove perceived barriers to calling for help. These steps are critical as 

part of a larger effort to inform the public, law enforcement, and health care professionals about 

the nature of prescription drug abuse, addiction, and overdose prevention. 

3 Food and Drug Administration. Extended Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation 

and Mitigation Strategy (REMS). U.S. Department of Health and Human Services. [August 2012]. Available: 

http://www.fda.gov/downloads/DrugslDrugSafetylPostmarketDrugSafetylnformationforPatientsandProviders/UCM 

31 I 290.pdf 

4 Food and Drug Administration. Extended Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation 

and Mitigation Strategy (REMS). U.S. Department of Health and Human Services. [August 2012]. Available: 

http://www.fda.gov/downloads/DrugslDrugSafety/PostmarketDrugSafetylnformationforPatientsandProviders/uCM 

311290.pdf 

5 CDC/Wonder; data extracted on January 28, 2013. 

8 
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Another area of expanded focus is the nexus between prescription drug abuse and heroin use. 

The number of primary admissions for heroin treatment services among 18 to 24 year olds 

increased from 37,000 in 2000 to 60,000 in 2011.6 Epidemiologists in all regions of the United 

States report increases in heroin use among young adults and those outside of urban areas.7 

Research also indicates that injection-drug users report prescription opioid use predates their 

heroin use, and increased tolerance to prescription opioids and lower costs motivate them to try 

heroin.8 ONDCP and researchers with the CDC are closely monitoring these trends to determine 

whether there is a relationship between prescription drug initiation and transition to heroin use, 

particularly among young people. The Administration is also ensuring that comprehensive 

overdose prevention properly considers the role of heroin in overdose, and is underscoring the 

importance of getting individuals abusing prescription drug into treatment before their tolerance 

leads to injection drug use. 

The Administration is also taking steps to understand and address the clinical and policy issues 

related to maternal addiction, including neo-natal abstinence syndrome (NAS), the withdrawal 

symptoms exhibited by some infants born to mothers exposed to illicit drugs and certain 

medications during pregnancy. Many hospitals with little experience caring for drug exposed 

newborns prior to the prescription drug abuse epidemic are now witnessing increases in births 

requiring additional hospital resources. Between 2000 and 2009, the rate of hospitals billing for 

NAS increased from 1.2 to 3.4 per 1,000 hospital births per year.9 This translates to roughly one 

infant per hour born with signs of drug withdrawal. In August 2012, ONDCP hosted a national 

leadership meeting that focused on NAS and evidence-based treatment and prevention options 

for maternal addiction. The conclusions reached at this meeting are reflected in a renewed 

emphasis on maternal addiction and neonatal abstinence syndrome in the National Drug Control 

Strategy. 

The Administration's efforts around PDMPs and health information technology (IT) have also 

progressed. In support of the Plan, ONDCP convened a Roundtable on Health IT and 

Prescription Drug Abuse shortly after the Plan's release. Over 30 attendees from the public and 

private sectors discussed integrating these innovative technologies with PDMPs so that 

prescribers and pharmacists can more easily and effectively access and use the PDMP data. 

They agreed on nine pilot studies, and HHS contracted with the MITRE Corporation to facilitate 

the development of some of these pilots. 1O 

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

Treatment Episode Data Set (TEDS). Data extracted as of October 15, 2012. 

7 Proceedings of June 2012, NIDA CEWG (Unpublished Data from NIDA). 

8 Lankenau SE, et al. (2012). Initiation into prescription opioid misuse amongst young injection drug users. Int J 

Drug Policy. 2012 Jan;23(l):37-44. Epub 2011 Jun 20. 

9 Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. "Neonatal abstinence 

syndrome and associated health care expenditures: United States, 2000-2009" JAMA. 2012 May 9;307(18):1934-40. 

Available: http://www.ncbi.nlm.nih.gov/pubmed/22546608 

10 Prescription Drug Abuse and Health Information Technology Workgroup, Behavioral Health Coordinating 

Committee, U.S. Department of Health and Human Services. "Action Plan For Improving Access to Prescription 

Drug Monitoring Programs Through Health Information Technology." June 30, 2011. 

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The pilots, which were completed in 2012 and early 2013, yielded encouraging results. II For 

example, one ofIndiana's health information organizations, the Indiana Network for Patient 

Care, leveraged its hospital network to offer information from the State PDMP along with a 

"narcotic score" alert (using a formula to determine high risk based on the number of 

prescriptions) to emergency room doctors as part of their normal view of a patient's record. In 

Kansas, a secure e-mail protocol called "DIRECT" was used to send a PDMP report securely 

from the PDMP to a provider's electronic health record (EHR) when a certain threshold was met, 

such as when the patient sought to fill five prescriptions from five providers during one calendar 

quarter. Finally, in Michigan, a vendor of an electronic prescribing (e-prescribing) module 

worked with that State's PDMP to pull information from the PDMP when a provider 

electronically prescribed a medication using the module. This allowed providers to receive alerts 

concerning previous prescriptions of controlled substances before submitting a new prescription. 

The mechanisms developed for these pilots and others conducted during the two year process 

remain in place in their respective states. While preliminary evidence and prescriber reaction 

were positive, wider implementation and more research will be needed to prove the effectiveness 

of these methods in increasing prescriber use ofPDMP data, leading to appropriate interventions 

when drug-seeking behavior is discovered. To further encourage the development of innovative 

health IT integration with PDMPs, SAMHSA awarded nine two-year tgants in FY 201 I and is in 

the process of awarding up to $2.8 million in grants to states this year. 2 As part of these health 

IT integration efforts, SAMHSA and Office of the National Coordinator for Health IT (ONC) are 

working with states to explore data standards that would allow PDMPs and health IT systems to 

be more interoperable. This work is aimed at allowing EHRs to use PDMP data more effectively 

for clinical purposes. 

These and other efforts build upon the foundational 2011 Plan, and ONDCP and Federal 

interagency partners continue to respond to emerging issues, and identifY new opportunities to 

prevent the diversion and abuse of prescription medications. 

9. In your testimony, you note that 49 states have laws authorizing PDMPs. Why do 

Missouri and the District of Columbia not have legislation authorizing PDMPs? 

a. Which states have the best PDMP programs? 

b. What makes PDMPs effective? 

c. Are all PDMPs built upon a similar model? 

d. Are there any outstanding PDMPs that have proven to be more successful than 

others? 

e. Would you please explain the importance of state PDMPs being interoperable with 

other states; PDMPs? 

ANSWER: 

11 MITRE. Connecting Prescribers and Dispensers to PDMPS through Health IT: Six Pilot Studies and Their Impact. 

2012. http://v.ww.healthit.gov/sitesidefaultffiJes/pdmp pilot studies summarv O.pdf 

12 Substance Abuse and Mental Health Services Administration. Cooperative Agreements for Electronic Health 

Record (EHR) and Prescription Drug Monitoring Program (PDMP) Data Integration. RF A No. TI-13-013. 2013 

http://www.samhsa.gov/grants/2013/ti-13-013.pdf. 

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Missouri and District of Columbia 

ONDCP has engaged in discussions with leaders in both the Missouri and the District of 

Columbia governments about potential legislation to authorize PDMPs in their jurisdictions. 

Missouri's legislature considered multiple bill proposals during the past legislative session to 

authorize a PDMP. Two such bills were considered in the Missouri Senate Committee on 

Veterans' Affairs and Health on March 7, 2013. 13,]4 The two bills both included provisions to 

address concerns expressed by members of the legislature about maintaining the privacy of 

individuals who are filling prescriptions for controlled substances. The 2013 Missouri legislative 

session ended on May 17. My office will continue discussions with State leadership in Missouri 

about the importance ofPDMPs in preventing prescription drug abuse and will support their 

efforts to pass legislation in the 2014 legislative session. 

With advice and encouragement from ONDCP, the Washington D.C. Department of Health and 

the Mayor's office have worked with the Washington D.C. City Council to develop a proposal 

that would authorize a District-wide PDMP. As a result of their efforts, City Council Chairman 

Mendelson introduced legislation in February 2013 that would authorize a PDMP.IS The 

Council's Committee on Health held a public hearing on July 12 and heard extensive witness 

testimony in support of the legislation.16 We are hopeful that the District of Columbia will soon 

authorize the creation of a PDMP. 

PDMPModels 

All state PDMPs are built upon a general model. They collect information reported electronically 

by dispensers of controlled medications to a database managed by the state. PDMPs give certain 

persons or agencies access to the information, often through a web portal, in order to deter the 

over-dispensing of prescription drugs. 

However, there are some important variations within this common state PDMP structure. States 

have different requirements about how frequently dispensers must report to the state PDMP, 

ranging from real-time reporting to monthly reporting. 17,18 Importantly, state PDMPs also vary in 

terms of which agency they assign to house and manage the database. Some states house their 

PDMP in one of their law enforcement divisions, such as their Bureau ofNarcoticsl9 or their 

13 Missouri Senate, Missouri Senate Bill 233, Bill Status. 

http://www.senate.mo.gov/13info/BTS Web/Bill.aspx?SessionTypc=R&Bi1IlD= 17590490 

14 Missouri Senate Bill 146, LR Number 0976S.01I. 

http://v,;ww .senate.mo. gov 113 infoll3TS W eblBiIl.aspx?SessionType=R&B ill I D= 17254382 

IS Council of the District of Columbia. Legislative Information Management System, Legislation, Legislation No. 

B20-0 127. http://dcdimsl.dccouncil.usllims/legislation.aspx?LegNo=B20-0 127. 

16 Council ofthe District of Columbia. Council Hearing Archive. Committee on Health, Public Hearing, Yvette M. 

Alexander, Chairperson, July 12,2013. http://dccouncil.us/granicus/archivc/. 

17 Oklahoma Bureau of Narcotics and Dangerous Drugs Control. Prescription Monitoring Program. 

http://www.ok.gov/obnddiPrescription Monitoring Programl 

18 Alaska Prescription Drug Monitoring Program. Dispenser Information. http://I';ww.alaskapdmp.com/dispenser/ 

19 Oklahoma Bureau of Narcotics and Dangerous Drugs Control. Prescription Monitoring Program. 

http://www.ok.gov/obndd/Prescription Monitoring Program! 

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Attorney General's office.20 Other states house their database in the Department of Public 

Health,21 the State Board ofPharmacy,22 or State medical licensing boards.23 

States also vary in how they obtain funds for running their PDMP. Some states rely solel~ on 

Federal grant monies and private donations, expressly prohibiting the use of State funds. 4 In 

addition to Federal grants, states fund their PDMPs with general funds, licensure fees, and civil 

and administrative recoveries. BJA recently released a technical assistance document on funding 

options for state PDMPs developed by the Prescription Drug Monitoring Program Training and 

Technical Assistance Center.25 This document provides helpful tips to states on ways that other 

states have supported their PDMPs with funding. 

Effective PDMPs and State Examples 

New research shows that relative to states without PDMPs, states with PDMPs mitigate the 

prevalence of prescription opioid abuse and misuse in both the general population and among 

those in opioid treatment programs.26 Although some states' PDMPs have existed for several 

years, many are early in the establishment and implementation process. As a result, there is a 

paucity of available research on effectiveness and outcomes of implementing specific PDMP 

features. In September 2012, the Prescription Monitoring Program Center of Excellence at 

Brandeis University, a BJA-funded program, published a paper ofPDMP best practices.27 This 

paper examined observations about PDMPs from peer-reviewed journals and developed 35 

potential best practices for PDMPs. However, the authors noted that there are major gaps, such 

as a lack of randomized control trials, systematic reviews, or meta-analyses that need addressing 

in future research.28 Based on Brandeis's analysis and the underlying research on PDMPs, the 

following list represents what the ONDCP believes are promising practices, which, if enacted, 

would improve the utility ofPDMPs as public health tools. The ensuing discussion includes 

examples of state PDMPs that illustrate these practices: 

I. Access to and regular consultation ofPDMPs by prescribers and other healthcare 

professionals; 

20 State of California Dept. of Justice, Office ofthe Attorney General. CURESIPDMP. http://oag.ca.gov/cures-pdmp 

21 Rhode Island Department of Health. Prescription Drug Monitoring Program. 

http://Yvww.health.ri.gov/programs/prescriptionrnonitoringi 

22 Health Information Designs. Colorado Prescription Monitoring Program. http://www.hidinc.comicopdmp 

23 State ofindiana Professional Licensing Agency. Indiana Scheduled Prescription Electronic Collection and 

Tracking Program (INSPECT). http://www.in.gov/plalinspectlindex.htm 

24 Revised Statutes of the State of New Hampshire (Title XXX, Ch. 318-B) § 318-B:32: "II. All costs incurred by 

the board for the implementation and operation of the program shall be supported through grants, gifts, or user 

contributions. The board may charge a fee to individuals who request their own prescription information. The 

amount charged for an individual's request for his or her prescription information shall not exceed the actual cost of 

providing that information. III. There shall be no state general funds appropriated for the implementation or 

operation of the program." 

2, PDMP Training and Technical Assistance Center. Funding Options for Prescription Drug Monitoring Programs. 

2013 http://www.pdmpassist.orglpdf/PDMP Funding Options TAG.pdf 

26 ReWer LM, Droz D, Bailey JE, Schnoll SH, Fant R, Dart RC, Bucher Bartelson B. Do prescription monitoring 

~rograms impact state trends in opioid abuse/misuse? Pain Medicine 2012; 13: 434-442. 

7 Clark T, Eadie J, Kreiner P, Strickler G. Prescription Drug Monitoring Program Center of Excellence. 

Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices. September 20, 2012, 

http://www.pdmpexcellence.orgisites/all/pdfslBrandeis ]DMP _ Report.pdf. 

28 Ibid at 64 

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2. Real- or near-real-time collection and reporting of prescription drug data; 

3. Unsolicited reporting of prescription drug use information to prescribers and pharmacists; 

4. Access by researchers and medical examiners to individual-level PDMP data for 

surveillance/research; 

5. Interstate data sharinglharmonization and interoperability of data across states. 

Access to and consultation ofPDMPs by prescribers and other healthcare professionals: 

Not all states currently allow or encourage prescribers and/or dispensers to access the data. In 

Pennsylvania, for example, State law does not allow prescribers to access the PDMP; it is solely 

used as law enforcement tool.29 States that do allow access approach giving access differently. 

In some states, registration and access are completely optional. 30 In other states, such as 

Kentucky, access is mandatory before prescribing or dispensing controlled substances.3

! 

Regardless of whether or not states require checking the PDMP, states will not experience the 

full benefit of these databases unless prescribers and pharmacists use the data as an opportunity 

to intervene and help individuals get treatment for addiction. As mentioned previously, states 

that are working to improve prescriber access to their PDMPs through electronic health records 

have had some success in making access to the information a part of the prescriber's existing 

workflow. These technological developments will continue to be important both in states where 

access is required to prescribe certain controlled substances and in states where access to the data 

remains optional. 

Some states only give PDMP access to providers who have controlled substance prescription 

privileges. PMDP legislation in Maryland, Indiana, North Dakota, Utah, and Colorado 

authorizes PDMP access to providers other than prescribers.32.33.34.35.36 Providers who do not 

29 Title 28 PA Consolidated Statute, Chapter 25, Subchapter A, Section 25.131 available at 

http://www.pacode.com/secure/datal028/chapter25/chap25toc.html#25.13I. See also 

http://www.attorneygencral.gov/drugs.aspx?id=5946 

30 Criminal Offenses (720 ILCS 570), Illinois Controlled Substances Act. 

http://www.ilga.gov/legisiationiilcs/ilcs5.asp?ActID= 1941 &ChapterID=53 

J1 Kentucky (Title 18, Chapter 218A) § 218A.202: "(2) A practitioner or a pharmacist authorized to prescribe 

or dispense controlled substances to humans shall register with the cabinet to use the system provided for in this 

section and shall maintain such registration continuously during the practitioner's or pharmacist's term of licensure 

and shall not have to pay a fee or tax specifically dedicated to the operation ofthe system .... (1) Prior to the initial 

prescribing or dispensing of any Schedule II controlled substance or a Schedule III controlled substance containing 

hydrocodone to a human patient, a practitioner shall: ... (b) Query the electronic monitoring system established in 

Section 4 of this Act for all available data on the patient;" 

32 Maryland (Title 21, Subtitle 2A) § 21-2A-06: "(b) The Program shall disclose prescription monitoring data, in 

accordance with regulations adopted by the Secretary, to: ... (5) A rehabilitation program under a health 

occupations board, on issuance of an administrative subpoena Maryland Senate Bill Page 13 line 30 linked to May 

24,2012. http://mlis.state.md.us/2011rs/bills/sb/sb0883t.pdf 

"Indiana (Title 35, Article 48, Chapter 7) § 35-48-7-11.1: "(d) Except as provided in subsections (e) and (t), the 

board may release confidential information described in subsection (a) to the following persons: ... (8) A substance 

abuse assistance program for a licensed health care provider who: (A) has prescriptive authority under IC 25; and 

(B) is participating in the assistance program 

34 North Dakota (Title 19, Chapter 19-03.5) § 19-03.5.03: "3. Unless disclosure is prohibited by law, the board may 

provide data in the central repository to: ... j. A licensed addiction counselor for the purpose of providing services 

for a licensed treatment program in this state 

35 Utah CONTROLLED SUBSTANCE DATABASE ACT 58-37f-301. 2. Access to database.(i) a mental health 

therapist, if: (i) the information relates to a patient who is: (A) enrolled in a licensed substance abuse treatment 

program; and (B) receiving treatment from, or under the direction of, the mental health therapist as part of the 

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prescribe controlled substances, such as counselors, may use PDMP data to identity patients who 

are continuing to access controlled substances while they are pursuing treatment, and intervene 

appropriately. 

Real- or near-real-time collection and reporting of prescription drug data: 

As health providers, dispensers, and others begin to use PDMPs and are given better access to 

them, it is important for states to ensure that they have access to as accurate a list of the 

prescriptions dispensed as possible. Any lag time between the prescription being dispensed, and 

being recorded in the PDMP presents an opportunity for pill mills and doctor shoppers to evade 

detection. State law mandates that dispensers report prescribing data to the PDMP anywhere 

from instantaneously to monthly.37.38 Oklahoma was the first state to require "real time" 

reporting, or within 5 minutes of delivery of the substance, starting in January 2012.39 While it is 

too early to measure the effectiveness of real time reporting, prescribers have voiced concern 

with relying on PDMP data when there is substantial lag time. As a result, real-time reporting 

may provide another incentive for prescribers and dispensers to check and use the PDMP data. 

Unsolicited reporting of patients' prescription drug use information to prescribers and 

pharmacists: 

States report data from their PDMPs to those authorized to see it in two different ways: 

"solicited" and "unsolicited." Solicited reports are those that the PDMP returns upon an 

authorized request. For example, a prescriber might log on to the PDMP through a web portal 

and type in identitying information about a patient to retrieve the list of controlled substances 

dispensed to that patient. Unsolicited reports are sent from the PDMP, either manually or in an 

automated fashion, to specific persons authorized by State law when a pre-determined threshold 

of excessive dispensing is met. While it is very important for PDMPs to offer solicited reports, 

unsolicited reports provide a way to inform prescribers, dispensers, licensing board employees, 

and other users about excessive prescribing and dispensing even if they do not check the PDMP 

regularly. States such as Nevada have created an automated mechanism to trigger the creation of 

an unsolicited report to a prescriber when a patient exceeds a pre-established threshold for the 

number of providers and pharmacies visited within a given time period.4o A study of Wyoming's 

patient's participation in the licensed substance abuse treatment program described in Subsection (2)(i)(i)(A);(ii) the 

information is sought for the purpose of determining whether the patient is using a controlled substance while the 

patient is enrolled in the licensed substance abuse treatment program descried in Subsection (2)(i)(i)(A); and (iii) the 

licensed substance abuse treatment program described in Subsection (2)(i)(i)(A) is associated with a practitioner 

who: (A) is a physician, a physician assistant, an advance practice registered nurse, or a pharmacist; and (B) is 

available to consult with the mental health therapist regarding the information obtained by the mental health 

therapist, under Subsection (2)(i), from the database http://www.dopl.utah.gov/programslcsdb/58-37C2012-01-

Ol.pdf 

'6 Colorado (Title 12, Article 22, Part 7) § 12-22-705: "(3) The program is available for query only to the following 

persons or groups of persons: ... (c) Practitioners engaged in a legitimate program to monitor a patient's controlled 

substance abuse 

37 Alaska Prescription Drug Monitoring Program. Dispenser Information. 

http://www.alaskapdmp.comfdispenser!Oklahoma Bureau of Narcotics and Dangerous Drugs Control. Prescription 

Monitoring Program. http://www.ok.gov/obnddiPrescription Monitoring Program! 

"Oklahoma Bureau of Narcotics and Dangerous Drugs Control. Prescription Monitoring Program. 

http://www.ok.gov/obnddlPrescription Monitoring Program/ 

'9 Ibid. 

40 Prescription Monitoring Program Center of Excelience at Brandeis, Notes from the Field 2.5 Nevada's Proactive 

PMP: The Impact of Unsolicited Reports http://v.ww.pmpexcelience.org/sites/ali/pdfsfnevada_nfC 10_26 _II.pdf 

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POMP showed that unsolicited reports can increase the frequency with which practitioners 

request solicited reports from the POMP, suggesting that unsolicited reporting raises awareness 

about the database and its usefulness to providers. 4J 

Access by researchers and medical examiners to individual-level PDMP data/or 

surveillance/research: 

POMP data, particularly when combined with data from other sources, can provide researchers 

and state officials with valuable information about the scope and location of prescription drug 

abuse. For example, epidemiologists in Utah matched individual patient death records and 

poison control center data to individual POMP records to identifY a range of issues, including the 

source of the medication involved with overdose deaths.42 Researchers in New Mexico similarly 

used POMP data to show that some types of controlled prescription drugs presented a higher risk 

of overdose than others and that certain doses or combinations of controlled medications were 

also particularly risky.43 Access to individual-level POMP data, consistent with applicable 

privacy safeguards, permits a fuller understanding of the extent of the prescription drug abuse 

problem. 

State Interoperability 

While prescription drug monitoring programs have shown positive effects within states, doctor 

shoppers and pill mills can evade detection by doing business across state lines. A recent study 

showed that "shoppers" of opioids travelled a median of over 83 miles to obtain their 

prescriptions in 2008. Almost 20% of these individuals travelled across state lines.44 The study 

concluded that effective data sharing between state POMPs may improve program effectiveness 

in reducing opioid shopping behavior. 

BlA, the Office of the National Coordinator for Health Information Technology (ONC) at HHS, 

and private entities, such as the National Association of Boards of Pharmacy (NABP) and the 

Alliance of States with Prescription Monitoring Programs, have worked on architecture and 

standards to allow the interoperability needed for interstate data sharing. There are currently 15 

states that are sharing information through the PMP InterConnect hub, established by the NABP 

using the standards developed with the support ofBJA and the Alliance of States with 

Prescription Monitoring Programs.45 In addition to the data being shareable across state lines, it 

is essential that practitioners be allowed by state law to access the prescription information from 

states in which they are not licensed. Some state POMP laws currently do not allow the sharing 

POMP data to prescribers in other states. 

41 PMP Center of Excellence, "Trends in Wyoming PMP prescription history reporting: evidence for a decrease in 

doctor shopping?" 20 I O. http://www.pmpexcellence.orgisites/all/pdfsINFF _ wyominLrev_II_16 _10.pdf. 

42 Sims SA, Snow LA, Porucznik CA. Surveillance of methadone-related adverse drug events using multiple public 

health data sources. J Biomed Inform. 2007 Aug;40(4):382-9 

43 Paulozzi LJ, Kilbourne EM, Shah NG, Nolte KB, Desai HA, Landen MG, Harvey W, Loring LD. A history of 

being prescribed controlled substances and risk of drug overdose death. Pain Med. 2012 Jan; 13( I ):87-95 

44 Cepeda MS, Fife 0, Yuan Y, Mastrogiovanni G, Distance Traveled and Frequency oflnterstate Opioid 

Dispensing in Opioid Shoppers and Nonshoppers . .J Pain. 2013 Jun 19. pH: SI526-5900(l3)00992-9. "Shoppers" 

was defined in the study as individuals who fill more than three opioid prescriptions from multiple doctors in at 

least three different pharmacies with at least one day of overlap. 

45 National Association of Boards of Pharmacy. NABP PMP Interconnect Map. June 28, 2013. 

http://wwlV.nabp.netlsvstem/redactor assets/documents/5691 Set 41 WI and NE 6-28-13.pdf. 

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Conclusion 

Improving PDMP quality, harmonization, and interoperability and, in some cases, establishing 

PDMPs authorized by newly-passed state laws will ensure they provide maximal utility as 

surveillance and public health clinical decision support tools, augmenting their initial use as 

enforcement tools. 

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The Honorable Bill Cassidy and H. Morgan Griffith 

An L.A. Times investigation recently uncovered that a small number of doctors were 

responsible for most of the prescription drug overdose deaths between 2006 and 2011 in 

Los Angeles, Orange, Ventura and San Diego counties of California. The investigation 

consisted of examining publicly available cause-of-death, toxicology reports and other 

information in county coroners' files, including lists of prescription medications found at 

death scenes. If an L.A. Times reporter can uncover provider-specific data on 

inappropriate prescribing of prescription drugs from publically available data, why can't 

the federal or state governments do so as effectively with even more robust data monitoring 

tools? 

ANSWER: The recent Los Angeles Times investigative report did much to bring the Nation's 

attention to the problem of prescription drug overdose. Unfortunately, many of the data sources 

used by the Times' reporters are not consistently collected or uniformly available to the public 

across jurisdictions. For reporting on overdose deaths, the Federal Government relies upon cause 

of death data compiled by the Centers for Disease Control and Prevention (CDC) from death 

certificates prepared by local coroners and medical examiners. These death certificates do not 

routinely provide the level of detail, such as specific drugs that may have been involved in a 

death, which was reported in the Times. This is especially true with respect to scene of death 

investigations and provider-specific data on inappropriate prescribing, and these sorts of data 

have been proven to be of great value in determining the extent of this problem. In 2009, the 

CDC and local public health and safety officials investigated overdose deaths in West Virginia 

and found results similar to those reported by the Times. 46 However, such special investigations 

are labor intensive, costly, and dependent upon close collaboration with local authorities and 

access to the data. 

The Administration is committed to working with partners at the state and local level to identify 

and address all pathways of diversion, including "pill mills" and improper prescribing. 

Innovative enforcement strategies, particularly those involving collaboration across Federal, 

state, and local agencies, are helping many communities shut down these illegal operations. 

In accordance with state laws, prescription drug monitoring program (PDMP) information may 

also be used by state regulatory and law enforcement officials to pursue cases involving 

prescribers or pharmacists operating outside the bounds of proper practice, "pill mills," and other 

sources of diversion. But these important programs can function more effectively. We are 

working with our Federal partners and states to make these systems more user-friendly so that 

agencies tasked with detecting fraud, such as medical boards and licensing agencies can access 

or receive PDMP information more quickly and easily. Additionally, the Drug Enforcement 

Administration makes its registrant database available to any state, without a fee, for use in 

their PDMP or other state agency charged with investigating health care fraud or controlled 

substance diversion. 

46 Paulozzi LJ, Logan JE, Hall AJ, McKinstry E, Kaplan JA, Crosby AE. A comparison of drug overdose deaths involving 

methadone and otheropioid analgesics in West Virginia. Addiction 2009;104(9):1541-8. 

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Also, increased reporting and access to PDMP information from entities outside oflaw 

enforcement and prescribers can be useful. Some states have allowed medical examiners to 

access individual level PDMP data. This access allows them to make comparisons to other 

information, such as death records, which can help in determining a cause of death and detecting 

"pill mill" operations. 

In addition, the National Institute of Justice awarded three new grants in FY 2012 to promote 

research on illegal prescription drug market interventions: IdentifYing High Risk Prescribers 

Using PDMP Data: A Tool for Law Enforcement; Non-Medical Use of Prescription Drugs: 

Policy Change, Law Enforcement Activity, and Diversion Tactics; and Optimizing Prescription 

Drug Monitoring Programs to Support Law Enforcement Activities. These grants are enabling 

Federal, state, and local law enforcement agencies to better use data and share best practices to 

shut down sources of diversion. 

Further, CDC is analyzing various data sources to identifY appropriate metrics for outlier 

prescribers. CDC is also working with Brandeis PDMP COE to validate these metrics using 

various state and national data sources. 

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The Honorable Gus Bilirakis 

1. Recently, there was a drug summit in Pasco County, FL where public health officials 

were talking about the growing problem of babies born addicted to prescription drugs. The 

Pasco-Pinellas area ranks first in the state for babies born addicted. What tools, programs 

and grants are available for my community to combat this problem? 

ANSWER: The Federal Government supports state and local efforts to help prevent and treat 

the growing problem of babies born exposed to prescription drugs. The Attachment lists grant 

programs awarded to state and local groups in Florida in FY 2012 that could be used in part to 

help reduce drug use. Highlighted below are a few specific Federal programs that target 

prescription drug abuse and treatment of prescription drug dependence both in the mothers and 

their newborns: 

Department of Health and Human Services 

• Administration for Children and Families - Promoting Safe and Stable Families 

Program: Provides competitive grants for regional partnerships to provide services and 

activities to work with children and families impacted by a parent's or caretaker's substance 

abuse. 

• Center for Medicare and Medicaid Services - Medical Assistance Program - Grants to 

States for Medicaid: Shares the cost for Medicaid services which may include the treatment 

of prescription drug dependence both in the mothers and their newborns. 

• Health Resources and Services Administration - Healthy Start Initiative - provides for 

universal risk screening of pregnant women and newborn infants to identify those at risk of 

poor birth, health and developmental outcomes. Healthy Start includes targeted support 

services that address identified risks including prevention and treatment of prescription drug 

dependence both in the mothers and their newborns. 

• National Institutes of Health - Drug Abuse and Addiction Research Programs: Provides 

research into the prescription drug abuse and prevention and treatment of prescription drug 

dependence both in the mothers and their newborns. 

• Substance Abuse and Mental Health Services Administration (SAMHSA) - Block 

Grants for Prevention and Treatment of Substance Abuse: Provides states with flexible 

fimding which can be allocated to localities for the prevention and treatment of prescription 

drug dependence both in the mothers and their newborns. 

• SAMHSA - Projects of Regional and National Significance - Cooperative Agreement for 

the Physician Clinical Support System for the Treatment of Substance Use Disorders 

with Buprenorphine: The SAMHSA-funded Physician Clinical Support System (PCSS) is 

designed to assist practicing physicians, in accordance with the Drug Addiction Treatment 

Act of 2000, in incorporating into their practices the treatment of prescription opioid and 

heroin dependent patients using buprenorphine. 

19 
99 


85445.059

• SAMHSA - Projects of Regional and National Significance - Cooperative Agreement for 

the Physician Clinical Support System for Medication Assisted Treatment. The 

SAMHSA-funded Physician Clinical Support System (PCSS-MA T) is designed to assist 

physicians interested in incorporating into their practice the treatment of prescription opioid 

addicted patients using Food and Drug Administration approved medications (buprenorphine, 

methadone and naltrexone (oral and extended release). 

• SAMHSA - Projects of Regional and National Significance - Screening, Brief 

Intervention and Referral to Treatment: Supports a health system-level approach to 

screening and brief intervention within primary care, general medical and community 

settings-including physician offices, hospitals, educational institutions, and mental health 

centers including screening for prescription drug dependence both in the mothers and their 

newborns. 

• SAMHSA - Projects of Regional and National Significance - Pregnant & Postpartum 

Women Residential Treatment for Pregnant and Postpartum Women and Residential 

Treatment for Women and their Children: Provides cost effective, comprehensive, 

coordinated systems of care to improve outcomes for the entire family that can be sustained 

over time. To accomplish this comprehensive service system, it is necessary to partner with 

multiple systems of care. These partnerships include agencies/organizations such as local 

public housing authorities (for permanent housing for families), child welfare, health, mental 

health, family court, criminal justice, employment, education programs, and child-serving 

agencies. 

More infonnation on each of these efforts is avaiJable on the agency web sites. 

2. What changes can we make to our prescription drug laws to make it harder for people to 

improperly obtain and abuse prescription drugs? 

ANSWER: It is clear that we are not doing enough to prepare our health care providers to 

adequately address pain management, substance abuse, and use safe prescribing practices. As 

many healthcare providers would agree, managing a patient's pain is a crucial and often very 

difficult task. However, research indicates that students in medical school receive on average 

only 11 hours of training on pain education, and most schools do not offer specific training on 

opioids, substance abuse and addiction, or clinical decision making.47 A 2011 Government 

Accountability Office report on education efforts related to prescription pain reliever abuse 

found that "most prescribers receive little training on the importance of appropriate prescribing 

and dispensing of prescription pain relievers, on how to recognize substance abuse in their 

patients, or on treating pain.,,48 

47 Mezei, L., et a!. Pain Education in North American Medical Schools. The Journal of Pain. 12(12):1199-1208. 

2011. 

48 U.S. Government Accountability Office. Prescription Pain Reliever Abuse. [December 2011]. Available: 

http://mvw.gao.go\'/assets/590/587301.pdf 

20 
100 


85445.060

For these reasons, the Administration continues to support mandatory education on proper 

prescribing and addiction potential for prescribers and dispensers of these controlled substances, 

including for prescribers working for the Federal Government. Several states, including Iowa, 49 

Massachusetts,s° and Utah,S1 have passed mandatory prescriber education legislation, and we 

strongly encourage other states to explore this as an option. 

49 Iowa Board of Medicine. "New rules require physicians to complete training on chronic pain, end-of-life care." 

State ofIowa. [August 2011]. Available: 

hltp:llmedicalboard.iowa.gov/Board%20News/2011INew%20rules%20physicians%20to%20complete%20training% 

20chronic%20pain 08182011.pdf 

50 Executive Office of Health and Human Services. "PMP and Mandatory Educational Requirements for 

Prescribers." Commonwealth of Massachusetts. [October 2011). Available: 

hltp:llwww.mass.gov/eohhs/provider/licensingloccupationaI/dentistirmp-and-mandatory-educational-reguirementsfor-pre.html 

51 Utah Division of Occupational and Professional Licensing. Utah Controlled Substances Act, 58-37-6.5. State of 

Utah. [May 2012]. Available: http://www.dorl.utah.gov/laws/58-37.pdf#page=24 

21 
101 


85445.061

FflED HENRY A WAXMAN, CALIFORNIA 

FL·\NKJNG 

ONE HUNDRED THIRTEENTH CONGRESS 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HOUSE OFFICE BU!LOINC 

Dr. Ooug C. Throckmorton 

Deputy Director for Regulatory Programs 

Center for Drug Evaluation and Rtlsearch 

U.S. Food and Drug Administration 

10903 New Hampshire A vcnllc 

Silver Spring, MD 20993 

Dear Dr. Throckmorton: 

DC 20515-6115 

July 10,2013 

Thank you for appearing before the Subcommittee on Health on Friduy, Junc 14,2013, to testij'y 

at the hearing entitled "Examining the Federal Government's Respollse to the Prescription Drug Abuse 

Crisis." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open tor ten business days to permit Members to submit additional questions for the record, which arc 

attached. The format ofyollf responses 10 these questions should be as follows: (I) the name of the 

Member whose question you afC addressing, (2) the complete text of the question you are addressing in 

bold. and (3) your answer to tbat question in plain text. 

To facilitate the printing ofthe hearing record, please respond to these questions by the close of 

business on Wednesday, July 24, 2013. Your responses should be mailed to Sydne Harwick, Legislative 

Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office Building, Washington, D.C. 

20515 and e-mailed in Word formattoSnlne.lIunvickfiV.mail.honse.goy. 

Thank you again lor your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The J IOflorable Frank Pallone, Jr., Ranking Member. Subcommittee 011 Health 

Attachment 
102 


85445.062

DEPARTJ\lIENT OF HEALTH & HUMAN SERVICES 

The Honorable Joseph R. Pitts 

Chairman 

Subcommittee on Health 

Committee on Energy and Commerce 

House of Representatives 

Washington. D.C. 20515-6115 

Dear Mr. Chairman: 

Food and Drug Administration 

Siiver Spring, MD 20993 

SEP 262013 

Thank you for providing the opportunity for the Food and Drug Administration (FDA or 

the Agency) to testify at the June 14,2013, hearing before the Subcommittee on Health, 

Committee on Energy and Commerce, entitled "Examining the Federal Government's 

Response to the Prescription Drug Abuse Crisis." This letter provides responses for the 

record to questions posed by you and one of the Committee Members, Congressman 

Bilirakis, which we received on July 10,2013. 

If you have further questions, please let us know. 

~ 

Sincerely, 

Deputy Commissioner 

Policy, Planning, and Legislation 

cc: The Honorable Frank Pallone, Jr. 

Ranking member 
103 


85445.063

Page 2 - The Honorable Joesph R. Pitts 

We have restated your questions below in bold, followed by our responses. 

The Honorable Joseph R. Pitts 

1. FDA has taken a number of steps this year to encourage the development of 

abuse-deterrent opiates and to protect the public from being inundated with 

non-abuse-deterrent versions ofthose safer products once they have been 

introduced to the market. There remains the threat, however, that drug makers 

continue to seek approval of new opiate products that have no abuse-deterrent 

features. Last December, one such product was brought before an FDA advisory 

panel which voted 11 to 2 against approving the product, in part because it 

would have been readily crushable and abusable just as OxyContin used to be. 

An agency spokesperson at the meeting (Rappaport), however, expressed 

uncertainty whether the FDA is legally empowered to refuse to approve a new 

opiate drug product on the ground that it lacks abuse deterrent features. 

a. Has the agency, since last December, decided whether it has the legal 

authority to accept its own expert advisory panel recommendation and 

refuse to approve a new opiate drug product on the ground that it lacks 

abuse deterrent features considered necessary to the safety of the drug? 

FDA shares your concerns regarding prescription drug abuse, including the abuse of 

opioid analgesics. Your question references the December 7,2012, meeting of the 

Anesthetic and Analgesic Drug Products Advisory Committee, which focused on a 

specific pending application. Under applicable statutory and regulatory provisions, 

we are generally prohibited from disclosing iniomlation about any pending new drug 

application (NDA). 

FDA is strongly committed to finding ways to reduce abuse and misuse of opioid 

medications. As part of our ongoing mission to protect the public health, we often 

seek advice from advisory committees on a wide range of medical and technical 

issues. Advisory committees are comprised of outside experts with a broad range of 

expertise and different backgrounds. Advisory committee recommendations are not 

binding 011 the Agency; however, they are considered carefully. When considering 

whether to approve a proposed new opioid drug product, FDA must determine if the 

product meets the statutory approval standard, which is whether the product has been 

shown to be safe and effective. In addition, the Agency considers the known risks 

associated with the drug along with the potential benefits the drug will provide. 

While we consider the views of advisory committee members, ultimately FDA must 

review and evaluate the science and determine whether the product that is the subject 

of a given new drug application meets this approval standard. 
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85445.064

Page 3 . The Honorable Joesph R. Pitts 

b. Is there a need for legislation to clarify that FDA has this authority? 

The Administration has taken no position on the need for legislation in this area. 

2. FDA provided guidance in January on the development and testing of new 

abuse-deterrent opiate drugs. However, my understanding is that it has so far 

chosen not to develop guidance on the requirements for approval of generic 

versions of abuse-deterrent drugs. 

a. Why did the agency choose not to issue guidance on the development and 

testing of abuse-deterrent generic drugs? 

It is correct that FDA has not issued guidance on the development and testing of 

generic versions of drugs with abuse-deterrent properties. However, FDA is actively 

working on the scientific and regulatory issues surrounding the dcvelopment and 

evaluation of abuse-deterrent generics, and we may address this topic in future 

guidance documents. 

Providing guidance in this area needs to be a sequential process, beginning v.ith 

guidance on the development of abuse-deterrent products by innovators. We 

understand the critical role generics play in our health care system and that the issues 

around the development of generics that are abuse-deterrent need to be addressed. 

b. How is the agency assuring that generic versions of abuse-deterrent drugs 

have the same abuse-deterrence features as the innovator products they 

would substitute for? 

FDA has been working internally on the scientific and regulatory issues surrounding 

development and evaluation of abuse-deterrent generics. In addition, FDA will be 

presenting at an upcoming meeting focused on issues concerning development and 

evaluation of abuse-deterrent generics. The public meeting, "Abuse Deterrent 

Formulation Science Meeting on the FDA Draft Guidance," has been organized by 

Cross Company Abuse Liability Consortium and will be held on September 30-

October 1, 2013. J 

FDA may also address this topic in future guidance documents. 

c. How does the agency intend to publicize the requirements for abusedeterrent generic drugs so that generic drug makers can design and test 

their products accordingly and the public can have confidence that 

appropriate standards are being applied? 

FDA may address this topic in future guidance documents. 

1 See ·www.adjsciencemeeting.com 
105 


85445.065

Page 4 - The Honorable Joesph R. Pitts 

3. As you are aware, DEA's current strategy of attempting to curb prescription 

drug abuse is what they eall a "chokepoint" approach, in which they are 

targeting prescription drug wholesalers and chain pharmacies with enforcement 

actions to restrict the amount of controlled substances being provided to 

patients. I am hearing that this is causing significant problems for patients with 

chronic pain to access their critical pain medications. What is your agency doing 

to ensure that patients continue to have access to critical pain medications? If 

people who use these medications legitimately are having problems accessing 

them, to whom should they report the information? 

Under the Controlled Substances Act (CSA), the authority for quota-setting for 

controlled substances is vested with the Drug Enforcement Agency (DEA), not FDA. 

However, FDA provides DEA ",-jth infoID1ation to aid in the process. FDA 

determines annual estimates of medical need for the drugs listed in Schedule II of the 

CSA. 

The estimates of medical needs for each Schedule II active pharmaceutical substance 

are provided to DEA to assist them in setting manufacturing and production quotas. 

The estimates of medical need for each substance are derived from previous years' 

sales data. In addition to projecting estimates, FDA also provides information it has 

received that relates to newly approved drug products on the market as well as 

discontinued drug products that are no longer available. In this way, DEA will have 

current, up-to-date information to assist them in setting the appropriate quotas for 

each substance. 

If FDA is informed about a possible shortage of a drug, FDA informs DEA so that 

DEA can revise the quota, if appropriate. If patients are experiencing difficulty 

obtaining their prescribed medications because of a shortage of the drug, FDA's Drug 

Shortage Staff (DSS) may be contacted at drugshortages(il)fda,hhs,gov. DSS will 

provide infonnation about how to obtain the drug ifit is available and, if there is a 

shortage, will work to address it with the manufacturer. 

In addition, individuals can contact the Board of Pharmacy in their state to report 

problems accessing medications. 

4. How is interagency development of REMS for controlled substances 

coordinated? For example, how is DEA brought in to ensure that a REMS will 

not conflict with DEA's regulations? Does FDA consult with SAMHSA and/or 

the HHS-Office of Civil Rights on REMS compliance with HIP AA and other 

privacy laws regarding information about controlled substances? Finally, how is 

it ensured that controlled substance REMS do not put pharmacists in the 

untenable position where compliance with a REMS would require violating state 

controlled substance or state pharmacy laws? 

FDA has and will continue to consult \vith other agencies as needed to ensure that a 

Risk Evaluation Mitigation Strategy (REMS) ,\Till not conflict with other Federal 
106 


85445.066

Page 5 The Honorable Joesph R. Pitts 

laws, such as the CSA. For example, the Substance Abuse and Mental Health 

Services Administration (SAMHSA) participated in reviewing the syllabus for the 

prescriber education programs under the REMS for extended-release and long-acting 

(ERlLA) opioids. As part of the Office of National Drug Control Policy (ONDCP), 

National Drug Control Strategy, FDA and SAMHSA have been working together 

with other Federal partners to explore mandatory prescriber education. 

FDA strivcs to craft REMS in a way that is specific enough to ensure that the benefits 

of a drug outweigh its risks, but general enough to avoid conflict with state pharmacy 

or other laws. 

The Honorable Gus Bilirakis 

1. What changes can we make to our prescription drug laws to make it harder for 

people to improperly obtain and abuse prescription drugs? 

Combating opioid misuse, abuse, and addiction has long been a priority for the FDA. 

As a scientific and public health regulatory agency, FDA's approach to regulation of 

prescription opioids must be grounded in science; specifically we must bring to bear 

the best available knowledge and understanding conceming both the treatment of pain 

and the potential adverse consequences of opioid use. 

Over the last decade or so, under its existing authorities within the FD&C Act, FDA 

has worked to pursue a targeted, science-based, multi-pronged approach that 

addresses misuse, abuse, and addiction at critical points in the development of an 

opioid product and in its use throughout the health care system. 

We would like to highlight three areas of recent activity within a broader 

comprehensive approach: 

Abuse-deterrent fO~l!J~ti9ns: FDA is committed to finding ways to reduce abuse 

and misuse of opioid medications. As part of our ongoing mission to protect public 

health, FDA has concluded that ifthe Agency determines that a formulation of an 

extended-release opioid drug product has abuse-deterrent properties, the Agency has 

authority under the FD&C Act to require generic versions of the product to have 

abuse-deterrent properties also. In addition, we have the authority to refrain from 

approving non-abuse-deterrent formulations of that drug and to initiate procedures to 

withdraw non-abuse-deterrent versions already on the market. 

FDA recently made a determination regarding a drug reformulated with the intention 

of deterring misuse and abuse: OxyContin ER (oxycodone hydrochloride). After an 

extensive, science-based review, on April 16, 2013, FDA approved product labeling 

describing reformulated OxyContin's properties that are expected to make abuse via 

injection difficult and to reduce abuse via the intranasal (snorting) route. The Agency 

also concluded that the benefits of the earlier formulation that lacks abuse-deterrent 

properties no longer outweigh its risks, and that the earlier formulation of OxyContin 
107 


85445.067

Page 6 The Honorable Joesph R. Pitts 

was withdrawn from the market for reasons of safety or effectiveness. That 

determination precludes approval of generic versions of the earlier formulation of 

OxyContin. 

This decision was the subject of extensive consideration by FDA experts over the 

course of many months. FDA's decision took into account the totality of the 

evidence for OxyContin. 

Improving appropriate use of opioids through prescriber education: It is critically 

important to improve prescribers' knowledge about the best uses of opioids, including 

knowing when these products should be used and by which patients. Thus, prescriber 

education is an important element of FDA's REMS for ERILA opioids. Under the 

ERJLA opioid REMS, manufacturers are required to ensure that prescriber training 

programs-offered by accredited continuing education providers-are made available 

for all U.S.-licensed prescribers, using a syllabus developed by FDA with input from 

many stakeholders. As a part of our assessment of this REMS, these courses will be 

audited to ensure that they are unbiased and accurate. The fIrst of these voluntary 

prescriber training programs was rolled out on March 1,2013. 

While voluntary training is an important public health measure, a new Jaw requiring 

mandatory training would go even further to help ensure the safe use of opioid drugs. 

That is why the Administration stated in Epidemic: Responding to American 's 

Prescription Drug Abuse Crisii that it will work with Congress to amend Federal 

law to require practitioners who request DEA registration to prescribe controlled 

substances to be trained on responsible opioid prescribing practices as a precondition 

of registering and receiving their license to prescribe a controlled substance. 

Improving the availability of products to treat abuse and overdose: FDA has been 

working with many stakeholders to explore the best ways to treat overdoses of 

opioids, including overdoses of FDA-approved opioid medications. Each year, 

prescription opioid medications are involved in over 15,000 deaths. Naloxone is an 

injectable medication that is the standard treatment to rapidly reverse the overdose of 

either prescription (e.g., oxycodone) or illicit (e.g., heroin) opioids. Naloxone is most 

commonly used by trained medical personnel in emergency departments and on 

ambulances. There is a growing interest by prescribers, patients, and advocates in 

exploring the broader uses of naloxone, including its usc in non-medical settings such 

as nursing homes and hospices. 

FDA, working with other parts of the Federal Government, is looking at new ways of 

giving naloxone that are potentially easier and do not require needles or syringes. 

The goal of this work is to expand the availability of naloxone in the places patients 

might overdose, and make it easier to administer to save lives. For example, FDA 

can grant priority review to products that involve new ways of delivering naloxone, 

such as using autoinjectors or intranasally, that would be easier to use in non-medical 

settings. 

2 http://www. whitehouse.gov/sifesldeJault/fileslondcplpofiq-and-researchlrx_abuseylan.pdf 
108 


85445.068

HiED UPTON, MICH!GAN 

CHAiRMAN 

HENRY WAXMAN, CALIFORN!A 

R,\NK!NG 

ONE HUNDRED THIRTEENTH CONGRESS 

COMMITIEE ON ENERGY AND COMMERCE 

Dr. H. Westley Clark 

Director 

Center for Substance Abuse Treatment 

Substance Abuse and Mental Health 

Services Administration 

1 Choke Cherry Road 

Rockville. MD 20857 

Dear Dr. Clark: 

July9,2013 

Thank you for appearing hefore the Subcommit1ee on Health on Friday, June 14, 2013, to testifY 

at the hearing entitled "Examining the Federal Government's Response to the Prescription Drng Abuse 

Crisls,n 

Pursuant to the Rules (lfthe Commiuce on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for (he record, which are 

attached, The formal oryour respollses to these questions should be as follows: (1) the name of the 

Member whose question you arc addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing oflhe hearing record, please respond to these questions by the close of 

business on Tuesday, July 23, 2013, Your responses should be mailed to Sydnc Harwick, Legislative 

Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office Building, Washington, D.C. 

20515 and e,mailed in Word format to Svdnc.Harwick(a;mail.house.gov. 

Thank you again for your time and effbrt preparing and delivering testimony bclbrc the 

Subcommittee. 

Chairman 

Subcommittee on Health 

cc: The HOllorable Frank Pallone, Jr., Ranking Member, Subcommittee on llealth 

Attachment 
109 


85445.069

Dr. H. Westley Clark, Director, SAMBSA Center for Substance Abuse Treatment 

Responses to Questions for the Record 

Energy and Commerce Committee, Subcommittee on Health Hearing 

June 14,2013 

"Examining the Federal Government's Response to the Prescription Drug 

Abuse Crisis" 

The Honorable Joseph R. Pitts 

1. The Center for Substance Abuse Treatment (CSAT) recently released an RFA for a 

"Physician Clinical Support System - Medication Assisted Treatment" to support 

physician education on the use of medication to treat opioid addiction. The RFA 

states" ... the number of people who have been inducted to extended release 

injectable naltrexone remains relatively low" and that" •.• training in the 

appropriate use and indications for extended release injectable naItrexone is highly 

needed." How does CSAT plan to expand its efforts to increase awareness and 

knowledge about this medication? 

The new Substance Abuse and Mental Health Services Administration (SAMHSA) 

Physician Clinical Support System - Medication Assisted Treatment (PCSS-MAT) grant 

will increase prescribers' awareness and knowledge about extended release 

naltrexone (Vivitrol ®) by providing training opportunities that utilize several different 

formats including online modules, case studies, webinars and others. These activities are 

expected to reach approximately 30,000 physicians over the three years of the grant 

period. 

2. Earlier this year SAMBSA reported that "Hospital emergency department visits 

linked to buprenorphine have increased 10-fold from 2005 to 2012 with 52 percent 

of these emergency room cases involving non-medical (illicit) use." Likewise, the 

DEA's Office of Diversion Control reports that buprenorphine is now the 3n1 most 

diverted prescription opioid today, surpassing methadone, and second only to 

oxycodone and hydrocodone. Given these unintended and other unwelcomed and 

unanticipated conseqnences, what is CSAT doing to help reduce the illicit use of this 

medication? 

Buprenorphine abuse and diversion are measureable; however, the levels of actual 

abuse (not adjusted for rate of use) and diversion are noticeably less than other 

opioids. In addition, certain peer-reviewed studies looking at buprenorphine diversion 

and nonmedical use indicate that some of this use is occurring because people do not 

have access to substance abuse treatment. 

SAMHSA is currently updating the agency's buprenorphine curriculum. The new 

curriculum has a specific section addressing the issue of non-medical (illicit) use. The 

revised curriculum, titled "The DATA 2000 Waiver Course," will emphasize the 

importance of using state prescription drug monitoring programs prior to and over the 
110 


85445.070

course of treatment as well as appropriate use ofbuprenorphine products in the treatment 

of opioid dependence. The importance of toxicology screening, of requiring psychosocial 

treatment in addition to medication use, appropriate dose determination, and methods of 

monitoring progress in treatment which should be considered in setting frequency of 

office visits and amount of prescribed medication that is provided to a patient will also be 

emphasized in the curriculum. 

3. SAMHSA supports a number of web-based treatment locators for the professional 

community and the general public. We found one that lists methadone clinics and 

one that lists physicians who offer buprenorphine treatment. Does SAMHSA have a 

similar locator for patients who are seeking extended release naltrexone? What 

plans does SAMHSA have to provide, on an equal basis, information for accessing 

all FDA-approved medications to treat opioid dependence? 

SAMHSA's Behavioral Health Treatment Services Locator (Locator)' currently allows 

referring professionals and the general public to search for facilities that provide 

medication-assisted opioid therapy with methadone and buprenorphine. The information 

in the Locator is collected by the National Survey of Substance Abuse Treatment 

Services (N-SSATS), an annual census of specialty substance abuse treatment facilities. 

A question on Vivitrol (extended-release injectable naltrexone) was added to the NSSATS 2013 survey. Thus, the next time the Locator is updated, currently scheduled for 

early 2014, it will allow visitors to identify facilities that provide treatment with Vivitrol. 

4. In Administrator Hyde's testimony before the Energy and Commerce Committee on 

Oversight and Investigations Hearing on May 22, 2013, she stated that much of 

SAMHSA's funding goes to the block grants, which are passed on to the states to 

fund substance abuse treatment- which is about $1.8 billion for substance abuse 

prevention and treatment. We understand that a significant portion of addicted 

individuals relapse to drug use. Further, we understand that for the treatment of 

opioid dependence, SAMHSA dedicates a great deal of funding, time and effort on 

the development and delivery of education training activities with respect to 

substitution, or replacement therapies. Is it within the authority of SAMHSA to 

provide stronger guidance to states to use some percent oftheir block grant funds 

on FDA-approved non-addictive medications? 

The statute (42 U.s.C. §§ 300x-21 through 300x-66) and implementing regulations 

(45 CFR 96.120 through 96.137) governing the Substance Abuse Prevention and 

Treatment Block Grant (SABG) program provide states and jurisdictions with the 

flexibility to plan, carry out and evaluate activities to prevent and treat substance abuse 

according to the needs in that state. SAMHSA has provided guidance to the states on the 

services and levels of care that constitute a full continuum of care which includes 

medication-assisted treatment. The statute and regulation do not include any prescriptive 

language regarding any specific service, including pharmacologic therapies. However, in 

I http://findtreatment.samhsa.gov. 

2 
111 


85445.071

the application guidance for the block grant application (Table 4, page 30), under the 

heading "SAPT Projected Expenditures for Treatment and Recovery" SAMHSA has 

clarified that up to 10 percent of the funds available can be used for medication 

management, pharmacotherapy (including all FDA-approved medications for treating 

substance use disorders), and laboratory services. 

5. Over the last two fiscal years, SAMHSA has reduced funding of its Opioid 

Treatment Programs from $12.8 million in FY 2012 to $8.746 million in FY 2014-

including a proposed $200,000 reduction in the coming fiscal year. While we 

applaud the fiscal restraint, we are concerned that funding is being reduced from 

the opioid Treatment Programs initiatives in particular. Is there a rationale for this 

particular reduction in light of the prescription drug epidemic and increasing 

number of opioid overdose deaths? 

The funding for Opioid Treatment Programs (OTP) in FY 2012 totaled $12.9 million, of 

which $8.9 million came from SAMHSA budget authority and $4 million from the 

Prevention and Public Health Fund. In FY 2013, SAMHSA's budget authority for all 

programs was reduced by 5 percent due to sequestration. However, given the 

Department of Health and Human Services' priority on prescription drug abuse 

prevention and treatment, SAMSHA reallocated funds within its appropriation as 

displayed on its FY 2013 operating plan to include $12.4 million for OTPs. 

6. According to the Drug Abuse Warning Network (DAWN) report released by 

SAMHSA in July of 2012 emergency department visits for drugs misuse and abuse 

for pharmaceuticals rose 115% between 2004 to 2010, would you talk about this 

data and the reason for the increase? 

Over 80 percent of the annual increase of about 720,000 emergency department (ED) 

visits for misuse and abuse of pharmaceuticals from 2004 to 2010 is due to increases in 

the misuse and abuse of two types of medications: prescription opiates and opioids, and 

benzodiazepines .. According to the Centers for Disease Control and Prevention (CDC), 

this increase in ED visits is paralleled by an increase in opioid and benzodiazepine related 

overdose deaths. Misuse and abuse of prescription opiate and opioid 

medications (approximately 350,000 more visits in 2010 than in 2004, an increase of 

about 175 percent) and benzodiazepines (approximately 235,000 more visits in 20 I 0 than 

in 2004, an increase of about 140 percent) have caused increasing concern over the last 

decade. Opiates and opioids and benzodiazepines are safe and effective medications 

when they are used as directed by the people for whom they are prescribed. However, 

they are also addictive substances with potential for abuse. It is likely that there are 

multiple causes contributing to the increase in misuse and abuse of these medications. 

Some portion may be associated with the greater number of prescriptions being written, 

making prescription drugs more accessible and able to be diverted and used for 

nonmedical purposes. 

7. SAMHSA's National Survey on Drug Use and Health revealed an estimated 54% of 

the prior-year non-medical users of prescription pain relievers obtained the drugs 

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for free from a friend or relative where less than 1 % reported receiving them from 

the internet. How do we solve a problem that is primarily happening at home? 

SAMHSA has partnered with the National Council on Patient Information and Education 

on the "Not Worth the Risk - Even IfWs Legal" campaign to develop and distribute a 

comprehensive range of educational and outreach messages encouraging parents to talk 

to their teens about preventing prescription drug abuse. In addition, SAMHSA has 

partnered with the Community Anti-Drug Coalitions of America (CADCA) to host 

Community Prevention Day where participants receive training and technical assistance 

that is specific to substances abuse prevention including prevention of prescription drug 

abuse. SAMHSA works with CADCA to get the message out to patients, parents, family 

members and other involved persons in communities to promote the responsible use of 

pain medications and other prescription drugs. 

SAMHSA's Strategic Prevention Framework - Partnerships for Success II (SPF-PFS II) 

grant is designed to address two ofthe nation's top substance abuse prevention priorities: 

(I) underage drinking among persons aged 12 to 20; and (2) prescription drug misuse and 

abuse among persons aged 12 to 25. The program promotes the alignment and leveraging 

of prevention resources and priorities at the federal, state, and community levels. 

SAMHSA's Drug-Free Communities Support Program grants, in partnership with the 

Office of National Drug Control Policy (ONDCP), provide funding to support established 

community-based youth substance use prevention coalitions capable of effecting 

community-level change. 

The SABG is a formula-based grant provided to states and territories to provide financial 

support for its prevention and treatment programs and services. Federal statute requires 

states and territories to direct at least 20 percent of the SABG toward substance abuse 

prevention services. For many states and territories, this funding represents the vast 

majority of their substance abuse prevention budget. Under the SABG, states are 

requested to identify the categories of substances, including prescription drugs, they 

intend to address with the 20 percent set-aside for prevention based on data collected and 

analyzed from statewide and local needs assessments. 

Educating prescribers and dispensers of controlled substance pharmaceuticals on the 

potential abuse caused by these substances is also critically important as they will, in 

turn, provide patient education. SAMHSA funded the development of live and online 

CME courses on Prescribing Opioids for Chronic Pain for providers in consultation with 

the American Academy of Pain Medicine, Case Western Reserve University School of 

Medicine, and an independent panel of experts in medical education, pharmacology, pain 

management, regulation, and addiction. Variations of the course were developed to meet 

the needs of the Indian Health Service, the military and medical specialties such as 

emergency medicine. 

SAMHSA is working with the Drug Enforcement Administration (DEA) on Take Back 

programs which provide a safe, convenient, and responsible means of disposing of 

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prescription drugs. SAMHSA is working with physician and pharmacy groups to 

promote the adequate education of patients and consumers. 

Ultimately, the transformation of attitudes at the local level involves local people. 

SAMHSA, in conjunction with our colleagues at the National Institutes of Health, the 

Food and Drug Administration, CDC, and DEA can assist by providing technical 

assistance to local authorities and local organizations to aid in the shifting in attitudes 

about the appropriate use, storage and disposal of prescription drugs. 

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The Honorable Phil Gingrey 

1. Over the past decade, SAMHSA has expended substantial resources in the 

development and implementation oftraining, education and demonstration 

programs with respect to buprenorphine. What plans does SAMHSA have for 

comparable education and training programs on the injectable naItrexone? 

The new PCSS-MAT grant will increase prescribers' awareness and knowledge about 

extended release naltrexone by providing training opportunities that utilize several 

different fonnats including online modules, case studies and webinars on the use of 

naltrexone in both oral and injectable fonnulations. These activities are expected to reach 

approximately 30,000 physicians over the three years of the grant period. 

2. On November 30, 2006, SAMHSA released a report entitled "Diversion and Abuse 

of Buprenorphine: A Brief Assessment of Emerging Indicators Final Report." At 

that time, the Summary of the Report stated "The phenomenon {of diversion] may 

reflect lack of access to addiction treatment, as some non-medical use {of 

buprenorphine] appears to involve attempts to self-medicate with buprenorphine when 

formal treatment is not available." As of today, however, buprenorphine appears to 

be widely available, with well over a million people dosed and sales in the U.S over 

$1 billion annually. Given the recent reports by the DEA and others, do you agree 

that an npdated review of buprenorphine diversion and abuse is warranted? 

It is important to note that two publications2 from 2009 address diversion and abuse of 

buprenorphine and arrived at essentially the same conclusions as the 2006 SAMHSA 

report. An updated review of diversion and abuse ofbuprenorphine is being considered 

by SAMHSA. At this time, SAMHSA notes that, to be most valuable, a review on 

diversion and abuse ofbuprenorphine would need to be designed to assess the degree to 

which previous recommendations have been implemented and the impact of such 

activity. Given the N-SSATS 2011 shows a significant unmet need for opioid addiction 

treatment, any new report should also assess the availability and impact of medication 

assisted treatment not only on diversion and abuse, but also on overdose fatalities. 

3. How many patients are currently treated eacb year with the three medications 

approved by the FDA for the treatment of opioid addiction: buprenorphine, 

methadone, and injectable naltrexone? Is the "exit strategy" for transitioning opioid 

dependent Americans who are currently being treated with opioid dependence 

therapies from physical dependence on opioids to opioids-free and medication-free? 

2 Johanson CE, Arfken CL, di Menza S, Schuster CR. Diversion and abuse ofbuprenorphine: findings from national surveys of 

treatment patients and physicians. Drug Alcohol Depend. 2012 Jan I; 120(1-3):190-5. doi: 1O.1016/j.drugalcdep.2011.07.019. 

Epub 20 II Aug 21. 

Center for Substance Abuse Research (CESAR) at University of Maryland, "CESAR Fax Special Series: Buprenorphine," 

June 13,2011 - September 12,2011, available at: 

http://www.cesar.umd.edu/ccsarlpubsI20 II 0915%20Buprenorohine%20CESAR%20FAX.pdf. 

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According to N-SSATS 20 II: 

306,000 persons were receiving methadone for addiction treatment in 2011 through 

SAMHSA certified OTPs. 

32,676 persons received buprenorphine through licensed treatment programs. This 

number includes 7,020 who were in treatment at OTPs and 25,656 who were in 

treatment at substance abuse treatment facilities that were not OTPs.3 

SAMHSA does not collect information on how many individual patients are treated with 

buprenorphine outside of licensed treatment facilities or with injectable naltrexone. 

SAMHSA sponsored programs provide education to physicians on clinical strategies to 

taper and discontinue opioids including opioid analgesics or heroin, but research 

consistently indicates high relapse rates after medical withdrawal. Similarly, relapse rates 

following discontinuation of opioid agonist therapy (methadone or 

buprenorphine/naloxone) for opioid dependence are very high and associated with 

significant morbidity and mortality. Research is needed to identifY modifiable variables 

associated with relapse, positive predictors of ongoing remission of addiction after 

treatment with opioid agonists and optimal time-frames and dosing schedules for titration 

off of medication as well as the effectiveness of a transition to naltrexone following 

medical withdrawal. 

4. In December 2012, SAMHSA issued new regulations that expauded the use of 

buprenorphine in opioid treatment programs (OTPs), or what formerly were 

referred to as methadone clinics. In the section oftbis Regulations labeled "Costs 

and Benefits." It states "There may be additional diversion and abuse risks 

associated with the possible expansion of treatment, but the secretary believes that 

the benefits of increased flexibility and increased access to care in OTP settings 

outweighs these possible risks." Please elaborate on the risk/benefit analysis 

undertaken, as referred to in this regulation. 

OTPs are highly regulated and are required by law to provide behavioral therapy and 

monitor patient toxicology screens which assure maximum benefit of treatment for the 

patient. To assure safety of the community, patients are not permitted to take medication 

home for unsupervised self-administration unless they meet specific criteria designed to 

establish their stability, progress in recovery, and ability to protect their medication from 

misuse or diversion (42 CFR 8.l2(i)(2». All of these stipulations continue to apply to 

patients receiving buprenorphine from an OTP. The rule published in December 2012 

allows physicians who are treating OTP patients with buprenorphine to dispense 

buprenorphine for unsupervised self-administration without fulfilling the time-in3 OTPs are certified by SAMHSA and are the only kinds offacHities that can legally dispense methadone or buprenorphine for 

the treatment ofopioid addiction. Other substance abuse treatment facilities that are not SAMHSA-certified OIPs can prescribe 

buprenorphine if they have a specially qualified physician on staff, but they may not dispense buprenorphine or methadone. Only 

OTPs can dispense these drugs. 

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treatment requirements which continue to apply to methadone. Based on experience to 

date with the safety ofbuprenorphine provided via the less restrictive environment of 

office-based treatment, allowing earlier and more individualized consideration for takehome dosing was deemed an appropriate measure to reduce the cost of treatment to the 

patient. Relaxing the need to present daily at the OTP in order to receive buprenorphine 

reduces distance and time spent traveling and permits a more expeditious reintegration of 

the recovering individual to family and work life. Finally, as noted that it would in the 

Final Rule, SAMHSA is sending a formal guidance letter to all OTP Medical Directors 

encouraging them to complete buprenorphine training and obtain a waiver. In the letter, 

SAMHSA provided links to Web sites where OTP physicians can complete on-line 

qualifying training. 

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85445.077

The Honorable Bill Cassidy and H. Morgan Griffith 

In your oral testimony, you indicated that the federal government is moving toward using 

electronic health records (EHRs) to develop algorithms to identity outliers of physicians 

prescribing large amounts of controlled prescription drugs. Please define precisely how the 

federal government plans on using EHRs for this purpose, including the scope of 

information the federal government will have access to. Specially, what level of patient 

information will the federal goverument have access to? 

In September 20 II, the Centers for Medicare & Medicaid Services (CMS) began working on an 

approach to help health plans to identifY and manage the most egregious cases of opioid 

overutilization. Comprehensive policy was set forth in a final Call Letter (April 2012) and in 

more detail in final supplemental guidance (August 2012). In September 2012, CMS issued a 

memorandum which provided supplemental guidance regarding the section of the Final CY 2013 

Call Letter entitled, "Improving Drug Utilization Review Controls in Part D" which sets forth 

how Medicare Part D sponsors can comply with drug utilization management (DUM) 

requirements (42 CFR 423.153 et seq.) to prevent overutilization of prescribed covered Part D 

drugs. 

As noted in the Final CY 2013 Call Letter, Part D sponsors are, and have been, responsible for 

establishing reasonable and appropriate drug utilization management programs that assist in 

preventing overutilization of prescribed medications. Through discussions with the industry, 

CMS has determined that sponsors need to employ more effective concurrent and retrospective 

drug utilization review (DUR) programs to address overutilization of medications in order to 

protect beneficiaries, to comply with DUM requirements and to reduce fraud, waste and abuse in 

the Part D program. CMS is developing monitoring tools which will identifY outliers in opioid 

use. 

SAMHSA is beginning to work with CMS to explore ways to collaborate on addressing the 

issues of overutilization of opioids and utilizing the capabilities of health information 

technology (IT) and electronic health records (EHRs). In addition, SAMHSA has focused efforts 

on HIT to improve access to Prescription Drug Monitoring Programs (PDMPs). 

In 201 I, SAMHSA initiated the Enhancing Access to PDMPs Project with the goal of using 

health information technology to improve access to PDMPs in an effort to reduce prescription 

drug abuse, misuse and overdose in the United States. The project was funded by SAMHSA and 

managed by the Office of the National Coordinator for Health Information Technology (ONC) in 

collaboration with SAMHSA, CDC, and ONDCP. During the first part of this two-part project, 

workgroups of individuals representing state and federal governments as well as industry, trade 

and advocacy groups, convened to discuss problems related to the transport and use ofPDMP 

data. Recommendations were developed with the aim of facilitating information sharing for 

healthcare providers in order to make better informed clinical decisions. The second part of the 

project identified, developed, and implemented pilots that tested linkages between PDMPs and 

provider EHR systems and pharmacy systems. The results demonstrated the value of increased 

access to PDMP data at the point of care. 

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In 2012, SAMHSA provided additional funding to ONC to extend the project for six months to 

increase the number of pilot sites or the number of states supplying PDMP data in existing pilots 

and also launch new pilots to test new types of integration. The next phase of the project began 

in early 2013 and will expand the number of sites (to test scalability) or the number of states 

supplying PDMP data. Additional pilot sites also tested new types of integration including 

connecting through a health information exchange and looking at how data can be sent in near 

real-time from a pharmacy to the PDMP. This phase also focused on work around the goal of 

creating and disseminating messaging to PDMP stakeholders, especially prescribers and 

dispensers. Additionally, a "PDMP Resource Center" was developed to enable the entire PDMP 

community to share its experiences in one location. The Resource Center includes information 

on an open source reference implementation on PDMPIEHR exchange that can be adopted by 

PDMPs. 

In FY 2012, SAMHSA established the PDMP Electronic Health Record Integration and 

Interoperability Expansion program, with $4 million in funding from the Prevention and Public 

Health Fund. Working collaboratively with the Harold Rogers Prescription Drug Monitoring 

National Training and Technical Assistance Program at the Department of Justice, this program 

complements existing federal efforts by improving real-time access to PDMP data through 

integration into existing technologies, such as EHRs, to improve the ability of state PDMPs to 

reduce the nature, scope, and extent of misuse. CDC will evaluate the program and report on the 

best practices developed and impacts ofPDMP-EHR integration and how they can be utilized by 

other states working to link PDMPs to other health IT systems. 

In FY 2013, SAMHSA anticipates awarding up to eight grants for EHR and PDMP data 

integration. The purpose of this program is to reduce prescription drug misuse and abuse by 

providing healthcare providers with access to PDMP data to make sound clinical decisions 

without disturbing their regular clinical work. 

The PDMP EHR grant cooperative agreement program addresses minimum requirements for 

security of the database, specifically: "information from the PDMPs must be stored and protected 

in an electronic manner and must, at a minimum, be equivalent to the standards set forth in 

regulations promulgated under section 262 of HIP AA. This would include the technical 

safeguards standards of the HIPAA Security Rule under 45 CFR 164.312. In addition, this 

program does not supersede the requirements of the Federal substance abuse confidentiality 

law (42 U.S.C. 290dd-2) and regulations under 42 CFR Part 2." 

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85445.079

The Honorable Gus Bilirakis 

1. Recently, there was a drug summit in Pasco Country, FL where public health 

officials were talking about the growing problem of babies born addicted. What 

tools, programs and grants are available for my community to combat this 

problem? 

The statute (42 U.S.C. § 300x-22; 42 U.S.C. §300x-27) and implementing 

regulations (45 CFR 96.1 24(c)(e) and 45 CFR 96.131) governing the SABG program 

requires states to focus preventative efforts on substance-using pregnant women and 

women with dependent children.4 In the FY 2013 SABG report, prepared and submitted 

by the Substance Abuse and Mental Health Program Office of the Florida Department of 

Children and Families, the state obligated and expended $12.4 million for services 

designed for such women and their dependent children. During the state fiscal 

year 2011-2012, the state served 1,235 pregnant women. The Substance Abuse and 

Mental Health Program Office ofthe Florida Department of Children and Families 

distributes its SABG and state general revenue funds to the state's 20 circuits. 

The National Center on Substance Abuse and Child Welfare (NCSACW)5 is an initiative 

of the Department of Health and Human Services and jointly funded by SAMHSA's 

Center for Substance Abuse Treatment and the Administration on Children, Youth and 

Families' Children's Bureau's Office on Child Abuse and Neglect. The center provides 

targeted technical assistance to states and community-based organizations to improve 

systems and practice for families with substance use disorders who are involved in the 

child welfare and family judicial systems. NCSACW's goals are to develop and 

implement a comprehensive program of information gathering and dissemination, to 

provide technical assistance and to develop knowledge and its application that promotes 

effective practice, organizational, and system changes at the local, state, and national 

levels. 

SAMHSA's Residential Treatment for Pregnant and Postpartum Women program 

expands the availability of comprehensive, residential substance abuse treatment, 

prevention, and recovery support services for pregnant and postpartum women and their 

minor children, including services for non-residential family members of both the women 

and children. This program approaches service delivery from a family-centered 

perspective, meets the multiple individual needs of the population of focus, and considers 

41n FY 1994. states were required to expend not less than five percent of the SABG funds to increase the 

availability of services for women. The women's set-aside is the requirement that states expend a percentage of their 

annual SABG funds on services designed for pregnant women and women with dependent children. For FY 1995 

and subsequent fiscal years, states are required to expend for such services for women not less than an amount equal 

to the amount expended by states in fiscal year 1994. States are not required to establish additional new programs or 

expand existing treatment capacity above the capacity developed in FY 1994. 

5 http://www.ncsacw.samhsa.gov/. 

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the health and well-being of the family members within the context of their families and 

other important relationships. Most recently, grants were awarded in 

FY 2011. Depending upon funding availability, another grant announcement may be 

forthcoming in the future. 

SAMHSA efforts to outreach to prescribers and to the public regarding safe and 

appropriate use of opioid medications also help to prevent the development of addiction 

and women of childbearing potential are an important focus group for these trainings and 

materials which are available to individuals and groups in your community. 

Finally, the Maternal, Infant and Early Childhood Home Visiting program is authorized 

by the Affordable Care Act and funded for five years at $1.5 billion. The program is 

administered by the Health Resources and Services Administration, in collaboration with 

the Administration for Children and Families. The Florida Department of Health is the 

designated lead agency and is working in partnership with the Department of Children 

and Families to plan and implement the program. The program will identifY and focus on 

communities that have high rates of: premature birth, low birth weight infants, infant 

mortality; poverty; crime; domestic violence; high school drop-outs; substance abuse; 

unemployment; and child maltreatment. 

2. What changes can we make to our prescription drug laws to make it harder for 

people to improperly obtain aud abuse prescription drugs? 

In 2011, ONDCP released the action plan "Epidemic: Responding to America's 

Prescription Drug Abuse Crisis" on preventing and reducing prescription drug abuse. 

The action plan included the following action items that would require a change in 

Federal law: 

Work with Congress to amend Federal law to require practitioners (physicians, 

dentists, and others authorized to prescribe) who request DEA registration to 

prescribe controlled substances to be trained on responsible opioid prescribing 

practices as a precondition of registration. This training would include assessing 

and addressing signs of abuse and/or dependence. 

Support reauthorization of the National All Schedules Prescription Electronic 

Reporting Act, which created a formula grant program administered by SAMHSA 

that funds state PDMPs. The program outlines specific, uniform criteria states 

must have in place to be awarded funding, which increases consistency among 

state PDMPs. 

• Work with the Congress on legislation to authorize the Departments of Defense 

and Veterans Affairs to share patient information on controlled substance 

prescriptions with state PDMPs. 

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