    [House Hearing, 112 Congress]
    [From the U.S. Government Publishing Office]

           WARNING: THE GROWING DANGER OF PRESCRIPTION DRUG DIVERSION

    =======================================================================

                                    HEARING

                                   BEFORE THE

               SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND TRADE

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED TWELFTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 APRIL 14, 2011

                                   __________

                               Serial No. 112-39

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

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                        COMMITTEE ON ENERGY AND COMMERCE

                              FRED UPTON, Michigan
                                     Chairman

    JOE BARTON, Texas                    HENRY A. WAXMAN, California
      Chairman Emeritus                    Ranking Member
    CLIFF STEARNS, Florida               JOHN D. DINGELL, Michigan
    ED WHITFIELD, Kentucky                 Chairman Emeritus
    JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
    JOSEPH R. PITTS, Pennsylvania        EDOLPHUS TOWNS, New York
    MARY BONO MACK, California           FRANK PALLONE, Jr., New Jersey
    GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
    LEE TERRY, Nebraska                  MICHAEL F. DOYLE, Pennsylvania
    MIKE ROGERS, Michigan                ANNA G. ESHOO, California
    SUE WILKINS MYRICK, North Carolina   ELIOT L. ENGEL, New York
      Vice Chair                         GENE GREEN, Texas
    JOHN SULLIVAN, Oklahoma              DIANA DeGETTE, Colorado
    TIM MURPHY, Pennsylvania             LOIS CAPPS, California
    MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
    MARSHA BLACKBURN, Tennessee          CHARLES A. GONZALEZ, Texas
    BRIAN P. BILBRAY, California         JAY INSLEE, Washington
    CHARLES F. BASS, New Hampshire       TAMMY BALDWIN, Wisconsin
    PHIL GINGREY, Georgia                MIKE ROSS, Arkansas
    STEVE SCALISE, Louisiana             ANTHONY D. WEINER, New York
    ROBERT E. LATTA, Ohio                JIM MATHESON, Utah
    CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
    GREGG HARPER, Mississippi            JOHN BARROW, Georgia
    LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
    BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin
    BRETT GUTHRIE, Kentucky              Islands
    PETE OLSON, Texas
    DAVID B. McKINLEY, West Virginia
    CORY GARDNER, Colorado
    MIKE POMPEO, Kansas
    ADAM KINZINGER, Illinois
    H. MORGAN GRIFFITH, Virginia

                                     7_____

               Subcommittee on Commerce, Manufacturing and Trade

                           MARY BONO MACK, California
                                     Chairman
    MARSHA BLACKBURN, Tennessee          G.K. BUTTERFIELD, North Carolina
      Vice Chairman                        Ranking Member
    CLIFF STEARNS, Florida               CHARLES A. GONZALEZ, Texas
    CHARLES F. BASS, New Hampshire       JIM MATHESON, Utah
    GREGG HARPER, Mississippi            JOHN D. DINGELL, Michigan
    LEONARD LANCE, New Jersey            EDOLPHUS TOWNS, New York
    BILL CASSIDY, Louisiana              BOBBY L. RUSH, Illinois
    BRETT GUTHRIE, Kentucky              JANICE D. SCHAKOWSKY, Illinois
    PETE OLSON, Texas                    MIKE ROSS, Arkansas
    DAVID B. McKINLEY, West Virginia     HENRY A. WAXMAN, California (ex
    MIKE POMPEO, Kansas                      officio)
    ADAM KINZINGER, Illinois
    JOE BARTON, Texas
    FRED UPTON, Michigan (ex officio)

                                      (ii)

                                 C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Mary Bono Mack, a Representative in Congress from the State
      of California, opening statement...............................     1
        Prepared statement...........................................     3
    Hon. Charles A. Gonzalez, a Representative in Congress from the
      State of Texas, opening statement..............................     4
    Hon. Mike Pompeo, a Representative in Congress from the State of
      Kansas, prepared statement.....................................     5
    Hon. Brett Guthrie, a Representative in Congress from the
      Commonwealth of Kentucky, prepared statement...................     6
    Hon. Pete Olson, a Representative in Congress from the State of
      Texas, prepared statement......................................     6
    Hon. Gregg Harper, a Representative in Congress from the State of
      Mississippi, prepared statement................................     6
    Hon. David B. McKinley, a Representative in Congress from the
      State of West Virginia, prepared statement.....................     7
    Hon. Marsha Blackburn, a Representative in Congress from the
      State of Tennessee, prepared statement.........................     7
    Hon. Edolphus Towns, a Representative in Congress from the State
      of New York, opening statement.................................     7
    Hon. Fred Upton, a Representative in Congress from the State of
      Michigan, prepared statement...................................   296
    Hon. Joe Barton, a Representative in Congress from the State of
      Texas, prepared statement......................................   297
    Hon. John D. Dingell, a Representative in Congress from the State
      of Michigan, prepared statement................................   299

                                   Witnesses

    R. Gil Kerlikowske, Director, Office of National Drug Control
      Policy.........................................................     9
        Prepared statement...........................................    11
        Answers to submitted questions...............................   301
    Michele M. Leonhart, Administrator, Drug Enforcement
      Administration.................................................    17
        Prepared statement...........................................    19
        Answers to submitted questions...............................   305
    Rick Scott, Governor, State of Florida...........................    41
        Prepared statement...........................................    44
    Steve Beshear, Governor, Commonwealth of Kentucky................    51
        Prepared statement...........................................    53
    Phil Bauer, father of Mark Bauer and Parents Advisory Board
      member, Partnership at Drugfree.org............................    82
        Prepared statement...........................................    85
    Kathy Creedon, mother of Ryan Creedon and founder, Mothers
      Against Prescription Drug Abuse, accompanied by Courtney
      Creedon, sister of Ryan Creedon................................    91
        Prepared statement...........................................    93
    April Rovero, mother of Joey Rovero, and founder, National
      Coalition Against Prescription Drug Abuse, and Parent
      Ambassador, Partnership at Drugfree.org........................   102
        Prepared statement...........................................   104
    Dan Harrison, Drug Court graduate................................   111
        Prepared statement...........................................   113
    Carol J. Boyd, Director, Institute for Research on Women and
      Gender, and Professor of Nursing, University of Michigan, Ann
      Arbor..........................................................   119
        Prepared statement...........................................   121
        Answers to submitted questions...............................   321
    Amelia M. Arria, Director, Center on Young Adult Health and
      Development, University of Maryland............................   158
        Prepared statement...........................................   160
        Answers to submitted questions...............................   330
    Sean Clarkin, Executive Vice President and Director of Strategy,
      Partnership at Drugfree.org....................................   175
        Prepared statement...........................................   178
    Arthur T. Dean, Chairman and Chief Executive Officer, Community
      Anti-Drug Coalitions of America................................   186
        Prepared statement...........................................   188
    John M. Coster, Senior Vice President, Government Affairs,
      Generic Pharmaceutical Association.............................   211
        Prepared statement...........................................   213
        Answers to submitted questions...............................   340
    Kendra Martello, Assistant General Counsel, Pharmaceutical
      Research and Manufacturers of America..........................   221
        Prepared statement...........................................   223
        Answers to submitted questions...............................   345
    Michael S. Mayer, President, MedReturn, LLC......................   236
        Prepared statement...........................................   238
    Patrick Coyne, Clinical Director, Thomas Palliative Care Unit,
      Virginia Commonwealth University Medical Center, on behalf of
      the Oncology Nursing Society...................................   250
        Prepared statement...........................................   252
        Answers to submitted questions...............................   356

                               Submitted Material

    Article, ``UW a force in pain drug growth,'' by John Fauber of
      the Journal Sentinel, dated April 2, 2011, submitted by Mrs.
      Bono Mack......................................................    71
    Letter, dated April 11, 2011, from George Doyle, President and
      CEO, Boehringer Ingelheim Roxane, Inc., to Hon. Michele
      Leonhart, Administrator, Drug Enforcement Administration,
      Department of Justice, submitted by Mrs. Bono Mack.............   265
    Report, ``The Importance of On-Dose Technologies in the Fight
      Against Misuse, Abuse and Illegal Diversion of Opioids,'' by
      John Glover, undated, submitted by Mrs. Bono Mack..............   267
    Statement, dated April 2011, of the National Association of Chain
      Drug Stores, submitted by Mrs. Bono Mack.......................   278
    Statement, dated April 14, 2011, of the National Community
      Pharmacists Association, submitted by Mrs. Bono Mack...........   284
    Letter, dated April 13, 2011, from American Academy of Pain
      Management et al., to Mrs. Bono Mack and subcommittee members,
      submitted by Mrs. Bono Mack....................................   289
    Statement, dated April 14, 2011, of Hon. Harold Rogers, a
      Representative in Congress from the Commonwealth of Kentucky,
      submitted by Mrs. Bono Mack....................................   292

           WARNING: THE GROWING DANGER OF PRESCRIPTION DRUG DIVERSION

                                  ----------

                            THURSDAY, APRIL 14, 2011

                      House of Representatives,
    Subcommittee on Commerce, Manufacturing, and Trade,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 8:05 a.m., in
    room 2123 of the Rayburn House Office Building, Hon. Bono Mack
    (chairman of the subcommittee) presiding.
        Members present: Representatives Bono Mack, Blackburn,
    Stearns, Harper, Lance, Cassidy, Guthrie, Olson, McKinley,
    Pompeo, Kinzinger, Butterfield, Gonzalez, Towns and Inslee.
        Staff present: Paul Cancienne, Policy Coordinator,
    Commerce, Manufacturing, and Trade; Brian McCullough, Senior
    Professional Staff Member, Commerce, Manufacturing, and Trade;
    Gib Mullan, Chief Counsel, Commerce, Manufacturing, and Trade;
    Anita Bradley, Senior Policy Advisor, Chairman Emeritus;
    Shannon Weinberg, Counsel, Commerce, Manufacturing, and Trade;
    Alex Yergin, Legislative Clerk; Michelle Ash, Democratic Chief
    Counsel; and William Wallace, Democratic Policy Analyst.
        Mrs. Bono Mack. Good morning. The subcommittee can now
    please come to order.
        Someone once said, I would like mornings better if they
    started later, and amen to that, especially as a Californian.
    But I truly appreciate the effort that everyone has made to be
    here for a somewhat unprecedented 8:00 in the morning hearing,
    although as I said, as a Californian, my clock still says it is
    5:00 in the morning.
        But seriously, when it comes to the topic at hand, there is
    no better time than right now to discuss it. Today,
    prescription drug abuse is a deadly serious and rapidly
    escalating problem all across America. We have an obligation to
    tackle it head on. The chair now recognizes herself for an
    opening statement.

     OPENING STATEMENT OF HON. MARY BONO BACK, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF CALIFORNIA

        Since 2003, more than 5,000 U.S. service men and women have
    died in Iraq and Afghanistan. As Americans, we celebrate their
    lives and we mourn their deaths. They will always be remembered
    by a grateful nation.
        Yet today, there is a mostly forgotten war also being
    fought right here at home in both small towns and large cities
    all across the United States. This costly and rapidly
    escalating struggle against prescription drug abuse and
    addiction is expected to claim the lives of some 30,000
    Americans this year alone.
        For the most part, this battle is being waged in remote
    outposts of the human mind, where scientists now tell us that
    childhood trauma, genetics, mental disorders, stress, thrill
    seeking, social pressures, severe pain from injuries and
    illnesses, and, yes, the horrors of combat, all contribute to
    devastating addictions, which in turn, all too often lead to
    tragic and avoidable deaths. But what is even more insidious is
    the way these powerfully addictive drugs quickly turn people
    without any real emotional or physical problems into desperate
    people suddenly facing life-or-death problems. Few things are
    more destructive.
        According to the Centers for Disease Control, drug overdose
    is the second leading cause of accidental death in the United
    States, in large part due to prescription drug abuse, and the
    problem is growing every single day. According to a recent
    national survey, some 7 million people age 12 or older
    regularly abuse prescription drugs, and there are approximately
    7,000 new abusers every single day, many of them teenagers and
    young adults. That alarming trend is taking a huge toll on
    society.
        Today, the abuse of prescription drugs, especially
    painkillers, stimulants and depressants, is the fastest-growing
    drug problem in America. As someone who has been deeply and
    personally affected by this issue, I hope today's hearing will
    lead to a better understanding of the enormous scope of this
    problem, the staggering costs, both emotionally and
    financially, that it imposes on families and communities, and
    the need for a greater sense of urgency as a Nation in
    addressing it.
        I believe one critically important first step is to do a
    better job of monitoring and limiting access to prescription
    drugs containing controlled-released oxycodone hydrochloride,
    including the popular painkiller OxyContin. Originally,
    OxyContin was intended to be prescribed only for severe pain as
    a way to help patients dealing with late-stage cancer and other
    severe illnesses. Today, however, more and more people across
    America are being prescribed OxyContin, as well as other
    generic oxycodone drugs, for less severe reasons, clinically
    known as moderate pain, greatly expanding the availability and
    potential for abuse of these powerfully addictive narcotics.
        For people all across America, prescription drug abuse is a
    day-to-day struggle. Over time, it destroys families and wreaks
    havoc on communities all across the Nation. Someone with a
    toothache or a sore back should not be prescribed a potentially
    addictive painkiller. I agree that expanded public education
    plays a role in addressing the problem, but we are not going to
    make any real progress until we limit access to these powerful
    narcotic drugs and ensure that only patients in severe pain can
    obtain them.
        The pervasiveness of prescription drug abuse made national
    headlines recently when Federal, State, and local law
    enforcement agencies, led by the Drug Enforcement Agency,
    cracked down on so-called ``pill mills'' in Florida, resulting
    in dozens of arrests, including five doctors.
        Congress needs to make it much more difficult for these
    rogue pain clinics to operate, and we should treat offenders
    like any other street drug dealer. By better coordinating the
    efforts of local, State and national agencies and by reducing
    the supply of highly addictive opioid painkillers, I am
    convinced that we can eventually save thousands of lives and
    spare millions of families from the headache and heartache of
    addiction.
        A recent Denver Post article highlighted why these powerful
    drugs are so attractive to thieves, drug dealers and
    unscrupulous doctors. According to the Post, OxyContin costs $1
    per milligram on the street and comes in doses ranging from 15
    to 80 milligrams. So a dealer selling 1,000 tablets can make up
    to $80,000.
        What does that mean in human terms? Well, a recent report
    by the National Institute on Drug Abuse has found that nearly
    one in 20 high school seniors have reported abuse of OxyContin.
    And yet another disturbing report by the Substance Abuse and
    Mental Health Services Administration shows a staggering 400
    percent increase in admissions of people aged 12 years and
    older for treatment of prescription drug abuse between 1998 and
    2008. Clearly, we have a daunting challenge in front of us.
        I would like to thank all of our distinguished panelists,
    especially DEA Administrator Leonhart, ONDCP Director
    Kerlikowske, Governor Scott and Governor Beshear for their
    personal commitment to this important issue. If we are going to
    win the war against prescription drug abuse, we must all serve
    as soldiers.
        [The prepared statement of Mrs. Bono Mack follows:]

                   Prepared Statement of Hon. Mary Bono Mack

        Since 2003, more than 5,000 U.S. service men and women have
    died in Iraq and Afghanistan. As Americans, we celebrated their
    lives and mourned their deaths. They will always be remembered
    by a grateful nation.
        Yet today, there is a mostly forgotten war also being
    fought--right here at home--in both small towns and large
    cities all across the United States. This costly and rapidly
    escalating struggle against prescription drug abuse and
    addiction is expected to claim the lives of some 30,000
    Americans this year alone.
        For the most part, this battle is being waged in remote
    outposts of the human mind, where scientists now tell us that
    childhood trauma, genetics, mental disorders, stress, thrill
    seeking, social pressures, severe pain from injuries and
    illnesses, and, yes, the horrors of combat--all contribute to
    devastating addictions, which in turn all too often lead to
    tragic and avoidable deaths.
        But what's even more insidious is the way these powerfully
    addictive drugs quickly turn people without any real emotional
    or physical problems into desperate people suddenly facing
    life-or-death problems. Few things are more destructive.
        According to the Centers for Disease Control, drug overdose
    is the second leading cause of accidental death in the United
    States--in large part due to prescription drug abuse. And the
    problem is growing every single day.
        According to a recent national survey, some 7 million
    people age 12 or older regularly abuse prescription drugs, and
    there are approximately 7,000 new abusers every day--many of
    them teenagers and young adults. That alarming trend is taking
    a huge toll on society.
        Today, the abuse of prescription drugs--especially
    painkillers, stimulants, and depressants--is the fastest-
    growing drug problem in America. As someone who has been deeply
    and personally effected by this issue, I hope today's hearing
    will lead to a better understanding of the enormous scope of
    this problem, the staggering costs--both emotionally and
    financially--that it imposes on families and communities, and
    the need for a greater ``sense of urgency'' as a nation in
    addressing it.
        I believe one critically important first step is to do a
    better job of monitoring and limiting access to prescription
    drugs containing controlled-release oxycodone hydrochloride,
    including the popular pain killer OxyContin.
        Originally, OxyContin was intended to be prescribed only
    for severe pain as a way to help patients dealing with late-
    stage cancer and other severe illnesses. Today, however, more
    and more people across America are being prescribed OxyContin,
    as well as other generic oxycodone drugs, for less severe
    reasons--clinically known as moderate pain--greatly expanding
    the availability and potential for abuse of these powerfully
    addictive narcotics.
        For people all across America, prescription drug abuse is a
    day-to-day struggle. Over time, it destroys families and wreaks
    havoc on communities all across the nation. Someone with a
    toothache or a sore back should not be prescribed a potentially
    addictive painkiller. I agree that expanded public education
    plays a role in addressing the problem, but we're not going to
    make any real progress until we limit access to these powerful
    narcotic drugs and ensure that only patients in severe pain can
    obtain them.
        The pervasiveness of prescription drug abuse made national
    headlines recently when Federal, state, and local law
    enforcement agencies, led by the Drug Enforcement Agency,
    cracked down on so-called ``pill mills'' in Florida, resulting
    in dozens of arrests--including five doctors.
        Congress needs to make it much more difficult for these
    rogue pain clinics to operate, and we should treat offenders
    like any other street drug dealer. By better coordinating the
    efforts of local, state and national agencies--and by reducing
    the supply of highly addictive opioid painkillers--I am
    convinced that we can eventually save thousands of lives and
    spare millions of families from the heartache of addiction.
        A recent Denver Post article highlighted why these powerful
    drugs are so attractive to thieves, drug dealers and
    unscrupulous doctors. According to the Post, Oxycontin costs $1
    per milligram on the street and comes in doses ranging from 15
    to 80 milligrams. So a dealer selling 1,000 tablets can make up
    to $80,000.
        What does this mean in human terms? Well, a recent report
    by the National Institute on Drug Abuse has found that nearly 1
    in 20 high school seniors have reported abuse of OxyContin.
        And yet another disturbing report by the Substance Abuse
    and Mental Health Services Administration shows a staggering
    400 percent increase in admissions of people aged 12 years and
    older for treatment of prescription drug abuse between 1998 and
    2008.
        Clearly, we have a daunting challenge in front of us. I
    would like to thank all of our distinguished panelists--
    especially DEA Administrator Leonhart, ONDCP Director
    Kerlikowske, Governor Scott, and Governor Beshear--for your
    personal commitments to this important issue.
        If we are going to win the war against prescription drug
    abuse, we must all serve as soldiers.

        Mrs. Bono Mack. The gentleman from Texas is now recognized
    for 5 minutes for an opening statement.

    OPENING STATEMENT OF HON. CHARLES A. GONZALEZ, A REPRESENTATIVE
                  IN CONGRESS FROM THE STATE OF TEXAS

        Mr. Gonzalez. Madam Chair, thank you very much, and thank
    you for calling this most important hearing and for inviting so
    many experts that will create our four distinguished panels of
    witnesses.
        I need to apologize because I will be absent for part of
    the hearing and hopefully will be returning, but at around 8:30
    I will have to go to another presentation and hopefully come
    back, but we should have some members on our side of the aisle.
        I also wish to extend the apologies of ranking members
    Butterfield and Waxman, who are disappointed that they cannot
    be here at this time, obviously due to a conflict in
    commitments.
        According to the 2010 National Drug Control Strategy, the
    fastest growing form of substance abuse in the United States is
    the non-medical use of prescription drugs including opiates,
    pain relievers, tranquilizers, sedatives and stimulants. Under
    the careful supervision of a doctor, these medications can
    alleviate severe pain or help those suffering from mental
    disorders like psychosis, depression, anxiety, insomnia or
    attention deficit hyperactivity disorder.
        Teens and young adults are increasingly susceptible to
    prescription drug abuse. Seven out of the top 10 substances
    most abused by young people are prescription medications. Like
    their older counterparts, teens most frequently obtain non-
    medical pain relievers, tranquilizers and stimulants from a
    friend or a family member. Despite popular misconceptions to
    the contrary, research indicates that even teens and young
    adults misuse prescription drugs not just to get high but for a
    variety of reasons. The Partnership for a Drug-Free America
    answers that teens do so to party, to get high in some cases
    but also to manage or regulate their lives. They are abusing
    some prescription stimulants to give them additional energy and
    ability to focus when they are studying or taking tests. They
    are abusing prescription pain relievers and tranquilizers to
    cope with academic, social or emotional stress.
        Many teenagers draw key distinctions between these drugs
    and illicit street drugs, characterizing their use of
    prescription drugs as responsible, controlled or even safe.
    Researchers have concluded that the growing popularity of
    prescription drugs also reflects the perception that these
    drugs are safer than street drugs. There are several programs
    at the Federal, State, and local level that seek to curb
    prescription drug abuse and diversion.
        I look forward to the testimony of our witnesses so that we
    may determine what is working and what more can be done to stop
    the growing problems. And Madam Chair, unlike many of the
    hearings we have, and we have such contentious differences of
    opinion, I don't think we are going to have that today. I think
    we are just going to try to identify what works and that we
    move forward and lend the assistance at the Federal level to
    everyone out there in attempting to curb a very serious
    problem, and I yield back at this time.
        Mrs. Bono Mack. I thank the gentleman for his words and for
    the spirit with which he said them, and now the chair
    recognizes Mr. Pompeo for 1 minute.

      OPENING STATEMENT OF HON. MIKE POMPEO, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF KANSAS

        Mr. Pompeo. Thank you, Madam Chair.
        I just briefly want to say thank you for holding this
    hearing. Thanks for bringing attention to this incredibly
    important issue. I am the father of a 20-year-old son. I know
    the kinds of things he is seeing at Kansas University. I know
    the kinds of challenges that young people have, and I look
    forward to your testimony this morning so that we can get the
    facts, learn a little bit about what works so that we can
    develop good Federal policy that will minimize the risk from
    this very real concern that I think lots of parents have all
    across the country.
        So thank you all for coming this morning. Thank you, Madam
    Chairwoman. I yield back the balance of my time.
        Mrs. Bono Mack. I thank the gentleman, and the chair
    recognizes Mr. Guthrie for 1-1/2 minutes.

     OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
               CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

        Mr. Guthrie. Thank you, Madam Chairman. I won't take too
    much time because I will speak a little later when our governor
    is here in the next panel. But I just want to thank you for
    bringing attention to this issue. It is important. It is
    important in my State, like all States, but we particularly
    have a problem and we are looking forward to the next panel,
    but I just wanted to say thank you so much for having this
    hearing today.
        Mrs. Bono Mack. I thank the gentleman, and recognize the
    gentleman from Texas, Mr. Olson, for 1-1/2 minutes.

       OPENING STATEMENT OF HON. PETE OLSON, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Olson. I am pleased to be here early this morning, and
    I thank the chair for her leadership in holding this hearing to
    shed light on a problem of prescription drug diversion and
    abuse. I know this issue is greatly important to the chair, and
    I commend her on assembling an impressive group of witnesses.
        Prescription drug abuse in America is not an issue we
    should take lightly. As a parent of two children, it is very
    concerning to me to see statistics showing that on a daily
    basis 2,500 American teenagers are trying prescription drugs
    for the first time, 2,500 per day. The vast majority of these
    teens are getting drugs from their own house, taking them from
    their parents' medicine cabinet and using them or giving them
    to friends. Given this, it is so important that parents are
    educated about the risks of prescription drug abuse in addition
    to knowing about and utilizing drug disposal and take-back
    programs.
        I thank the chair for her commitment to America's youth and
    I look forward to hearing from our witnesses. I yield back.
        Mrs. Bono Mack. I thank the gentleman, and the chair
    recognizes Mr. Harper for 30 seconds.

      OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN
                 CONGRESS FROM THE STATE OF MISSISSIPPI

        Mr. Harper. Thank you, Madam Chair, and I certainly welcome
    the witnesses. It is quite an impressive lineup. We look
    forward to hearing what each has to say today.
        This is an important issue, and it has devastated families
    that I know back home. Spending years as a prosecutor, you see
    what it does to many unintended victims in this, and I just
    look forward to looking for solutions and ways that we can
    solve this and help these families, and I want to thank you,
    Madam Chair, for holding this very important hearing.
        Mrs. Bono Mack. I thank the gentleman. Everybody is so
    happy this morning. The chair recognizes Mr. McKinley for 30
    seconds.

     OPENING STATEMENT OF HON. DAVID B. MCKINLEY, A REPRESENTATIVE
              IN CONGRESS FROM THE STATE OF WEST VIRGINIA

        Mr. McKinley. Thank you, Madam Chairman, and I join that. I
    thank you for holding this hearing this morning on this topic.
    As a father of four and a grandfather of six, I see what they
    are going to be facing. I saw what happened in our society back
    in the 1960s. It wasn't pretty, and what these kids are facing
    today is shocking.
        My wife is a critical care nurse and works in the emergency
    room of a hospital, and she tells me time and time again of the
    horrors, so many people come in that have abused the drugs and
    what it is doing to our Nation.
        So I welcome you and thank you very much for holding this
    hearing so we can learn more how we can address this and save
    our next generation. Thank you very much.
        Mrs. Bono Mack. I thank the gentleman, and the chair is
    pleased to recognize the vice chair of the committee, Ms.
    Blackburn, for 30 seconds.

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

        Mrs. Blackburn. And thank you, Madam Chairman.
        Welcome to our witnesses, and thank you all for being here
    with us today.
        There are three points that I think that as we work through
    what is an emotional debate that we need to be thinking about.
    First, to what extent should duly licensed prescription drug
    manufacturers be required to spend time, money and resources on
    trying to envision every new way that their product might be
    abused? Secondly, if we begin to restrict the approval of new
    prescription drugs, what impact will it have on patients who
    desperately rely on them to cope with debilitating pain and are
    just trying to make it through another day? And perhaps the
    most important question is, How do we deal with personal and
    parental responsibility? And I yield back.
        Mrs. Bono Mack. I thank the gentlelady, and the chair
    recognizes the gentleman from New York, Mr. Towns, for 5
    minutes.

     OPENING STATEMENT OF HON. EDOLPHUS TOWNS, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF NEW YORK

        Mr. Towns. Thank you very much, Madam Chair. Let me thank
    you and Congressman Butterfield for having this hearing and
    also I want to thank Congressman Gonzalez for filling in on his
    behalf.
        This is a very serious issue, and I am very pleased,
    however, that a number of provisions in the recently enacted
    Patient Protection and Affordable Care Act could yield some
    very positive results in our efforts to curb this growing
    problem.
        We must educate families about the dangers of loose
    prescription drugs in their households. We must also utilize
    other relevant Federal laws and procedures in order to
    safeguard against prescription drug diversion. Some of these
    safeguards include a recently proposed risk evaluation and
    mitigation strategy. If implemented by the FDA, this strategy
    could train prescribers, catalog patient information and
    administer periodic effectiveness assessment tests. Other
    safeguards would involve improving the communication abilities
    of our law enforcement officials, doctors, pharmaceutical
    dispensers so that frequent abusers can be brought to justice.
        Tackling the growing danger of prescription drug abuse will
    require bipartisan support, and that is the reason I was happy
    to hear the comment made by Congressman Gonzalez, that we are
    all on the same team when it comes to these kinds of things and
    when it comes to protecting our young people, and I am really
    happy about that.
        This public health issue requires the input and resources
    of all relevant stakeholders to ensure this problem is fully
    addressed. This is not one that we should get involved in the
    blame game. I think there is enough blame here for everybody to
    share. I think it is time to come together to see in terms of
    what we can do on both sides of the aisle, of course, every
    stakeholder that is involved in this issue, because this is an
    issue that if blame would solve it, then it would not even be
    here because of all the years we have been complaining about
    it.
        But I think the time now has come when we must roll up our
    sleeves and together work to see what we can do to be able to
    curtail the fact that especially with our young people who the
    numbers seem to keep going up and up.
        I look forward to hearing from our witnesses today and
    working with my colleagues to ensure Congress plays a vital
    role in protecting families from the growing danger of
    prescription drugs. And let me say to the chairperson that I
    really, really appreciate her involvement here and hope that we
    will continue to work together to see in terms of what we might
    be able to do to protect the lives of many of our young people
    who have gotten involved in this and of course I think that we
    can do a lot better.
        Thank you very much. I yield back.
        Mrs. Bono Mack. I thank the gentleman, and now to move to
    the panel. We have the first panel, one of four that will be
    before us today. Each of the witnesses has prepared an opening
    statement that will be placed in the record. Each of you will
    have 5 minutes to summarize that statement in your remarks.
        On our first panel, I am honored that we would have these
    two distinguished witnesses, the Hon. Gil Kerlikowske. When I
    first met him, I couldn't say the name and so I have come a
    long way. Hon. Gil Kerlikowske, Director of the Office of
    National Drug Control Policy, and the Hon. Michele Leonhart,
    Administrator of the Drug Enforcement Agency.
        Good morning to both of you, and thank you for your hard
    work, and you will each be recognized for 5 minutes. You
    probably know the drill. There are lights over there, and as
    they are green, you are well on your way. When you see the
    yellow lights, you are down to the wrap-up time, and when you
    hit red on the light, if you could then sum up your comments
    and we will then move on to the next witness.
        So Director Kerlikowske, you may begin with your first 5
    minutes. Thank you.

    STATEMENTS OF R. GIL KERLIKOWSKE, DIRECTOR, OFFICE OF NATIONAL
     DRUG CONTROL POLICY; AND MICHELE M. LEONHART, ADMINISTRATOR,
                    DRUG ENFORCEMENT ADMINISTRATION

                      STATEMENT OF GIL KERLIKOWSKE

        Mr. Kerlikowske. Well, thank you, Ms. Chairman Bono Mack,
    and thank you, Ranking Member Gonzalez and the distinguished
    members of the committee for the opportunity to address
    prescription drug issues.
        I really applaud the committee's focus on this topic.
    Prescription drug abuse has been a major focus since my
    confirmation, and I have directed that the national drug
    control program agencies address this epidemic in our country.
        Let me pause for a minute. As a long-time police chief in
    Seattle for 9 years, I paid attention to what caused harm in my
    community. Quite frankly, the abuse of prescription drugs
    wasn't on my radar screen, and quite frankly, I believe that
    around the country this has not received the attention that it
    needs.
        As the President's chief advisor on drug policy, this
    position demands that I raise public awareness and take action
    on drug issues affecting the Nation. The efforts in the
    President's drug control strategy are balanced. They
    incorporate new research, evidence-based approaches to address
    drug use and its consequences.
        In 2008, over 23 million Americans ages 12 or older needed
    treatment for an illicit drug or alcohol use problem. However,
    only 11 percent received that necessary treatment for that
    substance use disorder.
        Well, today I am here to talk about prescription drug
    abuse. Prescription drug abuse, as was mentioned, is the
    fastest growing drug problem in the United States and it is
    categorized as a public health epidemic by the Centers for
    Disease Control and Prevention, and in recent years the number
    of individuals who for the first time consumed prescription
    drugs for non-medical purposes was similar to the number of
    first-time marijuana users. The 2010 Monitoring the Future, a
    national survey on youth drug use, found that six of the top 10
    substances used by 12th graders were pharmaceuticals. We have
    also seen a fourfold increase in addiction treatment admissions
    for individuals, primarily abusing prescription painkillers.
    That was from 1997 to 2007. And even more alarming is the fact
    that over the last 5 years, emergency visits linked to misuse
    or abuse of pharmaceuticals has nearly doubled, and at the same
    time emergency room visits for illegal drugs like heroin and
    cocaine remained relatively flat.
        Furthermore, deaths from prescription drugs are increasing
    at a staggering rate, and State data show that seven people in
    Florida, four people in Ohio, three people in Kentucky die
    every day from an unintentional overdose. The latest national
    data found that more than 27,000 Americans died from
    unintentional drug overdoses in 2007. Prescription drugs,
    particularly the opioid painkillers that were mentioned, are
    considered major contributors to the total number of drug
    deaths. And in 17 States and the District of Columbia, drug-
    induced deaths are now the leading cause of injury death.
        And there are two unique reasons for the growth of the
    prescription drug abuse: easy accessibility to these drugs and
    the perception of risk. For instance, persons age 12 or older
    who use pain relievers non-medically in the past year between
    2008 and 2009, nearly 70 percent obtained the drug they abused
    from a friend or a relative. And research shows that because
    prescription drugs are manufactured by reputable pharmaceutical
    companies, they are prescribed by licensed clinicians, they are
    dispensed by pharmacists, they are perceived as safer to abuse
    than illegal drugs, and we know that is not true and we know
    that young people aren't buying them in a piece of tinfoil from
    behind a gas station.
        In addition, recent studies found perceived prescription
    drug abuse as safer, less addictive and less risky than using
    illegal drugs, and the drugs obtained from the medicine cabinet
    or the pharmacy were in their perception not as dangerous as
    those drugs that were obtained in other ways.
        A comprehensive approach is required to address the
    epidemic because prescription drug abuse problems pose unique
    challenges. It is important to balance prevention, education
    and something close to my heart, enforcement, with the need for
    legitimate access to the controlled substances was mentioned.
    Therefore, the Administration has created an inclusive plan
    which brings together a variety of Federal, State, local, and
    tribal groups to reduce prescription drug diversion and abuse,
    and while we have outlined our approach to this issue in the
    2010 Drug Control Strategy, the Administration developed a
    separate plan focused specifically on prescription drugs and
    next week Director Leonhart and I along with our Federal
    partners will release the Administration's plan. Our
    prescription drug abuse prevention plan has four parts:
    education, prescription drug monitoring programs, proper
    medication disposal and enforcement, and the first part of our
    response plan is education. Mandatory prescriber education as
    well as patient and parental education is essential.
        Second, each State should have a prescription drug
    monitoring program. These known as PDMPs are statewide
    databases that contain information on dispensed and controlled
    substances prescribed by health care providers. PDMPs should be
    interoperable and have the ability to share prescriber
    information.
        The third part of our plan calls for proper medication
    disposal. Seventy percent of the people, as I said, reported
    getting their painkillers from a friend or relative, and we
    need to ensure that proper medication disposal programs are
    available, and in September, DEA held their National Take Back
    Day and collected over 120 tons.
        Let me just close and say that I thank you for your
    attention, and I really appreciate the witnesses that will be
    coming after me, and my heart as a police chief goes out to
    those that have suffered.
        [The prepared statement of Mr. Kerlikowske follows:]

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        Mrs. Bono Mack. Thank you.
        Administrator Leonhart, 5 minutes.

                     STATEMENT OF MICHELE LEONHART

        Ms. Leonhart. Chairman Bono Mack and Ranking Member
    Gonzalez, distinguished members of the subcommittee, thank you
    for the opportunity to discuss the growing epidemic of
    prescription drug abuse and the critical role of the Drug
    Enforcement Administration in the enforcement of our Nation's
    drugs laws and regulations.
        The diversion and abuse of pharmaceutical controlled
    substances is a significant and growing problem in the United
    States. Every leading indicator shows increases over relatively
    short periods of time in the use and abuse of these drugs. Pain
    clinics have emerged as a major source of controlled substances
    for non-legitimate medical purposes. DEA and other Federal,
    State, and local law enforcement agencies have developed great
    working relationships and continuously coordinate efforts to
    combat this emerging threat. Federal administrative and
    criminal actions against a physician with controlled substance
    privileges are rare. However, such actions are warranted when a
    physician is issuing controlled substance prescriptions for an
    illegitimate purpose and operating outside the usual course of
    professional practice, and as Administrator, I have made
    prescription drug abuse a top priority for the DEA.
        I am especially alarmed that another contributing factor to
    the increase of prescription drug abuse is the availability of
    these drugs in the household. In many cases, prescription drugs
    remain in household medicine cabinets well after medication
    therapy has been completed, thus providing easy access for non-
    medical users for abuse, accidental ingestion or illegal
    distribution for profit. The 2010 Partnership Attitude Tracking
    Study, PATS, as we call it, noted that 51 percent of those
    surveyed believe that most teens get prescription drugs from
    their own family's medicine cabinets. DEA manages a robust
    regulatory program aimed at preventing and curbing diversion
    all the way from manufacturing levels to the dispensing of
    these medications to patients, and in working with Congress,
    DEA also obtained new authority last year to regulate the
    disposal of unused medications by ultimate users, thereby
    getting unused medications out of household medicine cabinets
    in a lawful and safe manner.
        DEA is working diligently to promulgate disposal
    regulations, and in the interim, DEA launched a nationwide
    take-back initiative in September of last year, resulting in
    the collection of 121 tons of unwanted or expired medications,
    and I am pleased to announce that DEA is planning a second
    nationwide take-back initiative on April 30th, and we will
    continue to hold periodic take-back events until regulations
    are in place.
        DEA's obligation under the law and to the public is to
    ensure that pharmaceutical controlled substances are prescribed
    and dispensed only for legitimate medical purposes in
    accordance with the Controlled Substances Act. By carrying out
    this obligation, DEA strives to minimize the diversion of
    pharmaceutical controlled substances for abuse while ensuring
    that such medications are fully available to patients in
    accordance with the sound medical judgments of their
    physicians. In this manner, DEA is committed to balancing the
    need for diversion control and enforcement with the need for
    legitimate access to these drugs.
        DEA closely monitors the closed system through
    recordkeeping requirements and mandatory reporting at all
    levels through the supply chain, and due to enhancements to our
    regulatory resources, controlled substance manufacturers,
    distributors, importers, exporters and narcotic treatment
    programs are receiving more inspections and audits than ever
    before.
        A key component to our enhanced investigative resources are
    tactical diversion squads. These are unique groups that combine
    the skills of special agents, diversion investigators,
    intelligence analysts and taskforce operators. TDS groups are
    dedicated solely towards investigating, disrupting and
    dismantling those individuals or organizations involved in
    diversion schemes, and as of today, DEA has 37 operational TDS
    groups across the country, and we plan to add an additional 26
    more over the next few years.
        One example of the effectiveness of these tactical
    diversion squads is Operation Pill Nation, which targeted rogue
    pain clinics in south Florida since February of last year and
    culminated in a series of major takedowns in February of this
    year. This led to 32 arrests including 12 doctors and five pain
    clinic owners. DEA also immediately suspended 63 DEA
    registrations and issued orders to show cause on six more,
    which resulted in the surrender of 29 DEA registration numbers,
    and this caused a ripple effect throughout south Florida and
    resulted in 50 more DEA registrations being surrendered, and in
    total, we closed down 38 clinics.
        DEA recognizes that it can't solve this problem alone. DEA
    is working closely with our Federal, state, and local and
    private-sector partners as a part of the Administration's
    comprehensive approach to combating prescription drug abuse.
    Many States have also adopted prescription drug monitoring
    programs which are deemed to be a valuable tool in curbing
    diversion.
        In closing, I want to commend the courage of those who are
    testifying later this morning for putting names and faces of
    loved ones to this problem, and I want to express my heartfelt
    sympathy on behalf of the men and women of DEA for their loss.
    I am keenly aware that many others possibly here even today
    have struggled with drug abuse by friends and family, and DEA
    joins in this fight.
        So thank you for the opportunity to appear here today.
        [The prepared statement of Ms. Leonhart follows:]

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        Mrs. Bono Mack. I thank both of the panelists, and I will
    recognize myself for the first 5 minutes of questions, and I
    will begin by asking both of you to turn your attention to the
    charts on your right. Although the data is old--2007, 2006--
    would you both just, yes or no, is it fair to assume that the
    trend continues to grow at an alarming rate, that the numbers
    today are far worse than they were in 2006 and 2007?
        Mr. Kerlikowske. Yes.
        Ms. Leonhart. Yes.
        Mrs. Bono Mack. Thank you. Administrator Leonhart, you were
    specifically talking about Florida. Can you tell me how many
    doctors have been convicted or have had their DEA registration
    denied or revoked for over-prescribing schedule II prescription
    drugs? When Governor Scott points out that 98 of the 100 top
    prescribing doctors who prescribe these painkillers that are in
    Florida, doesn't that send up a huge warning flag?
        Ms. Leonhart. Absolutely, Chairman. The actual numbers of
    doctors across the country that have been convicted or
    prosecuted, I can get you those numbers, but I can tell you
    that you are absolutely correct in that 90 of the top 100 are
    in Florida, and Operation Pill Nation identified those top
    doctors.
        Mrs. Bono Mack. Can you tell me what took so long?
        Ms. Leonhart. Well, I can tell you that the trends have
    changed. The pill situation, the pill mill situation in Florida
    is a really new phenomenon. We first targeted the Internet,
    which if you go back 4 and 5 years ago, drugs that we were
    finding on the street and we were asking where they came from,
    they were coming from the Internet, and it was unregulated,
    uncontrolled, and our first efforts were there. It is because
    of the Ryan Haight Act that Congress gave us and our actions
    going after those organizations and individuals dealing on the
    Internet that we were able to basically shut those rogue
    Internet sites down, and then we saw the shift over the last
    couple of years in Florida. We spent the last year identifying
    the pill mills and with a huge operation involving 12 of these
    tactical diversion squads over a period of a year were able to
    do those undercover buys that resulted in the takedown of Pill
    Nation, and we believe that that one consolidated takedown and
    actions over the past year will have a chilling effect on
    anyone attempting to open up a clinic or to continue in the
    same manner that they have continued over the past couple of
    years.
        Mrs. Bono Mack. I see you have a chart on page 10 of your
    testimony that sort of reflects how effective the raids were,
    but I have a couple of questions for you just on basic math and
    perhaps to both of you. Some people will say that last year we
    took back 272 tons of unwanted prescription drugs. Does that
    mean we are over-prescribing 272 tons of these prescription
    drugs? And if that is the case, can you explain the quota
    system to me? It seems to me that there is simple math that you
    all are overlooking in a quota system. You both have the
    ability to determine how much of these painkillers are
    manufactured and pumped out into our society but the quota is
    just simply based upon demand? I will turn to both of you.
        More specifically, if you look, Florida dispensed more than
    41 million oxycodone pills. The second highest prescribing
    State dispensed 1 million pills. Large States like California
    have dispensed fewer than 400,000. What a disparity. Doesn't
    that clearly indicate that there are probably 40 million extra
    pills in the supply chain if you look at that mathematical
    equation?
        Mr. Kerlikowske. Let me mention, I think, two things, and
    you bring up an excellent point on the quotas. So one thing is
    that the most recent data for all of 2010 for the first time in
    8 years shows that the aggregate production of opioid
    painkillers actually flattened, so instead of seeing that
    incredibly steep increase in abuse and the increase in
    manufacturing, we also saw a flattening. I think as we brought
    more attention to this, it is going to be coming down.
        The other concern would be trying to restrict particular
    quotas for particular drugs. We will just turn to a different
    drug with a different problem, and it could lead to subsequent
    abuse. So I think quotas is one answer and I think that it
    needs to be more robustly looked at, and I think those
    questions along with our FDA partners are important ones, but I
    also think that we are beginning to turn the corner on not only
    the aggregate amount of these painkillers that are produced but
    also on the registrants who will have to have the mandatory
    education, the number of scripts they write.
        Ms. Leonhart. And I agree with Director Kerlikowske. A
    hundred and twenty-one tons of pills were collected at the
    take-back in September. There are a number of reasons, a number
    of things we need to look at. Over-prescribing, you brought up
    as an issue. I believe that is correct. I believe that it
    requires more education for the practitioners who are
    prescribing, more education for parents, more education for
    young adults and teens who are turning in amazing numbers to
    prescription drugs as their drug of choice, and DEA is looking
    at the entire spectrum, and we are striking at every level of
    the distribution chain, and our problem is that with quotas,
    you know, we have a job to make sure that there is enough
    medication produced and available for patients in need and we
    need to balance that with making sure that people that are not
    patients that have a medical reason for these drugs don't get
    it. So it is that balancing act, and the problem with quotas is
    also that no matter what we do there, there will still be a
    legitimate group of people that need that medication and so we
    try to get that target number.
        Mrs. Bono Mack. Excuse me. My time is expired. I just wish
    I would hear you focus more on the people who are dying from
    these narcotics and painkillers than worrying about getting
    more out there. To me, the problem is 30,000 people a year are
    dying.
        And with that, I need to yield to Mr. Gonzalez for 5
    minutes.
        Mr. Gonzalez. Thank you very much, Madam Chair, and again,
    thanks to the witnesses. And I understand that once a drug is
    manufactured, there are only certain ways it gets out there to
    the consumer, and that is going to be--it is on the shelves of
    the hospitals or the pharmacist and then there is the
    prescription written by the doctor. So I want to talk about
    databases.
        The first thing that occurs to me is that the most
    effective databases, and you have to have the assistance of all
    these individuals I just indicated. Those are the points of
    origin. So like you are going to deal with any problem, you
    have to figure out if you go there first and try to control it
    the best you can, then we can deal with the other things that
    take the responsibilities of parents and such to make sure that
    there is not the availability of those drugs in the medicine
    cabinet and so on. And then there are some other issues but I
    will discuss it with another panel, and it is going to go to
    what the chairwoman was talking about, the amount of
    prescription drugs out there and what we can do.
        But until we really have, in my opinion, a truly robust and
    very effective, widespread adoption of electronic medical
    records, health information technology, which is something that
    we have been attempting to do since I got here some years ago,
    I don't see how effective it is really going to be. Do you have
    any concerns about the abilities of all these different
    providers or points of origin to be able to access and to
    supply information in a manner that is timely and is going to
    be available and of course electronically based?
        Mr. Kerlikowske. You are absolutely right. I think it is a
    shame that when we have to have a chart that goes to the most
    recent data of 2006 or 2007. The President's Drug Control
    Strategy devoted an entire chapter to the fact that timely,
    robust, critical information, whether it is the Drug Abuse
    Warning Network, which is number of people brought into the
    emergency rooms, whether it is the number of people we test in
    only 10 jails in the country for the drug problems of people
    coming in to the jail regardless of what they were arrested
    for. All of that information is so helpful, and frankly, it is
    not timely and it is not as relevant as it should be and
    therefore it makes it difficult, I am sure for you in the
    policymaking area and it certainly makes it very difficult for
    us in that area. So we have devoted this entire chapter to
    strengthening these kinds of systems, and I agree with you,
    electronic health records will be an important step forward.
        Mr. Gonzalez. Administrator Leonhart?
        Ms. Leonhart. I agree as well, and last June we started the
    e-prescribing. I had signed for that, and it went into effect
    in June and we are hoping that e-prescribing helps. I agree
    with you completely. And also, we do have 34 States that
    currently are using prescription drug monitoring program system
    and we see the value in doing that, how having a doctor or a
    pharmacist have the ability to look into a system and find out
    that someone has been doctor shopping or going from pharmacy to
    pharmacy has definitely assisted the States that have enacted
    those systems in preventing diversion.
        Mr. Gonzalez. And I know that we are always going to have
    this conflict. First of all, you have to respect
    confidentiality, the relationship of the patient with the
    doctor or the pharmacist, the professional and so on. How do we
    balance all that? I mean, my fear is that people--one of the
    greatest impediments is people don't like the fact that this
    kind of information is going to be shared or is going to be
    made available. Now, I just believe that if it is made
    available to the health care professional and in fact they act
    professionally, they are an incredible player or actor in this
    whole chain of how these drugs get out there. How do we balance
    the confidentiality aspects of it with, as we have said, a
    timely and robust database?
        Mr. Kerlikowske. The PDMPs, I think the value in them is
    that they are designed by the States. So when the States enact
    them, they can put in the patient privacy and the
    confidentiality rules that they feel are best. They can also
    design them as to who has access to them. Some allow at certain
    points access by law enforcement agencies. But frankly, the
    practice of medicine is governed by the States, the boards of
    pharmacy and the medical boards in each of those States having
    access to those including routine reports that are generated
    from the PDMPs actually put the information in the hands of the
    people that have the power to regulate medicine within each
    particular State.
        Ms. Leonhart. On your next panel, you have Governor Beshear
    here, and I know Kentucky is a State that implemented PDMPs,
    was very concerned about privacy issues and their systems have
    been up and running and have not had problems in that area, and
    as we look at the other 33 States that have PDMPs up and
    running, they have addressed those privacy issues and that has
    not been a deterrent that has worked and that is why nine
    additional States have moved and have pending legislation in
    their States and are moving towards PDMPs. They have worked
    those issues out.
        Mr. Gonzalez. Thank you very much. I yield back.
        Mrs. Bono Mack. I thank the gentleman. The chair recognizes
    Mr. Guthrie for 5 minutes.
        Mr. Guthrie. Thank you, Madam Chairman. In the interest of
    time, I just want to ask one question and throw it out to both
    of you.
        I understand that prescription drugs are more accessible to
    people in the family. They get them from family members. You
    know, a parent may have OxyContin in the house where they
    wouldn't hopefully have one that you would typically get on the
    street without prescription drugs. But however, what level is
    the prescription drug trade also in organized crime, the drug
    cartels? You know, is it just doctors over-prescribing or is
    there a whole network like you have in other type of drug
    issues?
        Ms. Leonhart. I can tell you from our enforcement cases,
    and we were surprised a few years back, we thought that they
    would act, there would be different organizations, they would
    act differently because they for the most part are from the
    medical profession, they are pharmacists, and actually they are
    organized. We learned from Florida, these pill mill
    organizations, they are organized just like other organized
    crime and other crime groups selling coke and heroin.
        Mr. Guthrie. Are they the same groups? Are the cartels
    organizing the pill mills or is a different structure, I guess
    is my question?
        Ms. Leonhart. I will say that they are for the most part
    different groups. We don't have a problem with prescription
    drugs coming from the Mexican drug cartels, for instance. This
    is one of those cases where the sources of supply are not in
    Columbia, are not in Mexico. The sources of supply are right
    here domestically.
        Mr. Kerlikowske. I held a law enforcement roundtable last
    month in Buffalo, and one of the enforcement agents talked
    about a drug dealer in a particular section of the city in
    which heroin was being dealt and then they had a subcomponent
    with a dealer dealing prescription drugs across the street.
        Mr. Guthrie. Thank you, Madam Chairwoman. I will yield back
    in the interest of time.
        Mrs. Bono Mack. Will the gentleman just yield for one quick
    question?
        Mr. Guthrie. Yes, I will yield to the chairwoman.
        Mrs. Bono Mack. Just briefly, can you explain how many
    people are dying from the illicit drugs any longer as compared
    to prescription drugs?
        Mr. Kerlikowske. The prescription drug overdose death, that
    is driving the numbers that have spiked so significantly. They
    cause more deaths than both heroin and cocaine combined.
        Mrs. Bono Mack. Thank you, and the gentleman yields back so
    the chair recognizes Mr. Towns for 5 minutes.
        Mr. Towns. Thank you very much.
        Let me begin by--you mentioned the fact that there were 34
    States using the monitoring system. Have you been able to
    detect that those States that are using the monitoring system,
    that the problem is not as severe in those States?
        Mr. Kerlikowske. There are two things that I think will be
    helpful, and one is that there is a recent evaluation done by
    the CDC through a contract, I believe, on prescription drug
    monitoring programs. They are relatively new. Some are used
    more and some are more robust than others. The other issue will
    be, how can they exchange information across State lines. All
    of the physicians that I have talked to and all the people that
    I have been privileged to be engaged with that have had these
    programs find them not only to be helpful in identifying
    doctors who may be over-prescribing but patients who may be
    doctor shopping, and the doctors themselves talk about it as a
    patient safety tool.
        Ms. Leonhart. I will say that we are looking at the trends.
    Florida is ground zero for prescription drug abuse, and there
    is----
        Mr. Towns. Do they monitor?
        Ms. Leonhart. There is no current PDMP in place in Florida.
    As we took action over the last year in Operation Pill Nation,
    we are seeing these pill mills actually move and they are
    starting to show up in Georgia. Georgia is a State without a
    prescription drug monitoring program. So we are concerned. We
    believe that States that do enact prescription drug monitoring
    programs, that is one of the first things they can do to combat
    diversion in their States.
        Mr. Towns. Is there any program in place to work with
    families that might be taking a certain type of medication that
    might be very susceptible to illegal use in terms of a drug, if
    it in a cabinet that is locked? Is there any kind of training
    program in place?
        Mr. Kerlikowske. And I think when you hear later on from
    General Dean and the CADCA group, and we fund through our
    partner SAMHSA 740 drug-free communities, part of those
    coalitions will be, part of their mission is to educate people
    about the dangers of the prescription drugs. There are now
    locking medicine cabinets that have been made available. There
    are pill containers that have locks. But we also think the
    important part is bringing this to the attention of people
    about what is inside. As the chairman mentioned, when you
    collect 121 tons of pills across the country in one 4-hour
    period, thanks to the leadership of DEA, that should be in my
    old job a clue that we have a problem.
        Ms. Leonhart. We have been able to use the take-back
    initiative and will on April 30th do the same thing to make it
    not only be a way to safely dispose of your expired and unused
    medication but also to educate, and I attended one of the sites
    on September 25th for the take-back, talked to a number of
    people who showed up turning in their prescription drugs, and
    to a T they all said they didn't realize they had the
    medications stacking up in their medicine cabinet because they
    didn't want to flush it, they didn't want to throw it in the
    trash in case could someone else could get it, they didn't know
    what to do with it. So the beauty of the take-back has been a
    way to educate, educate families about how to secure the
    medications, and overall having people realize that they don't
    need to hold on to that medication and that they have elderly
    in the home that could be confused and take the wrong
    medication and they have young adults in the home, and that is
    the number one source of supply for them.
        Mr. Towns. Thank you very much, Madam Chair. I yield back.
        Mrs. Bono Mack. I thank the gentleman. The chair recognizes
    Mr. McKinley for 5 minutes.
        Mr. McKinley. Thank you, Madam Chairman.
        I am just curious. In the Appalachian area of this country
    that has such a high prevalence of misuse, why is that
    occurring? Is that because the medical community is abusing
    their prescription authority? I am just trying to get a sense
    of why is one area so highly using painkilling medicine?
        Mr. Kerlikowske. We just spent 4 days, 3 days in eastern
    Kentucky and 1 day in West Virginia, and spent a lot of time
    asking people and looking at that including interviewing 14
    women who were in the jail system as a result, 13 of them for--
    --
        Mr. McKinley. Can you speak up just a little bit, please?
        Mr. Kerlikowske. Thirteen of them as a result of
    prescription drugs, and what we found, particularly in
    Appalachia, was that, one, people all know each other and they
    sometimes share those drugs that are in their medicine cabinet,
    somebody has a back pain and somebody else shares and says here
    is something that I found helpful. The other problem came about
    as a result of people who had been prescribed a painkiller as a
    result of an injury, it could have been even a mining injury,
    and then ended up in a problem with that. It is a huge and
    significant problem and we couldn't have made the inroads in
    understanding it better without the support of Congressional
    staff that spent the 4 days with us there just less than 2
    months ago.
        Ms. Leonhart. And I would like to add that from our
    investigations and what we see, just as Kentucky, Ohio,
    Tennessee, we saw people that went down to Florida and would go
    to these pill mills. We saw that that is a major source of
    supply for the pills that are on the streets in West Virginia,
    junkets, people that, you know, busloads of people that would
    go down to Florida, go to all these pill mills, get as many
    pills as they can, return to your area and not only were some
    of them addicted themselves but they had multiple----
        Mr. McKinley. I am just struggling to understand why
    Appalachia. Why not Georgia? Why not Alabama? Why is it the
    Appalachia area is singled out for such high drug use, high
    painkiller use. I just wonder if the prescribing physicians
    are--if it is the prescribing physician. Maybe it is a pill
    mill. But what can we do? Because I struggle with it is just a
    region. I think it is a national issue.
        Mr. Kerlikowske. It is.
        Mr. McKinley. Because I think neighbors in New York City
    know their neighbors just as well as we do in West Virginia.
        Mr. Kerlikowske. And you are absolutely right. As my
    travels across the country have clearly shown, the prescription
    drug problem affects everyone regardless of race, ethnicity,
    gender or economic station in life. In particular, I think it
    gets more attention in Appalachia because of the abuse, and we
    heard a number of different reasons. I also think that it
    doesn't get quite the attention perhaps in some places because
    everyone that we met, they are community minded, they know each
    other, and there were no secrets. So if you had a friend or a
    relative that was suffering as a result of prescription drug
    abuse, other folks knew about it. But I think that bringing
    attention to it, I think the work that the Congressional staff
    has done in both places, West Virginia and Kentucky, will make
    a big difference.
        Mr. McKinley. Thank you. I yield back my time.
        Mrs. Bono Mack. I thank the gentleman. The chair recognizes
    Mr. Harper for 5 minutes.
        Mr. Harper. Thank you, Madam Chair.
        Director Kerlikowske, as you look at this issue, are PDMPs
    the only option out there for States to implement the sharing
    of this type of information?
        Mr. Kerlikowske. Right now for looking at doctors who may
    be over-prescribing or patients who may be doctor shopping, the
    only systems available are those state-run, statewide PDMPs.
        Mr. Harper. Well, are there any State PDMPs that stand out
    to you as a role model for other States to follow that you
    really are impressed with?
        Mr. Kerlikowske. As the Administrator also mentioned, I
    think we are both very impressed with what has happened in
    Kentucky.
        Mr. Harper. With that, I yield back, Madam Chair.
        Mrs. Bono Mack. I thank the gentleman, and the chair now
    recognizes Ms. Blackburn for 5 minutes.
        Mrs. Blackburn. Thank you so much, and I want to thank you
    all for being here. Very quickly, just a couple of things.
        Listening to you, reading your opening statements,
    accessibility is the big problem, it seems, and you are trying
    to get into that, part of that, as I mentioned in my questions
    to you, looking at both the education components with
    individuals' physicians and I think also personal
    responsibility and parental participation in this.
        Let me talk just a minute with you. Ms. Leonhart, you
    mentioned State monitoring systems, the problems in Florida,
    the pain clinics as being a problem. In Tennessee, I mean, we
    have been talking about over-prescribing by physicians since
    the days of Elvis, and, you know, how are you all working with
    that? If you are doing State monitoring systems, is there a
    method that you are using to incentivize or grant to the
    States? What is your position on that and how are you helping
    with the local and the State component of that, and if you want
    to submit this in writing, because I know we are tight on time,
    that is fine. But listening to you, it seems if you going to
    say let us get to the crux of this, that getting to that
    linkage between your local and State agencies is part of the
    crux and dealing with that over-prescribing is another
    component.
        Ms. Leonhart. We would be glad to submit to you after the
    hearing information on specifically what we are doing in
    Tennessee and know that the law enforcement officials in
    Tennessee have worked with us, are partnered with us to do what
    we can to help Tennessee and in many ways they were kind of
    ahead of everyone, Tennessee and Kentucky, when it came to use
    of the Internet. We learned from Kentucky and Tennessee, for
    instance, that there were all these deliveries being made to
    people who were ordering substances over the Internet. Working
    with them, they helped us develop an Internet strategy. They
    are up on the problem. They have worked with us on the problem.
    But I will provide additional information.
        Mrs. Blackburn. That will be great, and articulate what you
    are doing with the grants and the incentive end.
        Thank you. Yield back.
        Mrs. Bono Mack. I thank the gentlelady. The chair
    recognizes Dr. Cassidy for 5 minutes.
        Mr. Cassidy. I will also submit a few extra questions for
    the record, but in the interest of time, I will limit myself.
        Ms. Leonhart, in your testimony you refer to civil
    penalties levied against McKesson, CVS, Cardinal. So what is
    the role of these intermediaries and what is the role of the
    manufacturer in terms of controlling this problem?
        Ms. Leonhart. Well, manufacturers and distributors have a
    part to play. They have responsibilities, and what we do at DEA
    is we make sure that we make them aware of methods of diversion
    and ways that their companies, their organizations can do more
    to prevent diversion. In these cases, our investigations showed
    over and over again that these companies were not doing enough
    to prevent diversion. So we used our administrative authorities
    working with U.S. Attorney's offices around the country. We
    have brought more civil----
        Mr. Cassidy. Well, let me ask you, I am sure there is
    supply chain control. Are they required to report to you that
    Smith's Pharmacy in Dade County is ordering 500 percent more
    prescription drugs than you would think normally such a
    pharmacy would?
        Ms. Leonhart. Yes, they have a responsibility to report
    diversion. They have a responsibility to report any suspicious
    order.
        Mr. Cassidy. Define ``diversion.''
        Ms. Leonhart. I am sorry.
        Mr. Cassidy. Define ``diversion.''
        Ms. Leonhart. Diversion is where the controlled system for
    pharmaceuticals is not used, where pills and substances find
    their way outside of this closed distribution system. For
    instance, thefts, they are to report thefts and losses but they
    are also to report pharmacies or rogue pharmacies that are
    ordering from them and ordering amounts that changed or
    anything that raises a red flag that they are outside of their
    normal practices. We have investigated many cases that have
    actually started from tips from the companies who have reported
    these suspicious orders.
        Mr. Cassidy. OK. Thank you very much.
        Ms. Leonhart. And those that are not doing it, then we hold
    them responsible.
        Mr. Cassidy. I yield back.
        Mrs. Bono Mack. I thank the gentleman, and the chair
    recognizes the gentleman from Washington, Mr. Inslee, for 5
    minutes.
        Mr. Inslee. Thank you, Madam Chair. Thanks for letting me
    join you today.
        Chief, thanks for your leadership here. I just wonder if
    you can give us an update on the implementation of our drug
    take-back legislation, and it is very timely. I just left Lisa
    Jackson, the EPA Administrator, and we were talking about
    endocrine disruptors in the water system that are changing the
    basic physiology of fish and frogs in rather disturbing ways.
    So we would like to know how we are doing on this.
        Mr. Kerlikowske. Earlier, the remarks were made about truly
    what a bipartisan issue this is, and to see the legislation
    passed in both Houses and the President sign it and then DEA to
    be so involved and having public hearings already to look at
    how to restructure the way that pills can be safely disposed of
    and not causing environmental damage has been really
    heartening. We have had great cooperation from EPA. DEA is
    certainly the lead and I am sure the Administrator can mention
    that. But we are making good progress, and I think the other
    part is the interim steps that DEA has been taking through the
    drug take-backs. The next one will be April 30th for your
    calendar.
        Mr. Inslee. Thank you.
        Ms. Leonhart. And I will add that we did hold a hearing a
    few months ago. Over 150 witnesses appeared. We took their
    information, their comments. We are working that, and we
    believe that we will actually have a proposed rule by the end
    of the summer. We will publish that proposed rule. That will go
    out for a comment period and we will then review all those
    comments and move forward with a final rule. But it is on track
    and comments have come in. We are reviewing them, and we want
    to especially thank you for participating in that.
        Mr. Inslee. So what would you describe as your biggest
    challenges to make this actually work? You know, law
    enforcement is stressed. We have had reductions in the COPS
    program, and everybody has budgetary issues. If you were going
    to describe challenges that perhaps we could help you with in
    any way, what would you say they are?
        Ms. Leonhart. Well, making sure that law enforcement has
    the tools to combat this at every level of the distribution
    chain, but it is also doing what we can. One of your panels has
    a number of the community coalitions and the community groups,
    the prevention groups. It is making sure that they are getting
    the message out and they are getting the support to be able to
    do that. It is working with doctors and prescribers and the
    medical community. It is what Director Kerlikowske and I will
    be announcing next week with this new prescription plan.
        Mr. Kerlikowske. Reauthorizing NASPER, removing the barrier
    that restricts the Veterans Administration from sharing
    prescription drug information, these are all things that
    Congress can actually do, requiring mandatory prescriber
    education, those things.
        Mr. Inslee. Thank you very much.
        Mrs. Bono Mack. I thank the gentleman. The chair recognizes
    Mr. Kinzinger for 5 minutes.
        Mr. Kinzinger. Thank you, Madam Chairwoman.
        In the interest of time, I am going to keep this pretty
    short. For Ms. Leonhart, I have learned that certain companies
    are beginning to do a lot of reformulating of opiates drugs to
    make it more difficult for abusers to use and abuse the
    product. Do you believe reformulating has been effective in
    preventing the abuse of these drugs?
        Ms. Leonhart. I appreciate the efforts in trying to
    reformulate so that they are not easily abused. However, I am
    concerned because we have seen with OxyContin that as soon as
    that was put out, we heard that even on the Internet they were
    announcing ways that you could go around that. So we are very
    concerned but we don't want to discourage industry from
    continuing to develop these drugs that can't be easily abused.
        Mr. Kinzinger. So have there been for either of you any
    discussions about encouraging drug companies and generics to
    follow suit or is this something that you personally feel is
    ineffective and not really worth pursuing?
        Ms. Leonhart. I believe it is worth pursuing.
        Mr. Kinzinger. That is pretty much all I have unless you
    have something, sir. All right. I will yield back.
        Mrs. Bono Mack. I thank the gentleman very much, and I
    believe that concludes this panel. I want to thank our
    witnesses very, very much for your hard work on this issue,
    certainly the boots on the ground who are working this day in
    and day out and risking their lives to keep our society safe.
    We thank them all very much. Again, appreciate your being here.
        The subcommittee will take about a 5-minute recess while we
    switch panels.
        [Recess.]
        Mrs. Bono Mack. The hearing will come back to order,
    please. On our second panel today, we have two very
    distinguished witnesses who are both deeply involved in the
    issues of prescription drug abuse and prescription drug
    diversion, which obviously go hand and hand. We are honored to
    have Florida Government Rick Scott and Kentucky Governor Steve
    Beshear with us today for a perspective on how this battle is
    faring in their States.
        Without objection, I would like to yield 1 minute each to
    Mr. Stearns and to Mr. Guthrie for welcoming remarks. Mr.
    Stearns, you are recognized for 1 minute.
        Mr. Stearns. Good morning, and thank you, Madam Chair.
        I am delighted to introduce my distinguished governor, Rick
    Scott, to testify today on prescription drug abuse. He is a
    U.S. naval veteran and a lawyer from Southern Methodist where
    he received his law degree. He started a business himself and
    met a payroll. He actually started Columbia Hospital
    Corporation and later became HCA. He has had experience with
    small business that he and his wife and family and mother
    started to eventually become a large business. He was elected
    the governor in November 2010. He is the 45th governor in our
    State. He lives in Naples, Florida, with his wife, Ann, of 38
    years and they have two lovely daughters, and I am certainly
    very proud to introduce Governor Rick Scott.
        Thank you, Madam Chair.
        Mrs. Bono Mack. And thank you. Mr. Guthrie, you are
    recognized for 1 minute to introduce your witness.
        Mr. Guthrie. Thank you, Madam Chairman, and my voice is
    kind of raspy because Kentucky is in full splendor. Its bloom
    is there and it is a beautiful place to be, and I invite people
    to come. And in a month, we will have the world watching us,
    which we are excited about, with the Kentucky Derby.
        But I am pleased to have Governor Beshear here, and I can
    speak for the whole delegation on our side that we worked
    together on this issue and we will work with our governor on
    this issue and make sure we move forward in Kentucky because it
    is a big issue. We have a great State, a beautiful State, but
    this is a problem that we are exposing here today and we are
    working to address.
        And Governor Beshear has been involved in Kentucky politics
    since being elected president of his UK class, University of
    Kentucky, so just a few years ago he got started in politics.
    But he has been in the General Assembly, attorney general,
    lieutenant governor, and very active in civic life as an
    attorney in Lexington, and actually from West Kentucky, but
    practiced in the Lexington area. We are really pleased to have
    you here. Unfortunately, he got elected in 2007, I got elected
    here in 2008, so we only had a year that we worked together in
    Frankfort but enjoyed working with you and I am pleased to have
    you here today. Thank you.
        Mrs. Bono Mack. I thank my colleagues, and also join them
    along with the entire subcommittee in welcoming the two of you
    today. You will each be recognized for 5 minutes. There are
    timers on either side of your table that will reflect green. As
    they turn yellow, that means you are, surprise, surprise,
    getting close to needing to wrap it up, and when it hits red,
    if you could come to a conclusion of your remarks as quickly as
    you can, we would appreciate it very much.
        So Governor Scott, you are recognized for 5 minutes.

    STATEMENTS OF RICK SCOTT, GOVERNOR, STATE OF FLORIDA; AND STEVE
              BESHEAR, GOVERNOR, COMMONWEALTH OF KENTUCKY

                        STATEMENT OF RICK SCOTT

        Mr. Scott. Chairman Bono Mack and members of the
    subcommittee, thank you for convening this important hearing on
    the perils of the illegal distribution of prescription drugs. I
    ask that my full testimony be submitted for the record.
        During my campaign and since becoming Florida's governor on
    January 4th, I have heard firsthand the heart-wrenching stories
    from family members and friends of those who have lost their
    livelihoods and tragically their loved ones to prescription
    drug addiction. So I have been working on solutions to this
    problem since being elected. And Chairman Bono Mack, I know you
    have been personally touched by this epidemic.
        Florida, like much of the Nation, has a long history in the
    fight against criminal drug distribution. The names of the
    drugs have changed but the problem has remained. Today, one of
    the most common names in the fight is oxycodone. Consider some
    of the statistics from my State and the scope of the problem
    becomes clear. Ninety-eight of the top 100 doctors dispensing
    oxycodone nationally are in Florida concentrated around Miami,
    Tampa and Orlando. A hundred and twenty-six million pills of
    oxycodone are dispensed through Florida pharmacies. By far,
    more oxycodone is dispensed in the State of Florida than in the
    rest of the Nation combined.
        The targets for law enforcement have often been the street
    dealers and addicts, essentially the bottom level of the
    distribution chain. One tool that focuses on end users is a
    database focused on the patient level. This month in Florida,
    my Department of Health began implementation of such a
    database. While the database moves forward, I am working on
    satisfying the privacy concerns of law-abiding concerns. In
    2009, the Associated Press reported a massive privacy breach
    when hackers broke into Virginia's prescription drug database.
    They obtained more than 8.2 million patient records and a total
    of nearly 36 million prescriptions. In Florida, I continue
    working with my legislative partners to find solution that
    protect patient privacy.
        More important than computer databases, though, is focus on
    the resources of my administration on a law enforcement
    solution that starts at the top of the distribution chain
    instead of the bottom. Every day, we see that pharmaceutical
    manufacturers and wholesalers turned a blind eye when massive
    amounts of narcotics stream into the same regions of Florida.
    Meanwhile, unscrupulous doctors work with storefront pill mills
    masquerading as legitimate health clinics. At each level, there
    is an opportunity for law enforcement to intervene and stop the
    illegal flow of drugs into our communities.
        In these first few months of my administration, I committed
    to provide a law enforcement solution, a statewide drug strike
    forces. It ensures open channels of communication and multi-
    agency cooperation. The goal is clear: target the sources of
    these drugs before they hit the streets. It gives our local
    sheriffs and police chiefs a statewide coordinated effort that
    provides intelligence, analytical and investigative support. As
    I speak to you today, local law enforcement strike teams are
    working to identify, investigate and apprehend those in the
    medical and pharmaceutical distribution chains. I also directed
    all the state agencies in Florida to identify investigative
    resources, licensing and registration information and
    analytical research that can be used by law enforcement.
    Florida Attorney General Pam Bondi is working with prosecutors
    across our State to ensure these criminals are prosecuted to
    the fullest extent of the law. I am grateful to all of these
    professionals for their commitment to this important work.
        Not only are these efforts focused on Florida, we are also
    coordinating with other States to shut down a national
    prescription drug pipeline that some have called the Oxy
    Express. We are aggressively working to shut down the illegal
    supply of prescription drugs from our State both inside and
    outside of Florida. Since the beginning of my administration,
    there have been more than 50 arrests around the State including
    a statewide sweep by law enforcement that raided 15 pill mills
    in three south Florida counties.
        Just the other day, I was disappointed to learn that a
    deputy sheriff in south Florida was the first drug trafficking
    arrest made since the initiation of the strike force. It is too
    early to go into the details on this and other cases but I can
    tell you more investigations are underway and arrests will
    continue.
        With my partners in the Florida Legislature, we will pass
    legislation in the next 3 weeks to prevent doctors from
    dispensing narcotics and require doctors to divest of their
    pharmacies. Doctors who have forsaken their commitment to
    people's health in exchange for the quick buck of unethical and
    criminal dispensing must be put to an end. We will also closely
    review the activities of wholesalers in Florida and we will put
    in place tough penalties for these manufacturers and
    distributors who fail to help us turn off the illegal supply
    chain.
        Let me conclude by telling you that this strategy centered
    on a law enforcement solution and targeting the top of the
    distribution chain rather than the bottom will make a
    difference. I applaud this committee for taking a serious look
    at the issue and I want to ask you to also focus your energy at
    the sources of this problem. Together, if we hold the
    manufacturers, wholesalers, doctors and pharmacies accountable,
    we can win this fight. Thank you very much.
        [The prepared statement of Mr. Scott follows:]

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        Mrs. Bono Mack. Thank you, Governor Scott.
        Governor Beshear, you are recognized for 5 minutes.

                       STATEMENT OF STEVE BESHEAR

        Mr. Beshear. Thank you, Madam Chairwoman, members of the
    committee. Thank you for allowing us to come here and discuss a
    national crisis that has been particularly destructive in
    Kentucky and in Appalachia in general, and that is the crisis
    of prescription drug abuse.
        Let me be frank. Our people in Kentucky are dying. An
    average of 82 Kentuckians each month fall victim to drug
    overdoses, the majority related to prescription drugs. That is
    more than two people a day. To put that in perspective, more
    people in Kentucky die from overdoses than from car wrecks.
    Greater still is the number of families decimated by the
    financial and social toll of this illicit drug use. In the
    words of our law enforcement officials, medical professionals
    and coroners, what has long been a problem has become an
    epidemic.
        Our response in Kentucky has been aggressive. We have
    ramped up enforcement. We have expanded the availability of
    treatment and we have implemented high-tech monitoring and
    recordkeeping while working to share that information with
    other States. Our prescription drug monitoring program called
    KASPER was created more than a decade ago as a tool for both
    the medical and law enforcement communities and is now
    available electronically. Singled out by the White House in
    2006 as a national model, KASPER is inclusive and easily
    accessible. Furthermore, in 2005 Kentucky became one of the
    first States to require a doctor's examination for the writing
    of scripts for powerful painkillers and to require Internet
    pharmacies to be licensed in the State. Three years later,
    Congress passed the Ryan Haight Act.
        But these innovative efforts have not been enough because
    as Kentucky has tightened its net, illicit drug users have
    found ready supplies of prescription drugs in other States with
    looser regulations, and we are not equipped to stop that. What
    is needed clear is an aggressive nationwide response, one that
    recognizes that this country's prescription drug strategy is
    only as strong as the weakest link in the chain.
        I am here to push three thoughts. One, I urge Congress to
    continue providing resources to the Harold Rogers Prescription
    Drug Monitoring Grant Program so that the work toward data
    sharing among States can continue. We have come too far with
    that program to stop now. Forty-five States have authorized
    prescription drug monitoring programs and 34 are currently
    operating.
        At this point I want to stop and salute the efforts of
    Congressman Harold Rogers of Kentucky. He has been a warrior on
    this issue of prescription drug abuse.
        Secondly, training must be mandated for those who prescribe
    controlled substance, especially schedule II narcotics. These
    drugs and the risk of addiction and fatal overdoses must be
    more clearly understood by both doctors and patients. We can't
    leave this education simply to the pharmaceutical sales reps.
        And three, the Department of Justice must focus more
    attention and resources on Florida, especially south Florida,
    to stop the flow of prescription drugs. As Governor Scott and I
    have talked, it is a tremendous issue in his State and we both
    acknowledge that. Some 60 percent of the prescription drugs
    sold and consumed illegally in Kentucky come from the loosely
    regulated pain clinics in Florida with each trafficker bringing
    back on average more than $10,000 worth of drugs. In 2009,
    Kentucky State Police arrested more than 500 people from
    eastern Kentucky in its largest drug roundup ever, and every
    single suspect had ties to Florida. These pill traffickers are
    not amateurs. They are sophisticated. They are well-organized
    operations. And the fight against them must be well organized
    as well.
        I appreciate the very aggressive efforts that Governor
    Scott is implementing in Florida to attack this problem. I
    appreciate the fact that I believe now they are going ahead to
    implement the monitoring system that they passed a year or so
    ago.
        And that, my friends, is good but it is a start. As we both
    know, it is just a start. It is one piece of a much larger
    strategy that we have to apply. This is a national problem that
    demands national solutions, and the sooner we come together to
    recognize that, the greater our success will be. Thank you.
        [The prepared statement of Mr. Beshear follows:]

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        Mrs. Bono Mack. I thank both our governors and recognize
    myself for the first 5 minutes.
        I want to thank you both very much. I have encouragement
    that the two of you are sitting together, for those in the
    audience to recognize this is a bipartisan panel, and if you
    were to have only read your written testimony, you would have
    thought there would have been some sparks flying, but it seems
    that there is definitely a meeting of the minds here and a
    recognition first and foremost that the problem exists.
        Governor Scott, congratulations on your recent election,
    but to you, I am encouraged to hear you are going to move
    forward now but I am also hoping you are going to continue to
    reject the $1 million that Purdue Pharma offered you. Are you
    going to accept or reject that $1 million Purdue Pharma offered
    you to fund a database?
        Mr. Scott. We are not accepting it.
        Mrs. Bono Mack. I thank you for that very much. Can you
    speak a little more as a businessman? You saw first and
    foremost that the law was being broken and you wanted to come
    at it from law enforcement. Can you speak a little bit more
    about this approach? Because I would love to see people go to
    jail. I would love to see some of these bad actors in handcuffs
    being taken off. Can you speak to your efforts a little bit
    more thoroughly from the law enforcement side?
        Mr. Scott. Well, here is what we can do. We are in
    legislative session right now and so we have a very aggressive
    bill that is going forward that will help law enforcement, but
    in the meantime, we have a strike force. Our Florida Department
    of Law Enforcement, we took monies out of that budget right now
    and we took a lot of investigators from there, from the
    Department of Health and other agencies and provided help to
    each of our sheriffs and each of our police chiefs because they
    are just overwhelmed with this issue right now. At the State,
    we have got a lot more analytical and investigative research
    that we can do, so we are helping them deal with that. On top
    of that, we have a very aggressive attorney general. Attorney
    General Bondi is very aggressive on this issue and so we have
    done a good job with arrests so far. Eighty-seven percent of
    the oxycodone that comes out of the country comes out of
    Florida right now. So the strike force is going to have a big
    impact. But I think a bigger impact is going to be the fact
    that the doctors will not be able to both prescribe and
    dispense, so that will stop that. They are not going to be able
    to own the pharmacies. We are going to limit the number of
    prescriptions they can do a day. That will have a big impact.
    So it is just piece after piece after piece. And then of
    course, as we know, they will figure out something and then we
    will have to continue to change. But I think all those things
    put together with all the data that we are helping our local
    law enforcement will have a big impact.
        Mrs. Bono Mack. Governor, do you need any help changing
    laws up here in Washington that you have found? Are you
    changing state law?
        Mr. Scott. You know, I think that probably the biggest
    thing we need to look at is regulating these manufacturers and
    what should these drugs be allowed to be used for. So I think,
    you know, the usage of it--I mean, the fact that you can
    prescribe for these things, you know, as Governor Beshear said,
    some of the things requiring the doctors to have to do a
    medical exam and all that, you know, that is already being done
    and it is never enough. There is always something else we are
    going to have to keep doing. But the first thing is, why are
    they even able to sell these things and for what purpose and
    should there be a much more limited purpose that these drugs
    can be used for.
        Mrs. Bono Mack. Well, I look forward to working with you on
    these answers and moving forward, and I applaud that you are in
    the fight. I also would like to mention Governor Kasich as a
    third governor who has become very involved.
        Governor Beshear, just a little bit of information. My
    parents met and fell in love before World War II at a little
    teeny tiny college called Berea, if you know Berea College in
    Kentucky. So it is a near and dear place to my heart.
        But you also came in here sort of loaded for bear, ready to
    set your sights only on Florida, but can you speak a little bit
    about what you are hearing the governor say? You are encouraged
    about this willingness to cooperate?
        Mr. Beshear. Listen, this is not a partisan issue. This is
    a life-and-death issue as we all know, and it requires us to
    work together. I don't know that there is ever going to be
    total solution to this problem. It is always going to be with
    us, but we can sure make a significant impact if we work
    together and bring all the tools that we have got and cooperate
    together. You mentioned Governor Kasich in Ohio. You know, we
    are working right now with Ohio trying to figure out how to
    share the information between our monitoring systems so that we
    can do an even better job than what we are doing.
        Mrs. Bono Mack. For the sake of time, one of the biggest
    concerns of course is a privacy breach, and we are all very
    sensitive to that, and I think nowhere more so than in health
    care. Can you speak specifically how you are protecting that
    data and consumers can feel confident that they have privacy
    that they need?
        Mr. Beshear. You know, we have had the system now for 10
    years and we have got very strict privacy guidelines. It has a
    successful track record. It has never been breached. It is a
    felony for folks to breach that system. And it has worked. The
    integrity of the system has held together. I don't know of any
    system, whether it is with the CIA or the State Department or
    the Defense Department or our monitoring system that you can
    guarantee will never be breached, that will never find a way
    for somebody to hack into it. We obviously will continue to
    strengthen with the latest technology those security systems.
        But is really a matter of weighing the issues here. You
    know, there is a slight risk always whether it is e-health
    records or whatever that some breach can occur, but when you
    are looking at 82 Kentuckians a month dying, when you are
    looking at about seven Floridians a day dying because of drug
    overdoses of legal prescription drugs, that is a pretty easy
    answer for me.
        Mrs. Bono Mack. I thank you very much, and my time is
    expired. I recognize Ms. Blackburn for 5 minutes.
        Mrs. Blackburn. I want to stay right there with the privacy
    and the online database issue because we are the committee of
    jurisdiction with telecommunications and the Internet. That is
    one of our subcommittees. And the privacy issue is one that we
    will do some work on this year. And Governor Beshear, you have
    had KASPER for 10 years, and I think it would be helpful to us
    as a committee as we consider both the larger privacy debate
    and as we look specifically at the prescription drug program to
    have some guidance from you all, some suggestions of what you
    think we could focus on.
        And Governor Scott, let me just continue with the
    chairman's question to you. With these databases, what
    suggestions do you have and where are you seeing the problems?
    Have you all come up with a way to guard against the breaches
    and have you had any breaches?
        Mr. Scott. Well, we just started to implement ours. When I
    came to office, there was a lawsuit that prevented us from
    implementing it. So we are just now getting started. And so
    what we are doing is, we are looking at what all the different
    States are doing with regard to privacy to come up with the
    best answer on dealing with that, because it is a big issue and
    we have people worried about it.
        Mrs. Blackburn. All right. And Governor Beshear, did you
    say that you had or had not had a breach on your system?
        Mr. Beshear. No, we have never had a breach.
        Mrs. Blackburn. You have never had a breach in the 10
    years?
        Mr. Beshear. Right.
        Mrs. Blackburn. So you feel like your firewalls--and do you
    do an opt-in or opt-out on information and data share? Get back
    to me on that. I know time is----
        Mr. Beshear. I will. I am not sure on that.
        Mrs. Blackburn. OK. Let us talk about education just a
    second because this is something with the prior panel as we had
    the DEA before us that we looked on just a little bit, and I
    think that it is important for us to continue to move forward
    with education. I would like for you each to give me just a 1-
    minute response on what you are doing with public education,
    with personal responsibility education, with parental
    education. I know in Florida the pain clinics are a problem
    that was recently discussed, and then you have a little bit of
    history, Governor Beshear, so if you all would talk about the
    education component, that would be helpful. Governor Scott
    first.
        Mr. Scott. Sure. Well, what we are doing is, first off is
    making sure the public knows just through articles and things
    like that, make sure the public knows how big the problem is. I
    have done press conferences and things like that. I have
    brought it up through--we have had testimony in the legislature
    to talk about the issue. We spent a lot of time this
    legislative session going through what the problems are. So
    that is the biggest thing we are doing right now.
        Mr. Beshear. Certainly the public education part of it in
    terms of talking about it publicly, and it is talked about a
    lot publicly in Kentucky right now, and I am glad of it because
    at least it is exposing all of our citizens to this dreaded
    problem. Also in our pharmacy schools, in our medical schools,
    we are pushing to make sure that our doctors really understand,
    the ones that are coming out, and the pharmacists understand
    what they are really doing and that they don't get their
    information just from the drug reps, that they have the kind of
    information they need to handle these kinds of drugs very
    carefully and very effectively.
        Mrs. Blackburn. Do you think most Kentuckians realize you
    have the KASPER system in place?
        Mr. Beshear. I think there is probably a general knowledge
    we do, although it is probably not understood in terms of what
    it really does. But we are looking at strengthening that
    system. Right now, you know, doctors can voluntarily be in it
    or not be in it. I am thinking of beginning discussions about
    making that a little stronger.
        Mrs. Blackburn. Having it be mandatory?
        Mr. Beshear. Making that a little stronger. You know, I
    think doctors ought to be in that program.
        Mrs. Blackburn. Thank you both, and I yield back in the
    interest of time.
        Mrs. Bono Mack. I thank the gentlelady. The chair
    recognizes Mr. Stearns for 5 minutes.
        Mr. Stearns. Thank you, Madam Chair.
        Governor Beshear, when you mentioned that more people are
    dying from overdose than automobile accidents, that is
    appalling. That is just a frightening statistic.
        Governor Scott, earlier we had a Florida delegation, Madam
    Chair, so I heard some of the testimony from the governor, and
    I guess the question that came up when we had the delegation
    meeting, can pain clinics be subject to additional scrutiny
    before they are licensed to practice? Is that a place where we
    could start?
        Mr. Scott. We are doing that now. We are doing it through--
    we already have where they have to be licensed so we are doing
    that. But it is not perfect. It is not easy to get around, but
    you can get around it. So that is actually one of the things
    that is in our bill. But the big thing is, think about this. We
    know the manufacturer, we know the distributor, we know the
    doctors that are distributing it. We ought to be able to stop
    this if we just keep tracking it. Now, people will change and
    there will be a new drug or something like that but this is a
    legal distribution system that is doing it the wrong way so we
    ought to be able to--if we track it all the way and have
    criminal penalties and civil penalties for everybody that is
    doing the wrong thing, I think we will have a dramatic impact
    in Florida for a period of time and then something will change.
        Mr. Stearns. Governor Beshear, anything you want to add to
    that?
        Mr. Beshear. No. I think we need to be as aggressive as
    possible in all of these areas. We need to be aggressive in
    regulation of all of these folks and regulation of what the
    pharmaceutical companies can do in terms of who gets these
    drugs and how they are dispensed. We need to be very aggressive
    in the law enforcement area. And I think what Governor Scott is
    doing in Florida is showing that kind of commitment very
    quickly, and we have been doing that in Kentucky for some time
    also.
        Mr. Stearns. Intuitively, the relationship between the
    doctors and the pharmacies, is that anything that you as a
    governor, either one of you can do in terms of educating or
    threatening or somehow trying to influence the relationship
    between the pharmacy and the doctor, or is that sort of
    sacrosanct, that there is nothing you can do?
        Mr. Scott. We are doing it in our bill. The doctor that
    prescribes will not be able to own a pharmacy.
        Mr. Stearns. Oh, that is good.
        Mr. Scott. So we are going to completely separate it, and
    then we will have the data. We will be able to track all the
    way through. But I think stopping the ownership will have a
    significant impact.
        Mr. Stearns. Is there any State that has in place some of
    the things you have already talked about, Governor?
        Mr. Scott. I haven't seen anybody that restricted the
    ownership of pharmacies.
        Mr. Stearns. Yes?
        Mr. Beshear. One of the other things, and I am not sure how
    his laws are set up, but I appoint the doctors to the board of
    medical licensure and the pharmacists to the pharmacy
    regulatory board, and I have made it a very clear point before
    I appoint anybody, I have them come in and we talk about these
    kinds of issues, and I get a commitment from these folks to
    really bore in and try to address these kinds of issues as much
    as possible, and I think that is just another tool that we have
    to attack this problem.
        Mr. Stearns. Now, is there anything that the Federal
    Government, either one of you think we as legislators on the
    Federal side or perhaps direct the Federal agencies in some way
    that could make your job easier so we can stop these drugs from
    coming down the pipeline? So any suggestions you have would be
    very helpful. Governor Scott?
        Mr. Scott. Sure. I think the biggest thing is, why--I mean,
    there ought to be restrictions on how these drugs can be used
    and what they can be prescribed for.
        Mr. Stearns. From the Federal level?
        Mr. Scott. Yes.
        Mr. Stearns. From the FDA?
        Mr. Scott. Right.
        Mr. Stearns. OK.
        Mr. Beshear. Another area that I hope you all will pay
    particular attention to are continued funding for the Hal
    Rogers Act that is on the books now. That will help the States
    to share information and develop the systems to share
    information, and that will be effective in this battle, the
    HIDA, the Erns Jag awards and grants that are made that help us
    fight this specific problem. I know that just as Governor Scott
    and I are fighting budget battles every day, you all are too,
    but some things are more important than others and that is the
    way we all have to look at the way we balance our budget. That
    is what I do. That is what he does. And I just ask you in that
    priority, put this priority up there.
        Mr. Stearns. Well, I want to thank you. My time is expired.
    But I think the fact that both of you governors took the time
    to come up here to talk about this serious problem, I think is
    a commendation to you and also for us having this hearing,
    Madam Chairman, because this shows that even though we are
    trying to reduce spending up here, this is a priority, I think,
    that is very serious in this country, and we have ways to stop
    it. So thank you for your testimony.
        Mrs. Bono Mack. Thank you, Mr. Stearns. Mr. Guthrie, you
    are recognized for 5 minutes.
        Mr. Guthrie. Thank you very much, Madam Chairwoman. And
    also your roots are from Muhlenberg County, or several
    generations back, I believe.
        Mrs. Bono Mack. That is right.
        Mr. Guthrie. Which is near where the governor is from, a
    couple counties over from where the governor is from. So thanks
    so much. And I did mention the first lady, she is from my area,
    so I should have mentioned that in the introduction. So I
    appreciate what she is doing as well for our State.
        When we did KASPER, I remember it coming forth, and I will
    tell you, there is not a legislative session that doesn't go
    on, particularly the legislators from Appalachia, have always
    pushed what can we do to improve monitoring, interdiction. So
    the Kentucky leadership is focused on this and trying to help
    solve this problem.
        If I remember some of the participation in the Medicaid,
    because it seems that the prescription drug problem is in areas
    that are heavily Medicaid as well, and I don't know if you know
    the correlation between that or if you have seen as well,
    Governor.
        Mr. Beshear. Certainly, you know, prescription drugs are
    allowed under the Medicaid program obviously and every State is
    involved in that program, and you are going to have some abuse
    within that program, and we are very aggressive in the Medicaid
    area of trying to weed that out and at the same time educate
    people. You know, we are pushing in the Medicaid program the
    ability of our local health departments and those regional
    medical centers to educate our folks about the dangers of these
    narcotics. You know, so many of these people that end up being
    addicts start out as legitimate drug users, you know, that they
    need something for their pain or this or that, and they start
    out in a very legitimate way and then they end up being
    addicted and then they get into this cycle of buying the drugs
    illegally, and that just grows the problem.
        Mr. Guthrie. And I know you weren't governor at the time,
    but when we passed KASPER, I don't remember Florida being such
    a big issue for us 10 years ago, but KASPER, did it just move--
    because I-75, wonderful highway, we love I-75 and people go to
    Florida and enjoy it and love it, but it also seems to be a
    pathway for the prescription drugs to come to Kentucky. Is that
    because we had KASPER because it helped curtail some of the
    problems we had so it just has moved?
        Mr. Beshear. Sure. You know, before we had KASPER, they
    would just stay in Kentucky and get these drugs illegally, and
    we haven't cut all of that out. I don't want to even imply
    that. But we made a significant impact in it by having this
    monitoring system among several tools that we have, and the
    fact is, no State is an island, you know. Folks, if we stop
    them doing something in Kentucky but they can do it across the
    State line, they will go do it across the State line. And that
    is why it is so important for all of us all across this country
    to find ways to address this. It doesn't have to be uniform
    everywhere but it has to be everywhere for this to really work.
        Mr. Guthrie. Well, thanks. And I think I saw you on the
    news a couple of weeks ago. I know Florida is in session, and I
    guess a bill had seemed to have failed in Florida that might
    have addressed this, but it sounds like Florida does have a
    bill moving forward in the legislature now. I don't know if it
    stalled or whatever. I am glad to see you all together working
    on this because it is a problem for all of us. But what is
    going on in the Florida legislature to address the tracking or
    the similar KASPER deal?
        Mr. Scott. Well, first off, the monitoring bill was passed
    last year, and there was a lawsuit that just got finished last
    Friday.
        Mr. Guthrie. Maybe that is what you were referring to.
        Mr. Scott. So that has finished. But we have a very good
    bill that looks like it is going to get out of both the house
    and the senate, which everybody has signed off on including the
    attorney general, who is very focused on this, and if you
    prescribe the drug, you can't dispense it out of your office.
    You can't own part of a pharmacy. There is a restriction on the
    number of prescriptions you can do a day. We have got tamper-
    resistant pads to write the prescriptions. We have got
    licensing of the pill mills and we have got criminal penalties,
    civil penalties going all the way up to the manufacturer. We
    are going to try to do everything we can to stop it. It is a
    big issue when 98 of the top 100 doctors in the country
    prescribing oxycodone are in Florida.
        Mr. Guthrie. So are Florida's laws different? Because I-75,
    you have to go through Tennessee and Georgia to get to Florida.
    Are you all just so different? I know you are working on that?
    But is it so different now, the current status than Georgia or
    Tennessee? I mean, Kentuckians aren't going to Tennessee, they
    are going to Florida, so what is the difference, I guess?
        Mr. Scott. Every State has been different.
        Mr. Beshear. And what has happened is that some of this is
    starting to move to Georgia because Georgia doesn't have a
    monitoring system. Tennessee does. And that is, I think,
    initially what pushed it south, and you know, Georgia may be
    the next place that we really have to push hard to get them to
    address this situation.
        Mr. Guthrie. Thanks, Governors. Thanks for making the trip
    to Washington today. I appreciate it. I have to yield back now.
    I am out of time.
        Mrs. Bono Mack. I thank the gentleman. Mr. Harper, you are
    recognized for 5 minutes.
        Mr. Harper. Thank you, Madam Chair, and welcome to each of
    you, and it is an honor to have you here. This is a very
    important issue. We all have friends who have had their
    families devastated, primarily by young people who get those
    prescription drugs from their medicine cabinet at home. That
    seems to be a major problem.
        So how do we solve the underlying problem here is that no
    matter what regulations we put on, which will be very helpful,
    how do we convince these young people not to use the drugs, not
    to take them? Are you doing anything in conjunction with, say,
    success in drug courts or any faith-based programs? Governor
    Beshear, I will ask you that first.
        Mr. Beshear. Yes, we have drug courts, we have faith-based
    initiatives that all work in this area. Obviously a part of it
    is education, and we are pushing that both in the public school
    system as well as through faith-based initiatives. The other
    end of it is treatment and rehabilitation, and we took a
    significant step recently in Kentucky by revising a major part
    of our corrections system and our approach to corrections to
    put a lot of time and effort into treatment and rehabilitation
    so that we can stop recidivism and stop that revolving door to
    where folks just get out, you don't give them any help, you
    just turn them loose again, and, you know, within 30 days, they
    are out trying to buy the drugs again and they are back in. And
    we brought the Pew Foundation into Kentucky and had a
    bipartisan effort of Republicans and Democrats, our house, our
    senate, our supreme court, the court system as well as the
    governor all got together, and we have made some major changes
    that I think on that end of the spectrum will address the
    recidivism rate.
        Mr. Harper. And Governor Scott, your State dealing with
    drug courts or faith-based initiatives to help in this effort,
    what is the story there?
        Mr. Scott. Well, the big thing we are doing since I have
    been in office is educate the public to make sure everybody
    gets on board, first off, making sure we get this legislation
    passed so that was very important to get that done. The strike
    force is very important. On top of that, just continuing to
    educate the public. The schools are educating the public. Also,
    the individual I put in charge of Department of Corrections is
    very focused on this and the same thing as Kentucky, very
    focused on the number of people that get out of prison and go
    right back and have the same problem. So he is somebody that is
    very focused on that issue.
        Mr. Harper. Well, obviously our goal is to make sure they
    never get into the court system in the first place and how do
    we encourage folks this is not the route to go?
        Mr. Scott. Well, one thing we have done is, our juvenile
    justice is run by an individual from Miami. She came up to work
    with me, and she is focused on a program that she has worked
    for 20 years in Miami that has had a dramatic impact in
    stopping sort of the--the first time you get stopped for
    something, you don't end up in prison just because it ends up
    being a cycle. So all the things she has done starting with
    civil citations and starting with, if you get stopped for the
    first time, it is not just that issue. You might have an issue
    over food, shelter, family issues, things like that, and having
    a holistic approach to it to stop them from ultimately ending
    up in prison. So we are taking all the things that she is doing
    and spreading them across the State. On top of that, we have
    legislation that would allow us to do a civil citation program
    rather than immediately moving into a criminal program.
        Mr. Harper. And how you secure the prescriptions at
    someone's home so that no one other than the intended patient
    gets it is a really tough thing to do.
        Mr. Scott. That is the hardest.
        Mr. Harper. I am interested in what you said about your
    task force that you have in place. How are you going to measure
    the success of the mission of that task force? What are you
    anticipating or hoping for out of that?
        Mr. Scott. Well, the numbers have to get better. We can't
    have 98 of the top 100 doctors, 126 million pills. It is
    basically, how do we stop basically all this happening in our
    State. But it is going to be arrests, it is going to be the
    number of prescriptions that are done. In the end, it is
    prescriptions and deaths.
        Mr. Harper. What about working in conjunction with your
    State medical association? What input have they given either of
    you?
        Mr. Scott. Well, in our case, they are very focused. I am
    doing something similar because I have the opportunity to
    appoint the members of the board of medicine, so as I am going
    through that process and talking to individuals about those
    positions, I have talked to them about how important this issue
    is and the fact that they have got to be engaged and the board
    of medicine has to be engaged.
        Mr. Harper. Governor Beshear?
        Mr. Beshear. Same thing here. You know, we are engaging the
    medical profession, the pharmacy profession as well as their
    regulatory boards, and you know, as I am sure Governor Scott
    would point out, those boards, their first duty is to protect
    the public and not just protect themselves, and we see a little
    bit of that in every regulatory environment whether that is
    lawyers, doctors, pharmacists, and I am a lawyer so I can say
    that about myself. But, you know, we have got to emphasize that
    their first duty is to the public and to protect the public,
    and it just comes down to appointing the right people.
        Mr. Harper. Thank you each for being here, and Madam Chair,
    I yield back.
        Mrs. Bono Mack. I thank the gentleman. The chair recognizes
    Dr. Cassidy for 5 minutes.
        Mr. Cassidy. Thank you for being here, gentlemen. My pain
    doctors really like the PDMPs because they feel like the pill
    mills give everybody else a bad name. Now, that said, I gather
    from testimony that some of these PDMPs are robust and some of
    them are limited in ability.
        Now, Governor Scott, clearly you have legitimate concerns
    regarding the privacy, but as much as you can say, and I gather
    Kentucky has a rather robust program, where do you imagine
    yours will be on the spectrum? And I just mention that because
    at the previous meeting, Florida was described as ground zero
    for the promulgation, if you will, or the source, if you will,
    for these drugs across the Nation.
        Mr. Scott. Well, it is clearly ground zero, so it is a
    significant issue and things that are--Florida's problem is a
    problem for the whole country because we haven't stopped the
    abuse. So our database will be--what we are doing is, being one
    of the later States to do it, we will be able to take all the
    benefits, take all the knowledge from the other States, which
    is what we are doing, both to make sure we have the right
    information and also have the right privacy concerns that we
    can address, so we will be doing both of those. But on top of
    that, we are going to make sure we are tracking from the
    manufacturer to the wholesaler to the doctor, not just at the
    pharmacy after the fact, because after the fact is going to be
    part of what we do but I think the biggest part is going to be,
    we are going to stop the distribution of it.
        Mr. Cassidy. I see that. OK. Now, let me ask you, my pain
    doctors also tell me part of the problem is that someone may
    live on the Pearl River borders between Louisiana and
    Mississippi, and I think there is a Pearl, Mississippi, and a
    Pearl, Louisiana, and they say live in one State and go to the
    other and they will get as much they can below the threshold
    here and then they will go back here, and they will do as well
    on the other side. Now, clearly, that just may require a
    Federal overlay, but as two fellows who obviously will be
    jealous and respective of States' prerogatives, how do we keep
    folks from popping across State borders to maximize--do you see
    where I am going with that, Governor Beshear?
        Mr. Beshear. Well, first of all, both States need the
    monitoring program, and do both of them have that?
        Mr. Cassidy. They both do, but each is self-contained.
        Mr. Beshear. Right, and they need to be doing what we are
    doing with Ohio right now. We are sitting down and trying to
    work out how to share information, and we are going to do that.
    Governor Kasich and I will end up--we will find a way to do
    that. And we are being helped by this Hal Rogers grant program.
    That is the money that has been provided to help States work to
    share information in these monitoring systems, and we need to
    continue that. We need that funding to continue doing this so
    that every State ultimately will be sharing across State lines.
    That is the only ultimate way that these programs will be as
    effective as possible.
        Mr. Cassidy. And so although you start off with Ohio, you
    share a border, you actually envision that eventually you may
    partner with Governor Scott, for example?
        Mr. Beshear. Yes.
        Mr. Cassidy. And wherever there is a potential
    distribution, to be able to go there?
        Mr. Beshear. Yes. We all need to partner eventually so that
    there is no place in this Nation that people can go and be able
    to do what they are doing now as freely as they do it.
        Mr. Cassidy. Now, Governor Scott, I have to admit, I am a
    gastroenterologist, which I tell people prepared me very well
    for Washington, D.C. So if what I am about to ask you seems
    very simplistic, it may be, but it seems like if you know who
    those 98 docs are, all you need to do is have an undercover
    person walk in. I am told these pill mills, you may $250 or
    something for a visit. Five minutes later, you walk out with a
    handful of prescriptions. It seems like you could go to each of
    these and put them out of business for inappropriate
    prescribing. Why not?
        Mr. Scott. The difficulty is that the smart ones, what they
    are doing is, it will appear legitimate. They will do the MRI,
    they will do the history, they will do all these things, and so
    it is not as easy as just walking in and saying that you are
    doing something wrong. You have to have--that is why we spent a
    lot of time on this legislation with the attorney general and
    with the sheriffs and the police chiefs to make sure that what
    we are passing is something they are going to be to convict
    with because they will do all the--everything I have been told,
    they will do all the basic things to make sure it is very
    difficult to stop them.
        Mr. Stearns. Will the gentleman yield just for one second?
        Mr. Cassidy. I will.
        Mr. Stearns. I would think if you just let out the word
    that you are going to do sting operations, I mean, I would
    think that would create a pale over those physicians that might
    retard them from doing this. So I know, Governor Scott, it
    sounds difficult but I think what the gentleman is saying is,
    the fact that these stings might or might not come would create
    some caution.
        Mr. Scott. I think the difficulty is, there is a lot of
    money in this. There is a lot of money being made.
        Mrs. Bono Mack. I thank the gentleman. We are fortunate to
    have the governors, I understand, until 10:15, so we would like
    to do a second round of questions until that point if my
    colleagues are so inclined, and I will recognize myself for the
    first 5 minutes and just point out a few things that I think
    are essential for this discussion.
        First and foremost, it was my understanding that OxyContin
    was originally approved for severe cancer, late stages of
    cancer for severe pain yet the number-one prescriber today of
    OxyContin to children 12 and over is dentists, and I think that
    should be pointed out.
        I would also like to talk a little bit about the parental
    education, words that keep coming up, and point out that we
    have two panels yet to speak who will show that parents of all
    walks of life are affected by this and that it is impossible to
    detect this problem until it is too late.
        Governors, in your travels and your meetings with addicts
    and loved ones of addicts, first of all, would you be--I
    contend that OxyContin is heroin. Would you take big umbrage
    with that? Would you say that is about right, what you are
    seeing?
        Mr. Scott. You know, you never know the definition, but I
    can tell you, we ought to really restrict what it can be
    prescribed for.
        Mrs. Bono Mack. I have a bill that does just that, and I
    will be looking forward to working with you on that. You keep
    speaking also, Governor, about limiting all of these leftover
    pills in the medicine chest, and I keep wondering why we are
    prescribing, you know, hundreds of tons of pills a year that go
    unused. If patients don't want them, why are they getting out
    there? That is another question that I look forward to
    exploring with you.
        And Governor Scott, I want to applaud you on your decision
    to reject the $1 million from Purdue Pharma for your database.
    Just recently there was an article here that points out that
    the CDC authored a study where they linked these powerful
    painkillers to deaths and the University of Wisconsin School of
    Medicine released a study that disputed that and talked about
    liberalizing opioids, and lo and behold, financed by Purdue
    Pharma, and I would like to submit this article for the record.
        [The information follows:]

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        Mrs. Bono Mack. And I think people need to start looking at
    the connection between these studies and these policies and the
    big money that you were just speaking about, Governor Scott.
        Governor Beshear, clarification again if I might. You did
    say the number of fatalities in Kentucky from drug overdoses
    has now surpassed automobile accidents. Is that legal or
    illegal drugs, again?
        Mr. Beshear. It is a combination but the majority of it is
    legal drugs, abuse of legal drugs.
        Mrs. Bono Mack. Thank you. And then Governor Scott, as a
    businessman, when you look at the chart for the dramatic
    increase of opioid abuse, it is ironic that the trend line
    started screaming upward shortly after OxyContin was approved.
    As a businessman, does that look kind of fishy to you like it
    does to me?
        Mr. Scott. Yes.
        Mrs. Bono Mack. Thank you.
        Mr. Scott. If you look at my testimony, you see how many--I
    mean, 87 percent of it coming out of Florida too and just the
    dramatic increase.
        Mrs. Bono Mack. Thank you. And another point, as somebody
    who has spoken publicly about my family's problem with this or
    being involved with this disease of addiction--and it is a
    disease and I am happy that Congressman Harper brought up that
    side, that they shouldn't be necessarily in the courts but we
    should treat it as a disease first and foremost. But as
    governors, when you meet the families that are suffering,
    aren't these just normal families, regular families? I can show
    you stacks and stacks, I know you have pictures too, of kids
    who are in their senior year of high school, one family whose
    son died just a week before his graduation from high school,
    and he was an all-star athlete, on the dean's list. Everything
    is right about these kids. Do you believe like I do that when
    these kids get access to these powerful painkillers they don't
    stand a prayer in the ability to stay off of them?
        Mr. Beshear. This cuts across income brackets, it cuts
    across every bracket. This is a problem that everybody is
    having, and I don't know that there is anyone in my State or
    any other State anymore that doesn't know somebody, whether it
    is in their own family or a friend or another family that has
    been affected by this.
        Mr. Scott. Yes. A good friend of mine's 18-year-old just
    died 2 weeks ago of an overdose, and he found her. It would be
    horrible. But it impacts everybody.
        Mrs. Bono Mack. Was your friend aware that his daughter was
    using?
        Mr. Scott. He had found out, sent her to a program. What
    happens to a lot of people is that, you know, the kids turn 18,
    they don't have to be in a problem.
        Mrs. Bono Mack. There is a mother who will speak to that on
    the next panel, to that very thing.
        Have either one of you ever met somebody who wanted to be
    addicted?
        Mr. Scott. No. I have a family member that has been
    addicted his whole life, never beat it. He started at a young
    age and never beat.
        Mrs. Bono Mack. And it is a lifelong struggle. Again, I
    thank you two very much. I look forward to our continued
    working relationship. Again, I appreciate your courage in being
    here today.
        I will now yield to Ms. Blackburn for 5 minutes.
        Mrs. Blackburn. Just a follow-on. Governor Beshear, you
    mentioned you were thinking about putting your program as a
    mandate, and as I have sat here listening to you all respond to
    the questions, I am thinking, you know, it must be very
    difficult, and you may have some guidance for having a program
    that is an opt-in for your pharmacists and your physicians, and
    it seems as if those who are illegally prescribing or
    illegitimately prescribing, over-prescribing, would choose not
    to use the system. So I wonder what--if you would just explain
    a little bit about what has led you to that, and as Governor
    Scott is setting his program up, what would you advise him?
    Would you advise him for it to be a mandate from the get-go?
        Mr. Beshear. Well, I am going to be sitting down with our
    medical licensure board and our medical association and the
    dentists and the pharmacists and talk about this, but so far it
    has proven effective the way it is set up in that the doctors
    that are using it can actually detect other doctors even if
    they are not using it that are over-prescribing and are abusing
    the system as well as being able to detect those who----
        Mrs. Blackburn. So you are using it as an accountability
    tool even for those that are outside of the system?
        Mr. Beshear. Yes.
        Mrs. Blackburn. OK. That is great. Now, how do you pay for
    your system and what is the cost of it each year?
        Mr. Beshear. It is paid for by State funds.
        Mrs. Blackburn. Taxpayer dollars?
        Mr. Beshear. Taxpayer dollars, and I am not sure, I can't
    tell you offhand what it costs.
        Mrs. Blackburn. If you would submit that?
        Mr. Beshear. It costs a fraction of what it costs to handle
    the problem the other way.
        Mrs. Blackburn. All right. And Governor Scott, you said you
    are not taking a grant that was offered to you so how do you
    all intend to pay for your system?
        Mr. Scott. We have funding from other individuals and
    companies that are putting the money up.
        Mrs. Blackburn. Are they pharmaceutical companies or----
        Mr. Scott. No. We have got 2 years of funding right now. We
    are just starting to implement ours.
        Mrs. Blackburn. Correct.
        Mr. Scott. But no, it is not pharmaceutical companies.
        Mrs. Blackburn. So it is private funding?
        Mr. Scott. Right.
        Mrs. Blackburn. So there is no taxpayer dollar involved?
        Mr. Scott. No.
        Mrs. Blackburn. OK. Thank you. I yield back.
        Mrs. Bono Mack. The chair recognizes Mr. Guthrie for 5
    minutes.
        Mr. Guthrie. Thank you, Madam Chairwoman.
        Again, I think that if I remember the problem, we were
    trying to define it in the legislature, it seemed to be
    Medicaid, you know, where if you have private insurance and
    they limit how many prescriptions you can get over and over,
    and we had to address that with the Medicaid but it just seemed
    that is where a lot of the prescriptions were coming, not
    everyone. It cuts across all swaths of people. But the
    concentration of it was. And you weren't here, Governor
    Beshear, earlier but Mr. McKinley asked the question to the
    panel before, to the DEA, about why does Appalachia seem to be
    in a bigger--you know, because it is not only Appalachia using
    drugs in Kentucky, I can tell you that. In my area, though, it
    is methamphetamine. So every time we would show up in Frankfort
    for our legislative sessions, groups of us were trying to fight
    meth and other groups were fighting this. But it does seem the
    prescription drug part of it is concentrated in Appalachia
    where in my area it is the illegal manufacture of meth. I don't
    know the answer to that, and I thought it was a good question.
    I don't know if you all have looked at that way, why Appalachia
    seems to be more on the prescription side. Maybe it is I-75
    access to Florida versus our area is not that way. I don't
    know.
        Mr. Beshear. Well, it is obviously a nationwide problem.
    There are, I think, concentrations of prescription drug abuse
    in some places. There are concentrations of things like meth--
    --
        Mr. Guthrie. In my area.
        Mr. Beshear [continuing]. And illegal drugs in other
    places, but obviously it blankets the United States and it is
    getting worse, not better.
        Mr. Guthrie. You know, when we come to Washington and talk
    about problems in our State, we have to do that, but obviously
    we have--and you are the governor of my favorite State and
    obviously a beautiful place, but we have to talk about these
    problems and we have to get together and try to solve them. So
    thank you very much for being here today.
        Mr. Beshear. Well, the first step is to recognize that we
    have got the problem.
        Mr. Guthrie. I think Governor Scott wants to comment.
        Mr. Scott. Somebody just told me that there are no State
    taxpayer dollars but we are going to get some dollars from the
    Hal Rogers Federal grant, but there is no State taxpayer
    dollars.
        Mrs. Bono Mack. Thank you for the clarification.
        Mr. Guthrie. If you want my time, Madam Chairwoman, I will
    yield you my time back.
        Mrs. Bono Mack. Oh, thank you. I was taking it anyway.
        Mr. Guthrie. OK. Go ahead.
        Mrs. Bono Mack. I think an important issue is whether or
    not there was other pharmaceutical money involved, which is a
    question we debate here on many things, but in this specific
    instance, I thought the Purdue Pharma, your decision on that
    was a good one, and I applaud both of you to wrap it up and to
    thank you for your time today and your spirit and the
    willingness to truly address this problem. We are not going to
    end it. We are not going to solve it entirely. But I do believe
    good, innocent people are suffering, and crime, it is a very
    basic situation for me. The FDA approves and regulates and the
    DEA is supposed to control, and with statistics like that, it
    shows that we are failing, and it is time to stop. Too many
    people are dying and too many of our constituents, and more and
    more of my colleagues would have participated today. I know
    Congressman Vern Buchanan is very interested now, Congressmen
    from Massachusetts are very interested. This is not only
    Kentucky and Florida, it is nationwide, and as the panels go
    on, we will focus on California and what is happening. So
    Florida, don't feel that it is all you because it is throughout
    the country.
        But thank you, gentlemen, very much. I look forward to
    working with you.
        At this point the subcommittee will take a very brief
    recess to seat the third panel.
        [Recess.]
        Mrs. Bono Mack. The subcommittee will come back to order,
    please. I thank the staff for being so quick in switching the
    panels over.
        On our third panel, as you can see, we have seven witnesses
    as I introduce them all at once. First is Phil Bauer, surviving
    father of Mark Bauer. Phil serves on the Parent Advisory Board
    for the Partnership for a Drug-Free America. Our next witnesses
    are Kathy and Courtney Creedon, surviving mother and sister of
    Ryan Creedon. Kathy is also Founder of Mothers against
    Prescription Drug Abuse, and I am blessed and lucky enough to
    call them my own constituents. Also testifying will be April
    Rovero, surviving mother of Joey Rovero and Founder of the
    National Coalition against Prescription Drug Abuse. Our next
    panelist is Dan Harris, who overcame a prescription drug
    addiction to gain custody of his children. He is a drug court
    graduate and also a constituent of mine. And finally, we are
    pleased to have Dr. Carol Boyd and Dr. Amelia Arria, who are
    widely respected nationally for their insight into addiction.
    On a personal note, staff told me to say what I already said
    about how proud I am to have some constituents on this panel.
        So welcome to each and every one of you. I really
    appreciate your being here. If you can see the timer boxes down
    there, it is just like a traffic light, green, yellow and red.
    You know what they mean. The total time you are allotted will
    be 5 minutes each, so we are now going to recognize Phil Bauer
    for 5 minutes.

      STATEMENTS OF PHIL BAUER, FATHER OF MARK BAUER AND PARENTS
       ADVISORY BOARD MEMBER, PARTNERSHIP AT DRUGFREE.ORG; KATHY
     CREEDON, MOTHER OF RYAN CREEDON AND FOUNDER, MOTHERS AGAINST
       PRESCRIPTION DRUG ABUSE, ACCOMPANIED BY COURTNEY CREEDON,
    SISTER OF RYAN CREEDON; APRIL ROVERO, MOTHER OF JOEY ROVERO AND
     FOUNDER, NATIONAL COALITION AGAINST PRESCRIPTION DRUG ABUSE,
        AND PARENT AMBASSADOR, PARTNERSHIP AT DRUGFREE.ORG; DAN
      HARRISON, DRUG COURT GRADUATE; CAROL J. BOYD, PH.D., R.N.,
    F.A.A.N, DIRECTOR, INSTITUTE FOR RESEARCH ON WOMEN AND GENDER,
     PROFESSOR OF NURSING, UNIVERSITY OF MICHIGAN, ANN ARBOR; AND
    AMELIA M. ARRIA, PH.D., DIRECTOR, CENTER ON YOUNG ADULT HEALTH
                AND DEVELOPMENT, UNIVERSITY OF MARYLAND

                        STATEMENT OF PHIL BAUER

        Mr. Bauer. Good morning, Chairman Bono Mack, Ranking Member
    Butterfield and members of the subcommittee. My name is Phil
    and I am from York, Pennsylvania, and I am here today speaking
    as a dad.
        If you were to ask any parent what their biggest fear in
    life is, their worst nightmare, most would tell it would be
    losing a child. We are living that nightmare and it is worse
    than we ever could have imagined.
        Our youngest son, Mark, died from prescription drugs. His
    death was preventable and avoidable, and I believe the
    underlying cause was ignorance: my ignorance. Of all the things
    I worried about as a dad, abuse of medicine wasn't among them.
    Unfortunately, there are many people who continue to
    underestimate the dangers of abusing prescription drugs and, as
    I know all too well, ignorance can be fatal.
        On June 4, 2004, my wife Cookie and I, along with our
    oldest son Brian, attended the high school graduation of our
    youngest son Mark. As you know, there are many emotions that
    come with graduation, and it is a significant milestone and
    accomplishment in a young person's life, and the emotions are
    not just for the graduate but for their families as well--
    pride, happiness, relief, fear, sadness. It is a transition in
    life, and some refer to it as the beginning.
        The words I would use to describe our emotions at Mark's
    graduation are devastation, emptiness and confusion. It marked
    the end of our son's life. I can remember so well sitting there
    and staring at an empty chair where Mark should have been
    sitting with his cap and gown draped over the back of the
    chair, and his diploma and yearbook laying on the seat, but
    Mark wasn't there.
        On May 28, 2004, on what would have been his last day of
    high school, just one week before graduation, Mark died. That
    morning, I responded to my wife's screams and went to see what
    was wrong, and she said that she couldn't wake Mark up. I
    started CPR and Cookie called 911. When the emergency personnel
    arrived, we followed the ambulance to the hospital, were
    escorted to the little room, and then heard the words that our
    son was dead. We went back to see him to try to say our
    goodbyes, and we cried on his lifeless body. For Cookie and I,
    life as we knew it ended that day.
        In his room that morning, we found a clear plastic bag of
    loose pills. They weren't his, nor did they belong to anyone
    else in our family. There were seven different types of pills
    in the bag, and 119 pills in all. When the toxicology report
    came back 3 months later, it was consistent with what we found
    in the bag in his room. Mark died from a lethal mix of
    oxycodone, acetaminophen, morphine and stimulants.
        Just to give you a little background of our family, when
    our sons were born, they became the focal point of our lives.
    Their mom quit work and became a stay-at-home mom, and she has
    been a terrific mom. To me, being their dad has been the most
    rewarding and important part of my life. I was a diaper-
    changing, bath giving, story-reading, full-service dad. I took
    them everywhere I went, diaper bag and all, and we were
    together constantly. Throughout the school years, our sons
    never came home to an empty house.
        Mark was quiet and an introvert. He didn't let many people
    into his life; you had to bring him into yours. When people
    took the time to get to know him they found a wonderful, caring
    person. Never much for words, he had a terrific sense of humor
    and could make you laugh just by his expressions and
    mannerisms. He loved sports, especially basketball, and was an
    avid weightlifter from the time he was 11. In the later stages
    of his life, Mark was 5-foot-9, 175 pounds. He could dunk a
    basketball and bench-press 400 lbs. Besides sports, he loved
    his family, friends, the Outer Banks of North Carolina,
    puppies, Star Wars, playing video games, any Leslie Nielson
    movie, shopping with his mom, and making fun of his dad.
        One thing we will never know is why Mark chose to take
    these pills. We don't know if he was abusing prescription drugs
    to get high or self-medicate or to self-regulate. We also don't
    know if he had an addiction problem that went undetected, or if
    this was just an opportunity that presented itself. I know now
    that abuse of medicine can lead to the same dependence and
    addiction as that of illicit drugs. They can also be lethal on
    the first use, especially if mixed with other substances.
        Unfortunately, there are still many people who
    underestimate the dangers of abusing prescription drugs. They
    believe that abusing these medicines is safer than using
    illicit drugs yet it is causing more deaths in our country than
    heroin and cocaine combined, and filling up our treatment
    centers. Based on the numbers from the CDC, on an average day
    in the United States, 31 people will die from prescription
    painkillers alone.
        From the motivation and inspiration that I draw from Mark's
    life and death, I have dedicated myself to do anything possible
    to raise awareness about prescription drug abuse. I have
    learned so much about this issue over the past several years
    and have had many mentors. My journey has included forging
    partnerships with organizations and agencies which share my
    passion and commitment to combat this issue. I am pleased and
    grateful to have the opportunity to now serve on the Parent
    Advisory Board of The Partnership at DrugFree.org and to help
    promote and support their wonderful tools for parents.
        I have also had many opportunities to speak on this topic
    at national conferences, to law enforcement, to health care
    professionals, to community groups and parent groups throughout
    Pennsylvania, and to high school students. I plan to continue
    these efforts as long as I am able. Abuse and misuse of
    prescription drugs is devastating too many families, causing
    crime and other social issues, filling our treatment centers,
    and killing too many of our children.
        There is no way to tell someone what it is like to lose a
    child. You either know what it is like or you don't, and I
    truly hope you don't. I am committed to do anything I can to
    help others avoid the devastation that Cookie and I live with
    every day. Today, I would like to offer my assistance to this
    subcommittee, if there is anything at all that I can do to
    support or promote your efforts to combat this public health
    crisis. Thank you.
        [The prepared statement of Mr. Bauer follows:]

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        Mrs. Bono Mack. Thank you very much.
        Ms. Creedon, you are recognized for 5 minutes.

                       STATEMENT OF KATHY CREEDON

        Ms. Kathy Creedon. Thank you. Good morning, everyone. Thank
    you, Chairman Bono Mack. I am so grateful to be here today, and
    I hope that my testimony provides valuable information that
    will help bring awareness about the epidemic of prescription
    drug abuse and diversion we currently face in our Nation.
        My story is about the most severe consequences of abusing
    prescription drugs. I lost my son Ryan on September 4, 2009, to
    an overdose of OxyContin. He was just 21 years old, and I
    agreed to come here today because I know there are thousands of
    families who are struggling with the pain of this situation
    just like I am. I sit here before you today on behalf of all of
    us and hope for some victory. My daughter Courtney is here with
    me today available to answer any questions after my testimony.
        So I just wanted to say that I fought relentlessly to save
    Ryan's life, but when addiction is present, it is like spinning
    your wheels to try to keep up with their compulsive behavior. I
    believe the science that says addiction is a disease and it is
    not a moral failure.
        As my written testimony details, my son was easily able to
    obtain these medications from doctors. He didn't get his pills
    from my medicine cabinet. Once I realized he was getting
    medication through prescriptions and not on the streets, I
    thought I could stop it. He was an adult by this time, and
    HIPAA privacy laws made it difficult for me to communicate my
    concerns about him abusing pills to his doctors but that did
    not stop me. I was able to get my foot in the door more than
    once. However, my concerns were mostly ignored and Ryan still
    continued to receive OxyContin many times for something as
    simple as a backache. In some cases, even when doctors stopped
    prescribing OxyContin, they still prescribed other narcotics
    that a person with a history of drug addiction should never
    have had.
        In the last 13 months of Ryan's life, I documented seven
    pages of medical records for visits to doctors, urgent care and
    emergency rooms. There were six near-death overdoses that
    always resulted in a 911 call and hospitalizations, once for 8
    days in a lockdown facility. It was a life-or-death struggle
    for Ryan many times, and we lived in fear.
        I saw my son's addiction progress rapidly once he became
    addicted to OxyContin. I believe that was the result of the
    aggressive off-label marketing practices of Purdue Pharma. He
    was never a candidate to receive such a powerful, addictive
    narcotic, and I feel he might be alive today if he had not
    discovered OxyContin. He made several attempts to get off the
    powerful opiate OxyContin but did not make it longer than 30 to
    90 days at a time.
        After my son's death, I had the opportunity to discuss all
    the careless mistakes made by the HMO that provided his care. I
    was told in that meeting that they were not aware of the
    dangers of OxyContin at the time my son was receiving it. They
    were told it was safer than other pain medications including
    methadone, morphine and fentanyl. That confirmed everything I
    had read regarding lawsuits and Purdue Pharma, and now my
    family was a victim of their misleading practices.
        In general, Kaiser Permanente, which was the HMO in our
    county, claims it was not aware of the abuse of prescription
    drugs taking place among our youth. I was quite surprised
    hearing that because I thought that if I knew, surely they
    should have known. I then realized how important it was to
    figure out a way to bring awareness of the situation to the
    medical community as well. I believe that this lack of
    understanding contributed to my son's death.
        In addition to the fact that they continued prescribing him
    narcotics after they knew he was an addict, I feel that
    prescription education is so important. Ryan's addiction to
    OxyContin resulted in a felony conviction for altering a
    prescription at a pharmacy. He was obtaining prescriptions from
    many sources at the time that could have been averted if a
    prescription monitoring program was in place. Some of those
    drugs ended up on the streets. Ryan basically became a drug
    dealer to support his addiction to OxyContin. It was unbearable
    to see what was happening to my son, at what lengths addiction
    will take a person to.
        So in closing, I would like to say I will not stop fighting
    for my son in his memory. As a result, I have joined with some
    mothers to create an organization to fight this epidemic. Our
    goal is to make a difference and to try to save lives by
    bringing awareness to as many people as possible. So I appeal
    to those of you in this room today from the bottom of my heart
    to help me make a difference.
        I thank you all so much for being here, and I would like to
    request that each of you reach out to other Members of
    Congress, your colleagues, friends and family to spread the
    word about this epidemic, and please be open-minded and learn
    all you can. Together we can make a difference. Thank you.
        [The prepared statement of Kathy Creedon follows:]

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        Mrs. Bono Mack. Thank you, and Courtney. I appreciate your
    being here to take questions at the end if we have them, but we
    will go to Ms. Rovero for your 5 minutes of questioning.

                       STATEMENT OF APRIL ROVERO

        Ms. Rovero. Chairman Bono Mack and Ranking Member
    Butterfield and members of the subcommittee, thank you so much
    for having me here today.
        On December 18, 2009, just a week before Christmas, my
    husband and I received the devastating and inconceivable news
    from a Tempe Police Department detective that our youngest son,
    Joey Rovero, had had been found dead by friends in his
    apartment off campus near Arizona State University, where he
    attended college. Over the next few days, as we worked to get
    his body returned home to California, where we live, and
    funeral arrangements made so we could bury him the day after
    Christmas, a story began to unfold that we were completely
    stunned by.
        We learned that Joey had been invited by a couple of
    students from ASU that he knew to travel with them on a 6-hour
    journey from Arizona to Rowland Heights, California, on
    December 9th, which was just 9 days earlier than his death, to
    visit a doctor who was well known for freely prescribing
    narcotic medications. All three students walked into this
    doctor's office together after the 6-hour drive and all they
    all walked out a short time later with prescriptions in hand.
    Joey's prescriptions, the first time she had ever seen him and
    after just a $75 payment to her, cash, and an X-ray that showed
    no problems in hand for him, was prescribed 90 30-milligram
    tablets of Roxicodone, 90 350-milligram tablets of Soma and 30
    2-milligram tablets of Xanax. He and his friends were directed
    to a pharmacy that was at least 35 miles away from this
    doctor's office. They drove there together and all of them had
    their prescriptions filled with absolutely no questions asked.
    We have since learned that both the doctor and the pharmacy had
    been under investigation for at least 2-1/2 years before Joey
    died. The DEA has since revoked her registration. The medical
    board has moved to revoke her license, and that is in process,
    and criminal prosecution is expected for Joey's death, among
    several others for this doctor.
        Joey had never been previously treated for any of the
    conditions that were cited in his medical record by the doctor
    as the basis for the prescriptions that he received that day,
    and there was absolutely no indication that she counseled him
    on how dangerous these medications could be if they are misused
    or abused, especially with alcohol. So again, just 9 days after
    he saw her, he was dead, and that was after partying with
    friends in a college, a typical college setting, wee into the
    morning. Joey went to sleep and he simply didn't wake up.
        The coroner's report indicated that he died from low levels
    of Xanax and moderate levels of Roxicodone mixed with alcohol.
    His level of alcohol was .013. So he didn't have huge amounts
    in his system. The medical examiner indicated that none of the
    individual ingredients were lethal but all of them in
    combination were. So it was the polymix that was the problem.
        Joey was due home for winter break the day after he died,
    and the Christmas we expected to share with him never happened.
    Instead, we somehow managed to get through the most awful week
    of our lives. Stunned, shocked and grieving, we picked out a
    gravesite, coffin and clothes for Joey to be buried in. I had
    to write an obituary for a young man who had not had time to
    develop the lifetime achievements that he should have been able
    to cite.
        Through it all we struggled to understand how this could
    have happened to him, how our perfectly normal family could
    have been dealt such a blow. There are really no words that can
    adequately describe what my husband, Joey's brother and all of
    the other members of our family have experienced with his
    death. He was my husband's only biological child, and his
    brother is now left with no sibling. As his mother, I truly
    feel as though a part of me is gone and just ripped away from
    me forever. Our lives were irrevocably changed the night that
    he died.
        Joey wasn't a troubled young man. I want you to know that.
    He was a senior at ASU just 5 months away from graduating. He
    was a gifted athlete and a good student, even making the dean's
    list at ASU in the fall of 2008. He worked every summer. He
    made money. He spent it wisely. He had a loving and caring
    relationship with all of his family members. He had tons of
    friends all over the country, and over 200 of them appeared at
    his funeral to support us and to honor Joey. His life has
    affected them also dramatically.
        Unfortunately, tragedy struck once again 9 months to the
    day after my son's death when one of his two college roommates
    shot and killed himself in front of his girlfriend after a
    heavy night of drinking and prescription drug abuse. This
    problem has just continued to manifest itself in that college
    environment. There have been six young men that have died over
    the course of the last year at that university alone.
        In addition to that, as we have heard today, in Florida we
    lost seven people a day, and over 32,000 people a year die from
    adverse reactions to medications, so something simply has to be
    done with this epidemic.
        It is extremely important to me that I do whatever I can to
    make a difference. We formed our National Coalition Against
    Prescription Drug Abuse, and I speak everywhere I possibly can
    to parents, students, educators and community leaders about
    this problem.
        One thing that I wanted to point out that hasn't been
    mentioned today. I have a whole list of recommendations, many
    of them have been talked about today. I think the one that I
    really want to make sure is mentioned is that the
    pharmaceutical industry has been allowed over time to expand
    its influence over virtually every facet of American life using
    its near-unlimited financial resources to influence the FDA and
    other governmental agencies, our educational research
    facilities, our legislators, unfortunately, and most
    alarmingly, our physicians and other medical providers. They
    are influencing medical research, drug trials and are
    compensating doctors to prescribe medications they want to
    become their next blockbuster drug. The spider web of influence
    needs to be dismantled.
        Thank you very much for having me here today.
        [The prepared statement of Ms. Rovero follows:]

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        Mrs. Bono Mack. Thank you, Ms. Rovero.
        Mr. Harrison, you are recognized for the 5 minutes, and
    please do try to keep an eye on that red light for me.

                       STATEMENT OF DAN HARRISON

        Mr. Harrison. Thank you, Chairwoman Bono Mack, Ranking
    Member Butterfield and distinguished members of Commerce,
    Manufacturing and Trade Subcommittee for giving me this
    opportunity to speak before you today. I am very honored to be
    here.
        My name is Dan Harrison. I am a tribal member of the
    Muskogee Creek Nation of Oklahoma. I currently reside in Palm
    Springs, California, for the past 20 years. I worked as a
    structural ironworker and achieved apprenticeship status. In
    September of 1995, I took a fall on a construction site. My
    fall not only resulted in a severe back injury but led to a
    life of addiction.
        After injuring my back, I went on disability for a couple
    of months, then finally went to an orthopedic surgeon, and I
    was told that I would need to have surgery which could result
    in never achieving 100 percent mobility. I chose not to have
    the surgery and developed my own solution of physical therapy
    and pain medication. After 90 days, I stopped going to physical
    therapy and started drinking to intensify the effects of the
    pain medication.
        As the days went on, my drinking and opiate use increased
    and my life started spiraling out of control. During this time,
    my wife and I separated, and I shared custody of our two
    daughters. In 1999, I remarried and soon after my third child
    was born. This all occurred while I had severe dependence on
    opiates and alcohol. The drugs are what got me through the day.
    I never had to go back to the doctor's office after my initial
    injury. I developed such a strong relationship with the doctor
    that I needed only to call and they would refill my
    prescription with no questions asked. I would go into local
    emergency rooms where the doctor would see me and wave me back
    for regular pain injections. I rarely had to resort to the
    streets for my medications. Depending on what type of narcotic
    I wanted and the method of administering it resulted in which
    doctor I would call.
        In October of 2008, I decided I wanted to fight for full
    custody of my daughters. I felt that the mother was not caring
    for them the way I felt they should be cared for. I decided to
    call Child Protective Services. After the investigation, they
    were removed from the mother's care. When the caseworker showed
    up unannounced at my home, I had several cabinets full of
    prescription medication. When I was confronted, I admitted to
    the recent use of OxyContin, Vicodin, morphine, Lortab,
    Demerol, Dilaudid and marijuana.
        After hearing myself admit to the amount of drugs in my
    system and seeing the caseworker's response, I knew it was time
    to make a change. The only way I would ever get custody of my
    daughters was to get help. I entered the Family Preservation
    Court, otherwise known as Family Dependency Treatment Court.
    The Family Preservation Court applies the drug court model to
    child welfare cases that involve an allegation of child abuse
    or neglect related to substance abuse. The Family Preservation
    Court seeks to do what is in the best interest of the family by
    providing a safe and secure environment for the child while
    intensively intervening in the treatment of the parents'
    substance abuse and other comorbidity issues. This approach
    also results in better collaboration between agencies and
    better compliance with treatment and other family court orders
    necessary to improve child protective case outcomes.
        Since graduating from the program, I have learned that
    there are 2,500 drug courts including over 300 family
    dependency treatment courts in the United States. I am humbled
    to know that now over 120,000 addicted people a year have the
    opportunity for treatment and restoration in these courts, and
    I hope that somebody they are available to everyone who needs
    them. These courts have been proven to cut up to 40 percent of
    the crime rate and produce up to $27 for every dollar invested.
        When I first entered the Family Preservation Court, I had
    not accepted my problem. I was a little uneasy with myself or
    calling the CPS since the investigation turned on me. However,
    after my intake and sharing my history with the family
    preservation counselor, I realized how bad things had gotten.
    Through the Family Preservation Court, upon counseling and
    obtained guidance in educating my daughters about the
    addiction, I participated in parenting courses that taught me
    to effectively communicate with my children, how to create
    healthy boundaries. I was given support by my counselors and
    peers throughout my struggles with the reunification process.
        In 2010, I graduated from the Family Preservation Court.
    Today I am thankful that I called the CPS. Without their
    intervention, I would not be here today. Family Preservation
    Court has helped me realize I needed to get help for myself as
    well as my family. As a result of completing the program and
    completing other parenting courses, I have vowed to work
    diligently with the program and CPS side by side to work to do
    some outreach work for the ones that are still suffering from
    prescription drug use in the local community as well as the
    tribal community in southern California.
        I thank you for allowing me to come here and share just a
    little bit of my story. I realize today that I am a miracle
    that sits here because of my addiction and going through the
    process of my recovery, I realized how serious this epidemic is
    today.
        So thank you for inviting me here today to share my story.
    I am very humbled by that. Thank you very much.
        [The prepared statement of Mr. Harrison follows:]

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        Mrs. Bono Mack. Thank you, Mr. Harrison.
        Dr. Boyd, you are recognized.

                        STATEMENT OF CAROL BOYD

        Ms. Boyd. Thank you. Thank you for inviting me today. My
    comments draw on my research that is primarily funded by the
    NIH, among other sources. I have been studying this for the
    past 10 years.
        You have heard today that over the past 15 years,
    prescriptions for controlled medications have nearly doubled
    for adolescents and young adults, and these come from office
    visits, from ER visits and, significantly in this age group,
    from oral surgeons. And once the youth have the pills in their
    hand, they are at risk for diverting them. Approximately 10
    percent of adolescents in a given year have diverted their pain
    medicine. Fifteen percent have diverted their stimulant
    medications. And like other researchers, we find that girls are
    more likely to divert by loaning and giving and boys are more
    likely to divert by selling. There are also socioeconomic
    differences among these adolescents.
        Approximately 10 percent of all youth will divert their
    pills to their parents. Overall, one in six adolescents with
    legal prescriptions will be approached in a given year to
    divert their medicines, and in some cases, they will be asked
    to rent them. It is usually stimulants in this age group that
    are being diverted but not exclusively. We have found that the
    more elite the school and the more elite the university, the
    more likely diversion is to occur, and again, it is often
    stimulants. This is not to say that opiates are not the problem
    either, though.
        Motives to divert as well as to use diverted medications
    are wide ranging, and it should not be assumed that the motives
    always involve getting high. Indeed, motives are one of the
    reasons that this problem is so difficult to prevent. So I
    would like to share with three cases from our own studies, and
    they highlight what we found in our research.
        The first one is a 16-year-old teen. She is an honor
    student. She was going to homecoming. She had a new boyfriend.
    Four hours before the event, she got a migraine headache, and
    she went to her mother and her mother gave her one of her own
    hydrocodone tablets that she had leftover from her
    hysterectomy. The teen took it, went to the event. When I
    interviewed her, she had had a great time and she did not use
    hydrocodone again.
        The second case, a 15-year-old boy attends an elite high
    school and he is having trouble getting his work done. His best
    friend has a prescription for Adderall and keeps it on the
    dresser in the house. And when his friend leaves the house, his
    friend takes the Adderall. When I talked to this young man, he
    said well, you know, everyone in my school is using it,
    everyone uses it to study.
        And then in the third case, this is a high school girl. She
    did have a history of alcohol abuse. She was given an oxycodone
    tablet from her girlfriend, who had also gotten it for oral
    surgery. She wanted to experiment to see what it does. Now,
    this is a girl that also was abusing alcohol. She crushed and
    snorted the pill and she found herself continuing to use what
    she called Oxy when she wanted to party with her friend.
        Now, these cases represent what we have found in our
    research. First, diversion in this age group usually occurs
    among family and friends. Two, there are gender differences.
    Three, it usually involves one primary prescription and it is
    often from oral surgeons and dentists. Four, the diverted
    medicine is often started for the purpose of self-treatment so
    that you see youth thinking that they are going to use it for a
    headache or that they are going to study harder but then once
    they start using it, they have it available to them. And
    finally, the controlled medications are readily available. They
    are advertised on television. We do advertise controlled
    medications on television with direct-to-consumer marketing.
    And they are not stored properly nor are they disposed of, and
    I hear this time and again from youth.
        The adolescent girl that was in my case three is the one
    that is at the absolute highest risk. She is a poly-drug user
    and she is using for recreational purposes. It is these
    sensation-seeking youth that our data find have the biggest
    problems and are at the greatest risk for drug addiction and
    death.
        Most social scientists end their talk by saying we need
    more data, and I am going to tell you that as well. It is
    difficult to understand why a country such as ours has data
    from 2006. We need regional data. We need national data that
    has more nuance, that tells us the complexity of the problem.
        But policymakers can also do something. The FDA has
    recently stipulated that medicine bottles need to carry the
    schedule on them. I called my son, who has a prescription for
    Adderall, before I came here today and I said did you pick up
    your prescription bottle, and he said yes, and I said, well,
    what about the labeling, did it look different. No, he said, it
    doesn't look any different. I said come on, Joseph, look, see
    if it looks different; oh, yes, maybe. This isn't enough. I
    have a prescription that tells me on the back not to use it
    with grapefruit juice. These prescription bottles need to be
    clearly labeled that it is unlawful to share the medication,
    that they need to be stored correctly, and how they need to be
    disposed of.
        The solution to this problem lies in the recognition that
    it is far more complex than actually street drug use, and it is
    going to require cooperation with pharmaceutical companies,
    health care providers, families, young people and policymakers.
    Thank you.
        [The prepared statement of Ms. Boyd follows:]

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        Mrs. Bono Mack. Thank you.
        Dr. Arria.

                       STATEMENT OF AMELIA ARRIA

        Ms. Arria. Chairman Bono Mack, Ranking Member Butterfield,
    members of the subcommittee, thank you for this opportunity to
    testify on the problem as it manifest among our Nation's youth.
    I come at this issue as a researcher at the University of
    Maryland and the Treatment Research Institute in Philadelphia,
    but I am a mom too.
        Since 2003, with my dedicated staff, I have led the College
    Life Study, a NIDA-funded study of more than 1,200 college
    students. Consider our findings regarding non-medical use. By
    the fourth year of college, 13 percent used a tranquilizer, 23
    percent an analgesic and 30 percent a stimulant without a
    prescription. We found that more than one-third with
    prescriptions shared or sold their medications, usually to a
    friend. Most commonly diverted are stimulants such as Adderall
    with a 62 percent diversion rate. And individuals who divert
    prescription drugs are typically non-medical users themselves.
        Let me sharpen the focus on this particular aspect of the
    problems, stimulants. They are widely available and attractive
    to students with high task demands, especially those
    experiencing academic difficulties. There is a popular
    assumption that taking stimulants non-medically confers an
    academic edge and is therefore beneficial. Headlines
    referencing smart drugs perpetuate the notion that non-medical
    prescription stimulant use increases academic performance.
    Scientific evidence tells us quite the opposite. It is not the
    academically successful students who use them but the
    unsuccessful ones. We know that non-medical users compared to
    non-users are more likely to be dependent on alcohol and/or
    marijuana, skip class more frequently and spend less time
    studying, and digging even deeper, we see that these academic
    problems are related to heavy drinking and marijuana use. What
    the research shows is that non-medical prescription stimulant
    use is an unsuccessful shortcut, an attempt to compensate for
    declining academic performance and is a red flag for an
    underlying alcohol or drug problem.
        What can policymakers do about prescription drug abuse? The
    single best thing is to tighten the chain of custody that
    ultimately governs supply. For example, put in place better
    prescription monitoring programs, reform physician dosing
    practices and create timely surveillance databases. National
    data are often old and State-level data are not even available
    to researchers.
        The prescription drug problem has complicated the landscape
    of existing drug threats. It does not occur in isolation.
    Individuals who use prescription drugs non-medically are very
    likely to be heavy drinkers and/or illicit drug users.
    Therefore, in addition to deal with this devastating symptom,
    we must redouble our efforts to develop innovative solutions to
    the root issue, that is, the larger public health problem of
    drug use and addiction in the United States.
        What specific strategies should be proposed? Today is
    recommend two things regarding prevention and intervention.
    One, modernize the Nation's infrastructure for early detection.
    We can identify those who are at highest risk for drug
    problems, just like knowing who is at risk for other chronic
    health conditions, with an approach that involves standardized
    assessments, early intervention and promotes teamwork between
    parents, physicians and educators. We can put these young
    people back on track to fulfill their potential. To this end,
    NIH research has yielded valuable information about risk and
    resiliency, the interplay between genetics and the environment
    and the natural history and course of addiction. Effective
    solutions to this enormous public health threat will require
    continued funding for NIH research.
        Number two: connect the dots between drug use and academic
    problems. This link cannot be ignored any longer. Making this
    connection loud and clear will get the attention of parents who
    want more than anything else to see their child succeed. Tacit
    approval by parents and students of underage drinking as
    normative and college as a 5-year party, especially when there
    are stimulants drugs as a last resort, is completely misguided
    by regrettably an all too common notion. Similarly, we must
    engage the leaders of our education system who are concerned
    about the high school dropout crisis and less than optimal
    college graduation rates. They must recognize the very real and
    contributory role of drug use to poor academic achievement.
    Sustaining our economy and navigating future challenges will
    require a clear mind and a sharp focus, which is inconsistent
    with underage drinking, excessive drinking, illicit and non-
    medical prescription drug use.
        Again, thank you for shedding light on this continuing
    public health problem and allowing me to contribute to the
    discussion on solutions.
        [The prepared statement of Ms. Arria follows:]

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        Mrs. Bono Mack. Thank you. I thank you all the panelists
    very much. Certainly the parents who are hurting, I thank you
    for your advocacy and your passion turned towards helping
    others.
        Dr. Boyd, the statistics I am looking at completely dispute
    what you are saying. As I look at the Drug Abuse Warning
    Network statistics as published by SAMHSA, you said that
    stimulants are the problem and you also say that opiate
    addiction has doubled. Did I not hear that correctly?
        Ms. Boyd. No, that prescriptions for controlled medications
    for young adults and adolescents--I think this is what you are
    referring to--has nearly doubled since 2007.
        Mrs. Bono Mack. Now, this is not specific to adolescents,
    but when I look at these numbers for the increase of emergency
    department visits, now, old data, but from 2004 to 2009
    stimulants all together, again not specific to adolescents but
    I would think the trend would be similar, 20,490 admitted to
    ERs in the year 2004. That increased to 25,889 by 2009, a
    5,000-person increase over those years, while oxycodone and
    combinations thereof, 41,701 in 2004. One would think that the
    crisis is similar, that that would double, but in fact it
    actually increased to 148,449. So you spent the bulk of your
    time talking about stimulants but I am not aware particularly,
    and I am sorry I don't have the data here, but would you say
    that the trend line for stimulants and fatalities for
    stimulants is similar to opiates and OxyContin?
        Ms. Boyd. No, I wouldn't, and actually I did not intend to
    give the impression that I was mostly talking about stimulants
    actually. When I was speaking of the controlled medications, I
    was speaking of the four schedules and that for instance, 10
    percent in our sample had diverted their pain medication where
    15 percent had diverted stimulants.
        Mrs. Bono Mack. Let me jump to Ms. Creedon here and even to
    Mr. Harrison, and thank God that you are here as a recovering
    addict. I am so proud of your courage. Thank you for being
    here. And to Kathy Creedon, this is the scientific community
    and you guys have lived it in the real world. Is this just
    diversion from the simple places they see? Ms. Creedon, in your
    testimony, I wish you had gone on a little bit more. You talk a
    great deal, and you mentioned you have seven pages of
    documentation that show the runaround and what they call the
    smurfing, the great lengths your son went to that had nothing
    to do with your medicine cabinet. Would you be willing to
    submit your seven pages and 72 entries of medical history?
    Would you be able to submit those things for the Congressional
    record so we can take a look at all of that? But are you
    hearing on the real street side of what is really happening out
    there in California and the homes? Is it paralleling what the
    scientists are saying here?
        Ms. Kathy Creedon. That the drugs are coming from parents'
    medicine cabinets? Is that the question?
        Mrs. Bono Mack. Perhaps I just--I am a little on edge. It
    almost seems that you act as if the 16-year-old honor student
    was given hydrocodone, Dr. Boyd, and the teen went to the
    event, she had a great time but she never used hydrocodone
    again. So it seems to downplay, and you are acting as if the
    diversion is, well, Mom gave it to a 16-year-old, she had a
    great time at a party, and I just take issue with that because
    this is a mother who never, ever dreamt of doing such a thing.
        Ms. Boyd. Absolutely, but speaking as a social scientist,
    this is also happening so that when we look at the data on
    diversion, we see all kinds of diversion and we see that also
    parents are role modeling, share medications that are
    controlled. The mother shouldn't have had extra hydrocodone.
        Mrs. Bono Mack. OK, but Ms. Creedon, you had no
    hydrocodone, you had no oxycodone. Can you speak a little bit
    about the great lengths your son went to that had nothing to do
    with this? You are like Ms. Rovero and Mr. Bauer, a loving
    parent doing your best to raise a teenager, or young Ms.
    Creedon.
        Ms. Courtney Creedon. If I can speak to this, I mean, I
    think the reputation certainly is out there, and we have heard
    a lot of that today that I guess there were some statistics
    floating around that most people get these drugs from their
    parents' medicine cabinets, but in our case, that did not
    happen. We never had any of these drugs in our house. My mother
    never condoned using drugs. I mean, when we do submit these
    records, I mean, Ryan went out of his way to visit every doctor
    imaginable and finagle every aspect of the system to make this
    work, and surprisingly, it wasn't that difficult. So it is kind
    of hard for us to sit here and hear people talk about I guess
    parent responsibility when really I think the bigger issue is
    responsibility or rather irresponsibility of the medical
    community in that none of these drugs came from our home. All
    of these drugs that Ryan used and the drugs he died from were
    obtained legally from licensed physicians.
        Mrs. Bono Mack. Thank you. I have to yield now to the
    ranking member, Mr. Butterfield, but we will have a second and
    third round of questioning. So Mr. Butterfield is recognized.
        Mr. Butterfield. Let me thank the chairman for convening
    this very important hearing today. Those of us on this side of
    the aisle are also acutely aware of the pervasive problem that
    we have with prescription drug abuse, and so the hearing today
    is very timely and I want to thank the witnesses for their
    testimony.
        In my prior life, I was a trial judge in North Carolina. I
    did that for 15 years, and so I have seen and heard heart-
    wrenching stories for many years over my career, and I want to
    extend my personal condolences and concern to those families
    who have been directly affected.
        I want to just ask one or two questions. I won't belabor
    this unnecessarily but let me start this way. Prescription drug
    abusers do so for a variety of reasons, and I think we
    recognize that today. There are many reasons that contribute to
    this problem. Some people use them recreationally, some seeking
    their euphoric, relaxing or energizing effects. Other people
    with or without a prescription use them inappropriately seeking
    to alleviate minor pain and treat a perceived illness or even
    to manage stress. Still other people use prescription drugs for
    their intended purpose but obtain them without a prescription.
        To Dr. Arria and Dr. Boyd, do we have data in percentage
    terms which demonstrate either for the population as a whole or
    for high school- or college-age individuals why prescription
    drugs are being used? In other words, for what reasons by
    percentage do young people decide to take prescription drugs
    without a prescription?
        Ms. Arria. The percentages vary by class of prescription
    drugs, so for stimulants, I would say about three-quarters of
    people who use stimulants take them to increase concentration,
    to study and the scenario sort of plays itself out that I
    explained where they are having academic difficulties. Only a
    small percentage of them will crush stimulants to get high. On
    the analgesic side, many, many more, a higher percentage,
    probably about 80 percent, will use them to get high and a very
    small minority will use them because of curiosity reasons or
    for other reasons. And for the tranquilizers, we see a lot of
    self-medication going on where there might be an underlying
    mental health issue. So it varies by class, and that is for the
    college age-population, young adult populations. We do not have
    that level of data at the national level. The national survey
    on drug use and health does not collect that level of
    information for us.
        Ms. Boyd. And I studied 12- to 17-year-olds so it is a
    younger group, and they are less likely to use any drugs, the
    12-year-olds and 13-year-olds, so you see some differences. We
    also see differences by drug class, and they mimic much of what
    Dr. Aria said with the exception being the opioids where
    disproportionately the younger the child with the opioid, the
    more likely they say they are treating pain. Once they get
    older so that now they are into 11th and 12th grade, now when
    they are using diverted opioid medications, they are using it
    to experiment, to get high, to help them sleep, but that may be
    because they are using stimulants or they are drinking or
    partying, but so it would be for sensation-seeking or
    recreational reasons.
        Mr. Butterfield. Can we quantify what percentage of users
    snort as opposed to crushing the medication? What percentage
    are snorting it? Do we know?
        Ms. Boyd. Of 12- to 17-year-olds?
        Mr. Butterfield. Well, your age group, yes.
        Ms. Boyd. Relatively few are snorting it, and it depends by
    grade. Twelve-year-olds and 13-year-olds are not snorting it.
    We see about 5 to 10 percent snorting it by the time they get
    into high school.
        Mr. Butterfield. What about combining it with alcohol?
        Ms. Boyd. They all combine it with alcohol.
        Mr. Butterfield. That is a common----
        Ms. Boyd. Absolutely. Our data show that any youth that is
    using the opioid products to get high or to sensation seek or
    for recreational purposes are using other drugs as well, and
    they are also using other prescription medications.
        Mr. Butterfield. Would that be the same in the older age
    groups as well, Dr. Arria?
        Ms. Arria. What we find is that there is always a history
    of excessive drinking or a history of marijuana involvement,
    and in some cases they are using it at the same time
    concurrently during the same session. For instance, in our
    data, 88 percent of the non-medical prescription drug users had
    a history of marijuana use in the past year.
        Mr. Butterfield. So there are similarities between the 12
    to 17 and the 18 and above?
        Ms. Boyd. There are, and particularly when you get to 16-,
    17- and 18-year-olds. The younger ones, which I am also
    studying, who are in middle school, they do look different.
        Mr. Butterfield. Well, let me thank you and thank all of
    you for your testimony. I yield back.
        Mrs. Bono Mack. Thank you, and I do ask unanimous consent
    that the information that I requested from Ms. Creedon be
    allowed to be included in the record. No objection? OK. So
    ordered.
        Mrs. Bono Mack. Dr. Arria, you keep mentioning the history,
    the history, the history of use. It is my belief as a mother
    who just got through high school that the powerful nature of
    these painkillers that our kids do not have a chance. Can you
    speak to the adolescent brain, specifically what does happen
    when they get that tablet of OxyContin? Can you speak also to a
    pharm party and explain what that is?
        Ms. Arria. Sure. I think it is very true that the addictive
    potential of opioid analgesics trump what we are talking about
    when we see marijuana, other drugs. So what really appears to
    be the issue is that because it is more typical for alcohol and
    marijuana to be used at younger ages, there are some people who
    are more predisposed to using substances. We know that. And the
    adolescent brain is more set up to take risks naturally, and so
    that combination of being an adolescent and having a propensity
    for addiction sets up a course where you get involved with
    alcohol and marijuana and then it exposes you to drug-using
    peers. Like I said, you begin to lose interest in other things,
    you get involved in prescription drugs and then you get a very,
    very highly addictive substance and that is what you are
    talking about when they don't stand a chance. So if they have a
    propensity for addiction plus they are in this age of
    adolescence----
        Mrs. Bono Mack. I have no Ph.D., but I beg to differ that
    if they have a predisposition to addiction, because I believe
    that every human being----
        Ms. Arria. I stand corrected.
        Mrs. Bono Mack [continuing]. Has the potential to be
    addicted.
        Ms. Arria. One hundred percent of people have some
    propensity for addiction.
        Mrs. Bono Mack. I am sorry. Can you repeat that?
        Ms. Arria. One hundred percent of people are at risk for
    addiction if they are exposed to addictive substances.
        Mrs. Bono Mack. And then an adolescent then?
        Ms. Arria. An adolescent would be even more so because of
    their risk-taking behaviors.
        Mrs. Bono Mack. But risk-taking, a white pill to them is a
    lot less risky than meth?
        Ms. Arria. Well, what we find is that in terms of, we have
    done studies on perceived risk and the risk of medications
    falls in between marijuana and cocaine, so they don't see it as
    less risky than marijuana. They see taking prescription drugs
    medically or non-medically as more risky than marijuana but
    less risky than cocaine, so that is where it falls.
        Mrs. Bono Mack. Briefly, let me just lead you to the answer
    that I want to hear on another question, pharm parties. It is
    my understanding, is it not true, that kids now go to parties,
    throw bunches of pills into a bowl and grab whatever they can
    and swallow it to be risky?
        Ms. Arria. We have heard of that happening. We are not sure
    how often it happens. What we do know is that the variety of
    drugs used is much--there is much more variety of different
    drugs used on the same occasion than there were years ago. That
    is what we know now.
        Mrs. Bono Mack. Thank you.
        Mr. Harrison, how helpful now is the medical community? If
    you walk into a pharmacy, do you have the ability to tell your
    pharmacist I am a recovering addict, please don't prescribe my
    drug of choice to me or help me if I do? Do you have that
    ability? Are they helpful to you now?
        Mr. Harrison. I went through a process of a second back
    surgery with a 12-month sobriety, and it was difficult for me
    to have them administer more intravenous drugs to me because I
    was going through recovery, but I haven't yet attempted to gain
    any access since my recovery, so I haven't attempted to talk to
    any doctors that I have dealt with in the past. Them knowing
    the severity of my injury, in the past, like I said, I had
    built a relationship with them and I see them from time to time
    in the community, and so access was real easy. But since my
    recovery, 30 months in recovery, and I haven't yet attempted to
    go back.
        Mrs. Bono Mack. Well, congratulations on your 30 months.
        Mr. Bauer, are you finding a good avenue for your advocacy
    and making a difference out there?
        Mr. Bauer. Yes.
        Mrs. Bono Mack. Good answer. Nice, short and sweet. OK. I
    will yield to Mr. Butterfield for the next 5 minutes.
        Mr. Butterfield. Thank you very much, Madam Chairman.
        During one of the earlier panels--and I apologize for not
    being here. I forewarned the chairman that I had another
    commitment this morning and I could not resolve. But during one
    of the panels this morning, a lot of time was devoted to
    discussing monitoring programs. I believe databases are an
    important tool that should be in our toolbox, but we need to
    treat the non-medical use of prescription drugs with many
    different tools, with multiple tools and treat it as a public
    health issue, not just a law enforcement issue. For example, we
    need better education of patients and parents and friends and
    doctors and dentists and every person in society.
        Dr. Boyd, in your testimony you mentioned better labeling
    as one of those tools. Can you describe what you would envision
    to be on a label and would this be on all prescription drugs or
    just those that are the most risky if diverted?
        Ms. Boyd. Well, I am also a nurse and I would like to see
    better labeling on all medications, but let me direct my
    attention to the controlled medications that are more likely to
    be diverted and abused. I would recommend that we label them
    that it is unlawful to distribute them. Many, many of the kids
    that I interview do not know, and parents do not know, that
    mother of the girl going to homecoming, she didn't know she was
    doing something illegal. They should know it. It should be
    labeled on the bottom. There should also be directions on how
    to dispose of extra medicine that is left in the bottle so it
    is not sitting in the medicine cabinet. And finally, not only
    should they know where to dispose of it and that it is unlawful
    to distribute it but they should also know that it has
    addictive potential and abuse potential. Many medications I
    have gotten have been labeled more fully than the medications
    that are controlled.
        Mr. Butterfield. All right. Let me come to the other end of
    the table. Ms. Creedon, aside from labeling--and I like Dr.
    Boyd's assessment of this--but aside from labeling, what can we
    do to increase public awareness of prescription drug abuse? We
    have got to become more proactive so other families do not have
    the tragedy that you have experienced. What can we do?
        Ms. Kathy Creedon. You know, that is a really good
    question. I don't know the answer yet but I intend to hopefully
    be able to make a difference by this organization that I have
    started and our goal is to reach out, first of all, to students
    in high schools, middle school, college age, the parents, and I
    really would like to reach out to the medical community as well
    because that was a specific problem in my son's, well, that led
    up to his death. In these seven pages, I document it, if I
    could just take a minute, in the beginning where my daughter
    and I had a face-to-face meeting with the director of the
    medical facility where we said to him, Ryan has an addiction
    problem, and like I said, because of privacy laws, we were not
    able to speak about certain things, you know, because of
    breaking laws. But he did tell me that he would go and speak to
    the physician that Ryan had an appointment with 2 days later.
    That conversation apparently never took place, and I just feel
    that if he would have taken our conversation seriously coming
    from a family member of Ryan's history of drug abuse, that
    could have stopped the other six pages of his hospitalizations
    and everything else that went on. So for me particularly, I
    feel that the medical community doesn't take addiction
    seriously because maybe they are just not aware, you know, of
    what a few pills can do to somebody. In my son's case, it led
    to his death.
        Mr. Butterfield. What about public service announcements on
    TV channels that are watched by young people?
        Ms. Kathy Creedon. That is one of the things that we hope
    to be able to do.
        Mr. Butterfield. MTV and BET and some of the other
    channels.
        Ms. Kathy Creedon. Absolutely. There are some things
    already being done directly to young people on the Web sites
    and things that they listen to about the dangers of
    prescription drug abuse.
        Mr. Butterfield. We need to do it and we need to do it
    repetitively.
        Ms. Kathy Creedon. Exactly.
        Mr. Butterfield. One thing we have learned in Congress, if
    you say something over and over and over again, people will
    listen and sometimes believe it.
        Ms. Kathy Creedon. And that is what I read in all the
    educator material that I have been researching lately is that
    it does have to be repetitive and so it would almost mean being
    present on a high school property on a weekly basis just over
    and over telling them the dangers of the drugs before they go
    to a party on Friday night.
        Mr. Butterfield. Thank you. Thank you again. I yield back.
        Mrs. Bono Mack. All right. Thank you. We will do 5 more
    minutes and then we will conclude the panel and move on to the
    next, unless you would like another five, I am certainly fine
    with it.
        Mr. Butterfield. We are going to have votes in about an
    hour.
        Mrs. Bono Mack. Dr. Boyd, back to you. Labeling--my
    understanding through the years of my research on OxyContin
    that actually the label is what turned kids on to the ability
    for the misuse. I think that labeling is not going to be the
    answer. I don't know how old your son is, but I believe that it
    goes back to me to the DEA and the FDA and the supply chain and
    figuring out how this stuff is getting out there and why we are
    taking back hundreds of pounds of this stuff, whatever the
    astronomical number is. It has got to be beyond labeling.
        Let me just jump to Ms. Creedon again. Again, your
    testimony is terrific, but you spoke about the medical
    community, your frustrations with them, but since Ryan's death
    you have worked with the medical community and the doctors
    overseeing the HMO, and it is my understanding that they did
    learn a lot from you and that they have agreed to change their
    prescribing practice for such powerful painkillers. Is that
    true, and have you followed up on that, that you are able to
    actually educate in your community, your HMO, and get a change?
        Ms. Kathy Creedon. Yes, that is true, and I was very happy
    that they were receptive to hearing the information. I printed
    out a lot of information from the Internet and shared it with
    them, and in fact, the medical director told me that he took
    the information that I gave him and presented it in front of a
    staff meeting that they had, and they in fact after my meeting
    made a policy within their organization that covers
    approximately 3,000 physicians and over 300,000 members that
    those physicians could no longer prescribe OxyContin for the
    patients unless they had fourth-stage cancer and they had tried
    everything else. So I feel that was a huge victory that the
    education that I gave them made that change, and I haven't been
    able to follow up with the outcome. I intend to do that, but I
    don't know right now if that is still happening.
        Mrs. Bono Mack. I congratulate you on that, and it goes to
    Ms. Rovero, in your testimony you say the same thing. You say
    that your son had never been treated for any of the conditions
    listed on the doctor's record as the basis for her prescription
    for the powerful painkillers. Were you surprised by how easy it
    was for him to get access to those medications?
        Ms. Rovero. Not only surprised, I was shocked. I had never
    heard the term ``pill mill.'' I had not heard about dirty
    doctors. This last year has been a complete education for me.
    Shocked, absolutely shocked, and I have learned that that is
    the case throughout the country. I talk now to parents all over
    the place, California to Florida, and it is happening. There
    are so many unscrupulous doctors out there that are giving it
    out, they are in a pill mill kind of environment, but it is not
    just those doctors, it is also those that are really well
    meaning but they are not really well educated about pain
    management treatment. I have been told, I don't know if it is
    true for sure, but I have been told that doctors get less pain
    management training than veterinarians do, and that is
    horrifying to think about, but if it is true, my gosh.
        Mrs. Bono Mack. Would you agree with that statement, Dr.
    Boyd, Dr. Arria? Do you know about the level of training that
    physicians do get before they can prescribe these things?
        Ms. Arria. I know it has gotten better but I know that I
    can speak to the addiction medicine side. They really are not
    given proper training at the graduate medical education level
    on addictive disease.
        Mrs. Bono Mack. Dr. Boyd?
        Ms. Boyd. I agree with that. It is just inadequate.
        Mrs. Bono Mack. Thank you. And I will just use my last
    minute. I think we agree with Ms. Creedon, Ms. Rovero, on
    trying to limit the scope on when it is prescribed. I think
    that is something we can push for in Washington. But I really
    just want to thank you all very much for your commitment, your
    advocacy to this, and I don't know where it is going to go. I
    am frustrated last night in my research to see that there was a
    Senate hearing in 2002 that is very much like the one we are
    holding today. I think that is frustrating, and I think we are
    failing. It is a tough time for budget cuts and we all have
    questions on how we spend our money, but we can do a better job
    and I think the American people want an effective government,
    and in this case, it is not being effective.
        So I look forward to working with each and every one of
    you, and if you had another five, I am willing to yield to the
    gentleman. If not, we will take a quick recess and seat the
    next panel. Thank you very much.
        [Recess.]
        Mrs. Bono Mack. First up will be Sean Clarkin, Executive
    Vice President of Partnership for a Drug-Free America. Also
    joining us is General Arthur Dean, Chairman and CEO of the
    Community Anti-Drug Coalitions of America. Then we will have
    Dr. Coster, Senior Vice President of the Generic Pharmaceutical
    Association. Our fourth panelist is Kendra Martello, Assistant
    General Counsel, Pharmaceutical Research and Manufacturers of
    America. Also testifying, Michael Mayer, President of Frank
    Mayer and Associates. And our sixth witness is Patrick Coyne,
    Registered Nurse, testifying on behalf of the Oncology Nursing
    Society.
        Welcome, everyone. Thank you much for being here today. I
    think you know the drill, 5 minutes, green, yellow, red. In
    America, we generally know what that means. So just please make
    sure you press the microphone to turn it on, and Mr. Clarkin,
    you are recognized for 5 minutes.

       STATEMENTS OF SEAN CLARKIN, EXECUTIVE VICE PRESIDENT AND
     DIRECTOR OF STRATEGY, THE PARTNERSHIP AT DRUGFREE.ORG; ARTHUR
     T. DEAN, CHAIRMAN AND CEO, COMMUNITY ANTI-DRUG COALITIONS OF
     AMERICA; JOHN M. COSTER, PH.D., R.PH., SENIOR VICE PRESIDENT,
    GOVERNMENT AFFAIRS, GENERIC PHARMACEUTICAL ASSOCIATION; KENDRA
     MARTELLO, ASSISTANT GENERAL COUNSEL, PHARMACEUTICAL RESEARCH
        AND MANUFACTURERS OF AMERICA; MICHAEL MAYER, PRESIDENT,
       MEDRETURN, LLC; AND PATRICK COYNE, R.N., M.S.N., CLINICAL
     DIRECTOR, THOMAS PALLIATIVE CARE UNIT, VIRGINIA COMMONWEALTH
     UNIVERSITY MEDICAL CENTER, ON BEHALF OF THE ONCOLOGY NURSING
                                SOCIETY

                       STATEMENT OF SEAN CLARKIN

        Mr. Clarkin. Good morning, Chairman Bono Mack, Ranking
    Member Butterfield, members of the subcommittee, thank you for
    inviting me to testify about the problem of prescription drug
    abuse and the diversion of prescription medicine.
        The abuse of prescription medications, legal substances of
    tremendous benefit if used appropriately, is the single most
    troubling phenomenon on today's drug landscape. According to
    the 2010 Partnership Attitude Tracking Study, the PATS study,
    one in four, 25 percent of teens, report taking a prescription
    drug not prescribed for them by a doctor at least once in their
    lives and more than one in five teens, 23 percent, has used a
    prescription pain reliever not prescribed for them by a doctor.
        Why have we as a Nation not been able to reduce this highly
    risky behavior? There are several reasons, many of which we
    have already heard today. The first is ready access. These
    substances are readily available to teens in their own medicine
    cabinets and the medicine cabinets of friends and family, and
    very often they are available for free. Nearly half, 47
    percent, of teens in our PATS survey say that it is easy to get
    these drugs from parents' medicine cabinets, and more than a
    third say it is available everywhere.
        Another reason is low perception of risk, the low
    perception of risk that is associated with abusing prescription
    drugs. Partnership research shows that less half of teens see
    great risk in trying prescription pain relievers such as
    Vicodin or OxyContin that a doctor did not prescribe for them.
    Low perception of risk coupled with easy availability is a
    recipe for an ongoing problem.
        The third reason that we have heard a lot about, especially
    from Dr. Boyd, is the motivation to abuse. We have
    traditionally thought of teens abusing illegal drugs and
    alcohol either to party or to self-medication for some serious
    problem or disorder, adolescent depression, for example. But
    our research, like Dr. Boyd's, shows that teens appear to be
    abusing these drugs in a utilitarian way, using stimulants to
    help them cram for a test or to lose weight, pain relievers to
    escape some of the pressure they feel to perform academically,
    tranquilizers to wind down at the end of a stressful day. Once
    these substances have become integrated into teens' lived and
    abused as study or relaxation aids, it may become increasingly
    difficult to persuade teens that these are drugs are
    unnecessary or unsafe when taken without a prescription.
        The fourth reason, and this is a particular focus of the
    partnerships, is the lack of parental activism in prevention of
    this behavior. Parents who are usually our most valuable ally
    in preventing teen drug use find it hard to understand the
    scale and purposefulness with which many of today's teens are
    abusing medications, and it is not immediately clear to these
    parents that the prime source of supply for abusable
    prescription drugs may well be their own medicine cabinet. Many
    parents themselves, moreover, are misusing or perhaps abusing
    prescription drugs without a prescription. In research that we
    did in 2007, 28 percent of parents said that they themselves
    had used a prescription drug without having a prescription for
    it, and 8 percent of those parents said that they had given
    their teenaged child a prescription drug that was not
    prescribed for them.
        Finally, the reason we have not been able to reduce teen
    abuse of prescription medications is that our efforts as a
    Nation have been inadequate, at least to date. There simply has
    not been sufficient public attention or resources dedicated to
    this threat. The backdrop to all of this is that the national
    drug prevention infrastructure has been eroding for the past
    years as the budget for the National Youth Anti-Drug Media
    Campaign has shrunk significantly, the Safe and Drug-Free
    Schools and Communities State Grant has been eliminated, and
    changes have been proposed to the state prevention and
    treatment block grant that could put prevention funding in
    jeopardy. With dwindling resources, it is impossible for
    government to be able to mount the kind of effort that is
    necessary.
        We know that if there is, when there is a well-funded
    effort to educate parents about the dangers of prescription
    drug abuse, we can increase awareness and we can make a
    difference. In the first half of 2008, the Office of National
    Drug Policy's National Youth Anti-Drug Media Campaign devoted
    $14 million with which the media match was a $28 million effort
    to a parent-targeted campaign aimed at raising awareness about
    the risks of medicine abuse and motivating parents to take
    action. The campaign actually in terms of parents' perceptions
    of the problem and intent to take action was demonstrably
    successful. This shows that a major public education campaign
    can help to turn the tide on this entrenched behavior. The
    media campaign's funding is in jeopardy and may even be
    eliminated in the coming year, so we can't assume that that
    campaign will be around to deliver this message. The private
    sector will need to help finance a campaign of the magnitude
    necessary to change the attitudes that underlie this behavior.
        While the partnership is grateful for the unrestricted
    support we have received from a number of pharmaceutical
    companies, if our Nation is going to reduce teen abuse of
    prescription medication, we need to step up efforts
    dramatically. We need a sustained, multi-year effort funded by
    the pharmaceutical industry, the generic drug manufacturers and
    other key stakeholders to first support a major independent
    paid media campaign alerting consumers to the risks of abusing
    medicine and the importance of safeguarding and safely
    disposing of medicine. This effort might including tagging the
    pharmaceutical industry's large inventory of direct-to-consumer
    advertising and pointing viewers towards an objective and
    comprehensive online prevention resource. Second, we need to
    educate and enlist prescribers, pharmacists and other health
    care professionals. Third, we need to educate policymakers so
    that we can promote policies that will help reduce both the
    supply of and the demand for prescription drugs of abuse. And
    finally, implement an evaluation tool that would measure and
    hold this program accountable.
        In conclusion, at the partnership we believe that the abuse
    of prescription medications, legal substances of great benefit
    when used properly, is the single most troubling phenomenon on
    today's drug abuse landscape. We appreciate the time and the
    attention that the subcommittee is giving to raising awareness
    and looking for ways to reduce the abuse of prescription drugs
    in our country. The Partnership at Drugfree.org stands ready to
    work with the subcommittee on this and other substance abuse
    matters. Thank you very much.
        [The prepared statement of Mr. Clarkin follows:]

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        Mrs. Bono Mack. Thank you, Mr. Clarkin.
        General Dean, you are recognized for your 5 minutes.

                      STATEMENT OF ARTHUR T. DEAN

        Mr. Dean. Chairman Bono Mack, Ranking Member Butterfield
    and other distinguished members of the subcommittee, thank you
    for the opportunity to testify today on behalf of Community
    Anti-Drug Coalitions of America, CADCA, and our more than 5,000
    community coalitions nationwide. I am pleased to provide you
    with CADCA's perspective on the complex problem of prescription
    drug abuse.
        CADCA has been on the front lines addressing prescription
    drug abuse for nearly 10 years. We have hosted town hall
    meetings, developed publications and toolkits for coalitions,
    and produced television programs on this subject. In 2009, we
    were fortunate enough to conduct a rally with over 1,000
    community leaders on Capitol Hill to raise the awareness of
    over-the-counter as well as Rx abuse. CADCA recognizes that the
    misuse and abuse of prescription drugs is a multidimensional
    problem that demands comprehensive, coordinated solutions at
    all levels, local, State and national. Population-level changes
    in substance abuse including prescription drug abuse can be
    achieved by a comprehensive, data-driven approach. This
    approach mobilizes key community sectors that work together to
    educate, reduce access and availability, and change perceptions
    as well as social norms. Where this infrastructure is in place,
    communities have successfully prevented and pushed back against
    a variety of drug problems such as marijuana, methamphetamines,
    K2 and the misuse and abuse of prescription drugs.
        The Drug-Free Community, DFC program is the best example of
    a comprehensive community-wide approach being taken to scale
    nationwide. Since 1998, the DFC program has been a central
    bipartisan component of our Nation's drug reduction strategy. A
    recent evaluation of the program found that youth drug, alcohol
    and tobacco use are significantly lower in DFC-funded
    communities than in communities without a DFC coalition.
        CADCA trains DFC grantees and other community anti-drug
    coalitions to execute seven evidence-based strategies to effect
    community change for drug use. Coalitions across the country
    are implementing these strategies, and these strategies range
    from raising awareness to changing policies, and they are
    achieving measurable results and reducing local prescription
    drug abuse rates.
        In the interest of time, I would like to share just one
    example from Caribou, Maine. The Aroostook coalition used a
    multisector approach to identify prescription drug problems and
    to craft a strategic action plan to address them. The coalition
    did the following: one, they implemented a comprehensive social
    marketing campaign; two, they provided training to health care
    providers about proper prescribing; three, promoted and funded
    a prescription drug take-back program; and four, created a
    monthly mailer for health care providers that lists individuals
    charged with prescription drug-related crimes in their
    communities. As a result of this data-driven multisector
    approach, the coalition achieved significant outcomes. Through
    the coalition's effort, the county has Maine's lowest rate of
    past 30-day prescription drug use among high school students.
    Similar coalition examples are highlighted in my testimony, and
    I would invite those to your attention.
        CADCA's primary message today to this committee is that
    community coalitions are evidence-based and effective and
    should be utilized as a major component of any prescription
    drug prevention strategy. We recommend that the coalition model
    be implemented in concert with a number of other key
    approaches. For example, CADCA supports the expansion of
    effective prescription drug monitoring programs to ensure
    adequate coverage in every State. The data from these programs
    can also help identify hot spots and appropriately direct the
    attention to other resources. We need enhanced education
    opportunities for training for medical and dental professions.
    We also need increased awareness and education about the
    danger, proper storage and disposal of drugs. We support
    enhanced opportunities to make prescription take-back programs
    routinely available. We strongly support increased law
    enforcement to remedy such things as pill mills. Our nation
    needs to embrace and enhance all these strategies. We need to
    expand the number of DFC-funded communities. And finally, we
    need to increase training at the local level so that more
    communities can effectively address this major public health
    and safety threat.
        I thank you for the opportunity to testify before you today
    and applaud you for your great work. Thank you.
        [The prepared statement of Mr. Dean follows:]

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        Mrs. Bono Mack. Thank you, General, and we are honored that
    you are here, and I thank you for your service and that you
    came under the wire, because there is one person I couldn't
    gavel down, and that would be you, sir.
        Mr. Dean. And thank you for your great support and on a
    continuing basis. We appreciate it very much.
        Mrs. Bono Mack. Thank you. I look forward to our continued
    work together.
        Dr. Coster, you are recognized for 5 minutes.

                        STATEMENT OF JOHN COSTER

        Mr. Coster. Thank you. Good morning, Chairwoman Bono Mack,
    Ranking Member Butterfield, Congressman Lance, members of the
    subcommittee. I am John Coster, Senior Vice President of
    Government Affairs at the Generic Pharmaceutical Association
    and a licensed pharmacist. On behalf of GPhA and our member
    companies, thank you for calling this hearing and for the
    opportunity to testify.
        Let me begin by giving some background on the role of the
    generic drug industry in the United States. About 75 percent of
    all prescriptions are filled with generic medications, although
    that percentage does vary by therapeutic class. We are proud
    that our industry helps make high-quality, safe, effective
    prescription medications more affordable for millions of
    Americans while saving the health care system billions of
    dollars each year.
        GPhA's member companies manufacture FDA-approved generic
    versions of brand-name drugs in all therapeutic categories
    including prescription painkillers. We are as concerned as the
    members of this committee when medications that are made to
    improve lives or alleviate pain are abused. We believe that
    address this issue, as you have heard from the previous
    witnesses, will require a continued coordination among Federal
    and State agencies, State, local and Federal law enforcement,
    health professionals, drug manufacturers, pharmacists, patients
    and their families. Because it is a multifaceted problem, it
    requires a multifaceted solution.
        As we work together to shape public policy to end the
    misuse of pain medications, we must recognize that the
    overwhelming majority of individuals including millions of
    seniors and cancer patients do rely on these important drugs
    for their proper pain treatment. We are absolutely committed to
    the safe and reliable manufacturing and delivery of generic
    drugs.
        As an industry, we have invested millions of dollars into
    technologies and delivery systems to help assure that our
    products reach their destinations safely and securely. For
    example, with respect to opioid medications, the DEA has a
    closed system of distribution to prevent diversion. Our
    industry works with the DEA to assure that these products do
    not fall into the hands of abusers. For example, the DEA
    administers drug allotment and accountability systems to assure
    against the loss of diversion of controlled substances.
        Recent studies suggest that the problem of prescription
    drug abuse stems not from drugs that have escaped legitimate
    supply chain or been obtained illegally through the black
    market but instead from those that were legally prescribed and
    available in the home. Why are these medicines sitting in
    medicine cabinets? Shouldn't patients have already taken them?
    It is not uncommon to find many medicine cabinets in America
    are stocked with unused prescription drugs. Some of these may
    be for mild conditions such as allergy while others may be
    unused medications that were prescribed to treat the discomfort
    of a surgery. Many Americans have no recourse to return these
    unused medications, especially controlled substances, because
    Federal law prohibits the transfer of controlled substances
    from an ultimate user to anyone other than law enforcement.
    This will soon change as DEA implements the Safe and Secure
    Drug Disposal Act, which will permit ultimate users such as
    patients with excess controlled substances in their medicine
    cabinets to return them to DEA registrants such as willing
    pharmacists so they can be destroyed.
        What has our industry been doing to help address this
    problem? In general, we have tried to support efforts that are
    dedicated to raising awareness to the dangers of prescription
    drug abuse as well as the need to properly dispose of unneeded
    or unwanted prescription medications. We think education is a
    key component to this. For example, we support efforts such as
    the American Medicine Chest Challenge, which is a community-
    based public health initiative with law enforcement partnership
    to raise awareness about the dangers of drug abuse. We are
    pleased to let you know that we will be partnering with PhRMA
    to produce a public service announcement that will promote the
    upcoming DEA Take Back Day on April 30th, which we hope will be
    as successful as the one from last fall.
        We are also a board member of NCPIE, the National Council
    on Prescription Information and Education, a broad-based
    coalition on addressing raising awareness about prescription
    drug abuse. For example, NCPIE most recently developed a
    college resource kit to help educate students about the dangers
    of prescription drug misuse.
        In addition, over the last few years our industry companies
    have focused efforts in this area by joining with the brand-
    name industry, patient groups and the FDA on working on a REMS
    program for long-acting and extended-release opioid
    medications. REMS are special programs that are used by FDA to
    help prevent adverse outcomes in patients. At this point, I
    don't believe the FDA has implemented that program yet.
        Madam Chairwoman, we applaud you for the countless hours
    you have devoted to raising awareness about this issue and the
    great work you have done. With the cooperation of physicians,
    law enforcement and others, we can expand education efforts,
    keep our supply chain safe and secure, and help to ensure that
    patients and family members are not alone in this fight. We
    thank you for holding this hearing, and I would be happy to
    answer any questions you may have.
        [The prepared statement of Mr. Coster follows:]

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        Mrs. Bono Mack. Thank you, Dr. Coster.
        Ms. Martello.

                      STATEMENT OF KENDRA MARTELLO

        Ms. Martello. Good morning. Thank you, Madam Chairman and
    distinguished members of the subcommittee, Ranking Member
    Butterfield and Congressman Lance. My name is Kendra Martello
    and I am pleased to offer this testimony today on behalf of the
    Pharmaceutical Research and Manufacturers of America, or PhRMA.
    PhRMA's members represent America's leading pharmaceutical
    research and biotechnology companies. Last year, our members
    alone invested over $49 billion in discovering and developing
    new medicines. Industry wide, research and investment reached
    more than $67 billion last year, a record.
        The prescription medicines our members research and develop
    are life-saving and life-enhancing medicines that allow
    patients to live longer, healthier and more productive lives
    when used appropriately and as intended. It is important as we
    consider the non-medical use of prescription medicines that we
    also balance the need to maintain patient access to these
    medicines for legitimate medical use.
        We believe addressing the public health problem of
    prescription drug abuse is a shared responsibility. It requires
    a comprehensive, consistent and sustained approach and
    commitment from a wide range of stakeholders including
    prescribers and pharmacists. No one manufacturer, brand or
    generic, recognizing that approximately 75 percent of the
    prescriptions are for generic medicines, no one trade
    association and no one stakeholder group is solely responsible
    for implementing a solution that will truly be effective. We
    all must work together to achieve a common goal, and PhRMA and
    our member companies are committed to being part of the
    solution.
        An important part of our educational message surrounds the
    appropriate use of medicines, which can reduce health care
    costs overall. Data also show that the majority who misuse or
    abuse prescription medicines do obtain them from a friend or a
    family member. We believe that education can have a significant
    impact in helping to inform the public and reducing the overall
    rates of prescription drug abuse. We have developed four simple
    messages as part of our education effort on this important
    issue.
        First, take your medication exactly as prescribed. Second,
    store all medicines in a safe manner out of the sight and reach
    of children and adolescents in particular. Third, don't share
    your medicines with anyone including friends or relatives. And
    fourth, promptly dispose of any unused medicine in a safe
    manner, either through the household trash or an appropriate
    take-back program such as the one administered by the DEA. In
    fact, to help further this last message, PhRMA partnered with
    the U.S. Fish and Wildlife Service and the American Pharmacists
    Association in 2007 to create the Smart Disposal Program, which
    educates consumers about how they may safely dispose of most
    medicines through the household trash.
        PhRMA and our member companies have also undertaken
    significant educational efforts regarding prescription drug
    abuse. For example, we have recently worked with the Washington
    Health Foundation and the State Attorney General to develop
    education for college students and with Dare America to help
    educate students in grades 5 through 12. We also believe
    specific educational efforts must be targeted towards
    prescribers and pharmacists and could help them to detect and
    refer for treatment those who may be abusing prescription
    drugs.
        Other ideas that could have a significant impact on
    reducing the rate of non-medical use of prescription drugs:
    first, increase the use of and improvements to State
    prescription drug monitoring programs which can be an important
    tool in preventing and detecting abusers and referring them for
    treatment. Second, reauthorize NASPER, which provides grants
    for these State monitoring tools and which is legislation that
    PhRMA has supported. Third, increase penalties for and
    enforcement against pill mills, medicine diverters and those
    who go outside the legitimate medical supply chain including
    rogue Internet drug sellers. Fourth, work with FDA and others
    to facilitate the development of medicines to treat addiction
    and mechanisms to make medicines less susceptible to abuse. And
    finally, work with the DEA as it develops regulations to allow
    ultimate users and long-term care facilities to return
    controlled substance for disposal.
        In conclusion, prescription medicines when used as
    prescribed are critical to improving and extending patient
    health. However, when they are misused or abused, they can be
    dangerous and even deadly. No one solution to this public
    health problem exists. Education is of critical importance and
    it is a key first step but we must not stop there, and all
    stakeholders have a role to play in helping to develop
    solutions. We are committed to working with the subcommittee,
    members of Congress and other stakeholders on this important
    public health issue. Thank you.
        [The prepared statement of Ms. Martello follows:]

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        Mrs. Bono Mack. Thank you.
        Mr. Mayer.

                     STATEMENT OF MICHAEL S. MAYER

        Mr. Mayer. Madam Chair, Ranking Member Butterfield and Mr.
    Lance, I appreciate the opportunity to appear before you today.
    I am here today representing MedReturn. MedReturn is a
    subsidiary of Frank Mayer and Associates, an 80-year-old
    family-owned company in Grafton, Wisconsin. Our core business
    is designing and manufacturing in-store displayers,
    merchandisers and interactive kiosks for Fortune 500 companies.
        Our involvement in the issue of prescription drug abuse
    stems from the commitment to provide a safe, secure,
    sustainable and environmentally friendly way to help law
    enforcement agencies and communities collect unwanted or
    expired prescription medication and over-the-counter drugs.
        The genesis of MedReturn began over 3 years ago when I
    challenged the associates in my company to research and develop
    new ideas. The challenge was called WITT, Wish I'd Thought of
    That. As we began investigating the prescription drug disposal
    issue, we quickly became aware of the management of
    prescription medication and drugs that sit unused or expired in
    our medicine cabinets. We began researching and looking for
    existing take-back programs and realized there was no
    consistent method or program available. Over a 2-1/2-year
    period, we developed, prototyped, presented, tested, improved
    and produced the MedReturn drug collection unit. Noting the
    importance of education, we incorporated a sizable graphic
    panel that States and communities can customize.
        We launched MedReturn at the International Association of
    Chiefs of Police conference in October 2010. To date, our drug
    collection has been placed in 50 police and sheriffs
    departments across 11 States. We helped implement only the
    second county-wide ongoing drug collection program in the
    United States.
        Attached statements from law enforcement agencies confirm
    the positive response of their communities to sustained drug
    collection. Lieutenant Tim Doney of the Medford, Oregon, Police
    Department notes usage of their program is so heavy, they are
    emptying the collection unit at least 4 days a week. Other e-
    mail feedback we have received illustrates the demand for
    permanent medicine return programs. Sheriff David Peterson of
    Waushara County, Wisconsin, reports collecting 200 to 250
    pounds of medication in 3 months, and Lieutenant Wayne Strong
    believes the Madison, Wisconsin, Police Department has
    collected 230 pounds in that same time frame.
        What started as an effort to supplement our core business
    has quickly evolved in a passionate desire to be a smart part
    of the solution to the prescription drug abuse problem. We have
    devoted and continue to devote significant amounts of time and
    money to let State and local law enforcement agencies and
    community groups know we are available to answer inquiries. We
    know the DEA is working toward finalizing regulations that
    implement the Secure and Responsible Drug Disposal Act of 2010.
    We have talked with hundreds of law enforcement officers. Many
    of them are asking us how to implement their programs. Others
    believe the collection and disposal process is too complicated.
    Others insist on recording and inventorying all collected
    medications and others don't realize the scope of the problem.
        We believe a lack of understanding may be a deterrent to
    establishing a permanent take-back program. We also find a
    varied interpretation of what constitutes safe disposal. Some
    departments accept pills in a bottle while others want pills
    placed in plastic bags. Others will hold the collected contents
    until the annual Take Back Day. One officer admitted he
    collected the drugs but then flushed them down the toilet.
    Ideally, we would like to refer potential users of MedReturn to
    a central resource that outlines Federal and State requirements
    and best practices.
        At MedReturn, our vision is a sustainable, nationwide
    program as widely available as plastic, glass and paper
    recycling are today. By our calculation, there are some 30,000
    communities that could benefit from a take-back program. We are
    in the process of seeking corporate or foundation partners that
    might speed this process.
        We appreciate the amount of attention prescription drug
    abuse is receiving from Members of Congress and the
    Administration. We hope you will continue to consider the
    challenges of those who want to establish a sustainable drug
    collection program at the grassroots level. We stand ready to
    serve as a resource in any way that is appropriate. Thank you.
        [The prepared statement of Mr. Mayer follows:]

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        Mrs. Bono Mack. Thank you, Mr. Mayer.
        Mr. Coyne.

                       STATEMENT OF PATRICK COYNE

        Mr. Coyne. Good morning, Madam Chair and distinguished
    members of the subcommittee. It is a great honor that I testify
    today regarding pain management and the potential implications
    for patients in need of pain relief from diagnosis to
    survivorship.
        My name is Patrick Coyne. I have been a clinical nurse
    specialist for over 25 years, focusing on pain management and
    symptom control, typically in cancer patients. I am the
    Clinical Director of the Thomas Palliative Care Services within
    the Massey Cancer Center at Virginia Commonwealth University in
    Richmond. In my role, I care for individuals on a daily basis
    who are dealing with life-limiting diseases and significant
    issues with pain. The patients I care for are from all walks of
    life, living in both urban and rural areas throughout the
    Commonwealth. I also teach in the schools of nursing and
    schools of medicine in our university and beyond. Today I
    represent the Oncology Nurses Society, ONS, the largest
    professional oncology group in the United States composed of
    more than 35,000 nurses and other health care providers.
        I would be naive not to recognize that the problem of
    opiate diversion is a very severe one and can destroy both
    patients, families and communities. More must be done to treat
    the significant issue. However, what about those patients who
    live daily with intractable, unrelenting pain? Daily, I
    encounter patients who will not see their next birthday and
    often travel hours to see someone within our institution for
    appropriate analgesia because their local health care provider
    is uncomfortable with prescribing the medications the patients
    need or fearful that their license may be revoked for using too
    much opiate pain medication.
        This population of patients is frail, dealing with
    countless issues, which I hope I never have to, and often has
    no voice. I hope to be their voice and ensure their comfort. I
    also wish to support their privacy so that nobody needs to know
    about their illness unless they choose to release this
    information.
        The challenges within pain management are many. Individuals
    respond differently to different medications including
    oxycodone. Many clinicians receive far inadequate training in
    prescribing analgesics, assessing pain and other treatment
    options and have false concerns regarding the role of
    analgesics. Certain areas in this country have limited
    resources for managing pain well. We know adequate pain
    management as demonstrated in several studies can increase both
    survival and quality of life for patients with life-limiting
    diseases. Caregivers often suffer from depression and financial
    impact when pain is poorly controlled. Pain is a serious and
    costly public health issue. Unmanaged pain is a tragedy. What
    really seems to be the tragedy is this patient population may
    suffer because of those conducting illegal activities.
        Pain management is challenging in any population. Cancer
    patients fear pain as do their families, but what of cancer
    survivors who suffer daily in pain but are disease-free?
    Consider those individuals with pain from poor cardiac output,
    sickle cell disease or burn injuries as examples of just a few
    populations of patients who may be at risk without the
    availability of certain opiates. Addiction and misuse of
    analgesics is exceedingly rare in patients in pain yet they may
    carry the burden and suffer the decisions made by others.
        All discussion about the issue of opiate pain medications
    needs a balanced exploration of the risks but also the benefits
    of the medications when used appropriately. Limiting a pain
    medication, any medication, might take a very safe option away
    from countless patients living with moderate or severe pain.
    Education of prescribers is clearly needed to better assess
    pain and implement appropriate treatment options but limiting
    options may ruin many individuals' lives.
        I have treated many patients with oxycodone, OxyContin and
    other analgesics, mostly cancer patients who have not tolerated
    other medications or did not get adequate relief from other
    opiate or non-opiate pain medications. Patients and their
    families need better education and support regarding the safe
    and appropriate use of, storage and disposal of medications.
    The needs of countless patients suffering in pain need to be
    part of this and any discussion.
        I want to thank you for your time and commitment regarding
    this exceedingly important subject. I have devoted my life to
    pain management and I fear that many patients I care for may
    suffer if poor decisions are made regarding pain management,
    and I welcome your time and questions. Thank you very much.
        [The prepared statement of Mr. Coyne follows:]

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        Mrs. Bono Mack. Thank you to all of the panelists for your
    expert testimony.
        Mr. Coyle, first of all, I applaud you in your efforts and
    think that we share the same goals. My father was suffering
    from the last stages of cancer just a couple of years ago, and
    I watched him go through it, so I appreciate what you see in a
    clinical setting. But at the same time, I have seen people
    suffering from opiate withdrawal, so I too care about those
    people and the pain that they suffer and the life of living
    with that addiction. Once you are an addict, as you know, you
    are an addict for the rest of your life. So hopefully we can
    continue to work to make sure that the people who you need to
    treat are treated to the best of your ability and we can also
    keep the drugs out of the hands of the bad guys.
        And it goes to Ms. Martello. I keep hearing this
    reoccurring thing that it is coming from friends and family and
    medicine chests, and I can't believe that you all are serious
    when you think that is the big problem. You know, just this
    week there is an article about another prescription drug sting
    with 15 arrested in San Diego, California. Now, I will grant
    that they were arrested because they had prescription pills
    that they didn't have prescriptions for but they also had
    cocaine, methamphetamine and other street drugs, but can we
    take our head of the sand and quit acting like it is all
    grandma's medicine chest and admit the fact--and let me just go
    to Dr. Coster.
        You are a licensed pharmacist. In 2008, the Partnership for
    a Drug-Free America or Drugfree.org's president, Steve Pasierb,
    he said in a Reuters interview, and I quote, ``OxyContin is
    pharmaceutical heroin. There is really no difference between
    the two.'' Do you care to explain the difference
    pharmacologically between OxyContin and heroin, how far off it
    is?
        Mr. Coster. To be honest, Madam Chairman, it has been so
    long that I have been in pharmacy school, I would probably get
    it wrong if I did it, so if you like, we can provide you an
    explanation after, but at this point I probably wouldn't be
    able to do it.
        Mrs. Bono Mack. Well, it is my understanding, it is one
    molecule off. I mean, that would be a fair characterization,
    and certainly you can submit that to me in writing later, but
    would you say that OxyContin and heroin the way they are
    consumed by the human body, the only difference is the delivery
    mechanism?
        Mr. Coster. You know, again, I wouldn't be able to comment
    on that, you know, from a pharmacological perspective. I
    wouldn't want to give you any incorrect information or
    inaccurate information, so again, if you like, I would be happy
    to provide whatever I can in writing after the hearing.
        Mrs. Bono Mack. Well, it is my belief and my contention
    that they are pretty darn near the same, but to both you and
    Ms. Martello, you keep using ``underadherence'' and
    ``medication noncompliance'' and those terms in your testimony.
    When you talk about the problem with underadherence and
    noncompliance, are you lumping in therapeutics, antibiotics,
    other drugs into that category? Can you really say that there
    is a problem that people are not taking all 30 days of
    OxyContin when they are prescribed it?
        Ms. Martello. I think appropriate use of medicines can go a
    long way to helping patients improve their health conditions,
    and as I said in my testimony----
        Mrs. Bono Mack. Including 30 days of OxyContin?
        Ms. Martello [continuing]. This is a shared responsibility.
    This is something that I think as we have heard throughout the
    testimony this morning, there are a variety of stakeholders
    that have a role to play.
        Mrs. Bono Mack. Now, let me get back to this simple
    question. Are you saying that it is for the patient's benefit
    that they take 30 days' worth of painkillers like OxyContin?
        Ms. Martello. I think health care professionals are on the
    front line of this every day, and I think part of the
    educational effort that we can engage in----
        Mrs. Bono Mack. No, this is a yes or no. And to Dr. Coster
    too, this is a yes or no.
        Mr. Coster. I mean, I can give you a personal experience if
    this helps. I had surgery a couple years ago, and when I left
    the physician said here is a prescription for, I can't remember
    if it was 30 or 50, for OxyContin, and I went to get it filled,
    and he said if you need them, take them. So I guess he thought
    that in my case I might need two or I might need, you know, a
    week's worth. So I think, and again, not to justify how these
    drugs are used, but some people, I guess some physicians feel
    like I will give you this quantity, and if you need them, take
    them, if you don't, they don't really tell them what to do with
    them. So I don't know if it is a yes or no answer but in terms
    of a personal----
        Mrs. Bono Mack. No, the question is, is extending the life,
    extending the quality of life--you are lumping this in, it
    seems to me, with therapeutic drugs or antibiotic or something
    when you talk about underadherence of drugs.
        Mr. Coster. Again, in terms of like if you are taking a
    blood pressure medication where you absolutely have to take it
    every day or a cholesterol medication----
        Mrs. Bono Mack. But we are not focused on those drugs
    today.
        Mr. Coster. No, I know that.
        Mrs. Bono Mack. But we keep saying underadherence,
    underadherence.
        Mr. Coster. Again, I am not a prescriber, but in the case
    of pain, oftentimes you get prescribed a quantity of medication
    because a physician doesn't know, for example, how you are
    going to tolerate a certain procedure. He might say you might
    need for 5 days, you might need these for 10 days. Again, I am
    not justifying this. I am just saying as a pharmacist who has
    seen a lot of patients come in and fill prescriptions for pain
    where the patient says I may not need all these or why the
    doctor did give me all these, you are trained to tell the
    patient that the physician probably gave these to you because
    he is not sure how many you are going to actually need.
        Mrs. Bono Mack. My time has expired, but we will come back
    to that, and I am sure Mr. Mayer is very appreciative of the
    over-prescriptions.
        Mr. Butterfield, you are recognized for 5 minutes.
        Mr. Butterfield. Thank you, Madam Chairman.
        As we have heard, 70 percent of non-medical prescription
    drug users get those drugs from family or friends. It can be
    given to them, it can be sold. They can actually unfortunately
    steal it from others. We also know that the family medicine
    cabinet is bulging with unused and no longer needed medicines.
    Disposing of these medicines properly must be a priority and we
    must work to reduce their negative impact on the environment.
    When people do not have a safe place outside of the home where
    they can dispose of their unused drugs, they typically flush
    them, causing them to ultimately end up in our waterways.
        Question: I understand that a number of communities have
    created take-back days in which medicines are safely collected
    by law enforcement. Also, the Secure and Responsible Drug
    Disposal Act sponsored in the House by Mr. Inslee of Washington
    will allow more people and places to collect these unused
    medicines. This question is for Mr. Clarkin. Does the
    partnership that you represent have any examples of times when
    a take-back operation works particularly well?
        Mr. Clarkin. Not specific instances in specific
    communities, but we first of all support the whole take-back
    program that the DEA has spearheaded in the most recent take-
    back initiative, I think it was pointed out earlier was
    terrifically successful in terms of the quantities of drugs
    that were actually brought back and safely disposed of, and we
    look forward to supporting the DEA at the April 30th take back.
        Mr. Butterfield. Thank you.
        Next to General Dean. Thank you for your service to our
    country. What branch were you a part of?
        Mr. Dean. The U.S. Army.
        Mr. Butterfield. Ever stationed at Fort Bragg?
        Mr. Dean. [Inaudible.]
        Mr. Butterfield. All right. And thank you for that.
    According to reporting by the North County California Times--I
    almost said North Carolina--the North County California Times a
    couple years ago, military doctors wrote service members nearly
    3.8 million prescriptions for painkillers up from less than
    900,000 10 years ago. The Defense Department estimates that
    abuse of prescription drugs in the military is double that of
    the general population. First of all, do you agree or disagree
    with that, that military drug abuse is more and probably twice
    as much?
        Mrs. Bono Mack. Excuse me. General, would you please turn
    your microphone on?
        Mr. Dean. I agree that the military has a significant
    problem with this issue. I don't have the exact statistics on
    it.
        Mr. Butterfield. But you have no reason to disagree with
    that statistic?
        Mr. Dean. I have every reason to agree with that.
        Mr. Butterfield. And it appears that one study in 2009 even
    found that 20 percent of Marines had abused prescription drugs,
    mostly painkillers, at some point in the previous year. Our
    active service members face significant anxiety overseas and
    many live through pain every day when they are on duty, but if
    they develop a physical dependence or addiction to prescription
    drugs, it can follow them back home to their civilian life, and
    I have seen it all of my life.
        General, what should the Administration do with regard to
    training veterans hospitals to be on high alert for this type
    of abuse?
        Mr. Dean. I think it is a multifaceted approach that needs
    to be taken in order to assist our military members and their
    families and the communities that they reside in. I have had
    some discussions, my organization has, with the Army. I have
    another meeting scheduled with them in the very near future to
    address just this issue of helping them be more holistic in
    their approach of dealing with this issue that is not only
    soldier focused but also for the family members as well as the
    other civilians as well.
        Mr. Butterfield. Are there other programs geared to
    prescription drug abuse by veterans? For example, veterans may
    receive health insurance from the Federal Government. Are the
    insurers instructed to be on the lookout for abuse and not
    simply for the sake of law enforcement but really to help the
    veteran?
        Mr. Dean. The answer is yes. I have a board member who runs
    the VA substance abuse center, the big VA center in Atlanta,
    Dr. Karen Drexler, and the VA has programs but the resources
    and the number of people that they have in my opinion--I am not
    speaking for the VA--needs to be expanded and there needs to be
    greater information provided and there need to be greater
    educational programs, but do they have the programs, yes, but
    my understanding would be that there needs to be a substantial
    enhancement in those programs.
        Mr. Butterfield. Thank you. Thank you, one and all. I yield
    back.
        Mrs. Bono Mack. Thank you, Mr. Butterfield. The chair
    recognizes Mr. Lance for 5 minutes.
        Mr. Lance. Thank you very much, Madam Chair, and good
    afternoon to you all. I find this testimony very interesting. I
    don't have the honor of representing Fort Bragg but I do
    represent the district in the United States that has more
    medical and pharmaceutical employment than any other district
    in this country, and certainly this is an issue in the district
    as well as across the country.
        To Dr. Coster or to Ms. Martello or to both of you
    regarding the risk evaluation and mitigation strategy at the
    FDA, based upon your expertise, do you feel that it has
    contributed to the mitigation of prescription drug diversion
    and has there been any unforeseen consequence such as access
    issues for patients?
        Ms. Martello. When we look at policies in this area,
    certainly balancing the need between legitimate patient access
    and ensuring that the product's benefits continue to outweigh
    its risks is an important public health consideration and I
    think those are the issues that are currently being grappled
    with. The FDA has a variety of tools in its arsenal to make
    sure that the product's benefits continue to outweigh the risks
    of any product.
        Mr. Lance. Dr. Coster?
        Mr. Coster. Yes, sure. It is an excellent question,
    Congressman. There is so much focus and attention that has been
    placed on this program, and even though it has not yet been
    fully implemented by the FDA, I think just by the attention it
    has received, it has caused physicians to maybe look more
    closely on how they prescribe and patients on what they do in
    terms of taking these medications, but I agree with Ms.
    Martello that any program put in place like this should assure
    that it doesn't interfere with the appropriate prescribing of
    these medications, the appropriate dispensing of them and that
    patients in pain are able to get them, and I think the agency
    itself is struggling with what that right balance is right now
    for these extended-release and long-acting opioid products.
        Mr. Lance. Thank you.
        And to Ms. Martello, you state, and I agree with you, that
    you do not want to see barriers to patient access for needed
    prescription medicines. You highlight one potential barrier
    could be unnecessarily restrictive drug control regulations and
    practices. Could you give us in a little greater detail what
    you mean by that?
        Ms. Martello. I think health care providers play a pivotal
    role in helping to ensure that patients have access to the
    medicines that they need and so we would want to have health
    care providers and pharmacists frankly to be part of this
    conversation to help ensure that they can work with patients
    and counsel them on medication management and using medicines
    appropriately as prescribed.
        Mr. Lance. Thank you.
        And to General Dean, thank you, sir, for your service to
    our Nation. Have you seen greater abuse given the fact that we
    now have military operations in the field in both Iraq and
    Afghanistan and has there been a tracking of this in
    relationship to other times when we have had our military
    personnel in combat situations?
        Mr. Dean. Well, as you know, I have been retired for a few
    years so I am giving you information from my perspective and
    not from within the Department of Defense, but clearly the
    protracted wars that we have been in and the extensive number
    of severely wounded soldiers and other member of the armed
    forces have contributed to an increased number of them needing
    and benefiting over a long period of time from these medicines,
    and as a result of that, it is clear, and my friends have told
    me, that there is an increasing number of them who
    unfortunately are now abusing them and they are trying to find
    ways to combat that. Just recently, we had an officer as senior
    as a three-star general admit that he was addicted to pain
    medicine. So it is an issue. I am not actively involved in it
    now. I am looking to work with the military services to help
    them build some procedures that would get at training and
    education around military bases that would help combat this,
    but it is a significant issue.
        Mr. Lance. Thank you very much. And Madam Chair, I yield
    back my remaining 4 seconds.
        Mrs. Bono Mack. Thank you for your generosity. I recognize
    myself for 5 minutes again and say that it is so unfortunate,
    General, that we are hearing that this is truly carrying over
    into our troops, and it really makes a huge punctuation point
    on how important it is that we are doing this here today, so I
    thank you for your testimony and for being here.
        Quickly, just to point out, thought, that the FDA does not
    currently have a REMS program for long-acting and extended-
    release opioids, so it is not currently in place, and I am
    wondering how long it will take for them to do it and how many
    deaths will it take for them to do it, and I am curious, you
    know, fen-phen was taken off the market really quickly. If
    either one of the two pharmaceutical reps can explain to me why
    fen-phen would have been removed from the market or some of
    these drugs that are so quickly and what the difference is
    between that and these opioids that are now up to tens of
    thousands of deaths a year.
        Ms. Martello. It would be inappropriate for me to
    substitute my judgment for that of the independent scientific
    expert agency, the FDA, which evaluates the safety and efficacy
    of all marketed medicines, and so from my perspective, I think
    it would be inappropriate for me to comment on that.
        Mrs. Bono Mack. OK, fine. Then let me use my time with
    somebody who can actually comment, if that is all right.
        Mr. Clarkin, any of you, can you explain to me why the
    abusive opioid drugs because a problem so quickly, the trend
    lines screaming up there, anybody who is out there in the field
    in the real world?
        Mr. Clarkin. I think there is probably a combination of
    factors, and clearly supply has been a factor. I think the
    environment of marketing, direct-to-consumer marketing in the
    pharmaceutical industry, has expanded the abuse of prescription
    drugs not just prescription opioids.
        Mrs. Bono Mack. In fairness, I have never seen an
    advertisement ever for OxyContin.
        Mr. Clarkin. That is correct, but my point is, that the
    direct-to-consumer advertising, and I think there is fairly
    robust literature on this, is creating a sense of a reliance on
    medicine to address a variety of different ills and so we see
    in our research, which I mentioned, and Dr. Boyd sees the same
    thing, an increasing reliance on the part of teens, at least,
    to be addressing not just to self-medicate or recreate with
    these substances but to address life management issues, and I
    think that is linked in some measure, not entirely but in some
    measure, to aggressive marketing.
        Mrs. Bono Mack. Thank you. Does the partnership have any
    explanation just from an observing standpoint why rogue
    pharmacies specialize in hydrocodone versus oxycodone or other
    controlled substances yet the pill mills specialize in
    oxycodone instead? Has anybody figured out that discrepancy?
        Mr. Clarkin. I don't have an answer for you on that.
        Mrs. Bono Mack. Anybody? No? OK. Mr. Mayer, the take-back
    program, what do you see as the key features of a successful,
    always available program?
        Mr. Mayer. Local community support. Education is going to
    be the biggest key. Letting the communities, the public know
    that there is a sustainable take-back program within their
    community. The program that we put together, the county-wide
    program which is in our county actually was a combination of
    news media and support from local newspapers but it was also
    putting flyers in the pharmacies, letting individuals know when
    they pick up their prescriptions that they can dispose of
    unused, expired at the local law enforcement agencies.
        Mrs. Bono Mack. Terrific. Thank you.
        Mr. Mayer. Education is the key.
        Mrs. Bono Mack. OK. Dr. Coster, when you see the statistics
    and graphs that Governor Scott presented earlier showing the
    disproportionate share of drugs dispensed from Florida and
    national statistics on drug diversion, do you think that the
    DEA and FDA quota system needs to be reevaluated in light of
    the high percentage of diversion, particularly in Florida?
        Mr. Coster. Well, I know the way the quota system works
    now. It is based on a combination of factors both in terms of
    what the data show in terms of demand, FDA data and other data
    that feed into DEA and then DEA then determines how much our
    individuals manufacturers can make. You know, in terms of the
    situation in Florida, it sounded like part of the issue down
    there was that they didn't have a prescription monitoring
    program which hopefully that will deter some of the abuse. But
    we are happy to talk with the committee and the DEA about
    whether the system needs to be recalibrated.
        Mrs. Bono Mack. Let me just back that up. I am sorry. I am
    down to my last 15 seconds. You just said the quota is based
    upon the demand? Isn't that the problem here? If anybody wants
    it, then they are allowed to make it. That is the simple--that
    is it. That is the way you just explained it.
        Mr. Coster. Well, again, I am not intricately familiar with
    how the FDA determines its actual quotas so I just gave you a
    broad overview, so as I said, maybe it is time that that whole
    system is looked at again in terms of how those quotas are
    determined based upon what is happening in the State.
        Mrs. Bono Mack. Thank you, Doctor.
        Mr. Butterfield, you are recognized.
        Mr. Butterfield. Thank you.
        Let me drill down on prevention for just a moment if I can.
    If we can prevent abuse, we know we can save millions of
    dollars and, more importantly, we can save many, many precious
    lives. As prepared by the Office of National Drug Control
    Policy, the 2010 National Drug Control Strategy called for
    Federal, State, and local entities as well as non-governmental
    partners to seek earlier intervention opportunities in health
    care. One of the opportunities that the strategy highlights is
    working with physicians to achieve consensus standards on
    opiate painkiller prescribing.
        Mr. Clarkin, I am going to go back to you. What do you
    believe are the best ways to seize this opportunity? How
    specifically should stakeholders unite around consensus
    standards? For example, should task forces or working groups
    that include doctors, nurses, pharmacists and others be
    created? What role can the partnership play in such a process?
        Mr. Clarkin. I think we have heard a lot today pointing to
    the need for prescriber education, first of all, on appropriate
    prescription of opioids and other medications. One of the
    measures that the partnership supports is the explicit linkage
    of education of prescribers to their DEA registration renewal
    every 3 years, so I believe that is an important piece and one
    that Director Kerlikowske also cited when he spoke here
    earlier. I think the dialog too between health care
    professionals, whether they are prescribers or pharmacists, the
    dialog between those health care professionals and consumers,
    particularly parents, needs to be much more mindful of the
    risks of abuse, the risks of addiction, and I know one of the
    pieces that is under discussion as part of the long-term opioid
    REMS and one that the partnership supports is the adoption of
    effective prescriber-patient agreements at the point of
    prescription so that the patient very clearly understands the
    risks. First of all, there is a screener so that the doctor is
    aware if the patient indeed is particularly susceptible to
    addiction but the patient is also aware of the risks of abuse,
    the risks of addiction and the need to effectively safeguard
    meds and dispose of them appropriately.
        Mr. Butterfield. Perfect timing. We have just been called
    to the floor. You heard the buzzer. I am going to have to yield
    back. Thank you.
        Mrs. Bono Mack. I thank the gentleman. And does the
    gentleman from----
        Mr. Lance. I do not, Madam Chair, have any more questions.
    I yield to you.
        Mrs. Bono Mack. I thank the gentleman for yielding back,
    and I believe that we should wrap this thing up.
        Before I do, I would like to ask unanimous consent that
    these four items that we have previously discussed with the
    minority be included in the record.
        Mr. Butterfield. No objection.
        [The information follows:]

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        Mrs. Bono Mack. I thank the gentleman. And we also have
    statements from members who are not on the subcommittee that
    will be submitted for the record without objection.
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        Mrs. Bono Mack. I just wanted to say that as we wrap things
    up today, I want to thank all of our panelists as well as my
    colleagues and their staffs for their time and their commitment
    to this critically important issue.
        If 30,000 Americans died every year from food poisoning,
    Congress would take action. If 30,000 Americans died from
    pesticide exposure, Congress would take action. And if 30,000
    Americans died in airplane crashes every year, trust me,
    Congress would take action in a huge way. So why are the
    victims of prescription drug abuse treated differently? I don't
    have an answer, but I encourage everyone here to help us find
    one.
        I remind members that they have 10 business days to submit
    questions for the record, and I ask the witnesses to please
    respond promptly to any questions they receive. Again, I thank
    you all and I look forward to our work together in the future.
        The subcommittee hearing is now adjourned.
        [Whereupon, at 12:35 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]

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