[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
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
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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