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WHAT IS THE FEDERAL GOVERNMENT DOING 

TO COMBAT THE OPIOID ABUSE EPIDEMIC? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

MAY 1, 2015 

Serial No. 114–38 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

DAVID B. MCKINLEY, West Virginia 

Vice Chairman 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

H. MORGAN GRIFFITH, Virginia 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

GENE GREEN, Texas 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

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

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

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 5 

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

prepared statement .............................................................................................. 7 

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

New Jersey, prepared statement ........................................................................ 8 

WITNESSES

Michael P. Botticelli, Director, Office of National Drug Control Policy .............. 10 

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

Answers to submitted questions ...................................................................... 138 

Richard G. Frank, Ph.D., Assistant Secretary for Planning and Evaluation, 

Department of Health and Human Services ...................................................... 29 

Prepared statement .......................................................................................... 31 

Answers to submitted questions ...................................................................... 144 

Nora D. Volkow, M.D., Director, National Institute on Drug Abuse, National 

Institutes of Health .............................................................................................. 41 

Prepared statement .......................................................................................... 43 

Answers to submitted questions ...................................................................... 150 

Douglas C. Throckmorton, M.D., Deputy Director, Center for Drug Evaluation 

and Research, Food and Drug Administration .................................................. 56 

Prepared statement .......................................................................................... 58 

Answers to submitted questions ...................................................................... 159 

Debra Houry, M.D., M.P.H., Director, National Center for Injury Prevention 

and Control, Centers for Disease Control and Prevention ............................... 71 

Prepared statement .......................................................................................... 73 

Answers to submitted questions ...................................................................... 164 

Pamela S. Hyde, J.D., Administrator, Substance Abuse and Mental Health 

Services Administration ...................................................................................... 81 

Prepared statement .......................................................................................... 83 

Answers to submitted questions ...................................................................... 170 

Patrick Conway, M.D., M.S., Deputy Administrator for Innovation and Quality, and Chief Medical Officer, Centers for Medicare and Medicaid Services . 92 

Prepared statement .......................................................................................... 94 

Answers to submitted questions ...................................................................... 178 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 125 

Article of April 30, 2015, ‘‘Physician-Issued Opioids Associated With Higher 

ED Use,’’ by Alicia Ault, MedScape, submitted by Mr. Murphy ...................... 136 

(1) 

WHAT IS THE FEDERAL GOVERNMENT DOING 

TO COMBAT THE OPIOID ABUSE EPIDEMIC? 

FRIDAY, MAY 1, 2015 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 9:00 a.m., in room 

2322, Rayburn House Office Building, Hon. Tim Murphy (chairman 

of the subcommittee) presiding. 

Members present: Representatives Murphy, McKinley, Burgess, 

Griffith, Bucshon, Flores, Brooks, Mullin, Collins, Upton (ex officio), DeGette, Schakowsky, Tonko, Clarke, Kennedy, Green, and 

Pallone (ex officio). 

Staff present: Noelle Clemente, Press Secretary; Jessica Donlon, 

Counsel, Oversight and Investigations; Brittany Havens, Oversight 

Associate, Oversight and Investigations; Charles Ingebretson, Chief 

Counsel, Oversight and Investigations; Alan Slobodin, Deputy 

Chief Counsel, Oversight; Sam Spector, Counsel, Oversight; Christopher Knauer, Democratic Oversight Staff Director; and Una Lee, 

Democratic Chief Oversight Counsel. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Well, good morning. Welcome here to the Oversight 

and Investigations Subcommittee hearing. 

I just want to say it’s Mental Health Month, so it’s fitting that 

we are here today on this issue. This is the third in a series of 

hearings examining the growing problem of prescription drugs and 

heroin addiction that is ravaging our country. This is our Nation’s 

single biggest public health concern. 

Over the past 5 weeks, this subcommittee has heard from addiction experts working with local communities and our leading academic and research centers. Dr. Robert DuPont, the former White 

House Chief of Drug Control Policy and the first director of the National Institute on Drug Abuse, testified that Federal programs 

lack direction and standards on treating addiction as a chronic condition, and noted what is being done to follow up with patients to 

prevent relapses and put them on a path of real recovery? He challenged us to even ask the most fundamental question, ‘‘What is recovery?’’ 

Dr. Anna Lembke of Stanford Medical School provided critical 

testimony on how we must revise our healthcare quality measures 

2 

to reduce overprescribing, reform medical privacy regulations, and 

incentivize the use of prescription drug monitoring programs. 

We know that those with opiate addiction disorders need a broad 

range of treatment options and that many with substance abuse 

disorders have co-occurring psychiatric disorders, but we need to 

tear down Federal policy and funding barriers that keep us from 

treating both simultaneously. 

About 3 weeks ago, one of today’s witnesses, Mr. Michael Botticelli, the Director of the Office of National Drug Control Policy, presented a slide—I’m going to show it here—at the National Rx Summit on major causes of death from injury from 1999 to 2013. Quite 

a revealing slide. While the trends of other major causes of death, 

such as auto accidents went down, drug poisoning continued to go 

up 21 percent from 2008 till 2013. In many States, these numbers 

are soaring at high double-digit rate increases. As Mr. Botticelli 

has indicated to me privately and at the Rx Summit, we must do 

better, and we have much work to do. 

Today, we will hear from Federal agencies charged with providing guidance, direction, and leadership in our Nation’s public 

health response to the opiate epidemic. No Federal agency is more 

central in this ongoing epidemic than the Department of Health 

and Human Services or HHS. HHS and its Substance Abuse and 

Mental Health Services Administration, also known as SAMHSA, 

are responsible for leading our Nation’s public health response to 

the opiate heroin abuse and addiction crisis. 

SAMHSA regulates our country’s 1,300 opiate treatment programs, and SAMHSA is responsible for certifying the 26,000 physicians who prescribe the most commonlyused opiate maintenance 

medication, buprenorphine. According to testimony provided by 

SAMHSA before this subcommittee in April of last year, there were 

nearly 1.5 million people treated with these opiate maintenance 

medications in 2012, which is a fivefold increase in the last 10 

years. 

Has SAMHSA defined the goal of recovery for what these federally subsidized treatment programs are supposed to accomplish? Is 

SAMHSA collecting and evaluating meaningful data at an individualized level that would hold grant recipients individually accountable for effective results? So far, preliminary examination indicates 

the answers are no. And when you don’t define where you’re going, 

every road you take still leaves you lost. So we’re hoping we can 

get some direction today. 

The numbers indicate we are failing as a Nation, and we darn 

well better come to terms with that. The 43,000 lives lost last year, 

the thousands of babies born addicted to opiates tell us the terrible 

toll this epidemic has taken. You’ve heard my thoughts about the 

Government-sponsored promotion of what I’ve characterized as addiction maintenance, and I refer to buprenorphine as heroin helper, 

not because the medication is altogether lacking, because it is helpful, but rather, because infrastructure the Federal Government has 

created for the use of this highly potent and important medication 

is not fully working and, worse yet, in many cases, contributing to 

the growing problem. This has to be fixed, and I hope we’ll find 

some solutions, and that is what we need to discuss today openly, 

honestly, and humbly. 

3 

If we do not reverse the current trend, where is this going to 

end? How many millions of citizens do we want to have on opiate 

maintenance? How many more must die? And how many more lives 

and dreams must be shattered before we recognize the depth of 

this national scourge? 

Now, I don’t believe in better living through dependency. And, 

again, please do not misconstrue this critique as a general indictment of opiate maintenance. It is not. For some people, opiate 

maintenance is the most appropriate bridge treatment, and there 

should be no shame or stigma associated with it. But opiate maintenance therapy should not be the only treatment offered to the 

opiate-dependent individuals, and it is not the only goal. 

What patients on opiate maintenance can be successfully transition off of these medications? What protocols are best for affecting 

this transition? What are the best practice for prevention of relapse 

for those patients who end opiate maintenance treatment? There 

are nonaddictive medications approved for this use, but are these 

medications widely available and how well do they work? 

The diversion of buprenorphine for illicit nonmedical use is a related problem, because this is how the opiate epidemic can be 

spread. According to the DEA, buprenorphine is the third most 

often seized prescription opiate by law enforcement today. Where 

is a call to modernize our existing opiate addiction treatment system to ensure that the right patient gets the right treatment at the 

right time? Why aren’t we hearing about expanding access to nonaddictive narcotic treatments that have zero potential for abuse or 

diversion, such as Naltrexone and evidence-based counseling? 

These are all incredibly important tools, and we want to make sure 

HHS talks more about these. 

Last week, Dr. Westley Clark, the former Director of SAMHSA 

Center for Substance Abuse treatment and the man who oversaw 

the growth of buprenorphine over the past decade declared before 

the American Society of Addiction Medicine that many 

buprenorphine practices have become pill mills where doctors and 

dealers were increasingly indistinguishable and physician negligence and alleged laboratory fraud prevailed. The problem is not 

with buprenorphine, however. The problem lies with current practices, and this is what we need to discuss. 

I consider opiate maintenance as a bridge for those with addiction disorders to cross over in the recovery process. And as I said, 

it is not a final destination. We seek to lay out a vision for recovery 

that includes complete withdrawal from opiates as an option. For 

cancer, for diabetes, for AIDS, we want people to be free of the diseases, not just learn to live with it. We need to commit the same 

sorts of things through our research and clinical efforts that boldly 

declare what we must change here. 

I thank our witnesses for being here today. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Today we convene the third in a series of hearings examining the growing problem of prescription drugs and heroin addiction that is ravaging our country. This 

is our Nation’s single biggest public health concern. 

4 

Over the past five weeks, this subcommittee has heard from addiction experts 

working within local communities and our leading academic and research centers. 

Dr. Robert DuPont, the former White House Chief on drug control policy and the 

first director of the National Institute on Drug Abuse, testified that Federal programs lack directions and standards on treating addiction as a chronic condition and 

noted: What is being done to follow-up with patients to prevent relapses and put 

them on a path of real recovery? He challenged us to even ask the most fundamental question: what is recovery? Dr. Anna Lembke of Stanford Medical School 

provided critical testimony on how we must revise our healthcare quality measures 

to reduce over-prescribing, reform medical privacy regulations, and incentivize use 

of Prescription Drug Monitoring Programs. We know that those with opioid-addiction disorders need a broad range of treatment options, and that many with substance abuse disorders have a co-occurring psychiatric disorder—but we need to tear 

down Federal policy and funding barriers that keep us from treating both simultaneously. 

About three weeks ago, one of today’s witnesses—Mr. Michael Botticelli, the Director of the Office of National Drug Control Policy—presented the following slide 

at the National Rx Summit on major causes of death from injury 1999–2013. While 

the trends of other major causes of death such as auto accidents went down, drug 

poisoning continued to go up 21 percent from 2008 to 2013. In many States these 

numbers are soaring at high double digit rates of increase. As Mr. Botticelli has indicated to me privately and at the Rx Summit, we must do better and we have 

much work to do. 

Today, hear from the Federal agencies charged with providing guidance, direction, 

and leadership in our Nation’s public health response to the opioid epidemic. 

No Federal agency has a more central role in this ongoing epidemic than the Department of Health and Human Services (HHS). HHS and its Substance Abuse and 

Mental Health Services Administration (SAMHSA) are responsible for leading our 

Nation’s public health response to the opioid, heroin abuse and addiction crisis. 

SAMHSA regulates our country’s 1,300 opioid treatment programs, and SAMHSA 

is responsible for certifying the 26,000 physicians who prescribe the most commonly 

used opioid maintenance medication: buprenorphine. According to testimony provided by SAMHSA before this subcommittee in April of last year, there were nearly 

1.5 million people treated with these opioid maintenance medications in 2012— 

which is a 5-fold increase in the last 10 years. Has SAMHSA defined the goal of 

recovery for what these federally subsidized treatment programs are supposed to accomplish? Is SAMHSA collecting and evaluating meaningful data at an individualized level that would hold grant recipients individually accountable for effective results? So far, our preliminary examination indicates the answers are no. And when 

you don’t define where you are going, every road you take still leaves you lost. 

The numbers indicate we are failing as a nation, and we darn well better come 

to terms with that. The43,000 lives lost last year, the thousands of babies born addicted to opioids tell us the terrible toll thisepidemic has taken.You have heard my 

thoughts about the Government-sponsored promotion of what I have characterized 

as’’addiction maintenance.’’ 

I have referred to buprenorphine as a ‘‘heroin helper’’ not because the medication 

is altogether lacking,but rather, because the infrastructure the Federal Government 

has created for the use of this highly potentand important medication is not working 

and worse yet, contributing to the growing problem. It has to befixed, and that is 

what we need to discuss—honestly, openly, humbly. 

If we do not reverse the current trend, where will it end? How many millions of 

citizens do we want tohave on opioid maintenance? How many more must die? How 

many more lives and dreams must beshattered before we recognize the depth of this 

scourge? 

I do not agree in ‘‘better living through dependency.’’ 

Again, please do not misconstrue this critique as a general indictment of opioid 

maintenance. It isnot. For some people, opioid maintenance is the most appropriate 

bridge treatment and there should be no shame or stigma associated with it. But 

opioid maintenance therapy should not be the only treatment offered to opioid dependent individuals, nor the only goal. 

What patients on opioid maintenance can be successfully transitioned off of these 

medications? What protocols are best for effecting this transition? 

What are the best practices for the prevention of relapse for those patients who 

end opioid maintenance treatment? There are non-addictive medications approved 

for this use, but are these medications widely available? 

The diversion of buprenorphine for illicit, non-medical use is a related problem because this is how the opioid epidemic can be spread. According to the DEA, 

5 

buprenorphine is the third most often seized prescription opioid by law enforcement 

today. 

Where is the call to modernize our existing opioid addiction treatment system to 

ensure that the right patient gets the right treatment at the right time? Why aren’t 

we hearing about expanding access to nonaddictive, non-narcotic treatments that 

have zero potential for abuse or diversion, such as naltrexone and evidence-based 

counseling? These are incredibly important tools that are barely mentioned in the 

HHS plan. 

Last week, Dr. Westley Clark, the former Director of SAMHSA’s Center for Substance Abuse Treatment, and the man who oversaw the growth of buprenorphine 

over the past decade, declared before the American Society of Addiction Medicine 

that many buprenorphine practices had become pill mills where ‘‘Doctors and Dealers’’ were increasingly indistinguishable and ‘‘Physician Negligence’’ and ‘‘Alleged 

Laboratory Fraud’’ prevailed. The problem is not with buprenorphine, however. The 

problem lies with current practice and this is what we need to discuss. 

I consider opioid maintenance as a bridge for those with addiction disorders to 

cross over in the recovery process. It is not a final destination. I seek to lay out a 

vision for recovery that includes complete withdrawal from opioids as an option. For 

cancer, diabetes, AIDS, we want people to be free of the disease, not learn to just 

live with it. We need to commit to research and clinical efforts that boldly declare 

that we must change. 

Mr. MURPHY. And I now recognize the ranking member of the 

subcommittee, Ms. DeGette from Colorado, for 5 minutes. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you so much, Mr. Chairman. 

I think it’s really important to hear from our witnesses today 

about the work the Federal Government is doing to address this serious public health issue, and I know all of the agencies represented before us do critical work to prevent and treat this epidemic. 

In March, Secretary Burwell announced an initiative to combat 

the opioid crisis. I applaud the Department’s actions, and I’m gratified to hear that this is one of the Secretary’s top priorities. I want 

to hear more about this initiative today and how all the agencies 

before us are working together to accomplish its goals. But at the 

same time, I have some hard questions about our approach to caring for those who have substance abuse disorders. 

Last week, we heard from a panel of medical experts who have 

vast experience in treating opioid addiction. Unfortunately, as the 

chairman said, they gave us a fairly bleak view of the opioid treatment landscape in this country. For example, one witness, Dr. 

Adam Bisaga, a psychiatrist at Columbia University and a research 

scientist at the New York State Psychiatric Institute, told the committee that the majority of patients being treated for opioid addiction received treatment that is both, ‘‘outdated’’ and ‘‘mostly ineffective.’’ He described this approach of rapid detoxification, followed 

by an abstinence-only method without the use of important treatment medications. Dr. Bisaga added that this is potentially dangerous because it raises the risk of an overdose if a patient relapses. 

As troubling as this testimony from our last hearing was, today 

we have Dr. Volkow on our panel, who is one of the world’s top experts on addiction research. And she notes—I’m sure you’ll talk 

more about this, Doctor—in her written testimony that, ‘‘Existing 

6 

evidence-based prevention and treatment strategies are highly underutilized across the United States.’’ 

Why is that, Mr. Chairman? Why do we have experts week after 

week telling us that the bulk of the treatment Americans are receiving for this devastating disease are ineffective, outdated, and 

not evidence based. 

We need to be asking ourselves some tough questions. For example, Dr. Westreich, the president of the American Academy of Addiction Psychiatry, told us last week, ‘‘Patients and their families 

need to know that detoxification treatment and drug-free counseling are associated with a very high risk of relapse.’’ Are patients 

enrolling in treatment getting sufficient data so they can make 

medically informed choices? Are families and loved ones being told 

what approaches have high failure rates before choosing an approach to treatment? Frankly, this is not a decision that should be 

taken lightly. Getting ineffective treatment may not only be financially costly, but it may result in a fatal relapse. 

Finally, Mr. Chairman, recent testimony, including some I saw 

in the written statements for today, raises important questions 

about whether taxpayer dollars should fund certain approaches for 

combating this opioid epidemic over others. This is an issue I’ve 

been talking about week after week. We all agree that we need the 

most effective treatment, and our experts agree that this treatment 

needs to be a broad menu of options that is different from patient 

to patient. 

So we might not have a silver bullet to cure opioid addiction at 

this point, but we do know what treatments work better than others. Evidence tells us—and all the medical experts we heard from 

last week agree—that for most patients a combination of medication-assisted treatment and behavioral treatment, such as counseling and other supportive services, is the most effective way to 

treat opioid addiction. If that’s the case, we should pursue more 

policies that encourage this approach as a clear option and steer 

away from any efforts that are not evidence based. It’s costly, and 

it’s dangerous to the patient. 

So I hope we can all work together to fight this epidemic, and 

I do look forward to hearing from all of our witnesses. I’m glad Secretary Burwell and the department are devoting serious attention 

to addressing both the prevention and treatment sides of this problem. 

And, Mr. Chairman, this has been a really great series. I’m 

happy to have a whole investigation like this in this committee. 

There’s one group that we haven’t heard from yet, I’m hoping—— 

Mr. MURPHY. States. 

Ms. DEGETTE. Good. The States. We haven’t heard from the 

States yet. It’s critical we hear from them because that’s where the 

rubber is hitting the road. We need to hear what the States are 

doing to address this problem and understand the reasoning behind 

some of the choices being made. Some States are picking effective 

treatment methods, and others are not. 

So I think we need a multifaceted approach that this is what our 

research has showed, and I know we can work together to continue 

this important investigation. 

7 

I just want to add one more note. The witnesses and the audience may see members jumping in and running out. We have another hearing in Energy and Commerce Committee going on down 

on the first floor, so people will be coming and going. But I know 

certainly, from my side of the aisle, people recognize this is a very 

serious issue. Thank you. 

Mr. MURPHY. Thank you. And I know that they’ll be calling votes 

at 9:30 for first vote series. 

Ms. DEGETTE. I thought it was at 11:00 

Mr. MURPHY. Something has changed. First and only vote series 

of the day. I’m here for the duration, so we want to hear from you 

and hopefully the members. 

And now we recognize Mr. Upton. 

Mr. UPTON. We really are going to have votes at 9:30? 

Mr. MURPHY. That’s what it says now. 

Mr. UPTON. Well, I’m going to submit my statement for the 

record then. 

Mr. MURPHY. OK. All right. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Today we continue our important review of the opioid abuse epidemic. In recent 

weeks we have heard valuable testimony from academics and State and local leaders, including folks on the frontlines in Southwest Michigan, and today we will hear 

what the Federal Government is doing to combat this pressing issue. 

The abuse of painkilling opioids and heroin is a complex and growing public 

health crisis that has sadly been outpacing the Nation’s efforts to reverse this epidemic. A lot of people are dying, and a lot of families are suffering. In Kalamazoo 

County, where the reality of heroin overdoses has hit hard, we remember two young 

women who were friends. In 2008, we lost Amy Bousfield at 18 years old. In 2012, 

her friend Marissa King died at 21 years old. Marissa began using heroin in 2009, 

despite having lost two friends to the drug. Marissa was diagnosed with bipolar disorder, had struggled with depression, and had abused prescription drugs before 

turning to heroin after graduating from high school. 

Every community has been hit by heartbreak. According to the Michigan Department of Community Health, ‘‘Unintentional poisoning deaths in Michigan involving 

opioids comprise 20 percent of unintentional poisoning deals in 2012, compared to 

11 percent in 1999. Unintentional poisoning deaths involving opioids increased more 

rapidly than those from any other drug.’’ This subcommittee’s diligent review of 

every perspective of this issue is important. 

Last week, we took an important step. The House approved bipartisan legislation 

coauthored by the full committee Vice Chairman Marsha Blackburn, and Representatives Tom Marino, Peter Welch, and Judy Chu to clarify language in the Controlled 

Substances Act and promote collaboration between agencies and stakeholders to ensure patients have access to medications. 

But this subcommittee’s hearings have shined a light on how much more needs 

to be done. Our review has introduced us to many health professionals, scientists, 

community leaders, and public servants who are working their hearts out to make 

a difference and to help reduce this problem. There are a number of worthy ideas 

on how to strengthen the Federal response. 

To take on the enormous challenge posed by the opioid abuse epidemic, we need 

to be unified and find common ground. These hearings provide a foundation for this 

committee to proceed in a bipartisan fashion to take constructive and effective actions. I am ready to work with my colleagues on the committee on both sides of the 

aisle, the president, Secretary Burwell, and the rest of the administration to 

produce positive results in fighting this epidemic for the American people. 

We want to help. I welcome our distinguished Federal Government witnesses and 

look forward to their testimony. 

Mr. UPTON. Yield back. 

Mr. MURPHY. All right. 

8 

Mr. Pallone, 5 minutes. 

Mr. PALLONE. I’ll do the same, Mr. Chairman, because we both 

have to go to the other hearing. 

Mr. MURPHY. OK. 

Mr. UPTON. It’s his bill. It’s his bill we’re talking about. 

Mr. MURPHY. See how much we get along? 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Mr. Chairman, thank you for holding this hearing today—the third in a series on 

the opioid abuse epidemic. This problem has affected every one of our districts, and 

I am glad this subcommittee is taking a serious look at this issue. 

Today’s hearing gives us the opportunity to hear from Federal Government agencies about what they are doing to tackle the opioid addiction crisis. I am pleased 

to see that Secretary Burwell and the Department are taking important steps on 

both the prevention and the treatment of opioid abuse and I look forward to working 

with them on addressing this burgeoning crisis. To that end, it is critical also that 

we approach this problem on both sides of this issue—upstream, where overprescribing is occurring, and downstream, where better treatment across this country 

is desperately needed. 

The opioid addiction and abuse epidemic is inextricably tied to the overprescribing 

of these drugs for the treatment and management of chronic pain. I want to hear 

from you about how we can reduce the overprescribing of opioids and assist medical 

professionals in making informed prescribing decisions. 

On the treatment side, we need to focus our attention on what works. There is 

consensus in the medical community that medication-assisted treatment—or MAT— 

is an essential component of effective treatment. However, it is still not available 

in large parts of the country and as others have already told this committee, many 

Americans are receiving outdated and ineffective treatment. We need to understand 

why that is the case and how we can increase access to the most effective treatment 

protocols currently available. 

I also want to use today’s hearing as an opportunity to hear from these Federal 

agencies about the implementation of the Affordable Care Act. When we passed the 

law, we took significant steps to expand access to health care for all Americans, including those with substance use disorders. 

For many, the lack of insurance or the cost of treatment presents an insurmountable barrier to receiving the treatment help they need. The Affordable Care Act addresses some of these problems by expanding insurance coverage and requiring that 

insurance cover the cost of substance abuse services. This will mean that millions 

of people will have access to the tools they need to break their addictions. 

Additionally, the Affordable Care Act provides us with a historic opportunity to 

transform a fragmented, underfunded system for treatinu substance abuse disorders 

into one that promotes coordinated, patient-centered care. I look forward to hearing 

from Dr. Frank and others about how the Affordable Care Act is transforming the 

landscape for behavioral health services, and what more needs to be done to truly 

inteurate behavioral health services into our broader healthcare system. 

Thank you again for holding this important hearing and to all our witnesses. I 

look forward to continuing our work on this issue. 

I yield my remaining time to Rep. Kennedy. 

Mr. MURPHY. Is there anybody else on either side that needs recognition? Go right into this. 

OK. Let me find my—— 

Ms. DEGETTE. No. Wait, wait. Mr. Kennedy. 

Mr. PALLONE. Oh, he wanted a minute. Mr. Chairman, can I 

yield just 1 minute to Mr. Kennedy? 

Mr. MURPHY. Yes. You can yield your minutes to Mr. Kennedy 

of Massachusetts. 

Mr. KENNEDY. Thank you very much for the consideration. I 

yield back. 

Mr. MURPHY. OK. All right. Let me now introduce the witnesses 

on the panel for today’s hearing. We have the Honorable Michael 

9 

Botticelli, the Director of the Office of National Drug Control Policy, which is part of the Executive Office of the President. Welcome 

here. Dr. Richard Frank, the Assistant Secretary For Planning and 

Evaluation at the U.S. Department of Health and Human Services; 

Dr. Nora Volkow, who is the Director of the National Institute on 

Drug Abuse with the National Institutes of Health; Dr. Douglas 

Throckmorton, who is the Deputy Director of the Center for Drug 

Evaluation and Research of the Food and Drug Administration; Dr. 

Debra Houry, the Director of the National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention; the Honorable Pamela Hyde, the Administrator for the Substance Abuse and Mental Health Services Administration; and Dr. 

Patrick Conway, the Deputy Administrator for Innovation and 

Quality and the CMS Chief Medical Officer at the Centers for 

Medicare and Medicaid Services. Welcome. 

You are aware that—now swearing in the witnesses—the committee is holding an investigative hearing and, when doing so, has 

a practice of taking testimony under oath. Do you have any objection to testifying under oath? 

None of the witnesses have objection. So the Chair then advise 

you that under the rules of the House and the rules of the committee, you are entitled to be advised by counsel. Do any of you desire to be advised by counsel today? And none of the witnesses say 

so. 

So, in that case, please rise. Raise your right hand. I’ll swear you 

in. 

Do you swear that the testimony you’re about to give is the 

truth, the whole truth, and nothing but the truth? 

Thank you. All the witnesses answered in the affirmative, so you 

are now under oath and subject to the penalties set forth in title 

18, section 1001 of the United States Code. 

You may now each give a 5-minute opening statement. Please 

stick to the 5 minutes. If you don’t have to fill it, that’s OK, too. 

We’d like to get through. 

Mr. Botticelli. 

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STATEMENTS OF MICHAEL P. BOTTICELLI, DIRECTOR, OFFICE 

OF NATIONAL DRUG CONTROL POLICY; RICHARD G. FRANK, 

PH.D., ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE 

ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; DOUGLAS C. THROCKMORTON, M.D., DEPUTY DIRECTOR, CENTER 

FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG 

ADMINISTRATION; DEBRA HOURY, M.D., M.P.H., DIRECTOR, 

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND PREVENTION; 

PAMELA S. HYDE, J.D., ADMINISTRATOR, SUBSTANCE ABUSE 

AND MENTAL HEALTH SERVICES ADMINISTRATION; AND 

PATRICK CONWAY, M.D., M.SC., DEPUTY ADMINISTRATOR 

FOR INNOVATION AND QUALITY, AND CHIEF MEDICAL OFFICER, CENTERS FOR MEDICARE AND MEDICAID SERVICES 

STATEMENT OF MICHAEL P. BOTTICELLI 

Mr. BOTTICELLI. Thank you, Chairman Murphy, Ranking Member DeGette, and members of the subcommittee for the opportunity 

to provide testimony to you today about the administration’s efforts 

to address the opioid epidemic in the United States. 

Mr. Chairman, as you recognized, in 2013 almost 44,000 Americans died of a drug overdose. That’s one drug overdose death every 

12 minutes. Using ONDCP’s role as the coordinator of the Federal 

Drug Control agencies, in 2011, we published the administration’s 

Prescription Drug Abuse Prevention Plan to address the sharp rise 

in prescription opioid drug abuse in this country since 1999. As you 

know, the plan consists of action items categorized under four pillars: Education of patients and prescribers; increased prescription 

drug monitoring; proper medication disposal; and informed law enforcement. 

With the work of our HHS partners here today, and other Federal partners as part of the Interagency Prescription Drug Work 

Group convened by ONDCP, we have made some strides in each of 

these areas, but there is much more to be done. 

Since time in graduate medical education programs devoted to 

the identification of treatment of substance abuse disorders is rare, 

we have worked with our Federal partners to develop continuing 

education programs about substance abuse, managing pain appropriately, and treating patients using opioids more safely. Many prescribers in Federal agencies, including HHS, are receiving this important training. Despite this, a large percentage of prescribers 

have not availed themselves of this training. Therefore, the administration continues to press for mandatory prescriber education tied 

to controlled substance licensure. I am pleased that Secretary 

Burwell has expressed her support for working with Congress to 

set requirements for specific training for opioid prescribers. 

Today, all States but one, Missouri, have prescription drug monitoring programs that allow prescribers to check on drug interactions as well as alert them to the signs of dependence on opioids. 

Missouri is also working to authorize a PDMP program. With almost all States implementing PDMPs, we are focusing on improvVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
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ing State-to-State data sharing, and improving access to PDMP 

data within the health record systems providers use every day. 

In October, the Drug Enforcement Administration’s final regulation on controlled substances disposal became effective. ONDCP 

and our Federal partners and stakeholders have begun to inform 

the public about these regulations and look to ways to stimulate 

more local disposal programs in partnerships with pharmacies, 

local government, community groups, and local law enforcement. 

And the work of our law enforcement partners at the Federal, 

State, and local levels is ongoing. Those engaged in fraud across 

the drug control supply chain are being investigated and prosecuted. 

Recent data shows we are seeing an overdose from prescription 

opioids leveling off in this country, but a dramatic 39 percent increase in heroin overdoses from 2012 to 2013. This is creating an 

additional need for treatment in a system where a well-known gap 

between treatment capacity and demand already exists. Therefore, 

we must redouble our efforts to address people who are misusing 

prescription opioids, since we know this is a major risk factor for 

subsequent heroin use. 

Earlier this week, the administration held the inaugural meeting 

of the congressionally mandated interagency Heroin Task Force. 

Mary Lou Leary, our Deputy Director for State, Local, and Tribal 

Affairs, is one the cochairs for this committee. In addition, the 

President’s FY ’16 budget request includes $99 million in additional funding for treatment and overdose prevention efforts. 

We have also been working to increase access to the emergency 

opioid overdose reversal drug, naloxone, and to promote Good Samaritan laws so that witnesses can take steps to help save lives. 

Many police and fire departments have already trained and 

equipped their personnel with this life-saving drug, and loved ones 

of people with opioid drug use disorders are equipping themselves 

as well. 

And while law enforcement and other first responders have an 

important role to play, the medical establishment also must become 

more engaged to identify and treat heroin and prescription opioid 

use disorders. Every day, these people appear in our emergency departments and other medical settings, and more models and interventions are needed to get these individuals engaged in care. 

We also need to expand availability of evidence-based opioid use 

disorder treatments. Medication-assisted treatment, which uses 

FDA-approved medications, combined with behavioral and other recovery supports, has been shown to be the most effective treatment 

for opioid use disorders. Decisions about the most appropriate 

treatment options and their duration need to be agreed upon by 

both the patient and the treatment provider. 

We must also provide community supports, such as access to 

housing, employment, and education, to give patients the functional tools they need to lead healthier lives and fully integrate 

into the community as part of their recovery process. 

While we support multiple pathways to recovery, the literature 

shows that short-term treatment, such as detoxification alone, is 

not effective and carries risk of relapse and overdose death. Because of the lack of availability of evidence-based maintenance 

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treatments and the strong connection between injection of opioid 

drugs and infectious disease transmission, we also promote the use 

of public health strategies that will help prevent the further spread 

of infectious disease. The HIV and hepatitis C outbreak in Scott 

County, Indiana, is a stark reminder of how opioid use can spread 

other diseases, how comprehensive public health strategies, such as 

syringe exchange programs, need to be part of the response to the 

opioid use epidemic, and how rural communities that have limited 

treatment capacity may experience additional public health crises. 

Finally, we are continuing our efforts to address neonatal abstinence syndrome. Research published just yesterday shows that the 

incidence of NAS has grown nearly fivefold between 2000 and 2012 

and that 81 percent of the 2012 hospital charges for NAS were attributed to Medicaid. We must consider that the best interest of babies with NAS is often served by best addressing the interests of 

the mother. Therefore, we need to provide safe harbor for pregnant 

and parenting women seeking prenatal care and treatment. 

In conclusion, we look forward to working with Congress and our 

Federal partners on the next stage of action to address this epidemic. Thank you. 

[The prepared statement of Mr. Botticelli follows:] 

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Mr. MURPHY. Thank you. 

Dr. Frank, we’re going to try and get your testimony and then 

we’re going to run off and vote, and we’ll be back. Go ahead. 

STATEMENT OF RICHARD G. FRANK 

Dr. FRANK. OK. Chairman Murphy, Ranking Member DeGette, 

and members of the subcommittee, thank you for the opportunity 

to discuss how the Department of Health and Human Services is 

addressing the opioid abuse epidemic. 

Containing the abuse and misuse of prescription opioids and heroin is a high priority for the HHS leadership team, and we’re 

pleased to be here with you today. I would like to use my time 

today to give you an overview of how we view the challenge and 

describe how we are working to develop a multifaceted solution to 

this problem. It’s going to take a lot of collaboration, and we are 

pleased to work with you and other stakeholders on this issue. 

Addiction to and abuse of opioids, including both prescription 

painkillers and heroin and the terrible outcomes associated with 

them, are growing at an alarming pace. Just over a third of drug 

overdose deaths in 2012 and 2013 were from prescription opioids, 

while heroin-related deaths have spiked dramatically, almost tripling since 2010. 

The sharp increase in the misuse and abuse of opioids places a 

great burden on the health system. There were 259 million prescriptions filled for opioids in the U.S. in 2012, a large increase 

over just a few years prior. The Medicare program under part D 

spent $2.7 billion on opioids overall in 2011, 1.9 billion of that 

total, or 69 percent was accounted for by the top 5 percent of opioid 

users. Those spending patterns on these drugs reflect some of our 

concerns. 

The cost of abuse and misuse of opioids shows up in preventable 

use of very expensive health care. Heroin presents an equally troubling, but different abuse and overdose pattern. We saw increases 

between 2002 and 2009 in a number of people using heroin, but 

that number has held fairly steady since 2009. 

The striking new trend is that there’s an increasing share of the 

users that are dying from heroin overdoses. So what I’m telling you 

is that we have a opioid prescribing problem, sitting alongside a 

drug abuse and misuse problem. 

Secretary Burwell is committed to aggressively addressing the 

epidemic. She’s driving us towards two main goals: One, reducing 

opioid overdoses and overdose-related mortality; and two, decreasing the prevalence of opioid use disorder. She directed us to use the 

best science and to focus on the most promising levers that can 

make a difference for the people who struggle with opioid addiction 

and their families. 

HHS agencies have been collaborating on this problem for some 

time, and we hope you will agree after today that the whole is 

greater than the sum of the parts. 

Our actions informed by the evidence and discussions with States 

and other stakeholders fall into three general categories: One, addressing opioid prescribing practices; two, expending the use of 

naloxone; and three, promoting medication-assisted treatment. 

30 

Let me outline the plan in a bit more detail. First, PDMPs. We’re 

increasing investments in prescription drug monitoring programs, 

which are among the most promising clinical tools to curb prescription opioid abuse. We’re investing it through State grants and technical assistance and supporting best practices to maximize the impacts of PDMPs. 

Second, naloxone, which is the life-saving drug that can reverse 

overdose from both prescription opioids and heroin. We’re supporting the development of user-friendly formulations and delivery 

mechanisms and are working with State and local governments to 

support training and other measures that get naloxone into the 

hands of those that are in a position to reverse overdoses. 

Finally, we have plans to support the appropriate use of medication-assisted treatment, or MAT. The enactment of the Mental 

Health Parity and Addiction Act opens up new opportunities to expand access to these evidence-based treatments. 

We are also working on identifying best practices in primary care 

settings, increasing access to MAT through SAMHSA grant support 

and potentially increasing the supply of MAT providers by reviewing the policy and regulations that limit the types of individuals 

certified to prescribe. Our commitment to halting this complex public health epidemic is set out in the President’s 2016 budget that 

includes a $99 million increase for parts of our initiative. 

Finally, evaluation will help us identify the most effective activities, allow us to continuously learn, and inform future policy making in order to address this public health concern. 

So, in closing, this is critical for HHS and for the Nation, and we 

can’t do it alone. We need help. Thank you for encouraging an open 

discussion of this today, and we are committed to turning the tide 

on this scourge that has become the opioid epidemic. 

[The prepared statement of Mr. Frank follows:] 

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Mr. MURPHY. Thank you, Doctor. 

Now, for the members—so votes are in progress. And even 

though time is running out, just to let you know, I think only about 

20 people voted so far. So, apparently, this is throwing everybody 

off in their schedules. 

I apologize. This is what happens on Capitol Hill. But we’re committed to hear from you. We know how important this is and we 

value your testimony. So we’re probably going to be back in a little 

under an hour. So we look forward to hearing from you then and 

getting the rest of this testimony. Thank you. 

[Recess.] 

Mr. MURPHY. All right. Thank you for being patient. 

All right. Dr. Volkow, you’re recognized for 5 minutes. 

STATEMENT OF NORA D. VOLKOW 

Dr. VOLKOW. Good morning, Chairman Murphy, Ranking Member DeGette, and other members of the subcommittee. I want to 

thank you for organizing and inviting me to participate in this important hearing. 

The nonmedical use of prescription pain relievers is a particular 

public health challenge, for it demands solutions, on the one hand, 

to prevent their diversion and misuse, while at the same time, it 

demands so many solutions that will not jeopardize access to these 

medications for those that need them. 

Opiate medications are probably among the most effective painkillers that we have for the management of acute severe pain, and 

the proper use can actually save lives. They act by activating opioid 

receptors that are located in the areas of the brain that perceive 

pain, but there are very high concentration of opioid receptors in 

brain reward regions, and hence, the problem. Activation of these 

receptors is what is associated with their addiction potential. 

There are also high levels of receptors in areas of the brain that 

regulate breathing, which is why their use is associated also with 

a high risk of death from overdose. 

We have heard the devastating consequences from the escalation 

of the abuse of prescription medications in our country, the overdose deaths and transition to injection of heroin and associated infections with HIV and hepatitis C, and increasing numbers that we 

are seeing for the neonatal abstinence syndrome. 

NIDA’s role in helping solve this epidemic is to support the research that will help develop solutions to prevent and treat abuse 

of prescription medications that could be implemented now, while, 

at the same time, funding research that in the future will provide 

transformative solutions. 

There are already evidence-based practices that have been shown 

to be effective in the prevention of overdose death that include the 

use of medications for opioid addiction and the use of naloxone to 

reverse opioid overdoses. 

There are three medications currently available to treat opioid 

addiction: methadone, buprenorphine, and naltrexone, which, when 

used as part of a comprehensive addiction treatment plan, have 

been shown to facilitate abstinence and reduce overdoses and HIV 

infections. Also, when coupled to prenatal care in pregnant women 

addicted to opioids, these medications reduce the risk of obstetrical 

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fetal and neonatal complications. Yet, despite the strong evidence, 

less than 40 percent of those receiving treatment for opioid addiction get treated with these medications. Toward this end, NIDA is 

funding research on implementation strategies that facilitate the 

use of medications for opioid addiction in the healthcare system. 

Another key component to decrease the overdose deaths is to expand the use of naloxone, so NIDA has partnered with pharmaceutical companies to develop user-friendly, effective delivery systems for naloxone that will facilitate their use by those that have 

absolutely no medical training. 

In addition, NIDA supports research on the treatment of pain 

and on the treatment of opioid addiction that will offer new solutions for the treatment of these two disorders. Examples for the 

management of pain include the development of drug combinations 

or new formulations with less addiction potential, the development 

of analgesics that do not rely on the opioid system, and the development of nonmedication interventions, such as the use of 

transcranial magnetic or electrical brain stimulation for pain management. 

Examples of research on the treatment of opioid addiction include the development of slow-release formulations that need only 

once-a-month or once-every-6-months dosing—which will facilitate 

compliance and use—and the development of vaccines against heroin, which will prevent the delivery of the drug into the brain, 

hence, interfering with its rewarding effects and adverse consequences. 

Because the epidemic of prescription drug abuse resulted from a 

lack of knowledge by healthcare providers, the importance of developing curriculum to train both in pain and in substance abuse disorders is another priority which NIDA has developed in partnership with the other institutes and NIH Centers of Excellence. 

There were over 24,000 deaths from opioid overdoses in 2013. 

Twenty-four thousand. This highlights the urgency to address this 

epidemic. Solutions are already available. The challenge is the implementation. This requires strong integration of efforts, and NIDA 

will continue to work closely with other Federal agencies, community organizations, and private industries to address this complex 

challenge. 

[The prepared statement of Dr. Volkow follows:] 

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Mr. MURPHY. Thank you. 

Dr. Throckmorton, 5 minutes. 

STATEMENT OF DOUGLAS C. THROCKMORTON 

Dr. THROCKMORTON. Mr. Chairman, Ranking Member DeGette, 

and members of the subcommittee, I am Dr. Douglas 

Throckmorton, Deputy Director for Regulatory Programs within 

FDA’s Center for Drug Evaluation and Research. Thank you for the 

opportunity to be here today to discuss FDA’s role in combating 

opioid abuse and encouraging the safe use of these important 

drugs. 

Our goal is to find the balance between needing to treat patients 

with pain, including the use of opioids where appropriate, and 

needing to reduce opioid drug abuse. This work is being done together with other parts of the Federal Government, and we know 

that a successful and sustainable response must include Federal 

and State Government, public health officials, opioid prescribers, 

addiction experts, researchers, manufacturers, and patient organizations. 

For our part, FDA plays a central role in the regulation and use 

of drugs from their discovery and throughout their marketing. For 

example, when FDA reviews a drug for possible marketing, we also 

approve drug labeling, which includes information about approved 

uses about the medicine, as well as information about potential 

safety risks. FDA also carefully follows drugs after they are marketed, including opioid drugs. Where necessary, this enables us to 

take a variety of actions to improve their safe use, such as changes 

to approved labeling. 

The first area of FDA activity I’d like to highlight is our work 

to support the development of abuse-deterrent formulations that 

make opioids harder or less rewarding to abuse. While this is not 

a silver bullet that will prevent all abuse, FDA believes abuse-deterrent opioids can help reduce opioid abuse. To incentivize their 

development, FDA recently issued final guidance on abuse-deterrent formulations, guidance we are using now to meet with sponsors interested in developing them. 

To date, FDA has received some 30 investigational new drug applications from manufacturers. In addition, we have approved four 

opioid drugs with abuse-deterrent claims in their labeling. 

Overall, then, while we are in the early stages of development, 

I am encouraged by this level of work. FDA envisions a day not far 

in the future when the majority of opioids in the marketplace are 

in effective, abuse-deterrent forms. 

Next, with regards to prescribing opioids, we know that they are 

powerful medicines, and FDA believes that it is critically important 

to ensure that prescribers have high quality education about how 

to use them in pain management. 

Over the past several years, FDA has done several things to improve educational materials on opioids. For example, we recently finalized required changes to the approved labels of extended-release, long-acting opioids, changing their indication to inform prescribers that these drugs should only be used for pain severe 

enough to require daily around-the-clock treatment when alternative treatments would not work. 

57 

At the same time, FDA strengthened significantly the safety 

warnings on these opioids. We want prescribers to use them with 

care, and today, the labels for extended-release, long-acting opioids 

are among the most restrictive of any drugs that we have in the 

center, and have clear language that calls attention to their potentially life-threatening risks. 

FDA’s also working to improve the information available for prescribers in other ways. Under certain circumstances, FDA can require manufacturers, as a part of a risk evaluation and mitigation 

strategy, to address safety concerns such as opioid abuse. In 2012, 

FDA required manufacturers to fund the development of unbiased 

continuing education programs on opioid prescribing practices for 

prescribers. In the first year since that program has been in place, 

approximately 6 percent of the 320,000 prescribers, around 20,000 

prescribers of extended-release and long-acting opioids, have completed one of those courses. We believe this training for prescribers 

is important. We also support mandatory education for prescribers 

of opioids, as called for by the administration in the 2011 Prescription Drug Abuse Prevention Plan, and reemphasized in the 2014 

National Drug Control Strategy. 

Finally, FDA has been working with many other stakeholders, 

including the agencies here today, to explore the best ways to prevent overdose deaths by the expanded use of naloxone. As others 

have said, it can and does save lives. FDA is working to facilitate 

the development of naloxone formulations that could be easier to 

use by anyone responding to an overdose. First, FDA meets with 

manufacturers whenever needed and is using whatever tools we 

can to expedite product development. We recently approved the 

first auto-injector formulation of naloxone, which is intended to be 

administered by people witnessing an overdose, such as family 

members and caregivers. We completed that review and approved 

this product in 15 weeks. 

Going forward, we continue to work on how best to use naloxone. 

As a part of this work, FDA, and many of the others agencies at 

this table, are planning a public meeting in July to bring together 

key stakeholders to deal with questions of access, coprescribing of 

naloxone, and State and local best practices. 

In conclusion, as a society, we face an ongoing challenge and a 

dual responsibility. We must balance efforts to address opioid drug 

misuse, abuse, and addiction against the need for access to appropriate pain management. These are not simple issues and there are 

no easy answers. FDA is taking important actions we hope will 

achieve this balance. 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 turn the tide on this devastating epidemic. 

Thank you for this opportunity to testify. I look forward to answering any questions that I can. 

[The prepared statement of Dr. Throckmorton follows:] 

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Mr. MURPHY. Thank you, Doctor. 

Dr. Houry. 

STATEMENT OF DEBRA HOURY 

Dr. HOURY. Chairman Murphy, Ranking Member DeGette, I 

would like to thank you for inviting me here today to discuss this 

very important issue. I would also like to thank the committee for 

your continued interest in prescription opioid abuse and overdose. 

My name is Dr. Debra Houry, and I am the director of the National 

Center for Injury Prevention and Control at the CDC. 

As a trained emergency room physician, I have seen firsthand 

the devastating impact of opioid addiction on individuals and their 

families, as well as the importance of prevention. Together, we 

have witnessed a deadly epidemic unfolding in States and communities across the country. The overdose epidemic is driven, in large 

part, by fundamental changes in the way healthcare providers prescribe opioid pain relievers. Enough prescriptions were filled in 

2012 for every American adult to have their own bottle of pills. As 

the amount of opioids prescribed increased, so has the number of 

deaths. 

In alignment with the Department’s initiative, I want to highlight CDC’s work in developing evidence-informed opioid prescribing guidelines for chronic pain and providing direct support to 

States to implement multi-sector prevention programs. 

CDC is currently developing guidelines for the prescribing of 

opioids for chronic noncancer pain. This undertaking is responsive 

to a critical need in the field. These new guidelines will redefine 

best practices around opioid prescribing for chronic pain and make 

important advances in protecting patients. The audience for these 

guidelines are primary care practitioners, who account for the 

greatest number of prescriptions for opioids compared to other specialties. The guidelines process is underway, and our goal is to 

share a draft for public comment by the end of this year. We have 

plans in place to encourage uptake and usage of the guidelines 

among providers, which is key for improving prescribing practices. 

The second activity I would like to highlight is our major investment in State-level prevention. States are at the front lines of this 

public health issue, and CDC is committed to equipping them with 

the expertise they need to reverse the epidemic and protect their 

communities. Utilizing the newly appropriated $20 million, we recently published a new funding opportunity called Prescription 

Drug Overdose: Prevention for States. It builds upon existing CDCfunded State programs and targets States that have a high drug 

overdose burden and those that demonstrate readiness needed to 

combat the epidemic. It requires collaboration across sectors for a 

truly comprehensive response. 

The goals for this program are to make prescription drug monitoring programs more timely, easier to use, and able to communicate with other State PDMPs, to implement Medicaid or Workers’ 

Compensation interventions to protect patients at risk, and to 

bring data-driven prevention to the communities struggling with 

the highest rates of drug abuse and overdose. States also will be 

given the flexibility to use the program to respond to emerging criVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00075 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
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ses and develop innovative interventions so they know what works 

to reduce overdose and save lives in their community. 

The development of opioid prescribing guidelines and our State 

prevention program are two key ways that CDC’s broad work on 

the epidemic contributes to the Department’s initiative. 

We are also examining the increase in heroin use and overdose. 

Heroin overdose deaths have more than doubled since 2010, and 

prescription opioid abuse, a key risk factor for heroin use, has contributed significantly to this rise in heroin use and overdose. We 

will leverage our scientific expertise to improve public health surveillance of heroin and evaluate effective strategies to prevent future heroin overdoses. 

Addressing this complex problem requires a multifaceted approach and collaboration among a variety of stakeholders, but it 

can be accomplished, particularly with the ongoing efforts of all of 

the organizations represented here on this panel. 

CDC is committed to tracking and understanding the epidemic, 

supporting States working on the front lines of this crisis, and providing healthcare providers with the data, tools, and guidance they 

need to ensure safe patient care. 

Thank you again for the opportunity to be here with you today 

and for your continued work and support of us protecting the 

public’s health. I look forward to your questions. 

[The prepared statement of Dr. Houry follows:] 

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Mr. MURPHY. Thank you, Doctor. 

Pamela Hyde, welcome back. 

STATEMENT OF PAMELA S. HYDE 

Ms. HYDE. Good morning, Chairman Murphy, Ranking Member 

DeGette, and members of the subcommittee. Thank you for inviting 

SAMHSA to be part of this hearing, and thank you for your interest in this important public health issue. 

According to SAMHSA’s National Survey on Drug Use and 

Health, the prevalence rate of nonmedical use of prescription 

opioids is high, approximately 4.5 million individuals in 2013. Heroin use is much lower, About 289,000 individuals reporting past 

month use, but that’s doubled in 5 years. 

Fortunately, the nonmedical use of pain relievers has actually 

decreased some from 2009 to 2013, especially among young people 

12 to 17. However, as you know, overdoses and overdose-related 

deaths from both prescription drugs and heroin have risen dramatically among all ages. And as you’ve heard, few who need treatment 

are receiving the comprehensive community-based services they 

need to live lives in recovery, free of addiction. 

SAMHSA believes prevention is the priority and recovery is the 

goal. SAMHSA’s programs, data, practice improvement, public education, and regulatory efforts are all designed to prevent addiction 

and overdoses, help provide the treatment and services needed for 

people with substance abuse disorders to achieve recovery, support 

their families, and foster supportive communities. 

SAMHSA funds the American Academy of Addiction Psychiatry, 

together with six other medical societies, to train prescribers in the 

best approaches to pain management. SAMHSA also educates physicians on medication-assisted treatment for opioid addiction. 

SAMHSA’s Addiction Technology Transfer Centers provide training 

and materials on opioid use disorders, and are cofunded with NIDA 

to distribute research-based best practices to the field of addiction 

treatment. 

To help prevent opioid-overdose-related deaths, SAMHSA alerted 

States last year that substance abuse treatment block grant funds 

may be used to purchase and distribute naloxone and increase education and training on its use. Also in 2014, SAMHSA updated its 

opioid overdose prevention toolkit to educate individuals, families, 

first responders, and others about steps to prevent and reverse the 

effects of opioid overdoses, including the use of naloxone. This toolkit’s one of the most downloaded resources on SAMHSA’s Web site. 

The President’s 2016 budget includes $12 million in discretionary 

grants for States to purchase and distribute naloxone, equip first 

responders in high risk communities, and support education on the 

use of naloxone and other overdose prevention strategies. 

SAMHSA also supports medication-assisted treatment as part of 

a recovery-oriented, person-centered care model. Medication-assisted treatment is not meant as a standalone approach, but rather 

is designed to include medication, counseling, behavioral therapies, 

and recovery supports. 

In March 2015, SAMHSA issued revised Federal guidelines for 

opioid treatment programs which highlight this recovery-oriented 

care model, and encouraged the use of any of the three FDA-apVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00085 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
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proved medications for the treatment of opioid use disorder based 

on an assessment of each individual’s unique needs. 

SAMHSA’s also taking an integrated clinical care approach as 

part of a new 2015 grant program to expand and enhance the 

availability of medication-assisted treatment and other clinically 

appropriate services in States with the highest rates of opioid admissions. The President’s 2016 budget proposes to double this program. 

In collaboration with DOJ and ONDCP, SAMHSA added language to its 2015 treatment drug court grant requirements to ensure that drug court clients will not be compelled to stop or be prevented from using medication if it is prescribed or dispensed consistent with a licensed prescriber’s recommendation, a valid prescription, or as part of a regulated opioid treatment program. 

SAMHSA regulates opioid treatment programs, which are expected to provide a full range of services for their patients. In collaboration with the Drug Enforcement Administration, SAMHSA 

provides waivers to physicians wishing to treat opioid use disorders 

with buprenorphine in a practice setting other than an opioid treatment program. 

SAMHSA also funds efforts to help prevent prescription opioid 

misuse and heroin use. For example, in 2014, SAMHSA’s Strategic 

Prevention Framework—Partnerships for Success program, made 

preventing and reducing heroin use one of its focus areas, along 

with prescription drug misuse and abuse, and underage drinking. 

For 2016, the President has proposed $10 million for the Strategic 

Prevention Framework Rx, or SPF Rx, to help States use data, including PDMP data, to identify and assist communities at high risk 

for the nonmedical use of prescription drugs. 

We want to thank you, again, for taking on this issue and for allowing SAMHSA an opportunity to share some of its efforts with 

you. We look forward to answering your questions. 

[The prepared statement of Ms. Hyde follows:] 

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Mr. MURPHY. Thank you, Ms. Hyde. 

Dr. Conway, you’re recognized for 5 minutes. 

STATEMENT OF PATRICK CONWAY 

Dr. CONWAY. Chairman Murphy, Ranking Member DeGette, and 

members of the subcommittee, thank you for inviting me to discuss 

the CMS’s work to ensure that all Medicare and Medicaid beneficiaries are receiving the medicines they need, while also reducing 

and preventing prescription drug abuse. 

As we have heard from other witnesses, opioid analgesics have 

increasingly been implicated in drug overdose deaths over the last 

decade. As a practicing physician, I understand the importance of 

this issue. 

CMS recognizes our responsibility to protect the health of Medicare and Medicaid beneficiaries by ensuring that appropriate safeguards are in place to help prevent overuse and abuse of opioids, 

while ensuring that beneficiaries can access needed medications 

and appropriate treatments for substance abuse disorder. 

Since its inception in 2006, the Medicare part D prescription 

drug benefit has made medicines more available and affordable, 

leading to improvements in access to prescription drugs and better 

health outcomes. 

Despite these successes, part D is not immune from the nationwide epidemic of opioid abuse. CMS has broadened its initial focus 

of strengthening beneficiary access to prescribed drugs to also address potential fraud and drug abuse by making sure part D sponsors implement effective safeguards and provide coverage for drug 

therapies that meet safety and efficacy standards. 

We believe that broader reforms that result in better coordinated 

care will help protect beneficiaries from the damaging effects associated with prescription drug abuse and to prevent and detect overutilization related to prescription drugs. 

A centerpiece of our strategy is to strengthen CMS’s monitoring 

of part D plan sponsors’ drug utilization management programs, to 

prevent overutilization of these medications. To accomplish this 

goal, the Medicare part D overutilization monitoring system, or 

OMS, was implemented in 2013. Through this system, CMS provides reports to sponsors on beneficiaries with potential opioid 

overutilization identified through analysis of prescription drug 

event data and through beneficiaries referred by the CMS Center 

for Program Integrity. Sponsors are expected to utilize various drug 

utilization monitoring tools to prevent continued overutilization of 

opioids. Recent data has shown that from 2011 to 2014, the OMS 

has reduced the number of potential opioid over-utilizers by appropriately 26 percent. 

CMS also utilizes the Drug Integrity Contract, or MEDIC, which 

is charged with identifying and investigating potential fraud and 

abuse, and developing cases for referral to law enforcement agencies. In 2013, CMS directed the MEDIC to increase its focus on 

proactive data analysis in part D. CMS has also used our rule-making authority to create new tools to take action against problematic 

prescribers and pharmacies. We recently finalized a provision that 

requires prescribers of part D drugs to enroll or have a valid optVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00096 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
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out affidavit on file, and establishes a new revocation authority for 

abusing prescribing patterns. 

State Medicaid agencies have also taken action to tackle the 

opioid abuse epidemic. Efforts include expanding the Medicaid benefit to include behavioral health services for those with addiction 

to prescription drugs and pharmacy management review programs. 

Although CMS does not determine what services are provided in 

each Medicaid program to prevent and treat opioid abuse, we are 

encouraged by the increasing efforts by States to develop effective 

strategies for designing benefits for this population. 

We recently launched the Medicaid Innovation Accelerator Program, or IAP, to provide States with technical assistance and other 

types of support to address this important issue. 

CMS, in coordination with CDC, SAMHSA, and NIH, issued an 

informational bulletin on medication-assisted treatment for Substance Abuse Disorder in the Medicaid program. This guidance outlines that a combination of medication and behavioral therapies is 

the most effective combination of treatment. We issued a similar 

bulletin focused on these services in the pediatric and youth population. 

CMS is dedicated to providing the best possible care to beneficiaries with opioid addiction, and is working with part D sponsors 

and State Medicaid programs to implement effective safeguards to 

prevent opioid abuse and treat patients effectively with substance 

abuse disorders. 

CMS has made progress, but there is more work to be done. CMS 

is undertaking multiple policy initiatives and interventions to reduce the rate of opioid addiction and overdoses in both Medicare 

and Medicaid. 

In previous testimonies, I’ve never had family here or the time 

to thank them, so I do want to thank my mother, Diane Conway, 

is here and my son, Jack, who’s out of school, as well as my wonderful wife, Heather, and daughters Alexa and Savannah. And 

without their love and support, I would not be able to work on 

issues like this that are critically important to our Nation. So 

thank you. 

[The prepared statement of Dr. Conway follows:] 

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Mr. MURPHY. Thank you, Doctor. And thank you for recognizing 

Take Your Family to Testifying Day. Apparently everybody else did 

not get the memo. 

I just want to start out by saying if talent and dedication alone 

could solve this crisis, we’d be there with the testimony of today 

and other days, but obviously, we still have problems. So let me 

start off with asking a few questions. 

First, for Director Botticelli, for the Office of National Drug Control Policy, or ONDCP, uses the term ‘‘recovery,’’ does it mean to 

include patients with opioid addiction in a buprenorphine or methadone treatment program and still using heroin or other illicit 

drugs, or would you say that’s not recovery? 

Mr. BOTTICELLI. So I think, you know, from our perspective, and 

also as a person in recovery, clearly we want to make sure that 

people are continuing to progress in their recovery, and that kind 

of freedom from substances is the ultimate goal of recovery programs, and I think everyone would agree on that, but we also know 

that substance use, and particularly opioid use disorders, are a significant chronic disorder, and that oftentimes, and even my own experience show me, that people often will experience relapse and 

will often, I think, need multiple attempts at treatment to get to 

that final goal of long-term recovery and long-term abstinence. 

And so we really want to make sure that we’re continuing to engage with patients, that we’re moving them toward better health, 

better recovery, and being free from substance abuse as part of 

long-term recovery. 

Mr. MURPHY. Well, let me ask in context of this, because we also 

heard from testifiers last week they felt there was not a uniform 

definition of recovery, but, I mean, this is the talent pool here, 

you’re the ones that do these. Do you all meet on a regular basis 

to talk about these issues? And when was the last time you all got 

together to talk about policy issues? Was it within the last—can 

someone answer that? Pam? Pam Hyde? 

Mr. BOTTICELLI. So let me start. 

Mr. MURPHY. Oh, you will start? OK. 

Mr. BOTTICELLI. Let me start with that, because it’s actually part 

of our statutory authority—— 

Mr. MURPHY. OK. 

Mr. BOTTICELLI (continuing). That we set in conjunction with, not 

just our HHS partners, but with all of the Federal agencies that 

have a role in substance use, and particularly in opioid use disorders. We have been engaged with the DOD and the VA and the 

Bureau of Prisons. 

Mr. MURPHY. So you all meet regularly? 

Mr. BOTTICELLI. We actually do meet regularly. So we have quarterly meetings to focus on where we are. 

Mr. MURPHY. Well, let me move on that too, because that’s going 

to be important. 

Ms. Hyde, let me ask you a question here in your response to our 

bipartisan letter of March 18 concerning the National Registry of 

Evidence-Based programs, you noted that, quote, ‘‘new submission 

and review procedures will improve the rigor of the registry and 

bring NREPP into closer alignment with other registries of evidence-based programs in the Federal Government.’’ 

105 

Now, prior to entering into this July 2014 contract, did SAMHSA 

feel that the scientific basis of the rigor of NREPP needed to 

strengthened, yes or no? I mean, do you feel it needed to be 

strengthened? 

Ms. HYDE. Thank you for the question. We thought the process 

that we used for determining what practices were reviewed needed 

to be strengthened, and in the process, we have also increased the 

rigor with which we look at them. 

Mr. MURPHY. Can you get us a list, not today, but can you get 

us a list of what you consider to be some of the models within the 

Federal registry that we can review as part of that, as evidencebased programs? 

Ms. HYDE. Certainly. 

Mr. MURPHY. OK. Thank you. 

Your response also indicates an outside contractor will assume 

the role of gatekeeper for NREPP, determining which studies and 

outcomes are reviewed in the screening and review of an intervention, with the aim of preventing bias in favor of the intervention 

developers. 

Was SAMHSA’s prior system for vetting and selecting interventions to be included in the NREPP prone to any kind developer bias 

or conflict of interest? Was that a concern? 

Ms. HYDE. Yes, Mr. Murphy, it was a concern. It was pretty 

much developer driven. So a developer had to want their practice 

to be reviewed, and then they had some control over what research 

we looked at. We have changed that with the new contract, which 

began last year, and we will help decide priorities together with the 

public input, but the contractor will help us look more objectively 

at evidence. 

Mr. MURPHY. Thank you. I just pulled up here—I just got a note, 

actually an article that, was this one of your constituents, Dr. 

Frank, from eastern Colorado? I don’t want to take all your Colorado thunder, but it was fascinating article, because it made reference to the increased use of emergency departments associated 

with opiates. And it’s interesting, they said that the reasons for 

this is—first of all, they said there’s 10–1/2 million estimated people with this, it’s probably an underestimate, that people go to the 

emergency rooms for treatment for withdrawal, but also many trying to get more opiates; and that when you have users with opiate 

prescriptions from more than one physician, they’re more likely to 

be involved in riskier practices. 

I wonder if any of you could comment on if that’s an area that 

we’re trying to address. I think, Dr. Volkow, you were also talking 

about issues with regard to prescribing practices, and Dr. Frank. 

Can some of you comment on those issues? 

Dr. VOLKOW. Yes. And I think that that article, I think, that 

you’re referring to the New England Journal of Medicine article 

that shows that there’s been a very significant, quadruple number 

of cases of neonatal abstinence syndrome in the intensive care 

units, and this does reflect the fact that many women are actually 

being prescribed opioid medications during the pregnancy itself. 

And, actually, based on another study, it was estimated that 21 

percent of women that are pregnant are going to receive an opioid 

medication, which, again, highlights the need to enforce better that 

106 

the guidelines on the management of pain need to be enforced in 

better ways. And this is also recognized by studies that have actually evaluated the extent to which physicians are following guidelines by the main medical organizations as it relates to the management of pain. So that is an area where there needs to be an aggressive increase in the education and enforcement of guidelines. 

Mr. MURPHY. Thank you. I’m out of time. I’d just ask unanimous 

consent that I can submit this research article for the record. 

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

Mr. MURPHY. Ms. DeGette, you’re recognized for 5 minutes. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Dr. Volkow, as I mentioned in my opening statement, you’re one 

of the world’s top experts on the issue of treating addiction. Briefly, 

what does the body of scientific evidence show regarding the effectiveness of methadone and buprenorphine in this treatment of 

opioid abuse disorders? 

Dr. VOLKOW. What the research has shown—and it has shown it 

not just for methadone and buprenorphine, but a more recent medication, naltrexone—is that these medications when used as part of 

a comprehensive program for the treatment of opioid addiction are 

quite effective, and they significantly improve the outcomes of individuals being able to stay, on the one hand, abstinent from the 

drug or to decrease the likelihood of relapsing, but it also protects 

them against the adverse outcomes, such as overdoses. 

Ms. DEGETTE. So in light of those studies, you also said in your 

testimony that existing evidence-based prevention and treatment 

strategies are highly underutilized across the United States. And 

last week we had an expert tell our panel that very few patients 

with opioid addiction today receive treatments that have been proven most effective. He was talking about this rapid detox followed 

by abstinence-based treatment. 

I’m wondering, Dr. Volkow, if you can help understand this. Why 

do we have a situation where people are not getting evidence-based 

treatment? 

Dr. VOLKOW. Well, one of the problems has been—and it’s a complex problem and there are many reasons why they’re not getting 

the correct treatment, including the fact of adequate education as 

it relates to the proper screening and management of substance 

abuse disorder, including the healthcare system. Then you have a 

whole infrastructure that has developed because addiction is stigmatized, so, therefore, the likelihood of people accessing that medical care is much lower. And then, of course, there is a difference 

between States in the way that they implement the treatment. So 

all of these factors account for the current situation. 

Ms. DEGETTE. Dr. Frank, do you have anything to add to that? 

Dr. FRANK. Yes, I do. I think that one thing that’s very important 

to remember is that overall, we treat 10 percent of the people with 

these disorders, so it’s not surprising that people aren’t getting evidence-based treatment, because they’re not getting treatment, period. 

Second part is why aren’t they getting evidence-based treatment 

among those who do? And I think that there are insurance dynamics that hopefully we’re fixing, there are, as Dr. Volkow said, access 

to trained professionals who are trained in the best things, and 

107 

then there’s, in a sense, trying to kind of get the systems and the 

infrastructures aligned so that they support the best practices. 

Ms. DEGETTE. And, Dr. Houry, several of our witnesses, including you, mentioned the role of the States in this. Can you talk 

about that for a minute? 

Dr. HOURY. Absolutely. I think States have different populations, 

different issues, different prescription drug monitoring programs, 

and so tailoring these programs for States so they can best identify, 

whether it’s their State Medicaid program, other high-risk programs or patients and how to best target them, and that’s why the 

program at the CDC is really helpful, because we have the higher 

level view to work across the States for this. 

Ms. DEGETTE. And do you think the States have work to do in 

terms of implementing these programs that are science-based and 

that work? 

Dr. HOURY. You know, I think we’re starting to do that. Like, our 

program itself has only been in existence for 6 months, but we’re 

seeing great progress. And if you look at some of the policies that 

States are implementing, we’re seeing reductions in what we call 

doctor shopping and patients going to different doctors, because of 

utilizing prescription drug monitoring programs. So although it’s 

early in the stage, I’m very optimistic that we are making progress 

in the States. 

Ms. DEGETTE. OK. Dr. Volkow, I want to come back to you. One 

of our other experts last week said patients and their families need 

to know that detoxification treatment and drug-free counseling are 

associated with a very high risk of relapse. 

I’m wondering if you can tell us what the science shows. Is this 

type of treatment generally effective or less effective? What does 

the research show? 

Dr. VOLKOW. The research has shown that in general, fast detoxification of patients is associated with increased mortality, like 

what you just mentioned. And this reflects the fact that addiction 

is a chronic disease and the changes that occur in the brain persist 

months, years after you’ve stopped taking the drug. 

So what they do in this fast detoxification is just remove the 

physical dependence and assume that the addiction is cured, and 

these are two independent processes, and as a result of that, the 

patient feels that they are safe and then they relapse because they 

are still addicted—— 

Ms. DEGETTE. Thank you. 

Dr. VOLKOW (continuing). And many times they overdose. 

Ms. DEGETTE. Thank you. 

Thank you very much, Mr. Chairman. 

Mr. MURPHY. I now recognize Mr. Collins for 5 minutes. 

Mr. COLLINS. Thank you, Mr. Chairman. This is truly a fascinating topic we’re discussing, and it’s obvious there’s no very easy 

solution. I mean, we’ve heard it’s a chronic disease, 10 percent are 

seeking treatment. I guess my question maybe for Ms. Hyde at 

SAMHSA is, you know, certainly with pregnant women that may 

have young kids at home, and inpatient treatment might be the 

preferred, and we just can’t let perfect be the enemy of good, what 

other options are you looking at for people who can’t get in, I mean, 

they’re just not going to enter inpatient, so they may be part of the 

108 

90 percent not getting treatment at all? Some treatment better 

than no treatment, as frustrating as that might be? What are your 

comments to the young mother that’s got kids at home and she’s 

pregnant and she’s dependent and she just can’t go into an inpatient center? What do we do for that patient? 

Ms. HYDE. Thank you for the question. The issue of pregnant and 

parenting women is a big one in our field. We do have a small program to address that issue, but you’re right, it’s a 

residentiallybased program. 

We have increasingly been looking at ways to take what we learn 

in that program about the best ways to treat pregnant and parenting women and take it into other settings, so whether it’s our 

opioid treatment programs or the training that we do for physicians who are using medication-assisted treatment to deal with 

pregnant and parenting women. So we’re trying in every way that 

we can to make those services available to those women. 

Mr. COLLINS. So, again, with pregnant women, and we’re looking 

at other treatments, I guess, whether that’s buprenorphine or 

methadone, are there studies that show whether that has an impact on the fetus and the baby? 

Ms. HYDE. You’re right to be concerned about the child. What we 

see is that this prevents death, it prevents addiction of the baby, 

it prevents a lot of other issues that may come with allowing the 

young woman to continue with the illicit drug use or the prescription opioid misuse. So definitely providing treatment helps both the 

woman and the child. 

Mr. COLLINS. Now, as you’ve counseled these women, what kind 

of reaction are you getting? Are they recognizing—and you would 

think the genuine concern they have for the baby. I mean, there’s 

very much a complicated balancing act going on here. What kind 

of reactions are you getting from the women acknowledging the 

problem and wanting to treat it? 

Ms. HYDE. You know, most pregnant and parenting women really 

want to do the best thing for their babies, and they want to do the 

best thing for themselves, but as you’ve heard, addiction is a chronic disease and it’s very difficult; changes the brain, changes the 

ability to make decisions. 

The women who are in the programs that we provide support for 

find it a very helpful program with the kind of supports, because 

we provide a range of programs, and we’ve recently introduced 

medication-assisted treatment into those programs as well. 

Mr. COLLINS. So are these women finding you on their own, or 

are their physicians guiding them to you? 

Ms. HYDE. The women who come to our programs come from a 

variety of places; some from the correctional system, some from 

physicians, some from family, some from self-referral. So they come 

from a number of places, and we don’t make a distinction between 

where they come from in terms of providing the care. 

Mr. COLLINS. Well, it’s something this committee’s very concerned with. And, again, Mr. Chairman, thank you for holding this 

hearing and for all of your testimony. I wish there was an easy solution. There just doesn’t appear to be one. So this is going to have 

to be addressed on a lot of fronts. And with that, I yield back. 

Mr. MURPHY. Mr. Tonko, you’re recognized for 5 minutes. 

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Mr. TONKO. Thank you, Mr. Chairman. And let me join in welcoming the Conway family to the hearing, and let me compliment 

the Honorable Michael Botticelli for having the roots, origins in the 

20th Congressional District of New York. So welcome all. 

One of the biggest concerns I hear from individuals and families 

struggling with addiction is the difficulty they have accessing treatment. As you know, with the Mental Health Parity and Addiction 

Equity Act, as well as with our Affordable Care Act, millions more 

people have gained access to mental health and substance use services. However, recent reports have laid bare the fact that these new 

treatments as options sometimes exist on paper only. 

So my question first to Assistant Secretary Frank, Dr. Frank, 

what is HHS planning to do to increase the public disclosure of the 

Medicaid management practices insurers use both on the commercial side and on Medicaid and CHIP so that consumers can truly 

evaluate their health plans to make sure they are in compliance 

with parity? 

Dr. FRANK. Thank you for the question. We, too, view the Mental 

Health Parity Act as an incredibly important opportunity to increase the use of evidence-based practice and access to treatment. 

We are doing a number of things. We work with both the Department of Labor on the ERISA side of the commercial health insurance side. We’ve trained the ERISA investigators in how to detect 

deviations from parity arrangements within insurance, and so they 

are out there fully trained now working on these issues. We have 

a group within HHS who regularly provides technical assistance to 

State insurance commissioners and works with them to resolve 

complaints as they arise. And we’ve continued a series of forums 

and technical assistance around the country. And we’re working 

with stakeholders, some of whom are in this room today, to improve our ability to ask for disclosure and to offer up consumers the 

opportunity to really make that evaluation that you referred to. 

Mr. TONKO. Thank you, Assistant Secretary. 

And Director Botticelli, I would like to talk about another barrier 

to treatment for some patients. And press accounts have suggested 

that some States are denying patients access to drug courts if they 

are receiving medication-assisted treatments, or MATs. I understand this has been a problem in Kentucky, at least according to 

some press accounts. So, Director, can you explain what is going 

on here? Given the importance of MATs, why are some judges attempting to cut patients off of medicines that can actually help 

them recover? 

Mr. BOTTICELLI. Thank you, Congressman. And as many of my 

colleagues have talked about today, increasing access to medication-assisted treatment along with other behavioral therapies is the 

best course of treatment for people with an opiate use disorder. Unfortunately, one of the access issues that we find in addition to 

issues around payment has been particularly lack of access within 

the criminal justice system, and we know that many people with 

opioid use disorders are ending up in our system. 

Drug courts, some drug courts have not adapted policies that the 

National Association of Drug Court Professionals endorse in terms 

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cess to those medications, as well as not predicating their participation that they get off these medications. 

Part of what we’ve been doing on the Federal level is using our 

Federal contracting standards to ensure that people with opioid use 

disorders, whether it’s in a drug court or a treatment program or 

in other venues, are offered access to medication-assisted treatment 

and are not denied participation based on the fact that they are on 

physician-prescribed medication. 

Mr. TONKO. Dr. Volkow, on that same issue, do you agree with 

the assessment? 

Dr. VOLKOW. Yes, I agree very much. And at the same time, we 

are developing alternatives that may be more amenable for the 

criminal justice system, like prison or jail, like the naltrexone antagonist, so there is no reason why they should not get access to 

medication. 

Mr. TONKO. OK. And another barrier that patients face is the 

lack of available treatment providers who can prescribe MATs. Director Botticelli, can you comment on this dearth of providers who 

can prescribe buprenophrine, for example, what are some of the 

reasons for the shortage and what can we do to address it? 

Mr. BOTTICELLI. One of the other opportunities that we have is 

ensuring that all of our treatment programs either offer medication-assisted treatment or to refer to programs that have medication-assisted treatment. An analysis of our treatment programs 

show that a very low percentage of them have incorporated medication-assisted therapies into their programs. Some of this, Congressman, quite honestly, has been by myth and misunderstanding and 

this divide between abstinence-based care and medication-assisted 

treatment, which I think is really unfortunate that we have here, 

so we really want to make sure that if a client is entering a treatment program that has particularly Federal funding needs to offer, 

by way of its own offering or through referral, medication-assisted 

treatment. 

Mr. TONKO. All right. Thank you very much. And thank you to 

the entire panel for guiding us in this crisis situation. 

Mr. MURPHY. I just want to ask as a clarification for the question 

you were asking about the drug courts and the use of a medicationassisted treatment. So you’re recommending medication-assisted 

treatment as part of an option package, although you say obviously 

we want to get people free from drugs all together, does it require 

a recommended practice from your agencies to get drug courts to 

do that? Does it require regulatory changes from one of your agencies to do that? Or does it require a legislative solution from us to 

do that? 

Mr. BOTTICELLI. And other panelists could add—this is—we’ve 

actually been doing that as a condition of their Federal—— 

Mr. MURPHY. OK. 

Mr. BOTTICELLI (continuing). Drug court language. 

Mr. MURPHY. OK. 

Mr. BOTTICELLI. You know, again, we want this to be decided by 

an expert in addiction services in consultation with the—— 

Mr. MURPHY. OK. 

Mr. BOTTICELLI (continuing). But we just didn’t want to have categorical denial. 

111 

Mr. MURPHY. Ms. Hyde, are you adding to that question? 

Ms. HYDE. I did mention in consultation with ONDCP and also 

with the Department of Justice, we have changed the language in 

our request for applications for drug courts so that they can’t require that someone either get off of or not be on medication-assisted treatment if it is prescribed appropriately by a physician or 

a certified program. 

Ms. DEGETTE. So I just wanted to add, though, what you can do, 

you can make the Federal funding contingent on full programs, but 

we can’t force the States or whatever regulatory agency is setting 

up the drug courts to offer this. They just can’t get Federal money 

if they don’t offer it. 

Mr. BOTTICELLI. And this is where I’m glad the committee is actually going to be talking at State level, because as a former State 

administrator, States do play a crucial role. There are many, many 

programs out there that actually don’t receive Federal funding, or 

drug courts that don’t receive Federal founding. We hope that our 

policies and procedures are adopted by those nonfederally funded 

programs, but States play a key role in licensing treatment programs. 

Mr. MURPHY. Thank you. 

Mr. BOTTICELLI. And they, I think, can look at the opportunities 

of increasing or ensuring that State licensing treatment programs 

also the have same kind of language. 

Mr. MURPHY. Thank you. Speaking of States, go to the gentleman from West Virginia, Mr. McKinley, for 5 minutes. 

Mr. MCKINLEY. Thank you very much, Mr. Chairman, and thank 

you again for these hearings that we’ve been having on this topic. 

As an engineer, I need to see things in perspective, and so I 

guess we’ve been following this over the last 4 years in Congress, 

and especially on this committee, been trying to look at this issue, 

and I think at one of the last meetings we just had, I tried to put 

it in perspective by saying from—Botticelli, you said there were 

44,000 overdose deaths. I want people to understand, that’s more 

than died in Vietnam in combat. I don’t know that the American 

public understands that. And every day on the news, NBC or whatever, they had body counts and they had that, and people were outraged over that. 

I’m not getting the sense of outrage over every year we lose as 

many people to drug overdose as we did in a 10-year war in Vietnam. I’m concerned when I had affirmed that in West Virginia, one 

in five babies born in West Virginia, and I’m sure it may be one 

in four in other States or so, but one in five babies, they’ve been 

affected with drugs. I keep thinking this in perspective by saying 

in Europe, the overdose rate is approximately 21 per million; in 

America, it’s seven to 10 times that amount. 

Now, I get a little on the verge of outrage. You know, I’m the father of four and grandfather of six, and I see these are what we’re 

giving our kids, this is what the future is. And I hear this testimony from this panel of seven and the seven before that and the 

seven before that, and quite frankly, I get confused, because I don’t 

known what the priority is. 

From the business community and you all here in Washington, 

everyone loves to plan, but they don’t carry out. Now, that may be 

112 

insulting, and I don’t mean it in an insulting fashion, but we still 

have 44,000 people who will die between now and next year because we don’t have a prior—I’d like to think that we could come 

up with one plan, one way, if you had at least one, prioritize it, 

what’s the one thing, and then let’s put everything we have into 

it, that Manhattan-type project, go after that one solution and see 

if that doesn’t start the ball rolling in the right way, and then we 

can do two, three and four with it, but a focus; but I don’t see a 

focus. I didn’t see a focus from you. I heard seven, eight different 

ways that we might be able to approach this problem, because the 

planning—everyone loves to plan, but the implementation falls 

short. 

So, since you’re meeting on a regular basis, couldn’t you come up 

with one—one idea to where we ought to begin to where we can 

really—the metrics, we get the optics and everything, we can really 

dig into that, and then we can have plan B, C and D, but let’s 

achieve one instead of continuing to melt down as we do at this. 

I don’t want to see another statistic of 44,000 more people die of 

overdose. 

So I hesitate to ask, can you come up with an idea today in the 

time frame, is there one, just one idea that we should focus on? 

What’s the best way? Is that in the drug use, is that in real-time 

on purchasing the prescription drugs that it’s a national database, 

is that the number one thing we should do? I mean, my God, the 

Federal Government just changed the sentencing guidelines for 

heroin and they said if you’re caught with 50 hits of heroin, you 

get probation. What are we doing? Are we fighting heroin or not? 

I’m really frustrated with this, so I really—give me some more 

guidance on plan one. 

Mr. BOTTICELLI. So, Congressman, I appreciate your attention to 

this. And, you know, myself and many of our colleagues have been 

doing this work for a long time and, I think, are filled with a sense 

of tragedy in terms of where we are, and know that we can do better and know that we can work with Congress. 

You asked for one. I think there are three areas, and some of 

these are articulated in the Secretary’s plan, that we’ve got to do. 

We’ve got to change prescribing patterns in this. We are prescribing way too much medication, and that’s starting the trajectory. We need to increase our capacity to treat the disease so that 

people who go down that path have adequate access. And the third 

is that we really need to focus on reducing overdose deaths. 

Those are three areas that I think we can work with Congress 

on to really look at how do we increase our efforts. 

Dr. FRANK. Let me add on to that on behalf—it seems that people from West Virginia all sort of think alike that way. And our 

Secretary, who shares the same experience you do has pushed us 

to focus and to take action in those three areas. And, you know, 

with it—this year we more than quadrupled our funding in those 

areas, and we’re going to triple that again if our plan goes through, 

and these are in those three focused areas, because that’s where 

the evidence says we should be doubling down, and that’s sort of 

what is guiding us. 

Mr. MURPHY. Thank you. Is the Secretary asking for legislation 

on this, then, to facilitate the answer to that question? 

113 

Dr. FRANK. There are some legislative proposals, and some of it 

is just increasing some of the use of our discretionary funds, and 

we got some additional appropriations this year, and then in the 

President’s budget, we have sort of some legislative proposals 

for—— 

Mr. MURPHY. Could you please let this committee know if there’s 

enabling language we have, and that would help address Mr. 

McKinley’s question? 

Dr. FRANK. Yep. 

Mr. MURPHY. Thank you. 

Ms. Clarke of New York, you’re recognized for 5 minutes. 

Ms. CLARKE. I thank you very much, Mr. Chairman, and our 

ranking member, and thank you to all of our witnesses for giving 

the committee the benefit of your expertise and experience today. 

I’d like to focus my questions on the prevention side of the equation, how do we prevent opioid addiction in the first place. So, Dr. 

Volkow, picking up actually on a point that Mr. Botticelli made just 

a moment ago about way too many prescriptions, this is to you: 

Why are so many prescriptions being written for opioids? Are physicians not getting the appropriate level of training and education 

in pain management for responsible opiate prescribing practices? 

What would you say? 

Dr. VOLKOW. There are both. Actually, what had happened is we 

have to recognize that there’s another epidemic, of chronic pain in 

our country, estimated at 100 million people, according to the Institute of Medicine. As a result of the pressure of needing to address 

this problem, the joint accreditation require that hospitals and physicians in hospitals ask questions about pain and treat them. This 

was in 2000. And the problem was that that was not associated 

with the education required in order to be able to properly screen 

pain, but also to manage it, and to manage it and use opioid medications adequately. So there was a big gap between the need to implement better treatment for pain, but an inadequate education of 

that system, so that is a major problem. 

I think that in terms of prevention, we have to recognize two aspects of this epidemic that are different from the others. One of 

them, we do have individuals that start diverting and they get the 

medications because they want to get high, but then there’s the 

other element that is as important, of individuals that are properly 

prescribed the medication because they have pain. And in the past, 

it was believed that if you got an opioid and you had pain, you 

would never become addicted. Now the data shows us that that’s 

not correct. We don’t exactly know what percentage of individuals 

that will be treated for their pain will become addicted. The range 

goes enormously from none to something like 40/60, so we have no 

real idea. And that’s why I highlighted the notion of, we need to 

be very aggressive in the education of healthcare providers on the 

screening and management of pain, but also be very aggressive on 

the education of healthcare providers for the recognition of substance abuse disorder so that they can determine who’s vulnerable, 

and when a person that’s properly being treated is transitioning, 

and how to intervene. 

Ms. CLARKE. Very well. Thank you very much. 

114 

Director Botticelli, does ONDCP believe that the Federal Government should mandate continuing medical education on responsible 

opioid prescribing practices as a precondition of DEA registration 

to prescribe controlled substances? And can you elaborate on how 

that would work if that’s the case? 

Mr. BOTTICELLI. Sure. We do support mandatory prescriber education. I think for all of the evidence that you’ve heard today, it’s 

very clear that if we really want to prevent both prescription drug 

misuse and heroin use and overdoses, we need to stop prescribing 

these medications so liberally. 

There was a recent GAO report that showed that physicians get 

little to no pain prescribing, and actually veterinarians get more 

pain prescribing than physicians in the United States. So we don’t 

think that it’s overly burdensome to require physicians in this epidemic to have education. 

I think, as you talked about it, we’d have to work with the legislature to look at changes to the Controlled Substances Act to ensure that a certified continuing medical education program would 

be linked to the DEA licensure or relicensure process, and that we 

would oversee those courses that we believe have the core competencies that we think are important and monitor who takes 

those. 

Ms. CLARKE. Very well. Thank you very much. 

Dr. Throckmorton, manufacturers of opioid pain relievers are 

currently required to offer free voluntary education to physicians or 

responsible opioid prescribing practices. However, as I understand 

it, physician participation rates for these voluntary educational 

courses are fairly low. Is that correct? 

Dr. THROCKMORTON. We do have those programs in place. They 

were put into place about 18 months ago, and so the initial year 

was spent putting into place a process to allow the education to be 

available, prescribers to make use of it. During that time, we saw 

about 20,000 prescribers that are using extended-release, long-acting opioids sign up for one course. That’s true, 20,000 out of 

320,000 prescribers that prescribe these medicines is not a large 

fraction. It is progress. What we hope is in the second year, which 

will end in July of this year, we’ll see a larger increase in terms 

of uptake and use of this education. We have been working with 

the continuing education community to make better use of it, make 

it more available. We’re optimistic. We hope that we’ll see more 

use. 

It’s one of two pillars of education, from our perspective. Combined with the mandatory education that Mr. Botticelli just spoke 

about, we believe both of these things provide important opportunities to educate prescribers. 

Ms. CLARKE. Very well. I yield back. Thank you very much. 

Mr. MURPHY. Thank you. 

Mrs. Brooks of Indiana, 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman, for continuing the focus 

on this critical subject for our country. 

I want to start with you, Dr. Volkow. We talked about how the 

opioid addiction facing the country is, in large part, due to chronic 

pain. And you mentioned that 100 million people suffer from chronVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00118 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
115 

ic pain. I’ve heard up to one in three Americans actually possibly 

suffer from chronic pain. 

And one of the goals of this hearing is to try to focus on evidencebased treatment and new treatments in trying to find out what it 

is that is working. And, obviously, one treatment doesn’t work for 

everyone, as we’ve heard. 

But I learned about, in the course of examining this, that there 

are some technologies that are new, not completely new, but one 

being—I was told about spinal cord stimulation, which targets 

nerves with electrical impulses rather than drugs, and that clinical 

studies have shown it to be safe: 4,000 patients have received this 

stimulator. And so it obviously is a device, a technology that can 

actually stop that stimulation and can help hopefully end that addiction, but yet NIH hasn’t included that in its draft pain strategy. 

It didn’t mention technologies like SCS. 

Can you talk at all about why it wouldn’t be promoting this FDAapproved type of technology? And are there other technologies we 

ought to be talking about other than medication for chronic pain? 

Dr. VOLKOW. Yes. Thanks for the question. 

And this is an area that is rapidly evolving. And if it’s not mentioned, it’s because many of the findings are way too recent. And 

the one that you’re commenting on in terms of stimulation is one 

of the strategies in which we’re also promoting research. And the 

same strategy can be utilized to be able to actually inhibit the emotional centers of the brain that react to pain. 

So researchers are utilizing a wide variety of tools and technologies that have evolved as part of our initiative to understand 

the brain. That, again, highlights—but it brings up something that, 

I think, is facing us in this epidemic: the need that we have to develop better strategies for the management of chronic pain, because 

the physicians are forced—patients in great suffering, they don’t 

know what to do, and they give an opioid even though the evidence 

does not really show us they are very effective for the management 

of chronic pain. But there are not many out there. 

So recognizing that this is an area where we are required to invest resources for having alternatives for patients suffering from 

chronic pain is an extremely important part of an initiative of addressing the opioid epidemic. 

Mrs. BROOKS. How would you recommend we increase, then, patient access and educate more physicians about this type of technology? 

Dr. VOLKOW. Well, this is a new technology, some of them. Actually, the evidence is just emerging. It will have to be submitted to 

the FDA for approval. And then physicians, as part of their training, should be exposed to them. And I would say—I am just highlighting in the notion because Michael Botticelli very clearly delineated, I also think it’s important that medical students, as part of 

their basic training, have an understanding of these technologies 

because pain is part of every medical condition, almost of every 

medical condition. 

Mrs. BROOKS. Thank you very much. 

I’d like to ask you, Mr. Botticelli, my State, State of Indiana, recently passed a law allowing physicians to prescribe the naloxone 

116 

to parents and to others and friends, giving them greater access to 

the reversal heroin drug. 

Would you speak as to what’s known about the impact of the 

naloxone programs and whether you have concerns about whether 

the naloxone might encourage actually more risk-taking? Because 

I met with law enforcement who said they had given naloxone, had 

saved their lives and, a couple weeks later, saved their life again 

with the naloxone. And so I am somewhat concerned—and I absolutely want to save lives, and we must. And we know there aren’t 

enough treatments. This is obviously a huge problem. 

But might that encourage an addict, if they knew their mom, 

dad, or friend had the save right there? Can you talk to us about 

these naloxone programs? 

Mr. BOTTICELLI. Sure. So, to your first question, obviously, 

naloxone distribution by as many people who have the potential to 

witness an overdose is particularly important. And law enforcement, particularly in rural counties, also play a key role in that effort. 

I will tell you, by way of—when I was in Massachusetts, we significantly increased access to naloxone and actually did a peer-reviewed study that showed when you introduced naloxone into a 

community, overdose rates go down. And the more naloxone you introduce, the better the scale effect. 

You know, one of the pieces that we are concerned about—but 

there is absolutely no evidence to show that naloxone distribution 

actually increases drug use. Some of the issues that you mentioned 

become critically important, that overdoses are often seen as a significant motivator for people to seek care. But having treatment on 

demand is a particular issue. Treatment on demand, particularly 

in some of our rural communities, is particularly an issue. 

Interventions that are emergency departments to get people into 

care become critically important. So while we know that addiction 

is a chronic disease, and some people do continue to use, when you 

have these adverse events, but we also need to know we have to 

have a comprehensive response, not just saving someone’s life. 

Mrs. BROOKS. Thank you. I completely agree, and I certainly 

hope the results in Indiana prove out to be the same as in your 

State. 

And I yield back. Thank you. 

Mr. MURPHY. Gentlelady yields back. 

Mr. Mullin from Oklahoma, you’re recognized for 5 minutes. 

Mr. MULLIN. Thank you, Mr. Chairman. 

Before I get to some questions, I have got a followup question for 

Ms. Hyde. The last time that you were in front of this committee, 

which I really appreciate you coming back, we had discussed your 

Web sites and if they were an effective use of taxpayer dollars. At 

that time, you stated that you were all in the process of evaluating 

that. Have you finished that process yet? 

Ms. HYDE. That process continues. Thank you for asking the followup question. The process continues. I think the Web site that 

you indicated most concerns about was one of the Web sites that 

we were in the process of reviewing. It was originally developed 

based on data and knowledge from NIDA. 

Mr. MULLIN. Right. And which—— 

117 

Ms. HYDE. And we have—— 

Mr. MULLIN. Well, that was for the 3- to 6-year-old for suicide 

prevention. Have you finished that one yet? 

Ms. HYDE. Yes. Building blocks—— 

Mr. MULLIN. Right. 

Ms. HYDE (continuing). I think is the one you were concerned 

about. We have worked with our colleagues at NIDA and determined that the Web site hadn’t been updated in a while, so it needed to be updated. So we have taken it down and are in the process 

of updating it. 

Mr. MULLIN. Could you give me some process reports on that, 

just so I can kind of know where you guys are at? We just want 

to make sure that taxpayer dollars are being used in an effective 

way. 

Ms. HYDE. Certainly. 

Mr. MULLIN. To get to the questions, Dr. Throckmorton, just a 

simple yes or no. Does the FDA recommend that methadone be 

used as a first line of therapy for chronic pain? 

Dr. THROCKMORTON. Methadone is approved for use for pain, yes. 

Mr. MULLIN. But I am specifically speaking to the first line, for 

a first line of defense, basically. 

Dr. THROCKMORTON. It’s one of the medications that we have approved for pain. I will say, however, that if you look at methadone, 

if you look at the labeling that we have for methadone, it calls it 

out as far as a product that has particular characteristics that 

make it challenging to use for pain. 

Mr. MULLIN. So that would be a no for the first line. 

What is your recommendation for first line? 

Dr. THROCKMORTON. Our recommendation is prescribers think 

very carefully before using methadone. There are things that make 

it a challenging product to use. It is approved for use in that setting, but I hope doctors think very carefully before they do it. 

Mr. MULLIN. Well, the FDA put out a warning about the drug 

safety and basically said that you guys—that insurers should not— 

should not be referred as a preferred therapy, unless special instructions and education was put onto it. So I would take that as 

the FDA would, by this statement, that it’d be a no, that you 

wouldn’t recommend it unless there’s a lot of consideration taken. 

Dr. THROCKMORTON. Personally, what I just said is where I 

would be. 

Mr. MULLIN. OK. 

Dr. THROCKMORTON. I need to look at the statement and get back 

with you about the specifics of it. 

Mr. MULLIN. OK. 

Dr. THROCKMORTON. But it is a drug that has a very long half 

life that is variable patient to patient. It has unique cardiac 

toxicities. There are other drugs that are useful for pain that don’t 

have those characteristics and I—— 

Mr. MULLIN. Sure. All I’m really looking for is a yes or no because I’m really trying to get further on down the line for questions. I do appreciate you being here. And I like the last name; 

that’s my sister’s last name. And I got some beautiful—— 

Dr. THROCKMORTON. A very good last name. 

118 

Mr. MULLIN. I know. I’ve got three beautiful nieces. But the 

spelling usually gets messed up. 

Dr. Houry, what about the CDC? Do you guys consider this 

methadone as being a first line of defense for pain? 

Dr. HOURY. At CDC, we just focus really on the primary prevention and not as much of the care, so I would defer to the sister 

agencies on that. 

Mr. MULLIN. Which would be? 

Dr. HOURY. The panelists here. FDA. 

Mr. MULLIN. Well, Dr. Throckmorton kind of gave his personal 

opinion. But the statement of FDA you heard about. So would you 

follow the statement, I’m assuming? 

Dr. HOURY. I would follow his statement. I don’t have a personal 

opinion on methadone for pain. It’s not something I did in my prior 

practice. 

Mr. MULLIN. OK. Dr. Conway—by the way, I’m always jealous 

when people have their family with them. I have got five wonderful 

kids. And if you ever want to see me cry, that’s about the only 

thing that will make me cry. I miss them. 

Mr. MURPHY. How are your kids doing? 

Mr. MULLIN. Thanks. I appreciate that. I will take a deep breath 

and wipe the tear away. 

Are you aware that methadone accounts for 30 percent of overdose deaths while only accounting for about 2 percent of the prescriptions that are prescribed for chronic pain? 

Dr. CONWAY. I am aware that it’s a higher percentage of deaths 

compared to prescriptions because of the long half-life and risks described. 

Mr. MULLIN. Would you personally recommend it as a first line 

of defense for pain? 

Dr. CONWAY. So I’m a practicing physician. I do not, as a practicing physician, typically use methadone as a first defense. However, I think it depends on the individual patient characteristics 

and would defer to the physician’s judgment with that individual 

patient. 

Mr. MULLIN. Well, according to the Pew research, they put out 

a deal that said methadone is available in low-cost generic form 

and is considered a preferred drug in many States by the Medicaid 

programs, despite FDA warnings about the drug safety and the 

statements by the American Academy of Pain Medicine that insurers should not be preferred this therapy unless it’s especially educated and provided to the individual. 

I just kind of wonder if—overall, I would think, we’re considering 

it not being there. Why is this still listed as a first line with Medicaid, I mean, when we’re seeing so many deaths? It almost makes 

you think, is the cost of a life not more valuable than the cost of 

a low drug? 

Dr. CONWAY. So I’d make a few points. Statutorily, the Medicaid 

programs have the ability to set their preferred drug list. However, 

we have taken a couple of actions that I think to try to address this 

issue. One, working with SAMHSA, NIH, and others on this panel, 

we have put out an informational bulletin to the Medicaid programs talking about this issue and a complete array of pain, both 

on the medication side, the risks of methadone, and the other opVerDate Mar 15 2010 15:58 Oct 19, 2015 Jkt 037690 PO 00000 Frm 00122 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X38OPIOIDEPIDEMIC\135X38OPIOIDEPIDEMICWORKING WA
119 

tions and, also, importantly as others have said, the importance of 

both behavioral treatment and medication treatment. 

I’d also call out, in our Medicaid Innovation Accelerator Program, 

the first area we’re working on is substance abuse disorders. We 

have over 30 States involved, and they’re taking a comprehensive 

approach to the Medicaid program to appropriate substance abuse 

treatment, including appropriate use of medications and also other 

therapies. 

Mr. MULLIN. Dr. Conway, appreciate it. 

Mr. Chairman, I yield back. 

Mr. MURPHY. Mr. McKinley has a followup question. Then I have 

a followup question, too. 

Mr. MCKINLEY. Thank you for the opportunity just to follow up 

because one of the questions or statistics I was giving you in talking about prospector is the model or the situation that they’re facing in Europe. What do we have there in Europe? The average is 

21 per million. And I was just looking at—that’s the average. 

Italy is below that. Latvia, Netherlands, Belgium, Greece, 

France, Poland, Portugal, Bulgaria, the Czech Republic, Slovakia, 

Hungary, Turkey, Romania, all have less than that, significantly 

less. What are they doing right? What are they doing differently in 

Europe than we are in America? Are we learning anything from 

them? 

Dr. VOLKOW. There is something that we’re doing very differently. And, actually, you picked up exactly on the point. If you 

look at the United States, for some of the medications we may be 

consuming 95 percent of the total production in the world. 

So the question is, Are we a Nation that is so much in pain that 

we require these massive amounts of opiate medications? Or is 

there something that we are doing in terms of their access to them 

that is inadequate? 

And I want, again, to reiterate the notion that, yes, we are overprescribing opiate medications, on the one hand. But, at the same 

time, which is not exclusionary, sometimes we are undertreating 

patients with pain. So we are in a situation that we have it bad 

in both ways. Overprescribing, making these drugs available, 

which then can be easily diverted, and prescribing them to those 

that don’t need them can also result in adverse consequences. You 

don’t see that level of prescriptions in any of the European countries. 

Mr. MCKINLEY. So what’s the—why not? What are they doing? 

Are their doctors more sensitive to this issue than our doctors in 

America? Are they concerned about the trial lawyers? What’s the 

difference between it? 

If there are 10 to 15 times more people dying in America than 

there are in Europe, something is wrong. They’re doing something 

differently, and I’d like to know what it is. 

Dr. VOLKOW. And that’s exactly the way that I say we have to 

aggressively institute the education of the healthcare providers on 

the proper screening and management of pain—that’s a crucial 

component—while also educating them about the adverse effects as 

it relates to substance abuse disorders. 

120 

And we need to face the fact that we need to also provide alternative treatments for the management of chronic pain that are effective. 

Mr. MCKINLEY. OK. 

Yield back. 

Thank you very much for that. 

Mr. MURPHY. Ms. Brooks, you have a quick question? 

Mrs. BROOKS. Thank you. Actually, I realize Mr. Botticelli mentioned it in his opening, and I wanted to have an unrelated followup if I might, Mr. Chairman. 

Mr. MURPHY. Yes, you may. 

Mrs. BROOKS. You mentioned—and we are having a crisis in Indiana in Scott County, a community of 4,300 people, an outbreak 

of HIV due to needle exchange. And I would simply like—and I 

hope that many of you have been following what has been happening and the number of citizens in Indiana who now have contracted HIV because of their, in all likelihood, heroin addiction, 

right. 

Mr. BOTTICELLI. Prescription drug. 

Mrs. BROOKS. Or prescription drug addiction and possibly heroin 

addiction as well. 

I am very curious, since I have this incredible panel of experts 

here, what you might say to our State and to the health professionals, our public health professionals who are dealing with this 

crisis, to our State and local government officials, what advice and 

thoughts do you have for our State? And I truly, if we could, this 

is a crisis in our State that I think could be in any State in the 

country. 

Mr. Botticelli. 

Mr. BOTTICELLI. Sure. 

Mrs. BROOKS. And then anyone else who might comment, please. 

Mr. BOTTICELLI. So, first of all, just about the staff from all of 

the agencies on this table coordinate on a daily basis in tight coordination with the Indiana Health Department to make sure that 

we are giving Scott County the resources they need to do that. 

Mrs. BROOKS. Thank you. And I’m sure Dr. Adams appreciates 

that. 

Mr. BOTTICELLI. You’re absolutely right that while we’re seeing 

huge—I think we’re over 145 cases of HIV now—one of the consequences we’ve seen nationally is increases in viral hepatitis as it 

relates to sharing needles. And I think it also points to some issues 

that we need to include about access to treatment services. 

So I think what’s happening in Indiana in Scott County is emblematic of the potential that we could see in other parts of the 

country but points to some of the issues that we’ve been talking 

about today in terms of making sure that people have access to 

good care, both infectious disease care and substance abuse care; 

they have adequate access to clean syringes so that they are not 

increasing infection in this most poignant case of what we need; 

and that they’re having timely access to treatment services, I 

think, are all areas to do that. 

We’ll continue to engage with folks in Scott County to make sure 

that whatever we can do on the Federal side can help alleviate the 

situation. 

121 

Dr. HOURY. And I’d just like to add to that I’m really proud of 

all of the efforts CDC is doing on the ground in Indiana and in conjunction with agencies here, I agree completely with Director Botticelli about the access to medication-assisted treatment as well as 

the HIV therapy. 

The other thing I would add is Indiana is number nine in the 

Nation for prescribing, and so there’s a lot that can be done when 

you’re looking at, again, trying to stop the epidemic before it even 

happens. So looking at, again, using the Prescription Drug Monitoring Programs, having better prescribing guidelines, so that people don’t get addicted to opioids, then inject them. So that’s the 

third component, I think, we really need to add. 

Mrs. BROOKS. Dr. Volkow—— 

Dr. VOLKOW. Yes. 

Mrs. BROOKS. Or, I’m sorry, and Administrator Hyde. Maybe Dr. 

Volkow and then Administrator Hyde. 

Dr. VOLKOW. I mean, we got caught by surprise with the Indiana 

epidemic of HIV, and I heard Tom Frieden say this is the fastest 

growing incidence of HIV cases that we’ve had since HIV entered 

the United States. 

But there’s been an extraordinary advance on HIV that has 

emerged really over the past 2 or 3 years, which is that if you initiate someone on antiretroviral therapy, not only are you going to 

be improving their outcome, but you are actually going to dramatically decrease their infectivity. 

So, in looking forward—one of the things I would have suggested 

to do is once you start to see a case, you immediately treat them 

with antiretroviral therapy. They’ll do better, and their infectivity 

will dramatically decrease. So this is another aspect, which actually relates to the issue of giving good infectious disease care to 

these individuals jointly with the interventions for substance abuse 

treatment. 

Mrs. BROOKS. Thank you. 

Ms. HYDE. So I just wanted to add that we are working collectively on this issue and that we understand there may be some 

legal barriers that we’ve been talking to Indiana about in terms of 

developing opioid treatment programs, and there’s not a lot of 

waivered physicians able to provide buprenorphine. I think the 

closest opioid treatment program is about 40 miles away. There 

may be some transportation barriers and some cost barriers and 

other things. So we’re collectively working with the State to try to 

help develop alternatives. 

Mrs. BROOKS. Thank you, Mr. Chairman, for allowing me to give 

that voice. 

Mr. MURPHY. Thank you. 

I have two quick followup questions. First, Ms. Hyde, last week, 

the subcommittee heard testimony from Dr. Anna Lembke, the program director of the Stanford University Addiction Medicine Program that the 42 CFR part 2 is an artifact of the past. She told 

us the law’s consent requirements are so stringent that two doctors 

seeking to treat the same patient for opioid addiction can’t communicate with each other about the patient’s medical condition. In 

fact, she cited that the subcommittee—and we received subcommittee reports. The rule was based upon a 1972 law, and it’s 

122 

causing havoc in the age of electronic records. I guess sometimes 

the police would actually raid a methadone clinic and arrest people 

there. 

So she has strongly recommend that we change that so we are 

not overprescribing people and a physician can know who is in 

treatment. 

Now my understanding is that SAMHSA is contemplating new 

42 CFR part 2 rules. And I just want to know if you’re committed 

that these rules will reflect the concerns that have been repeatedly 

voiced by so many in the medical community who treat patients 

with substance abuse who want nothing more than to make sure 

patients aren’t given double doses, so they can really communicate. 

Is that what SAMHSA is going to be working on? 

Ms. HYDE. I really appreciate that question. It is a complex issue. 

And you’re right; these laws and regs are decades old, before we 

had electronic health records, before we had collaborative care 

models and other things that we are now considering part of the 

practice. 

We, a couple of years ago, put together some subregulatory guidance to try to help this issue, but that wasn’t sufficient. So, last 

year, we held a listening session for stakeholders and have taken 

those pieces of input and are trying to balance the privacy concerns 

with the need for access to data. We hope that we will have something available for public input yet this year to try to address some 

of these issues. 

Mr. MURPHY. And please let the committee know. Thank you. 

And, Mr. Botticelli, I wanted to follow up on this Kentucky drug 

court issue. Could the drug courts’ decisions relate to the issue of 

diversion? I mean, at a previous hearing, we heard testimony from 

witnesses that Suboxone mills are popping up in Kentucky and 

West Virginia and these are high problematic States. And, when 

entering the drug court system, it’s nearly impossible to determine 

if the Suboxone is from an illicit source or prescribed by a doctor. 

Could this be part of the issue and that the drug courts could 

really work and perhaps have some flexibility to deal with this on 

a case-by-case basis? 

Mr. BOTTICELLI. So I think there are a number of issues. The National Association of Drug Court Professionals actually did a survey 

of drug courts in the United States. And for those drug courts that 

were not referring, it was actually more about judicial bias than it 

was about fear of diversion that kept people from doing that. 

I think the second piece that any treatment, whether it’s medication-assisted treatment or residential treatment, requires a level of 

collaboration and relationship between the court and the provider 

to ensure that courts who are referring to treatment are referring 

to high-quality treatment. 

You know, we do need to pay attention to diversion. And drug 

courts, I think in combination with treatment programs, can ensure that these are appropriately prescribed and appropriately 

monitored medications. And they need to make sure that they’re 

partnering with physicians who are implementing and dispensing 

medications in a high-quality way. 

Mr. MURPHY. Now, part of this—I just got an article that was— 

I’m not sure what newspaper it is. But it was talking about in 

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some of these courts, they’re using Vivitrol and for people in and 

out of incarceration trying to keep them off by maintaining 

Vivitrol. 

So I just want to make sure I understand. They want to keep 

these people, after they’re released from prison, drug-free. And so 

could you please clarify: Are you saying that unless they have some 

synthetic opiates, they’re going to have Federal funding cut, or they 

can still maintain Federal funding and then Vivitrol would be acceptable as another part of the program? 

Mr. BOTTICELLI. So we don’t dictate to drug courts what medications. That actually should be a decision between the treatment 

provider and the patient. 

I think our work here was just to make sure that there weren’t 

categorical prohibitions for drug courts either to not offer medication-assisted therapies and, if someone was on a recommended 

course of treatment, that they not have to get off the medications 

to do that. 

We actually don’t dictate what medications courts use to be able 

to do that. I think, like any treatment, you want to have an arsenal 

of medications. 

Mr. MURPHY. Dr. Frank, could you also respond to the Vivitrol 

question, too? Did you hear that? I’m just wondering as that as an 

option for States as a diversion to be using Vivitrol, that that could 

be part of what we could be—— 

Dr. FRANK. Well, I think that we are trying to have the full armamentarium available to the treating providers who are trying 

not to get between the provider and the patient as long as there 

is the opportunity to offer the richest menu of evidence-based treatments that are available. 

Mr. MURPHY. Mr. DeGette, do you have a followup? 

Ms. DEGETTE. Mr. Chairman, Mr. McKinley asked the witnesses 

what one thing would you recommend that we could do to try to 

start reversing this epidemic and this problem. He got as far as Dr. 

Frank when he ran out of time. So I just ask unanimous consent, 

if we can ask each one of the other witnesses—— 

Mr. MURPHY. Yes, please. 

Ms. DEGETTE (continuing). To supplement their testimony. They 

don’t have to say it right now. 

Mr. MURPHY. Get back to us. Thank you. 

Ms. DEGETTE. But if you can get back to us with that recommendation. We recognize there is a problem, and we are really 

struggling with the issue of what we do as a Congress to remedy 

it. Thank you. 

Mr. MURPHY. And I think what you’re also talking about, a partnership with the States—says we should be looking at Kentucky 

and some others—Indiana—— 

Mrs. BROOKS. Indiana. 

Mr. MURPHY (continuing). Colorado, of course, and see what else 

is going on. 

I want to thank this panel. We will follow up with the questions 

because we heard a number of recommendations from you, so we 

will ask for more clarifications of this. 

Look, I want to thank you. As I said last time, too, you know, 

if this was about a single airplane crash, this room would be filled 

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with media. But we have had more people die in the last year from 

drug overdose deaths than the combination of every airplane crash 

in North America from 1975 to the present. And we have to make 

sure we keep this on the front page. This is a serious crisis and 

one, whether it’s education of physicians, mandatory education, 

whether it’s options out there, we want to make sure the evidencebased care and that Federal funding is going in the right direction. 

So I’d like to thank all the witnesses and members that participated in today’s hearing. 

I remind members they have 10 business days to submit questions for the record, and I ask that all the witnesses agree to respond promptly to the questions. 

With that, this committee is adjourned. Thank you. 

[Whereupon, at 12:20 p.m., the subcommittee was adjourned.] 

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