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90–923 2015

EXAMINING THE GROWING PROBLEMS OF 

PRESCRIPTION DRUG AND HEROIN ABUSE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

APRIL 29, 2014 

Serial No. 113–140 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

GREGG HARPER, Mississippi 

PETE OLSON, Texas 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

BRUCE L. BRALEY, Iowa 

BEN RAY LUJAN, New Mexico 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

PETER WELCH, Vermont 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

GENE GREEN, Texas 

HENRY A. WAXMAN, California (ex officio) 

(III) 

C O N T E N T S 

Page 

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

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

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

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

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

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 6 

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

California, opening statement ............................................................................. 7 

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

of Pennsylvania, prepared statement ................................................................. 101 

WITNESSES

Michael Botticelli, Acting Director, Office of National Drug Control Policy, 

Executive Office of the President ........................................................................ 9 

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

Answers to submitted questions ...................................................................... 106 

Daniel M. Sosin, Acting Director, National Center for Injury Prevention and 

Control, Centers for Disease Control and Prevention ....................................... 26 

Prepared statement .......................................................................................... 28 

Answers to submitted questions ...................................................................... 126 

Nora D. Volkow, Director, National Institute on Drug Abuse, National Institutes of Health ...................................................................................................... 35 

Prepared statement .......................................................................................... 37 

Answers to submitted questions ...................................................................... 137 

H. Westley Clark, Director, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration .............................. 53 

Prepared statement .......................................................................................... 55 

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

Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion 

Control, Drug Enforcement Agency, U.S. Department of Justice .................... 65 

Prepared statement .......................................................................................... 67 

Answers to submitted questions ...................................................................... 161 

SUBMITTED MATERIAL

Op-ed entitled, ‘‘Senate must pass bills to fight tragedy of drug addiction,’’ 

The Courier-Journal, April 1, 2014, submitted by Mr. Yarmuth ..................... 103 

(1) 

EXAMINING THE GROWING PROBLEMS OF 

PRESCRIPTION DRUG AND HEROIN ABUSE 

TUESDAY, APRIL 29, 2014 

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

The subcommittee met, pursuant to call, at 10:00 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Michael Burgess 

(vice chairman of the subcommittee) presiding. 

Members present: Representatives Burgess, Blackburn, Gingrey, 

Scalise, Harper, Gardner, Griffith, Johnson, Long, Ellmers, 

DeGette, Braley, Lujan, Schakowsky, Castor, Welch, Yarmuth, 

Green and Waxman (ex officio). 

Staff present: Carl Anderson, Counsel, Oversight; Karen Christian, Chief Counsel, Oversight; Brittany Havens, Legislative Clerk; 

Sean Hayes, Deputy Chief Counsel, Oversight and Investigations; 

Tom Wilbur, Digital Media Advisor; Phil Barnett, Democratic Staff 

Director; Brian Cohen, Democratic Staff Director, Oversight and 

Investigations, Senior Policy Advisor; Kiren Gopal, Democratic 

Counsel; Hannah Green, Democratic Staff Assistant; Anne Morris 

Reid, Democratic Senior Professional Staff Member; and Stephen 

Salsbury, Democratic Investigator. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Good morning. I now convene the hearing of the 

Subcommittee on Oversight and Investigations, entitled Examining 

the Growing Problems of Prescription Drug and Heroin Abuse. 

Just a brief housekeeping detail for those of you who were expecting to see Dr. Murphy here in the chair, he was called away 

back to his district for a family issue, so you are stuck with me, 

as the saying goes, but we will get through this together. 

On the issue of prescription drug and heroin abuse, these are 

separate and distinct problems, but unfortunately, they do share a 

common endpoint; addiction, abuse, overdose, and death. As we 

know, the abuse of prescription drugs, and illegal drugs such as 

heroin, have plagued our nation for decades, however, over the last 

several months, there have been increasing reports that prescription drug and heroin abuse in communities around the country continues to grow. Sadly, those reports indicate that overdose deaths 

as a result of prescription drug and heroin abuse are also on the 

rise. Families have lost sons and daughters, mothers and fathers 

to this addiction. 

2 

Data from the federal agencies charged with addressing drug 

abuse paint a startling picture of the severity of the public health 

crisis. Prescription drug abuse kills more than 16,000 people a 

year. From 2007 to 2012, heroin use rose by almost 80 percent in 

this country, and 3,000 people die each year from heroin overdoses. 

The United States Attorney General, Eric Holder, declared recently 

that heroin abuse constitutes ‘‘an urgent and growing public health 

crisis.’’ 

Certainly, there is a law enforcement aspect to solving this problem, and stopping the bad actors who illegally distribute prescription drugs or traffic heroin, but the other part of the equation is 

treating the addiction, the addiction to prescription drugs and heroin, and preventing deaths. The answer to a burgeoning heroin epidemic, as the Administration has called it, is not to wage war on 

all opiates. To address a complex issue, the solution cannot be simple. 

The purpose of today’s hearing is to examine the federal response, including the public health response, to prescription drug 

and heroin abuse. Our oversight has revealed that this is a complex problem. Those who abuse drugs also have, often, an underlying mental illness. Treating their addiction means that the underlying mental illness must be successfully diagnosed and treated. 

As the testimony of Mr. Botticelli states, the substance abuse is a 

progressive disease. Those who suffer from addiction often start at 

a young age with alcohol, maybe marijuana, move on to other 

drugs like opiates. In examining opiate abuse, we must also consider the factors that lead people to abuse, and what we are doing 

to address those factors. 

Many Americans also suffer from chronic and debilitating pain. 

It is important to remember that the millions of individuals who 

safely use opiate narcotics under the guidance of their physicians, 

pain that we hope a loved one would never have to suffer is involved. As Dr. Volkow of NIH recognizes in her testimony, we need 

to recognize the special character of prescription drug abuse. On 

the one hand, we have a growing prescription drug and opiate addiction. On the other, we have a very real need for these drugs to 

treat chronic pain, treat acute pain, and alleviate suffering where 

it exists, especially in patients with chronic conditions who are suffering from illnesses like cancer. These drugs are safe when used 

as directed. It is their improper use that leads to abuse, overdose, 

and death. 

Over recent years, we have heard a great deal about doctor shopping, about pill mills, and about the efforts of the prescription drug 

monitoring plans to address these problems. We need to ensure 

that doctors and pharmacists have the tools at their disposal to 

adequately fill their role with ensuring appropriate prescribing, but 

addicts also get these drugs through illegal channels, such as rogue 

Internet pharmacies, off the street, and obtaining them through 

family members who may have an outdated prescription. Although 

some question whether federal efforts to crackdown and prevent 

prescription drug abuse have contributed to the recent rise in heroin abuse, and whether this should have been anticipated, there is 

no question that both are on the rise, and as a consequence, we 

have a responsibility to recognize and solve that problem. While 

3 

most prescription drug abusers do not go on to abuse heroin, there 

is data from the White House Office of National Drug Control Policy, and the Substance Abuse and Mental Health Services Administration, that indicates over 80 percent of people who started using 

heroin in 2008 to 2010 had previously abused prescription drugs. 

The Federal Government is devoting resources to drug control programs. Some would say significant resources; over $25 billion 

annually, of which about $10 billion goes towards drug abuse prevention and treatment programs across 19 different federal agencies. We will ask today’s witnesses to identify the specific policies, 

the programs, the initiatives that have been the most effective in 

combatting prescription drug and heroin abuse, and which have 

not. With 19 agencies having a hand in over 70 drug control programs, we need to know what is working and what is not. What 

can we do better? 

Is oversight by the federal agencies also an important issue as 

significant funding is block granted to the states for their treatment programs? 

Testifying before us today are representatives of five of the agencies with lead roles in addressing opiate abuse. Mr. Michael Botticelli, the Acting Director of the White House Office of National 

Drug Control Policy; Mr. Daniel Sosin of the Centers for Disease 

Control and Prevention; Dr. Nora Volkow of the National Institute 

on Drug Abuse; Dr. Westley Clark of the Substance Abuse and 

Mental Health Services Administration; and Mr. Joseph Rannazzisi 

of the Drug Enforcement Agency. 

This is a prestigious panel, and we are very grateful for your 

presence here today. We certainly look forward to your testimony. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Good morning. I now convene this hearing of the Subcommittee on Oversight and 

Investigations entitled ‘‘Examining the Growing Problems of Prescription Drug and 

Heroin Abuse.’’ 

These are separate and distinct problems with a common end point; abuse, overdose, and death. 

As we know, the abuse of prescription drugs and illegal drugs such as heroin have 

plagued our nation for decades. However, over the last several months, there have 

been increasing reports that prescription drug and heroin abuse in communities 

around the country continue to grow. Sadly, those reports indicate that overdose 

deaths as a result of prescription drug and heroin abuse are also on the rise. Families have lost sons and daughters and fathers and mothers to this addiction. 

Data from the federal agencies charged with addressing drug abuse paint a startling picture of the severity of this public health crisis. Prescription drug abuse kills 

more than 16,000 people a year. From 2007 to 2012, heroin use rose by 79 percent 

in this country and 3,000 people die each year from heroin overdoses. 

U.S. Attorney General Eric H. Holder declared recently that heroin abuse constitutes ‘‘an urgent and growing public health crisis.’’ Certainly, there is a law enforcement aspect to solving this problem and stopping the bad actors who illegally 

distribute prescription drugs or traffic heroin. But the other part of the equation is 

treating addiction to prescription drugs and heroin—and preventing deaths. The answer to a burgeoning heroin epidemic, as the administration has called it, is not to 

wage a war on all opioids. To address a complex issue, the solution will not be simple. 

The purpose of today’s hearing is to examine the federal response, including the 

public health response, to prescription drug and heroin abuse. Our oversight has revealed that this is a complex problem. Those who abuse drugs often have an underlying mental illness. Treating their addiction means that the underlying mental illness must be successfully diagnosed and treated. 

4 

As the testimony of Mr. Botticelli, states, substance abuse is a ‘‘progressive disease.’’ Those who suffer from addiction often start at a young age, with alcohol and 

marijuana, and then move to other drugs like opioids. In examining opioid abuse, 

we must also consider the factors that lead people to abuse—and what we are doing 

to address them. 

Many Americans also suffer from chronic and debilitating pain. It is important 

to remember the millions of individuals who safely use opioids under the guidance 

of their physicians, pain that we all hope us or a loved one would never suffer. 

As Dr. Volkow of NIH recognizes in her testimony, we need to recognize the ‘‘special character’’ of prescription drug abuse. On one hand, we have growing prescription drug and opiate addiction; on the other, we have the very real need for these 

drugs to treat chronic pain and alleviate suffering, especially in patients with conditions like cancer. These drugs are safe when used as directed—it is their improper 

use that leads to abuse and overdose. 

Over recent years, we have heard a great deal about doctor shopping, pill mills, 

and the efforts of Prescription Drug Monitoring Plans to address these problems. We 

need to ensure that doctors and pharmacists have the tools at their disposal to adequately fill their role in ensuring appropriate prescribing. But addicts also get these 

drugs through illegal channels, such as rogue Internet pharmacies, off the street, 

and obtaining them through family and friends. Although some question whether 

federal efforts to crackdown or prevent prescription drug abuse have contributed to 

the recent rise in heroin abuse, and whether this should have been anticipated, 

there is no question that both are on the rise and we have a responsibility to examine this issue fully. 

While most prescription drug abusers do not go on to abuse heroin, there is data 

from the White House Office of National Drug Control Policy (ONDCP) and the Substance Abuse and Mental Health Services Administration (SAMHSA) that indicates 

81 percent of people who started using heroin in 2008 to 2010 had previously 

abused prescription drugs. 

The federal government is devoting significant resources to drug control programs 

-over $25 billion annually, of which about $10 billion goes toward drug abuse prevention and treatment programs across 19 federal agencies. We will ask today’s witnesses to identify the specific policies, programs, and initiatives have been most effective in combatting prescription drug and heroin abuse—and which have not. With 

19 agencies having a hand in over 70 drug control programs—is this working? What 

can we do better? Oversight by the federal agencies is also an important issue, as 

significant funding is block granted to states for treatment programs 

Testifying before us today are representatives of the five agencies with lead roles 

in addressing opiate abuse: Mr. Michael Botticelli, Acting Director of the White 

House Office of National Drug Control Policy; Dr. Daniel Sosin of the Centers for 

Disease Control and Prevention; Dr. Nora Volkow of the National Institute on Drug 

Abuse; Dr. H. Westley Clark of the Substance Abuse and Mental Health Services 

Administration (SAMHSA); and Mr. Joseph Rannazzisi of the Drug Enforcement 

Agency. This is a prestigious panel, and I thank you for being here today. We look 

forward to your testimony. 

Mr. BURGESS. I would now like to recognize for 5 minutes for the 

purposes of an opening statement the ranking member, Ms. 

DeGette from Colorado. 

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

Ms. DEGETTE. Thank you so much, Mr. Burgess, and we are glad 

to have you presiding today. 

Prescription drug and heroin abuse is a public health crisis and 

it is growing every day. In many communities across the country, 

we are seeing an epidemic of opioid overdose deaths. I am interested in learning from the panel about what more we can do to prevent the abuse of these drugs, and also to save lives. 

The non-medical use of opioids has escalated in recent years. In 

2011, hospitals tallied nearly 1⁄2 million emergency room visits related to these medications. The number of these visits nearly triVerDate Nov 24 2008 11:50 Jun 05, 2015 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-140 CHRIS
5 

pled over a 7-year period. The link between prescription opioid use 

and heroin abuse is also deeply troubling, and as the Chairman 

noted, only a small percentage of people who use pain relievers go 

on to abuse heroin, but the opposite is not true. The vast majority 

of those who abuse heroin previously abused prescription drugs. 

While far more people continue to abuse prescription drugs, the 

number of individuals who reported heroin nearly doubled between 

2007 and 2012. There is also evidence to suggest that people who 

abuse prescription drugs move on to heroin as pain relievers become less available or too costly. A 2012 study in the New England 

Journal of Medicine found heroin use rose dramatically after the 

introduction of an abuse deterrent form of Oxycontin. 

The use of drugs that ultimately lead to addiction and abuse 

often begins innocently. The majority of people who illegally use a 

prescription drug get that drug from a friend or a family member 

often, and sometimes the drug has been stolen, but at other times, 

a parent may even give the drug to a child, unaware of the risks. 

We must educate patients on the dangers of abuse of these drugs, 

as well as the need to properly store and dispose of them. If we can 

reduce inappropriate access to drugs, we can also reduce the incidence of their abuse. We must change the public perception of the 

prescription opioids. We face the inaccurate perception that just because a drug is legal, it is somehow less harmless, less addictive 

and less risky. Providers should also be better educated on the use 

and potential abuse of these drugs, so they can be more effective 

in recognizing problems of abuse, and, in turn, more effective in 

educating and treating the patients. Studies show that even brief 

interventions by healthcare providers can be successful in reducing 

or eliminating substance abuse by patients who began abusing prescription opioids but have not yet become addicted to them. 

When prescribed appropriately, these medicines provide muchneeded relief, and many patients have had their suffering reduced 

by opioid pain killers. However, a patient with an acute short-term 

pain may be able to find relief from a less addictive pain killer. 

Prescription drug abuse is a public health problem, and it is not 

just a law enforcement problem. Reducing this abuse will require 

a multifaceted approach, and partnership among federal, state and 

local agencies. Every state should effectively use prescription drug 

monitoring programs. These databases help states identify and address drug diversion, so they should be as robust and effective as 

possible. States should be able to share information with due regard for privacy expectations. Information should be added to the 

databases regularly, including by encouraging prescribers and 

pharmacists to use the databases. When used, they can help doctors and public health authorities prevent and respond to the potential devastating effects of prescription drug abuse. 

I am interested in learning from our witnesses today about the 

effects of this medication assisted treatment that we are hearing 

about, and also whether we have the resources to meet the demand 

for these treatment programs. I am also interested in learning 

about the state of research into new medications with lower abuse 

potential, and how we can expand access to overdose interventions 

like naloxone. 

6 

Prescription opioid and heroin abuse, as you said, Mr. Chairman, 

is a serious public health threat. I look forward to hearing from all 

of the witnesses, and to working with all of my colleagues on both 

sides of the aisle to ensure that Congress plays a vital role in protecting families from the growing danger of these drugs. 

And I yield back the balance of my time. 

Mr. BURGESS. The gentlelady yields back. 

The Chair now recognizes the gentlelady from Tennessee 5 minutes for purposes of an opening statement please. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman. And I know we are 

all cheering for Congressman Murphy and his daughter, as they 

are about to welcome that new baby into their family. What an exciting, exciting time. I can only tell you the joys of being a grandparent are marvelous. It is a big part of my day. 

Well, I thank you for the attention that we are putting on this 

issue. Prescription drug and heroin abuse are epidemic in our country, and I think you can tell by what is being said in this room this 

morning; it is an issue that our committee is concerned about, and 

I applaud the efforts of the committee to take a very thoughtful approach and process as how we move forward. It is clear that we 

need to understand the factors that have contributed to the rise in 

prescription drug and heroin abuse. We need to understand which 

prevention, treatment, and law enforcement efforts are the most effective in reducing the abuse of prescription drugs and heroin. 

On the other side of this issue are the millions of Americans who 

have legitimate need for prescription medication for the control of 

pain, reduction of anxiety, and the overall improvement of their 

lives. These medications must be available to them. H.R.4069, the 

Ensuring Patient Access and Effective Drug Enforcement Act of 

2013, that is a Bill by Representative Marino and I, it will establish a combatting prescription drug abuse working group. This 

group will include members from the DEA, FDA, ONDCP, State 

Attorney Generals, patient groups, pharmacists, industry, 

healthcare providers and others. Within one year of enactment, the 

working group shall provide, they must do this, provide recommendations to Congress on initiatives to reduce prescription 

drug diversion and abuse. We think this is the right approach. 

We welcome each of our witnesses. We look forward to hearing 

your testimony and to the discussion. 

And with that, Mr. Chairman, I yield back my time, or to anyone 

who is seeking time. 

Mr. BURGESS. Seeing no one seeking time, the gentlelady yields 

back. 

The Chair now recognizes the ranking member of the full committee, Mr. Waxman, 5 minutes for an opening statement please. 

7 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Mr. Chairman, for holding this important hearing today. 

We are here to discuss the epidemic of opioid abuse. The numbers are stark. Each year, approximately 17,000 people die from 

prescription opioid overdoses, and 3,000 die from heroin overdoses. 

For far too long, prescription opiate pain relievers were prescribed too easily, without enough attention paid to the potential 

risks, and a large number of people became addicted. Some of those 

who became addicted to prescription opiates eventually moved on 

to heroin because that is a cheaper alternative, offering the same 

high. 

Fortunately, there are steps that we can take to fight this problem. I appreciate our witnesses being here today to discuss their 

efforts to educate the public and providers about the dangers of 

abusing these drugs. We will also hear how we can change prescribing practices, monitor the use of opiates, effectively treat those 

who are addicted, and investigate and prosecute those involved in 

diverting and trafficking these drugs. 

Our five witnesses, Mr. Rannazzisi from the DEA; Mr. Botticelli 

from ONDCP; Dr. Sosin from CDC; Dr. Volkow from NIH; and Dr. 

Clark from SAMHSA, represent an all-star panel of experts, and 

we are delighted that you are here. 

There are many reasons to be thankful for the launch of the Affordable Care Act. Let me repeat that. There are many reasons to 

be thankful for the launch of the Affordable Care Act. One that is 

often overlooked is the help the law offers to individuals addicted 

to prescription opiates and heroin. The lack of insurance and the 

high cost of treatment could present an insurmountable barrier to 

receiving the help they need. The Affordable Care Act addresses 

this problem by expanding insurance coverage, and requiring all 

policies to cover the costs of substance abuse services. This will 

mean that millions of individuals with addiction disorders will have 

access to the tools they need to help break their addictions. We 

need to build upon this hopeful step, and increase our efforts to 

combat this epidemic. 

Mr. Chairman, at this point, I wish to yield the balance of my 

time to Mr. Welch from Vermont. 

Mr. WELCH. I thank the member from California for yielding, 

and I thank the committee for having this hearing, but I want to 

give some credit to Governor Peter Shumlin of Vermont. He did 

something extremely unusual. He dedicated his entire State of the 

State Address to this single problem, and that was a bold decision 

for two reasons. One, most of the time, the State of the State is 

a laundry list of objectives and hopes. This got very specific about 

one topic. But second, in taking this on, he made public what people knew was real, but didn’t want to acknowledge. And what we 

have seen in Vermont as a result of that was that we are facing 

what is a terrible problem that creates enormous anxiety for the 

folks that are in the grip of this addiction, but their families. And 

before we began talking about this, it was restricted to our law enforcement folks and our mental health folks who were dealing with 

8 

these isolated individuals as though they were the only ones in the 

world that faced this incredible challenge. And what Governor 

Shumlin did is he brought it out in the open, and that was in large 

part because in his travels around, and governors do get around, 

he was talking to our law enforcement people, like Chief Taylor in 

Saint Albans, like Chief Baker in Rutland, and they were dealing 

on the street with kids that they knew and with adults that they 

knew who had jobs, but had this horrible addiction, and they had 

to deal with it. And what our police kept saying, who have frontline 

responsibilities, you cannot arrest your way out of this. And there 

is a distinction that they make between the dealers who came from 

out of state and started inflicting our kids and others with this opiate addiction, throw the book at them, forget about them, but a lot 

of the kids who are in the grip, they are our kids, they have a future, they have a challenge. And what has happened in our communities with the leadership of our police and our mental health 

people and our mayors, like Liz Gamache in Saint Albans, and like 

Chris Louras in Rutland, is that by bringing this out into the open, 

it has helped us talk about this in concrete ways so that there is 

not only the treatment program, the Hub and Spoke Program, 

which I hope you might talk about, but it also is allowing parents 

and the community to see this as something where we all have to 

be engaged to provide some basis of support for these kids and 

adults who want not to be in the grip of this horrible opiate addiction. 

So I thank you, the committee, for having this hearing, and making it a collective effort to try to bring our resources together to 

help people get whole. Thank you. 

Mr. BURGESS. The gentleman yields back. 

I would now like to introduce the witnesses on the panel for today’s hearing. Mr. Michael Botticelli is the Acting Director of the 

Office of National Drug Control Policy in the Executive Office of 

the President; Dr. Daniel Sosin, who is the Acting Director of the 

National Center for Injury Prevention and Control at the Centers 

for Disease Prevention; Dr. Nora Volkow is the Director of the National Institute on Drug Abuse at the National Institute of Health; 

Dr. Westley Clark is the Director of the Center for Substance 

Abuse Treatment within the Substance Abuse and Mental Health 

Services Administration; and Mr. Joseph Rannazzisi is the Deputy 

Assistant Administrator in the Office of Diversion Control within 

the Drug Enforcement Agency at the United States Department of 

Justice. 

I will now swear in the witnesses. As you are aware, this committee is holding an investigative hearing, and when doing so, has 

had the practice of taking testimony under oath. Do any of you 

have any objections to testifying under oath this morning? Seeing 

a negative response from the witnesses, the Chair then advises 

that under the rules of the House and the rules of the committee, 

you are entitled to be advised by counsel. Do any of our witnesses 

desire to be advised by counsel during testimony today? And negative response was received from the panel of witnesses. In that 

case, if you would please rise and raise your right hand, I will 

swear you in. 

[Witnesses sworn.] 

9 

Mr. BURGESS. Let it be noted that the witnesses answered affirmatively. You are now under oath and subject to the penalties 

set forth in Title XVIII, Section 1001 of the United States Code. 

We would now welcome a 5-minute summary of your written 

statements. We will start with Mr. Botticelli and move down the 

table. 

STATEMENTS OF MICHAEL BOTTICELLI, ACTING DIRECTOR, 

OFFICE OF NATIONAL DRUG CONTROL POLICY, EXECUTIVE 

OFFICE OF THE PRESIDENT; DANIEL M. SOSIN, ACTING DIRECTOR, NATIONAL CENTER FOR INJURY PREVENTION AND 

CONTROL, CENTERS FOR DISEASE CONTROL AND PREVENTION; NORA D. VOLKOW, DIRECTOR, NATIONAL INSTITUTE 

ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; H. 

WESTLEY CLARK, DIRECTOR, CENTER FOR SUBSTANCE 

ABUSE TREATMENT, SUBSTANCE ABUSE AND MENTAL 

HEALTH SERVICES ADMINISTRATION; AND JOSEPH T. 

RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE 

OF DIVERSION CONTROL, DRUG ENFORCEMENT AGENCY, 

U.S. DEPARTMENT OF JUSTICE 

STATEMENT OF MICHAEL BOTTICELLI 

Mr. BOTTICELLI. Chairman Burgess, Ranking Member DeGette, 

and members of the subcommittee, I want to thank you for the opportunity to appear today to discuss the tremendous public health 

and safety issues surrounding the diversion and abuse of opioid 

drugs, including many prescription pain killers and heroin, in the 

United States. 

I know that, given recent media attention to overdose deaths, 

there is a heightened public interest in the threat of opioid drug 

use, but this is something many communities have been dealing 

with for a very long time, and it is a matter of great concern for 

this Administration. 

According to the Centers for Disease Control and Prevention, 

drug overdose deaths, primarily driven by prescription opioids, now 

surpass homicides and traffic crashes in the number of injury 

deaths in America. In 2010, the latest year for which nationwide 

data are available, approximately 100 Americans died on average 

from overdose every day. Prescription analgesics were involved in 

almost 17,000 of those deaths that year, and heroin was involved 

in about 3,000, and more recent data posted by several states indicates that deaths from heroin continued to increase. 

While heroin use remains relatively low in the United States as 

compared to other drugs, there has been a troubling increase in the 

number of people using heroin in recent years, from 373,000 pastyear users in 2007 to 669,000 in 2012. 

It is clear that we cannot arrest our way out of the drug problem. 

Science has shown us that drug addiction is a disease of the brain, 

a disease that can be prevented, treated, and from which one can 

recover. We know that substance use disorders, including those 

driven by opioids, are a progressive disease. Many people who develop a substance use disorder begin using at a young age, and 

often start with alcohol, tobacco and/or marijuana. We know that 

as an individual’s abuse of prescription opioids becomes more freVerDate Nov 24 2008 11:50 Jun 05, 2015 Jkt 037690 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-140 CHRIS
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quent or chronic, that person is more inclined to purchase the 

drugs from dealers or obtain prescriptions from multiple doctors, 

rather than simply getting it from a friend or relative for free or 

without asking. This progression of an opioid use disorder may lead 

an individual to pursue a lower cost alternative such as heroin. 

With these circumstances in mind, we released the Obama Administration’s inaugural National Drug Control Strategy in 2010, 

in which we set out a wide array of actions to expand public health 

interventions and criminal justice reforms to reduce drug use and 

its consequences in the United States. That strategy noted opioid 

overdoses as a growing national crisis, and set specific goals for reducing drug use, including heroin. 

Three years ago, the Administration released the first comprehensive action plan to combat the prescription drug abuse epidemic. The Prescription Drug Abuse Prevention Plan strikes a balance between the need to prevent diversion and abuse, and the 

need to ensure legitimate access to prescription pain medications. 

The Plan expands on the National Drug Control Strategy, and 

brings together a variety of Federal, state, local, and tribal partners to support: 1) the expansion of state-based prescription drug 

monitoring programs; 2) more convenient and environmentally responsible disposal methods for removing expired or unneeded medication from the home; 3) education for patients and training of 

healthcare providers in the proper prescribing practices and treatment of substance use disorders; and 4) reducing the prevalence of 

pill mills and doctor shopping through enforcement efforts. This 

work has been paralleled by efforts to address heroin trafficking 

and use. 

The Administration is also focusing on several keys areas to reduce and prevent opioid overdoses, including educating the public 

about overdose risks and interventions, increasing access to 

naloxone, an emergency overdose reversal medication, and working 

with states to promote Good Samaritan laws and other measures 

that can help save lives. Because police are often the first on scene 

of an overdose, the Administration strongly encourages local law 

enforcement agencies to train and equip their personnel with this 

lifesaving drug. 

It is not enough, however, to save a life from an overdose. A 

smart public health approach requires us to catch the signs and 

symptoms of substance use early, before it develops into a chronic 

disorder. We have been encouraging the use of screening and brief 

intervention to catch risky substance use before it becomes an addiction, and since only 11 percent of those who needed substance 

use disorder treatment in 2012 actually received it, the Administration is dramatically expanding access to treatment. The Affordable Care Act and Federal parity law are extending access to substance use disorders and mental health benefits for an estimated 

62 million Americans, helping to close the treatment gap and integrate substance use treatment into mainstream healthcare. This 

represents the largest expansion of treatment access in a generation and can help guide millions into successful recovery. 

The standard of care for treating substance use disorders driven 

by heroin or prescription opioids involves the use of medication-assisted treatment, an approach to treating opioid addiction that utiVerDate Nov 24 2008 11:50 Jun 05, 2015 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-140 CHRIS
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lizes behavioral therapy along with FDA-approved medications, either methadone, buprenorphine, or naltrexone. Mediation-assisted 

treatment has already helped thousands of people in long-term recovery, and I applaud the recent commentary by my HHS colleagues in the New England Journal of Medicine to expand the use 

of medications to treat opioid addiction and reduce overdose deaths. 

There are some signs that our national efforts are working. The 

number of Americans 12 and older initiating the non-medical use 

of prescription opioids in the past year has decreased significantly 

since 2009. Additionally, according to the latest Monitoring the Future survey, the rate of past year use of Oxycontin or Vicodin 

among high school seniors in 2013 is at its lowest since 2002. And 

recent studies have shown that implementation of robust naloxone 

distribution programs and the expansion of medication-assisted 

treatment can reduce mortality and also be cost-effective. 

However, continuing challenges with prescription opioids and the 

re-emergence of heroin use underscore the need for leadership at 

all levels of government. We will therefore continue to work with 

our Federal, state, tribal and community partners to continue to reduce and prevent the health and safety consequences of prescription opioids and heroin. Thank you for the opportunity to address 

the committee today. 

[The prepared statement of Mr. Botticelli follows:] 

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Mr. BURGESS. The gentleman yields back. 

The Chair recognizes Dr. Sosin for the purposes of the 5-minute 

opening statement please. 

STATEMENT OF DANIEL M. SOSIN 

Dr. SOSIN. Good morning, Chairman Burgess, and members of 

the subcommittee. Thank you for the opportunity to testify about 

the public health issues related to prescription drug overdoses, and 

the Centers for Disease Control and Prevention’s role in preventing 

them. 

It is an honor to be with you today to talk about CDC’s approach 

to prescription drug overdoses and the prevention of them. 

Drug overdose death rates are higher than they have ever been, 

with prescription opioids being a key driver of this trend. More 

than 125,000 Americans have died from prescription opioid 

overdoses in the last decade. CDC has played an important role in 

raising the visibility of the health impact of prescription opioid 

overdoses, and helping to identify the role of increased inappropriate opioid prescribing in fueling this epidemic. Research also 

suggests that the growth in heroin use may be due in part to the 

increased addiction caused by the rise in prescribing of opioid pain 

relievers. 

The doubling in heroin use in the past 6 years is a worrisome 

trend, and undoubtedly has a relationship to prescription opioids. 

Reducing inappropriate opioid prescribing is one of the approaches 

needed to keep people from becoming addicted to opioids, and prevent them from later transitioning to heroin. 

Because of the complexity of these issues, the response demands 

engagement from a diverse group of federal, state and local partners. The partners at this table are all critical in the overall goal 

to reduce abuse and overdose of opioids while ensuring that patients with pain are safely and effectively treated. 

As the nation’s health protection agency, CDC is focused on upstream drivers of this epidemic, in this instance, the prescribing behaviors that created and continue to fuel this crisis. Our approach 

fits into three pillars that leverage CDC’s unique expertise: One, 

improving data quality and use to monitor the trends and causes 

of the epidemic. Timely, drug-specific information on prescribing, 

and the health effects of prescription drugs is critical. We generate, 

use, and improve data to identify threats, assess local trends, and 

evaluate the impact of prevention measures. Two, strengthening 

state prevention efforts. States maintain prescription drug monitoring programs, or PDMPs. States regulate healthcare professionals and institutions, they monitor the problem through their 

health departments, and they run large public insurance programs, 

including Medicaid. CDC provides resources and technical assistance to states to implement interventions and evaluate and adapt 

their approach to have the most impact. And three, improving patient safety by supporting healthcare providers and systems with 

tools and data needed to respond effectively. For example, CDC is 

working to promote responsible opioid prescribing through guidelines and decision support tools. 

While CDC has ongoing work in each of these areas, we are focusing this year on accelerating state prevention efforts. We will be 

27 

funding four to five state health departments for up to a total of 

$2 million per year to implement and evaluate the strategies I just 

outlined. 

The 2015 President’s Budget includes a request for $15.6 million 

in new funds to expand CDC’s Core Violence and Injury Prevention 

Program, which is a state-based program addressing injury and violence prevention. This will allow us to include additional states 

with the high burden of prescription drug overdose, to prevent injuries and violence, and expand the investment of these programs on 

reducing prescription drug overdose. 

In conclusion, prescription drug abuse and overdose is a serious 

public health problem in the United States. The burden of prescription drug abuse and overdose affects people of all walks of life, and 

many sectors of our economy. Addressing this complex problem requires a multifaceted approach and collaboration. CDC is committed to tracking and understanding the epidemic, supporting 

states working on the frontlines of this crisis, and rigorously evaluating what works to improve patient safety, prevent overdoses and 

save lives. 

Thank you again for the opportunity to be here today. 

[The prepared statement of Dr. Sosin follows:] 

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Mr. BURGESS. Thank you. The gentleman yields back. 

The Chair recognizes Dr. Volkow for 5 minutes for an opening 

statement. Thank you. 

STATEMENT OF NORA D. VOLKOW 

Dr. VOLKOW [continuing]. Is a component of the NIH to speak 

about the value of science in helping address the problem from the 

diversion and abuse of prescription opioid pain killers, and the related rising abuse of heroin. Opioids medications are the most effective intervention we currently have for management of severe 

pain. Unfortunately, these drugs not only inhibit pain censors in 

the brain, but they also potently activate brain reward regions, 

which is why they are abused and they can cause addiction. 

So we face the unique challenge of preventing their abuse, while 

safeguarding their value for managing severe pain, which, if untreated, is terribly debilitating. 

It is estimated that 2.1 million Americans are addicted to opioid 

pain killers, which reflects, in part, the widespread availability of 

these drugs. Indeed, the number of yearly prescriptions for opioids 

has more than doubled over the past 20 years, from 76 million to 

207 million prescriptions per year, during a period that in parallel 

saw a fourfold increase in death overdoses from prescription 

opioids. 

Pain killers, like Oxycontin and Vicodin, affect the brain similarly to heroin. They interact with exactly the same opioid receptors. Their difference depends on the potency, that is, how strongly 

they activate those receptors, and how rapidly they do so. So as for 

heroin, they can produce euphoria, which some abusers of prescription medications intensify by taking higher doses, crushing the 

pills so that they can snort them or inject them, or taking them in 

combination with other drugs like alcohol and Benzodiazepines. 

These practices make opioids far more dangerous, not only because 

they are more addictive, but also because they increase the risk for 

respiratory depression, which is the main cause of death from 

overdoses. 

Recent trends, as the other witnesses have mentioned, also indicate a rise in heroin abuse which currently affects more than 1⁄2

million Americans, and this rise is possibly driven in part by people 

switching from prescription opioids to heroin because it is cheaper 

and, in some instances, more available. 

Heroin is dangerous not just because of its high addictiveness 

and the overdose risk that it poses, but also because it is frequently 

injected which increases the risk of diseases like HIV and Hepatitis 

C, predominantly from the use of contaminated injection material. 

So what is NIDA doing about the problem? We are funding research in two major areas. One, research that will allow us to manage pain more effectively, research that will allow us to prevent 

deaths from overdoses from opioids, and that research will allow us 

to treat substance use disorders more effectively, including prescription medications. 

As it relates to the safe management of pain, we still don’t know 

enough about the risk for addiction among chronic pain patients, 

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tion opioids to influence their addictive potential, but ongoing research will help us clarify some of these issues. 

So with respect to treatment, we are funding research to develop 

non-opioid-based analgesics that are non-addictive, opioid medications that have less risk for diversion and abuse, as given by different formulations, or different ways of administering them, and 

finally, non-medication strategies such as transcranium magnetic 

stimulation, or electrical brain stimulation for the management of 

pain. 

Research related to preventing overdoses, making the effective 

opioid overdose antidote, naloxone, which is also very safe, more 

available, will help prevent many deaths. The FDA recently approved a handheld auto injector of naloxone that patients and others can use easily. NIDA is supporting the development of userfriendly naloxones in the form of nasal spray to be used by nonmedical personnel or the overdose victim. Also, since many 

overdoses occur when no one is around or during sleep, NIDA is 

supporting the development of self-activated systems that initiate 

an emergency response when wireless sensors signal that an overdose is occurring. 

As it relates to opioid addiction, methadone, buprenorphine and 

naltrexone have been shown to be effective in treating opioid addiction, and in preventing overdoses, but these medications are not 

being used widely. NIDA is working to overcome the barriers that 

interfere with their adoption. In parallel, research of new interventions such as vaccines for heroin will allow us to treat this problem 

in a different way and to prevent it. Additionally, we work with our 

partners, CDC, SAMHSA, ONDCP and ONC in implementing and 

evaluating evidence-based interventions. 

Again, I want to thank you for recognizing the urgency of the 

problem posed by the abuse of prescription opioids, and for inviting 

NIDA to discuss how science can help address this problem. 

[The prepared statement of Dr. Volkow follows:] 

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Mr. BURGESS. The Chair thanks the doctor. The gentlelady yields 

back. 

Chair recognizes Dr. Clark 5 minutes for the purposes of summary of your opening statement please. Your microphone, sir. 

STATEMENT OF H. WESTLEY CLARK 

Dr. CLARK. Thank you for inviting the Substance Abuse and 

Mental Health Services Administration to participate in this panel. 

I echo the testimony of my colleagues regarding the importance 

of the topics of this hearing. I will focus on SAMHSA’s programs 

and activities, but I want to point out that we work with our federal partners: with states, tribes and local communities. According 

to the National Survey on Drug Use and Health, which SAMHSA 

conducts, 4.9 million people reported non-medical use of pain relievers during the past month in 2012, 335,000 reported past 

month use of heroin, a figure that has more than doubled in 6 

years. In 2012, more than 1.89 million people reported initiating 

non-medical use of pain relievers, and 156,000 reported initiating 

use of heroin. One challenge in combating the misuse of pain relievers is educating the public on dangers of sharing medications. 

According to our national survey, 54 percent of those who obtained pain relievers for non-medical use in the past year received 

them from a friend or relative for free. Another 14.9 percent either 

bought them or took them from a friend or relative. Thus, we have 

both the public health problem intertwined with a cultural problem. 

SAMHSA has several programs focused on educating the public, 

including the ‘‘Not Worth the Risk Even If It’s Legal’’ campaign, 

which encourages parents to talk to their teens about preventing 

prescription drug abuse, our ‘‘Prevention of Prescription Abuse in 

the Workplace’’ effort supports programs for employers, employees, 

and their families. Our Partnership for Success grant includes prescription drug abuse prevention, as one of the capacity building activities in communities of high need. Our Screening, Brief Intervention and Referral to Treatment Program includes screening for illicit drugs, including heroin and other opioids. We have developed 

programs to help physicians maintain a balance between providing 

appropriate pain management, and minimizing the risk of pain 

medication misuse. Our expert medical residency program includes 

a module for prescription opioids for pain management and opioid 

misuse. Over 6,000 medical residents and over 13,700 non-residents have been trained nationally. Our physician clinical support 

system for Medication Assisted Treatment training is available via 

live in-person, live Online, and recorded modules, accessible at any 

time. SAMHSA funds a Prescribers’ Clinical Support System for 

Opioid Therapies, a collaborative project led by the American Academy of Addiction Psychiatry, with six other leading medical societies. We will be funding a Providers’ Clinical Support System on 

the Appropriate Use of Opioids in the Treatment of Pain and 

Opioid-related Addiction this fiscal year. 

Last week’s article in the New England Journal of Medicine, authored by HHS leadership, including Dr. Volkow and SAMHSA’s 

administrator, describes the underutilization of vital medications 

54 

and addiction treatment services, and discusses ongoing efforts by 

major public health agencies to encourage their use. 

Medication-assisted treatment includes three strategies: agonist 

therapy, which includes Methadone maintenance; partial agonist 

therapy, which includes buprenorphine; and antagonist therapy, 

which uses an extended release injectable naltrexone, or Vivitrol. 

SAMHSA is responsible for overseeing the regulatory compliance 

of certified Opioid Treatment Programs which use methadone and/ 

or buprenorphine for treatment of opioid addiction. We estimate 

that there are approximately 300,000 people receiving methadone 

maintenance. There are currently 26,000 physicians with a waiver 

to prescribe buprenorphine; of these, 7,700 are authorized to prescribe up to 100 patients. We estimate that there are 1.2 million 

people receiving buprenorphine. 

SAMHSA also issued an advisory encouraging drug courts to utilize Vivitrol in their treatment programs. In August of 2013, we 

published the Opioid Overdose Tool Kit to educate families, first responders, individuals, prescribing providers, and community members about steps to take to prevent and treat opioid overdose, including the use of naloxone. When administered quickly and effectively, naloxone restores breathing to a victim in the throes of an 

opioid overdose. This can be used as a teachable moment to assess 

treatment need and refer the person to the appropriate resources. 

We inform states and jurisdictions that the Substance Abuse Prevention and Treatment Block Grant primary prevention set-aside 

funds may be utilized to support overdose prevention education and 

training. In addition, we notified jurisdictions that block grants, 

other than the primary prevention set-aside funds, may be used to 

purchase naloxone and the necessary materials to assemble overdose kits to cover the costs associated with the dissemination of 

such kits. 

SAMHSA continues to focus on our mission of reducing the impact of substance abuse and mental illness on America’s communities, and we thank the subcommittee chairman and members for 

convening this important hearing, and providing SAMHSA with 

the opportunity to address this very critical issue. 

[The prepared statement of Dr. Clark follows:] 

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Mr. BURGESS. The gentleman yields back. 

The Chair now recognizes Mr. Rannazzisi 5 minutes for the purposes of summarizing your testimony please, sir. 

STATEMENT OF JOSEPH T. RANNAZZISI 

Mr. RANNAZZISI. Thank you, Chairman Burgess, and distinguished members of the subcommittee. On behalf of 

DEAAdministrator, Michele Leonhart, and the men and women of 

the Drug Enforcement Administration, I want to thank you for the 

opportunity to discuss today the relationship between prescription 

opioids and heroin, and how DEA is addressing the public health 

problem. 

First, let me say that the present state of affairs is not a surprise. DEA has been concerned about the connection between the 

rising prescription opioid diversion and abuse problem, and rising 

heroin trafficking use for several years. The DEA believes that increased heroin use is driven by many factors, including the increase and the misuse and abuse of prescription opioids. The signs 

have been there for some time now. 

Law enforcement agencies across the country have been reporting an increase in heroin use by teens and young adults who began 

their cycle of abuse with prescription opioids. Treatment providers 

report that opioid addicted individuals switch between prescription 

opioids and heroin, depending on price and availability. Non-medical prescription opioid use, particularly by teens and young adults, 

can easily lead to heroin use. Heroin traffickers know all this, and 

are relocating to areas where prescription drug abuse is on the rise. 

To give you an example, we know that many teens and young 

adults first get their prescription opioids for free, from medicine 

cabinets or friends. Let us assume that a teenager gets 

hydrocodone, a Schedule III prescription opioid, and also the most 

prescribed drug in the United States, from a family medicine cabinet or friend. Once that free source runs out, it could cost as little 

as between $5 and $7 a tablet on the street, but then the teen will 

eventually need more opioid to get the same effect that he is trying 

to achieve. Black market sales for prescription drugs are typically 

5 to 10 times their retail value. On the street, a Schedule II prescription opioid can cost anywhere from $40 to $80 per tablet, depending on the relative strength of the drug. These increasing costs 

make it difficult to continue purchasing, especially for teens and 

young adults who don’t have steady sources of income. Given the 

high cost to maintain this high, the teenager turns to heroin at a 

street cost of generally $10 a bag. The teenager gets a high similar 

to the one he got when he abused prescription drugs. It is just that 

easy. 

Any long-term solution to reduce opioid abuse must include actions to address prescription drug diversion and misuse, while also 

educating the public about the dangers of non-medical use of pharmaceuticals, educating prescribers and pharmacists and treating 

those individuals who have moved from misuse and abuse to addiction. 

The DEA currently operates 66 tactical diversion squads in 41 

states, the District of Columbia and the Caribbean. These groups 

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ficers and DEA agents to conduct criminal investigations in the diversion of pharmaceutical drugs. The DEA regulates more than 1.5 

million registrants. DEA diversion groups concentrate on the regulatory aspects of enforcing the Controlled Substances Act, utilizing 

increased compliance inspections. This oversight enables DEA to 

proactively educate registrants, and ensure that DEA registrants 

understand and comply with the law. 

The tactical diversion squads and the diversion groups have 

brought their skills to bear on what was previously known as 

ground zero for prescription drug use, Florida-based Internet pharmacies and pain clinics. As the current pill mill threat is driven out 

of Florida and moves north and northwest, DEA will continue to 

target the threat with the tactical diversion groups’ proven law enforcement skills, the diversion groups’ regulatory expertise, and by 

educating registrants. 

DEA and our law enforcement partners have aggressively targeted both prescription drug diversion and heroin trafficking. From 

2001 to 2012, there has been a staggering increase in drug analysis 

of opioid pain medications, 275 percent for oxycodone, 197 percent 

for hydrocodone, and 334 percent for morphine. There has also 

been a significant increase in heroin cases. From 2008 to 2012, 

there was a 35 percent increase. If the data for the first half of 

2013 remains constant, the increase from 2008 to 2013 would be 

approximately 51 percent. 

The increase in heroin abuse and trafficking is a symptom of our 

country’s appetite for prescription opioids that will eventually lead 

to abuse and addiction. It is a natural progression from the abuse 

of prescription opioids. 

There is a dangerous misperception that abusing prescription 

drugs is safer than abusing heroin. Both abuse of prescription 

opioids and heroin can lead to addiction and death. Preventing the 

availability of pharmaceutical controlled substances to non-medical 

users, and educating practitioners, pharmacists, and the public 

about pharmaceutical diversion, trafficking and abuse are priorities 

at DEA. As such, DEA will continue to work in a cooperative effort 

with other federal, state, and local officials, law enforcement, professional organizations, and community groups to address this epidemic. 

Thank you for your invitation to appear today, and I look forward to answering any questions that you may have. Thank you. 

[The prepared statement of Mr. Rannazzisi follows:] 

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Mr. BURGESS. The gentleman yields back. I thank the gentleman 

for his testimony. 

We will now hear from the members for questions, 5 minutes for 

each member. 

I will begin. 

Well, Mr. Rannazzisi, you just gave some rather startling statistics. Mr. Botticelli, you said in your testimony we can’t arrest our 

way out of this problem. So let me just ask you, from a federal perspective, we have put a lot of money and a lot of effort on behalf 

of taxpayers into this, what is it about this that is not working? 

Mr. Botticelli, we will start with you, and maybe we can just go 

down the line and just answer the question, how has this become 

the problem that it is? 

Mr. BOTTICELLI. Sure. I think a number of my Federal panelists 

have articulated some of the problems, and I think, first and foremost, a lot of this issue is driven by the vast overprescribing of prescription pain medication. A recent report by the GAO showed that 

the vast majority of physicians get little to no training in substance 

use disorders and little to no training in safe opioid prescribing. 

And a part of our—— 

Mr. BURGESS. Let me stop you there because this is not a new 

problem. I mean this was a problem 40 years ago when I was in 

medical school, and I would disagree with the statement that we 

got no training, but OK, the training may not be adequate to the 

scope of the problem, but honestly, can we say that this is something that just happened to us, and we were completely unaware 

that this was an issue? I mean how could you possibly make a 

statement like that? 

Mr. BOTTICELLI. I think part of what the balance has been, and 

I think it has been out of kilter, is that physicians, quite honestly, 

were pushed in terms of making sure that we adequately treated 

pain in the United States. And we absolutely need to make sure 

that we do that. I think we need to have a balanced strategy that 

understands the tremendous addiction potential of these drugs, the 

risky patients that we have before us in terms of who should be 

prescribed prescription medication, as well as monitoring those who 

are developing a problem. 

So I do think that this is a balanced approach in terms of both 

making sure that we are adequately treating pain, but we are also 

not inadvertently creating a problem by overprescribing these 

medications to people who are developing a problem, or who are at 

risk. 

Mr. BURGESS. I don’t want to put words in his mouth, but Mr. 

Rannazzisi seemed to imply that we are overprescribing. Is that a 

fair assessment of your testimony? 

Mr. RANNAZZISI. I think that if you are talking about 99.5 percent of the prescribers, no, they are not overprescribing, but our 

focus is in rogue pain clinics and rogue doctors who are overprescribing. Actually, they are prescribing illegally, they are not overprescribing, they are illegally prescribing. 

So, yes, if you are considering that overprescribing, yes. 

Mr. BURGESS. Well, that is your job. You are law enforcement, 

so you get to close them down, right? 

77 

Mr. RANNAZZISI. And we are trying. They are overwhelming us 

with numbers. 

Mr. BURGESS. All right, I do want everyone’s response to that because in the interests of time and wanting to keep to the 5-minute 

interval, I am going to submit that in writing to each of you. 

I want to bring up something because each—or several of you 

have brought it up, and that is the issue of making naloxone much 

more available. Maybe we should also be talking about making 

Ambu bags available for people who are going to overdose. I mean 

it is hard to know who is going to overdose, but, Mr. Botticelli, you 

brought it up, and I think, Dr. Sosin, you brought it up as well, 

but what is the issue here with making this available? 

Mr. BOTTICELLI. I think that we have been tremendously heartened, both at the Federal level, as Dr. Volkow talked about, in 

terms of the approval of new delivery devices for doing that. One 

of the main areas that ONDCP has been working with our state 

partners is the passage of state legislation to look at naloxone distribution. And so I think we have now 17 states that have enacted 

naloxone distribution legislation, which I think has really been 

helpful here. 

We have also been, quite honestly, working with many law enforcement agencies across the state—— 

Mr. BURGESS. Pardon me for a moment. It is a federally controlled substance, is it not? Naloxone? 

Mr. BOTTICELLI. It is not a controlled substance, if I remember 

correctly. 

Mr. BURGESS. OK. Is there a cost issue? 

Mr. BOTTICELLI. There is a cost issue, and one of the things, 

Chairman, that you asked is what are the opportunities that we 

have in terms of looking at this, and again, I think it was really 

helpful that SAMHSA looked at how we might use existing Federal 

funds, but I think if there is an area that we can continue to explore together it is how we might enhance resources for many overdose prevention efforts. 

One of the things that I have heard as I have traveled around 

the country is that having state legislation and having these devices is a great start, but many states and local areas are underresourced in terms of implementing it. 

Mr. BURGESS. Yes, and again, I may submit that in—for answer 

in writing as well, but, Dr. Volkow, let me just ask you. You mentioned in your testimony to address this problem, we have to recognize the special character of this phenomenon, and part of which 

is that opiates play a key role in relieving suffering. So as providers and policymakers, are we doing a good job of walking this 

line? 

Dr. VOLKOW. Based on the numbers, I don’t think we can say we 

are, and the reality is that in this country, we have both an undertreatment of pain and over-prescription of medications. These are 

not exclusive. And one of the issues that we have been faced with, 

and Mr. Botticelli had been discussing is, in 2000, when the Joint 

Committee for Accreditation of Hospital demanded that you treat 

pain, you see a steep increase in the number of prescriptions. So 

what you are doing in parallel, there has not been an increase in 

education in medical schools. So each 7 hours average in the 

78 

United States there is a diversity of opiate medications that are 

currently available, and there are many indications where actually 

patients are being given the opioids when it is not severe pain, and 

this, for example, is the case in many cases for young people with 

dentists that are prescribing the opiate medication, so there is a 

room for improvement on that education of providers. 

The other issue too that we have not understood very much when 

we were—I mean certainly, when I was in medical school, they will 

tell you if you prescribe an opioid medication with someone that is 

suffering from pain, they are not going to become addicted. Now, 

we can come to recognize that it is not the case, that there are patients that are taking the medication as prescribed, and they can 

become addicted. So the issue is who are they, how do we recognize 

them so we can prevent that transition. And—— 

Mr. BURGESS. Well, and my time has expired. I will just offer the 

observation, 40 years ago, I was given the admonition by a professor in anesthesiology, this stuff is so good, don’t even try it once. 

So clearly, it was known 40 years ago. 

I recognize Mr. Welch for 5 minutes for questions please. 

Mr. WELCH. OK, I want to thank the panel and the Chairman 

as well. 

You know, in Vermont, as I mentioned in my opening statement, 

we are just trying to face this directly, which is, I think, a much 

better approach than denial, and it has engaged the community in 

some very effective ways. And it has developed—I think it has 

helped our providers develop what they call a Hub and Spoke System where there is an emphasis on medication, which really does 

seem to be helping some folks who are willing to be helped, and 

then some wraparound treatment services for people who can benefit by that. And a lot of our ability to do that is because we are 

getting some federal help. We get about $6 million out of the Substance Abuse Prevention and Treatment Block Grant. That has 

been level funded. And my question really to Mr. Clark, can you 

explain the decision, I guess this is the Administration decision not 

to propose an increase in that program, given the intensity of the 

crisis. And I think with this discussion occurring all around the 

country, obviously, you are going to have many more states that 

are willing to roll up their sleeves and try to get engaged, which 

would suggest the resource need is there in order to help make this 

successful. 

Dr. Clark? 

Dr. CLARK. Mr. Welch, we are working very closely with state authorities, with organizations like NASADAD and NASMHPD to address these issues, but we also, as Mr. Botticelli pointed out, are 

approaching this from a comprehensive approach rather than simply using a single funding mechanism to address the issue. We 

need to keep in mind that we need multiple strategies to address 

this problem, and with those multiple strategies, we believe that 

we can make an impact. So relying, indeed, on the Affordable Care 

Act and other strategies, we can leverage the Block Grant Funding 

to target this. 

We are also allowing jurisdictions to prioritize using our prevention efforts, as well as our treatment efforts. The problems that 

they are experiencing—— 

79 

Mr. WELCH. All right. 

Dr. CLARK [continuing]. In their respective jurisdictions—— 

Mr. WELCH. OK, thank you. No—but no more money. Money is 

tight, I get it. 

And, Mr. Botticelli, your predecessor came up and had a great 

visit with us in Vermont. It was tremendous to have him there. 

And we have expanded the use of naloxone—how do you say that? 

Mr. BOTTICELLI. Naloxone. 

Mr. WELCH. Naloxone. Yes, and we have had some success with 

that. We have had a number of instances of it being used successfully just recently about 15 times. 

But do you think that the FDA should consider making that an 

over-the-counter medication? 

Mr. BOTTICELLI. Yes. So, first of all, like you, I really want to applaud you and Governor Shumlin in terms of calling significant attention to this issue. I spent the better part of my career in Massachusetts, and am very familiar with—— 

Mr. WELCH. Right. 

Mr. BOTTICELLI [continuing]. The heroin issue that we have had 

in New England for a long, long time. 

Our office, as part of our prescription drug abuse plan and overdose, has been looking for continued ways to expand the use of 

naloxone. Again, I think we are heartened by this delivery device. 

Our partners at NIDA are looking at and researching the expansion of and use of other ways. So we are having conversations with 

both Federal partners and, quite honestly, some external stakeholders who are really, really interested in terms of looking at how 

do we increase the—not only the availability of naloxone, but continue to promote easier to use and, quite honestly—— 

Mr. WELCH. OK. 

Mr. BOTTICELLI [continuing]. Perhaps some cheaper versions 

of—— 

Mr. WELCH. Right. 

Mr. BOTTICELLI [continuing]. Naloxone. 

Mr. WELCH. I have time for one more question. 

Dr. Volkow, I want to ask you about this issue with doctors and 

with patients. I have known close friends who have had serious 

medical issues and have been in a lot of pain, and once that line 

is crossed where they are getting the prescription medication, it almost seems like there is an undertow where the answer to the pain 

question always is essentially to get more medication and more 

powerful medication. And a patient in that moment is pretty vulnerable. And the doctor gets really persistent advocacy by the patient and sometimes the patient’s family. You have got to do something. So how do we help the doctors deal with what, Dr. Burgess, 

of course, we have another doctor here, but how do they, there are 

a lot of doctors around here, but how do we—the doctors really 

have to be on the frontline, and it is very tough because they have 

a patient who is in pain, they have a family who is saying will you 

do something, but the something that is getting done in many cases 

is resulting in long-term problems. 

Dr. VOLKOW. Yes, and you are touching on one of the hardest 

issues to deal with clinically: how do you manage severe chronic 

pain. What many people don’t know is that the risk of suicide for 

80 

patients with chronic pain is double that of the general population, 

so it is extraordinarily debilitating. And the strongest medication 

we have are opioids. The problem with opioids, apart from 

addictiveness, is that you become tolerant very rapidly, and so that 

requires that you increase the dose. So chronically, and then you 

have to shift to something more potent, and that is exactly where 

the whole problem lies around. They are not ideal, but it is what 

we have, and it can relieve the patients in the moment that they 

need them. 

The strategy is what other alternatives we can use other than 

just relying as—in opioids as the only alternative, and that is 

where research is ongoing to see—that is what I was mentioning 

in the whole area of brain neuroscience, the feasibility of devices 

that can actually be used potentially to handle and manage pain 

will be a breakthrough. You will rely less on medications. And I 

also think the aspect of we as a society have created the expectation that anything that is wrong with you should be treated with 

a medication. So zero tolerance for pain. And I think that as a culture, we need to revision that also. 

Mr. WELCH. Thank you. 

I yield back. Thank you very much. 

Mr. GINGREY [presiding]. Thank you. Thank you, Mr. Welch. 

And I am sitting in, obviously, for Dr. Burgess. Let me just make 

a brief statement, and then I will ask my question. 

As a physician of many years, I don’t think that even back in the 

day we were given the proper training in regard to pain medication. Also I will say this, there has been a lot of emphasis over the 

past 10 years or so about advanced directives and the necessity for 

that, and, of course, the hospice programs that have developed and 

that sort of thing, but I don’t hear hardly any discussion about patients given their wishes in regard to how they want their pain 

controlled in a terminal situation where there is no chance for recovery. I don’t know that people really understand, and in many instances pain medication is started because the family members 

don’t want their loved one to suffer. That is quite natural and appropriate, but before you know it, the patient has gone beyond the 

stage where they can say, look, I don’t want to be totally zonked 

out at the time of my demise. So that is just, I guess, food for 

thought in a way. 

I am going to ask my specific question, Mr. Rannazzisi. You said 

earlier in your testimony that the DEA is just getting overwhelmed 

by all these rogue pain clinics that are popping up everywhere. 

How is that happening? How do these places just pop up, as you 

put it, and why is it happening, why are you getting overwhelmed? 

Mr. RANNAZZISI. Well, that is a great question, sir. It is not just 

DEA that is overwhelmed. Our state and local counterparts are 

overwhelmed. Think about this. Prior to the Ryan Haight Act, the 

Internet drug bill that was passed, there were, say, seven clinics— 

pain clinics in Broward County, in 2010 there were 142 clinics in 

Broward County. Now, if you look, when we moved our enforcement groups down there, and we moved 10 tactical diversion 

squads to work with our state and local counterparts, and we started knocking off these rogue pain clinics, they moved up into Georgia. If you looked at the 75 corridor, there were over 100 pain clinVerDate Nov 24 2008 11:50 Jun 05, 2015 Jkt 037690 PO 00000 Frm 00084 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-140 CHRIS
81 

ics going up that 75 corridor. Some of them were right off of the 

interstate. You just get off and get back on. Then they moved into 

Tennessee. Tennessee now has approximately 300 clinics. 

Now, if you think that—state and local law enforcement and 

DEA doesn’t have the capacity to go after every one of these clinics 

quickly, because these are legal drugs that they are peddling, and 

we have to establish that that doctor is prescribing outside the 

usual course of professional practice, and not for legitimate medical 

purposes. It takes time. These cases take time. So what they are 

doing is they are just counting on the fact that they are going to 

run the clinic that is not being hit by DEA. So we are all overwhelmed, everyone in law enforcement. 

Mr. GINGREY. Yes, but what percentage would you say of these 

clinics are fraudulent? 

Mr. RANNAZZISI. In Florida, the vast majority of them. In Georgia, I believe that the vast majority of those clinics that popped up 

were. There are good pain clinics, don’t get me wrong. Every pain 

clinic is not bad. 

Mr. GINGREY. Yes. 

Mr. RANNAZZISI. But the pain clinics that we are looking at are 

absolutely atrocious. There is no medical care. 

Mr. GINGREY. Yes. 

Mr. RANNAZZISI. It is the modern-day crack house. 

Mr. GINGREY. Thank you for that answer. 

And any of you could answer this. Last year, GAO, the Government Accountability Office, found an overlap in 59 of the 76 programs it identified in the drug abuse and prevention area. What 

steps are any of your agencies taking to minimize overlap and more 

efficiently spend out taxpayer dollars? I mean you would think that 

we could get some efficiency here. Anybody? 

Mr. BOTTICELLI. Sure, Chairman. Our office has looked at that 

report and has been working with our Federal partners to look at 

the breadth of our prevention programs, and to make sure that we 

are not, quite honestly, duplicating programs. 

I do think that, however, if you talk to many, many people at the 

local level, they will tell you, however, that we don’t have enough 

prevention, and I think you heard from many, many folks up here 

that while we may have programs that are addressing the same 

issue, they are reaching not the entirety of the population. So we 

really want to make sure that, one, that we are not kind of duplicating the programs that we have already—— 

Mr. GINGREY. Well, very important, I would think that you guys 

are talking to each other, of course. Others? I have a little time 

left, 2 seconds, 1 second. Wait a minute, I am the chair now, aren’t 

I? I have 5 minutes left. Mr. Clark? 

Dr. CLARK. Well, as—— 

Mr. GINGREY. Dr. Clark, excuse me. 

Dr. CLARK. One of the things we are concerned about in the Administration is the issue of fragmentation, overlap, and duplication, 

and that we do work very closely with our federal partners to make 

sure that we minimize fragmentation, overlap, and duplication. 

And working under the assistance of ONDCP, we are able to address that. 

82 

As was pointed out, communities need multiple resources, and 

you find that sometimes you cannot completely eliminate some 

overlap because, indeed, the unique issues of individual communities require that there be some overlap, but we are very sensitive 

to both the GAO concerns and OMB’s concerns about fragmentation, overlap, and duplication, and assiduously try to avoid that. 

Mr. GINGREY. Thank you all. I thank the panel. My time has expired, and I yield 5 minutes now to Mr. Lujan. 

Mr. LUJAN. Mr. Chairman, Doctor, thank you so very much for 

the time today, and I am glad to see that we are having this hearing. This is important. By the chairman and the committee staff acknowledging that this hearing needed to take place, I think we are 

acknowledging there is a problem across the country. 

The question after this hearing today though is, are we going to 

sweep this under the rug again, or are we going to do something 

significant with recommendations that are going to come from experts? 

This is a problem plaguing America. The case in New York 

brought more attention to what was happening with heroin abuse 

and overdoses, but we have been losing lives across the country for 

years. And what are we going to do? There are recommendations 

that have been put on the table by many experts. It has been studied over and over and over. There is a program from 2011 on the 

prescription drug side to reduce abuse significantly over 5 years, I 

will be asking the question where are we with that, but every life 

that is lost as a result of this is one life too many. 

There are only so many parts of the world that are growing poppies. Do we not know, as the United States of America, where poppies are being grown and how they are migrating into the United 

States in the form of heroin and illegal substances? Seems to me 

we should. And what are we doing to stop that flow? That is very 

troubling. 

Now, going back to the prescription drug side, there have been 

presentations that we have seen in New Mexico that have been put 

together by some people that I respect very much, that show a correlation with drug overdoses with increased prescriptions that are 

coming out, not just pain medication facilities that are popping up. 

And so one of the questions that I have is, is there data that is reported to any of you that you do analysis on, where there is a 

court—at least with the data that I have seen, there is—it is shown 

that there is a correlation between overdoses and increased prescriptions that are being administered, and what do we do with 

that data? Are we able to go in or is that an area where we don’t 

have enough support now between the federal and the state partners? And I would ask anyone that would like to tackle that. 

Dr. SOSIN. Thank you, Congressman Lujan. 

You mentioned a New Mexico report. Dr. Paulozzi from CDC 

worked with scientists in New Mexico and health department staff 

there to analyze and demonstrate those relationships, and absolutely, there is a very tight relationship between the volume of 

opioid prescribing and opioid overdose deaths. That information 

does get used at a national level, and thinking about the areas to 

intervene, but also at the state and local level where it has to be, 

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tion, and the factors that are influencing the prescribing practices 

are being addressed there. 

One of the ways that CDC in particular works is by trying to liberate data by working with state and local health departments to 

understand the context of prescribing, of health system data, and 

of mortality data, to put a better picture and understand the context within which overdose deaths are occurring and abuse is occurring, and then be able to target programs like through their 

PDMP’s, like restriction programs, et cetera, that address those 

problems. 

Dr. VOLKOW. If I may, first of all, I want to thank you for bringing up that issue because the way that I view it, this is an urgent 

issue and we cannot put it under the rug, under no conditions. And 

I feel passionate because I do get the parents coming to me and say 

when we went to wake up our child, it was dead, and we didn’t 

even know that they were abusing opioids. 

The other issue is that we do have the tools to actually address 

the problem of opioid prescription abuse and opioid deaths. We 

need to implement them. We have treatments that work for drug 

addiction that can decrease the number of overdoses, but also we 

need to address the problem that we have with chronic pain in this 

country. How many people suffer chronic pain in this country? Estimated IOM, 100 million. 100 million. There is the notion on that 

100—that there is an increase in chronic pain, and that needs to 

be addressed. So from the healthcare perspective, we need to address it. 

Mr. LUJAN. And, Dr. Volkow, as my time expires, there are some 

questions that I will be submitting in to the record, but I would 

welcome your response as well. 

And, Mr. Chairman, I just wanted to share with you that there 

is a program in New Mexico that appears to be working with the 

distribution of Narcon, where there has been a reversal of more 

than 250 overdoses last year, where they are getting it into the 

hands of first responders and nurses. So it is not necessarily on the 

street, but it is with those that are responding to these accidents. 

And there may be a way for us to work on that with some ideas 

down the road. 

Mr. Chairman, again, I share, before you return to the hearing, 

how much we appreciate that you are doing this and you have 

brought this hearing, but I certainly hope that there is more that 

will be done, and that this hearing won’t be the last of hearings 

and conversations, and an approach that we can take as a Congress to work with our state partners to do something. This is a 

bad problem across the country, but it is also plaguing New Mexico. And I thank you for your attention to this, Mr. Chairman. 

Mr. BURGESS. The Chair thanks the gentleman, and does also observe that further hearings are likely to be necessary, and as Mr. 

Welch pointed out, to hear from governors, and I would like to hear 

from some of our mayors because they are on the first lines of this 

battle. 

The Chair now recognizes the gentlelady from North Carolina, 

Mrs. Ellmers, 5 minutes for questions please. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you to our 

panel for being here today, addressing this very important issue. 

84 

I would like to start by asking a question of Mr. Botticelli and 

Dr. Volkow. 

Understanding the path of addiction, there is, and I think you 

have both identified a genetic basis for that, one of the things I 

would like to know is, again, the progression. Is this something 

that starts with tobacco use, smoking, use of alcohol, drinking, and 

then how does it progress and how do you feel? And I will just start 

with you, Mr. Botticelli, and then have Dr. Volkow comment. 

Mr. BOTTICELLI. I do have to acknowledge that just about everything that this field knows about this has come from the work of 

Dr. Volkow. 

Clearly, we know that there is a genetic predisposition for many 

people in terms of family history of substance abuse, but we also 

know that there is, like many diseases, there are environmental 

factors that go into that issue. 

We know that substance use disorders are a disease of early 

onset, so that many people who do develop, left untreated, left 

undiagnosed, develop a substance use disorder, largely because of 

starting alcohol, tobacco and/or marijuana use—— 

Mrs. ELLMERS. Yes. 

Mr. BOTTICELLI. At a very young age. Clearly, there are some 

particular issues as it relates to the addiction potential of prescription drug medication—— 

Mrs. ELLMERS. Yes. Yes. 

Mr. BOTTICELLI [continuing]. But the vast majority of people 

that, at least, I have talked to, and the data show that those folks 

who do have a significant opioid use disorder have started from a 

very young age. And if you saw the Philip Seymour Hoffman story, 

he actually started with alcohol abuse at a very young age. So we 

know that there are prevention and intervention opportunities that 

we can have along the way to really make sure that we are identifying people early in their disease progression, and then we are intervening in this issue. 

Mrs. ELLMERS. Yes. 

Mr. BOTTICELLI. The other piece that you talked about, and 

again, I think it still warrants further work, is what about the progression from prescription drug use to heroin addiction. 

Mrs. ELLMERS. Yes. 

Mr. BOTTICELLI. Clearly, we know that it is a progressive disease, and people, left untreated, will often progress to more significantly harmful use patterns, but we also know that price plays a 

role, as the DEA mentioned, in terms of the progression. So we 

know that there are multiple factors that really affect peoples’ progression, not only in terms of overall development of a substance 

use disorder, but from prescription medication to heroin. 

Mrs. ELLMERS. Yes. Yes. Dr. Volkow? 

Dr. VOLKOW. Yes, and the questions you ask intrigue many scientists, and it is called—has led to the term of gateway—— 

Mrs. ELLMERS. Right. 

Dr. VOLKOW [continuing]. Hypothesis because all of the epidemiological studies have repeated corroborated that most individuals 

that become addicted to illicit substances started with nicotine or 

alcohol, then transition into marijuana and then the other drugs. 

85 

So the question is that just because it is more accessible that you 

start with nicotine or alcohol—— 

Mrs. ELLMERS. Yes. 

Dr. VOLKOW [continuing]. Or could it be that these drugs, including nicotine, alcohol, and marijuana, are changing your brain in 

such a way that it makes it more receptive to the addictiveness of 

drugs. 

Mrs. ELLMERS. Yes. 

Dr. VOLKOW. And there is data now from genetic studies and 

from studies in animals that suggest, at least for the case of nicotine and alcohol, and also marijuana, that it is changing the sensitivity of the brain reward sequence in a way that primes you—— 

Mrs. ELLMERS. Yes. 

Dr. VOLKOW [continuing]. To the addictiveness of these other 

drugs. And in the case of prescription opioids, that is also what 

they are observing, that most of the individuals that end up addicted to prescription opioids had a history of nicotine addiction 

earlier, or had started abusing alcohol. 

Mrs. ELLMERS. Yes. Thank you. 

My last question is for Mr. Rannazzisi. Obviously, your agency 

is working with many other agencies on this issue, and I am going 

to ask you a question that really falls under the FDA, but from 

your opinion, in the work that you are doing, do you believe that 

some of the prescription drugs, the deterrent formulas such as, you 

know, for Oxycontin, some of the deterrent formulas, will that 

make a difference and is it feasible that if we take this approach, 

that that is going to help on the wide and broad scope that you 

have outlined if we are using these deterrent forms? 

Mr. RANNAZZISI. Absolutely. The abuse deterrent formulations 

will make a difference. But those drugs will still be abused—— 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI [continuing]. Orally with a potentiator, like a 

muscle relaxer, or a Benzo, but in the end, it is going to stop them 

from crushing and snorting, or crushing and injecting. 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI. And we know that when you crush and inject, 

or crush and snort, you are raising the risk—— 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI [continuing]. Of overdose and death—— 

Mrs. ELLMERS. Yes. Yes. 

Mr. RANNAZZISI [continuing]. Just in that method of delivery. So, 

yes, do I think it is important? Absolutely, it is important. Look at 

what happened with the Oxycontin product, when it went from the 

OC to OP, you could bang that tablet with a hammer and it is not 

going to break. 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI. It balls up in your nose when you try to snort 

it. It is crazy—— 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI [continuing]. That, if you try to abuse that drug, 

but what do we see everybody doing? Immediately, they started 

moving to the Oxymorphone product—— 

Mrs. ELLMERS. Yes. 

86 

Mr. RANNAZZISI [continuing]. Or the immediate release Oxy 30s. 

OK, so they are adapting. 

Mrs. ELLMERS. Yes. 

Mr. RANNAZZISI. If we could figure a way to get an abuse deterrent formulation across the board, then we are going to see some 

significant results—— 

Mrs. ELLMERS. Thank you. 

Mr. RANNAZZISI [continuing]. Absolutely. 

Mrs. ELLMERS. Thank you so much for your answers, and your 

insight on this issue. 

And, Mr. Chairman, I yield back the remainder of my time. 

Mr. BURGESS. Gentlelady yields back. 

The gentleman from Kentucky, Mr. Yarmuth, recognized 5 minutes for your questions please. 

Mr. YARMUTH. Thank you very much, Mr. Chairman. And I 

thank the panel as well for the testimony, and for what is obviously a very committed effort across the spectrum of government 

to deal with this problem. I am glad to know that, I shouldn’t say 

glad, but it is somewhat reassuring to know that this is not just 

a Kentucky problem. Certainly, in my travels in my district and 

around the state, and talking with law enforcement and with mental health professionals, and everyone who is involved in this area, 

we have a huge problem in Kentucky. During the first 3 quarters 

of 2013 there were at least 170 Kentuckians who died from heroin 

overdoses, and that was 41 more people who had died the entire 

previous year, and is actually a 200-plus percent increase since 

2011. So we have a problem that is there and growing. 

And one of the young people who died was the nephew of a Kentucky state representative, Joni Jenkins, a good friend of mine and 

a great representative. Her nephew, Wes, they suspected, began 

with prescription drugs and then moved to heroin because of expense. He died in May of 2013. And she told her story in the Louisville Courier-Journal, and I would like to read one of the things she 

said because it prompts a question. She said, for an entire year, 

our family kept the addiction private. They were well aware of it, 

he had been in and out of treatment and they were working with 

him, but they kept it private so Wes would not suffer the social 

stigma of being a drug addict. I now know that there is a terrible 

shame attached to this illness, but we have to break through the 

silence to find a cure. And she said, I also know that I will search 

for answers the rest of my life for that. 

Is this a problem that you have seen? You are nodding your 

head, Mr. Botticelli, so respond to that, that much of the the access 

to treatment or the willingness to treatment is deterred because of 

a social stigma? 

Mr. BOTTICELLI. I have—and many of us have heard that story 

countless times from parents. Many of us were just in Atlanta with 

a conference sponsored by Chairman Rogers. And we hear that 

story repeatedly, and I think our collective efforts have really been 

to raise the visibility of ensuring that people know that addiction 

is a disease, and this is not about shame, this is not about guilt. 

We know that one of the reasons why people don’t seek treatment, 

and why parents don’t ask for help, is because of the shame and 

embarrassment that is related to that. And so part of what I think 

87 

all of our Federal partners are doing is how do we raise the understanding and visibility, and, quite honestly, the compassionate 

treatment of people with addiction—of addictive disorders into this 

work. And I think that we are seeing, quite honestly, a movement 

in terms of—like we did with other disorders that were shameful 

and stigmatized—— 

Mr. YARMUTH. Yes. 

Mr. BOTTICELLI [continuing]. That we have to elevate the voice 

of parents and people in recovery so that we do know that hope is 

possible, and that it would be easier for them to come forward and 

ask for help, but unfortunately, we have heard that story way too 

many times from—— 

Mr. YARMUTH. Yes. 

Mr. BOTTICELLI [continuing]. From parents and people who are 

affected. 

Mr. YARMUTH. Have you come up with any great answers? I 

mean what can we do to help that just as individual members? We 

do span the country anyway. 

Mr. BOTTICELLI. Yes. I think there are a couple of things that we 

are doing. A lot of our work at the Office of National Drug Control 

Policy, we actually established an Office of Recovery to really promote the fact—we are looking at the development of recovery support services, so that people in the community can see that recovery is possible. I think we have been promoting—those of us who 

are in recovery, talking very publicly about the fact that we are in 

recovery, because it shows to other people that this is not just 

about death and destruction, that there really is hope on the other 

side of this. So I think all of us play a role in terms of 

destigmatizing that. 

Just having these hearings really shows the fact that we have 

leadership in this country who are concerned about this, and it is 

not a shame. This is not a moral choice, this is not a moral failing, 

this is about a disease, and we have to deal with it from a public 

health perspective. 

Mr. YARMUTH. Yes. 

Mr. BOTTICELLI. So I really appreciate your acknowledgement of 

that—those challenges. 

Mr. YARMUTH. Well, it seems to me that much of this problem 

involves education. I assume that when these young people, or 

whether it is young or not, but predominantly young people begin 

on prescription drugs, they have no idea that this is the course that 

they could likely be on. And I don’t know whether that is a school 

issue, a PTA issue, what it is, but it seems to me like information 

is one of the greatest avenues for combatting this problem. 

Well, anyway, Mr. Chairman, I would request unanimous consent that this OpEd that I mentioned from Joni Jenkins be made 

a part of the record. 

Mr. BURGESS. Without objection, so ordered. 

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

Mr. YARMUTH. Thank you, and I yield back. 

Mr. BURGESS. The gentleman yields back his time. 

The Chair now recognizes the gentleman from Ohio, Mr. Johnson, 5 minutes for your questions please. 

88 

Mr. JOHNSON. Thank you, Mr. Chairman, and I really appreciate 

the opportunity to hear from the panel today on this very, very important issue. 

You know, prescription drug and heroin abuse are very serious— 

is a very serious epidemic in Ohio, and parts of my district in eastern and southeastern Ohio are some of the worst hit. 

In 2012, 5 Ohioans died every day from unintentional drug overdose with opioids, both prescription and heroin, as the driving factor. Attorney General Mike DeWine identified heroin as contributing to as many as 11 fatal overdoses a week. It is a major public 

health crisis. However, prescription opioids continue to be the lead 

contributor to fatal overdoses in the state. In 2012, for example, an 

average of 67 doses of opioids were dispensed for every Ohio resident. 

Law makers, nonprofit organizations, medical, industry leaders, 

communities and parents across the state have been working to coordinate their response to this epidemic, but in a corner of Ohio 

that shares borders with 3 other states, communities are struggling 

to get drug abuse under control. Individuals identified as abusing 

in one state may cross state lines to escape detection and abuse in 

another. A nonintegrated system also makes it harder to identify 

prescribing providers and pill mills. 

So for all of you on the panel, anyone that wants to try and respond to this, I realize that states are largely in charge of implementing their own prescription drug monitoring programs, but in 

multistate areas like I serve, the importance of working together 

to curb abuse cannot be emphasized enough. So what is being done 

at the federal level to encourage states to share information compiled by their respective PDMPs? 

Mr. BOTTICELLI. Thank you, Congressman, and as you have articulated, both the establishment of vibrant prescription drug monitoring programs, and, quite honestly, the interstate interoperability 

of those programs, has been key for much of the work that we have 

been doing on the Federal level. So, we are happy that in 2006 we 

only had about 20 operable prescription drug monitoring programs 

in the United States, and now we have 48 that are operable, one 

in the process and unfortunately, one state that doesn’t have a prescription drug monitoring program. And as part of this strategy, we 

have been working with the Bureau of Justice Assistance and the 

Boards of Pharmacy to really look at interstate operability so that 

those states that share a border can make sure that they are sharing data. So now we have 20 states that are able to share information across borders, and clearly, we have a goal of making sure that 

all of these programs share data among particularly neighboring 

states. 

Mr. JOHNSON. Yes, I will share with you that, as a 30-year IT 

professional myself, I can tell you that architecture and data standardization, interface standards, those are very, very critical components. If you don’t know where you are going, any road will get you 

there. And it is one thing to have a monitoring system, it is quite 

something else to have a monitoring system that adheres to standards so that it can be effectively used. 

89 

How do we make the nationwide PDMP system more effective, 

and what still needs to be done to fully achieve a fully-integrated 

network? 

Dr. SOSIN. Congressman Johnson, thank you for your question. 

Clearly, the PDMP and the ability to achieve successful, effective 

PDMPs is critical to the law enforcement side, the public health 

side as well, the clinical side as well. And as Mr. Botticelli commented, we are making progress, meaning that we are better understanding the components of these PDMPs, and what it is that 

needs to be shared and how to share them. The work that you all 

are doing in raising visibility, that governors and mayors are doing, 

saying that this is an issue that they are going to address, also allows this opportunity to set the standards for what we need to 

share and how we will share that information across borders. 

The CDC, working with the FDA and the Bureau of Justice Assistance, has been funding at Brandeis, the prescription behavioral 

surveillance system, which takes from 20 states the PDMP data 

they have, to better understand what these factors are that increase the success of PDMP’s. 

Mr. JOHNSON. Let me get to one more quick question. I have to 

move quickly. 

How can we shift drug abuse prevention efforts from the collection of silo data like we are talking about, to a system in which 

this information isn’t lost every time an individual realizes that 

they are being tracked, and takes evasive measures like leaving a 

health plan, for example, because not only do you have working 

across state lines, but an abuser that goes from one health plan to 

another can also hide. So how do we solve that problem? 

Mr. BOTTICELLI. And some of my colleagues can add on to this, 

but part of what we have been really trying to focus on is make 

sure that we are treating and integrating substance use issues as 

part of mainstream healthcare, of really looking at things like making sure that people are getting screened and intervened as part 

of their overall health plan so that, you know, for a very, very long 

time, we have had two systems of care in the United States. We 

have had medical care over here and behavioral healthcare over 

here, and that we haven’t necessarily really looked at how we make 

sure that we are treating substance use disorders as a medical condition. 

So part of our goal is more thorough integration of mental health 

and substance use services within our primary care settings—— 

Mr. JOHNSON. Sure. 

Mr. BOTTICELLI [continuing]. Because it is really important that 

we not see these as two separate issues. 

Mr. JOHNSON. Yes. 

Mr. Chairman, I have many, many more questions. Obviously, 

this is a complex and sensitive issue for many Americans, but I 

have run out of time so I yield back. Thank you. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back his time. 

The Chair recognizes the gentlelady from Florida, Ms. Castor, 5 

minutes for your questions please. 

Ms. CASTOR. Thank you, Mr. Chairman, and thank you to the 

panel very much. 

90 

This hearing is really hitting home for me today because yesterday I learned that the death of a friend last month was tied to her 

long-term opioid addiction. Her sister sent me an email, I got it 

just yesterday, and she committed suicide, and her sister said because of her long-term addiction. So she left a daughter and a husband and an entire family, and the sister is asking please do more. 

So I hope we can all come together to tackle this. It is causing so 

much pain for so many families. 

And the State of Florida has really been at the heart of the problem. And still in Florida, they say that every 7 to 8—every—I can’t 

believe it, 7 to 8 minutes, someone overdoses in the State of Florida. I am also hearing from my local hospitals. They have had to 

add rooms in the NICU units of hospitals because of babies being 

born addicted, and these babies typically will cost $1 million to 

take care of, and they are in the hospital for a month. So we had 

better invest in prevention or else we are going to be spending a 

lot on the outside. 

So, Mr. Rannazzisi, Florida—the general talking points are, well, 

Florida has improved. There was a huge law enforcement crackdown. We have adopted a prescription drug tracking system, the 

PDMP. The problem is that doctors are not using it. The last statistics I saw, only 3.5 percent of all prescriptions being written are 

being checked on that database. 

What is your view right now in Florida? Have we made progress? 

What is left to do? 

Mr. RANNAZZISI. I think under the leadership of Attorney General Bondi and law enforcement leaders down in Florida, yes, we 

have made progress, absolutely. The problem is, again, we are overwhelmed by the numbers. There are so many people down there in 

Florida. We actually have cases where Florida rogue pain clinic operators were funding clinics in northern states, so when when the 

heat is on them, they are going to move into another state. 

I think that we are making progress, but again, it is going to 

take time. Now, the PDMP issue, I would love to see mandated 

PDMP use. The National Association of Boards of Pharmacy have 

gone out of their way to ensure that there is interoperability and 

interconnectivity between the PDMP’s. I think they have 25 states 

that are already connected, and they have done a phenomenal job, 

but if no one is looking at that PDMP, or very few are looking at 

that PDMP, it is not going to help. 

Ms. CASTOR. So do you agree that the local law enforcement efforts—what I see on the ground in my community, in the Tampa 

Bay area, we used to have these long lines with cars from out of 

state, people waiting outside in the alley for these pill mills to open 

up. You don’t really see that anymore, but with these statistics on 

the rate of deaths from overdose, something else is happening. We 

are not really making a dent there. Has it shifted to the internet, 

are they going out of state, is it both? What is going on? 

Mr. RANNAZZISI. I think they are moving to more rural areas 

where there is less law enforcement presence. I think the operators 

understand—I have a great video I would have loved to have 

shown you of a clinic, and what happens as soon as the clinic 

opens. I think that they are adapting. The clinic owners are adapting very well, and they are one step ahead of us right now, but in 

91 

the end, local law enforcement is doing a phenomenal job, and they 

are moving people out of the Tampa Bay area and out of the 3- 

county area, but it is still there—— 

Ms. CASTOR. Yes. 

Mr. RANNAZZISI [continuing]. It is just moving to more rural 

areas where they can’t address the problem as quickly. 

Ms. CASTOR. So in this very sad e-mail from my friend that I got 

yesterday, she said she has read now about the FDA approval of 

Zohydro, pure Hydrocodone, non-tamper resistant, 10 times stronger than Vicodin, the Vicodin prescription opiate. I know that the 

Advisory Committee to FDA had some very serious concerns with 

this, yet it has been approved. 

Dr. Volkow, could you give me your opinion on whether this drug 

should be readily available? 

Dr. VOLKOW. Well, we clearly have a very large number of opioid 

medications, and we are overprescribing them. I wouldn’t point my 

finger at one or the other. I do think that the feasibility of getting 

formulations that cannot be diverted is something that is very powerful, and the FDA should be commended because it came up— 

pharmaceuticals can come up with an indication for a medication 

that is deterrent proof, and that is incentivizing to the development 

of these types of medications. 

Zohydro is Hydrocodone, it is slow delivery over 12 hours, and it 

actually does not have Acetaminophen, and because the way that 

you have—correctly which is Vicodin, the way that you have it is 

combined with Acetaminophen which produces liver toxicity, which 

led the FDA to consider if someone needs Hydrocodone, do you 

need to give them Acetaminophen, and it was in that context that 

they approved it—— 

Ms. CASTOR. And—— 

Dr. VOLKOW [continuing]. But—— 

Ms. CASTOR [continuing]. Could I ask, since my time is short, Mr. 

Botticelli, do you agree with the FDA’s approval, or do you have 

concerns? 

Mr. BOTTICELLI. I think the important point, and again, I don’t 

think the FDA has their own process in terms of how they approve 

medications. I would agree that how we continue to make sure that 

we have abuse-deterrent formulations is really important. I also 

think that this really underscores the importance of prescribing, 

and training on prescribing, because I think the point is that we 

have many medications that are open for a potential to abuse, and 

we want to make sure that physicians and other prescribers really 

understand the risks associated with these drugs. 

Ms. CASTOR. And, Mr. Rannazzisi, local law enforcement has expressed concern about this new drug on the street because it is so 

potent, and because it is likely, if a child takes it, it could death. 

What is your view? 

Mr. RANNAZZISI. Yes, local law enforcement and DEA and our 

federal partners have all expressed. We all lived through the 

Oxycontin problem back in the ’90’s into the 2000’s, and we just 

don’t want history to repeat itself. Too many people passed from 

the abuse, circumventing that delivery system. 

Mr. BURGESS. The gentlelady’s—— 

Ms. CASTOR. And my—— 

92 

Mr. BURGESS [continuing]. Time has expired. 

The Chair recognizes the gentleman from Virginia, Mr. Griffith, 

5 minutes for your questions please. 

Mr. GRIFFITH. Well, let me pick up there. You are concerned 

about this newer drug, and so my question is what do you all do, 

and I would ask it of all of you but I start with you, Mr. 

Rannazzisi. 

Mr. RANNAZZISI. Rannazzisi. 

Mr. GRIFFITH. Rannazzisi, thank you. And that would be, how do 

we do a better job of predicting where we are going to see spikes 

and abuse on drugs as they come forward, because some people say 

that we should have probably seen the increase in the prescription 

drug abuse of opioids and heroin? 

Mr. RANNAZZISI. Well, we monitor the amount of drug going into 

a particular state through our ARCOS system, but in the end, what 

we generally see is the drug being abused in the Appalachian area 

of the country, and then it spreads out from there. So when we 

were looking at Oxycontin, for instance, the Oxycontin abuse epidemic started in that area, Kentucky, Tennessee, southern 

Ohio—— 

Mr. GRIFFITH. Southwest Virginia. 

Mr. RANNAZZISI. Yes, southwest Virginia—well, yes, absolutely. 

And then spread out. And we believe that pattern is going to happen again with this new product. It is just a matter of time. We 

know that product is now in the pharmacies and being dispensed, 

so—— 

Mr. GRIFFITH. And, now, for the people that we—that you have 

identified, I think that one of the other speakers said abuse-deterrent formulations. Once we know somebody is abusing, I have always liked the lock-in, where you lock into a pharmacy and you 

lock into a doctor, because one of the problems in southwest Virginia that you mentioned a minute ago is, is that you can be in 

West Virginia, Tennessee, Kentucky and North Carolina all within—no matter where you are in southwest Virginia, within an hour 

or 2 hours, you can be in any one of those states because of the 

way the geography is, and you can go from one rural area to another. 

So what are we doing on that? Are we looking at that as a possible means? Dr. Clark, if you want to answer, that is fine. I am 

just trying to find answers. 

Dr. CLARK. Clearly, there is no simple answer, and your question 

is a very important one, and this committee is trying to address it. 

We are working with the Association of State and Territorial 

Health Offices, and the Federation of State Medical Boards, and 

the Boards of Pharmacy. We do collect surveillance data from our 

household survey and working with our colleagues in the CDC, so 

part of the issue is monitoring the movement of individuals, getting 

practitioners, whether they are pharmacists, nurse practitioners or 

physicians, to monitor what it is that they are doing. Getting people to access and actually use the PDMPs, and having interoperability, as was pointed out. So—and then involving community coalitions, because, as was pointed out from the representative from 

Florida, people know where the places are. And what we need to 

do is—— 

93 

Mr. GRIFFITH. Sure. 

Dr. CLARK [continuing]. To get community coalitions—— 

Mr. GRIFFITH. Well, that is why—— 

Dr. CLARK [continuing]. To carry that information. 

Mr. GRIFFITH. That is kind of why I like the lock-in because then, 

you lock them into a doctor, into a pharmacy, if you know, now, I 

don’t want to do that to folks who haven’t been identified as having 

a problem, but once you know they have a problem, then that gives 

you a better handle on what they are doing if you lock them in and 

that is the only place they can go. Wouldn’t you agree, and I need 

to hurry because I have other things I want to ask? 

Dr. CLARK. That is one strategy that can be employed. So you 

want to make sure that if you do that, that they have access to the 

resources necessary to be in that—— 

Mr. GRIFFITH. Sure. And here is the dilemma that we have, because one of the things that the DEA is—has done, and we talked 

about this the last time you were here, is that they are asking the 

distributors to, you know, say, OK, don’t sell so much to a pharmacy if that pharmacy looks like they are above the average, or if 

you see some sign that they may be abusing. And I told the story 

about what happened when I went to my local pharmacy, and there 

were two people in there who were both being told you have to 

come back next month, which was not a few—but a few days away, 

because we used up our allotment. And I intuited that maybe they 

only had 1 supplier, and then that supplier said, he’s above average 

for other people who have more than 1 supplier. I went back and 

checked and that is exactly what is going on. He didn’t know that 

was the problem, but I said, you only have one supplier, don’t you? 

He said, yes, I use one distributor. And I think that is the problem. 

So we have on the one hand, we want to lock out people who are 

abusing it. On the other hand, we want to make sure people who 

need it, get it. So I guess what I am saying in the second matter 

is, for the rural areas, it may be a problem because that is less law 

enforcement, and we recognize that, and why a lot of my region is 

in different HIDA designations. At the same time, you want to 

make sure people are getting the drugs they need, and if you are 

in a rural area, you are a small pharmacy, you may only be using 

one distributor. While the DEA doesn’t have a quota, the distributor then is putting a quota on because, based on other pharmacies, that particular pharmacist or drugstore is ordering more 

drugs, but it is because they are only using the one supplier as opposed to using two or three. 

How do we solve that problem? And I think Dr. Volkow wants 

in on this. 

Dr. VOLKOW. Yes, I was smiling because the notion is we have 

situations where a patient cannot get their medication, and yet at 

the same time, the DEA has to collect this massive amount of pills 

that people are not using, which tells you we are overprescribing 

the number of pills that are necessary. 

So coming back to the point that we have been discussing, we 

really need to educate the healthcare system on the optimal way 

of prescribing them, not just when they need them, but the number 

of tablets that you are given. I mean all of us have the idea, go 

to the dentist, 2 weeks of opioid prescriptions. I mean you need one 

94 

day. So it is the whole notion of educating the healthcare system, 

and educating the lay public, and making the responsibility too 

of—why do we need to provide so many pills. And the insurers can 

get involved into these type of solutions. 

Dr. CLARK. And the lock-in approach works as part of a treatment plan—— 

Mr. GRIFFITH. That is right. 

Dr. CLARK [continuing]. With someone who suffers from chronic 

pain, the practitioner develops a treatment plan, the patient 

agrees, and that actually benefits everyone. 

Mr. GRIFFITH. Very good. 

Mr. BURGESS. The—— 

Mr. GRIFFITH. I know my time—— 

Mr. BURGESS. The gentleman’s time has expired. We will give an 

opportunity perhaps for a second round, but I wanted to go to Mr. 

Griffith because he has been waiting so long. 

Mr, GRIFFITH. Absolutely. 

Mr. SCALISE. Thank you for that, Mr. Chairman, and for our panelists for this important discussion. I know in my home parish of 

Jefferson, Louisiana, we have seen spikes in increase of drug-related deaths over the last few years, and each year it just seems 

to be going up higher. When I talk to my coroner in Jefferson, 

Gerry Cvitanovich, who works very closely in trying to, of course, 

they see the end result of it, but they also try to work on the front 

end in doing some of the education that Dr. Clark has talked about 

and others. They have seen that heroin is the one that seems to 

be popping up the most. I think last year, heroin deaths accounted 

for a majority of all the drug-related deaths, over 100 of those. And 

in my home parish of Jefferson, like I said, we are seeing this 

across the board. 

One of the things they do work on is just trying to educate people 

in the community. And I know, Dr. Clark, you have talked about 

this in your testimony, and alluding to work with not just pharmacists but others. 

What are the different things that you have been doing, and if 

you have had success on the education front, especially not just 

within the medical community, but within the targeted populations 

of those folks that might have the highest likelihood of being exposed to heroin? 

Dr. CLARK. Again, one of the things, a comprehensive strategy 

becomes critical, and I talked with prevention, working with community coalitions, so that we have that message. We have already 

heard about the issue of chronic pain management, and people 

moving from the use of a prescription opioid to drugs like heroin. 

So having good strategies for pain treatment, working with state 

health and territorial health officers, federation and state medical 

boards, nursing organizations, dental organizations and even veterinarians, because they, too, have access to prescription—— 

Mr. SCALISE. Right. 

Dr. CLARK [continuing]. Opioids, we can address that end of the 

agenda, then—— 

Mr. SCALISE. Yes, I want Mr. Rannazzisi—— 

Dr. CLARK [continuing]. Probably—— 

95 

Mr. SCALISE [continuing]. To answer this too because I know you 

talked about this in your testimony as well, so if you can touch on 

your experiences there. 

Mr. RANNAZZISI. We never turn down the opportunity to go out 

and speak to professional organizations. We have a very good relationship, or a fine relationship with the National Association of 

Boards of Pharmacy, the individual pharmacist associations, and 

the medical associations. When they ask us, we will come out. The 

Pharmacist Diversion Awareness Conference, we go out and we 

have been to 14 states, and trained over 6,000 pharmacists in their 

corresponding responsibility, the trends and trafficking for pharmaceuticals, to make them aware of what is going on so they know 

how to deal with this when a bad prescription comes in and what 

they are supposed to do. 

We have industry conferences. We bring industry in. October of 

last year, we brought the distributors in to talk about what we are 

seeing trendwise, and what they need to do as far as their legal 

obligations under the Act. We bring the manufacturers and importers in. In April or May of last year, we brought them in. And we 

do this on a regular basis to show the trends and trafficking. We 

are out there educating as much as possible because it is one of the 

pillars in the pharmaceutical initiative that the White House is 

pushing for. 

Mr. SCALISE. One of the things when you talk to the people on 

the ground, our local, whether it is coroners, law enforcement, 

there are a lot of different federal programs out there, and I do 

want to touch on that GAO report because there are some concerning issues that they raised that have been touched on a little 

bit, but I want to get into a little bit more, but on that front, when 

you look at all the grants that are out there, I know in Louisiana, 

I think grants come in from five different departments through 

thirty different programs for some of these treatment programs. So 

there is a lot of overlap and duplication, but is there a better way 

maybe to block grant these, to put them together in a way that 

would be more flexible? And maybe, Dr. Clark, you can answer, are 

we giving states enough flexibility today and with the duplication 

can we do a better job and maybe consolidating those grants in a 

way that allow the states to do what they do best, without having 

to go through so many different processes, through so many different agencies, where you have this duplication? 

Dr. CLARK. Well, clearly, we have to work with states and their 

discretion in how to prioritize what it is that they view as important epidemiologically in their jurisdiction. And so we have supported the use of block grant funds to the discretion of the states, 

and worked with both the individual state authorities and the national organizations associated with that. 

We are also working with recovery-oriented organizations so that 

we have peers, people who are recovering from substance use disorders to help speak up and carry out the message, working with 

community coalitions and others because, indeed, they can tell a 

better story than professionals or regulators, et cetera. So—— 

Mr. SCALISE. OK, and—— 

Dr. CLARK [continuing]. The—— 

96 

Mr. SCALISE [continuing]. And let me apologize, my time is about 

to go, I do want to at least ask for the record, if I can get this information on the GAO report, because it did identify, you have, what, 

15 different federal agencies, 76 different federal programs that all 

have abuse prevention or treatment programs, and they also identified overlap of 59 of the 76 programs. And so I think Dr. Gingrey 

had earlier asked Mr. Botticelli and Dr. Clark to talk about what 

your agencies are doing to address that overlap, those problems 

that were identified in the GAO report. 

If, Dr. Sosin, I am sorry, Dr. Volkow and Mr. Rannazzisi can also 

get me their information to—just to show what you all are doing 

to try to address the overlap problems that were raised in that 

GAO report. 

And with that, I will—— 

Mr. BURGESS. Well, the gentleman’s time has expired. I think 

that information will be generally interesting to the committee, so 

if the committee staff will provide that information to the committee. 

Mr. SCALISE. Would you all be OK with getting that to the committee? Thank you. 

Mr. BURGESS. And the Chair would recognize the gentleman 

from Texas, Mr. Green, 5 minutes for your questions please. 

Mr. GREEN. Thank you, Mr. Chairman. And I thank the O&I 

Committee for having this hearing. 

Prescription drug abuse is a real growing and public health 

threat that must be addressed. The consequences of abuse and addiction to opioids such as prescription pain relievers and heroin has 

a devastating effect on our communities. We need a comprehensive 

solution that protects public health, preserves patient access to the 

needed therapies, and improved access to treatment. 

Last week, an article was published in the New England Journal 

of Medicine discussing the Department of Health and Human Services’ efforts to address the prescription opioid overdose epidemic, 

including improving access to the addiction treatment services. 

Dr. Volkow, you were one of the authors of this article, and, Dr. 

Clark and Dr. Sosin, the heads of your respective agencies also authored this article. The article makes clear that the treatment of 

addiction to prescription drugs and other opioids with proven approaches like Methadone and other medication assisted therapy is 

of crucial importance. It describes the importance of the Affordable 

Care Act in increasing access to care for many Americans, including those who are struggling with addiction disorders. 

Dr. Volkow, can you elaborate on how the ACA builds on the 

Mental Health Parity and Addiction Equity Act, and improve on insurance coverage for people who are addicted to prescription drugs, 

heroin or other substances? 

Dr. VOLKOW. Yes, the problem is that, as I mentioned in my testimony, is that less than 1⁄3 of patients that require, that could benefit from opioid medications, are getting them for the treatment of 

their addiction. And these reflect, among other things, the fact that 

many of the people that are addicted to drugs do not have an insurance, and rely on the state funding to get their treatment. And as 

a result of that, we have removed the healthcare system for a position there—where they could not just act in preventing substance 

97 

use disorders, but on treating them. The healthcare act, by providing insurance to those that currently don’t have it, will give 

them the opportunity to be treated in the healthcare system for 

substance use disorders, as well as, in those instances where the 

addiction has not occurred, for the healthcare system to intervene 

in prevention. So that is why it is so important. 

Mr. GREEN. Dr. Clark, do you agree with that? 

Dr. CLARK. Indeed. When people who present for treatment can’t 

get treatment, are asked why they couldn’t get treatment, the largest reason is cost and access to treatment. 

Mr. GREEN. OK, thank you. I understand the ACA provision creates an optional Medicaid state plan, benefit for states to establish 

health homes for the coordination of beneficiaries with chronic conditions, has also supported some states in their effort to address 

the drug abuse. 

Dr. Clark, can you elaborate on how the Health Home Program 

is beneficial in tackling the problem of abuse? 

Dr. CLARK. Well, we have actually, with regard to opioids, we 

have got several jurisdictions that are looking at health homes as 

a way of dealing with opioids. So in Vermont, one jurisdiction, I 

think, Rhode Island, I will have to clarify that, is also taking that 

approach. Comprehensive services being offered where a person’s 

care is adequately monitored offers us an opportunity to reduce 

some of the complexities associated with opioid misuse. 

Mr. GREEN. Thank you. It is clear from the comments the Affordable Care Act makes it possible for many people with substance 

use disorders, whether it is addiction to prescription drugs, heroin, 

or other substances, to access the treatment they so desperately 

need. 

Mr. Chairman, I know we have had our differences over the Affordable Care Act, but I would hope we all share the goal of providing more robust treatment to those who are working to overcome this addiction. 

And I yield back my time. 

Mr. BURGESS [presiding]. The gentleman yields back. Our discussion with the Affordable Care Act will continue at a later date. 

Mr. GREEN. I am sure it will. 

Mr. BURGESS. We have now I think heard from all members who 

wanted to ask a question. I would ask unanimous consent that a 

follow-up question be allowed for those of us who remain. 

Mr. GREEN. I don’t have any problem with that. I can’t stay, 

but—— 

Mr. BURGESS. Very well, but I wanted to get that unanimous 

consent agreed to before you left, so it is not just on my shoulders. 

Mr. GREEN. I trust the Chairman. 

Mr. BURGESS. Mr. Griffith, I interrupted you before. Would you 

like to follow up on your line of questioning? 

Mr. GRIFFITH. Well, I would just like to give an opportunity, 

Mr.—— 

Mr. RANNAZZISI. Rannazzisi. 

Mr. GRIFFITH [continuing]. Rannazzisi. 

Mr. RANNAZZISI. Yes. 

Mr. GRIFFITH. Thank you. I am sorry I have such a hard time 

with that this morning. But Mr. Rannazzisi was about to comment 

98 

on the dilemma that we have with the small rural pharmacists, or 

pharmacy, that has one distributor. 

Mr. RANNAZZISI. Yes, and I want to thank you for clarifying that 

DEA has not set a quota downstream for the distributors. 

The distributors are working through their issues regarding due 

diligence to determine if there is a problem pharmacy or if it is not 

a problem pharmacy. I think that the rural pharmacies present a 

specific problem because they do need to get medication to their patients, and they need that downstream supply. We are hoping that 

the distributors are on site, looking at their operations before they 

completely cut off the distributor, or limit the pharmacy, but again, 

that is a business practice and, unfortunately, I have no control 

over their business practices. 

Mr. GRIFFITH. Well, and I would just say it is because of the concerns and I am sure some memos have been put out by the DEA, 

we are all trying to do the right thing, that has caused the distributor to be concerned, and maybe if there could be some acknowledgement from the DEA to the distributors, hey, keep an eye 

out if it is rogue, but if it is just you are looking at, you know, this 

pharmacy is more than another pharmacy, find out if they have 

just one distributor because that makes a huge difference in whether or not they are truly distributing more of the opioids than somebody else. And if you all could do that, that would be greatly appreciated. 

Mr. BURGESS. The gentleman yields back. I thank the gentleman 

for his follow-up. 

Dr. Volkow, you made a statement that was really fairly provocative a few moments ago, and I just wanted to follow up on it a little 

bit with you when you were discussing the effect of nicotine, alcohol on developing—I guess you were talking about developing 

brains and then you added the—with the addition of marijuana, 

and I ask you not to say anything about the rightness or wrongness 

of the public policy, but as you know, this nation is right now engaged in a significant experiment where some states have legalized 

marijuana. Are you all studying that and the effect of this decriminalization in some states? Are we prepared for what might happen 

next? 

Dr. VOLKOW. Yes, definitely. I know, unfortunately, it is one of 

those experimental situations that is happening, whether we like 

it or not. So what we have done is provided, identified the grantees, 

the researchers, in those communities where there has been legalization for recreational or medical purposes to actually give them 

supplemental money so that they can look at the consequences of 

these changes in policy, in the education of systems, in accidents, 

in emergency room admissions, in productivity in the workforce. 

We need to have evidence that can then—hopefully can guide policy, as opposed to doing policy in darkness on the beliefs of people, 

and what—since you brought up the issue, to one of the things that 

is also a concern as discussing the prescription, people are using 

prescriptions because they feel that are prescribed by physicians, 

they cannot be so harmful. 

The notion that marijuana has so-called medical purposes is also 

changing the perception of this drug cannot be so harmful if it has 

medicinal properties. And the whole perception of risk is changing, 

99 

which, again, has opened the willingness of young people to take 

marijuana and to consume it regularly. 

Mr. BURGESS. Well, I do hope that you are monitoring the situation, since society has provided you the experimental situation. I 

also hope that you are preparing to deal with what the downstream 

effects are from this rather bold social experiment that some of the 

states are undertaking right now. And I hope that is more than 

just sending more money to those states. I hope that it is something that you are—that oversight is happening at your level, that 

there will be a national monitoring of this. 

Dr. VOLKOW. The way that we oversee research protocol is very, 

very rigorous. If the scientist is not producing or the methodology 

is not adequate, we do not fund them. 

Mr. BURGESS. Just speaking of downstream effects, there is also 

the issue, and it has been brought up several times this morning, 

and any of you feel free to comment on this, the issue of, of course, 

the device by which the drug is administered, and then the possibility for exposure to Hepatitis B or C, or HIV. From a public 

health perspective, are we preparing ourselves for any differences 

in the incidence of these illnesses as a consequence of the delivery 

device? 

Mr. BOTTICELLI. I will start on that. One of the main concerns 

of HHS has been, obviously, the increase in viral hepatitis and hepatitis C among the very young cohort of injection drug users. So we 

have been working in concert with the Health and Human Services 

who has put forth actually an action plan to diminish viral hepatitis, and clearly, there is a lot of overlap in terms of the issues 

that we are talking about here. So this is obviously a significant 

public health concern, so we want to make sure that we are dealing 

with this in a concerted way. 

Mr. BURGESS. Yes, and, of course, the good news right now is 

Hepatitis C is one of those things that looks very well like there 

may be a cure that is not just on the horizon but is here. The only 

problem is it is very expensive. And my differences with Mr. Green 

over the Affordable Care Act aside, ultimately though, someone has 

to pay for that, so I hope we are doing the necessary—I hope we 

are monitoring and doing the necessary preventive things to keep 

that in check, and to prevent the disease, rather than just simply 

now being able to cure it with a very expensive therapy that, 

thankfully, is available. 

Mr. Botticelli, did you have some additional observations on the 

issue of the states that are legalizing marijuana? 

Mr. BOTTICELLI. I do, and what I wanted you to know is that in 

addition to the additional NIDA grants that are out there, our office has actually convened a group of Federal partners to look at 

the eight criteria that the Department of Justice has laid out for 

Colorado and Washington, and are really committed to gathering 

data on the Federal, state and local level, looking at what is the 

impact in terms of legalization in Colorado and Washington have 

on both the public health and public safety consequences that we 

have. So in addition to some of the public health-related work that 

Dr. Volkow has funded, we are also looking at what are the public 

safety consequences, things like increase in drugged driving, interstate transportation of marijuana from Colorado to other states. So 

100 

our office has really been committed in terms of ensuring that we 

have good public health and public safety data to monitor what is 

happening in Colorado and Washington. 

Mr. BURGESS. And, Mr. Rannazzisi, I would assume that your 

agency is participating in that as well? 

Mr. RANNAZZISI. It still is a Schedule I controlled substance. We 

are still doing investigations concerning marijuana downstream. 

Mr. BURGESS. And are you monitoring the downstream effects in 

neighboring states, in the incidences—as Mr. Botticelli talked 

about, the incidence of driving while impaired, the incidence of 

even just crime, are you compiling those statistics so they will be 

available to policymakers in subsequent hearings? 

Mr. RANNAZZISI. We are talking to our state and local counterparts in all of the surrounding states, and we are gathering information. I don’t know how all-inclusive that information is because, 

quite frankly—some of the state and locals are not keeping that 

type of information, but we are keeping tabs with our state and 

locals on what is going on within their states. 

Mr. BURGESS. Very well. 

Mr. GRIFFITH. Mr. Chairman. 

Mr. BURGESS. Yes, the Chair recognizes the gentleman from Virginia. 

Mr. GRIFFITH. I would be remiss, since we have taken on marijuana, not to mention that I have just introduced a Bill to legalize 

the use of marijuana in medicinal circumstances, akin to the Virginia plan that was passed in 1979, that requires a doctor’s prescription, thus, changing the scheduling. The Bill actually calls for 

the changing of the scheduling. The DEA is in a tough spot. Some 

of these states are doing it, but it is still a Schedule I, which means 

that the DEA has a hard time collecting the data that you just 

asked for without stumbling across felons that they are not prosecuting. So they are in a catch 22. I think it is much better to have 

doctors and pharmacists, and the regular system working, because 

then you get real data for your scientists to look at and see if it 

is effective, as they designed it to be. 

So the Bill doesn’t go as far as Colorado or Washington might 

want it, or the Crazy California Plan as I often call it, but it allows 

real doctors with real pharmacists and real distributors, controlled 

by and under the laws of the United States, to use true marijuana 

if it can be used in a real way medicinally. 

Mr. BURGESS. Very good. The gentleman yields back. 

I am all for giving doctors more power. 

That actually concludes all of the questions that we have from 

members. I neglected to mention at the start of the hearing, ask 

unanimous consent that members’ written opening statements be 

introduced into the record. Without objection, the documents will 

be entered into the record. 

In conclusion, I would like to thank all of our witnesses. I will 

thank the member that have participated in today’s hearing. I will 

remind members they have 10 business days to submit questions 

for the record, and I will ask the witnesses to all agree to respond 

promptly to the questions submitted in writing. 

With that, the subcommittee is adjourned. Thank you for your 

attendance today. 

101 

[Whereupon, at 12:06 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Three months ago, the country was shocked and saddened by the death of actor 

Philip Seymour Hoffman. Like many who battle addiction, Mr. Hoffman struggled 

to stay clean as he alternated between pain pills and heroin. His story is far too 

common. Opiate addiction surrounds us—from cities, rural towns, and affluent suburbs—and it breaks our heart to see so many families torn apart by abuse of drugs 

that are both legal and illegal. 

My own district has suffered terribly from opiate overdoses. Last year, more than 

90 people in Westmoreland County lost their lives to prescription drug and heroin 

abuse. That was four times the number of overdose deaths in the county compared 

to a decade ago. Allegheny County saw more than 20 deaths linked to fentanyl-laced 

heroin this past January. 

Heroin-related deaths have increased 400 percent in Cleveland. Vermont Governor Peter Shumlin dedicated his entire annual ‘‘State of the State’’ address to 

what he called the ‘‘fullblown heroin crisis’’ facing his state. Kentucky, West Virginia, New Mexico, and other states are also experiencing rising rates of prescription drug overdoses and heroin abuse. 

Here’s the awful truth about this public health crisis: prescription painkillers are 

involved in more overdose deaths than cocaine and heroin combined. Prescription 

drug abuse kills more than 16,000 people a year. 

While most prescription drug abusers do not go on to abuse heroin, data from the 

White House Office of National Drug Control Policy (ONDCP) and the Substance 

Abuse and Mental Health Services Administration (SAMHSA) indicates that 81 percent of people who started using heroin in 2008 to 2010 had previously abused prescription drugs. 

As authorities have cracked down on access to legal pain killers in the last five 

years, heroin use has risen by an astonishing 79 percent. 

Certainly, there is a law enforcement aspect to solving this problem and stopping 

the bad actors who illegally distribute prescription drugs or traffic heroin. But the 

other part of the equation is treating addiction to prescription drugs and heroin— 

and preventing deaths. 

The purpose of today’s hearing is to examine the federal public health response 

to prescription drug and heroin abuse. Our oversight has revealed that this is a 

complex problem. For example, 40 percent of those who abuse drugs have an underlying mental illness. Treating their addiction successfully necessarily means that 

the underlying mental illness must be successfully diagnosed and treated. 

But just as when someone has a mental illness, those who are battling addiction 

are unlikely to get effective treatment, too. More than 90 percent of persons with 

a substance abuse disorder won’t get medical care. And of those who are enough 

to access care, 90 percent of them will not get evidence-based treatment. 

There are effective treatments available, but too often the substance abuse debate 

is divided between those who adhere to the abstinence or 12-step model, and those 

who promote medical assistance therapies. These groups must come together and 

find a solution because thousands of lives are at stake. 

As the testimony of Mr. Botticelli, the Acting Director of the Office of National 

Drug Control Policy, states, substance abuse is a ‘‘progressive disease.’’ Those who 

suffer from addiction often start at a young age, with alcohol and marijuana, and 

then move to other drugs like opioids. In examining opioid abuse, we must also consider the factors that lead people to abuse—and how federal programs are addressing them. 

Prescribing practices are an issue. Roughly 20% of prescribers prescribe 80% of 

all prescription painkillers. Those suffering from chronic and debilitating pain need 

access to opiates, but we also need to make sure those individuals who develop an 

addiction are referred to treatment. Right now, too many states lack a robust prescription drug monitoring program that would help physicians and emergency rooms 

keep tabs on patients receiving powerful opiates. 

Educating doctors and pharmacies about appropriate prescribing will address one 

part of the problem—but addicts also get these drugs through illegal channels, such 

as rogue Internet pharmacies, off the street, and even from the medicine cabinets 

of family members and friends. 

The federal government is devoting significant resources to drug control programs—over $25 billion annually, of which about $10 billion goes toward drug abuse 

prevention and treatment programs across 19 federal agencies. With 19 agencies 

102 

having a hand in over 70 drug control programs, we have to ask, ‘is our current 

approach working and what can we do better?’ Oversight by the federal agencies is 

also an important issue, as significant funding is block granted to states for treatment programs. How are you confident that we are funding treatments with the 

best chances of success in preventing and treating opiate abuse? 

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