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78–123 2013

H.R. 5710, THE NATIONAL ALL SCHEDULES 

PRESCRIPTION ELECTRONIC REPORTING 

REAUTHORIZATION ACT OF 2010; AND H.R. 

5809, THE SAFE DRUG DISPOSAL ACT OF 

2010 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

JULY 22, 2010 

Serial No. 111–146 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

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

New Jersey, opening statement .......................................................................... 1 

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

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 20 

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

of Pennsylvania, opening statement ................................................................... 21 

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

opening statement ................................................................................................ 21 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 23 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 23 

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

California, prepared statement ........................................................................... 60 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 63 

WITNESSES

R. Gil Kerlikowske, M.A., Director, Office of National Drug Control Policy ...... 25 

Prepared statement .......................................................................................... 27 

Joseph Rannazzisi, J.D., Deputy Assistant Administrator, Office of Diversion 

Control, United States Drug Enforcement Administration .............................. 38 

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

SUBMITTED MATERIAL

H.R. 5710 .................................................................................................................. 8 

H.R. 5809 .................................................................................................................. 15 

Letter of February 28, 2010, from National Association of Chain Drug Stores 

to Committee ........................................................................................................ 67 


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H.R. 5710, THE NATIONAL ALL SCHEDULES 

ELECTRONIC REPORTING REAUTHORIZATION ACT OF 2010; AND H.R. 5809, THE SAFE 

DRUG DISPOSAL ACT 

THURSDAY, JULY 22, 2010 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The Subcommittee met, pursuant to call, at 10:04 a.m., in Room 

2322 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. [Chairman of the Subcommittee] presiding. 

Members present: Representatives Pallone, Green, Barrow, Inslee, Shimkus, Whitfield, Pitts and Gingrey. 

Staff present: Karen Nelson, Deputy Committee Staff Director 

for Health; Ruth Katz, Chief Public Health Counsel; Naomi Seiler, 

Counsel; Rachel Sher, Counsel; Stephen Cha, Professional Staff 

Member; Emily Gibbons, Professional Staff Member; Anne Morris, 

Professional Staff Member; Alvin Banks, Special Assistant; Ryan 

Long, Minority Professional Staff Member; and Clay Alspach, Minority Professional Staff Member. 

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

Mr. PALLONE. I call the meeting to order. 

Today we are having a hearing on NASPER and safe drug disposal, and I will recognize myself initially for an opening statement. 

The two important pieces of legislation that we are addressing 

basically deal with the growing crisis of abuse of prescription medications. First is the reauthorization of the National All Schedules 

Prescription Electronic Reporting Act, or NASPERR. This is a bill 

that I believe the gentleman from Kentucky is the prime sponsor 

but myself and others on the subcommittee have been involved 

with it in the past. And secondly is the Safe Drug Disposal Act. 

According to the 2010 National Drug Control Strategy put forth 

by the White House, prescription-drug abuse is the fastest-growing 

drug problem in the United States. Since 1999, deaths from drug 

use have more than doubled, surpassing homicide, suicides and 

gunshot wounds as causes of death, and this increase in drug overdose death rates is largely because of prescription opioid painkillers. Deterrence of prescription-drug abuse is complicated by the 


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fact that prescription drugs are often obtained with ease from those 

closest to the drug abuser. Studies show that upwards of 70 percent of people who use prescription drugs for non-medical purposes 

got them from a friend or relative for free, for money or by stealing 

them, sometimes unnoticed from the family’s medicine cabinet, and 

many people, particularly teenagers, believe prescription drugs are 

safer than illicit drugs because they are prescribed by a health care 

professional. 

The Office of National Drug Control Policy working with other 

federal, State and local community partners has taken a leadership 

role in promoting comprehensive strategies that ensure prescription drugs are only used for their intended purpose and that unused or expired medications are disposed of in a timely, safe and 

environmentally responsible manner. Ridding the family medicine 

cabinet of leftover prescription drugs is easier said than done for 

a variety of reasons. 

I am therefore particularly proud of an initiative in my State, 

New Jersey, last year supported by the Administration called Operation Medicine Cabinet. This was the first in the United States 

where we had a statewide day of disposal of unused, unwanted and 

expired medicine. New Jersey residents in communities in all 21 

countries participated in a public health initiative sponsored by the 

Drug Enforcement Administration, or DEA, in New Jersey. This 

was in the Office of the Attorney General and also in combination 

with the Partnership for a Drug-Free New Jersey. 

I should note that the huge success of New Jersey’s program led 

to the creation of the American Medicine Chest Challenge, which 

is a national day of prescription-drug disposal that will be held this 

November 13th. 

Today we will hear from the Administration on their support for 

the Safe Drug Disposal Act, which will make necessary changes in 

the Controlled Substances Act to make it easier for people to return unwanted drugs through the drug take-back programs, and 

this bill is the product of the hard work of Representative Inslee 

and also Representative Bart Stupak. 

Now, we are also going to hear from our distinguished panel 

today on their support to reauthorize the second bill, the NASPER 

bill. This law, which was originally enacted in 2005, created an 

HHS grant program administered by SAMHSA for States to establish prescription-drug monitoring programs. PDMPs track drug 

prescriptions with the goal of preventing overuse and illegal diversion. Approximately 40 States maintain PDMPs or have laws that 

authorize their establishment. Starting in fiscal year 2009, Congress appropriated funding to support NASPER grants in 13 States 

and the bill before us will reauthorize the program until 2013. 

I mentioned that NASPER was an initiative that Representative 

Whitfield, who is here now, worked on in 2005. You also, Mr. Shimkus, Bart Stupak, were involved in this. I think it is a good program. It certainly needs to be reauthorized. 

[The prepared statement of Mr. Pallone follows:] 


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Mr. PALLONE. So now I would recognize Mr. Shimkus for his 

opening statement. 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

I want to welcome our panel this morning. I think these bills are 

another good example of what we can do when we work together. 

These two pieces of legislation will both aid in tackling drug safety 

issues in the United States. 

First, we will do so by reauthorizing the NASPER. NASPER addresses use and access problems. By reauthorizing this, we will ensure funds remain accessible to strengthen existing State programs 

while new ones get off the ground. I was an original cosponsor, as 

you mentioned, along with yourself and our colleague from Michigan, Mr. Stupak, and I want to really congratulate my colleague 

from Kentucky, Mr. Whitfield, who is the lead sponsor and the 

champion of the bill. His leadership has been very, very helpful 

and I am also glad he made it here on time for the hearing. 

We also have the Safe Drug Disposal Act, which will ease the 

cumbersome process of disposal of unused controlled substance. 

There is a system in place for safe distribution of controlled substances. It only makes sense that we establish the same for the disposal of these drugs. Pharmacies and many others on the State and 

local level stand ready to provide these services in their communities if given the ability. 

The Safe Drug Disposal Act would create these avenues by working with existing framework of already up-and-running drug takeback programs. I support this legislation and thank the chairman 

for continuing to work with the minority to get language to a comfortable level for everyone. I also look forward to continuing to 

work together to help move both of these bills through the committee for consideration and by the House. 

Finally, last week I mentioned the desire from our side to invite 

Dr. Berwick to testify before this committee. Obviously I haven’t 

heard a response yet so we will be formalizing a letter to Chairman 

Waxman for a request to do that. We know that Dr. Berwick is now 

officially in his role as CMS director. He will serve in a key role. 

He had made some very interesting comments and we just need to 

have a chance to ask him about those comments or how he will operate in his new position or if there is some change as far as the 

rationing debate and how we will handle this new health care law. 

It is the biggest thing we have done since I have been here in Congress, and it is just time to start getting some questions answered 

on this. 

I am not going to belabor the point, Mr. Chairman. You have 

heard it before. And I will yield back my time. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Barrow. 

Mr. BARROW. Thank you. I will waive. 

Mr. PALLONE. The gentleman waives. 

Next we have the gentleman from Kentucky. I think I should 

mention that he—oh, Mr. Pitts. Oh, I am sorry. The gentleman 

from Pennsylvania, Mr. Pitts. 


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

OF PENNSYLVANIA 

Mr. PITTS. Thank you, Mr. Chairman. 

There is no doubt that prescription-drug abuse and particularly 

abuse of controlled substances is a serious problem in our country. 

The cost to society is high in lost productivity and wasted lives but 

also in direct costs to many government programs. 

In September of last year, GAO released a study on Medicaid 

fraud and abuse related to controlled substances. In just this one 

federal program in just five States surveyed, GAO found the following: ‘‘Tens of thousands of Medicaid beneficiaries and providers 

were involved in potential fraudulent purchases of controlled substances, abusive purchases of controlled substance or both through 

the Medicaid program in California, Illinois, New York, North 

Carolina and Texas. About 65,000 Medicaid beneficiaries in the five 

selected States acquired the same type of controlled substance from 

six or more different medical practitioners during fiscal years 2006 

and 2007 with the majority of beneficiaries visiting from six to 10 

medical practitioners.’’ These activities, known as doctor shopping, resulted in about $63 

million in Medicaid payments and do not include medical costs, 

that is, office visits, related to getting the prescriptions. GAO even 

found that according to Social Security Administration data, pharmacies filled controlled substance prescription of over 1,800 beneficiaries who were dead at that time. 

These examples come from just one government program and 

they represent just one facet of the problem. But today we are addressing a tool that can be used to cut down on the fraud and 

abuse associated with controlled substance. The National All 

Schedules Prescription Electronic Reporting Reauthorization Act, 

or NASPERR, allows doctors to access the controlled substances 

prescription history of their patients in an effort to detect and deter 

abuse. I am pleased to be a cosponsor of this commonsense piece 

of legislation which had it been in place and funded during the 

time GAO was doing this study might have reduced the amount of 

doctor shopping that went on, may have prevented some of these 

fraudulent prescriptions for controlled substances from being written and may have saved taxpayers millions of dollars. 

I look forward to hearing from our witnesses. Thank you, and I 

yield back. 

Mr. PALLONE. Thank you, Mr. Pitts. 

Mr. Green, I know you just walked in. Would you to do an opening statement? 

Mr. GREEN. What about my colleague? 

Mr. PALLONE. I already tried him. He waived. 

Mr. GREEN. Well, then I will give mine. 

Mr. PALLONE. The gentleman from Texas is recognized. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing 

today. We actually have subcommittees dealing with health care 


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issues, one in our first-floor committee room, and I apologize for 

being late. 

Thank you, Mr. Chairman, for holding this hearing on prescription-drug monitoring programs in the NASPER program, which 

Congress enacted in 2005. Our ranking member, Mr. Whitfield, 

was author of the National All Schedules Prescription Electronic 

Reporting Act, and I am proud to have been a cosponsor of this bill 

and supported it when it came through our committee in both the 

108th and 109th and now again in the 111th. 

The NASPER was clear to us then as it is now on both law enforcement level and drug safety level with safe prescription monitoring programs sporadic and not interoperable. It is relatively 

easy for individuals who abuse prescription drugs to doctor-shop for 

controlled substances or obtain prescription drugs illegally with little detection from physicians or law enforcement. 

The Texas prescription-drug monitoring program called the 

Texas Prescription Program was established more than 25 years 

ago in 1981. Each year the Texas Prescription Program collects 3.3 

million prescriptions and monitors schedule II prescription drugs. 

During the first year of the Texas Prescription Drug Program enactment, the number of schedule II prescriptions filled in the State 

fell by 52 percent. The program helped the State crack down on the 

pill mills and forged prescriptions but it is clearly a law enforcement program and housed at the Texas Department of Public Safety. 

Without question, prescription-drug monitoring programs offer 

significant benefits for law enforcement but they should go hand in 

hand with drug safety and public health benefits. I am pleased that 

we are here to discuss reauthorizing the program and I fully support the legislation introduced by Mr. Whitfield, Mr. Stupak and 

Mr. Pallone. 

Additionally, we discussed legislation introduced by Mr. Stupak 

and Mr. Inslee on drug take-back programs. I am an original cosponsor of Mr. Inslee’s legislation, the Safe Drug Disposal Act, 

which amends the Controlled Substances Act to allow end users or 

caretakers of an end user to safely dispose of unused prescription 

drugs and over-the-counter drugs through the Drug Enforcement 

Agency approved State-run drug take-back programs. Current law 

and DEA enforcement of the Controlled Substances Act can make 

it extremely difficult for end users to turn over unused meds for 

safe disposal. DEA rules are very strict and controlled substance 

can only be passed into the possession of law enforcement, which 

means they must be present at collection sites and drives. This requires coordination of law enforcement as part of this effort and it 

is impossible to have law enforcement at every collection site. 

There is also a lack of public awareness of this rule and on what 

constitutes a controlled substance. This is a barrier in properly disposing of unused medications. Today unused meds are becoming a 

gateway to drug abuse, and flushing down the toilet can be harmful to our environment. We want to assist States and localities by 

facilitating the safe disposal of prescription medication, and I know 

Mr. Stupak and Mr. Inslee have been working to combine their legislation. I look forward to supporting their efforts. 

And again, I thank our witnesses for being here, Mr. Chairman. 


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Mr. PALLONE. Thank you, Mr. Green. 

And now Mr. Whitfield. I should tell you that Mr. Whitfield talks 

about NASPER all the time and has been constantly trying to improve and implement the program since he first got involved. I recognize the gentleman. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Well, thank you, Chairman Pallone and Ranking 

Member Shimkus. I would like to thank also Gene Green and Bart 

Stupak as well as Chairman Pallone and John Shimkus because it 

did take a real effort to get this legislation where it is today, and 

I might add that there was a program initiated in the Appropriations Committee a number of years ago around 2002 and they appropriated money that went to the Justice Department, and that 

prescription-drug monitoring program was primarily focused on 

law enforcement, which is vitally important, but the program had 

never really been authorized, and the Energy and Commerce Committee did have jurisdiction and we were able to introduce the legislation. It has been passed. There is now a monitoring program in 

40 States, and we think it has potential to do a great deal of good 

for the American people to provide information for physicians as 

they treat patients that go across State lines and will dramatically 

improve the safety and effectiveness of our medical system. 

So I look forward to the hearing today. I know the markup is 

going to be later this afternoon. But all of us know how complex 

health care is and how difficult the issues are, and frequently when 

I am at home, people ask me, well, you don’t know anything about 

health care so how can you be up there doing what you are doing. 

Fortunately, we have Dr. Gingrey, who is a doctor, and I guess Dr. 

Burgess, but also some of us are fortunate to have some advisors 

that came up here as interns sometimes, and we have one with us 

this morning that is working on our staff for a while, and it’s Dr. 

Jason Pope, and he is right here. He is on the staff at Cleveland 

Clinic and he is an assistant professor of anesthesiology at Vanderbilt. So I do want you all to know that we feel like we have some 

good, competent advice on a lot of these issues and we are glad to 

have Dr. Pope with us for a while here in Washington, D.C. 

And I yield back the balance of my time. 

Mr. PALLONE. Thank you. 

I should mention there has been a change in plans. I think we 

have notified the staff that our intention is to have the markup 15 

minutes after the hearing, so I don’t know when that is exactly 

going to be but we are trying to move things as quickly as we can, 

so I thought I would mention that. 

The gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you. I thank Mr. Whitfield 

for his kind remarks about me and Dr. Burgess. I thank God for 

Dr. Pope because our information is a little dated, and I am sure 


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that if Burgess was here, he would say well, Gingrey’s is a lot more 

dated than mine. 

In any regard, Mr. Chairman, thank you for holding the hearing 

today. Prescription-drug abuse is a major problem in this country. 

In my home State of Georgia, the fact that a number of pain clinics 

were charged with illegally prescribing strong narcotics to patients 

is but one reminder that our country is not doing enough to curb 

this startling trend. 

Prescription drugs, when taken appropriately for a medical condition, can improve a patient’s quality of life or help them cope 

with a debilitating illness. However, when they are improperly 

taken, they can lead to chemical dependency, certainly from these 

pain clinics, and subsequently great hardship, loss of job, loss of 

marriage, loss of home. I could go on and on. 

The two pieces of legislation that we are going to consider this 

morning have been drafted hopefully to address this problem, and 

I would like to thank the sponsors for their work in this area. Of 

particular note, I want to thank Congressman Whitfield for his continued efforts in electronic prescribing reporting through NASPER. 

It has been 5 years since Congressman Whitfield first championed 

the legislation into law and I am proud that I was asked to be a 

cosponsor of these efforts here today. I believe that the reauthorization of NASPER is a necessary step in the fight to address prescription-drug abuse and it will give States the support that they 

need to help prevent the overuse and illegal diversion of prescription drugs, particularly pain medication. 

In addition, I would like to commend the sponsors of the various 

pieces of legislation that the subcommittee will be marking up this 

afternoon, both those that I serve with here on the committee and 

those off of the committee for their efforts. Given the nature of today’s dual hearings, I would like to take a moment and single out 

a few sponsors personally for their efforts. First, Chairman 

Stupak’s legislation, H.R. 903, the Dental Emergency Responders 

Act of 2009, is a commonsense solution to a problem that could 

benefit many during a national emergency. Therefore, I want to 

thank Chairman Stupak for sponsoring this legislation and I look 

forward to supporting it today. 

Dr. Tim Murphy, my colleague on the committee and a fellow cochair of the GOP Doctors Caucus, has advocated tort protection for 

volunteer providers, physicians from this committee for a few years 

now and I know our peers in the medical community appreciate his 

efforts. I look forward to supporting that bill, H.R. 1745, in committee today, and as a cosponsor going forward. 

To all my colleagues, I understand that the process that led us 

here today has been a bipartisan one, thank goodness, for a 

change. And for that, I would like to commend Chairman Pallone 

and Ranking Member Shimkus for their efforts, and Mr. Chairman, 

I will yield back now. 

Mr. PALLONE. Thank you, Mr. Gingrey. 

I think we are done with our opening statements. We will turn 

to our two witnesses. Let me introduce them at this time. First on 

my left is the Hon. Gil Kerlikowske, who is Director of the Office 

of National Drug Control Policy, and then we also have Joseph 

Rannazzisi, who is Deputy Assistant Administrator from the Office 


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of Diversion Control for the U.S. Drug Enforcement Administration. I can’t believe I got those two right. Your names are so long. 

We ask you to try to keep to 5 minutes, although you are the 

only two, so I am not going to be strict, and then you can submit 

comments if you wish for the record, and after the hearing you may 

get additional written questions from us beyond what we question 

you on today. 

So we will start with Mr. Kerlikowske. 

STATEMENTS OF HON. R. GIL KERLIKOWSKE, M.A., DIRECTOR, 

OFFICE OF NATIONAL DRUG CONTROL POLICY; AND JOSEPH RANNAZZISI, J.D., DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, UNITED STATES 

DRUG ENFORCEMENT ADMINISTRATION 

STATEMENT OF R. GIL KERLIKOWSKE 

Mr. KERLIKOWSKE. Thank you, Mr. Chairman and Ranking Member Shimkus and the distinguished members of the subcommittee. 

I think you have already made it very clear about the numbers, the 

information that has been provided as the CDC has said determined the epidemic and prescription-drug issues, so I will move 

past some of that. 

But reducing prescription-drug diversion and abuse has been a 

major focus of the Office of National Drug Control Policy since my 

arrival a little over a year ago, and we have made it one of three 

signature initiatives within the office. The significant contributing 

factor to the diversion and abuse of prescription drugs is the widespread availability. Many people are not purchasing prescription 

drugs from a drug dealer on the street. In 2007 and 2008, among 

the persons aged 12 or older who used pain relievers non-medically 

in the past 12 months, approximately 70 percent report having obtained the pain relievers from a friend or a relative. So this problem doesn’t lend itself to traditional interventions. These drugs are 

originally dispensed, as Dr. Gingrey mentioned, for legitimate purposes and too often the public’s perception is that they are safe for 

uses other than those for which they are prescribed, and we have 

to help change that public perception and the societal norm to one 

where unused or expired medications are disposed of in a timely, 

safe and environmentally responsible manner. 

One aspect of President Obama’s National Drug Control Strategy 

relates directly to the disposal of unused or unwanted prescription 

drugs, and the family medicine cabinet is a significant source of diversion for those seeking to abuse prescription drugs. Yet the difficulty in disposing of such medications in a fashion that is simple, 

legal and environmentally responsible has been a challenge. 

Currently, the federal government advises controlled-substance 

users to dispose of controlled substances in one of three ways: to 

throw them in the trash after taking proper precautions, to flush 

down the toilet in limited cases for the very dangerous drugs, or 

to participate in take-back programs, as had been mentioned earlier, oftentimes community-based with the approval of DEA and in 

conjunction with law enforcement. 

This legislation that the subcommittee is considering today will 

facilitate the establishment of pharmaceutical take-back programs 


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around the country by making a statutory change to the Controlled 

Substances Act. This step is required before the Drug Enforcement 

Administration can fully implement the legitimate take-back of frequently abused prescription drug products containing controlled 

substances, and such a step will greatly improve the ability of consumers to legally, safely and securely dispose of drugs. 

The strategy also calls for the expansion of prescription-drug 

monitoring programs. These statewide databases recording the controlled substances dispensed by doctors, nurse practitioners and 

prescribers is important, and reauthorization of H.R. 5710, the National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010, will be a great step in that direction. Information 

contained in a PDMP can be used by prescribers to guard against 

prescribing two or more drugs that might have negative interactions, can be used by pharmacists or prescribers to identify patients who may be shopping for prescriptions to sustain a prescription-drug addiction, and under specific circumstances by regulatory 

and law enforcement officials when pursuing cases involving rogue 

prescribers or pill mills. Prescription-drug monitoring programs are 

authorized in 43 States but only 34 States’ programs are fully operational. 

Each State’s PDMP authorizing legislation determines where and 

how the PDMP in that State will function. We must ensure every 

State has a functional PDMP in place, prescribers and pharmacists 

regularly use these databases, and that PDMPs are developed with 

the capability to share information across State lines. 

If these two measures are approved that are under consideration 

today, I believe it will be a tremendous step in the direction of limiting the harmful consequences of prescription-drug abuse in this 

country. I look forward to working with this subcommittee and I 

look forward to answering any of your questions. Thank you. 

[The prepared statement of Mr. Kerlikowske follows:] 


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Mr. PALLONE. Thank you. 

Mr. Rannazzisi. 

STATEMENT OF JOSEPH RANNAZZISI 

Mr. RANNAZZISI. Thank you, Chairman Pallone, Ranking Member 

Shimkus and distinguished members of the subcommittee. On behalf of Acting Administrator Michelle Leonhart and the nearly 

10,000 members of the Drug Enforcement Administration, I am 

honored to appear before you today to provide testimony concerning 

two very important measures that will help stem the growing tide 

of pharmaceutical controlled substance diversion and abuse, the 

disposal of pharmaceutical controlled substances from our household medicine cabinets and the creation and utilization of prescription-drug monitoring programs. I would be remiss in not thanking 

Director Kerlikowske for his leadership in these initiatives and addressing the overall problem of drug abuse. 

Addressing the diversion and abuse of pharmaceutical controlled 

substances continues to be one of the DEA’s top priorities. One way 

to accomplish this goal is to help our communities dispose of unwanted, unused or expired controlled substances that remain in 

household medicine cabinets long after they are needed. The medicine cabinet provides easy and free access to controlled substances 

by drug seekers and non-medical users such as teenagers and increases the risk of accidental ingestion and poisoning of children 

and the elderly. The Controlled Substances Act provides for a 

closed system of distribution with stringent procedures on procurement, distribution and possession of controlled substances. As part 

of this closed system, all persons who possess controlled substances 

must either be registered with the DEA or be exempt from registration. Under the Controlled Substances Act, ultimate users or 

patients are exempt from the requirement of registration when 

they possess this drug for a legitimate medical purpose. Although 

exempt, this exemption does not allow ultimate users to transfer 

controlled substances to any entity, even if the sole purpose of that 

transfer is for disposal. Therefore, the ultimate user or household 

member is left to personally dispose of the controlled substance. In 

many cases, the drugs remain in the household indefinitely or disposed of in an inappropriate manner, potentially impacting the 

water supply and environment. 

States, countries and municipalities have tried to develop pharmaceutical collection and disposal programs to address the problems resulting from unwanted or unused medicines in household 

medicine cabinets. These programs are beneficial in many ways but 

the Controlled Substance Act provides for the collection and disposal of controlled substances in very limited circumstances. DEA 

has provided technical guidance to various law enforcement agencies’ efforts to conduct collection and disposal initiatives over the 

last several years but these operations were limited to specific cities or counties. As the chairman mentioned, in November 2009 

DEA Newark in cooperation with the Partnership for Drug-Free 

New Jersey, State and local law enforcement partners and community coalitions initiated Operation Medicine Cabinet. In just 4 

hours, over 9,000 pounds of unused, unwanted and expired meds 


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were collected at law enforcement-run community collection sites 

throughout the State. 

In order to stop the diversion of pharmaceutical controlled substances from the medicine cabinet, there must be a means by which 

ultimate users can transfer these substances to other entities for 

disposal. There are several bills pending to address this issue. In 

May 2009, the Department of Justice issued a views letter in support of H.R. 1359, the Secure and Responsible Drug Disposal Act 

of 2009. This bill provides a means by which ultimate users may 

lawfully transfer controlled substances to other entities for disposal, affords the Attorney General discretion to promulgate regulations and provides the requisite flexibility to address collection 

and disposal in a comprehensive manner. Without this legislation, 

DEA does not have authority to create a regulatory infrastructure 

to support the transfer of controlled substances from ultimate users 

to others for disposal. 

Another initiative to address diversion and abuse of pharmaceutical controlled substances is the implementation and utilization 

of State prescription-drug monitoring programs. Although these 

programs vary from State to State, in general PDMPs reduce prescription fraud and doctor shopping by providing doctors and pharmacists with information concerning a patient’s prescription history 

while ensuring patient access to needed treatment. Doctor shopping 

by drug seekers is one of the most common ways individuals unlawfully obtain pharmaceutical controlled substances. A doctor 

shopper may or may not have a legitimate medical condition. He 

or she visits several doctors that ultimately prescribe controlled 

substances for the same medical condition. The acquired drugs are 

then used to feed addiction or for illegal sale and distribution. 

When authorized, PDMPs can assist law enforcement agencies 

and State regulatory bodies in the investigation of individuals involved in doctor shopping or medical professionals or individuals 

involved in the division and illegal distribution of controlled substances. Approximately 34 States currently have operational 

PDMPs and the DEA supports the establishment of these programs 

in every State and urges the States to work together to promote 

sharing of this information from State to State. 

In conclusion, the collection, removal and safe disposal of unwanted or unused medications from households and the expansion 

of PDMPs will reduce or even eliminate some potential avenues of 

drug diversion and ultimately limit the availability of medications 

to drug seekers and abusers. We look forward to working with Congress to establish a solid foundation for take-back disposal programs and support any effort to expand the implementation and 

utilization of PDMPs to minimize avenues for diversion while protecting the public health and safety. 

I thank the subcommittee for the opportunity to appear before 

you today and welcome any questions you may have. 

[The prepared statement of Mr. Rannazzisi follows:] 


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Mr. PALLONE. Thank you. 

We will take questions now from the panel, and I will start with 

myself, and I wanted to ask these questions of Mr. Kerlikowske. 

Basically I wanted to ask about the National Drug Control Strategy first and then about interoperability, and both relate to 

NASPER. 

With regard to your office, you recently released a new National 

Drug Control Strategy, and I want to know how State prescriptiondrug monitoring programs fit into that broader strategy and if you 

can describe how the office will promote prescription-drug monitoring programs through that strategy. 

Mr. KERLIKOWSKE. We have been very supportive of PDMPs, particularly shortly after coming into office and having visited south 

Florida and looked at some of the problems that were occurring 

with so-called pill mills in that area, and then visiting with other 

States. The Department of Justice has been very good about holding the PDMP workshops, bringing people together, and of course 

in this legislation, it would require that the director of ONDCP be 

involved in the advertising to people about how PDMPs can be 

helpful and can be useful, and so we are supportive of them. We 

have seen them work. We have worked with our partners at the 

Drug Enforcement Administration and could not think more highly 

of them. 

Mr. PALLONE. Okay. You know, Mr. Whitfield reminded me of 

the difficulties we have had over the years that he struggled with, 

you know how we had these sort of two different programs, and so 

my second question is if you agree that prescription-drug abuse 

needs to be considered a public health problem and not just a law 

enforcement problem, and what else is the office doing to reduce 

prescription-drug abuse? 

Mr. KERLIKOWSKE. We made it a signature effort in several 

ways. The first was that it actually until—and many members of 

this subcommittee have been involved in this but it really hasn’t 

been recognized for the dangerousness. When I was—and I will just 

give you a great example of my own lack of knowledge. I had been 

a police chief for a long time, and I actually think I keep up with 

the literature and really know this stuff inside out. When I was 

told at confirmation that more people are dying from drug 

overdoses than from gunshot wounds and that that was being driven by prescription drugs, I said well, you know, I really didn’t know 

that. I tested a number of my colleagues, none of whom I will 

name, to ask them if they also recognize the dangerousness of prescription drugs that were out there. Quite frankly, they did not either. And when I talked to judges and when I talked to prosecutors, they didn’t either. So first, getting this front and center with 

the American public about the dangers. 

The second thing is, is working with the hospitals, the Joint 

Commission on Accreditation, to help them develop protocols. We 

also have visited a number of medical schools. Quite often we don’t 

see an awful lot in the curricula for doctors throughout their training in recognizing dependence, in recognizing addiction and in understanding some of those problems. So those are just a few of the 

ways, and there are others that are highlighted in the drug control 

strategy. 


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Mr. PALLONE. Okay. And then on the interoperability issue, the 

bill sets a new requirement that States specify a timeline for 

achieving interoperability of their programs with bordering States 

that participate in the NASPER program and it also directs the 

Secretary to monitor States’ efforts to achieve interoperability. I 

know that that is important. I know it also began because of some 

of the concerns, you know, what they had in Kentucky where people were just going to other States. So my understanding is that 

the office is not trying to encourage all States to have identical prescription-drug monitoring programs. Is that accurate? Well, let me 

say this. Why is interoperability so important? Is it true that the 

office is not trying to encourage all States to have identical programs but then can different States’ programs achieve some level 

of interoperability even if they are not identical? 

Mr. KERLIKOWSKE. Mr. Chairman, I think that Kentucky led the 

way in working with the State of Ohio to absolutely address that. 

These statewide databases are important, and the fact that so 

much of the regulatory work is done by the Boards of Pharmacy 

and the medical boards and having a one-size-fits-all is not something that we would recommend. That being said, the NASPER legislation is particularly helpful because it lays down essentially 

basic guidelines for what should be included. And so that exchange 

of information among the States would be the things that would be 

most useful according to the practitioners that use these in identifying this. 

And lastly, I would tell you that again in our visit to the pill 

mills in south Florida, a number of arrests that occurred through 

the HIDTAs, which are part of ONDCP also, back in Kentucky, 

Tennessee and West Virginia, were people that were traveling from 

those three States to south Florida in order to obtain such things 

as OxyContin. 

Mr. PALLONE. So, but, I mean, again, you don’t see a problem in 

the fact that the programs aren’t identical in order to achieve the 

interoperability? 

Mr. KERLIKOWSKE. I don’t, as long as there is some basic information that can be exchanged electronically so that those boards 

and those States that need that basic level of information can use 

them and utilize them to begin to slow down or even reverse this 

terrible problem that you have identified. 

Mr. PALLONE. Okay. Thank you. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Mr. Director, a lot of my questions are similar to what the chairman mentioned, so obviously you feel that the prescription-drug 

monitoring program is an important aspect of this fight. That is 

question one. And we are talking about prescription drugs. A lot of 

the problems, even connecting—I border Mr. Whitfield’s district 

and I also border southeastern Indiana. What about the whole 

meth issue and ingredients that are not prescription-drug issues? 

You have the same issue as States themselves are trying to limit 

and have lists to prohibit the pseudoephedrine purchase across 

State lines. Can you speak to that? 

Mr. KERLIKOWSKE. I can. As you know, Mr. Shimkus, the Office 

of National Drug Control Policy was not as particularly attentive 


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to methamphetamine in its early years as I believe it should have 

been, and having spent 9 years in the West I clearly recognized the 

issue of methamphetamine. I don’t intend for ONDCP to allow that 

to happen again, and we want to make sure that we are on top of 

it. So methamphetamine in the grand scheme of our national drug 

issues is not as high as some other issues. On the other hand, 

when your small areas in southern Illinois or places just outside 

Seattle were being devastated by methamphetamine, we should 

have been on top of it and moved more quickly. Congress did that 

through the Combat Meth Act. 

Unfortunately, what we are seeing is that now the people who 

are so good at purchasing over-the-counter or behind-the-counter 

drugs through false IDs, et cetera, are circumventing the Combat 

Meth Act. We have seen two measures of success so far. One is in 

the State of Oregon, which has made pseudoephedrine a prescription only, and their numbers of methamphetamine problems are in 

single digits as far as laboratories. And then recently Governor 

Haley Barbour just signed into law in Mississippi similar legislation to make pseudoephedrine a prescription only. There is no definitive evaluation but certainly what we have seen in Oregon 

bears worth watching. 

Mr. SHIMKUS. Thank you. I appreciate the focus and your expertise in having to deal with this. 

Let me ask Mr. Rannazzisi, do you think the drug take-back bill 

allows DEA to mandate that registered entities implement or establish a drug take-back program, current registered entities? Your 

evaluation, what do you think this legislation does to them? 

Mr. RANNAZZISI. I think the legislation provides us with the opportunity to create a framework for drug disposal. When we create 

regulations for something like drug disposal, we don’t try and 

specify who, what or where. What we try and do is create a framework and allow people to fit within that framework. 

Mr. SHIMKUS. And just to follow up, the concern would be 

through regulations, mandates being placed on entities that currently don’t have mandates and then they will have the funds to 

be able to implement that, so that is the focus of this question and 

that is why I asked that. 

Mr. RANNAZZISI. I don’t think I could comment on how the regulatory process is going to proceed until we actually have a piece of 

legislation, and even then because of the APA rules, Administrative 

Procedure Act rules, I don’t believe I could comment on them. 

Mr. SHIMKUS. Well, and I agree, but part of this process is a twoway process. 

Mr. RANNAZZISI. Yes. 

Mr. SHIMKUS. So hopefully people are listening to comments here 

to realize that we want to make sure that an unfunded mandate 

may not fall upon someone who is not expecting it. 

Mr. RANNAZZISI. I could assure you that during rulemaking we 

go through notice and comment and we take all of those comments 

were very seriously. 

Mr. SHIMKUS. Yes, I am not asking you to commit yourself. I am 

just using the bully pulpit to just make a point. 

On these programs, who do you envision would run these programs? I mean, you have done some war gaming. 


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Mr. RANNAZZISI. Absolutely. The problem is that the programs 

are such a hodgepodge of different organizations and groups all 

surrounding law enforcement. At this point in time, you know, 

while we have not decided who would run the programs, we look 

to the States and the State regulatory boards to assist us with the 

program and kind of guide us along about what they would look 

at towards a program. So at this point in time, we always look to 

the States, you know, and take their recommendations to heart. So 

at this point in time we would probably look to the States. 

Mr. SHIMKUS. Mr. Chairman, that is all I have and I yield back. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. Kerlikowske, PDMPs track prescriptions for drugs that 

might be subject to diversion or abuse. However, it is important to 

monitor the tracking programs to find out what is working and 

what is not. Is SAMHSA collecting information to help evaluate the 

NASPER program? 

Mr. KERLIKOWSKE. Mr. Green, I actually don’t know what information SAMHSA is collecting but I can tell you there are two 

things going on with evaluations of prescription PDMPs. One is, 

and it is a bit dated now, the 2006 study that was done that 

showed some benefits of the PDMPs. The second thing is that the 

CDC will be releasing, I believe by the end of summer, some research and evaluation on PDMPs. I would tell you that they are 

not perfect and that we need to make sure that more prescribers 

are using the PDMPs. That will be a key aspect and I think it is 

perhaps one of the weaknesses. But it is part of the responsibility 

for all of us, I believe, to get that word out to the prescribers that 

this is an effective, useful database, and if they do engage in it, it 

will help them a great deal. 

Mr. GREEN. Are there any federal efforts to evaluate the State 

prescription-drug monitoring programs? 

Mr. KERLIKOWSKE. There are. The CDC effort is an evaluation, 

and I don’t know how many States, but it is an evaluation of different efforts in some of the different States. 

Mr. GREEN. I have one more question, Mr. Chairman. Let me 

find it. 

Mr. Rannazzisi, as we have heard, the Controlled Substances Act 

should not create a pathway for patients and others with leftover 

controlled substance to return them to pharmacies or take-back 

programs for proper disposal. To address the resulting problem, 

you stated the DEA has utilized existing regulations to assist law 

enforcement agencies to conduct community take-back programs. 

My question is, can you explain to us the logical issues and resource implications for the DEA in assisting these programs and 

can you describe how these programs ideally would operate if we 

amended the Controlled Substances Act so the DEA could issue 

regulations to enable drug take-back programs to accept these controlled substances? 

Mr. RANNAZZISI. First of all, I noticed somebody on the panel 

mentioned that it was DEA regulations, a problem with DEA regulations. It is not a regulation problem, it is a statutory problem. 

The statute prohibits anyone, except for registrants, from transferring controlled substances. When an ultimate user obtains a conVerDate Mar 15 2010 04:32 Mar 28, 2013 Jkt 078123 PO 00000 Frm 00058 Fmt 6633 Sfmt 6633 E:\HR\OC\A123.XXX A123

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trolled substance, he is exempted from the registration requirement 

of the Controlled Substances Act. Because law enforcement has an 

exemption also, they could obtain or take in controlled substances. 

Currently, that is the only way we could do this, DEA or law enforcement working with communities, but the law enforcement office or the law enforcement agency has to be present, has to take 

that drug. It can’t be done by any other person but the law enforcement agency. 

I can’t tell you exactly how the—since we don’t have the bill yet, 

I can’t tell you exactly how we would create an infrastructure. 

What I can tell you is law enforcement will still probably be involved, not so much on every take-back program but they will still 

have the exemption and they will still want to be involved. I know 

that our law enforcement partners on all of these initiatives have 

been very straightforward with us. They want to be involved because this is so important to them. As the director said, prescription-drug abuse is a nationwide problem and law enforcement is 

very aware of that problem and they will do everything in their 

power to remove those drugs from the illicit market. 

Mr. GREEN. Well, it would seem like we need, particularly our 

committee and our jurisdiction, to provide assistance for folks so 

they can dispose of their prescription drugs including controlled 

substances in some way instead of just flushing them down into the 

water supply, and the studies we have seen and I think a lot of 

people have of the amount of prescription medication that is now 

in some of the water that ultimately we will be drinking is one 

way, if we can make it easier for people to legally and safely return 

unused prescriptions. So I appreciate what you are doing. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Green. 

Next is the gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. Rannazzisi, expand a little bit on how individuals currently 

dispose of their prescription drugs. With respect to controlled substances, how are individuals allowed to dispose of prescription 

drugs? I mean, do you allow pharmacies to accept those drugs? 

Mr. RANNAZZISI. Pharmacies are not able currently to accept controlled substances back from their patients. That is just a requirement under the Act. The Act, again, allows for transfer of controlled substances from registrant to registrant. Since an ultimate 

user is not a registrant, a pharmacy cannot accept that back from 

them. 

Mr. PITTS. So how do individuals currently dispose of prescription drugs? 

Mr. RANNAZZISI. As the director said, there’s three ways. Currently, ONDCP and HHS on their website, or ONDCP on its 

website has a model for drug destruction. It involves taking the 

drugs, deactivating them in something like wet coffee grounds, 

wrapping up and then throwing them in the trash. There’s also on 

both ONDCP and HHS websites a list of narcotics and other controlled substances that may be flushed, or there are ongoing law 

enforcement take-back programs in certain communities where 

they could drop their medicines off. 


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Mr. PITTS. Mr. Kerlikowske, NASPER sets standards for protecting patient privacy in the controlled-substance monitoring program including restricting who may have access to prescribing information. Can you speak to this issue? Do you think it’s important 

to have minimum criteria among these programs with regard to patient information? 

Mr. KERLIKOWSKE. It is. It is one of the things that I think 

makes NASPER such an attractive law, and that is that it is driven by the States but clearly the States have taken on different 

issues regarding the blend between a law enforcement issue and a 

medical practice issue. There are State medical boards that work 

very hard to make sure that the physicians or all the prescribers 

are following those rules and regulations. There are certain protocols then for turning over the information at the particular appropriate time to law enforcement, and at the same time the States 

have made great strides forward under NASPER to make sure that 

patients and professionals in the medical practice, that the privacy 

issues are protected, and so I think that that is a wonderful part 

of the legislation. 

Mr. PITTS. Now, NASPER requires that dispensers like pharmacies report each dispensing of a controlled substance no later 

than one week after the date the drug was dispensed. Do any 

States have real-time reporting in the controlled-substance monitoring programs and can you discuss the advantages or disadvantages of having a uniform real-time reporting requirement? 

Mr. RANNAZZISI. I am not familiar with any of the real-time reporting requirements that the States have had. I think that one of 

the reasons for the one-week position is that quite often, particularly if it is—and this could apply more in rural areas—that the 

ability to have information stack up or pile up and not get entered 

into the database in a fairly timely manner could cause some difficulties both for a prescriber who wants to find out if in fact this 

patient was going to multiple other places in a short period of time 

and that would be helpful. I think many times the goal would be, 

if it was online and real time, would be helpful. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Mr. Whitfield. 

Mr. WHITFIELD. Thank you all very much for your time today 

and testifying on this legislation. 

Mr. Rannazzisi, early on there was some policy discussions and 

really some disagreements about whether this program should be 

at HHS or Department of Justice. As someone involved in law enforcement, do you feel that there are adequate safeguards in this 

legislation that you can have access to fulfill your needs and objectives? 

Mr. RANNAZZISI. And I am no expert on NASPER legislation, but 

from what I understand, currently there are adequate safeguards 

for us, for law enforcement. 

Mr. WHITFIELD. Because we do think that that is important, and 

of course, I think the main thrust has been the safety of the use 

of prescription drugs, but we know it is a serious problem, drug 

abuse, and I had a lot of law enforcement people in my district, and 

I have actually been a little bit surprised that have actually formed 


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taskforces now to deal with the abuse of prescription drugs, and I 

really was not aware that it was such a major problem nationally, 

but from hearing your testimony, it is one of the most serious problems. Is that correct? 

Mr. KERLIKOWSKE. Mr. Whitfield, you are absolutely correct. I 

don’t think that the recognition has been there, and I think that 

spans across an awful lot of the populace about the dangers of prescription drugs and also about the problems that we are seeing 

from the abuse of prescription drugs. I think the most recent arrests in Kentucky, Tennessee and West Virginia from south Florida, almost 500 arrests, really helped to highlight that, but, you 

know, during the National Governors Conference, I had a chance 

to visit with Governor Manchin, and he said I cannot go anywhere 

in West Virginia to a public meeting in which someone is not telling me about a prescription-drug problem. 

So I think all of the time and the attention that all of the federal 

agencies, ONDCP, DEA, EPA, et cetera have given to it, to work 

with this subcommittee and the subcommittee staff on this legislation, both in PDMPs and also in take-backs, is a good example of 

getting the information out there, and it is a good example of really 

government being so responsive and listening to essentially the 

cries of the public about this problem that will make us all safer, 

and I commend the subcommittee for their work. 

Mr. WHITFIELD. Do either of your agencies or departments have 

any ongoing programs that are active in working with local law enforcement to give them suggestions on how to be more effective in 

this area of prescription-drug abuse? 

Mr. RANNAZZISI. To start off, we reorganized the Office of Diversion Control and the field elements of the Office of Diversion Control and created tactical diversion squads, which are State and 

local taskforce. We have 34 in operation right now. We hope to 

have within the next year and a half 65 throughout the United 

States, and all they will concentrate on is prescription-drug diversion and chemical diversion. That’s a State and local cooperative. 

And Kentucky State Policy is a perfect example. KSP has been on 

the leading edge of going after and tracking down people who are 

diverting controlled substances and we work very closely with Kentucky State Police and the State of Kentucky. 

It is so important to address this problem as a State and local 

cooperative effort because of funding issues and because of fact 

that, you know, this is one issue that we are not going to be able 

to do it alone. 

Mr. KERLIKOWSKE. And Congress has recognized the value of 

high-intensity drug trafficking areas, the 28 HIDTAs that are funded, and all of the HIDTAs which are comprised of State, local and 

federal law enforcement but also include some aspects of prevention and treatment. All of the HIDTAs are very much aware of the 

prescription-drug problem, and in many of these areas have shown 

real leadership and innovation in attempting to both work on takebacks to support PDMPs but also to do the necessary investigation 

and enforcement when we have either doctor shopping or physicians in fact, or prescribers, I should say, that may be abusing the 

law. 

Mr. WHITFIELD. Thank you, Mr. Chairman. 


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Mr. PALLONE. Thank you, Mr. Whitfield. 

Mr. Gingrey. 

Mr. GINGREY. Mr. Chairman, thank you, and I am going to ask 

a series of questions of both Mr. R and Mr. K, and you can call me 

Mr. G. 

First of all, the obvious, but what kind of prescription drugs are 

the most likely to be abused? 

Mr. KERLIKOWSKE. The opioid painkillers. 

Mr. RANNAZZISI. Yes, I have to agree with that. 

Mr. GINGREY. And the reason I ask that, I expected that response, I have noticed that a lot of the even legitimate doctors who 

are involved in pain management, a lot of these physicians start 

out their professional career as anesthesiologists, but not always, 

and you see so many of these pain clinics that are popping up, as 

both of you know, and opioids, but recently it was brought to my 

attention that a lot of these doctors prescribe methadone now for 

pain, and as I said in my opening statement, I am a little bit dated. 

I haven’t practiced for 10 years. But I was always thinking of 

methadone as what you gave people at these drug clinics where the 

hopeless addicts that could not ever get off opioids and you would 

give them a prescription for methadone. Tell me a little bit about 

that, what your knowledge of that is, and your concerns, if any. 

Mr. KERLIKOWSKE. Methadone was originally created as a painkiller in the early 1900s. It became the gold standard for narcotic 

addiction treatment in the 1970s, and it is now reemerging as a 

very, very fine painkiller, especially in certain areas where the 

drug is used in combination with other drugs. The problem with 

methadone is the kinetics of the drug. The drug accumulates, and 

there are a lot of overdoses because of that. 

Mr. GINGREY. It accumulates? 

Mr. KERLIKOWSKE. Yes, it accumulates in the body. It stays in 

the body for a very long period of time. If a person is not following 

the doctor’s instructions on how to take the drug, there could be 

overdoses. If the person is taking other substances with the drug, 

it affects the clearance of the drug, the patient could overdose. If 

it is an opioid-naive patient who has never taken an opioid before, 

the person could overdose. The drug is a very cheap, good painkiller, but it does have its issues if it is taken inappropriately without a doctor’s supervision. 

Mr. GINGREY. A two-edged sword, if you will. 

Mr. KERLIKOWSKE. Yes. 

Mr. GINGREY. Maybe Mr. Whitfield just asked this question 

about NASPER, and of course Chairman Pallone and Ranking 

Member Shimkus along with Mr. Whitfield have done the major 

work on NASPER and leading up this reauthorization, but do you 

feel that this will help in regard to all these concerns with abuse 

of prescription drugs, particularly the pain medication like methadone and other opioids? 

Mr. KERLIKOWSKE. It is not the silver bullet but we have seen 

success in these programs. We think it has to be done in conjunction with a lot of the other things that were mentioned, the education of the public, both NASPER but also the take-back I think 

is a wonderful combination for Congress to take on and to move 

forward. I think we can actually—we took a hard look at the 10 


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months before I was in office, the 10 months after I came to office 

about the number of mentions in the press about prescription 

drugs, and it was a significant increase, so I think the more—and 

as Mr. Shimkus said, using the bully pulpit that you all have to 

bring this to the attention of the public and Dr. Gingrey, you in 

particular having the medical background, you serve as wonderful 

spokespersons to alert people to dangers that perhaps they just 

really have not recognized. 

Mr. GINGREY. Well, I thank you for that, those kind words, and 

in fact, I have got a chemical background, a bachelor of science in 

chemistry, and a medical background. I had no idea that you could 

wrap up that medication with coffee grounds and throw it away. 

Can you tell me a little bit more about how that works, and if that 

information is on your website, how many people are going to go 

look and find that out and then all of a sudden rummaging through 

the trashcans looking for coffee grounds? 

Mr. KERLIKOWSKE. Well, I think that is the real benefit of this 

hearing today and the real benefit of also the work that, as you 

said, Chairman Stupak did and Congressman has done on working 

on a clear, simpler, more easily understood take-back program. I 

think that is tremendously helpful. There are some drugs that are 

so potent and can be absorbed in the skin that EPA, FDA and 

ONDCP have recommended that they be disposed of by flushing 

down the toilet. There are others that need to be, as you said, made 

in combination with other things that are in the garbage that 

would make them particularly unattractive to be able to use. But 

having the take-back programs that are widely known and thought 

of I think will be a big help. 

Mr. GINGREY. Well, I appreciate that. 

I know my time is expired, Mr. Chairman, but I don’t want to 

see people rooting through the trashcan or the toilet bowl, for that 

matter, so I like the take-back program. I yield back. 

Mr. PALLONE. Thank you. 

Let me ask unanimous consent to include in the record the annual report of the Operation Medicine Cabinet New Jersey. This is 

the Partnership for a Drug-Free New Jersey program that I mentioned before. 

Without objection, so ordered. 

[The information was unavailable at the time of printing.] 

Mr. PALLONE. And now we have joining us with the subcommittee today Mr. Inslee, who is the prime sponsor of the Safe 

Drug Disposal Act legislation that we are considering. Mr. Inslee. 

Mr. INSLEE. Thank you. Thank you for letting me join you. Before I ask a couple questions of a couple great witnesses, I just 

wanted to thank some people involved. This has been a great team 

effort, bipartisan. Particularly I want to note Bart Stupak, who has 

been working for a long time on this issue. Bart now at the end 

of his Congressional career will be known throughout history not 

only as making the greatest catch ever in Congressional history in 

the Republican dugout but also championing this issue, and I really 

want to thank Bart’s leadership on this. 

Also, Representatives Stupak, Waxman, Moran, Baldwin and 

Pallone, it has just been a great effort, and I think we have got a 


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good product here, and I appreciate the two witnesses, so I will ask 

a couple softball questions, if I can. 

First, Mr. Kerlikowske, we are having a heck of a time filling 

your shoes back in Seattle. We are trying. It is really tough. We 

might have to hire three people actually to fill your shoes, and I 

appreciate your work on this. I just wonder if you might comment 

on the importance of making sure that the programs we do design 

are accessible and are easily accessed by communities and giving 

communities flexibility and how they are going to design these programs. I just wonder if you might want to comment on that. 

Mr. KERLIKOWSKE. I do. Your work and initiative on this along 

with Congressman Stupak’s work has been particularly helpful to 

us. I am really so impressed with the Safe Drug Disposal Act that 

is being considered because it really is kind of a whole-of-government approach, and we often sometimes hear that government 

doesn’t listen or pay attention. This is a model bill. One of the 

things that I think will be particularly important is that we work 

very closely to make sure with the Department of Justice and the 

Attorney General’s Office that the programs that are put into effect 

make sense, are easily understood, and more importantly, are evaluated and used, for helping to rid the medicine cabinets of some 

of these dangerous drugs and rid them in a way that, as you have 

remarked to me on a number of occasions, gotten rid of in a way 

that is very environmentally sensitive and make sure that we are 

protecting the environment. This is a wonderful opportunity for us 

to do a better job of protecting the public and to bringing to their 

recognition some of these dangers, and with the passage of this, as 

the process moves forward, we will be particularly attentive to the 

concerns that you have raised throughout the formulation of this 

legislation. 

Mr. INSLEE. Thank you. I appreciate it. 

Mr. Rannazzisi, I wonder if you would like to comment on the 

number of options that will be available, the number of locations 

where these take-back programs maybe appropriate. Do you just 

want to give us thoughts on that? 

Mr. RANNAZZISI. Again, it would be premature without the legislation, the actual statute to comment on it. However, I could tell 

you that we have said all along what we would like to do is create 

a regulatory infrastructure that is not specific to one or two or 

three different programs but allows the States and entities within 

the State to create a program within those guidelines to fit the 

needs of their citizens, and I believe we could do that if given the 

opportunity by regulation, that flexibility to do that. 

Mr. INSLEE. We will look forward to that. Again, thank you for 

your work. This is a big deal on a bipartisan basis. Actually, I 

think last week I saw a headline in Seattle that prescription-drug 

abuse became number one as far as abuse, I think in the State. So 

know this is happening nationwide, and we appreciate your work 

and thanks for all the bipartisan work, our teammates. Thank you. 

Mr. PALLONE. Thank you, Mr. Inslee. 

Mr. WHITFIELD. Chairman Pallone. 

Mr. PALLONE. Sure. You want to—— 


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Mr. WHITFIELD. No, I would just ask unanimous consent that 

each member have five legislative days to submit additional letters 

of support. 

Mr. PALLONE. Absolutely, and also I would remind our witnesses 

that you may get additional questions from members. I asked the 

members to submit those additional written questions within 10 

days or so, so you may get those additional questions from us. 

Mr. SHIMKUS. Mr. Chairman. 

Mr. PALLONE. Yes. 

Mr. SHIMKUS. And I would ask just for a second, because Oregon 

was mentioned and it is prescribing pseudoephedrine, and that is 

an issue that we have talked before, and we will have debate, especially in the health care arena and access to family, cost of drugs, 

but I think it is also important to note that there has been an increase in Mexican drug meth cartel in Oregon at the same time. 

So there may be some benefits in home cooking. There may be an 

uptick in Mexican drug cartel, and it is important to keep that in 

the record. 

Mr. PALLONE. Sure. Thank you. 

So anyway, thank you very much for your input. We are actually 

going to go to markup pretty soon on the legislation. So this was 

very helpful to us. I appreciate it. 

Let me mention to the members, we are supposed to have a vote, 

I don’t know, any minute, I guess, within the next—two votes within the next few minutes on the Floor. So what I would ask is that 

we come back here about 15 minutes after the Floor votes and then 

we will begin the markup at that time, which is not only on these 

bills but some other bills as well that had previous hearings. 

So without further ado, thank you all, and this subcommittee 

hearing is adjourned. 

[Whereupon, at 11:12 a.m., the subcommittee was adjourned.] 

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