[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]








                   EXAMINING THE FEDERAL GOVERNMENT'S
                   RESPONSE TO THE PRESCRIPTION DRUG 
                              ABUSE CRISIS

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 14, 2013

                               __________

                           Serial No. 113-55





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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania             GENE GREEN, Texas
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee          LOIS CAPPS, California
  Vice Chairman                      MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia                JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             JIM MATHESON, Utah
ROBERT E. LATTA, Ohio                G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington   JOHN BARROW, Georgia
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            DONNA M. CHRISTENSEN, Virgin 
BILL CASSIDY, Louisiana                  Islands
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
CORY GARDNER, Colorado               BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas                  PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          JIM MATHESON, Utah
PHIL GINGREY, Georgia                GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            JOHN BARROW, Georgia
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky                  Islands
H. MORGAN GRIFFITH, Virginia         KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida            JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)
















                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     3
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, prepared statement..............................     4
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................     5
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     6
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, prepared statement........................    67

                               Witnesses

R. Gil Kerlikowske, Director, Office of National Drug Control 
  Policy, Executive Office of the President......................     8
    Prepared statement...........................................    11
    Answers to submitted questions...............................    79
Doug Throckmorton, Deputy Director for Regulatory Programs, 
  Center for Drug Evaluation and Research, U.S. Food and Drug 
  Administration.................................................    19
    Prepared statement...........................................    21
    Answers to submitted questions...............................   101
H. Westley Clark, Director, Center for Substance Abuse Treatment, 
  Substance Abuse and Mental Health Services Administration......    32
    Prepared statement...........................................    34
    Answers to submitted questions...............................   108

                           Submitted Material

Statement of National Association of Chain Drug Stores, submitted 
  by Mr. Pitts...................................................    68

 
 EXAMINING THE FEDERAL GOVERNMENT'S RESPONSE TO THE PRESCRIPTION DRUG 
                              ABUSE CRISIS

                              ----------                              


                         FRIDAY, JUNE 14, 2013

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:32 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Joe Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Burgess, Whitfield, 
Rogers, Murphy, Gingrey, Cassidy, Guthrie, Griffith, Bilirakis, 
Ellmers, Capps, Schakowsky, Green, Butterfield, and Castor.
    Staff present: Clay Alspach, Chief Counsel, Health; Gary 
Andres, Staff Director; Sean Bonyun, Communications Director; 
Matt Bravo, Professional Staff Member; Paul Edattel, 
Professional Staff Member, Health; Brad Grantz, Policy 
Coordinator, O&I Sydne Harwick, Legislative Clerk; Carly 
McWilliams, Professional Staff Member, Health; Katie Novaria, 
Professional Staff Member, Health; Andrew Powaleny, Deputy 
Press Secretary; Chris Sarley, Policy Coordinator, Environment 
and the Economy; Heidi Stirrup, Health Policy Coordinator; Alli 
Corr, Democratic Policy Analyst; Eric Flamm, Democratic FDA 
Detailee; Elizabeth Letter, Democratic Assistant Press 
Secretary; Karen Lightfoot, Democratic Communications Director 
and Senior Policy Advisor; Anne Morris Reid, Democratic 
Professional Staff Member; and Rachel Sher, Democratic Senior 
Counsel.

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

    Mr. Pitts. The subcommittee will come to order. The chair 
will recognize himself for an opening statement.
    Today's hearing is the first in a series of hearings this 
subcommittee will hold on the subject of prescription drug 
abuse, which has been described by the Centers for Disease 
Control and Prevention as an epidemic in the United States.
    In 2010, 7 million individuals aged 1.2 or older--that is 
2.7 percent of this population--were current nonmedical users 
of prescription, or psychotherapeutic, drugs, and over one 
million emergency department visits that year involved 
nonmedical use of pharmaceuticals. Nearly all of these drugs 
were originally prescribed by a physician.
    According to the National Institute on Drug Abuse, 
prescription drug abuse is most prominent among young adults 
age 18 to 25. NIDA also reports that in 2010, almost 3,000 
young adults died from prescription drug--mainly opioid--
overdoses, which is more than the total number of people that 
died from overdoses of any other drug, including heroin and 
cocaine combined.
    Opioid pain relievers, such as Vicodin and OxyContin, are 
the largest class of abused prescription drugs, followed by 
stimulants for treating attention deficit hyperactivity 
disorder--ADHD--such as Adderall or Ritalin, and central 
nervous system depressants for relieving anxiety, such as 
Valium and Xanax.
    According to the National Survey on Drug Use and Health, 
published by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), of those individuals who used 
prescription painkillers non-medically in 2010 and 2011, nearly 
\3/4\ received the drugs from a friend or relative, either for 
free, that is 54.2 percent; through a purchase, that is 12.2 
percent; or by stealing the drugs, 4.4 percent.
    Today's hearing focuses on the Federal Government's 
response to the prescription drug abuse epidemic. It should be 
noted that this committee has played a key role in facilitating 
Prescription Drug Monitoring Programs by authorizing the 
National All Schedules Prescription Electronic Reporting Act 
(NASPER), co-sponsored by Representative Whitfield and Ranking 
Member Pallone. NASPER, which is housed at the Department of 
Health and Human Services, was signed into law on August 11, 
2005, to assist States in combating prescription drug abuse of 
controlled substances through the PDMP.
    It provides grants to set up or improve state systems that 
meet basic standards of information collection and privacy 
protections that will make it easier for States to share 
information. PDMPs enable authorities to identify prescription 
drug abusers, as well as the ``problem doctors'' who either 
overprescribe or incorrectly prescribe prescription drugs.
    While NASPER is an excellent step in the right direction, 
the program has not been funded since fiscal year 2010, 
although HHS continues to fund state PDMPs through grants to 
support interstate interoperability and integration of PDMPs 
with electronic health records and to improve the timeliness of 
access to PDMP data.
    It is abundantly clear that the prescription drug abuse 
epidemic is a crisis in the U.S. However, while we discuss this 
complicated and dynamic issue we need to keep in mind that many 
of these medications that so many are abusing are critical for 
many patients living with chronic pain.
    The Institute of Medicine estimates that there are more 
than 100 million adults in the U.S. living with chronic pain. 
It is critical as we move forward that we remember that these 
medications are vital for many Americans experiencing such 
pain.
    This hearing will help us better understand and define the 
various components of the issues and the challenges we face. In 
addition, this subcommittee will learn about the programs we 
currently have in place and their level of effectiveness.
    Today's witnesses represent the Office of National Drug 
Control Policy, the FDA, and the Substance Abuse and Mental 
Health Services Administration. I look forward to hearing their 
testimony. Thank you.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    The Subcommittee will come to order.
    The Chair will recognize himself for an opening 
statement.Today's hearing is the first in a series of hearings 
this Subcommittee will hold on the subject of prescription drug 
abuse, which has been described by the Centers for Disease 
Control and Prevention (CDC) as an epidemic in the United 
States.
    In 2010, seven million individuals aged 12 or older (2.7% 
of this population) were current nonmedical users of 
prescription-or psychotherapeutic-drugs, and over 1 million 
emergency department visits that year involved nonmedical use 
of pharmaceuticals.
    Nearly all of these drugs were originally prescribed by a 
physician.
    According to the National Institute on Drug Abuse (NIDA), 
prescription drug abuse is most prominent among young adults 
(age 18 to 25).
    NIDA also reports that in 2010, almost 3,000 young adults 
died from prescription drug (mainly opioid) overdoses-which is 
more than the total number of people that died from overdoses 
of any other drug, including heroin and cocaine combined.
    Opioid pain relievers, such as Vicodin or Oxycontin, are 
the largest class of abused prescription drugs, followed by 
stimulants for treating Attention Deficit Hyperactivity 
Disorder (ADHD), such as Adderall or Ritalin, and central 
nervous system depressants for relieving anxiety, such as 
Valium or Xanax.
    According to the National Survey on Drug Use and Health, 
published by the Substance Abuse and Mental Health Services 
Administration (SAMHSA), of those individuals who used 
prescription painkillers non-medically in 2010 and 2011, nearly 
three-quarters received the drugs from a friend or relative-
either for free (54.2%), through a purchase (12.2%), or via 
stealing the drugs (4.4%).
    Today's hearing focuses on the federal government's 
response to the prescription drug abuse epidemic.
    It should be noted that this Committee has played a key 
role in facilitating prescription drug monitoring programs 
(PDMPs), by authorizing the National All Schedules Prescription 
Electronic Reporting Act (NASPER), co-sponsored by Rep 
Whitfield and Ranking Member Pallone.
    NASPER, which is housed at the Department of Health and 
Human Services, was signed into law on August 11, 2005, to 
assist states in combating prescription drug abuse of 
controlled substances through a PDMP.
    It provides grants to set up or improve state systems that 
meet basic standards of information collection and privacy 
protections that will make it easier for states to share 
information. PDMPs enable authorities to identify prescription 
drug abusers, as well as the ``problem doctors'' who either 
over-prescribe or incorrectly prescribe prescription drugs.
    While NASPER is an excellent step in the right direction, 
the program has not been funded since FY2010, although HHS 
continues to fund state PDMPs through grants to support 
interstate interoperability and integration of PDMPs with 
electronic health records and to improve the timeliness of 
access to PDMP data.
    It is abundantly clear that the prescription drug abuse 
epidemic is a crisis in the U.S. However, while we discuss this 
complicated and dynamic issue we need to keep in mind that many 
of these medications that so many are abusing are critical for 
many patients living with chronic pain.
    The Institute of Medicine estimates that there are more 
than 100 million adults in the US living with chronic pain. It 
is critical as we move forward that we remember that these 
medications are vital for many Americans experiencing such 
pain.
    This hearing will help us better understand and define the 
various components of the issues and the challenges we face. In 
addition, this Subcommittee will learn about the programs we 
currently have in place and their level of effectiveness.
    Today's witnesses represent the Office of National Drug 
Control Policy, the FDA, and the Substance Abuse and Mental 
Health Services Administration, and I look forward to their 
testimony.
    Thank you, and I yield the balance of my time to Rep. ----
--------------------------------.

    Mr. Pitts. And does anyone seek time? I guess I don't have 
time. Thank you. I yield the balance of my time and now 
recognize the gentlelady Ms. Schakowsky for 5 minutes for an 
opening statement.
    Ms. Schakowsky. Thank you, Mr. Chairman.
    First, I would like to ask if I could put the opening 
statement of Mr. Waxman into the record.
    Mr. Pitts. Without objection, so ordered.
    [The prepared statement of Mr. Waxman follows:]

               Prepared statement of Hon. Henry A. Waxman

    Prescription drug abuse is a serious and growing problem in 
America. The number of deaths due to unintentional overdoses 
with prescription drugs dwarfs the number of deaths from 
illegal drugs, and almost doubled between 2000 and 2007. 
According to the Centers for Disease Control and Prevention, 
there were over 16,650 deaths in 2010 due to overdose with 
prescription painkillers.
    Although these drugs can cause harm if abused, they can 
also offer tremendous relief to patients, such as those with 
cancer or with chronic pain that responds poorly to other 
medications. The challenge, then, is to identify the means to 
prevent abuse while preserving access to these drugs by those 
who truly need them. I hope our witnesses today will provide 
information that can help us meet this challenge.
    Clearly, there is no silver bullet, or any single simple 
approach that will solve the problem. However, there are a 
number of avenues that may be worth pursuing, many of which are 
reflected in the Administration's prescription drug abuse plan.
    First: Providers should be better educated on the use and 
potential abuse of these drugs, so they can be more effective 
in recognizing developing problems of abuse, and, in turn, more 
effective in educating and treating their patients. Studies 
show that even brief interventions by health care providers can 
be successful in reducing or eliminating substance abuse by 
patients who have begun abusing prescription opioids but have 
not yet become addicted to them.
    There are a number of potential mechanisms that could 
enhance provider education. For example, Congress or possibly 
the Drug Enforcement Administration could include among the 
eligibility standards for DEA registration, a requirement that 
physicians receive adequate and appropriate training in the 
prescribing and use of controlled substances. FDA could also 
require that pharmaceutical companies develop educational 
materials and physician training programs as part of a Risk 
Evaluation and Mitigation Strategy (REMS) tied to opioid drug 
approval.
    Second: We must educate patients on the risks of abuse of 
these drugs, and the need to properly store and dispose of 
them. According to a 2009 national survey by the Substance 
Abuse and Mental Health Services Administration, over 70% of 
people who abused these drugs got them from friends or 
relatives, rather than from drug dealers or over the internet. 
If we can reduce inappropriate access to these drugs, we can 
also reduce the incidence of their abuse.
    A third approach involves efforts of drug companies to 
develop abuse-deterrent formulations of controlled drugs--
making them difficult or impossible to crush or dissolve, for 
example, so they cannot be taken by inhalation or injection for 
an enhanced effect. FDA is supportive of such activities, and 
recently released a draft guidance to assist industry in 
developing new formulations of opioid drugs with abuse-
deterrent properties. The guidance describes FDA's current 
thinking about the studies companies would be expected to 
conduct to demonstrate the abuse-deterrent properties of a 
specific formulation, including the process by which FDA would 
evaluate such studies as well as the labeling claims FDA might 
approve based on the results.
    This is a positive development and I applaud FDA for making 
this guidance a top priority. But I am concerned about the 
increasing evidence that brand companies are using abuse-
deterrent technologies as a tool to thwart generic competition.
    Indeed, the brand manufacturers of opioid drugs appear to 
be timing the release of their new abuse-deterrent formulations 
to coincide with the expiration of their patents and periods of 
marketing exclusivity. Upon FDA approval of the new 
formulations, the companies remove the old formulations from 
the market, claiming that they are no longer safe. If FDA 
agrees the brand formulations were removed for safety reasons, 
FDA is precluded from approving generic competitors without 
comparable abuse-deterrent formulations.
    When a brand manufacturer's new formulation truly deters 
abuse, there is no question FDA should not approve a generic 
version without comparable abuse-deterrent properties. In 
making that evaluation, however, FDA must be careful to ensure 
that the claimed abuse-deterrent properties are effective 
enough to justify a decision that the original version is no 
longer an acceptably-safe product.
    To be clear: Abuse deterrence should not become a new 
``work-around'' through which brand companies avoid generic 
competition. Instead drug manufacturers should engage in this 
area in accordance with both the letter and the spirit of the 
law. Towards that end, FDA should also provide guidance to 
companies on what they are expected to do to obtain approval of 
abuse-deterrent generic formulations.
    No doubt, we need to address the growing problem of 
prescription drug abuse in this country. But we must do so 
through means that recognize and preserve the critical role 
opioid pain medications play in improving the quality of life 
of those with otherwise intractable and chronic pain. I hope 
our hearing today will enable us to make progress towards this 
goal.

       OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 
     REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Thank you.
    I am happy that we are having this hearing on drug abuse in 
the United States and I am glad that we can work together in a 
bipartisan manner to tackle this problem. I want to welcome all 
of our witnesses today.
    This hearing provides an opportunity to raise awareness and 
discuss action that we can take to end a crisis that is truly 
destroying lives, hurting families and communities across the 
country.
    My constituent, Peter Jackson, tragically lost his 18-year-
old daughter Emily to this epidemic. While visiting family, 
Emily's cousin offered her an OxyContin tablet that had 
belonged to her uncle, who had recently died of cancer. After 
taking the OxyContin tablet while drinking, Emily went to sleep 
and never woke up. She died from respiratory depression; she 
stopped breathing.
    While Emily's story of dying after taking a single un-
prescribed OxyContin tablet may be extremely rare, death from 
the abuse and misuse of prescription opioid drugs are not. 
Prescription opioid drugs were involved in 16,650 overdose 
deaths in 2010, accounting for more deaths than from overdoses 
of heroin and cocaine combined. This represents a 313 percent 
increase in deaths over the past decade.
    In addition to those tragic deaths, there are other 
negative health consequences that result from prescription drug 
abuse. For every overdose death in 2010 there were an 
additional 10 abuse treatment admissions, 26 emergency 
department visits, 108 people with abuse or dependence, and 733 
nonmedical users of those drugs.
    In addition to the human toll, there are financial costs 
associated with prescription drug abuse that our health care 
system simply cannot afford. The direct health care cost of 
prescription drug abuse exceeds $70 billion each year. Research 
has found that, on average, opioid abusers generate direct 
costs 8.7 times higher than non-abusers each year. It is a 
national imperative that we work to end this crisis. Reducing 
the prevalence of prescription drug abuse will save lives and 
save money.
    There are actions underway that are helping to combat this 
problem at the federal level. Last year, we passed several 
provisions as part of the Food and Drug Administration's Safety 
and Innovation Act to combat prescription drug abuse, including 
a requirement that the FDA hold a public meeting on the 
scheduling of hydrocodone and issue guidance on developing 
abuse-deterrent products. Federal agencies are also operating 
programs to combat prescription drug abuse, including 
developing and supporting efforts to educate providers and 
populations at risk for prescription drug abuse.
    While federal efforts are critical, we must partner with 
States if we are to be successful in ending prescription drug 
abuse due to States' responsibility to license and train the 
health care professionals that prescribe and dispense these 
drugs. We must also build on current efforts by identifying 
additional steps that we can take to tackle such abuse. We must 
make drugs containing hydrocodone schedule II drugs. While it 
will be important to take steps to ensure this change does not 
limit access to patients with legitimate medical needs, this 
change is needed to adequately reflect the potential risk these 
drugs pose to public health.
    We should also take steps necessary to restrict the use of 
oxycodone pain relievers to severe pain, rather than moderate 
to severe pain, in order to prevent the overprescribing of 
these powerful medications.
    I look forward to hearing from our witnesses about the 
Federal Government's efforts to combat prescription drug abuse, 
to learn additional steps we can take to stop the abuse and 
misuse of opioid drugs, and I would appreciate any comment on 
the suggestions that I made it my testimony.
    And I yield back.
    Mr. Pitts. The chair thanks the gentlelady and now 
recognizes the vice chairman of the subcommittee, Dr. Burgess, 
for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. I thank the Chairman for the recognition.
    Now, the fact of the matter is that we lose more people in 
this country to the drug overdoses than we do to automobile 
accidents. And of those drug overdoses, \2/3\ of them are 
prescription drug overdoses. So we have got a plenty big 
problem. The good news is there is plenty we can do about it. 
But unfortunately, the agencies and lawmakers have, so far, not 
taking anything other than a short-term approach. We really 
need a broad-based, comprehensive strategy that is focused on 
going after the bad actors.
    So to start we could go after the pill mills. They may be 
hard to find, but maybe not. They advertise, so we are very 
fortunate. They tell us where they are, what their hours are, 
they tell us their charges. So if I can find them, how come the 
Board of Pharmacy can't? How come law enforcement can't? And 
take a hard look at this.
    Look, I ran a medical practice for 25 years, never once did 
I advertise a free initial visit, dispensing onsite, discounts 
off meds, coupon included. This warrants a hard look. It just 
doesn't fit a normal type of medical practice.
    We should reauthorize and fight to fund NASPER. This 
committee reauthorized it in the past. It is the only 
authorizing legislation that encourages state Prescription Drug 
Monitoring Programs. NASPER was a product of this committee, 
bipartisan, drafted with medical providers, States and patients 
in mind.
    We should encourage qualitative drug screening and reject 
contrary Medicare policies. We should encourage abuse deterrent 
formulations and reward investment in these technologies. We 
might also work with Canada to align our policies in approving 
and reimbursing these technologies. We should look at and 
examine the personal use exemption to see if it encourages 
bringing controlled substances into the country. We should do 
more to shutdown the rogue internet pharmacies at home and 
abroad.
    It boils down to this: right now, you can go to a 
publication; you could go on the internet and buy a controlled 
substance by pointing and clicking at two things, two 
statements you have to make: one, I need the drug; and two, I 
ain't lying. Most people can meet that bar.
    I am open to discussing provider education if it does not 
subvert medical judgment. We have allowed a few bad actors to 
jeopardize a doctor's ability to offer pain care and care for 
the patients out of fear for patient abuse and diversion. And 
this is an important point. Being someone who has written 
prescriptions, I do have a perspective on this that says we 
have got to stop the diversion but we also need to be careful 
that our--whatever we do is not so prescriptive that it 
prevents people who have a legitimate need and use of this 
medication to not obtain it.
    So pain costs are estimated at more than $100 billion 
yearly and they are the cause of 25 percent of sick days. 
Prescription medications may be an important part of pain 
therapy. If we don't stop the bad actors, we are going to hurt 
the people who have legitimate uses for these medications. The 
bad actors cannot be allowed to jeopardize a doctor's ability 
to alleviate human suffering.
    Again, there is much we should do. I understand why this 
may be a series of hearings and, Mr. Chairman, obviously I look 
forward to working with you. We need to involve doctors; we 
need to involve patients as witnesses.
    Thank you, Mr. Chairman, for the consideration and I will 
yield the balance of the time to Dr. Gingrey.
    Mr. Gingrey. I appreciate my OB/GYN colleague from Texas 
for yielding to me because I agree with so much of what he 
said.
    You know, the problem is a huge problem in not only the 
cost of the legal dispensation or prescribing of these types of 
medications, pain medications, anxiolytics, antidepressants, 
whatever. But, just think about the cost of decreasing 
productivity in individuals that maybe are a little bit, just a 
little bit overmedicated. You know, this might sound a little 
harsh, but honestly, I think maybe a little pain or a little 
anxiety in our lives is a good thing. It can be a productive 
thing and make you appreciate that you have to work through 
that. And that if you try to completely eliminate each of those 
things, then that is where you get to the dependency, the 
addiction, the decreased productivity, or the cost to society.
    So I think physicians have a big role to play in this, and 
even the ones that are prescribing legally. And I am not 
talking here about the pill mills. The State's doing, I think, 
a good job of trying to crack down on that.
    But finally, we must take a close look at how we as a 
society support treatment and recovery for patients struggling 
to overcome addiction. We must look for new and innovative 
treatment plans which treat this dependence and leave the 
abuser without new addictions, where they are on some other 
medication that is supposedly helping them and they are almost 
just as addicted as they were before.
    Mr. Chairman, I yield back and I thank you for the time.
    Mr. Pitts. The chair thanks the gentleman.
    That concludes the opening statements. The Committee has 
one panel before us today and I will introduce those members at 
this time: Mr. Gil Kerlikowske, Director, Office of National 
Drug Control Policy is with us; secondly, Dr. Throckmorton, 
Deputy Director of Regulatory Programs, Center for Drugs 
Evaluation and Research, U.S. Food and Drug Administration; 
finally, Dr. Westley Clark, Director, Center for Substance 
Abuse Treatment, Substance Abuse and Mental Health Services 
Administration.
    Thank you for coming. Your written testimony will be made 
part of the record. You will be each given 5 minutes to 
summarize your testimony.
    Mr. Kerlikowske, you are recognized for 5 minutes for your 
opening statement.

STATEMENTS OF R. GIL KERLIKOWSKE, DIRECTOR, OFFICE OF NATIONAL 
  DRUG CONTROL POLICY, EXECUTIVE OFFICE OF THE PRESIDENT; DR. 
  DOUG THROCKMORTON, DEPUTY DIRECTOR FOR REGULATORY PROGRAMS, 
  CENTER FOR DRUG EVALUATION AND RESEARCH, U.S. FOOD AND DRUG 
ADMINISTRATION; AND DR. H. WESTLEY CLARK, DIRECTOR, CENTER FOR 
 SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE AND MENTAL HEALTH 
                    SERVICES ADMINISTRATION

                STATEMENT OF R. GIL KERLIKOWSKE

    Mr. Kerlikowske. Thank you, Chairman Pitts and 
representative Schakowsky and members of the subcommittee, and 
thank you for the opportunity to address the important issue of 
prescription drug abuse in this country.
    Preventing prescription drug abuse has been a major focus 
of our office since my confirmation now 4 years ago. We have 
worked very collaboratively with a number of federal agencies 
throughout government to address what the CDC has rightly 
termed an epidemic. My position allows me to raise the public 
awareness and take action on drug issues that affect the 
Nation, and the Administration recognizes that addiction is a 
disease, that prevention, treatment, and smart law enforcement 
all have to play a part of a comprehensive strategy to reduce 
drug use, to give help to those who need it, and to ensure 
public health and safety.
    And we are here today because the prescription drug abuse 
as a devastating consequences for public health and safety in 
the country. Increases in treatment admissions for substance 
use disorders, emergency department visits, and, sadly, the 
deaths that are attributable to prescription drug overdoses 
place an enormous burden upon communities across the country.
    In 2010 alone, more than 38,000 Americans died from a drug 
overdose; 22,000 of those overdose deaths were attributable to 
prescription medications; and most of those deaths, almost 
17,000, were attributable to prescription painkillers. And in 
response the Administration released a comprehensive program 
called Prescription Drug Abuse Prevention Plan.
    The plan brings together a variety of federal, state, 
local, and tribal partners to focus on the four major priority 
areas dealing with this: education, monitoring, proper 
disposal, and enforcement, and the plan promotes mandatory 
education and safe prescribing and addiction practices for 
prescribers and dispensers.
    Current training for health care providers on safe opioid 
prescribing and addiction can be an adequate and inconsistent. 
Medical school students receive an average of only 11 hours of 
training on pain education. Most schools do not offer specific 
training on opioids at all. Several States including Iowa, 
Massachusetts, and Utah passed mandatory prescriber education 
legislation. And we have come a long way in educating the 
general public about prescription drug abuse. We have worked 
with a wide array of state government leaders, medical 
associations, public health and safety organizations to 
prioritize prescription drug abuse and overdose prevention.
    The second pillar of the plan focuses on strengthening the 
Prescription Drug Monitoring Programs. In 2006, only 20 States 
had PDMPs. Today, 49 States have authorized legislation, 46 
States have operational PDMPs. There are currently 14 States 
that are able now to share data across state lines and we are 
supporting that expanded interoperability.
    The Administration has worked with Congress to allow the 
Department of Veterans Affairs to share prescription drug data 
with PDMPs and we are pleased to say that the VA's rulemaking 
process is nearing completion, and VA has authorized its health 
care providers to access those state PDMPs when consistent with 
state laws.
    And third, the Administration has continued to expand safe 
and proper disposal of unused and expired medication. Since 
2010, the Drug Enforcement Administration has partnered with 
thousands of local law enforcement agencies and our Drug-Free 
Communities coalitions to hold six national take-back days 
collectively, safely disposing of over 2.8 million pounds of 
unused medication.
    Lastly, the Administration plan focuses on improving law 
enforcement capabilities to reduce diversion. The National 
Methamphetamine and Pharmaceutical Initiative, funded through 
our office of high intensity truck trafficking areas, has 
trained more than 2,500 law enforcement and criminal justice 
professionals on pharmaceutical crime investigations and 
prosecutions. The federal law enforcement continues to partner 
with state and local agencies around the country to reduce the 
pill mills and prosecute those that are responsible for 
improper or illegal prescribing.
    The Administration is working to expand access to naloxone, 
an emergency overdose reversal medication for first responders 
who may encounter overdose victims and can help prevent a fatal 
opioid overdose. And we are also addressing many of the other 
consequences of the epidemic, including the emerging issues 
like neonatal abstinence syndrome and indications of increased 
heroin use in other places throughout the country.
    In closing, let me recognize that none of these things 
would be possible if my executive branch colleagues and I want 
to accomplish for this Nation without the ongoing support of 
Members of Congress. And thank you for the opportunity to 
testify.
    [The prepared statement of Mr. Kerlikowske follows:]


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    Mr. Pitts. The chair thanks the gentleman.
    Dr. Throckmorton, you are recognized for 5 minutes for an 
opening statement.

                 STATEMENT OF DOUG THROCKMORTON

    Dr. Throckmorton. Mr. Chairman and members of the 
subcommittee, I am Dr. Douglas Throckmorton, Deputy Director 
for Regulatory Programs in the Center for Drug Evaluation and 
Research at the FDA. Thank you for your opportunity to be here 
today to discuss the misuse and abuse of prescription drugs, 
especially prescription opioids.
    The importance of this problem is hard to overstate. Beyond 
the sobering statistics are individuals and their families 
whose lives have been shattered by prescription opioid misuse, 
abuse, and addiction. It is a crisis that affects us all, and 
meaningful and enduring solutions will require all of our 
collective efforts.
    Balancing the needs of patients suffering from pain with 
the need to combat opioid misuse, abuse, and addiction is a 
priority for the FDA and for me personally. In seeking this 
balance, FDA has pursued a targeted, science-based approach 
aimed at critical points in the development and use of opiod 
medications. While additional work remains to be done, I would 
like to mention some of the activities FDA is doing now.
    First, we are a science-based agency and are focusing on 
improving the safe use of pain medicines. These activities 
include recent work we have done to encourage the development 
of abuse-deterrent drug formulations for opioids. The FDA 
believes the development of these new formulations to 
successfully deter abuse is an important part of our efforts to 
improve their safe use.
    For example, in January of this year, the FDA issued a 
draft guidance document for industry outlining the development 
of abuse-deterrent opioid drug products. And in the fall, the 
FDA will participate in a public meeting to discuss the issues 
addressed in that draft guidance, as well as issues surrounding 
the development of abuse-deterrent formulations for generic 
drug products.
    In addition, the FDA has taken recent regulatory actions 
concerning two opioid products, OxyContin and Opana ER, that 
were reformulated with the intention of making the products 
more difficult to manipulate and abuse. The data for these two 
products were reviewed carefully and independently by FDA 
scientists and resulted in a change in the labeling for 
OxyContin. Our decisions relied on the totality of the evidence 
for the particular drug at hand, and given where we are in the 
evolving science of abuse deterrence, were made on a case-by-
case basis.
    A second critical area where we have devoted time and 
resources is the development of effective patient and 
prescriber education. The interaction between prescribers and 
patients plays a critical role in improving the safe use of 
these drugs and the FDA has taken a number of steps to improve 
the educational materials that are available for patients and 
prescribers.
    For example, in July of 2012 we approved a risk evaluation 
and mitigation strategy, known as REMS, for manufacturers of 
over 20 extended-release and long-acting opioids. Under this 
REMS, manufacturers are required to support the development of 
effective prescriber training programs offered by accredited 
continuing education providers and to make them available at 
little or no cost to health care professionals. The training is 
based on a syllabus developed by the FDA with input from other 
stakeholders. We are currently posting those educational 
materials on our Web site to make them easier for prescribers 
to find and make use of.
    A third critical area where we have devoted time and 
resources is on ways to prevent the overdose deaths associated 
with prescription opioids by improving the treatment of 
overdose. Naloxone is an injectable medication that is the 
standard treatment to rapidly reverse the overdose of either 
prescription or illicit opioid. And when given quickly, it can 
and does save lives.
    At a public meeting the FDA convened last year with several 
other parts of the Federal Government, stakeholders encouraged 
the exploration of new ways to administer naloxone that may be 
easier than currently available, such as auto-injectors or via 
intranasal administration. In this area, FDA is working to 
provide regulatory priority assistance to manufacturers, who 
are working on assessing these new ways to give naloxone.
    To finish my remarks, our society faces two important 
challenges. We must balance efforts to address the misuse, 
abuse, and addiction that harms our families and communities 
and the need for appropriate access to pain medications for 
patients that need them. There can be no doubt there is much to 
be done and that we must act now. These are not simple issues 
and there are no easy answers. Given the complexity of the 
issues surrounding this problem, real and enduring progress 
will require a multifaceted approach combined with the 
dedication, persistence, and full engagement of all parties.
    FDA continues to prioritize our efforts in this area to 
combat this significant public health crisis. We welcome the 
opportunity to work with Congress, our federal partners, the 
medical community, advocacy organizations, patients, and 
families to turn the tide on this devastating epidemic.
    Thank you for your continued interest in this important 
topic and for the opportunity to testify regarding FDA's 
contributions on this issue. I am happy to answer any questions 
you have.
    [The prepared statement of Dr. Throckmorton follows:]


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    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman, Dr. Clark, for 5 minutes for an 
opening statement.

                 STATEMENT OF H. WESTLEY CLARK

    Dr. Clark. Good morning, Chairman Pitts, Congresswoman 
Schakowsky, and members of the subcommittee. I am Dr. H. 
Westley Clark, and I am the director of the Center for 
Substance Abuse Treatment within the Substance Abuse and Mental 
Health Services Administration. Thank you for inviting me to 
testify today regarding SAMHSA's role in preventing non-medical 
use of prescription drugs and treating individuals who abuse 
those drugs.
    SAMHSA's mission is to reduce the impact of substance abuse 
and mental illness on America's communities. We envision a 
nation that acts on the knowledge that behavioral health is 
essential for our health, prevention works, treatment is 
effective, and people recover.
    The challenge of prescription drug misuse and abuse is a 
complex issue that requires epidemiological surveillance, 
interventions, prescriber education, access to effective 
treatment services, and continued research by the private and 
public sectors. SAMHSA's strategy to reduce prescription drug 
misuse and abuse aligns with the four-part strategy of ONDCP. 
We work across the U.S. Department of Health and Human Services 
by participating in the Behavioral Health Coordinating 
Committee's Prescription Drug Abuse Subcommittee. We are in 
active partnerships with the CDC, the FDA, the Office of the 
National Coordinator of Health Information Technology (NIH), 
and others aimed at preventing and treating prescription drug 
misuse and abuse.
    According to our 2011 National Survey on Drug Use and 
Health, nonmedical use of prescription drug ranks as the 
second-most common illicit class of drugs in the United States. 
You have mentioned these data and there is no need for me to 
repeat it, but it is important to know that there was a slight 
decline in nonmedical use between 2010 and 2011, which suggests 
that the national, state, and local efforts to reduce 
prescription drug misuse may be having an impact, but there is 
still much work to be done.
    State Prescription Drug Monitoring Programs, or PDMPs, are 
an important component in government efforts to prevent and 
reduce drug diversion and abuse. PDMPs monitor and analyze 
scheduled prescription drugs with the goal of preventing 
prescription drug misuse and abuse, as well as illegal 
diversion.
    In 2005, the National All Schedules Prescription Electronic 
Reporting Act, or NASPER, created a Department of Health and 
Human Services grant program administered by SAMHSA for States 
to implement or enhance PDMPs. NASPER received funding from 
Congress in fiscal years 2009 and 2010, which resulted in 
SAMHSA providing 26 grants to 14 States. However, in fiscal 
years 2011 and '12, Congress did not appropriate funding for 
the NASPER program.
    In 2011, SAMHSA funded the enhanced access to PDMPs through 
Health IT Project which was managed by ONC in collaboration 
with SAMHSA's CDC and ONDCP. The project was unlike the NASPER 
grants in that its purpose was to use health IT to increase 
timely access to PDMP data.
    In 2012, the PDMP Electronic Health Record Integration and 
Interoperability Expansion program was funded by SAMHSA. This 
program complements existing federal efforts by improving real-
time access to PDMP data through the integration of PDMPs into 
existing technologies such as electronic health records.
    SAMHSA has also engaged in the efforts to prevent and treat 
prescription drug misuse and abuse through education programs 
for prescribers and future prescribers, prevention and early 
intervention programs, treatment of prescription drug abuse, as 
well as through regulation. We support the education of current 
prescribers through continuing medical education courses and 
other less formal efforts such as webinars.
    The Screening, Brief Intervention, and Referral to 
Treatment program is an important tool for the early 
identification of persons who might be at risk for opioid abuse 
and other substance use. SAMHSA provides grants to States, 
territories, and tribal organizations to implement SBIRT for 
adults in primary care. We have a residency grant program 
through SBIRT to address future prescribers and include 
screening for prescription drugs.
    We support prevention and early intervention through 
several other grant programs. Our block grant program is 
targeted toward funding to States and territories for their 
prevention and treatment and services efforts. The Strategic 
Prevention Framework Partnerships for Success program is 
designed to address two of the Nation's top substance abuse 
prevention priorities, including underage drinking and 
prescription drug misuse and abuse among persons aged 12 to 25.
    We work with ONDCP on our Drug-Free Communities efforts in 
collaboration to make sure that communities can prioritize 
prescription drug abuse. We are working with other federal 
agencies to explore telemedicine to address the need for 
increased access in rural settings. Our strategy to reduce 
prescription drug misuse includes the expansion of improved 
access to treatment, the Drug Addiction Treatment Act of 2000 
permits qualified physicians to prescribe certain medications 
for the treatment of opioid addiction in outpatient settings.
    We also regulate opioid treatment programs that use 
methadone and buprenorphine approved by FDA to treat patients 
with opioid dependence. We are working in collaboration with 
the DEA.
    Through these and other efforts, SAMHSA is working daily to 
address the issue in order to reduce the significant long-term 
impacts of this serious public health problem. Thank you for 
the opportunity to testify regarding SAMHSA's efforts in this 
area and I welcome any questions that you might have.
    [The prepared statement of Dr. Clark follows:]


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    Mr. Pitts. The chair thanks the gentleman. The chair 
apologizes; we are trying to get the jackhammer to stop, but 
until that time, if you will please speak directly into the 
mike, we would appreciate it.
    Thank you for your testimony. I will begin the questioning 
and recognize myself for 5 minutes for that purpose.
    Director Kerlikowske, the ONDCP oversees and coordinates 
the many agencies involved in prescription drug abuse. Please 
describe the advantages and challenges that come with having so 
many agencies and departments involved in the fight against 
prescription drug abuse.
    Mr. Kerlikowske. Congress clearly recognized the need for 
coordination, the fact that there are 15 primary federal 
agencies that all have a role in the drug issue. I don't think 
anything is more complex or challenging than the prescription 
drugs. It is not like an issue where it is coming across the 
border; it is coming right out of our own medicine cabinets. 
The mere fact that it was not recognized as a significant 
problem except by subject matter experts in the health field, 
people that ran treatment programs, but generally, the public 
did not even begin to understand the magnitude of the 
prescription drug problem.
    We worked to bring everybody together to sit at the table 
and to develop a plan knowing that any one component, whether 
it was the law enforcement agencies, whether it was the 
regulatory agencies, that any one component would not be able 
to solve or at least significantly reduce this problem.
    Our partners, two of which are here, but a number of them 
are out as part of our program, all came together with one 
goal, and that is to reduce this tragedy not only in the loss 
of life but the expense, so we couldn't be more pleased with 1) 
their cooperation, and 2) at least the inkling, as Dr. Clark 
said, of some success in this area.
    Mr. Pitts. Thank you. Dr. Throckmorton, generic versions of 
long-acting opioids without abuse-deterrent properties entered 
the market in January of this year. Does the Agency intend to 
monitor real-time data in order to evaluate whether such entry 
affects opioid abuse and how well real-time data like this will 
be utilized by the Agency now and in the future when the FDA is 
evaluating the science regarding claims of abuse deterrents?
    Dr. Throckmorton. Mr. Chairman, the goal that our agency 
has set is to incentivize the development of successful abuse-
deterrent formulations and find ways to move them onto the 
market. Our intent is to set forth a roadmap that makes that 
successful, makes that happen in good time. Following up on 
that, we need to work to develop ways to move generics that 
also have abuse-deterrent technologies, make them possible to 
come onto the market as well.
    You asked about monitoring of the response of the 
marketplace to those sorts of decisions. We do watch that 
information. We have an Office of Epidemiology that focuses on 
marketing issues, as well as post-marketing safety issues. We 
use that information as we look at individual decisions to 
understand the impact that a decision that ours might have with 
regard to the use of products in the market.
    Mr. Pitts. And to follow up, the FDA has committed, through 
the user fee process, to increase transparency and 
predictability around the drug review and approval process. 
Earlier this week, we wrote to DEA regarding delays in 
reviewing FDA scheduling recommendations for new drug approvals 
containing controlled substances. Does the Agency have 
recommendations on improving this process to address the issue 
of DEA delays?
    Dr. Throckmorton. It is an important question that we make 
sure that we have timely access to new medicines that are 
recommended for controlling, but we need to remember that the 
final decision about the controlling is made by the Drug 
Enforcement Administration under the Controlled Substances Act. 
My focus in the Center for Drugs has been to make certain that 
there is a timely scientific assessment from the FDA that can 
in fact work to inform that decision by the Drug Enforcement 
Administration. So what we have been doing is looking back at 
our process to make sure that it is as efficient and timely and 
scientific as possible so we get our recommendations in good 
order to the Drug Enforcement Administration through our Office 
of Assistant Secretary for Health, which is at the Health and 
Human Services level.
    Mr. Pitts. Thank you. Dr. Clark, can you discuss your 
relationship with the 46 States that operate Prescription Drug 
Monitoring Programs?
    Dr. Clark. We are working in concert with the Department of 
Justice, the Harold Rogers program. We have, through our 
special initiatives, reached out to as many jurisdictions as 
possible so that we can link the PDMPs with electronic health 
records.
    As you know, as I mentioned, the NASPER program, which was 
targeted toward grants to States, has not been funded, so we 
have shifted our focus from that effort to looking at other 
technologies so that we can address the public health aspect of 
this by linking electronic health records to PDMPs so that we 
can have real-time data so that the practitioner in the clinic 
or in the emergency room has access to information about the 
client sooner than some of the delays associated with current 
State PDMP programs.
    We can't wait 2 weeks to inform the clinician. We would 
like to be able to get that clinician real-time access to 
information so that they can make appropriate decisions about 
the care. Sometimes, it is someone who is running a scam on the 
doctor; sometimes, it is a patient who is having a reaction to 
the medication. So it is really useful to have real-time access 
to the clinical context of using prescription drugs.
    Mr. Pitts. The chair thanks the gentleman. My time is 
expired. And the chair recognizes the gentlelady from 
California, Mrs. Capps, for 5 minutes for questions.
    Mrs. Capps. Thank you, Mr. Chairman.
    And I am so glad we are here today having a hearing on an 
issue that really clearly cuts across party lines.
    Prescription drug abuse is a real and pervasive problem, 
and while it clearly impacts families and communities across 
our Nation, it also affects our health care system. However, I 
want to make sure that efforts to address this issue, important 
as they are, do not cause other problems, especially those 
regarding people with chronic pain. This is a delicate 
balancing act in a way.
    Americans' struggle with pain has been an important issue 
for me for many years. In 2007, I introduced the National Pain 
Care Policy Act and was pleased to see the part of it was 
included with the Affordable Care Act. As a result, the 
Institute of Medicine was directed to do a study on pain, and 
what they found is that pain is the most common reason people 
seek medical care. Over 160 million US adults suffer from 
chronic pain. The severity, duration, and disabling 
consequences of pain vary from person to person, as does the 
response to treatment. But pain accompanies a range of other 
clinical conditions, as all of you know, including cancer, 
diabetes, arthritis, and on and on. Access to medications is 
critical for these patients and survivors in order to complete 
other prescribed treatments and maintain other activities of 
daily living. And many medications prescribed to patients for 
acute pain, as well as chronic pain contain hydrocodone. So Dr. 
Throckmorton, as FDA reviews the potential rescheduling of 
hydrocodone-containing medications, does sufficient data and 
analysis exists about the potential impacts rescheduling could 
have on patient access to hydrocodone-containing medications?
    Dr. Throckmorton. Thank you, Congresswoman. First, let me 
say I agree with you. Finding a balance between the necessary 
access for pain medicines for patients that require them and 
addressing this crisis of abuse is absolutely essential, 
something that the FDA keeps in mind as we are thinking about 
our regulatory activities. With regard to assessing access to 
pain medicines, it is something we have worked on internally; 
it is something I have discussed with outside groups 
extensively. I know there are a number of people looking at 
better ways to measure that.
    There is a part of our REMS implementation that we put in 
place last year. For instance, we required to the manufacturers 
to assess the impact of that REMS on access to pain medications 
because we understand that it is an important aspect of our 
regulatory activities and whatever we end up deciding to do in 
the future.
    With regards to hydrocodone, Congress, in the recent Food 
and Drug Administration Safety and Innovation Act directed us 
to hold public hearing on hydrocodone and up-scheduling, and in 
that direction included language directing us to talk to 
patients and groups that had experience on the impact that this 
might have with regards to the up-scheduling of hydrocodone. We 
held that meeting. We have over 700 comments to the docket 
about that meeting that we are currently looking at. A large 
number of them comment on the effects that different activities 
might have as regards to access, something that we are 
reviewing as we think about making our decisions.
    Mrs. Capps. Thank you. And if there are access problems, 
could you elaborate--I know there is not much time left--but on 
the process available to individuals who are rightfully 
prescribed these medications but encounter problems accessing 
them?
    Dr. Throckmorton. The reason why they are having trouble 
getting the medicine would be important to understand. So if 
there is a drug shortage, for instance, and their challenge is 
getting a drug that is not available anywhere in their area, 
FDA has a drug shortage staff that I supervise, and we would 
love to hear from you. We have a Web site. We would want to 
work with you to find other ways to make that pain medicine 
available to you.
    If it is due to lack of availability at a pharmacy or 
pharmacies near you, you know, because of concerns over 
scheduling or something like that, those things I would have a 
less clear answer on but I would suggest the Boards of Pharmacy 
or other local area groups like that might be somewhere to talk 
to.
    Mrs. Capps. Thank you. And, Mr. Chairman, I am about out of 
time and I didn't even get to ask the other 2 members of the 
panel. This is such an important topic I think for us to be 
discussing, and I would certainly hope that this is just one 
hearing, that we have many more because I wanted to get into 
prevention, and that is a whole other topic and involved may be 
some other people, too, but you certainly are experts on this. 
We could certainly use some more hearings on this topic in my 
opinion. So thank you very much for scheduling this one.
    Mr. Pitts. The chair thanks the gentlelady, and this is 
just the first in a series of hearings we plan.
    The chair now recognizes the vice chairman of the 
Subcommittee, Dr. Burgess, for 5 minutes for questions.
    Mr. Burgess. Thank you, Mr. Chairman.
    And Mr. Kerlikowske, you sent a letter--you heard me 
reference the alignment of our policies with those to our 
neighbor to the north and you sent a letter about this. And you 
got Dr. Throckmorton over there diligently working on abuse 
deterrents and OxyContin, but how do we align our policies with 
Canada to prevent the older generic form from coming across the 
border? Because I, probably as we speak about this, I can see 
someone developing a business plan that would involve the 
importation of large amounts of generic OxyContin that didn't 
have an abuse deterrent.
    Mr. Kerlikowske. It is an important issue because the 
United States has done a lot to reduce the easy availability 
and also the fact that the opiod prescription painkillers here 
are not as easily manipulated, but the fact that Canada has 
that was of great concern to us. So early on, before they hit 
the market, we had written to the Health Minister. The Health 
Minister from Canada replied that she actually didn't have the 
authorities within Canadian law to limit this, but she had not 
only heard from us; she had also heard from the provinces who 
were also concerned that this would be widely and easily 
available within the provinces.
    So we notified Customs and Border Protection first to 
identify and be aware of this in case they see these coming 
through. So far in Milwaukee that is the only location that we 
have received a report of seeing some of these, and it was not 
a great number of them.
    We have a meeting scheduled in July with our Canadian 
counterparts who will be here in Washington, D.C., and I will 
be traveling to Ottawa hopefully with a colleague from the Food 
and Drug Administration to also work with them.
    Mr. Burgess. So you will be monitoring it?
    Mr. Kerlikowske. Absolutely.
    Mr. Burgess. And would you be averse to providing periodic 
reports to the staff of this committee----
    Mr. Kerlikowske. I would be happy to.
    Mr. Burgess [continuing]. About that ongoing effort? You 
know, let me just ask you on your four pillars in your 
testimony you talked about, the last pillar was the enforcement 
piece. And despite the salacious nature of the covers of this 
magazine, I submit to you that I can help you locate the bad 
actors. They advertise and it is not hard to pick them out of a 
crowd. So I hope you are focusing some efforts on disrupting 
the supply chain because, again, these people are not shy about 
telling you who they are and where they are and their hours of 
operation, their prices, and a discount coupon.
    Mr. Kerlikowske. You can see certainly Broward County, 
Florida, was the kind of epicenter of this. They had 90 of the 
top 100 prescribing and dispensing----
    Mr. Burgess. This magazine is from Broward County----
    Mr. Kerlikowske [continuing]. Opioids.
    Mr. Burgess [continuing]. So I wasn't going to identify the 
location, but since you did--Dr. Throckmorton, let me just ask 
you. Are there any efforts at the FDA to make naloxone an over-
the-counter preparation like an inhaler or an autopen?
    Dr. Throckmorton. We think it is important to first 
understand how best to use the naloxone, so we are working as a 
part of a much larger group of federal agencies to understand 
the best uses of naloxone. As a regulator, my job in that 
discussion is not to decide as a policy how naloxone should be 
used, and instead, it is to lay out the regulatory pathway 
should a firm be interested in developing one of those 
products. So we have met regularly with the makers of 
autoinjector products, makers of inhalational products to lay 
out the pathways that are necessary for them to get approval as 
prescription products.
    At the meeting that we held last year, attended by NIDA, 
attended by the Office of National Drug Control Policy and 
SAMHSA, we heard loud and clear that there was a broad interest 
in moving naloxone to over-the-counter status.
    Mr. Burgess. Yes, let me just interrupt you. I am not sure 
I agree with that, but we live in a world where levonorgestrel 
now is available over-the-counter with the Tootsie Rolls and 
Snickers bars. If interdiction and abstinence is not going to 
work in other areas, you know, maybe this is something that 
needs to be looked at because anyone who has ever seen the 
dramatic reversal of an amp of NARCAN on an opiate overdose 
will understand that you go from crisis to normal in the space 
of 26 seconds, and it is dramatic.
    Again, I am not saying that I advocate that, but I just 
wonder in this brave new world that we have entered, is that a 
consideration? So I hear that you are in fact entertaining 
that.
    Mr. Kerlikowske, I also have to mention about drug 
diversion, and you mentioned the 11 hours in medical school. 
You do learn a lot in your very first years in residency and 
practice, and I just recall very vividly when I was a resident 
at Parkland Hospital moonlighting at community hospitals, and 
someone would come in with a textbook description--in fact, 
they probably memorized the textbook--but a textbook 
description of renal pain--renal colic pain and were savvy 
enough to bite their lip and spit in the cup before they 
collected a specimen for you so they had blood in their urine 
and fit the bill pretty quickly. And I know what it is, Doctor; 
I have an appointment with my urologist. I just need something 
to get me through the night. And about the fourth time you hear 
that story, you think, there is something fishy here.
    Of course, doctor shopping is a big problem and the doctors 
who are just leaving training and getting into practice, this 
is where a lot of that educational activity could do a lot to 
prevent diversion.
    Thank you, Mr. Chairman. I will yield back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentlelady from Florida, Ms. Castor, for 5 
minutes for questions.
    Ms. Castor. Thank you, Mr. Chairman.
    And thank you, gentlemen, very much. I am especially 
grateful to Director Kerlikowske because you have given us such 
great guidance in the State of Florida where, colleagues, it 
has been a horrendous problem in the State of Florida. You 
would not believe, you could drive by some of these pain 
management clinics and see lines of people early in the 
morning, and we would often hear from our colleagues in 
Kentucky, in Virginia, in Tennessee about how folks would just 
travel down to Florida, find a pain management clinic that 
would prescribe, give them onsite hundreds of pills, go back.
    And this pipeline, fortunately, has been squeezed now. 
Florida finally adopted a prescription drug database. We have 
some stops and starts with that. I am concerned their 
physicians and pharmacists are not using it; it is voluntary. I 
am a little bit concerned the State hasn't provided a long-term 
commitment to make it work, and I would like you all to address 
that.
    But local law enforcement, they are seeing some 
improvements from where we would have at least one death per 
day in our community from prescription drug abuse. They say now 
with county ordinances on these pain management clinics new 
requirements to go after the docs, arrests of doctors and 
prosecutions. But I know local law enforcement can't do it all.
    Can you all tell how is the State of Florida doing because 
I know it has been, unfortunately, one of the worst in the 
country? And then at the federal level what can we do to 
provide greater tools to local law enforcement? And then one of 
my local sheriffs says it is not up to local law enforcement; 
this is an addiction and we have go to do more.
    Director?
    Mr. Kerlikowske. As a graduate of the University of South 
Florida, I had a special affinity for the problems in Florida 
in particular. But I can tell you that Florida is doing 
markedly, remarkably better. The leadership of the attorney 
general, Pam Bondi, on this issue has been very good. We have 
worked hard with a number of groups there and Florida has 
actually reduced the problem I think from seven overdose deaths 
a day. They have been able to make progress.
    I think from the federal government's standpoint what we 
need to be able to do is to make sure that these prescription 
drug monitoring plans are interoperable. Fourteen States now 
can share data but we saw a moment of some of the physicians 
that were suspect, as the vice chair mentioned, from Florida to 
other States, and so that information needs to be done. So that 
is one thing the federal government can continue to do.
    Ms. Castor. You know, our database is voluntary and it 
hasn't been up and running for very long, but still, there is 
some frustration that you only have 10 percent of pharmacists 
that are using it and not many doctors. So if we have 
interoperability between States, that still doesn't get to the 
problem of incentivizing pharmacists and doctors, prescribers 
to use that. How do we better incentivize the use of the 
database?
    Mr. Kerlikowske. And we are actually seeing significant 
improvements. One is that the electronic health records system, 
which eventually will be compatible with these kind of systems 
so that you don't have one PDMP standalone system, and then you 
have got your other electronic health records.
    The other is the e-prescribing that has taken hold. 
Physicians are not very happy about being able to prescribe 
electronically a large number of different types of drugs, but 
when it comes to controlled substances, they go back to paper 
and pencil. All of these things are kind of underway, but I 
think the amount of education and information that is being 
made to the physicians is a result of using a PDMP and the 
stories that they have told and the fact that we are strongly 
encouraging mandatory prescriber education will be helpful. 
Thank you.
    Ms. Castor. OK. And, gentlemen, can you all tell me--I am a 
cosponsor of a bill, H.R. 1285 by Congressman Buchanan from the 
Sarasota area and Congressman Markey from the Energy and 
Commerce Committee. It would amend the Controlled Substances 
Act to make any substance containing hydrocodone a schedule II 
drug. Do you all support that? Could you just say yes or no 
because my time is limited?
    Mr. Kerlikowske. I don't believe the Administration has 
taken a position and we have strongly encouraged the science-
based evaluation for the scheduling. So I wouldn't be able to 
tell you right now.
    Ms. Castor. OK. Doctor?
    Dr. Throckmorton. He is speaking for the Administration.
    Ms. Castor. OK. And same answer, Dr. Clark?
    Dr. Clark. Speaks for the Administration.
    Ms. Castor. OK. Thank you all very much for your efforts in 
this area.
    Mr. Pitts. The gentlelady's time is expired.
    At this time I request unanimous consent to include a 
statement from the National Association of Chain Drug Stores 
into the record.
    Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. The chair now recognizes the gentleman from 
Illinois, Mr. Shimkus, for 5 minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. And I just have two 
brief questions.
    One is I understand in Europe 85 percent of their 
prescription drugs is in blister packaging. Whether that is 
correct or not, that is what I have been informed. Do you think 
that would have any positive effect on some of these specific 
prescription type drugs, especially for those that might be 
going to, you know, families or families who are taking care of 
seniors and really the accountability and the inability to 
really just disburse that without breaking up the package?
    Dr. Throckmorton. I think it is a very good question, and 
the use of innovative packaging and storage techniques to make 
a difference in this particular crisis, one of the things that 
we have not had an opportunity to think through as fully as we 
would like to.
    I have formed a group within the FDA to start looking at 
these issues. I have a part of my center that focuses on 
packaging and labeling and those things, and I have asked them 
to look at issues like this.
    One of the challenges about requiring blister packs for one 
kind of drug is that it spills over to requiring blister packs 
potentially for other kinds of drugs that have similar kinds of 
dangers, and there is a concern about access and impact in 
other ways on health care system. So we need to look broadly at 
how these packaging more creatively than we have, I believe.
    Mr. Shimkus. Anyone else want to add? No. We were talking 
about some of the--and I am not a medical doctor so I don't 
remember all the names and stuff of the various drugs or the 
drugs to remediate the drug effect, but I am curious as to how 
much coordination there is between each of you when there is a 
development of a promising treatment which could help address 
the national priority of abating the drug abuse crisis? And I 
do know the FDA really has the approval though, but are you all 
involved with them, especially in this case, Dr. Clark?
    Dr. Clark. Yes, not only the FDA has the leadership in that 
but we work in collaboration with ONDCP, NIH, and others, as 
the literature, which as Dr. Throckmorton mentioned, that the 
science-based literature produces new ideas. We have this 
ongoing dialogue. We have working groups that are multiagency, 
multi-department to examine the implications. We also work with 
the organized medicine and the various medical societies to 
address these issues. We try to track these developments so 
that we can decide whether they can be moved into clinical 
practice.
    Mr. Kerlikowske. We spend more time with each other than 
our family.
    Mr. Shimkus. That is true up here, too, many times, 
unfortunately.
    So, Mr. Chairman, that is all I have. I yield back the 
balance of my time. Thank you.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentlelady from Illinois, Ms. Schakowsky, for 5 
minutes for questions.
    Ms. Schakowsky. Thank you, Mr. Chairman. I wanted to also 
reinforce my view. I think I do have something as a comment 
that is already in the record, and when it comes to the 
changing the scheduling of hydrocodone from its current 
schedule III to schedule II of the Controlled Substance Act, 
that was one of the suggestions that came from my constituent 
who lost his daughter.
    The other was he suggested--and I don't know if this is 
under consideration--take steps necessary to restrict the use 
of oxycodone pain relievers to severe pain rather than moderate 
to severe pain, so that would change the packaging in order to 
prevent the overprescribing of these powerful medications. I 
wonder if any--actually, whoever knows best.
    Dr. Throckmorton. Yes, that is something that I can comment 
on. There are citizens' petitions, there are requests for 
action before my agency about the changes in labeling that you 
are referring to, so I won't be able to talk in great specific 
about the changes in what is called the moderate-to-severe 
language that is in current opioid indications.
    I mean I will say, however, that the FDA has always had an 
interest in making sure that our labels are accurate and fair 
and include all of the information that we know to be 
scientific.
    I had a public meeting earlier in this year where I posted 
a series of questions to academics, advocates, family members 
asking for their help in understanding how our current labeling 
for opioids might be improved, in general asking them for 
suggestions, and we got a number of comments and we are in the 
process of looking at those comments, looking at other ways to 
make sure those labels say what they need to. We believe 
educating prescribers begins with the approved labeling, which 
outlines how the products are best used based on our scientific 
judgment, and we need to make those as fully accurate as we 
can.
    Ms. Schakowsky. I wonder if part of the customer, the 
consumer education includes encouraging families with children 
between 12 and 18 to have a lockbox for certain drugs so that 
they keep them out of the hands of children, Dr. Clark?
    Dr. Clark. Yes, we do believe that prescription drugs 
should be treated very carefully. Lockboxes are good ideas. As 
Chairman Pitts pointed out, a lot of prescription drugs are 
shared between friends and family, so you have got this 
cultural dynamic that we also have to deal with. So consumers 
and family members need to be brought in.
    And our prevention efforts include not only take-back 
programs that Mr. Kerlikowske mentioned but the idea of 
promoting of the appropriate management of description drugs in 
the home. So lockboxes is our one strategy; making sure we have 
an informed consumer, another strategy; making sure that the 
delivery system educates the consumer about the potential risk 
of misuse and diversion of the medications, yet another 
strategy.
    And, as was pointed out, we need to reach out to consumer 
groups and parent groups and consumer coalitions so that we can 
promote this cultural shift in attitudes about these 
medications.
    Ms. Schakowsky. OK. I have one more question. It appears 
there is a new trend of manufacturers seeking approval of new 
abuse-deterrent formulations near the time of the expiration of 
their patents and marketing exclusivity, so they then withdraw 
the original formulation from the market claiming it is no 
longer safe in light of the availability of the abuse-deterrent 
formulations. And if the FDA agrees that the original 
formulation was removed for safety reasons, then the FDA is 
precluded from approving generic competitors without comparable 
abuse-deterrent formulations. And in the absence of generic 
versions, then patients are forced to pay higher monopoly 
prices for extended time periods, which in turn has the 
potential to decrease patient access to these drugs. Have you 
heard about this?
    Dr. Throckmorton. Yes. And this is back to the discussion 
of the balances, you know, that need to be kept in mind as we 
think about addressing this abuse crisis. So in this case we 
have the necessary balance between incentivizing the 
development of abuse-deterrent formulations that work. We want 
to have opioids in formulations that deter abuse. I believe 
that is in everyone's best interest to find a way to 
incentivize that while at the same time recognizing the impact 
and importance of the generics in the U.S. market, currently 
well more than 75 percent of the total prescriptions, et 
cetera.
    Accomplishing that balance is something that the FDA is 
thinking and working very hard on. Our first action was earlier 
in the year when we put out the guidance laying out how we 
would try to incentivize the development of new formulations. 
Following up on that, we are now thinking about ways to develop 
guidance on abuse deterrent formulations to generics to allow 
them to come on the market as well.
    In other places and in this place I would expect our focus 
would be on the performance of those generics and not on the 
technology that was used to make that generic. So we would 
require that the generics demonstrate they are abuse-deterrent, 
the thing that we would all want to have rather than that they 
used the same technology. We think that would incentivize the 
development of appropriate generics, generics that work, while 
recognizing the important role that the innovator plays here in 
terms of developing new innovative products.
    Mr. Pitts. The chair thanks the gentlelady and now 
recognizes the gentleman from Louisiana, Dr. Cassidy, for 5 
minutes for questions.
    Mr. Cassidy. Thank you, Mr. Chairman.
    Mr. Kerlikowske, what percent of docs write what percent of 
narcotics?
    Mr. Kerlikowske. Congressman, I actually don't know. I know 
that the information about the doctors said to prescribe, for 
instance, oncologists write a large number of the----
    Mr. Cassidy. So oncologists, pain doctors?
    Mr. Kerlikowske. The pain doctors, et cetera. And I think 
Dr. Throckmorton probably can also help me. I just play a 
doctor on TV. I am with a real doctor.
    Dr. Throckmorton. And I won't be able to give you specific 
numbers; we can certainly get that. The majority of pain 
medications are actually written by primary care doctors and--
--
    Mr. Cassidy. No, that is the majority----
    Dr. Throckmorton. Yes.
    Mr. Cassidy. But if we look at those who write an 
extraordinary amount, those that are two standard deviations 
out, by definition if you are two standard deviations out, you 
are 5 percent, right? So intuitively, if we are looking at the 
folks who we are concerned about, I am suspecting that it is 
going to be a small percent writing a lot of the inappropriate 
prescriptions. You are nodding your head. Do you think that 
intuition is correct?
    Dr. Throckmorton. It depends on where you cut that line off 
is 5 percent or it is something like that. But there is clearly 
a minority of physicians that are writing for large amounts of 
these opioids. I agree with that.
    Mr. Cassidy. Now, I am not sure to whom this would go; I 
think one of the two of you because I am not sure this is 
SAMHSA's gig, but I know if you got 46 States that have a 
Prescription Drug Monitoring Program, I am a doc; I have a DEA 
number. Every time I write that number it a goes into a 
database and they know if I have written an prescription. I 
think, although I was not able to confirm, these databases and 
likewise have patient information. Now, I keep on wondering if 
our goal is to find that small percent of docs who are writing 
inappropriately and we have a unique identifier for whom that 
doc is and we can look up in the phone book and see where their 
practice is, why don't we just turn it over to Google and let 
them data mine and tell us who are the crooks? Do you follow 
what I am saying?
    Aside from being tongue-in-cheek, if we have all these 
unique identifiers and all these databases are real-time data, 
what is the challenge in figuring out which docs are the bad 
actors?
    Mr. Kerlikowske. There are a couple challenges that really 
do come up. One is that things can change, particularly in 
rural areas, pretty dramatically if a physician leaves a 
practice and is gone and suddenly that physician taking his or 
her place has to write a lot more prescriptions because they 
have actually taken over.
    Mr. Cassidy. But as we look at the data, I mean knowing 
that the urban setting is where most of this is happening, but 
even if it is rural, what you describe is a little kind of 
codicil that is still broad sweep. It seems as if we have got a 
unique identifier, you have got a real-time database, and you 
have got 46 States with it; it doesn't seem like this should be 
such a challenge.
    Mr. Kerlikowske. You are right, but also the real 
devastation has been in the rural areas. Kentucky, southern 
Ohio----
    Mr. Cassidy. I will accept that as well, but again, you 
have got a unique identifier, you have got a real-time 
database; what is the great challenge?
    Mr. Kerlikowske. I think the other challenge is that 
because these are individual state programs, some are within 
the law enforcement component, some are within the medical 
practice component, and each State uses those individually to 
determine----
    Mr. Cassidy. So does DOJ have access to these Prescription 
Drug Monitoring Programs?
    Mr. Kerlikowske. Those who have access?
    Mr. Cassidy. Department of Justice or do you or does the 
executive branch?
    Mr. Kerlikowske. No.
    Mr. Cassidy. So it is entirely state jurisdiction?
    Mr. Kerlikowske. Exactly.
    Mr. Cassidy. Now, we mentioned interstate compacts. I 
presume in these interstate compacts the States are 
communicating one to the other as to, listen, this fellow just 
dropped out; he moved to your State. He is someone you should 
watch for. Dr. Clark, do you have a thought?
    Dr. Clark. Well, we are moving toward that position. It is 
really important to recognize that the electronic health record 
integration and interoperability activity is moving toward that 
position. Some jurisdictions are in fact trying to come up with 
algorithms where you can identify the outliers in terms of pain 
medication----
    Mr. Cassidy. Well, it just seems like a sort.
    Dr. Clark. It is a little more complicated than that, as 
Dr. Throckmorton pointed out, in part because you do in fact 
pull in the cancer doctors or the arthritis doctors----
    Mr. Cassidy. But I know that. But you know who the cancer 
doctors are. If there are 100,000 docs, there is going to be 
5,000 who are cancer and 5,000 who are legitimate pain docs, 
and then there is going to be somebody who you know just moved 
to this state from that state to the state.
    Dr. Clark. Indeed. And that is what the electronic health 
records and interoperability----
    Mr. Cassidy. Now, see, it concerns me that your electronic 
medical record, because really I don't want the government 
snooping in my electronic medical record. On the other hand, if 
we have a real-time database your Prescription Drug Monitoring 
Program, that is the subset of folks who are writing 
prescriptions and it is centered upon the physician, and you 
can look and see here is my top thousand writers, 500 are 
oncologists or pain docs or ortho, and here is--do you see what 
I am saying?
    Dr. Clark. Yes, well, HHS has actually done a survey 
looking at part D programs and it discovered it was a little 
more complicated because indeed trying to pigeonhole a practice 
isn't as simple as all that. But you are right with the advent 
of increasing monitoring capability and big data, we will be 
able to make some kind of reasonable assessment of a 
practitioner and at least explore that practitioner, what he or 
she is doing.
    Mr. Cassidy. OK. I yield back. Thank you.
    Mr. Pitts. I thank the gentleman and now recognize the 
gentleman from North Carolina, Mr. Butterfield, for 5 minutes 
for questions.
    Mr. Butterfield. Thank you so very much, Mr. Chairman, and 
thank you for convening this hearing and thank the three 
witnesses for their testimony here today.
    Prescription drug abuse is certainly a serious problem that 
impacts an estimated 12 \1/2\ million Americans and now is 
considered a health epidemic by the Centers for Disease 
Control. And so it is a serious problem. This hearing today is 
very appropriate. This is a conversation that we must have and 
we must do something about it if we can.
    In the last Congress I served as ranking member of the 
Commerce, Manufacturing, and Trade Subcommittee under the then-
leadership of Chairwoman Mary Bono. The issue of prescription 
drug abuse is one that was and continues to be very important 
to her and to me. Our subcommittee held several hearings on 
prescription drug abuse last Congress, and so I have a somewhat 
keen understanding and interest in stemming the growing 
problem.
    The chair then and I shared a deep concern for individuals' 
well-being, especially young people who gain access to an abuse 
prescription drugs. The multiple hearings that we had on this 
issue during the last Congress made very clear to me that drug 
manufacturers and the drug supply chain are not the problem. 
With Purdue Pharma developing next-generation crush-resistant 
drugs, the industry is playing an increasing role in stopping 
illicit use. Nefarious black markets and drug diversion at the 
end-user stage are the problem.
    And so the question is how do we address this problem while 
avoiding burdensome regulations on your manufacturers and 
others along the supply chain?
    And so I just want to follow up just a bit on Ms. 
Schakowsky's line of questioning a few moments ago. Abuse-
deterrent drugs are a fairly new addition to the market, and so 
what impact have abuse-deterrent drugs had on the illegal and 
illicit use of prescription drugs? And so just thinking out 
loud, I would just imagine that if one drug is made abuse-
deterrent, the person would just find another drug that is not 
abuse-deterrent that produces a similar result, shifting but 
not reducing the abuse.
    And I guess I can go to Dr. Throckmorton on this one. 
Should the FDA remove roadblocks to manufacturers who want to 
produce abuse-deterrent drugs so that they can speed the new 
formula to market to reduce overall abuse?
    Dr. Throckmorton. Yes, we should. And we are working to do 
exactly that. I view the development of abuse-deterrent 
technologies and encouraging their use in opioids as an 
incremental process. We are beginning now to walk a road where 
I had hoped to see a broad majority of opioids in abuse-
deterrent formulations. That is going to help address your 
concern, the squeezing the balloon if you will, people moving 
from abuse-deterrent formulations to another formulation that 
is easier to abuse.
    In the short-term here, I think we would be fooling 
ourselves if you imagine that wasn't going to happen, so my 
job--I think our agency's job is to incentivize the development 
of those new technologies broadly and to make certain that 
those technologies demonstrate that they work. So we should be 
developing abuse-deterrent formulations that successfully 
reduce abuse through reviewing of the data--I believe the FDA 
plays a critical role there--and then rewarding those new 
formulations in labeling, rewarding them in ways that will 
encourage their use by physicians and by patients with a long-
term goal of having a broad range of opioids that are in abuse-
deterrent formulations.
    Mr. Butterfield. Let me now go to Dr. Clark if I can.
    Dr. Clark, how can we educate health care providers to spot 
the warning signs of frequent flyers who might not have a 
legitimate need for powerful prescription drugs? Do you think 
the implementation of interoperable electronic medical 
records--you mentioned that earlier--would help to flag these 
individuals who are doctor-surfing only to get more and more 
prescriptions that they need to sell?
    Dr. Clark. Indeed. We think that the interoperability 
between electronic health records and the prescribing is very 
important. We are working with the Office of the National 
Coordinator for Health Information Technology to achieve that. 
We think that educating practitioners is important. We work 
with the FDA and the National Institute of Drug Abuse. We both 
have training programs, NIDAMED for the National Institute of 
Drug Abuse and SAMHSA has a training program associated with 
Boston University. We have trained over 13,000 prescribers. We 
work with state medical societies. SAMHSA sponsors state 
medical society training, and we have, as a result of this 
broader effort that the Congress has mobilized, we are 
fighting.
    More and more practitioners are showing up at our 
conferences to listen and learn about prescription drug abuse, 
to listen and learn about adequate pain management strategies, 
to listen and learn how to monitor for deviant behaviors and 
also while maintaining a good balance of care because indeed 
pain is a problem. So we want to continue that effort here and 
we think that is a useful effort.
    Mr. Butterfield. Thank you, Dr. Clark. My time is expired.
    I didn't get to Mr. Kerlikowske and I spent considerable 
time rehearsing your name and I won't be able to use it. But I 
yield back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Virginia, Mr. Griffith, for 5 
minutes for questions.
    Mr. Griffith. Thank you, Mr. Chairman. I appreciate it.
    Dr. Throckmorton, can you please update the Committee as to 
where the Agency stands related to requirements of the Food and 
Drug Administration's Safety and Innovation Act pertaining to 
public meetings surrounding the scheduling of combination 
hydrocodone products? Now, I know you mentioned in your 
testimony that a public meeting had been held and I think in 
one of the answers to the earlier questions you said you all 
were relying on science instead of going straight to 
rescheduling some of the drugs.
    But can you tell us, you know, what you hope for or we are 
hoping for an update on what you think is the process going 
forward on this rescheduling?
    Dr. Throckmorton. Sure. I won't be able to talk in any 
detail because we have not yet formed a recommendation about 
what, you know, the matter. Our task was to respond both to the 
science, the request from the Drug Enforcement Administration 
to reconsider our recommendation from 2008, as well as respond 
to the language that Congress gave us in FDASIA directing us to 
hold the meeting that included membership to solicit input on 
things like the impact of up-scheduling. We are taking those 
two things very seriously.
    As I mentioned previously, that meeting elicited 760 some 
comments, over 100 of them making specific recommendations for 
us to consider instead of up-scheduling, so making 
recommendations for other activities. We are trying to work 
through all of those to form the best science-based 
recommendations----
    Mr. Griffith. Any idea of a timeline on when you think 
something might come out?
    Dr. Throckmorton. I am afraid I can't give you a timeline. 
I can tell you that I understand your frustration. I understand 
that this is an important issue that we want to move forward. 
My people are doing everything that we possibly can to do it 
right.
    Mr. Griffith. I appreciate that. Thank you.
    Now, it may come as a surprise to some of you all that 
Virginia actually has the oldest medicinal marijuana law on the 
books dating back to the 1979 act. That was, however, unlike 
some of those States that have said, you know, if it makes you 
feel good, do it. Virginia actually requires that there be a 
medical reason and there be a prescription, which is not 
currently allowed.
    Wouldn't you agree with me, Dr. Throckmorton, that we need 
to have a discussion about the legitimate uses of medicinal 
marijuana and freeing it up so that Virginia can exercise its 
will so that doctors can actually prescribe it in those areas 
that are authorized by the Virginia law?
    Dr. Throckmorton. My own personal views aside, the FDA 
would not have a clear role in responding to issues around 
medicinal marijuana. We do have a role in the scheduling of 
marijuana in a somewhat similar fashion that we have a role to 
play in hydrocodone. So there is a recommendation process that 
the DEA requests of us. That is regarding the development of 
marijuana-related drugs.
    Mr. Griffith. But you would agree that we probably ought to 
be having a public discussion about legitimate medicinal 
marijuana usage?
    Dr. Throckmorton. I think I am not going to be able to 
comment on that, sir.
    Mr. Griffith. All right. I appreciate that.
    The Center for Substance Abuse Treatment recently released 
an RFA for Physician Clinical Support System, Medication-
Assisted Treatment to support physician educational on the use 
of medications to treat opioid addiction. My understanding is 
that a number of treatments have been approved by the FDA to 
directly treat opioid abuse. One such drug that I am aware of 
is--and I am probably going to mispronounce it--Vivitrol. How 
does CSAT plan to expand its efforts to increase awareness and 
knowledge about these new medications, Doctor--or either one of 
you?
    Dr. Clark. One of the things that we are doing is working 
with medical societies, working with the treatment programs so 
that they are very much aware of the existence of medication. 
We have promulgated advisories so that people can understand 
them and we are also meeting with the manufacturers so that we 
have a better understanding of what their strategies are. So we 
think this is an important issue.
    We work with the FDA and ONDCP so that we can promulgate 
increased access to treatment because that is one of our 
concerns, making sure that people have access to new treatments 
as they develop and the consumers have access to those.
    Mr. Griffith. I thank you.
    I would point out, Mr. Chairman, that I have heard a lot 
today about electronic medical records, and Dr. Cassidy issued 
a concern, a warning, a broad interpretation of the Smith v. 
Maryland case upon which the NSA relies on in its current 
standing would say that if you shared your medical records with 
a third party insurance company, you may also not require--I 
don't agree with that interpretation, but you may also not 
require a search warrant to get those records. I don't think 
that is right but that is another day.
    Thank you, Mr. Chairman. I yield back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Pennsylvania, Dr. Murphy, for 5 
minutes for questions.
    Mr. Murphy. Thank you, Mr. Chairman. I appreciate the panel 
being here.
    I want to follow up on some of the questions here about 
drugs used to treat opioid addiction. The current published 
information published by the FDA--and I address this to Dr. 
Throckmorton and Clark--allows for the use of generic 
buprenorphine, which is Suboxone, in the context of the doctor-
patient joint decision. However, there is a concern from 
psychiatrists who treat persons with addictions that the 
published indications are vague enough to allow for 
misinterpretation. Now, I have heard from doctors in my 
district that there is misinformation about when a doctor can 
prescribe generic buprenorphine versus the branded Suboxone 
strip. And so it is leading to access issues because 
pharmacists are concerned about prescribing the generic.
    Are any of you aware of a problem with this issue? And if 
not, is that something you can get back to me on or we can 
communicate on later? I am not trying to trip you up. I am just 
trying to see if we can start a dialogue on that.
    Dr. Throckmorton. It would probably be better if we had a 
little bit more specifics about that one.
    Mr. Murphy. Thank you.
    Dr. Throckmorton. There were recent issues about generic 
and innovator Suboxone. There was a citizens' petition that was 
submitted to our agency that we responded to. I am not sure if 
that is exactly it but we would be happy to follow up and----
    Mr. Murphy. I would appreciate it if we can talk directly.
    Let me also ask about this. Now, we are aware of all the 
overdoses and how much they have killed with prescription 
painkillers. We know that States are collecting information on 
prescriptions but how this helps is still a concern. One person 
can go to 10 different pharmacies with 10 different 
prescriptions and collect those, and the States can sometimes 
then pick up if it is the same person. But, of course, John Doe 
can also say, oh, I am filling a prescription for my 
grandmother, my aunt, and other things, and the question is can 
we find that person in the current system who may be using 
legitimate prescriptions or the next step is false names, et 
cetera?
    How does this collecting information by the States help us 
in finding such persons? Could some of you comment on that? 
Yes, sir.
    Mr. Kerlikowske. Congressman, the two important parts of 
these PDMPs, which are then run by the state Boards of 
Licensure, one is that a physician can have that instant access 
to, say, to a new patient or, you know, the number of doctors 
that that patient has also seen because these require, when 
they fill these prescriptions, identification. The other is 
that a Board of Licensure and the States regulate medicine, not 
the Federal Government, can use that to identify a prescriber 
who may be above and beyond and then take appropriate steps for 
inquiry.
    I think that people do look at innovative ways around this 
but the States--and I would recognize Kentucky as an example--
that have the most knowledgeable people running their PDMPs 
have been pretty successful in bringing this down. And of 
course the other part of that goal then is to get somebody into 
treatment to reduce the problem.
    Mr. Murphy. Well, let me add another element to this. A 
couple years ago Congress passed a law saying that people were 
picking up Sudafed had to show a photo ID, et cetera.
    Mr. Kerlikowske. Right.
    Mr. Murphy. And our concern is in terms of what you 
understand very well, for all of you, is that one person 
picking up multiple prescriptions for themselves we can pretty 
much identify that may be an abuse and that person can be 
picked up by the PDMPs, et cetera. One person who may be 
legitimately gathering prescriptions to pick them up for other 
family members we have to somehow identify who is a person with 
the problem, who is not. Can any of you comment on the concept 
of perhaps extending that, that requiring a photo ID so that 
person's name could also be checked if they are picking up 
more?
    Mr. Kerlikowske. I would certainly be happy to tell you 
what the state PDMPs are seeing as a result of that question. I 
would be glad to do that.
    Mr. Murphy. Any others have any comments on thoughts that 
agencies may have about extending that?
    Dr. Throckmorton. Well, one agency that is not here would 
be the Drug Enforcement Agency, and I think there are 
limitations on how people can fill prescriptions that are not 
written directly to them. And it would be important just to 
look into that. And I don't know those details so wouldn't want 
to, you know, try to answer.
    Mr. Murphy. Dr. Clark, do you have any comments?
    Dr. Clark. And while we are thinking about this in a more 
formal way, I do know that many pharmacies, especially the 
chain pharmacies, are requiring photo ID on presentation even 
for the person for whom the prescription is written, and 
whoever picks up the drug, the photo ID is required. So I know 
that people are concerned about the issue.
    Mr. Murphy. And I understand the chain drugstores then, 
they will begin to raise questions themselves by contacting the 
doctor, and obviously, we want to stop the illegality of this 
and we want to help the people in need. So I hope that is an 
area where we can move toward some--this is a concrete action 
that Congress can take on this and I look forward to talking 
with you more about that.
    Thank you very much, Mr. Chairman. I yield back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Texas, Mr. Green, for 5 minutes 
for questions.
    Mr. Green. Thank you, Mr. Chairman, and thank you for 
having the hearing today.
    Dr. Clark, you spoke about SAMHSA's effort to prevent 
prescription drug abuse in the first place and you have also 
described SAMHSA's treatment activities when addiction 
disorders rise. Treatment of addiction to prescription drugs is 
crucial in importance and, as we all know, promising behavioral 
and medical approaches exist to treat this form of addiction.
    The Affordable Care Act builds on bipartisan legislation 
cosponsored and supported by many members of this committee, 
the Mental Health Parity and Addiction Equity Act of 2008, to 
ensure that more individuals suffering from substance abuse use 
disorders receive the care they need.
    My first question is how do you anticipate the Affordable 
Care Act will impact access to services for people who are 
addicted to prescription drugs or have other substance use 
disorders?
    Dr. Clark. One of the things that is in the Affordable Care 
Act is in fact the provision of services for mental health and 
substance use disorders, which means that individuals who have 
no coverage currently and that has been one of the barriers for 
people seeking treatment, that barrier would be removed. So the 
Affordable Care Act will allow health coverage for individuals 
who cannot afford the cost of care and therefore would be able 
to engage in care.
    It will also allow for a broader reach for using the 
structures like Accountable Care Organizations so that we can 
identify individuals early before they develop full-blown 
addiction issues, risky behavior if you will, so that we will 
be able to intervene at an earlier point in time.
    Mr. Green. So Medicaid and the marketplace exchanges, 
whether they are state or national exchanges, will expand the 
population for those who receive substance abuse treatment?
    Dr. Clark. Indeed.
    Mr. Green. OK. It is clear from your comments the 
Affordable Care Act made it possible for many people with 
substance use disorders, whether it is addiction to 
prescription drugs or illicit drugs, to access treatment.
    Mr. Chairman, I know we have had differences over the 
Affordable Care Act but I hope we all share the goal of 
providing more robust treatment to those who are working to 
overcome prescription drugs.
    Director Kerlikowske--close enough, I hope--with your name 
like Green it is not hard to pronounce--how do you track the 
progress in completing action items identified in the 
Administration's plan in meeting the goals you have set?
    Mr. Kerlikowske. When we put together the prescription drug 
plan, we brought everyone to the table for a number of months, 
and all of the agreements that are in there continue into an 
interagency work group. So we set some specific goals and then 
we bring that where those people that are closest to the 
problem and on the ground and had a responsibility for each of 
their agencies together on a quarterly basis to go over their 
progress.
    So we are starting to see--and I come from a profession 
that isn't known for its optimism in law enforcement, but I can 
tell you that seeing the changes that Dr. Clark and the 
chairman talked about from 2010 to 2011, I think we are 
starting to turn the corner on this prescription drug problem.
    Mr. Green. Good. Dr. Clark, I am interested in hearing more 
about SAMHSA's coordination with the Centers for Disease 
Control and Prevention on surveillance activities. For example, 
you testified that SAMHSA funds the annual national survey on 
drug use and health which collects data on nonmedical use of 
prescription drugs, among other things. SAMHSA also oversees 
Drug Abuse Warning Network, or DAWN, surveillance activities of 
drug-related emergency department visits and drug deaths. Is 
that partnership going to continue and if you have any more to 
share with the Committee on that partnership because obviously 
we like agencies to work together?
    Dr. Clark. And indeed we are working together. I think the 
Assistant Secretary for Health Howard Koh and my immediate boss 
Pamela Hyde chairing the Behavioral Health Coordinated 
Committee, the objective is to make sure that we are working 
together, and Ms. Hyde works very closely with the director of 
the CDC to make sure that there is no duplication of effort but 
there is collaboration and coordination.
    And we have our data teams working together. The director 
of the Center for Behavioral Health Statistics and Quality, Dr. 
Pete Delaney, is working with the National Center for Health 
Statistics to make sure that we get the best data possible 
dealing with the epidemiology of substance abuse.
    Mr. Green. Thank you. Thank you, Mr. Chairman. I yield 
back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Kentucky, Mr. Guthrie, for 5 
minutes for questions.
    Mr. Guthrie. Thank you, Mr. Chair. And I thank you all for 
coming.
    These first couple of questions are for Dr. Throckmorton. 
And I have been a strong proponent--I am from Kentucky and we 
have been real aggressive with trying to deal with the drug 
problem in our area, prescription drug problem. And the tamper-
resistant technology has been important. In your written 
testimony you talked about there were two recent determinations 
from the FDA on different formulations for OxyContin and for 
Opana ER, and can you take a minute to explain why there were 
two different determinations of those two cases about the drug-
resistant technology?
    Dr. Throckmorton. Sure. I will speak in general terms. In 
both cases we looked at the available data on that product and 
specific the new formulation and then looked at it in 
comparison with the earlier formulation, the formulation that 
had been originally developed and asked questions about whether 
or not the new technology promised to reduce abuse. We think it 
is terribly important that this bar, this bar of concluding 
something is abuse-deterrent be high enough to be worth 
developing, make it an incentive, make it something that we can 
reward in labeling terms to make those products attractive for 
manufacturers to take the time and money to develop.
    In the case of OxyContin when we looked at the data, there 
were important aspects of the new formulation that really did 
predict it was going to be harder to abuse. One particular one 
is when people tried to make it ready to inject, it turns into 
a gel that is just physically impossible to inject into 
someone's arm. You know, some of that testing involved using 
people who are addicts trying to, you know, do things that, you 
know, that would allow this to be used and they were unable to 
do it.
    Now, so those sorts of evidence strongly suggest that a 
product with those formulation characteristics is going to have 
reduced attractiveness to abusers in the real world. We are 
tracking that real-world experience now going forward. On the 
other hand, when we looked at the totality of the data around 
the Opana ER product, we didn't see data of that same kind, 
data that suggested that that product was really going to be 
meaningfully harder to abuse, meaningfully meaning we would see 
less abuse----
    Mr. Guthrie. I want to ask you another one and I got one 
more that I want to ask, but thank you for that. And on Capitol 
Hill there has been a lot of discussion about whether generic 
prescription opioids must have identical abuse-deterrent 
technology or whether it must simply be comparable or meet or 
exceed of the other drug. Can you discuss your perspective on 
this debate and what you are doing to ensure the process 
remains science-based and technology-neutral?
    Dr. Throckmorton. Absolutely. And I think it is a very 
important question. We are going to be talking about--we are 
working internally on and we are planning on talking about it 
at a public meeting at the end of September and early October. 
What I anticipate is that we are going to rely on the generics 
demonstrating they are abuse-deterrent, not that they use the 
same technology. That would be the approach that we have used 
in other places.
    And so the testing that we will lay out, the testing that 
we will develop will be to decide whether or not the new 
formulation, however it is made, is abuse-deterrent to the 
level that it needs to be compared with the innovator, not that 
it used the same technology.
    Mr. Guthrie. Because I would like to ask Mr. Kerlikowske a 
question or just bring this up. A very good friend of mine--his 
name is Tommy Loving--he is head of our drug task force. Do you 
know Tommy? And very aggressive in this and we get together 
quite--I will see him in the morning actually for coffee 
probably.
    And he brought it to me a few months ago that heroin has 
really shown itself in an alarming statistic. And I said why is 
that kind of--you know, heroin, that seems like something that 
was 1970s, I guess? He said because our legislature has been so 
aggressive with the pharmacies, with the tamper-resistant, so 
now the prescription drugs are more difficult to get than 
heroin.
    And I just want to see--I know you are aware of that, just 
the strategy with that. The prescription drug abusers are now 
finding an outlet easier to get heroin than prescription drugs 
because we have been so good in our State of trying to control 
it.
    Dr. Throckmorton. And that has been going on for a while. 
The anecdotal evidence across the country is that there is an 
increase in heroin and some of the survey instruments are also 
showing that we have a younger population.
    There is another component about this, too, and that is 
that young people are heroin-naive. Older people really have an 
understanding of the dangers of heroin. Young people believe 
that it is not that powerful, that as long as they smoke it or 
snort it that they won't become an injecting drug user, and of 
course within a few weeks they do become an injecting drug user 
at the same time that prescription drugs are being made less 
available through all of the things that you have heard about 
today and the cost. And heroin is much less costly. So we have 
some real concerns about the heroin issue, and I couldn't agree 
with the drug task force commander more.
    Mr. Guthrie. Thank you and I yield back.
    Mr. Pitts. The chair thanks the gentleman and now 
recognizes the gentleman from Kentucky, Mr. Whitfield, for 5 
minutes for questions.
    Mr. Whitfield. Thank you, Mr. Chairman. And thank you all 
for being with us today.
    I want to give a little bit of historical perspective on 
the Prescription Drug Monitoring Program, and since my facts 
are oftentimes wrong, if I am wrong, you all can correct me. 
And then I want to just ask a couple of questions.
    Kentucky, as my understanding in 1998, started a 
Prescription Drug Monitoring Program. In 2002, Hal Rogers 
started the Prescription Drug Monitoring National Training and 
Technical Assistance Program at the Department of Justice. Now, 
that was an unauthorized program because this committee has the 
jurisdiction.
    Since that time, it has received an average of 7 or $8 
million a year, and we all acknowledge and say that it has been 
an effective program. I don't think anyone would dispute that. 
But in 2005, this committee that does have jurisdiction 
recognizing the success of that program initiated NASPER. Now, 
the only difference is that the Hal Rogers program was centered 
at the Department of Justice and NASPER was over at HHS.
    NASPER received funding in 2011, and '12 I believe did not 
get funding. And, as a matter of fact, someone at the 
Appropriations Committee in the report language in the Omnibus 
Bill even specifically said no money will be spent on NASPER, 
which I thought was a little bit mean-spirited myself.
    But regardless of that, you three fellows are the experts 
in the area and I would ask you the question, do we need NASPER 
anymore? Maybe we should just eliminate NASPER and let's just 
focus on the Hal Rogers program. Or should we try to combine 
them? Or should we try to reauthorize NASPER?
    You know, I think a lot of the problems we have in the 
Federal Government on a lot of programs is that Congress does 
not have a coherent, organized approach to dealing with the 
problem. So would you all just give us--because I mean our 
committee does have jurisdiction. Maybe we should reauthorize 
it and try to start over, but I would just ask for your 
guidance on this issue. And if each one of you would comment, I 
would appreciate it.
    Mr. Kerlikowske. I know that NASPER was designed to have a 
bit of a different take on the program versus the high 
technology of the Hal Rogers PDMPs. We are pleased that there 
is still money, as you said 7 to $8 million each year that is 
made available to the States to start up these PDMPs. And I 
would be happy to sit down with not only representatives from 
Congress but also some of these inner-agency people and provide 
some level of our expertise and what we have seen as to NASPER. 
We would be glad to do that.
    Dr. Clark. I agree with Director Kerlikowske. There needs 
to be, shall we say, a convening of minds to look at what it is 
that we are trying to achieve and how best can we achieve it. 
The specific program may not be the issue; it is the 
technologies that exist and it is bridging some of the 
limitations. And it is also dealing with some of the 
conflicting imperatives associated with both programs.
    So our focus on linking Prescription Drug Monitoring 
Programs with electronic health records, working with the 
Office of National Coordinated Health Information Technology 
and with the support of ONDCP in order to give practitioners 
real-time access, the amount of money and PDMPs just hasn't 
been a large amount of money in the first place, so the 
strategy might be how do we best use limited resources to 
enhance our efforts to deal with the prescription drug abuse 
problem without compromising the health of people who suffer 
from pain or other conditions requiring controlled substances.
    Mr. Whitfield. Yes. Now, Mr. Chairman, I might just suggest 
that--and maybe in a private setting--some of our staff could 
work with these three gentlemen and their staff to determine 
what can we do to make this program even more effective? I mean 
maybe all of the effort should be generated that the Hal Rogers 
program or maybe that there would be a combination or maybe 
there is something we can do. But since our program has 
expired, looking at reauthorization, I think it would be 
helpful to have these discussions. Thank you.
    Mr. Pitts. We will pursue that. Thank you.
    The chair now recognizes the gentlelady from North 
Carolina, Mrs. Ellmers, for 5 minutes for questions.
    Mrs. Ellmers. Thank you, Mr. Chairman. And thank you for 
holding this subcommittee hearing. Thank you to our panel.
    I have a couple of questions in regard to patient safety 
for those who truly are in need of pain medication and how, as 
we are trying to make the system more effective for, you know, 
identifying abusers and how to use and work on that problem, 
how do we protect those patients as well?
    You know, the first thing that comes to my mind is the 
Sudafed issue and how an individual has to basically show their 
license, their identification, and I know why that has been put 
in place. I am curious as to why that approach was taken. Is it 
because it was an over-the-counter drug initially, and because 
it is used to formulate other drugs? Dr. Throckmorton, can you 
tell us a little bit about that approach? Because I am 
concerned that we might take an approach like that into the 
future with others.
    Dr. Throckmorton. I want to make sure that I understand the 
question you are asking. So with pseudoephedrine--Sudafed 
itself is not abused. It is----
    Mrs. Ellmers. Correct.
    Dr. Throckmorton [continuing]. Obviously, what it is being 
used to create----
    Mrs. Ellmers. Correct.
    Dr. Throckmorton [continuing]. Highly dangerous, you know, 
methamphetamine. And, you are right, it was over-the-counter 
and, you know, Congress felt that there were additional 
restrictions that were necessary to ensure the safe use of that 
product.
    That is different than the conversation we are having 
around hydrocodone where----
    Mrs. Ellmers. Right.
    Dr. Throckmorton [continuing]. It in and of itself is a 
product that has the potential for abuse----
    Mrs. Ellmers. Addictive abuse.
    Dr. Throckmorton [continuing]. One that is already under 
some control for the Drug Enforcement Administration, the 
schedule III already has a----
    Mrs. Ellmers. So basically, the difference being that the 
Sudafed was an agent that was used to----
    Dr. Throckmorton. Create.
    Mrs. Ellmers [continuing]. Create another, and so 
therefore----
    Dr. Throckmorton. That is the----
    Mrs. Ellmers [continuing]. The idea was to find out who 
was--make sure that those individuals who were actually 
purchasing it were identified.
    The other issue is what other protections is the FDA 
putting in place to ensure that patients who really are in need 
of those critical pain medications for, whether it be chronic 
pain or acute pain, what protections are in place so that again 
we might--I hate when the pendulum swings one way when really 
what we need to do is kind of come up with a real balance.
    Dr. Throckmorton. Well, we think there are several things 
to do. So first and foremost, we have been listening carefully. 
So I have been now working on the opioids and, you know, for a 
substantial fraction of my time for the last several years. And 
I have had the opportunity to sit down with hospice care 
workers. I have sat down with cancer survivors. I have sat down 
with groups to see the need for access to pain medicines for 
patients that need them. I have also sat down with groups, you 
know, that see the cost that prescription drug abuse is, you 
know, having in America. So to fully understand sort of the 
broad spectrum of views, we are trying to listen as carefully 
as we can.
    At the end of the day, one of the things that we concluded 
was the better educated people were about how best to use these 
medicines--and that means both the prescribers and the 
patients--the more comfortable we believed they would be in 
making the right choices. And the right choices here could be 
not prescribing an opioid to avoid abuse, avoid misuse, or it 
could be to make a choice to prescribe it because they are now 
educated well enough to know how to do it well, how to monitor 
that patient well, how to spot the signs of abuse----
    Mrs. Ellmers. Sure.
    Dr. Throckmorton [continuing]. And so they are not scared 
to use a word----
    Mrs. Ellmers. OK.
    Dr. Throckmorton [continuing]. To use the opiates right.
    Mrs. Ellmers. And thank you because I think that is the 
best approach as well.
    But if there is an individual right now--and I appreciate 
especially working with hospice and certainly that is an area 
where those medications are used and I can see that issue 
occurring--but if there is an individual who feels that their 
pain, for whatever purpose, whatever reason, has an issue with 
access and feels that they are having difficulty obtaining, is 
there a phone number? Is there a way--who does that individual 
reach out to? And any of you can comment on any of these 
things.
    Dr. Throckmorton. Partly, it will depend on what the source 
of not being able to get the medicine is. So if it is a drug 
shortage, for instance, that the drug is not available the way, 
you know, sometimes drugs have gone into shortage recently and 
we have shortages with fentanyl, for instance, periodically or 
whatever, that is absolutely something the FDA wants to hear 
about. I have a staff that work on that 24/7 trying to 
understand, prevent, minimize those shortages. And we have a 
Web site at the FDA to allow people to report.
    If it is a pharmacy not carrying the drug, those are 
decisions that the FDA doesn't have a clear role in and I would 
suggest Boards of Pharmacy or some other local authorities 
would be the place to talk to.
    Mrs. Ellmers. Thank you. Thank you. I apologize, Mr. 
Chairman. My time ran over. Thank you very much.
    Mr. Pitts. The chair thanks the gentlelady and now 
recognizes the gentleman from Florida, Mr. Bilirakis, for 5 
minutes for questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it 
very much. And thank you for holding this hearing. And I thank 
the panel for their testimony.
    Along with many Floridians, I am concerned about the 
alarming increase in prescription drug abuse and illegal sales 
of prescription medications. I believe that issues concerning 
both overprescribing and the illegal use and sale of these 
drugs should be addressed. Prescription drug abuse is both a 
federal and state issue, and I have worked with both local and 
federal officials to take on this issue.
    In my district, Pasco and Pinellas Counties have had some 
of the highest oxycodone causes of death with 197. Hillsborough 
County, this is in the Tampa Bay area, was fourth in Florida 
with 128 deaths from oxycodone. Sadly, Pasco and Pinellas 
Counties also led the state in methadone deaths and hydrocodone 
deaths. The number of ER-related visits from misuse or abuse of 
prescription drugs has nearly doubled in the past 5 years.
    Recently, there was a drug summit in Pasco County where 
both health officials discussed the growing problem of babies 
born addicted to prescription drugs. Pinellas County ranks 
first in the state for babies born addicted. Florida has taken 
some positive steps to fight prescription drug abuse such as 
legislation to eliminate pill mills in 2011.
    Florida currently runs four drug tracking programs in 
addition to the Controlled Substance Reporting System. The 
number of doctors on the DEA's list of top 100 purchasers of 
oxycodone declined by 97 percent in a single year and pain 
management clinic registration decreased by 36 percent. This is 
a good start but there is much more work to be done. I am sure 
you will agree. That is why I have instructed my office to look 
into issues of prescription drug abuse and developing, of 
course, future legislation. And again, Mr. Chairman, I really 
appreciate you holding this hearing.
    I have a couple questions. Mr. Kerlikowske, I talked a bit 
about this of course, the growing problem of babies born 
addicted to prescription drugs such as oxycodone. This is a 
serious problem in our communities. I would like to have you 
come down if you will to the Tampa Bay area and meet some of 
the local officials, the health officials and providers who are 
dealing with this growing problem.
    I want to ask you a question. Are there any funds or 
programs available for the local community to tap into to help 
with the problem either on the prevention or treatment side? 
And I also want to ask Dr. Clark, are there resources for my 
community, of course, from SAMHSA? So those are the questions.
    Mr. Kerlikowske. Congressman, we fund the Drug-Free 
Communities program, these grassroots communities programs that 
do prevention, and of course oftentimes that local voice is 
more powerful and more important to people about prevention. 
And we have worked with them to help them understand and become 
more knowledgeable.
    We fund almost 700 of them around the country to become 
more knowledgeable about this neonatal abstinence syndrome 
because we are seeing in a number of States, Florida, who is--
and I attended the first meeting of the advisory committee that 
has worked so hard under the Attorney General to reduce that 
problem. It is a complex problem because there are women in 
pain that are also pregnant and are being treated. There are 
women in drug programs at the same time, and so there has to be 
a very careful balance.
    But I would also tell you I would be happy to visit the 
Tampa Bay area with you and examine this more closely.
    Mr. Bilirakis. Well, thank you very much. I appreciate 
that. I welcome that.
    Anyone else wish to comment on the panel?
    Dr. Clark. We have Targeted Capacity Expansion grants that 
are available to the States so the States can use their block 
grants to help promote education. We are developing an internal 
strategy to deal with NES. We recognize it is much broader than 
the prescription opioids. It involves heroin. But, as you know, 
that any time a woman has to take medication while she is 
pregnant, there is some associated risk for the neonate, and so 
what we will try to do is promote adequate education of 
consumers and practitioners so that we can address these 
issues.
    We have a Pregnant and Postpartum Women's program that 
allows women who have addiction problems to get into treatment. 
During the time that they are pregnant and when they deliver, 
we can deal with both the mom and the child. And the data do 
show that the outcomes of the birth are much more positive when 
we have those kinds of programs.
    But the most important thing is having this concerted 
effort involving multiple layers at the State level, at the 
local level, community level involving practitioners as well as 
consumers.
    Mr. Bilirakis. Thank you. Thank you very much. I yield 
back, Mr. Chairman.
    Mr. Pitts. The chair thanks the gentleman.
    The House is voting on the floor. There are less than 10 
minutes left to vote.
    That concludes the questions from the members. There might 
be other questions. We will submit those to you in writing if 
you would please respond promptly. And members should submit 
their questions by the close of business on Friday, June 28.
    So thank you very much to the witnesses, to the members for 
attending.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 11:23 a.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    According to the Centers for Disease Control and 
Prevention, prescription drug abuse is an epidemic. And 
unfortunately it is a growing problem that is affecting too 
many American families.
    Data from the National Survey on Drug Use and Health 
(NSDUH) show that about 15.7 million people aged 12 or older 
used prescription-type drugs non-medically in the past year, 
and that 2.5 million of these individuals reported using 
prescription-type drugs non-medically for the first time.
    Particularly alarming is the fact that many people, 
especially teenagers, believe prescription drugs are safer than 
illegal drugs because they are prescribed by a healthcare 
professional and dispensed by a pharmacist. But with more than 
20,000 deaths occurring each year due to the misuse and abuse 
of prescription drugs, we must ensure that our research, 
education, and prevention efforts are addressing this major 
public health and safety concern.
    The federal government has undertaken a number of positive 
initiatives. The National All-Schedules Prescription Electronic 
Reporting Act (NASPER), which I coauthored with my colleague Ed 
Whitfield from Kentucky, was enacted in 2005 to provide grants 
to states to establish prescription drug monitoring programs, 
so that these potentially dangerous substances are used only 
for intended purposes with legitimate prescriptions. The 
program, administered by the Substance Abuse and Mental Health 
Services Administration (SAMHSA), helped ramp up state efforts 
to reduce abuse and diversion of prescription drugs. It is 
critical that we continue to support this program through 
federal funding.
    There is also a great deal of work being done right now by 
the Food and Drug Administration (FDA) to implement provisions 
related to prescription drug abuse that were included in the 
Food and Drug Administration Safety and Innovation Act 
(FDASIA), which Congress passed last summer. FDA has been 
tasked with thoroughly reviewing all Federal programs regarding 
prescription drug abuse and treatments for those with 
prescription drug dependence and identifying any gaps. That 
report is due out this summer and I think will be useful in the 
work of this Subcommittee. In addition, as we will hear from 
FDA today, they have issued guidance on developing abuse-
deterrent products.
    The Administration has also made prescription drug abuse a 
priority, setting out a plan to address this health epidemic. I 
support those efforts, but it is clear that we still have an 
unsolved problem that needs further attention.
    I hope our witnesses today can help us navigate how we can 
find innovative approaches to combating prescription drug abuse 
while recognizing the critical use that many of these drugs 
have for patients across the country.
    Thank you.
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