[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
IMPROVING PREDICTABILITY AND TRANSPARENCY IN DEA AND FDA REGULATION
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
APRIL 7, 2014
__________
Serial No. 113-137
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
90-872 PDF WASHINGTON : 2015
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC,
Washington, DC 20402-0001
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 FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
LEE TERRY, Nebraska GENE GREEN, Texas
MIKE ROGERS, Michigan DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois
Vice Chairman JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
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)
(ii)
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........................................... 44
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 45
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 47
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 47
Prepared statement........................................... 48
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 48
Prepared statement........................................... 66
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 67
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 67
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 68
Witnesses
Janet Woodcock, Director, Center for Drug Evaluation and
Research, Food and Drug Administration, Department of Health
and Human Services............................................. 69
Prepared statement........................................... 72
Answers to submitted questions............................... 184
Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, Department
of Justice..................................................... 80
Prepared statement........................................... 82
Answers to submitted questions............................... 194
Nathan B. Fountain, Chair, Professional Advisory Board, Epilepsy
Foundation of America.......................................... 122
Prepared statement........................................... 126
John M. Gray, President and Chief Executive Officer, Healthcare
Distribution Management Association............................ 134
Prepared statement........................................... 136
D. Linden Barber, Partner and Director, DEA Compliance and
Litigation Practice, Quarles & Brady, LLP...................... 141
Prepared statement........................................... 143
Answers to submitted questions............................... 212
Wendy K.D. Selig, President and Chief Executive Officer, Melanoma
Research Alliance.............................................. 155
Prepared statement........................................... 157
Scott Faber, Senior Vice President for Government Affairs,
Environmental Working Group.................................... 163
Prepared statement........................................... 165
Submitted Material
H.R. 4069, the Ensuring Patient Access and Effective Drug
Enforcement Act of 2013, submitted by Mr. Pitts................ 2
H.R. 4250, the Sunscreen Innovation Act, submitted by Mr. Pitts.. 15
H.R. 4299, the Improving Regulatory Transparency for New Medical
Therapies Act, submitted by Mr. Pitts.......................... 41
Letter of April 7, 2014, from Gina F. Adams, Corporate Vice
President, Government Affairs, FedEx Corporation, to Mr. Upton,
et al., submitted by Mrs. Blackburn............................ 50
Statement of April 7, 2014, by the National Association of Chain
Drug Stores, submitted by Mrs. Blackburn....................... 51
Letter of April 7, 2014, from Alliance to Prevent the Abuse of
Medicines to Hon. Tom Marino and Mrs. Blackburn, submitted by
Mrs. Blackburn................................................. 64
Letter of April 4, 2014, from Brett M. Coldiron, President,
American Academy of Dermatology Association to Mr. Pitts and
Mr. Pallone, submitted by Mr. Whitfield........................ 108
Letter of April 7, 2014, from Bill Piper, Director, Office of
National Affairs, Drug Policy Alliance, to Mr. Pitts and Mr.
Pallone, submitted by Mr. Pallone.............................. 120
Statement of April 7, 2014, by the Global Healthy Living
Foundation, submitted by Mr. Pitts............................. 182
IMPROVING PREDICTABILITY AND TRANSPARENCY IN DEA AND FDA REGULATION
----------
MONDAY, APRIL 7, 2014
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 3:00 p.m., in
room 2123, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Whitfield,
Shimkus, Murphy, Blackburn, Lance, Griffith, Bilirakis,
Ellmers, Upton (ex officio), Pallone, Dingell, Green, Barrow,
and Waxman (ex officio).
Staff present: Clay Alspach, Chief Counsel, Health; Gary
Andres, Staff Director; Noelle Clemente, Press Secretary; Paul
Edattel, Professional Staff Member, Health; Sydne Harwick,
Legislative Clerk; Robert Horne, Professional Staff Member,
Health; Carly McWilliams, Professional Staff Member, Health;
Heidi Stirrup, Policy Coordinator, Health; John Stone, Counsel,
Health; Ziky Ababiya, Democratic Staff Assistant; Eric Flamm,
Democratic FDA Detailee; Elizabeth Letter, Democratic Press
Secretary; Karen Lightfoot, Democratic Communications Director
and Senior Policy Advisor; and Karen Nelson, Democratic Deputy
Staff Director, Health.
Mr. Pitts. The subcommittee will come to order.
The Chair will recognize himself for an opening statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Today's legislative hearing focuses on three bills designed
to improve the predictability and transparency in Drug
Enforcement Administration and Food and Drug Administration
regulation.
H.R. 4069, the Ensuring Patient Access and Effective Drug
Enforcement Act, introduced by Representatives Marino and
Blackburn, will facilitate greater collaboration between
industry stakeholders and regulators in an effort to combat our
Nation's prescription drug abuse epidemic.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. H.R. 4250, the Sunscreen Innovation Act,
introduced by Representatives Whitfield and Dingell, seeks to
expedite the FDA's approval process for active ingredients in
sunscreens that have long been approved for use in places like
Europe, Canada, and other countries to ensure that U.S.
consumers have access to the safest, most effective sunscreens
available.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. And H.R. 4299, the Improving Regulatory
Transparency for New Medical Therapies Act, which Ranking
Member Pallone and I introduced.
Mr. Pallone and I introduced H.R. 4299, which seeks to
improve the transparency and consistency of DEA's scheduling of
new FDA-approved drugs under the Controlled Substances Act,
CSA, and its registration process for manufacturing controlled
substances for use in clinical trials. Ultimately, this will
allow new and innovative treatments to get to patients who
desperately need them faster. It now takes on average well over
a billion dollars and 14 years from the time a drug is
discovered to the time of approval.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. This committee has taken steps to provide more
transparency and consistency in the drug approval process
through the Prescription Drug User Fee Program and a commitment
to review goals imbedded in the PDUFA agreements. However,
drugs that contain substances that have not been previously
marketed in the United States and that have abuse potential
must also be scheduled under the CSA by the DEA before they can
begin marketing their product. But under the CSA, there is no
deadline for the DEA to make a scheduling decision, and the
delays in DEA decisions have increased nearly fivefold since
the year 2000. This lack of predictability in the timing of
DEA's scheduling decisions leads to unnecessary uncertainty in
the drug development process and needless delays in patients'
access to new therapies.
H.R. 4299 simply requires the DEA to issue an interim final
rule 45 days after it receives FDA's scheduling recommendation
for a new drug, allowing patients access to new therapies 45
days after FDA approval. DEA would retain its authority to
subsequently transfer the drug between schedules under the
Section 201 of the CSA.
This bill also establishes a timeline for DEA to grant
approval of manufacturers' applications to register controlled
substances not yet approved by FDA to be used in clinical
trials, allowing companies to properly plan clinical trial
schedules for prospective new therapies. This provision will
get products to the market faster because innovators will be
able to get clinical trials under way in a timely and
predictable way, which is critical to drug developers and
patients alike.
H.R. 4299 requires that if the DEA has not made a final
decision on whether to approve a registration application for
products in the investigational new drug, IND, phase within 180
days of submission of the application, then the DEA shall
provide notice to the applicant on the outstanding issues that
must be resolved in order to reach a final decision and an
estimated date on which a final decision on the registration
application will be made.
Such a solution does not force the DEA to make a particular
decision but will provide transparency to the process so
companies can better plan when regulatory decisions will be
made.
I would like to thank all of our witnesses for being here
today. I look forward to having a constructive discussion on
these legislative proposals. These bills touch on very
important issues for this committee, and they offer and
excellent starting point for finding solutions.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
Today's legislative hearing focuses on three bills designed
to improve the predictability and transparency in Drug
Enforcement Administration (DEA) and Food and Drug
Administration (FDA) regulation:
H.R. 4069, the Ensuring Patient Access and
Effective Drug Enforcement Act, introduced by Reps. Marino and
Blackburn, will facilitate greater collaboration between
industry stakeholders and regulators in an effort to combat our
Nation's prescription drug abuse epidemic;
H.R. 4250, the Sunscreen Innovation Act,
introduced by Reps. Whitfield and Dingell, seeks to expedite
the FDA's approval process for active ingredients in sunscreens
that have long been approved for use in places like Europe,
Canada, and other countries to ensure that U.S. consumers have
access to the safest, most effective sunscreens available; and
H.R. 4299, the Improving Regulatory Transparency
for New Medical Therapies Act, which Ranking Member Pallone and
I introduced.
Mr. Pallone and I introduced H.R. 4299 seeks to improve the
transparency and consistency of DEA's scheduling of new FDA-
approved drugs under the Controlled Substances Act (CSA), and
its registration process for manufacturing controlled
substances for use in clinical trials. Ultimately, this will
allow new and innovative treatments to get to patients who
desperately need them faster.
It now takes, on average, well over a billion dollars and
14 years from the time a drug is discovered to the time of
approval. This committee has taken steps to provide more
transparency and consistency in the drug approval process
through the Prescription Drug User Fee program and a commitment
to review goals embedded in the PDUFA agreements.
However, drugs that contain substances that have not been
previously marketed in the United States and that have abuse
potential must also be scheduled under the CSA by the DEA
before they can begin marketing their product.
But, under the CSA, there is no deadline for the DEA to
make a scheduling decision, and the delays in DEA decisions
have increased nearly five-fold since 2000.
This lack of predictability in the timing of DEA scheduling
decisions leads to unnecessary uncertainty in the drug
development process and needless delays in patients' access to
new therapies.
H.R. 4299 simply requires DEA to issue an Interim Final
Rule 45 days after it receives FDA's scheduling recommendation
for a new drug, allowing patients access to new therapies 45
days after FDA approval.
The DEA would retain its authority to subsequently transfer
the drug between schedules under the Section 201 of the CSA.
This bill also establishes a timeline for DEA to grant
approval of manufacturers' applications to register controlled
substances, not yet approved by FDA, to be used in clinical
trials, allowing companies to properly plan clinical trial
schedules for prospective new therapies.
This provision will get products to the market faster
because innovators will be able to get clinical trials underway
in a timely and predictable way; which is critical to drug
developers and patients alike.
H.R. 4299 requires that if the DEA has not made a final
decision on whether to approve a registration application for
products in the investigational new drug (IND) phase within 180
days of submission of the application, then the DEA shall
provide notice to the applicant on the outstanding issues that
must be resolved in order to reach a final decision, and, an
estimated date on which a final decision on the registration
application will be made.
Such a solution does not force the DEA to make a particular
decision but will provide transparency to the process so
companies can better plan when regulatory decisions will be
made.
I would like to thank all of our witnesses for being here
today, and I look forward to having a constructive discussion
on these legislative proposals. These bills touch on very
important issues for this committee and they offer an excellent
starting point for finding solutions.
Thank you.
Mr. Pitts. I yield back the balance of my time and, at this
point, recognize the ranking member, Mr. Pallone, 5 minutes for
an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Pitts.
Today's important hearing will examine a number of bills
that aim to provide predictability and transparency for
medicines and other products.
This committee has an important balancing act it must play.
As prescription drug abuse threatens the safety and health of
too many people in this country, we must find ways to combat
this growing public health epidemic. At the same time as we
examine different policies to address this issue, we must also
ensure patient access to necessary medications. We all agree
that the Food and Drug Administration, the FDA, and the Drug
Enforcement Agency, the DEA, have critical missions.
FDA ensures that innovative medicines and other products
are safe and effective, while the DEA safeguards our
communities from illegal and diverted drugs. Once the FDA
approves a drug, the DEA's role is to utilize the scheduling
process under the Controlled Substances Act, which helps them
to keep the medicine in the hands of those who need them and
away from criminals and abusers who aim to break the law or, in
some unfortunate cases, abuse these drugs.
While both agencies typically work independently, it is
important that their authorities and actions work in a
complimentary way. There is no question that DEA has an
important role in combatting drug abuse, but there must be some
recognition by DEA of the legitimate therapies that improve the
public health.
One of the bills under consideration today is one that I am
proud to sponsor with Chairman Pitts. H.R. 4299, the Improving
Regulatory Transparency For New Medical Therapies Act, aims to
improve the DEA's scheduling process for new FDA approved drugs
under the Controlled Substances Act and the registration
process for the use of controlled substances in clinical
trials. In recent years, this committee has worked successfully
to improve review of new medications. Without weakening FDA
oversight, we have given manufacturers and patient groups a
more predictable process allowing patients to get timely access
to the latest innovation therapies available.
But unfortunately, when a medicine has abuse potential, the
DEA's authorities under the Controlled Substances Act are
hindering this progress. Specifically the draft bill would
require DEA to make a final determination 45 days after
receiving FDA's scheduling recommendation for a new drug.
Additionally, it would generate more transparency in the
application process for clinical trials by requiring the DEA
make a final determination within 180 days or provide the
applicant with details about what outstanding issues remain
unresolved. I hope we can better understand today what is
happening at the DEA and find ways to address it.
In addition today, we will examine H.R. 4069, the Ensuring
Patient Access and Effective Drug Enforcement Act, introduced
by Representatives Blackburn and Marino. The bill aims to
improve and better coordinate enforcement efforts within the
drug supply chain regarding prescription drug diversion and
abuse. It also aims to curtail unnecessary supply chain
disruptions that may be affecting patient access to needed
medications.
And lastly, we will hear from our witnesses about H.R.
4250, the Sunscreen Innovation Act, introduced by
Representatives Whitfield and Dingell. Skin cancer is the most
common cancer in the U.S., and one in five Americans will
develop skin cancer in their lifetime. Research has shown that
sunscreen helps reduce the risk of skin cancer and is essential
to protecting the public. However, to date, the FDA has not
approved a new sunscreen ingredient in nearly two decades. This
is a real issue that needs to be addressed, and I am hopeful we
can all work together to establish a process that promotes the
timely review of sunscreen ingredients while ensuring consumer
safety and product efficacy.
So I want to thank all of our witnesses here today.
Dr. Woodcock, I don't know, is this the second time in 2
weeks? And I look forward to your comments.
I would like to yield the remainder of my time to Mr.
Dingell, who is the lead sponsor, Democratic sponsor, of H.R.
4205.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, I thank the gentleman, and I
thank you and commend you for this hearing.
I am particularly grateful to the gentleman from New Jersey
for his courtesy to me. I ask unanimous consent that my remarks
be extended in the record.
And I would like to address H.R. 4250 and particularly with
my concerns as they might exist with regard to Food and Drug.
There is no reason why a piece of legislation like this is
necessary after 10 years, and why it is that the Congress of
the United States has not received the counsel of Food and
Drug, that they have had need of legislation of this kind to
address a serious problem like skin cancer. This is a great
shame indeed. It is the kind of thing that causes distress on
the part of the public, puts the public at risk, and puts them
at risk of a particularly deadly form of cancer, which is one
of the most frequently achieved levels of cancer and kinds of
cancer in our society.
Food and Drug did not come up here to talk to us about it.
We think that this is legislation, which was crafted somewhat
with and somewhat without the assistance of the Food and Drug
Administration, but it would have been so much better had Food
and Drug come up here with the legislation earlier on.
I want to thank you for holding this hearing, Mr. Chairman.
And I want to particularly thank my good friend Mr.
Whitfield for his leadership and responsibility in this matter.
I hope that we are going to have supportive testimony from Food
and Drug and that the Food and Drug Administration will not let
this kind of thing happen again.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the chairman of the full committee, Mr.
Upton, for an opening statement.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Thank you, Mr. Chairman.
Today the subcommittee will hear testimony on what I think
will be three bipartisan bills that address important problems
facing the Nation. First, Chairman Pitts and Ranking Member
Pallone are collaborating on H.R. 4299, the Improving
Regulatory Transparency for New Medical Therapies Act. Their
bill would provide more certainty among the Drug Enforcement
Administration's review of scheduling decisions for new drug
products.
Second, Vice Chair of the Committee Marsha Blackburn is
working with Representative Marino on H.R. 4069, the Ensuring
Patient Access and Effective Drug Enforcement Act. This bill
establishes a collaborative and coordinated approach to the
prescription drug abuse crisis that certainly is plaguing our
local communities across the country. And finally, we are going
to be discussing H.R. 4250, which is cosponsored by Ed
Whitfield and Mr. Dingell. Everyone does seem to agree that the
current system for approving sunscreen ingredients is broken.
It is long overdue that we find a solution to the current
backlog of sunscreen ingredients pending at the FDA, and this
bill does it. I want to commend my colleagues for working
together to develop these legislative solutions. We have had a
strong record of bipartisan success this Congress in our work
to improve public health, and these bills further that effort.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
Today the subcommittee will hear testimony on three bills
that address important problems facing our country.
First, Chairman Pitts and Ranking Member Pallone are
collaborating on H.R. 4299, the ``Improving Regulatory
Transparency for New Medical Therapies Act.'' Their bill would
provide more certainty around the Drug Enforcement
Administration's review of scheduling decisions for new drug
products.
Second, Marsha Blackburn, vice chair of the committee, is
working with Representative Marino on H.R. 4069, the ``Ensuring
Patient Access and Effective Drug Enforcement Act.'' The bill
would help establish a collaborative and coordinated approach
to the prescription drug abuse crisis that is plaguing our
local communities across the country.
Finally, today we will discuss H.R. 4250, which is co-
sponsored by Ed Whitfield and John Dingell. Everyone seems to
agree that the current system for approving sunscreen
ingredients is broken. This bill would help provide a solution
to the current backlog of sunscreen ingredients pending at the
FDA.
I want to commend my colleagues for working together to
develop these legislative solutions. We look forward to working
in a bipartisan manner to perfect them so we can move them
swiftly through the legislative process.
We have had a strong record of bipartisan success this
Congress in our work to improve public health, and these bills
further our efforts.
Thank you for holding this hearing.
Mr. Upton. And I yield the balance of my time to Ms.
Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. I thank the chairman for yielding, and Mr.
Pitts for the hearing.
And, yes, I have worked with Congressman Marino; 4069 is a
piece of legislation that we have put some effort into to come
up with the Ensuring Patient Access and Effective Drug
Enforcement Act. And there is a necessity to clarify a couple
of definitions and provide some certainty and some consistency.
We will talk more about that.
And Mr. Chairman, I would like to submit my full statement
to the record.
Mr. Pitts. Without objection.
Mrs. Blackburn. And also three letters of support for our
legislation, one from FedEx, another National Association of
Chain Drug stores, and then also the Alliance to Prevent Abuse
of Medications.
Mr. Pitts. Without objection, so ordered.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mrs. Blackburn. And I appreciate that so much.
Congressman Marino and I are working to clarify the two
phrases, ``consistent with public health and safety,'' and how
that corresponds to substantial relationship to preventing
diversion and abuse of controlled substances, and further
define ``imminent danger'' by providing clarification and
harmonizing the CSA with other statutes using the imminent
danger standard, such as the Federal Mines Safety and Health
Act. And these definitions do matter. We all realize that.
We are also interested in moving forward with the
prescription drug abuse working group, which would give
Government, public policy, and industry the ability to
collaborate and provide recommendations to Congress on
initiatives to reduce prescription drug diversion and abuse.
This is an issue that has grown to epidemic proportions in
our country, and we had about 27,000 unintentional drug
overdose deaths which occurred in the U.S. during 2007 and a
number that has increased fivefold since 1990.
[The prepared statement of Mrs. Blackburn follows:]
Prepared statement of Hon. Marsha Blackburn
Prescription drug abuse is an epidemic that is killing tens
of thousands of Americans each year.
According to the Centers for Disease Control and Prevention
(CDC), approximately 27,000 unintentional drug overdose deaths
occurred in the United States during 2007--a number that has
increased five-fold since 1990.
This is a problem that's greatly in need of a solution.
However, simply acknowledging the epidemic of prescription drug
abuse isn't enough.
There needs to be a clear distinction between the
legitimate pharmaceutical supply chain that directly serves
patients and the criminals who are diverting and selling
illegal drugs. Supply chain stakeholders need further guidance
on how to collaborate more effectively with law enforcement.
Stated simply, their obligation to prevent diversion is only
achievable if the DEA and other regulators will work with them
to get it done.
I believe these stakeholders--physicians, pharmacies, and
distributors who want to do the right thing--stand ready to
work with law enforcement in combating prescription drug abuse.
That's why I worked with my colleague Congressman Tom
Marino in crafting, H.R. 4069, the Ensuring Patient Access and
Effective Drug Enforcement Act of 2014.
Our legislation clarifies two definitions within the
Controlled Substances Act (CSA) which is essential to providing
a clear path forward for enforcement agencies.
We specify that the phrase ``consistent with the public
health and safety'' corresponds to a ``substantial relationship
to .preventing diversion and abuse of controlled substances.''
We also further define ``imminent danger'' by providing
clarification and harmonizing the CSA with other statutes using
the ``imminent danger'' standard such as the Federal Mine
Safety and Health Act.
Why do definitions matter? Because Congress--this
subcommittee--has a responsibility to make sure the law is
crystal clear for both DEA and legitimate businesses who want
to understand what the rules are so they can do the right
thing. Our job is to make sure they're on the same page.
We also expect industry to step up and do more to minimize
the risk of diversion. To protect the integrity of the
distribution system, we require criminal background checks and
drug testing for employees of distributors who have access to
controlled substances. I should note that we are continuing to
work with the interested parties to make sure that provision is
narrowly crafted to achieve the right policy objective.
Lastly, we establish a Prescription Drug Abuse Working
Group which will give Government, public policy and industry
the ability to collaborate and provide recommendations to
Congress on initiatives to reduce prescription drug diversion
and abuse.
I've said many times since I took the lead on this issue
over 2 years ago that on this one, the tragic prescription drug
abuse epidemic in America, we are all in this together. And
that's where Congressman Marino and I are coming from with this
bill. A bill which already has the support of three former
United States Attorneys now in Congress, including Mr. Marino.
I thank Chairman Pitts for holding this hearing this
afternoon, and I look forward to working with my colleagues and
our witnesses today on bringing an effective solution to this
growing epidemic. I yield back.
Mrs. Blackburn. At this time, I yield the balance of my
time to Mr. Whitfield.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Thank you very much.
FDA has not expanded its approval list of sunscreen
ingredients since 1999, even though many innovative products
have been used safely for years abroad. In fact, there are
eight pending applications, all of which have been used in
other parts of the world. Some of them have been under the
process of being scrutinized for 12 years.
That is why we have introduced the Sunscreen Innovation
Act, Mr. Dingell and others, and we look forward to working
with FDA because we need to pass legislation to make sure that
this process is speeded up in some way, and I yield the balance
of the time to the gentleman from Texas, Mr. Burgess.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the gentleman for yielding the time.
Glad to have both the FDA and the DEA here today. Time is
short. Let me confine my observations to the Drug Enforcement
Administration. I am hearing that manufacturers and
distributors are having a difficult time working with your
agency. They say the relationship is not collaborative. It is
one where intimidation and lack of communication is all too
common. I am willing to work with anyone to close loopholes to
target bad actors and even propose policies that might raise
the ire of those in my party, but I will not sit by while
patients cannot access lawfully prescribed medication. No
doctor, no wholesaler, no pharmacist, should live in fear that
in their attempt to alleviate human suffering, they are likely
to be put out of business.
I understand your mission, but I want to know that you have
a strong voice for patients, for providers, and I want you to
know the effect that you have. It is necessary to enter
conversations on everything from the scheduling of certain
drugs to prescribing drug abuse with an interactive
perspective.
No one should stand down in the face of bullying,
aggressive and narrow-minded tactics.
Thank you, Mr. Chairman. I will now yield back the balance
of my time.
Mr. Pitts. The Chair thanks the gentleman.
I will now recognize the ranking member, Mr. Waxman, for 5
minutes of opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Chairman Pitts, for holding this
hearing today.
Today's hearing focuses on three bills, all addressing
important issues. Mr. Marino and Mrs. Blackburn's bill, H.R.
4069, makes changes to the Controlled Substances Act that will
help drug distributors and others work with the DEA to keep
controlled substance prescription drugs out of the hands of
drug abusers. It also will help them avoid inappropriately
limiting legitimate access to these same drugs by patients who
need them. Achieving that balance is a difficult challenge. I
will be interested to learn DEA's views on the bill.
Mr. Pitts and Mr. Pallone's bill, H.R. 4299, would speed up
DEA decisions on scheduling new FDA approved drugs containing
controlled substances so they could get to patients more
quickly. It also would speed up the DEA registration process,
allowing the manufacture and distribution of controlled
substances for use only in clinical trials. It is aiming to
address a problem faced by those with epilepsy and other
patients, the delay in getting a new FDA approved controlled
substance medication to patients in need. I think their bill
could make a significant contribution to solving this problem,
and I applaud them for introducing it.
DEA's mission and focus is combatting drug abuse. I applaud
its work in that area. At the same time, we need to find a way
for new FDA-approved controlled substance medicines to get to
patients who need them more quickly, and I hope DEA shares that
goal and will work with the committee to achieve it.
Mr. Whitfield and Mr. Dingell's bill, H.R. 4250, aims to
speed up FDA's regulatory decisions on sunscreens that have
been marketed in other countries for at least 5 years.
Sunscreens are an important tool in lowering the risk of skin
cancer. Skin cancer is the most common cancer in the United
States, and its incidence continues to grow. Melanoma, the
deadliest kind, kills over 9,000 Americans a year. One way to
prevent skin cancer is to minimize exposure to UV rays.
I have had a long interest in this issue. I have been
working with Chairman Upton to protect teenagers from the
dangers of sun lamps. Getting better sunscreens to market and
increasing sunscreen use is another critical element in the
fight against skin cancer. We need a regulatory system that
enables safe and effective sunscreens to make it to the market
in a reasonable amount of time. Under our current system,
sunscreen applications have been languishing for 5 to 10 years.
I don't think anyone could call that a reasonable amount of
time.
Mr. Whitfield and Mr. Dingell, working with the PASS
Coalition, have made a good faith effort to come up with a bill
that would help FDA reach decisions in a timely fashion on such
sunscreen applications. I strongly support those efforts.
However, I do have concerns with a number of elements of the
bill, most notably the bill effectively cedes FDA's
jurisdiction to an advisory committee. If the advisory
committee recommends approval, the approval goes into effect,
unless FDA rejects it within 45 days, and even then, the burden
is on FDA to justify its decision not to accept the
recommendation. I think this would be a bad precedent.
I applaud the bill's sponsors and the PASS Coalition for
working on this issue and developing a bill for us to consider.
That alone is a step forward. I share the goal of having an FDA
review process that enables safe and effective sunscreens to
get to market as quickly as possible. I recognize that the
current system does not achieve that goal. I hope FDA will
commit to work with the committee and with the coalition and
other stakeholders to reach that goal.
I look forward to the hearing today and, while I may not be
here all of the time, to reviewing the testimony from our
witnesses.
Thank you, Mr. Chairman. I would be happy to yield my time
if anybody seeks it. If not, I yield it back.
Mr. Pitts. The Chair thanks the gentleman.
That concludes the opening statements. All members' written
opening statements will be submitted for the record.
We have two panels before us today. On our first panel we
have Dr. Janet Woodcock, Director, Center for Drug Evaluation
and Research of the U.S. Food and Drug Administration.
Thank you again for coming to the subcommittee.
And Mr. Joseph Rannazzisi, Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration.
Your written testimony will be made part of the record. You
will be each given 5 minutes to summarize. Thank you for coming
today.
And Dr. Woodcock, you are recognized for 5 minutes for your
opening statement.
STATEMENTS OF JANET WOODCOCK, DIRECTOR, CENTER FOR DRUG
EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND JOSEPH T.
RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION
CONTROL, DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
STATEMENT OF JANET WOODCOCK
Ms. Woodcock. Thank you and good afternoon.
I am Janet Woodcock, Director of the Center for Drug
Evaluation and Research at FDA, and thank you for the
opportunity to discuss important issues concerning sunscreen
products.
Now, as you know, manufacturers must have an approved new
drug or abbreviated new drug application before they can market
a drug in the United States, unless they have a drug that
complies with an over-the-counter monograph. The monograph is a
regulation that describes the conditions OTC drugs must meet.
This allows these monograph products to be offered in many
different configurations to the public without filing different
applications. And this has been a very successful program.
There are over 100,000 products out there, OTC products out
there, it is estimated, that are monograph products. And most
sunscreens are marketed in the U.S. under the sunscreen
monograph.
Now, the FDA must conclude that an ingredient is generally
recognized as safe and effective for the condition of use if it
is going to be put into a monograph. But the real world
conditions of use and what is scientifically considered safe
and effective can change over time. And by over time, I mean
over decades of time. And in the 1970s, when examination of
sunscreens began in the OTC drug review, they were used
primarily on a seasonal basis to prevent sunburn. That is what
sunscreens were thought to be for back in the day. And the
Sunscreen Advisory Panel thought people would be exposed to
these sunscreen active ingredients in modest amounts and for
short intermittent time periods. And also the ingredients
weren't thought to get below the skin, so systemic exposure to
these drugs was not a concern. This was before we had all the
transdermal skin products that we have now--for hypertension
and so forth--that are delivered through the skin. The advisory
panel safety evaluation focused on ensuring that sunscreen
products caused minimal skin irritation and sensitivity and
then, on their efficacy, just that they prevented sunburn.
Today people are urged to apply sunscreen in generous
amounts and to reapply it frequently and to use it year round,
resulting in exposure to the products that is massively greater
than what was contemplated originally in the monograph. In
addition, sunscreens are applied all over babies and children
repeatedly as well to prevent them from the deleterious effects
of the sun.
There is increasing evidence, though, that some sunscreen
ingredients are absorbed through the skin, and that leads to
systemic exposures that are chronic, that have not previously
been understood or anticipated. This shift in sunscreen use,
together with advances in scientific understanding and our own
safety evaluation methods have raised questions about what is
needed to assure sunscreen safety.
FDA has undertaken major actions on important sunscreen
issues in the last several years. We have not been inactive. In
2011, we published a regulation that updated efficacy testing
and sunscreen labels. This put on what people are used to now
the broad spectrum claim that we urge people to use to protect
against various types of UV, and also it put information in the
label about preventing skin cancer and about decreasing skin
aging, so important information about the use of these
sunscreens.
We also issued a proposed rule with a maximum SPF value of
50 plus for all sunscreen monograph products, and we put an
advance notice of proposed rulemaking about additional
information on the safety and effectiveness of various dosage
forms, like sprays, that raise new concerns about flammability,
for example, and inhalation.
We have also been evaluating these Time and Extent
Applications to add eight new ingredients to the sunscreen
monograph. This process, established in 2002, provides a
potential pathway for newer active ingredients. We recently
sent sponsors letters on two of these applications, giving them
feedback and noting that their record is insufficient to
establish that they are safe for OTC sunscreen use.
We will be holding a public meeting later this year to
further clarify our thinking about safety testing for all OTC
sunscreen products. And given the expansion of sunscreen use
and scientific advances since the OTC evaluation began, our
evaluation must include potential endocrine or other effects
from systemic absorption.
Now this process has taken too long. I agree with that, and
we really recognize the entire OTC monograph process is
outdated, and about 2 weeks ago, we had a public hearing to
discuss ways we might be able to modernize the process.
In closing, the OTC monograph process that had historically
been so successful is no longer really serving the needs of
consumers, industry or the FDA. We have embarked on
consideration of how to revise it to work in the current
environment, and the problem with sunscreens is really a
microcosm of the larger issues we have with the OTC monograph
process. Thank you.
[The prepared statement of Ms. Woodcock follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentlelady.
I now recognize Mr. Rannazzisi for 5 minutes for an opening
statement.
STATEMENT OF JOSEPH T. RANNAZZISI
Mr. Rannazzisi. Thank you, sir.
Chairman Pitts, Ranking Member Pallone, distinguished
members of the subcommittee, on behalf of Administrator Michele
Leonhart and the men and women of the Drug Enforcement Agency,
thank you for the opportunity to discuss today the drug
scheduling process and the registration and verification
suspension process.
First, the DEA was not given the opportunity to comment
when legislation that was pending before the subcommittee was
drafted. The Department and the administration has not taken a
position on the legislation. Therefore, I must emphasize that I
am unable to discuss with you the specific details of the
legislation.
The Controlled Substances Act provides the DEA with the
authority to administratively control substances with abuse
potential. As fully explored in my written testimony,
generally, the complexity and length of time to complete the
scheduling process depends on many variables. There are two
important points I will emphasize.
With respect to newly approved medicines, the DEA initiates
the scheduling process when it receives a recommendation from
HHS. The DEA might receive the recommendation before or after
the approval for marketing. One recent example I will share
involves two similar medications that are indicated for
epilepsy. The DEA completed the scheduling process in about the
same time, 10 and 11 months from the time we received the
recommendation. However, in one instance, we received the
recommendation 5 months before the drug was marketed--was
approved for marketing. In the other instance, we received it 4
months after it was approved for marketing. The result was that
one drug was controlled 6 months after market approval, and the
other drug was controlled 14 months after market approval. The
experience here is that the sooner DEA receives the
recommendation to control, the closer to market approval a drug
can be scheduled.
The next point also concerns timing. Patent holders of
recently approved medicines have paid fees to expedite their
products through the market approval process, but that is not
the process when it comes to scheduling. Like most Federal law
enforcement agencies, DEA must prioritize resources to meet the
threats and to accomplish the mission. Any perceived delays to
control newly approved drugs in the past 3 years must be viewed
as part of a bigger picture.
In the 13 years from 1997 to 2010, the DEA controlled nine
new pharmaceutical drugs and temporarily controlled four
substances to avoid an imminent hazard to public safety, but in
the last 3 years, DEA has controlled four new pharmaceutical
drugs and 28 different synthetic drugs to avoid imminent hazard
to public safety. To be sure, the additional responsibility to
control 28 different synthetic drugs had an effect on the time
to control new pharmaceuticals.
In 2010, designer drugs exploded in the retail market,
resulting in serious injury and death across America. Faced
with the responsibility to get these drugs off the retail
shelves, the DEA had no choice but to control these substances
as quickly as possible. The DEA acted to stop the imminent
hazard these drugs caused, which in turn required significant
resources.
Another use of DEA's administrative authorities to stop an
imminent threat is the authority to immediately suspend a DEA
registration. As a law enforcement agency with a regulatory
function, the DEA has the authority to revoke a registration
and also immediately suspend a registration that poses an
imminent danger. In addition to revocation and immediate
suspension, there are other nonpunitive actions available to
DEA, including a letter of admonition or an informal hearing.
From 2007 to 2013, the DEA issued approximately 5,500
letters of admonition and held approximately 118 informal
hearings. This fiscal year to date, DEA issued less than 20
orders to show cause and immediate suspensions combined. When
the DEA issues a show cause order, the registrant is afforded
the opportunity to present his case at a formal hearing in
front of a neutral fact finder before any action may be taken.
An immediate suspension is authorized during the pendency of
the show cause proceeding and is effective immediately.
Immediate suspensions are by law reserved for those entities
that are an imminent danger to public health and safety.
The DEA's administrative enforcement authorities are
important tools in DEA's arsenal to ensure compliance, deter
and prevent diversion, and ensure that every registration is
within the public interest. Without these administrative tools,
civil and criminal sanctions would increase, and it would be
tremendously more difficult to protect the public health and
safety from the diversion of pharmaceutically controlled
substances.
In closing, I would like to comment on other testimony that
the subcommittee will hear today. Some of the witnesses may
assume to advocate on behalf of DEA, representing that they
believe new legislation will help DEA. I encourage you to look
beyond the self-interested statements of witnesses who are here
to lobby you to protect their paying clients, present and
future, from administrative sanction.
The DEA has a responsibility to maintain the closed system
of distribution established by the Controlled Substances Act.
As such, the DEA's sole interest is protecting the public from
harm. That is what the administrative and regulatory process is
for. That is what we do best: Keeping industry in compliance
and protecting the public health and safety.
I appreciate the invitation to appear today and look
forward to your questions. Thank you.
[The prepared statement of Mr. Rannazzisi follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman.
We will now go to questioning. I will recognize myself for
5 minutes for that purpose.
Dr. Woodcock, with respect to scheduling of controlled
substances, would you elaborate on what types of data FDA uses
in conducting its analysis for a new molecular entity prior to
sending the agency's recommendation to DEA, and what is the
purpose of this evaluation? Do the scientists at FDA do
everything they can to make this evaluation as comprehensive
and accurate as possible?
Ms. Woodcock. Certainly. Well, the FDA and our partner, we
work with NIDA, are trying to predict, based on what data we
have, how abusable, how attractive, a drug may be once it is
out on the market for abuse and addiction. We use everything
from the structural knowledge of the drug to animal studies,
and there are animal studies that can look at whether the
animals find the drug attractive, to actual human studies,
likability studies, where we ask experienced humans what they
think of the effects of the drug, and that is very
illuminating.
We put all that information together plus epidemiology on
similar and related substances, and basically, we do what is
called an eight factor analysis, and we put all those factors
together into an analysis.
Mr. Pitts. Thank you.
Mr. Rannazzisi, what is the average time it takes DEA to
schedule a new molecular entity after your agency receives
FDA's recommendation?
Mr. Rannazzisi. I don't know what the average time is, but
it is very product specific. It depends on when we receive the
recommendation. See, in some products, we receive the
recommendation way before approval, so we could go ahead and
start our eight factor because, like my colleague, we have to
do an eight factor as well, and three of the factors are based
on DEA findings.
Mr. Pitts. And why does it sometimes take over a year to
make this determination?
Mr. Rannazzisi. Depending on when we receive the
recommendation, generally there could be problems. When we get
the recommendation, we have to send it back to FDA for a
clarification. There might have been something that FDA missed
that we want them to look at. Remember, when we take the final
scheduling action, and we publish it, there may be a hearing
and DEA, not FDA, but DEA has to justify the schedule that the
product is being put in. We have to provide the evidence that
the drug is properly scheduled. So if the scheduling action is
questioned and a hearing is requested, DEA is the one that goes
into court and justifies the scheduling. We bring FDA in to
provide testimony, but in the end, it is our scheduling action
based on 811.
Mr. Pitts. In your opinion, are there instances where the
agency has taken too long to schedule a new molecular entity
after FDA approval?
Mr. Rannazzisi. No. In fact, there was a statement I think
somebody made with a fivefold increase since 1999. I have no
idea where that number came from because you have to look at
when we received the actual recommendation. It is not when the
drug is scheduled. We have to go back because, like I said,
sometimes we get the recommendation well after the approval has
been done, 3 to 4 months, so that is when we start. We cannot
start the process until we receive the eight factor from HHS.
Mr. Pitts. Section 201-B of the Control Substances Act, it
states that DEA is bound by the medical and scientific
recommendations of the FDA. Is that correct?
Mr. Rannazzisi. That is correct.
Mr. Pitts. And FDA's recommendations are made after a
thorough analysis of the potential for abuse and misuse of the
drug products, right?
Mr. Rannazzisi. That is correct.
Mr. Pitts. Now, after a drug product is scheduled and
available for marketing, it can be rescheduled. Would you
explain how DEA participates in that process and how often has
DEA initiated these rescheduling discussions?
Mr. Rannazzisi. Rescheduling action, most recently we have
one pending with hydrocodone. We did a scheduling action on
carisoprodol, which we had to go and justify in court.
Carisoprodol is a muscle relaxant that was not scheduled. We
requested a medical and scientific evaluation from HHS on two
or three occasions. We finally got the justification necessary
to reschedule it. It was challenged. We went into court. We
justified based on evidence, and we prevailed. It just depends
on the specific drug that we are dealing with at the time.
Hydrocodone is pending. That is still a pending action.
Mr. Pitts. The Chair thanks the gentleman.
My time is expired. I recognize the Ranking Member, Mr.
Pallone, for 5 minutes of questions.
Mr. Pallone. Dr. Woodcock, do you want to respond to what
Mr. Rannazzisi said about, you know, when the clock stops, in
other words-- I mean, when the clock starts, that even after
you have approved the drug, it may be like another 4 months or
so before its scheduled? He was talking about that.
Ms. Woodcock. Well, there are multiple clocks involved
here. We are working off the user fee clock that has been
agreed to by Congress and so forth, and sometimes there may be
additional information that we need for the eight factor that
may come in at different times, and so that might prolong that
particular determination. At the moment, that doesn't prevent
us from approving the drug, so we go ahead and approve the
drug, but we are still working on information that we may have
received later in the cycle, which might mean a gap between the
time the drug is approved, and that is information on safety
and efficacy, and the drug, when we can make a recommendation
for scheduling.
Mr. Pallone. I am going to go back to Mr. Rannazzisi. I
just want to get a little information on some other aspects of
this scheduling process. I know Mr. Pitts has addressed this in
some way, so I apologize if some of these questions are
repetitive, but your responses are significant as we try to
move this bill. What is the percentage of times in which DEA
scheduled a new drug into a class different from which FDA
recommended?
Mr. Rannazzisi. I don't know of a time where we have not
scheduled the drug outside of the recommendation.
Mr. Pallone. OK. So there has never been any instance?
Mr. Rannazzisi. Not that I can remember.
Mr. Pallone. OK. Can you tell us how long it takes on
average for DEA to issue a final scheduling decision starting
from the time DEA receives a scheduling recommendation from the
FDA?
Mr. Rannazzisi. Again, I can't tell you on average because
different drugs require different time periods. It just depends
on the information that came back from the HHS on the eight
factor analysis. It depends on when we received that
information. It depends on if there needs clarification on any
one of the eight factors. It is variable. It depends,
especially on new molecular entity, because a new molecular
entity, we have to do our research, which we try and do as soon
as possible. But, again, it involves when we receive the
recommendation.
Mr. Dingell. Will you yield?
Mr. Pallone. Sure.
Mr. Dingell. Will you explain why you have to do your
research and why you can't use FDA's research and why you can't
get a memorandum of understanding as to how you are going to
cooperate?
Mr. Rannazzisi. Actually, we do have a memorandum of
understanding pending. It is being reviewed by both agencies.
Mr. Dingell. I am not hearing you say that today.
Mr. Rannazzisi. Well, we have a memorandum of understanding
pending, and we are working out the differences in the MOA, but
I am pretty confident that we will have that in place very
shortly. But in the meantime, again, our scientists are the
ones who will be testifying in the hearing when it is
challenged.
Mr. Pallone. I am going to run out of time, so I just want
to turn now to the process for registering manufacturers and
distributors of controlled substances. What is the statutory
deadline for making a decision on an application to become
registered as a manufacturer or distributor of a controlled
substance, or is there no deadline?
Mr. Rannazzisi. I think it is within a reasonable time
period.
Mr. Pallone. Within a what you said?
Mr. Rannazzisi. I think it is a reasonable time period.
Once we receive all of the data, we do an investigation of the
physical location. We grant the registration. As long as they
have the proper, appropriate, State licensing.
Mr. Pallone. How long does it usually take on average from
application of registration?
Mr. Rannazzisi. Again, it just depends on the entity we are
registering.
Mr. Pallone. Does the DEA look at any application to
manufacture or distribute a controlled substance for a clinical
trial any differently than an application to manufacture or
distribute for commercial use? Because I would imagine that the
quantities would be considerably smaller for clinical trials?
Mr. Rannazzisi. On a clinical trial, a researcher for a
clinical trial, they would send in their application with their
research protocols. Once we receive the research protocols, we
send the research protocols to FDA. FDA and NIDA review the
research protocols. They make a determination that the
protocols are consistent with good research. At that point in
time, they are approved. They come back to us, and we send
diversion investigators on site to review, to ensure that they
have the appropriate storage container to lock whatever
investigational drug that may be a controlled substance they
are using, and we give them the application once they
understand what paperwork's involved and security is in place.
It is no different than anybody else really, except that the
protocols must be approved by HHS.
Mr. Pallone. My time is expired, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the vice chairman of the full committee,
Mrs. Blackburn, for 5 minutes for questioning.
Mrs. Blackburn. Thank you so very much, and I appreciate
that both of you are here and have just a couple of questions.
I want us to be able to move on so we can get to the second
panel.
Continuing along kind of with the line that Mr. Pallone was
going, I think that when we look at the DEA and look at what is
happening with prescription drugs, you know, you can look at--
the laws are very clear when it comes to the illegal drug
trade. You know that distribution of heroin or the
methamphetamines, you know it is illegal. That type clarity is
very helpful in enforcing the law, but when we are talking
about the pharmaceutical products, what constitutes legal
prescribing and dispensing is not quite as clear.
So let me just ask you if you can list for us what you are
doing, articulate what the efforts are that the DEA is engaged
in to promulgate some clear standards for the prescribers, for
the pharmacies, for the distributors. What is your step by
step? You say you have got an MOA. You say that is pending, so
give me your tick list.
Mr. Rannazzisi. Well, let's talk about the prescribers
first. I believe that the courts have settled what a prescriber
must do. He must issue a prescription, a controlled substance
prescription for a legitimate medical purpose in the usual
course of professional practice. That was given to us by U.S.
v. Moore 1975, and that hasn't changed. It is very obvious.
When we go out and talk to physicians groups, we tell them that
is their standard. They know that is the standard. If you
looked back when we were doing the Internet pharmacy debacle,
when doctors weren't seeing patients--they were just writing
prescriptions without seeing the patient and having a pharmacy
over the Internet fill them--that was not for legitimate
medical purpose, not in the usual course of professional
practice. There was no established doctor-patient relationship.
Now let's talk about the pharmacists. The pharmacists have
a corresponding responsibility to ensure the prescription is
valid. We go out and we teach the pharmacists, as does the
National Associations of the Boards of Pharmacy and the
particular pharmacy boards that the pharmacist sits in, that
they have a corresponding responsibility to ensure that the
prescription is valid, that it is issued for a legitimate
medical purpose in the usual course of professional practice.
Pharmacists understand that. There is transparency in the case
law. There is transparency in how we do things. We have done
prescription drug pharmacy diversion awareness conferences in,
I think, 14 States.
Mrs. Blackburn. OK. Well, a lot of that we know. We were
looking for a little bit of that new information, and I guess
it is kind of a Monday attitude sort of day, so let me move on.
Mr. Rannazzisi. I would like to finish my answer. I guess
not.
Mrs. Blackburn. What are you doing to help well-intentioned
registrants to determine who they can do business with?
Mr. Rannazzisi. I am sorry? We don't dictate who the
registrant does business with.
Mrs. Blackburn. OK. I thought maybe you were doing a little
bit to help----
Mr. Rannazzisi. Well, we are, if I can proceed with the
wholesalers and distributors, besides having one-on-one contact
with the wholesalers and distributors in the distributor
initiative, telling them what to look for and what red flags to
look for, our yearly conference with the distributors as a
whole to talk to them about what red flags, what we are seeing
trend-wise and what they need to look for, besides the onsite
investigations that we do, the cyclical investigations, to
determination compliance and to assist them in complying,
besides the fact that they call in and request assistance----
Mrs. Blackburn. Let me move on, then, if it is laborious.
Mr. Rannazzisi. It is not laborious. You asked me to tick
off what I do: 16,651 people in 2010 died of opiate overdose,
OK, opiate-associated overdose. This is not a game. We are not
playing a game.
Mrs. Blackburn. Nobody is saying it is a game, sir. We are
just trying to craft some legislation.
Mr. Rannazzisi. Especially in Tennessee. There is 340----
Mrs. Blackburn. Your written statement indicates that the
DEA has initiated less than 20 administrative cases in the last
6 months. What is behind the significant decline in case
initiation, and are you satisfied with the number of cases
being initiated?
Mr. Rannazzisi. Well, we are initiating cases, for sure.
Our case numbers have not gone down.
Mrs. Blackburn. I think the case numbers have gone down.
OK. If DEA has only initiated 20 administrative cases in the
last 6 months, what is DEA doing to help registrants identify
the prescribers and pharmacies that they should refuse to do
business with?
Mr. Rannazzisi. Ma'am, that is a due process issue. We
can't direct a wholesaler or distributor or a pharmacy not to
sell to a particular person. They are afforded due process like
every other person. So if I told them, ``Don't sell to this
pharmacy, don't sell to this doctor,'' then they wouldn't be
afforded due process.
Mrs. Blackburn. My time has expired. I yield back.
Mr. Pitts. The Chair recognizes the ranking member of the
full committee, Mr. Waxman, for 5 minutes of questions.
Mr. Waxman. Thank you.
Dr. Woodcock, I think we can all agree that the current
process has not been working. Mr. Whitfield and Mr. Dingell
have a bill that attempts to fix the problem. Of course, it is
rather strange because we have got three different bills under
discussion, and I am taking a leap from the last one. While I
have concerns about elements of their bill, I share their
frustration with the current FDA process and their desire to
fix it. Will you commit to work with the committee, with the
PASS Coalition, and other stakeholders, to come up with a
process under which new, safe and effective sunscreens can get
to market quickly?
Ms. Woodcock. Yes.
Mr. Waxman. I would like to better understand the current
process and how we can help improve it. The central element in
H.R. 4250 seems to be giving an FDA advisory committee the
ability to make approval decisions, albeit providing FDA with
some authority to reject that decision. I have serious concerns
about such a model. Can you tell us if there are precedents at
FDA for using an advisory committee in this way, what are FDA's
views of such an approval, and it does at least appear to have
the virtue of speeding up the process?
Ms. Woodcock. Well, I believe possibly in the device realm
in the past, there were some areas where the panel
recommendations were more binding. However, this is not true
for pharmaceuticals.
The process problems with the OTC monograph go well beyond
sunscreens and related or pertain to the entire monograph
process, which has to be done by regulations. The Time and
Extent Applications is what we are talking about here for
sunscreens, were put in place by us actually in the early 2000s
to try to bring more products that seemed to be most
appropriate for monographs into the monograph system. However,
what happened is that got caught up into the prolonged and
torturous history of the sunscreen monograph and all the other
monographs that we have to get out under the OTC system.
So, personally, the administration does not have a position
on this bill, but I would say that, you know, it is making
steps forward, and we need to change some things if we are
going to make an efficient process that can respond both to
safety problems and get more products into the monograph.
Mr. Waxman. What do you think of the idea of an advisory
committee making that decision instead of you?
Ms. Woodcock. Well, I think that will be very difficult
because it is a voluminous amount of data, and one of the
problems that we have had in general is having time to go
through all these data, find out what is missing, figure out
what the gaps are, communicate with the sponsors. It is not a
typical type of thing that an AC would do.
Mr. Waxman. And do you think if there were such a process,
the committee members, I don't know how they would be chosen in
particular, how would it affect conflict of interest issues?
Ms. Woodcock. Well, like any other advisory committee, we
have to do an extensive screening for conflict of interest, and
a committee considering this wide range of issues would have to
have a very broad representation, all of whom would have to be
relatively free of conflict of interest.
Mr. Waxman. The bill sets outs mandatory time frames for
decisions both by the advisory committee and the FDA and even
time frames for applicants to submit new information. I
understand the sponsors' interest in moving things along
quickly. However, the time frame seems somewhat more ambitious
or optimistic than is reasonable.
The advisory committee would have 180 days to make its
recommendations after receiving an application. Considering
that there are eight outstanding applications, that could be a
lot of work to expect the committee to accomplish. It also
gives FDA 45 days to agree or disagree with the committee
recommendation. Again, that seems rather ambitious, even if the
committee were to be making only one recommendation for
consideration within that time frame. What are FDA's views on
those time frames? What times frames would FDA consider
reasonable?
Ms. Woodcock. Well, I understand the impetus behind the
desire for short time frames, however, I feel it may be self-
defeating. If it is not possible to identify all the problems
and get to a considered opinion in that time frame, then it
would be likely to turn something down rather than turn it
loose on the public.
Mr. Waxman. And what do you think about the shifting of the
burden? It appears the advisory committee decision is presumed
to be right, unless FDA can prove it is wrong. That seems like
an inappropriate shifting of the burden of proof. Seems like a
decision could be reversed simply because the FDA reviewer
didn't adequately write down the basis for the decision. What
is the FDA's view of the appeals process?
Ms. Woodcock. Well, I think this does put a tremendous
burden on the FDA. And probably inappropriate--as written
currently, difficult or undoable burden on the advisory
committees as well. So I am not sure this process would end up
with the desired outcome, which is clarity, public standards,
knowing what needs to be done, and the most efficient process
for getting it done.
Mr. Waxman. I thank you for your answers and especially
your willingness to work with us. I think that is going to be
very important.
Mr. Pitts. Chair thanks the gentleman, now recognize the
vice chairman of the subcommittee, Dr. Burgess, 5 minutes for
questions.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Woodcock, always good to have you back before the
committee.
And in fact, let me ask you a question, it is a little bit
off topic today. Can you provide the committee with the status
of the FDA's guidance on biosimilar naming?
Ms. Woodcock. It is still under consideration, it has not
been be issued.
Mr. Burgess. But when is that guidance likely to become
final?
Ms. Woodcock. I do not know. However, I realize that it is
urgent. We certainly hope that that program will get up and
running this year.
Mr. Burgess. Sure. Is there anyone advising, outside of
the--anybody in the administration outside of the FDA itself?
Is there anyone in the administration who is playing a role in
this, giving you suggestions or recommendations with respect to
the guidance?
Ms. Woodcock. Well, the administration has not come to a
conclusion on this topic.
Mr. Burgess. Who in the administration?
Ms. Woodcock. I would have to get back to you on that
question.
Mr. Burgess. I really would like for you to do that. And
please expect some follow-up on that, because it looks to me as
if the administration may be the impediment. You all are taking
the fall for it. But it is far too long, and we actually need
that.
Mr. Rannazzisi, you mentioned the memorandum of agreement.
And you and Dr. Woodcock, I think, both acknowledge there is a
memorandum of agreement that is pending; is that correct?
Mr. Rannazzisi. Yes, sir.
Mr. Burgess. You know, I don't know that I was aware of the
memorandum of agreement. Is that something, can you make the
text of the memorandum available to the subcommittee?
Mr. Rannazzisi. I don't believe we can. Well, you would
have to request that from the Department of Justice because it
is actually between the Department of Justice and HHS.
Mr. Burgess. Mr. Chairman, I would, then, suggest that the
subcommittee do request that from the Department of Justice.
What is your time line? What is your expectation of when
this will be accomplished?
Mr. Rannazzisi. There are several components to this MOA,
and I think there are just some things regarding proprietary
information that needs to be passed, and I think that is what
they were working on. The time limit, we hope to have it soon
because it will make the process more efficient in scheduling
once we get it in place.
Mr. Burgess. Let me ask you the same question I asked Dr.
Woodcock. Is there anyone in the administration that is
affecting the timeline of this thing adversely?
Mr. Rannazzisi. I don't believe so, no. It is----
Mr. Burgess. But you won't share it with us so we couldn't
possibly know that, could we? Since you won't share it with us,
I am going to let my imagination run wild. It seems as if we
have got someone in the administration that is holding this up,
and you won't allow us to see the memorandum.
I would suggest, Mr. Chairman, that that memorandum of
agreement be made available to the committee, and allow us to
participate before you just visit this upon everyone who is
involved in this process.
Mr. Rannazzisi. Well, the problem is, sir, the memorandum
of agreement is not finalized. If I gave you a memorandum of
agreement right now, it is not a final agreement.
Mr. Burgess. Share the draft with us.
Mr. Rannazzisi. I am going to share something that is not
finalized. Really?
Mr. Burgess. Sure. We could help you. We could inform you.
We could direct you. Sometimes the legislative and the
administrative branches have worked together historically; Mr.
Waxman, Mr. Dingell may be able to give you such a time that
that happened, but this administration has not worked well with
the legislative branch. Here would be an excellent opportunity
to start.
Let me just ask you a question. Because it keeps coming up.
We are going to hear from people on the supply side in the
second panel.
But, what are you doing to draw the line between
prosecuting those who overprescribe and not differentiating
between those individuals who are legitimately trying to help?
And bearing in mind the people they are trying to help is a
pretty vulnerable population?
Mr. Rannazzisi. Well, it depends. Again, every case is fact
specific. The U.S. Attorney makes a judgment call on how we
proceed on the cases based on the evidence that is presented to
him or her.
The fact is, is the cases that we bring forward are
generally pretty egregious. There is no doctor-patient
relationship attached, these pain clinics that are operating in
Texas, in Tennessee, and pretty much throughout the country
now, there is no medical care for rogue pain clinics. They are
operating as a facade to distribute controlled substances. In
Florida----
Mr. Burgess. And yet they continue to operate. So, you
know, look, we do have to get a balance here taking care of
people----
Mr. Rannazzisi. Absolutely.
Mr. Burgess [continuing]. Who really need the help that
they are looking to receive. But sometimes it seems that all
the DEA cares about is the number of enforcement actions and
not real solutions to stop the abuse.
Mr. Rannazzisi. That is not correct.
Mr. Burgess. Provide to us data on how that--what you have
done to stop the abuse without interfering with the legitimate
practice, medicine, pharmacy, and distribution.
Mr. Rannazzisi. If you would go on our Web site and look at
the cases that are posted on our Web site, both on the cases
against practitioners and also cases, the administrative cases
against registrants, you will see that----
Mr. Burgess. Well, it would have been great had you been
prepared to provide that for us.
Mr. Chairman, let me ask that on this memorandum of
agreement that we have been talking about, maybe at least the
Department could provide us with the goals of what they are
trying to achieve with this. Because, after all, we do have
legislation pending before this committee that could be
impacted as to what those goals are and how they would affect
the practice of medicine pharmacy.
I'll yield back my time.
Mr. Rannazzisi. May I finish my answer? I was not----
Mr. Pitts. You may finish.
Mr. Rannazzisi. The administration has a four-pillar
strategy, we follow the four-pillar strategy. Education,
treatment, enforcement. The three basic tenets that we provide.
Now, education, we provide education throughout the supply
chain. We make sure that the supply chain, the registrants
understand what their obligations are under the act. We provide
them with red flags. We provide all of the case law, all of the
administrative actions are posted on our Web site. We can
direct them to particular circumstances and cases that they are
inquiring about. We go out and look at them face to face and
explain to them. The distributors we talk to before enforcement
action is taken on them and give them an opportunity.
See, the fact is, we are not just enforcement, we are a
regulatory organization. We go out to their--on-site and look
at their facilities and determine if there is any exploitation
within their site that could be cause of diversion, and I don't
see where you think we are just an enforcement agency, because
we do so much more than enforcement. Talk to the pharmacists
that have been to our classes.
Mr. Burgess. Mr. Chairman, I will reclaim my time. But the
vice chair brought it up.
The clarity and the consistency of these regulations at the
level of the distribution are things that we hear about all the
time. But let's go on with the hearing, and I will yield back.
Mr. Pitts. Chair thanks the gentlemen.
Now recognize the ranking member emeritus of the full
committee, Mr. Dingell, 5 minutes for questions.
Mr. Dingell. Thank you for your courtesy.
I am reminded today of when I was a very small boy and used
to go to my granddad's farm out in Iowa. He had a bunch of
chickens, and so to keep the chickens happy and keep them
laying, when he would take the hens--rather, take the eggs out
from under the hens, he would always put a porcelain doorknob
in, and those damn chickens would sit on that porcelain
doorknob until hell froze over.
I am reminded very much, Dr. Woodcock, of those happy days
in Iowa and the chickens that were sitting there very happily
on the bloody doorknob.
Now, we got 2 million Americans developed skin cancer each
year. Sixty-one thousand developed melanoma last year, and
9,000 people died. How many of these do you have laying around
down there at Food and Drug where you have an application on
these? Just if you haven't got it, submit it for the record.
And how long has each one of them been laying around there?
And when will you have action taken on each of them? And how
long is it going to take to reach action on each of them? And
why have you not been able to reach action on any of them as of
this particular time?
Because I note, Doctor, that all of them have been approved
and are being used in Europe and other places which have food
and drug laws that are roughly equal to ours in terms of their
safety.
Ms. Woodcock. The sunscreens are marketed as cosmetics in
Europe.
Mr. Dingell. Well, you are still sitting on them like a hen
on a plastic doorknob, and I just find myself thoroughly
dissatisfied. So if you will please submit that for the record,
I believe it will be most helpful.
[The information apears at the conclusion of the hearing.]
Mr. Dingell. Now, skin cancer is an epidemic in the United
States. It is a pressing public health issue, is it not?
Ms. Woodcock. Yes.
Mr. Dingell. All right. One of the best ways that we could
ensure that the American people have access to the most
effective sunscreen ingredients is to see to it that we allow
those which are--been proven to be safe by long use in Europe;
isn't that so?
So you are just sitting there looking at these things. Food
and Drug is doing nothing about it. Very comfortable. You come
up here and tell us how concerned we are that we are not doing
anything.
So now, Doctor, do you believe that the American people
should have the access to the latest safe and effective
sunscreens to prevent skin cancer and melanoma?
Ms. Woodcock. Yes, I do.
Mr. Dingell. Rest of Food and Drug agree with that?
Ms. Woodcock. Yes.
Mr. Dingell. Now, Doctor, is it correct that there are
eight applications for new sunscreen ingredients that have not
received final determination under the time and extent
application process at FDA? Yes or no?
Ms. Woodcock. Yes.
Mr. Dingell. Do you believe that time and extent
application process has ever worked as intended, yes or no?
Ms. Woodcock. No.
Mr. Dingell. Yes?
Ms. Woodcock. No, I don't believe it has worked.
Mr. Dingell. But you still got eight sitting around and
Food and Drug sitting on them like a hen on an egg, right?
Now, do you believe that we need to reform this?
Ms. Woodcock. Yes.
Mr. Dingell. And this is precisely why I have been joined
by dear friend Mr. Whitfield to introduce the Sunscreen
Innovation Act. The goal of this legislation is to ensure a
predictable time frame for the review of new sunscreen
ingredients while making sure FDA has the final say on all
scientific and safety determinations.
Now, Dr. Woodcock, I know there is a request for technical
assistance on the Sunscreen Innovation Act that is still
outstanding. Will you commit to working with me on this
legislation with a goal of resolve the remaining differences by
the end of this month?
Ms. Woodcock. I will commit to working with you and with
the Congress.
Mr. Dingell. Well, and I would like to have the requested
information that I have sought: How many applications you got
sitting around down there? How long have they been there? What
is holding up each and every one of them? And the other
questions that I asked relative to the delay on them, if you
please.
Ms. Woodcock. Certainly. There are eight applications for
sunscreens to TEA. We have responded to two of those. We hope
to respond to the remainder soon.
Mr. Dingell. But in Europe they are all approved; right?
Ms. Woodcock. In Europe, they are marketed as sunscreens, I
am not familiar, but I don't believe there is an application
process, such as we are discussing here.
Mr. Dingell. They are selling them, aren't they?
Ms. Woodcock. Correct.
Mr. Dingell. And people are using them, aren't they?
Ms. Woodcock. Absolutely.
Mr. Dingell. Do you have any evidence of them being unsafe
or causing any danger or--there are two things that a
pharmaceutical has got to be in this country, one, it has got
to be safe, and the other, it has got to be effective. Do you
have any evidence that any of these doesn't meet those two
tests?
Ms. Woodcock. Well, that is part of the point of the TEA
process, to have people submit to us what the evidence is about
the safety in marketing.
Mr. Dingell. You know the affectionate respect I have for
you. But you also know that you are make a bad case today. You
just can't defend the fact that these things have been sitting
around for 8 to 12 years.
I yield back the balance of my time. Thank you.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Kentucky, Mr. Whitfield, 5
minutes for questions.
Mr. Whitfield. Thank you very much.
Dr. Woodcock, you had indicated earlier that FDA had not
taken a position on this legislation; is that correct?
Ms. Woodcock. That is correct.
Mr. Whitfield. And I think you said in your testimony and
in response to Mr. Dingell's questions and others, you do agree
that the TEA process is not working very well as it relates to
sunscreens; correct?
Ms. Woodcock. Generally, I believe the monograph process is
no longer functioning the way it was intended, and the TEA
process is simply a route to get into the monograph process.
Mr. Whitfield. Do you consider the TEA process working?
Ms. Woodcock. I think if it were coupled with a more
functional monograph process, it could work, yes.
Mr. Whitfield. Well, how difficult is it to get a more
functional monograph process?
Ms. Woodcock. Well, as I said, we had a public meeting 2
weeks ago, and we had few really substantive suggestions there,
except we should work harder.
Mr. Whitfield. Yes. Well, we all agree on that. But that is
why, you know, at least we have a product here, a piece of
legislation. Because there is genuine concern and everyone
agrees that there is genuine concern.
Ms. Woodcock. I share the concern.
Mr. Whitfield. And when you have these eight applications,
earliest of which was submitted in 2002, and you have only
responded to two of them in 12 years, you know, something is
not working.
Ms. Woodcock. That is a problem.
Mr. Whitfield. So Mr. Waxman, now, he pointed out that he
was concerned about this advisory committee, and yet you have
indicated in your testimony that in nonprescription drugs or in
medical devices, you do have an advisory committee that makes
recommendation, and, of course, we are talking about over-the-
counter here, we are not even talking about prescription drugs,
this is over the counter; and the medical devices, I mean, the
artificial knee joints are placed in bodies, and that is
recommended by advisory committee.
So are you genuinely opposed to the advisory committee part
of this legislation and the process that we have set out in
this bill?
Ms. Woodcock. I am not sure that the process you have set
out will be functional. I mean, the problem with the current
process is not functioning correctly, and I am worried that-- I
think that there are some good steps here, and we can build on
this. And perhaps get something that will really work for
everyone.
But, you know, if you press people too hard on matters of
safety where you are exposing much of the population of the
United States to something, you know, you need to give them the
appropriate time and tools.
Mr. Whitfield. Well, I think you know, I hope that you----
Mr. Dingell. Will the gentleman yield?
Mr. Whitfield. I would be happy to yield.
Mr. Dingell. Is 12 years too much pressing? Is 8 years too
much pressing? I don't find it so.
And I thank the gentleman for yielding.
Mr. Whitfield. Well, I mean, I agree, I mean, I think we
all agree this is ridiculous. Twelve years.
Ms. Woodcock. We all agree. I am not defending the fact
that it has taken that long. There are a variety of factors,
but that is not appropriate and this process is not working.
Mr. Whitfield. And these ingredients are being used
elsewhere. But, the commitment that I am asking for from you
and others at FDA is to work with us in a sincere way to
improve this process for the health and welfare of the American
people. Because we know that skin cancer is the most prevalent
cancer out there.
So you will make that commitment to me and we can work----
Ms. Woodcock. Yes, we would be delighted to work with you,
although we would like to reform the whole process of the
monographs. Because the sunscreens are just a microcosm, as I
said, of a process of has encountered tremendous problems.
Mr. Whitfield. Well we are focused on sunscreens because of
the prevalence of skin cancer.
And in concluding, I know my time hasn't quite expired yet,
but I would like to submit for the record, Mr. Chairman, a
letter of support from the American Academy of Dermatology
Association.
Mr. Pitts. Without objection.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Whitfield. And with that, I would yield back the
balance of my time.
Mr. Pitts. Chair thanks the gentleman.
And I now recognize the gentleman from Texas, Mr. Green, 5
minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Thank you and both our Ranking Member Pallone for having
this hearing, and our witnesses for taking the time.
First, Dr. Woodcock, I learned just recently that the FDA
advisory committee voted last week to recommend that the FDA
approve two new antibiotics. These drugs were approved based on
the GAIN Act that we passed, this committee passed last
Congress, and I know they were in the development stage and
before GAIN was enacted and their approval was welcome news.
And of course we didn't get everything we wanted to out of the
Senate, so we have a real bipartisan bill called Adapt that we
are working with FDA on now. But I appreciate that.
Mr. Rannazzisi, the FDA is vital to meeting the growing
challenges our country faces, including reducing prescription
drug abuse, one of our fastest growing public health threats. I
commend the FDA for meeting the public safety threats head-on
and appreciate it. Because I have seen those same clinics in my
area, and frankly, we have a pretty aggressive U.S. Attorney
sometimes that gets involved in them. So I am glad of that.
However, the FDA, as it tackles its mandate in a number of
fronts, it is critical that patients who desperately need these
medicines have access without undue delay, particularly those
with limited potential for abuse or addiction. In 2011, I sent
a letter to FDA after learning it takes an average of 5 to 6
months for the DEA--I sent a letter to DEA--5 or 6 months for
DEA to schedule a medicine, notwithstanding the drug's
classification or potential for diversion. Since then, we have
learned that the delays have not shortened and may actually
have increased.
I am concerned over the substantial and growing length of
time between when the FDA approves a new molecular entity and
provides a scheduling recommendation and when the DEA schedules
the drug. According to testimony from Dr. Fountain of the
Epilepsy Foundation and University of Virginia School of
Medicine, the average time between FDA approval and the DEA's
final scheduling increased from an average of 49.3 days in the
1990s to an average now of 237.6 days. These delays can result
in lack of patient's access to potentially life-saving
therapies. Also, a lack of transparency of the DEA scheduling
process provides disincentives to companies developing these
therapies.
Mr. Rannazzisi, specifically what is the sequence of the
internal actions at DEA from a receipt of recommendation by the
FDA to the DEA's Federal Register publication?
Mr. Rannazzisi. When we receive the recommendation, our
pharmacists, our pharmacologists begin the process of drafting
the eight factor. They look at all the information that has
been presented by FDA, and then all the information that they
have procured over the last however long when they know the
drug is coming. That is a lot of scientific data. They look at
all the abuse data, if there is any abuse data.
Remember, there is transparency in the system. It is called
the Administrative Procedures Act. The APA is our guidance on
how we get drugs into the scheduling process.
We provide a period of public comment after we do the
notice. We have to look at every one of those comments. At that
point in time, the public may request a hearing from an
administrative law judge.
So the process is very transparent. It just takes time
because it is a science. The scientific method takes time, and
our scientists, just like the FDA scientists, have to ensure
that we have the justification to prevail in court.
Mr. Green. Well, but it is still is the average increase
from the late 1990s to today was from 49 days to 237 days.
Mr. Rannazzisi. I don't know where that is coming from.
Mr. Green. OK, we will get it to you. We will get the
numbers there. Because if that is the issue, then somewhere
along the way, whether you are not giving some kind of courtesy
to what the FDA scientists did and, I expect--you know, I want
FDA to do it. But I also know that they expect----
What is your opinion of the shortest time that might
plausibly achieve to accomplish this process from start to
finish? Is there an average time that the DEA aims for?
Mr. Rannazzisi. I don't believe there is. Because it
depends on--if it is a new molecular entity, that is going to
take longer than an established drug that is in a different,
you know, a combination of formulations. A drug that we know, a
drug that we have done very significant research on.
Mr. Green. Well, I know Congress and the FDA is taking
steps to improve the transparency and consistency of the
regulatory process for new drugs, to provide patients access
for these new therapies in a timely manner. The lack of
predictability, though, and timing of the DEA scheduling
decisions, at least on certainty and drug development, and the
process and some delays.
Delays in patient access to new therapies should be
addressed in a manner that doesn't threaten public health or
weaken the DEA's ability to ensure public safety. But somewhere
along the way, we need to make the system work faster than we
are seeing.
And I know I am out of time, Mr. Chairman. Thank you.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentlelady from North Carolina, Mrs.
Ellmers, 5 minutes for questions.
Mrs. Ellmers. Thank you, Mr. Chairman.
Dr. Woodcock, and thank you to our panel for being here
today.
I do have questions about the sunscreen. I think that we
have gone over that pretty well here in committee, and as a
nurse prior to coming to Congress, obviously, this is an issue
that we are all very concerned about, with skin cancer. And I
guess what I would like to hear from you, is, please, can you
just tell our committee that you are committed to improving
upon this issue? I mean, obviously the time has been too long.
Ms. Woodcock. It has been too long. As I said a number of
months ago when I appeared before this committee, I think I am
almost as frustrated as the manufacturers and some of you all
about this issue. So I do commit to improving it. We have
already taken steps to speed up this process and move it along.
Mrs. Ellmers. OK. Moving along to some of the issues having
to do with Ensuring Patient Access and Effective Drug
Enforcement Act of 2013.
There again, a very important issue. This is one that I
think many of us, you know, we understand the drug abuse issue,
we understand the deaths that have occurred as a result, and we
need to be proactive on this issue.
One of the solutions that has been put forward that holds
promise is the development of abuse-resistant prescription drug
products. Such formulations make it harder for individuals to
break down prescription drugs for abuse purposes. Obviously,
that would be the actual drug itself.
And I would just like to thank you for the work that you
have been doing, and I do want a clarification. My
understanding is that there is some progress being made right
now, that the agency is contracting with some of the academic
and research institutions, utilizing research grant funding
through the Generic Drug User Fee Act, to study this evaluation
of abuse-deterrent formulations. Is this correct?
Ms. Woodcock. I can't comment on the funding. But the
research is correct, yes.
And we are trying to develop a framework so that as--we
don't want to approve abuse-deterrent formulations that then
disincentivize people from developing better ones. We have
approved one, and it has some abuse-deterrent properties.
However, we need to get much better than that. So what we need
to do is kind of establish both the--you know, the carrot and
the stick incentives, and we are doing research in our own
laboratories as well as elsewhere.
Mrs. Ellmers. Will the FDA in its guidance provide
flexibility and encourage manufacturers to pursue alternative
methods and approaches to develop meaningful abuse-deterrent
technologies rather than a single development path such that
the innovation and advancement in science are effective
harness--I mean, are there incentives that are being put
forward?
Ms. Woodcock. Absolutely. That is part of the strategy, is
to have multiple different abuse-deterrent mechanisms so that
if one might be overcome--Mr. Rannazzisi and I were talking
earlier that criminals are always sort of one step ahead of
you.
Mrs. Ellmers. Sure.
Ms. Woodcock. So we need to keep encouraging that
innovation.
Mrs. Ellmers. Thank you, Dr. Woodcock.
And, Mr. Rannazzisi, I think we have--there is a lot of
discussion of clarity and process on how things are moving
forward. You know, we are hearing repeatedly that registrants
are very concerned about the lack of clarity. However, you have
outlined that this is something that the DEA is working on. And
you say that you, and I am going to quote you, that you give
the opportunity for the registrants to come forward, that there
is plenty of opportunity for them.
Is there a process for appeal of a decision by the DEA? And
can you describe that, if a registrant is found to have been
revoked, their DEA ability to produce suspended or revoked?
Mr. Rannazzisi. I believe they could take it to district
court.
Mrs. Ellmers. You believe or you----
Mr. Rannazzisi. They could take it to the district court.
Mrs. Ellmers. OK, when we are talking about the hearing
process, I know my colleague across the aisle, Mr. Green, was
referring to some of the hearing procedures, and there seems to
be a lot of discrepancy on timing of how long a hearing would
take. Can you tell us what the average time is? I know my
colleague had said that he had heard of a time frame, and there
again, I don't know exactly the number. But you basically said
you weren't sure where that number came from. Can you tell us?
Mr. Rannazzisi. I don't believe that was for a hearing; I
believe that was for--I think that was for scheduling. The
timeframe it takes for scheduling action.
Mrs. Ellmers. To schedule?
Mr. Rannazzisi. Yes.
Mrs. Ellmers. OK.
Mr. Rannazzisi. For a hearing, again, it depends on if it
is an immediate suspension order with an order to show cause or
just a plain, ordinary----
Mrs. Ellmers. So to that point, how long would you say that
it does take a hearing to be scheduled? And then I know my time
is----
Mr. Rannazzisi. When we do an immediate suspension order
with an order to show cause, the date of the hearing is on the
order to show cause, and I believe if it is within 30 days.
Mrs. Ellmers. OK. Within 30 days. Thank you so much.
My time has expired.
Mr. Pitts. Chair thanks the gentlelady.
Now recognize the gentleman from Florida, Mr. Bilirakis,
for 5 minutes for questions.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it
very much.
And again, thank you for your testimony. Thank the panel.
Mr. Rannazzisi, numerous seniors in my district are
complaining. They call my office on a regular basis because
they can't get their pain medications, and the pharmacists have
stated that DEA is placing arbitrary and vague quotas on
wholesalers and pharmacies.
I also hear that DEA is telling pharmacists not to fill
prescriptions that raise red flags, but has given no guidance
about these red flags. I want to give you an opportunity to
respond.
But considering DEA's mission to ensure an adequate,
uninterrupted supply of controlled medications for patients'
needs, what is DEA doing to address the impacts on patients
that these confusing policies are causing?
And I know we have touched on this earlier. But if you
could elaborate, I would appreciate it.
Mr. Rannazzisi. To start, actually, last year we were down
in Florida, and we trained, I think, 1,400 pharmacists on what
their role is as far as corresponding responsibility and how
they review prescriptions. And we talked about the red flags,
and we are trying to do that in every State. The fact is that
we do not want patients to go without their medication, true
pain patients that need their medication. We don't want that.
But there is no quota----
Mr. Bilirakis. Tell me what you are doing about it?
Because, I mean, we get calls on a regular basis.
Mr. Rannazzisi. There are no quotas set by DEA concerning
how much downstream drug goes from the wholesalers to the
pharmacies. The wholesalers are required to report suspicious
orders. They should know their customers, they should do due
diligence. But they have certain things that they must do to
reconcile an order before it is sent downstream. The pharmacies
that are ordering those drugs, again, have a corresponding
responsibility to ensure that the prescriptions they are
filling are legitimate, are valid, are for legitimate medical
purpose.
That is exactly what happened in Sanford. In Sanford,
Florida, those two pharmacies that were stripped of their
registration, they were not doing any corresponding
responsibility, and there are wholesalers that were sending
drugs to them, were not doing their due diligence.
And they were filling hundreds of thousands of tablets per
year. And most of those prescriptions were not for legitimate
medical purpose. They were also filling prescriptions for
doctors that didn't have a valid DEA registration.
See, the problem is, is corresponding responsibility has a
quite a few different components to it. And this has been in
place for 40-plus years.
Mr. Bilirakis. Let me go on to the next one. Thank you for
that answer.
Does DEA meet the chronic pain patients groups and others
to ensure--do they meet with chronic pain patients groups and
others to ensure that agencies understand the need and concerns
of patients? And yes or no, and please elaborate.
Mr. Rannazzisi. If we were asked to meet with a pain
patient group, yes, we would.
Mr. Bilirakis. How often are you asked?
Mr. Rannazzisi. We meet with treatment groups, for
instance, American Association of Opiate--AATOD. AATOD. We meet
with them. We meet with physicians' groups. We meet with
pharmacy groups. Specific patient groups when they request.
Mr. Bilirakis. What is discussed during those meetings?
Give me an example.
Mr. Rannazzisi. We meet with--for instance, AATOD, we give
them a trend analysis of what is going on in drug diversions,
what drugs are being used. Then we ask them, what are you
seeing?
It is the same thing with community groups. We go into the
communities all the time. In fact, I am doing a community
function with doctors, pharmacists, and community leaders in
Weymouth, Massachusetts, next month.
Mr. Bilirakis. Thank you very much for the answer.
Dr. Woodcock, Zohydro is a new extended-release opioid
approved for the market by FDA but without any requirement for
abuse deterrents. I find this disturbing because FDA has taken
a number of steps to make sure opioid drugs would have these
deterrents. FDA has even blocked generics from entering the
market because they lacked abuse-deterrent properties.
Some brand name drug makers have changed their drug to
include abuse deterrents, saying their previous versions were
unsafe. 28 State attorneys general sent a letter to FDA asking
to reconsider the position on Zohydro. Your own advisory
council did not favor approving this drug, from what I
understand.
The drug company's own literature says an adult could
overdose on two capsules, a child could die from swallowing
just one, an addict can easily crush it and receive a dangerous
and potentially lethal high.
Why would you approve a drug with 5 times as much
hydrocodone as Vicodin with no abuse-deterrent properties?
Ms. Woodcock. Well, first of all, there is only one drug
that we have approved, and it is on the market, it is a high-
potency opioid that has abuse-deterrent properties. All other
opioids on the market do not have abuse-deterrent properties--
--
Mr. Bilirakis. But why was that drug approved?
Ms. Woodcock. Pardon me?
Mr. Bilirakis. Why was that drug approved?
Ms. Woodcock. Zohydro?
Mr. Bilirakis. Yes.
Ms. Woodcock. All right. Zohydro is a single ingredient,
high-potency opioid. You can't take--you said Vicodin. You
can't take a lot of those if you have severe pain because it
has acetaminophen in it, and it will be toxic to your liver,
and acetaminophen is a very big cause of liver failure, OK, and
liver transplants. Because people are getting too much
acetaminophen. So we need high-potency opioids for people who
have severe pain.
Mr. Bilirakis. But why wouldn't we make sure that it has
abuse deterrent prior to approval?
Ms. Woodcock. Abuse deterrence is really in its infancy,
unfortunately. We have approved one product with abuse-
deterrent properties. Those are quite limited, abuse-deterrent
properties. I don't want to talk about that further. But they
are present, OK. But we have a long way to go, and almost all
the opioids on the market do not have abuse-deterrent
properties.
Mr. Bilirakis. OK. Thank you very much.
I yield back the balance of my time.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Virginia Mr. Griffith for
5 minutes for questions.
Mr. Griffith. Let me pick up on some of what my colleague
was just talking about. Because a number of people are having
difficulty, particularly at their pharmacies, based on some of
the new rules or regulations that have come out.
In fact, I was standing in my local pharmacy waiting to get
some drugs for my son a couple of months back, and there was a
lady there getting some medication for her mother, and a local
judge get something medication for his wife, who just had
surgery, and the pharmacist, while I was standing there, had to
inform both of them that they had used their allotment under
the DEA's new regulations of those particular types of drugs,
and they would have to come back next week.
Now, wasn't a problem for the judge. He was coming in, you
know, a little early so that he didn't have that pressure, and
that she would have the medication she needed.
But for the lady who was getting drug for her mom, it was
very stressful. She said, my mother needs this medication. I
promised them I would look into it.
What do I tell them? I mean what are we doing to make sure
that these folks are heard from and that the drugs are
available when there is a valid prescription for a valid
patient who presents that to a pharmacist?
Mr. Rannazzisi. We talk to the pharmacists about this. The
pharmacists are being told by their distributors that DEA is
setting up a quota. There is no quota, there has never been a
quota when it comes to distributors. I defy anybody to show me
where there is a quota.
The fact is, we ask the distributors to know their
customers and ensure that the drugs they are sending downstream
are you know, if it is a suspicious order, that it is
reconciled before it is sent. But there has never been a quota
to, going downstream from wholesaler to pharmacy. The
pharmacists are reporting this. That is what they are being
told, but we are not telling them that.
Mr. Griffith. Well, can you figure out why it is that has
happened? I mean, are you all making the distributors worry
about it? So that if this particular pharmacy deals mostly, not
exclusively, obviously, but mostly with older patients, because
it has been there in one form or another on Main Street in
Salem, Virginia, for about a hundred years, and so a lot of
their folks are people that have been in the community for a
long time. Some of them are fourth generation, et cetera. But
some of them are also older, which means you are going to have,
probably, more of those prescriptions.
I think maybe that you all need to talk with the
distributors again make sure that if it, you know, is a long-
term situation, that drugstore may be a little higher than the
CVS down the street just because they have been there forever.
So their population by definition is going to be an older
population.
Mr. Rannazzisi. And I understand that, and DEA does not
want anybody to go without their medication, if they are a
legitimate patient. But the problem is I have no control to
tell a distributor to distribute to a pharmacy.
And the fact is that, if they just complied with the act
and complied with the regulations, there wouldn't be a problem.
Mr. Griffith. Well, clearly, there is confusion somewhere.
And I hope you will work with us to get that resolved.
Let me move to another subject now, involves the DEA, and
also may involve pain medication. Most people are unaware of
this, and let me state right up front, I do not support
recreational use of marijuana. But, believe it or not, Virginia
has the oldest medical marijuana law on the books. It was
passed in 1979. Either with the hope that the DEA was going to
come around and say these are certain legitimate uses, or in
the hopes of encouraging the DEA to do that. But it was passed
in 1979. It's 182251.1. And right now, it--as I think is the
proper way to deal with medicinal marijuana, it requires a
valid prescription from a valid physician, and then it has to
be taken to the pharmacist to be filled.
Virginia set the construct up, and they did it just for
cancer and glaucoma. Because in 1979, that is all the evidence
would have justified. So they were trying to work within the
construct of the Federal law and the DEA. Needless to say, no
doctor in his right mind or her right mind is going to
prescribe it, because that would get them in all kinds of
trouble with the DEA.
But when is the DEA going to take a look at medicinal
marijuana? Forget the crazy laws, as I sometimes call them,
that California has passed and some other States that make it
open. But a law that would allow the legitimate use of
marijuana, smoked marijuana as well, not just the pill form,
for purposes of relieving people on any number of areas, but
particularly on cancer and glaucoma. Because we know that has
been--that science has been out there for decades.
Mr. Rannazzisi. Well, I think I will answer it and then I
am sure my colleague would love to answer it as well----
We have a--maybe not.
We have a----
Mr. Griffith. Our impediment is the DEA won't allow it.
Mr. Rannazzisi. Well, a petition process where a person
could petition the Government to schedule, reschedule, or move
through the schedules any drug.
Now, in the case of marijuana, there are several factors.
But one is it is based on approval as a medicine, and FDA has
looked at this twice now, I believe, and the science is not
there. There is no scientific evidence that shows that smoked
marijuana is beneficial as a medicine.
Mr. Griffith. Well, and let me say, because my time is
running out. I haven't ever used marijuana recreationally or
otherwise. But I will tell you that I have numerous
constituents who feel that it has been of assistance to them,
and I tell a story when I go out and talk to people.
Decades ago, I went to--I knew somebody who was having a
problem with cancer, and the story was told to me at the time
by some of his friends that the doctors put on his chart
``Nobody goes in this room from 11:00 to 12:00, and then bring
his food at 12:00.'' Because the doctors recognized that that
would give him some relief.
He was trying to stay alive as long as he could so he could
see his 2-year-old child a few more days. Every day he could
get was important. I am telling that story in a high school
group, what I call my high school town halls. This kid raises
his hand up, and I thought it was going to be some question
about, what about recreational use? And he says to me, ``They
did that for my daddy too.'' And I was in a different part of
my district, and my district is about 4 hours long; there are
no way they could have been anyway close, plus the kid was way
too young. It wasn't the same deal. So we have got doctors out
there who are recognizing it.
Further, I would submit there is a Washington Post article
that says that it is difficult to get permission to even do the
scientific studies because of the DEA.
So I ask you to work on that, because that is a serious
issue, and the American people support it for legitimate use,
not abuse. Not recreational, but for legitimate use.
I yield back.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from New Jersey, Mr. Lance, 5
minutes for questions.
Mr. Lance. Thank you, Mr. Chairman.
Good afternoon to you both.
I don't want to beat a dead horse. I agree with
Congresswoman Ellmers on the issue of the sunscreen, and I hope
quick action can be taken, and I would personally benefit. I am
in a situation where the sun is poison to me. And I presume
that--I like going to the dermatologist about as much as I
assume you like hearing us bark at you this afternoon, and I
want to work with you so that we might bring these European
components to market here in a safe and effective way, Dr.
Woodcock.
On a completely different issue. I would like to ask you a
couple questions about special protocol assessments. It is my
understanding that Congress intended that these agreements
should be binding on both parties except when a substantial
scientific issue has come to light, after an agreement has been
reached and testing has begun.
Dr. Woodcock, could you explain to the committee what type
of scientific evidence would be so substantial as to cause the
FDA to rescind a special protocol assessment for a drug that
was otherwise safe and which had met all of its end points?
Ms. Woodcock. Certainly. Well, in some cases, for example,
we would learn for a class of drugs that there was a new safety
problem, and say for the nonsteroidal, anti-inflammatory
agents, we learned, as you recall with Vioxx and others, that
they caused cardiovascular events, myocardial infarction or so,
and if we had said, you don't have to study that in depth in
the premarket assessment, and then subsequently we learned that
that whole class of drugs caused that problem, we would be
remiss in approving that drug unless that safety problem had
been addressed.
OK. Now, similarly on the efficacy side, the special
protocol assessment has at what end points, how you study the
drug and what end points you use, and often we use surrogate
end points of different kinds or intermediate clinical end
points or whatever.
And if we find that, in the interim, there is evidence that
comes to light that that end point may no longer be valid and
actually predict what we are looking for, then we might say we
cannot any longer for any applicant rely upon that end point
because its validity has been brought into question.
However, I would say that out of--we have entered into
almost a thousand agreements since 2007. And we have only
rescinded 10 over that whole time.
Mr. Lance. As a matter of public policy, I do think the FDA
should be accountable for continued diligence in identifying
issues that bear on the continued enforceability of an SPA
agreement, and then notifying the sponsor of such issues within
a reasonable period of time after the FDA has become aware of a
new situation. Is my understanding correct as to how that
system works?
Ms. Woodcock. I am not sure it is a system. But I totally
agree with you that is what we should do.
Mr. Lance. Thank you. I hope to work with you in a more
extended way on this issue, and I appreciate your attention to
the matter.
And, Mr. Chairman, I yield back a minute and 20 seconds.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentleman from Pennsylvania, Dr. Murphy,
5 minutes for questions.
Mr. Murphy. Thank you, Mr. Chairman. I yield my time to
you.
Mr. Pitts. All right. Thank you.
Mr. Rannazzisi, with respect to scheduling, is it your
understanding that you cannot speak to, at the very least, the
goals of the MOA that DEA and FDA are trying to achieve?
Mr. Rannazzisi. The MOA will give us the opportunity to
share information, both proprietary and information pertaining
to our different databases, on just about anything in the
process. Not only scheduling, but other things as well, and
that is something that has never been in place before. So that
memorandum of understanding, will give us the opportunity to
move information back and forth under agreement of how it
should be maintained.
Mr. Pitts. Dr. Woodcock, is that your understanding?
Ms. Woodcock. Absolutely. And I would like to add that I
think it will be extremely beneficial in some--we work closely
with DEA, but we are not able to share certain information,
which impedes, say, in the premarket realm, us working as
closely as we would like.
Mr. Pitts. Thank you.
Will you both commit to working with the committee to
provide this information, as much information as possible, by
the end of the week to ensure that we can consider your efforts
as we work on our legislation?
Ms. Woodcock?
Ms. Woodcock. Yes, as much information as possible,
certainly.
Mr. Pitts. Mr. Rannazzisi?
Mr. Rannazzisi. I would agree with that.
Mr. Pitts. Well, that concludes the questions.
Mrs. Ellmers. Mr. Chairman, do you mind if----
Mr. Pitts. I yield to Ms. Ellmers.
Mrs. Ellmers. Mr. Rannazzisi, I just have one question that
just is burning in my mind. As we have had these discussions on
the process that the DEA is taking, I guess I just don't
understand why we are not going after the bad actors, those
physicians who are the ones who are writing the prescriptions
to those patients. We know they are out there. What is the DEA
doing about the physicians who--because, look, I am in the
medical community. I know it exists. And I know that I have
known doctors who have abused this system. Where is the
progress there?
Mr. Rannazzisi. Absolutely. Well, when we started initially
with the Internet, we went after the physicians, the physicians
that were prescribing over the Internet.
But the problem evolved. As soon as Congress passed Ryan
Haight, they immediately started opening rogue pain clinics. It
closed down the Internet, and rogue pain clinics flourished.
First in Florida, then in Georgia, Tennessee, Missouri,
Kentucky----
Mrs. Ellmers. OK, to that point, and I understand.
Because--you are pointing out a--we kind of went on an
explosion. But, you know, we all live in small--I live in a
very small community. I live in a small community where I know
this is happening.
Mr. Rannazzisi. Yes.
Mrs. Ellmers. What is the DEA doing in those communities
where you know they exist?
Mr. Rannazzisi. We have right now 66 task forces, State,
local, and Federal task forces, that are working with HHS, OIG,
and FBI and other agencies, and we go after these doctors.
But the problem is, there are so many bad clinics right
now. We are kind of overwhelmed, just as the States are. If you
look at what is happening in Georgia, there are a lot of bad
actors out there. And we are doing our best to keep up with
them.
As it spreads, as it spreads, for instance, in Texas, we
are just--you are overwhelmed by the numbers. And these are not
clinics that provide medical care. These are things that
distributing----
Mrs. Ellmers. Pain. And to that point, and then we will
finish here so that we can move on. But, you know I do believe
there is value in making an example of a physician, a
physician's office that repeatedly abuses the system and
continues to be that cycle.
Because, unfortunately, what we have learned is that those
who are in the community and they are drug seeking and drug
shopping, they network very well. They know who the physicians
are that will write those prescriptions, and I would just
imagine that, you know, maybe even just taking a step backward
and just looking at it in a more singular level, especially in
some of our rural communities, that that might go a long way.
Mr. Rannazzisi. That is exactly why the administrative--the
immediate suspension order is so important. Because I could
stop the hemorrhaging by issuing the immediate suspension
order, and, quite frankly, the burden is a lot less than
charging the bad actor with a crime. Not that he won't be
charged. But if I want to stop the hemorrhaging, I use the
immediate suspension order to stop him from doing it. Then
working with the State backtrack, and hit him with a criminal
charge.
So, yes, it happens, but it takes time. All of these cases
take time. It is not distributing heroin or LSD. Those are
illegal per se. It is distributing a legal substance illegally.
Mrs. Ellmers. Well, thank you, sir.
And thank you to the chairman for allowing me to use the
remainder of his time.
Mr. Pitts. All right. Chair thanks the members.
Mr. Pallone has a U.C. request.
Mr. Pallone. Thank you, Mr. Chairman, I have to just ask
unanimous consent to submit into the record a comment letter on
H.R. 4069 from the Drug Policy Alliance. I believe you have it.
Mr. Pitts. Without objection, so ordered.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. That concludes the questions of the members here
at this point. We will send follow-up questions to you. We ask
that you please respond as soon as possible.
And the subcommittee will take a 5-minute recess as we set
up for the second panel. Subcommittee is in recess.
[Recess.]
Mr. Pitts. We will ask the witnesses to please take their
seats. On our second panel today we have five witnesses, Dr.
Nathan Fountain, Chair, Medical Advisory Board, Epilepsy
Foundation; Mr. John Gray, President and CEO Healthcare
Distribution Management Association; thirdly, Mr. D. Linden
Barber, Partner and Director, DEA Compliance Operations,
Quarles and Brady; fourthly, Ms. Wendy Selig, President and CEO
of the Melanoma Research Alliance; and Mr. Scott Faber, Vice
President of Governmental Affairs, the Environmental Working
Group.
Thank you all for coming. Your written testimony will be
made part of the record. You will each be given 5 minutes to
summarize.
And, Dr. Fountain, we will start with you. You are
recognized for 5 minutes.
STATEMENTS OF NATHAN B. FOUNTAIN, CHAIR, PROFESSIONAL ADVISORY
BOARD, EPILEPSY FOUNDATION OF AMERICA; JOHN M. GRAY, PRESIDENT
AND CHIEF EXECUTIVE OFFICER, HEALTHCARE DISTRIBUTION MANAGEMENT
ASSOCIATION; D. LINDEN BARBER, PARTNER AND DIRECTOR, DEA
COMPLIANCE AND LITIGATION PRACTICE, QUARLES & BRADY, LLP; WENDY
K.D. SELIG, PRESIDENT AND CHIEF EXECUTIVE OFFICER, MELANOMA
RESEARCH ALLIANCE; SCOTT FABER, SENIOR VICE PRESIDENT FOR
GOVERNMENT AFFAIRS, ENVIRONMENTAL WORKING GROUP
STATEMENT OF NATHAN B. FOUNTAIN
Mr. Fountain. Thank you.
Thank you, Chairman Pitts and Ranking Member Pallone, for
allowing the Epilepsy Foundation to provide comments to H.R.
4299 today.
I am a neurologist at the University of Virginia and also
director of the comprehensive epilepsy program there. But I am
reporting the Epilepsy Foundation today--representing the
Epilepsy Foundation today as the chair of the professional
advisory board. The Epilepsy Foundation is the largest patient
advocacy group in the United States for epilepsy, indeed, in
the world.
And the two facts to start with, at least before our
earlier discussion, I thought were sort of not in dispute, was
first that DEA has progressively taken longer to schedule drugs
after approval by the FDA. So the information that was quoted
earlier is that in a referenced publication that we can provide
if it is not in my written comments, is that between the years
1997 and 1999, the average drug approval by DEA, so the time to
scheduling, was 49 days, so about a month and a half. In the
period between 2009 and 2013, that increased to 237 days, or
about 8 and a half months. So from 1 and a half months all the
way to 8 and a half months.
This second point that I think is at least clear to me is
that DEA has always agreed with FDA's recommendations for
scheduling, at least according to the same published analysis I
referred to before. I think we heard that as well.
The epilepsy community is so sensitive to this issue
because anti-epileptic drugs, or anti-seizure medications, the
medications that people with epilepsy have to take each day,
have progressively been more frequently scheduled by the DEA.
If you went back to older drugs for epilepsy, they weren't an
issue. But newer drugs, because of various reasons, are now
scheduled by the DEA.
So the most recently approved seizure medication was
approved by the FDA on October 22, 2012 and received scheduling
and approval for marketing by DEA on January 2, 2014, an
astounding 14 months later, according to FDA news. And I think
if I understood their comments, that was even 11 months after
it arrived at the DEA from FDA. So I think probably by any
measure a very long time.
Some brief background information about epilepsy
illustrates why this delay is so important to Americans.
Epilepsy is any condition that predisposes to spontaneous,
recurrent seizures. You can imagine it happens by many
different insults to the brain, such as a stroke or head
trauma. But in fact it most often is caused by some microscopic
change in the brain or some genetic predisposition to seizures
in people who are otherwise perfectly fine and perfectly
normal.
Seizures are an electrical storm of the brain. The kind of
seizure that people are most familiar with is a generalized
tonic-clonic or grand mal seizure, when someone stiffens up,
falls to the ground, and jerks rhythmically all over for a few
minutes. They are then unconscious for a little while and, over
the course of about an hour, return back to normal.
But the electrical storm of the brain can start in just one
spot. Seizures can arise focally in just one area, and the most
common focal area they arise is in the temporal lobe. The
temporal lobe, behind your temple here, controls consciousness
and awareness, and during temporal lobe seizures, people don't
fall down and jerk all over, but instead stare off, unaware of
what is going on around them.
They are awake, but they are confused and don't know what
is going on, and that means that they may continue to do
behaviors they are doing but they don't do it correctly. So,
for example, if they are ironing, they may continue to iron,
but unfortunately they may pick up the hot side of the iron,
and iron with that, burning their hand. If they are cooking
with boiling water, they may put their hand, immerse it into
the boiling water to pick something up because they are
confused about what they are doing. If they are chopping
something, they continue to chop and chop their own fingers. So
it can a very dramatic and difficult thing for people with this
kind of seizure, which is the most common type.
But the greatest risk from epilepsy is death. Death from
sudden unexpected death in epilepsy, or SUDEP, S-U-D-E-P,
sudden unexpected death in epilepsy, in which patients die for
no apparent reason. They are typically found dead in bed,
sometimes associated with a seizure, the same seizure they have
had ten, hundreds, thousands of times before. But for whatever
reason in this particular seizure, they don't awaken and they
die. SUDEP.
Matthew is an engineering student at a Virginia
university--I am from Virginia--with intractable epilepsy. He
had seizures in his sleep that happened several times a week.
Typically they weren't such a substantial problem because as
far as he knew, he didn't have them. They just occurred in his
sleep, but eventually, they started to occur during the day.
When they started to occur during the day, you can imagine all
different ways its disrupted his life. Besides the risk of
injury, there are more common ways in which you can imagine if
you have seizures that you can't drive, difficulty working and
so forth.
He was an otherwise very personable, pleasant young man. I
have an 18-year-old son who is at the University of Virginia, a
freshman. Could have about been my son, could have been your
son, could have been your daughter. And as his seizures
persisted, we tried more and more medications to treat them.
Eventually, for those situations we consider surgery. It is a
several month long evaluation to localize exactly where the
seizure is coming from in the brain; if that is a safe spot to
remove, then removing that spot. But unfortunately a couple of
months into his evaluation, I got an email message I received
too many times in which the subject line is ``sad news.'' And
whenever that happens, my heart just sinks because I know what
is coming next. So, on opening the email, it says, from my
nurse, ``Matthew's mother called today. He was found dead in
bed. He went to bed last night perfectly fine, but he didn't
come down for breakfast, I went to check. He was dead.''
So you can imagine there is no more devastating thing that
could happen to you. What could possibly be more devastating?
Most of us would rather cut off our arm than lose a child.
Right? And, of course, it doesn't just happen to children and
young adults. It happens to everyone with epilepsy. So the
question is, how common is this? What is the scope of the
problem? Is he just one guy in my thousands of patients with
epilepsy? No. I am afraid not.
Take a step back for the scope of the whole problem.
Epilepsy is common. About 1 in 26 people have epilepsy at some
time in their life. Earlier today there were 96 people in this
room. That means three or four of them had epilepsy. Some of
they had it as a child. They outgrew it. It went away. Some of
them haven't gotten it yet because its highest incidence is in
the very young and in the elderly, as you can imagine. But that
is pretty common. About 3 million Americans have epilepsy
today. That is quite a lot of Americans. And about a third of
these people have seizures that are not controlled with
available medications. That means they persist in having
seizures, despite our best efforts, like Matthew.
I follow about 2,000 people with epilepsy in my clinic per
year, and I get this message about twice per year. So I now
have accumulated about 50, actually 52 people with epilepsy who
have died, mostly in this manner. It is not a small problem. It
is a huge problem and as a general sense affecting almost 3
million Americans; in a specific sense, the risk of death for
those people with intractable epilepsy, at least a million.
Now, we started Matthew's evaluation when the last drug I
mentioned had been approved by the FDA but was awaiting
scheduling at the DEA. That is when he died.
Mr. Pitts. Could you please summarize, Doctor----
Mr. Fountain. One last sentence. So I can't tell that you
that Matthew would be alive if he had this drug available, but
he certainly might be, as would other patients with epilepsy
who desperately need these kind of treatments that have been
found safe and effective by the FDA. Thank you.
Mr. Pitts. Thank you.
[The prepared statement of Mr. Fountain follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. Mr. Gray, you are recognized for 5 minutes for
your summary.
STATEMENT OF JOHN M. GRAY
Mr. Gray. Good afternoon, and to members of the Energy
Subcommittee on Health, Ranking Member Pallone and Chairman
Pitts, I am John Gray, President and CEO of the Healthcare
Distribution Management Association. I want to thank you for
the opportunity to come here to talk about Representatives
Blackburn and Marino, the Ensuring Patient Access and Drug
Enforcement Act of 2014, H.R. 4069.
HDMA is the national association representing America's
primary pharmaceutical distributors, the vital link we say
between manufacturers, pharmacies and health care providers.
Our industries' prime mission is to operate the safest and most
secure supply chain in the world. As part of the mission, the
pharmaceutical distribution industry is committed to addressing
the serious national epidemic of prescription drug abuse. Drug
abuse and diversion as we have heard here today is a complex,
challenging problem calling for a collaborative effort on the
part of doctors, pharmacists, distributors, manufacturers and
importantly State and Federal authorities.
HDMA members are committed to working proactively with the
DEA, local law enforcement and other regulatory agencies, to
investigate potential cases of diversion and implement
protocols to monitor and report suspicious orders.
The supply chain is a complex one depending on numerous
core components working closely with one another to ensure
patients receive the medicines they need and to prevent the
diversion to individuals who would abuse the drugs. It is
sometimes difficult to find the balance between proactive and
anti-diversion efforts while not inadvertently limiting access
to appropriately prescribed and dispensed medications.
We hope this legislation will address the need for balance
and encourage some cooperation and collaboration between
prescribers, dispensers, distributors, manufacturers,
regulators and the like, while making sure that the legitimate
patient population continues to get what they require for
medication. All HDMA members take seriously this obligation to
fill only legitimate and appropriate orders for controlled
substances.
However, in many instances, our members struggle with
applying the Controlled Substances Act and it is accompanying
regulations to the specific situation when balancing the need
for preventing the diversion at the pharmacy or the doctor's
office and ensuring that the legitimate patient needs are
addressed. This is one of the reasons why HDMA supports 4069,
the legislation's timely and thoughtful approach to addressing
the prescription drug epidemic. And we believe it will foster,
again, better collaboration, communication and transparency
between the industry stakeholders and the regulators,
especially the DEA. Our members appreciate the importance of
DEA's law enforcement activities, confronting, disrupting, and
dismantling illegal drug trafficking. However, establishing a
collaborative working relationship between DEA and our members
will serve as a more effective way to curb the diversion of
legal medicines. We feel this legislation will improve the
interaction with DEA as they engage in their regulatory duties
to prevent the diversion of these substances. The several key
components, the bill clarifies the regulatory environment by
defining terms that will facilitate greater compliance with and
consistent enforcement of the Controlled Substances Act.
Another key provision is the bill establishes a corrective
action for plan registrants working with the DEA. This concept
first raised by Representative Blackburn during a hearing on
drug abuse here 2 years ago, is intended to mirror the way the
FDA interacts with and regulates pharmaceutical manufacturers.
The bill will allow DEA-registered companies to submit
corrective plans, to address and mitigate any of the agency's
concerns, we hope and we believe creating a more robust,
transparent, time-sensitive approach to addressing diversion.
Preventing this diversion and abuse requires a clear
understanding of the regulations consistent with the CSA and
prompt communication between supply chain members and the
regulators. The provision ensures that law enforcement
registrants will collaborate to achieve these aims.
Finally, the bill establishes a prescription drug abuse
working group to encourage meaningful dialogue and coordination
between the supply chain stakeholders, law enforcement, patient
advocacy groups, as well as State and Federal regulators.
Ultimately, the working group will provide guidance to Congress
on the most effective strategies to curb this prescription drug
abuse.
HDMA has long been working to improve the collaboration
among industry stakeholders. We recently joined the Alliance to
Prevent the Abuse of Medicines. The alliance is in the process
of developing a platform of policy recommendations to address
numerous aspects of the drug abuse diversion problem, and that
alliance does support 4069.
We recognize there isn't a one-size-fits-all solution to
this problem. There never is. But we believe pharmaceutical
distributors, along with our other supply chain partners, are
committed to a more coordinated and transparent approach,
balancing between addressing enforcement, public health and
treatment efforts. We are neither seeking to restrict DEA's
authority nor increase the regulatory burden on registrants.
What we are seeking is clarity, consistency to ensure that the
public health needs are adequately addressed in a balanced,
collaborative and effective manner. In the end, we share the
same goal, ensure patient access, sufficient, safe and secure
supply chain of medicines for the necessary therapies while
keeping these drugs out of hands of individuals who will abuse
them. The anti-diversion efforts need to strike a balance
between the need to reduce abuse and diversion while avoiding
disruptions to legitimate patients.
Thank you again for this opportunity to participate in the
hearing, and I hope this overview was valuable to the
committee. Thank you, Mr. Chairman.
[The prepared statement of Mr. Gray follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman and now
recognizes Mr. Barber 5 minutes for an opening statement.
STATEMENT OF D. LINDEN BARBER
Mr. Barber. Good afternoon, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee. Thank you for the
opportunity to testify.
My name is Linden Barber, Partner at Quarles & Brady. I am
a former associate chief counsel at DEA. H.R. 4069 provides
much needed clarity in the Controlled Substances Act, and that
clarity will foster compliance, communication and
collaboration, which is essential to preventing prescription
drug abuse and ensuring that patients have access to controlled
medications.
History tells us why clarity is important. In 2006, DEA
stopped issuing immediate suspensions for 8 months because a
Federal court ruled that the way DEA issued suspensions was
unconstitutional. During that critical time, Internet
pharmacies were fueling prescription drug abuse with millions
of pills, and the agency issued zero immediate suspensions.
That is Exhibit A for why clarity in the law is so important.
The CSA allows DEA to immediately suspend a registration based
on imminent danger to the public health, but the act does not
currently define ``imminent danger.'' This lack of clarity and
DEA's inconsistent approach to immediate suspensions has led to
judicial intervention. Defining imminent danger will protect
DEA's ability to issue immediate suspensions.
In 1974, a year after DEA was created, a pharmacy
successfully challenged DEA's immediate suspension order
because the alleged danger was one single incident that
occurred more than 7 months before the suspension, far from an
imminent danger. More recently, the 2006 case I mentioned
echoed that same theme, and last year, the DC Circuit Court of
Appeals raised pointed concerns about the DEA's apparent lack
of a standard in applying the imminent danger definition or
lack thereof when issuing suspensions. History is sending a
message. In the absence of clarity in the law, courts will
intervene, and they will curtail DEA's powers.
After the 2006 adverse decision, I became the associate
chief counsel at DEA and was charged with fixing the immediate
suspension process for the agency. As part of that, the agency
took a disciplined approach to applying the imminent danger
standard, an approach that is consistent with the definition of
imminent danger in H.R. 4069. Using that approach, we issued a
record number of immediate suspensions in 2007 and 2008. I am
confident that defining imminent danger the way this bill does
will not impede DEA's ability to issue immediate suspensions.
The lack of clarity in DEA's inconsistency has unintended
but devastating consequences for the public. Why would a
pharmacist tell DEA about a doctor's bad prescribing habits if
DEA was going to use that to suspend the pharmacy's
registration, even though the pharmacy was no longer filling
those prescriptions? This is not a hypothetical. The agency has
issued suspensions for conduct that it knew was no longer
occurring. Registrants get this message: Don't tell DEA about a
bad prescriber who is the real source of diversion because DEA
might take action against you.
Clarity in the law will remove that fear and foster
communication that helps DEA identify truly bad actors. Clarity
also promotes access to controlled medications for patients.
Without clarity, registrants often act to reduce the perceived
risk of regulatory action. A pharmacist refuses to fill
legitimate prescriptions for narcotics simply because
dispensing a high volume of narcotics brings the attention of
the agency and the supplier on the pharmacy.
No one wants cancer patients or wounded veterans or those
with chronic pain to go without their pain medication, but
restricting access is an unintended consequence of a regulatory
environment that lacks clarity.
The corrective action plan section of the bill also
promotes communication with the agency by assuring registrants
that the agency will consider remedial actions they have taken.
It is important to note that the remedial action section and
corrective action plan does not apply to immediate suspensions
for the reasons I discussed in my written testimony.
Nearly a decade ago, DEA crippled elicit Internet pharmacy
schemes. We issued a record number of administrative actions,
collected record-setting civil penalties, but prescription drug
abuse continued to rise. All along, DEA was working tirelessly
to protect the public, and all along, the vast majority of
registrants were looking for ways to cooperate with the agency.
Members of the subcommittee, how can these efforts of the
agency and industry be harnessed to effectively address
medications for patients and to prevent diversion? The answer
is with clarity. Clarity will produce compliance, communication
and collaboration, and that collaboration will produce real
results in preventing the prescription of diversion drugs and
their abuse.
[The prepared statement of Mr. Barber follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentleman.
I now recognize Ms. Selig, 5 minutes for an opening
statement.
STATEMENT OF WENDY K.D. SELIG
Ms. Selig. Thank you, Mr. Chairman, good afternoon, Ranking
Member Pallone and members of the subcommittee. My name is
Wendy Selig, and I am the President and CEO of the Melanoma
Research Alliance, known as MRA. Thank you again for inviting
me to testify today on behalf of my colleagues in the Public
Access to Sunscreens Coalition, known as the PASS Coalition, in
support of H.R. 4250.
The PASS Coalition is a multistakeholder group that
advocates for a regulatory pathway for new, safe and effective
sunscreen ingredients. The goal of the coalition is to work
collaboratively to establish a transparent and predictable
process for premarket review of sunscreen components. MRA is a
unique non-profit organization whose mission is to end
suffering and death due to melanoma by collaborating with all
stakeholders to accelerate powerful research, advance cures for
all patients, and prevent more melanoma. We are the leading
private funder of melanoma research, having awarded more than
$51 million in cutting-edge scientific projects around the
world.
Mr. Chairman, as has been discussed here this afternoon,
skin cancer is the most common form of cancer diagnosed in the
United States, with more new cases of skin cancer than breast,
prostate, lung, and colon cancer combined every year. Melanoma,
which is the deadliest of the skin cancers as a result of its
ability to move quickly and to spread to distant organs in the
body, is rising dramatically across demographic groups.
Each year, more than 76,000 Americans are diagnosed with
melanoma, one every 8 minutes, and more than 9,400 Americans
die, one every hour. So, in the time that we have been sitting
here, we have lost several melanoma patients.
We have made real strides on the treatment front, as four
new drugs have been approved for use by the sickest of these
patients. We commend the FDA and especially Drs. Woodcock and
Pazdur and their colleagues for their work in this area,
including landmark efforts in immune therapy, biomarket-driven
targeted therapies, combination therapies, and breakthrough
therapy designation to speed review processes. These new drugs
are saving lives, and their approval and use are paving the way
for continued investment and innovations that will bring about
even more dramatic progress.
Still we know that more effective options for patients are
urgently needed. Everyone is at risk for developing melanoma.
One of the risk factors, as we have been discussing today, for
all skin cancer and specifically for melanoma is exposure to UV
radiation. In fact, one blistering sunburn that happens during
childhood can double a person's lifetime chance of developing
this deadly skin cancer. We take every opportunity to urge
people to protect themselves and their loved ones by reducing
exposure to UV from the sun, from tanning beds, and to examine
their skin and watch for changes and see a dermatologist
regularly, especially if they notice a change.
A central message is that people should use effective
sunscreen protection all year round. As you know, FDA is
responsible for ensuring the safety and effectiveness of all
drugs, including evaluating medical claims related to
sunscreens and sunscreen ingredients. The 2002 TEA process
envisioned a 90 to 180 day evaluation process. Yet as we have
been discussing today, FDA as not completed the review of any
new sunscreen component under TEA or its preexisting OTC
process since the 1990s. I think everyone agrees the current
sunscreen premarket review process needs to be reformed.
It is important that I point out that the sunscreens
Americans use today can be effective for those who use them
correctly. However, the latest products developed and used
around the world can offer important steps forward and should
be made available in the U.S. if found to be safe and
effective. Finding innovative ways to make these products more
effective and user-friendly can help ensure more people are
using them properly and to maximum effect. Unfortunately, given
the history of stalled reviews under the FDA's current process,
there is a strong disincentive for investment in this kind of
sunscreen innovation for the U.S. market.
The Sunscreen Innovation Act would codify a time frame for
review and provide FDA with the authority to make a final
scientific decision on the application instead of going through
the cumbersome and delayed rulemaking process. While keeping
the existing process whereby FDA makes an ultimate eligibility
determination, the act says an existing advisory committee of
experts will review the safety and advocacy data. It ensures
that all submissions are reviewed within a predictable time
frame. Enactment of this legislation would be a victory for
everyone, for the FDA, for manufacturers, and, most
importantly, the American people. Mr. Chairman and members of
this subcommittee, I commend you for holding this hearing and
to Mr. Whitfield and Mr. Dingell for taking the lead on this
bill.
May is Melanoma Awareness Month, just a few weeks from now.
As the weather improves and people are once again making plans
for outdoor activities, MRA and the PASS Coalition look forward
to working collaboratively with you and the FDA to enact the
Sunscreen Innovation Act this year, and we hope perhaps we can
see progress on that in Melanoma Awareness Month.
Thank you, and I'd be happy to answer any questions.
[The prepared statement of Ms. Selig follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentlelady.
And I now recognize Mr. Faber, 5 minutes for an opening
statement.
STATEMENT OF SCOTT FABER
Mr. Faber. Thank you, Mr. Chairman, members of the
committee. EWG strongly supports the goals of the Sunscreen
Innovation Act, and we look forward to working with the
committee to expedite the review of sunscreen ingredients.
I don't think I need to spend any time describing why skin
cancer is a public health crisis or how FDA has not had the
incentives to quickly review and approve sunscreen ingredients
that have been used in Europe, Australia and other countries.
So let me just take a few minutes to describe some of the truly
modest improvements that we would propose to this act that we
think would ultimately make it a more workable piece of
legislation.
So, first, and Mr. Dingell referred to this, we believe
that to be eligible for expedited review, that a sunscreen
ingredient should have been used for 5 years in a country with
a competent regulatory system or, as Mr. Dingell put it,
roughly equal to ours. As currently drafted the Sunscreen
Innovation Act would allow expedited review for an ingredient
that has been used in any one country for 5 years. It doesn't
distinguish between any one country and other countries that
may have similar review systems to the U.S. review systems.
Second, ingredients that are subject to expedited review
should have been used as sunscreen ingredients, not as cosmetic
ingredients or ingredients in dietary supplements, and one
provision of the bill does suggest that those ingredients,
ingredients that have been used for this purposes, could be
eligible for this expedited review of sunscreen ingredients in
the U.S.
Third, and perhaps most importantly, I think it is very
important that the panel that does review these ingredients
that have been used in the EU and Australia and elsewhere has
the technical competency to review potential health risks posed
by sunscreen ingredients as Dr. Woodcock said, that might
result from repeated long-term exposures. And while the
Nonprescription Drugs Advisory Committee has many experts, they
may not have the expertise to quickly and thoroughly review all
of the potential health effects that might result from the
sorts of ingredients that we are requiring for review.
Fourth, and we have heard a little bit about this already.
We think that Congress should set deadlines but workable
deadlines for FDA and this advisory committee. For example, the
current draft, under the current draft, the expert panel would
be required to review all of the eight pending Time and Extent
Applications that FDA within 180 days, which seems like a
herculean task. So while we think deadlines are important, in
light of the long history of delay, deadlines are essential, we
think those deadlines need to be workable and, again, that the
advisory panel that reviews these ingredients has the technical
competency to really do a thorough evaluation.
Similarly, we think the FDA should have more than 45 days
to respond to a recommendation by the advisory panel envisioned
by the Sunscreen Innovation Act.
Fifth, we think that ultimately, although there is an
important role here to be played by a panel of experts, that
ultimately, FDA should make the final determination of
ingredient safety and that supervisors who are reviewing CDER
staff decisions should have the power to ask for more
information, either from FDA staff or from the panel, not
simply to decide whether or not the ingredient should be
intercommerce or not.
Sixth, we believe that applicants seeking expedited review
should provide both published and unpublished data regarding
the safety and efficacy of sunscreen ingredients, and that data
should be shared with the public. Obviously, the current bill
does envision a role for the public, and we appreciate that. I
think we just need to be clear about precisely what we are
asking companies to provide, if they are going to receive
expedited review and how much of that is available to the
public.
And then, lastly, we think it is critically important that
FDA be required to finalize a proposal to restrict the use of
SPF claims greater than 50. Other countries have taken steps,
including Australia and Japan and others, to restrict SPF
claims greater than 50. But we do think that FDA should be
given more time than is envisioned in the current bill to
assess the inhalation risks and other risks posed by aerosol
sprays. FDA has started to look at this question. It has only
begun in the last few years. It is a critically important
health question. We think they should be given the time to do a
thorough and a fair assessment.
Let me just simply close by saying that we applaud
Congressman Whitfield and Mr. Dingell for your leadership. We
share the goals of the Sunscreen Innovation Act. We look
forward to working with you to give FDA the help it needs to
quickly review and approve these promising ingredients. Thank
you.
[The prepared statement of Mr. Faber follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. Chair thanks the gentleman.
That concludes the opening statements.
We will now go to questioning. I will recognize myself 5
minutes for that purpose.
Dr. Fountain, can you please describe the impact DEA delays
have on patients suffering from epilepsy?
Mr. Fountain. Well, in addition to the impact we talked
about before, of the risk of death during the whole time
seizures are active, there is a much wider and more difficult
perspective. So about 3 million Americans have epilepsy and
about 1 million of them, so almost a million Americans, have
intractable epilepsy, meaning they continue to have seizures
despite our best efforts. So for all of those people, having a
delay in treatment can be life-threatening, as we talked about.
And that affects a relatively few people in a very important
way. There is also a huge effect on everyone else. Because for
the remainder of people, they need new drugs available soon
because they are waiting for a new drug to control their
seizures.
Epilepsy is difficult in many ways, but one of the ways is
that, although we now have almost 20 drugs available for the
treatment of epilepsy, we still have this group of people that
continue to have seizures despite our best efforts. But as each
new drug is approved, we are able to control more and more
people with epilepsy. And if you are in that group that is
controlled, then waiting for that drug is a longer time that
exposes you to the problems of epilepsy.
Mr. Pitts. Thank you.
Mr. Barber, do you believe DEA adequately factor legitimate
patient access into its registration and scheduling time frames
as well as its enforcement decisions?
Mr. Barber. Mr. Chairman, I will first address the issue of
scheduling, particularly with regard to new molecular entities.
The studies that are done by HHS are binding on DEA when it
comes to the medical and scientific factors, and so the delay
time in studying a new molecular entity is curious because
there is no law enforcement data for a molecule that has not
previously existed. So looking for issues of real diversion and
law enforcement activity around a new molecular entity seem
like they should be very brief because the entity has not
previously existed.
I believe that DEA does care about patient access. I am not
sure that they necessarily take into account the unintended
consequences of the significant delays that come with new
molecular entities when scheduling.
With respect to enforcement activity, certainly, Mr.
Chairman, I do believe and as a long-time DEA employee--I have
been gone for 2\1/2\ years--I believe the agency cares about
patient access. But, again, it is the unintended consequences.
Mr. Rannazzisi testified previously and knowing him, he is a
pharmacist, he does care about patient access. I am just not
convinced that the way the agency handles enforcement
activities contemplates all of the unintended consequences in
the supply chain.
Mr. Pitts. Mr. Gray, do you have anything to add on this
front?
Mr. Gray. I believe his assessment is correct. I think they
have a legitimate goal.
I think, as you said, Mr. Rannazzisi is a pharmacist
himself. But it is the law of unintended consequences when you
apply what I would call enforcement tactics for illegal drugs
to the legal market. And what happens is what has happened in
the case of our members is without specific guidance and detail
as far as how they are to interpret suspicious orders, then our
members are forced into situations where they make decisions to
terminate relationships with pharmacies, thereby immediately
limiting that pharmacy's ability to get certain Schedule II
drugs.
Mr. Pitts. Would either of you comment on how a more
collaborative relationship between supply chain, stakeholders,
and the DEA, would help in our effort to address prescription
drug abuse and diversion?
Mr. Barber. Certainly, Mr. Chairman.
I will point to a historical example that really brings
this to light. There was a significant problem with methadone
overdose deaths related to the 40-milligram methadone diskette.
And without any regulation, without any new law, DEA called
manufacturers and distributors in and asked them to voluntarily
not sell the 40-milligram methadone diskette, except for
narcotic treatment programs, not to sell it for dispensing for
pain. And the manufacturers and distributors responded and
voluntarily did that, and it reduced the overdose deaths
related to 40-milligram diskettes, so collaboration absolutely
actually addresses the real problem of prescription drug abuse.
Mr. Pitts. Ms. Selig, Mr. Faber, Dr. Woodcock committed to
working with the committee to improve the timelines and
predictability of the Time and Extent Application, TEA, process
is a it relates to new sunscreen ingredients. Do you think the
TEA process provides an efficient mechanism by which these
types of products can get to consumers in the U.S., and what
else can be done?
Ms. Selig. Thank you, Mr. Chairman. I appreciate Dr.
Woodcock's statement, and we look forward to continuing to work
with FDA. That said, I think that we have heard repeatedly from
FDA, and our own assessment is we need your help here in
Congress, and that is why we support this legislation, that the
current regulatory process that the TEA system and the OTC
system for sunscreens is based on has really been broken. And
in order to not only clear out the backlog that exists with
those eight applications that are pending, but to encourage
innovation and to bring the most cutting-edge innovation to
American consumers, we need your help with this legislation.
Mr. Pitts. Mr. Faber, do you want to add anything?
Mr. Faber. I will just had that this process has been in
place since 2002, and FDA has been unable to review and improve
even one sunscreen ingredient, and that six of the eight
ingredients that have sought applications, have filed
applications, have languished at FDA for more than 8 years. So
I think, clearly, as we have all heard today, that this process
is not working for consumers or for manufacturers.
I do think, with all due respect to Dr. Woodcock, that we
should not have to wait for a reformation of the sense of the
monograph process for FDA and with the help of an advisory
panel to review and approve some of these very promising
ingredients.
Mr. Pitts. The Chair thanks the gentleman. My time is
expired.
The Chair now recognizes Mr. Green 5 minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
Dr. Fountain, can you describe what your organization's
communication with DEA is like, and how do you think it could
be improved?
Mr. Fountain. Our communication has been limited to more or
less the issue at hand because of the seemingly desperate
situation that I mentioned before about how long it has taken
to have the most recently approved, FDA approved drug scheduled
by the DEA. In that case, the communication was sent to DEA and
received a response 7 and a half months later, and we don't
have--I would have to inquire of the whole organization, but I
am not aware of any ongoing dialogue.
Mr. Green. And as you know from my questions of the DEA, I
have problems with that. I think the DEA needs to be more
transparent in dealings with patients, doctors and companies
regarding scheduling and registration decisions. I think it
needs to have a predictable time frame for making these
decisions, and I think the decisions need to be made more
quickly, and I hope we can pass our bill to fix it.
Mr. Faber and Ms. Selig, H.R. 4250 could be seen as ceding
to FDA decisionmaking authority to an advisory committee,
although it does provide the FDA with some authority to reject
that decision. As far as I know, this would be unprecedented
use of the advisory committee. I would like to get both of your
reactions to the description in the bill.
Mr. Faber. As I said earlier, I do think that there needs
to be some very modest improvements made to the Sunscreen
Innovation Act that would give FDA more time to review the
recommendation of a technically competent advisory panel and
that the FDA should have the final say regarding the safety and
efficacy of a sunscreen ingredient. I think one of the
important changes is that there is an appeals process
envisioned in this bill where the supervisory staff, CDER
staff, could ultimately overrule a staff decision. That
supervisor should have the power to ask staff for more
information, to ask the panel for more information, and not
simply be in the position of having to approve the panel's
recommendation.
Mr. Green. Would the PASS Coalition be willing to work with
the committee and the FDA to improve the legislation to get a
bill that would work for all of us?
Ms. Selig. Absolutely. The coalition has been attempting to
work with everybody involved throughout this process and has
had multiple conversations and meetings with all stakeholders
and will absolutely continue to do that.
I think that the bill as drafted would be a great step
forward, and we envision, obviously, and from the perspective
of melanoma patients and from the public in terms of our
recommendation to the American people about using safe and
effective sunscreen and using it properly, we definitely want
to make sure that these products are reviewed in an appropriate
regulatory environment by the FDA to be both safe and
effective.
That said, the current process doesn't work. One reason
that we have been told that it has been so difficult is because
of the regulatory rulemaking process. So I think the proposal
that is in the legislation is aimed at trying to get out from
under that so that we can move these things forward in an
appropriately timely manner and get back to innovating in this
country, as opposed to watching the rest of the world have
access to more innovation than we are having here. So we
absolutely will work with everybody to try to make this bill
better, but we definitely want to see the legislation move
toward.
Mr. Green. Mr. Gray, prescription drug abuse is on the rise
and represents significant growing public health threat.
Congress and relevant Federal agencies in public and private
have responsibilities to address this epidemic and ensure the
health and safety of the American people. What in your opinion
is the appropriate role of prescription drug distributors in
the fight to eliminate and prevent this prescription drug
abuse?
Mr. Gray. Well, my members, we have 34 companies that
deliver over 98 percent of the prescription drugs in this
country, so we are a logical choice to look at where the drugs
are coming through and going to. We have the ability, as we do
every day, to monitor the ordering of Schedule II drugs to
every pharmacy and clinic in the country. We keep that data. We
give it weekly to the DEA. And, in fact, that has been one of
the conundrums we face is each distributor submits their data
to the DEA. The DEA collects the entire picture but does not
share even a redacted version of that entire picture. So one
distributor may know what they give to a certain pharmacy, but
they don't know the other wholesalers, what they are providing
that pharmacy. So it is not a complete picture. The information
is there. Our members have the technical capability to create
that information. And our goal here is to be able to work
collaboratively with DEA as a partner in this problem to say,
does your information show what our information is, that this
pharmacy is over its limits? Great. Cut that pharmacy off. And
unfortunately, that is not the relationship we have today.
Mr. Green. Thank you, Mr. Chairman. I am out of time.
Mr. Pitts. Chair thanks the gentleman.
I now recognize the vice chair of the full committee, Mrs.
Blackburn, for 5 minutes of questioning.
Mrs. Blackburn. Thank you so much, and I want to stay with
Mr. Gray and follow on with Mr. Green's questioning, because as
Mr. Rannazzisi said several times, DEA doesn't have quotas for
the distributors, so it is up to the distributors to basically
model how they are going to interact with the pharmacies on
this product. So looking at the answer you just gave, is there
anything else you would add into how these distributors are
modeling their activity on the distribution of these drugs? And
then I would like for you to talk for just a second about why
this is problematic for our smaller pharmacies.
Mr. Gray. Well, let's go back on that story line we were
just talking about. When our members submit their suspicious
orders on a weekly basis, DEA collects that data. They collect
data from all wholesalers. Imagine it as a piece of pie. They
see the pharmacy as a piece of pie. They will see the 360
degrees of that piece of pie. They see everything going in the
door of that pharmacy with respect to Schedule II drugs. The
particular distributor, who DEA may be questioning--and you can
correct me if I am wrong on this, Linden--but the DEA sees the
whole picture. That particular distributor sees only their
slice of the pie. They do not see what other distributors are
doing.
Mrs. Blackburn. So let me ask you. Would it be helpful then
if the DEA were to periodically give a report back to those
distributors as to where they are seeing patterns that are
troublesome?
And Mr. Barber, you may want to weigh in on this since you
basically were involved in taking action.
Mr. Gray. It would certainly help because I know, in many
cases, talking to my members, is that they will approach the
regional office of DEA and say, ``We have got a pharmacy here,
pharmacy X; pharmacy X to us has suddenly seen an increase in
ordering. This is out of their normal historical trend. Mr. DEA
agent or Ms. DEA agent, should we cut that pharmacy off?''
And the answer most typically back is, ``Well, that is a
business decision the wholesaler needs to make on their own,
and then we will essentially fundamentally let you know if you
were wrong after the fact.''
So you are right. He was right. There are no quotas, but
again, that creates the conundrum and the problem because not
having quotas gives DEA the flexibility to take enforcement
action I think without any kind of clarity to the wholesalers
as to whether or not they are making the right business
decision in terminating that pharmacy.
Linden, I don't know if you have a different opinion.
Mr. Barber. Mrs. Blackburn, I have looked at some of the
DEA information that they have provided the industry. One of
the things that we hear over and over again from the agency is
there is an average number of pills that a pharmacy uses, but a
pharmacy that fills 50 prescriptions a day uses a lot less
drugs than a pharmacy that fills 500 prescriptions a day, and
being above arrange is meaningless because if you have a normal
distribution curve, half of your customers are going to be
above average, and so it would be very helpful to industry if
there was trending and modeling done not just by the industry,
but by the agency who has all of the information.
Mrs. Blackburn. OK. Mr. Barber, in your testimony, you
focused a little bit on the importance of clarity of the law,
and are there some specific areas that you think we should
highlight in working with the DEA on how they should be more
clear with the registrant?
Mr. Barber. Certainly, and I think your bill takes a great
first step in creating the environment that is necessary by
clarifying what ``imminent danger'' means and what ``consistent
with the public health and safety'' means. At an industry
conference recently, a DEA official told the industry that it
means whatever DEA says it does. That is not really helpful
when you are trying to comply with the law. There are other
areas where I believe that oversight can be helpful,
particularly in the regulatory environment. The agency will
talk about things like due diligence by distributors on
customers and yet you won't find the term ``due diligence''
anywhere in DEA's regulation. And so areas like that require
clarification and notice and comment rule making because it is
those types of initiatives that actually will prevent
prescription drug abuse.
Mrs. Blackburn. Thank you.
I yield back.
Mr. Pitts. Chair thanks the gentlelady.
Now recognizes the ranking member emeritus Mr. Dingell for
5 minutes for questions.
Mr. Dingell. Mr. Chairman, thank you for your courtesy.
These questions are for Ms. Wendy Selig of the Melanoma
Research Alliance. They will only require yes or no answers.
Ms. Selig, do you believe that skin cancer is a public
health crisis in this country today? Yes or no.
Ms. Selig. Yes.
Mr. Dingell. Ms. Selig, is it correct that one American
dies of melanoma every hour? Yes or no.
Ms. Selig. Yes.
Mr. Dingell. Ms. Selig, is exposure to UV radiation a major
risk factor for skin cancer? Yes or no.
Ms. Selig. Yes.
Mr. Dingell. Now, Mr. Faber. This is for Mr. Scott Faber.
Mr. Faber, your organization has extensive experience in this
area. Do you agree that sunscreens which provide balanced UVA
and UVB protections help lower the risk of getting skin cancer?
Yes or no.
Mr. Faber. Yes, sir.
Mr. Dingell. Mr. Faber, to confirm, do people in Europe,
Canada, and elsewhere, have access to more new innovative
sunscreen products than do consumers in the United States? Yes
or no.
Mr. Faber. Yes.
Mr. Dingell. Very quickly, why is that?
Mr. Faber. Because our FDA has failed to provide a process
that allows expedited review of promising sunscreen
ingredients.
Mr. Dingell. I have been observing that they are sitting on
those regulations like a hen on a porcelain doorknob.
Mr. Faber. Yes, sir.
Mr. Dingell. Now, Mr. Faber, is it correct that FDA has not
acted on applications for several chemicals that offer strong
UVA protection but are already in use in the European Union and
in Australia? Yes or no.
Mr. Faber. Yes, sir.
Mr. Dingell. Mr. Faber, do you believe that the American
people deserve access to these promising sunscreen technologies
as long as they are proven to be safe and effective? Yes or no.
Mr. Faber. Absolutely. Yes, sir.
Mr. Dingell. Mr. Faber, do you agree that the legislation
is needed to improve FDA's review of sunscreen ingredients? Yes
or no.
Mr. Faber. Yes, sir.
Mr. Dingell. Mr. Faber, you have been before this committee
on a number of occasions, and I have always appreciated your
wisdom and assistance.
Thank you to our panel.
It is clear to me that skin cancer is today a major public
health crisis in this country, and legislation is needed to
improve FDA's review of new sunscreen ingredients, which they
are sitting most tranquilly by.
The Sunscreen Innovation Act is one way to do so. I look
forward to working with all of my colleagues to improve this
legislation in whatever bipartisan manner may be necessary so
it can be signed into law this year.
I would point out that each hour, there is going to be an
American somewhere dying of melanoma and skin cancer, and it
does seem that maybe the Congress can assist the Food and Drug
to come to a proper conclusion of addressing the concerns that
we have about keeping Americans safe and affording them the
same privileges and protections that are given in Europe, where
there have apparently been no backlash, no problems about the
question of safety with regard to these pharmaceuticals.
Ladies and gentlemen of the panel, thank you.
Mr. Pitts. The chair thanks the gentleman.
Now recognize the gentleman from Kentucky, Mr. Whitfield, 5
minutes for questions.
Mr. Whitfield. Thank you, and I certainly agree with all
the comments made by Mr. Dingell and particularly that relating
to the porcelain knob. I like that.
Let me just say this, Mr. Faber, thank you for your
testimony and for coming up with some concrete suggestions on
ways to improve the legislation, and Ms. Selig, I really do
want to thank you and the Melanoma Research Alliance as well as
the task group for sort of leading the charge on this issue. I
was wondering, had you been aware of the suggestions that Mr.
Faber made today before he made them today?
Ms. Selig. I think recently, yes, and we really appreciate
the constructive effort to help everybody come up with a
product that Congress can move forward with quickly.
Mr. Whitfield. I wish that the PASS group would get
together with Mr. Faber's organization and see if we can come
up with some improvements, and then maybe both sides of the
aisle working together, we can move this legislation. And I
know that Dr. Woodcock and others at the FDA have indicated
they want to do something, so maybe we can help them make the
decision on what should be done. So if you all would do that
and get back with us, we would appreciate it.
Mr. Faber. Absolutely.
Mr. Whitfield. I yield back now.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the gentleman from Virginia, Mr. Griffith,
5 minutes for questioning.
Mr. Griffith. Thank you, Mr. Chairman.
Mr. Gray, I am up here trying to problem solve and figure
these things out because you may have heard my example earlier
when I was standing in my local pharmacy, and they were under
the impression, DEA witness testified that that was incorrect,
that there is no quota, and you have said that as well, but the
distributors have to watch it and be careful, and they don't
really know when it is they are going to get in trouble with
the DEA.
Mr. Gray. Correct.
Mr. Griffith. So here is what I have come up with that may
be affecting--and I represent a fairly rural district that has
a lot of small pharmacies. We have fewer mom-and-pop pharmacies
than we used to, but still serve a fairly rural, somewhat
suburban, but fairly rural community, and that is that
apparently it may be true that at some of the smaller
pharmacies, they only use one distributor. Has that been your
experience, that maybe some of the small pharmacies use one
distributor for their drugs?
Mr. Gray. You know, I think that will depend upon the where
and the when. I mean, I would say, and this is just anecdotal,
that is probably true the more rural that it is. More than
likely it is one wholesaler involved.
But that being said, there is a growing secondary and
tertiary industry. When pharmacy cannot get product, they go
into those markets to get that product. So it very well may be
that they are actually dealing with other wholesalers that may
or may not be reporting data to the DEA. It is very possible.
Mr. Griffith. The concern that I have is that maybe they
are being flagged, and the distributor is saying, OK, we can't
send you any more because you are getting more than the
distributor, you know, next valley over or down the road,
depending on the size of the pharmacy. And if you are only
using one, that is going to flag. As you said, the DEA gets the
whole picture, but each distributor only sees what they are
doing.
Mr. Gray. Correct.
Mr. Griffith. And so they can see a pharmacist perhaps that
is using one wholesaler or distributor getting more drugs than
some of his contemporaries nearby, but they may be using two
distributors, but the first distributor is never going to know
that they are getting two sources or three sources versus just
the one.
Mr. Gray. Well, the layer of complexity to that is then it
depends upon the demographics of that pharmacy and the patient
population because the pharmacy in your district may have
historically a number of pain patients. They may be near pain
clinics. They may be hospitals or cancer clinics. And so it
does vary. This is a difficult target because it does vary by
pharmacy, by the location, by the demographics of the pharmacy,
by the business model, where it is relative to other health
care delivery systems in the area. So it is not as black and
white as you might think, and that is where any amount of
clarity we can get from the DEA as a wholesaler will be of
extraordinary help.
Mr. Griffith. And so that is why you feel that they ought
to share some of that information so that you all can get the
big picture, too. Not that we want to help the bad guys.
Mr. Gray. That is right.
Mr. Griffith. And so you think that perhaps the information
sharing that is envisioned by 4069 would be a good thing?
Mr. Gray. I think it would be an excellent thing.
Mr. Griffith. And you think that this might help my
pharmacy back home?
Mr. Gray. I think it would help your pharmacy back home
because whatever that wholesaler, whoever it was, made that
decision, made it because they know the historical purchasing
and delivering with that pharmacy, and they probably saw an
uptick depending upon the time of the year or whatever. And the
way it is played now, is if there is an uptick, then that is
defined in the wholesaler's mind, that is suspicious. And the
immediate reaction is if it is suspicious, you must terminate,
and then talk with the appropriate people. So the decision
always is to terminate first when in doubt.
Mr. Griffith. Now, in this case, they didn't apparently
terminate long term. Is that what the normal is, or just say no
more for this month, or this cycle?
Mr. Gray. Well, good point. It should be for a finite set
of time. In fact, we submitted a series of questions on two
occasions to the DEA in the last 24 months. Do not have answers
to those questions. One of them actually addressed that issue.
For example, we asked a group of our members, said is 90 days,
is 120 days, what is the appropriate amount of time before a
wholesaler should reinstitute sales to that? What is the
appropriate move on the trend line of the purchase order of
that pharmacy to make that decision? Unfortunately, to this
date, we have no answers. We have got no guidance from the
agency.
Mr. Griffith. It is a difficult answer, and so I certainly
don't want to be critical of the DEA trying to control
medications that shouldn't be out there on the street and
making sure that they are not going to folks who shouldn't have
them. At the same time, we want to make sure that the Judge's
wife that I mentioned earlier and that this lady whose mother
desperately needed that medication are able to get it. So it is
a balancing act. I appreciate that, and of course, being a
legislator by nature and at heart, having served here not so
long, but served a long time in Virginia, I recognize that it
is the role of the legislative body to help enact that and move
things forward, so I hope that we can get some form of 4069
passed.
And, Mr. Chairman, I yield back.
Mr. Pitts. The Chair thanks the gentleman and also thanks
the witnesses for your testimony, for answering our questions.
There will be follow-up questions. We will provide those to you
in writing. We ask that you please respond as promptly as
possible. I will remind members they have 10 business days to
submit questions for the record, and that means members should
submit their questions by the close of business on Monday,
April 21. Very important health and public safety issues raised
today. Thank you very much.
Without objection, the subcommittee is adjourned.
[Whereupon, at 5:50 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[all]