[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]


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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky               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:]
    
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    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:]
    
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    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:]
    
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    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:]
    
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    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:]
    
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    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:]
    
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    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.]
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