[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
                 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            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
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
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, 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

                             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


      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 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 
take-back 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.

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 
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.
    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 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 
co-chair 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 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 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 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 
prescription-drug 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.
    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 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 two-way 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.
    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 controlled 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.
    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 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 take-backs 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.
    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 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 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----
    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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