[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


                     MODERNIZING FDA'S REGULATION OF
                         OVER-THE-COUNTER DRUGS

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 13, 2017

                               __________

                           Serial No. 115-55
                           
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           
                           

      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                               __________
                               

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                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
TIM MURPHY, Pennsylvania             ELIOT L. ENGEL, New York
MICHAEL C. BURGESS, Texas            GENE GREEN, Texas
MARSHA BLACKBURN, Tennessee          DIANA DeGETTE, Colorado
STEVE SCALISE, Louisiana             MICHAEL F. DOYLE, Pennsylvania
ROBERT E. LATTA, Ohio                JANICE D. SCHAKOWSKY, Illinois
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas                    JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida            YVETTE D. CLARKE, New York
BILL JOHNSON, Ohio                   DAVID LOEBSACK, Iowa
BILLY LONG, Missouri                 KURT SCHRADER, Oregon
LARRY BUCSHON, Indiana               JOSEPH P. KENNEDY, III, 
BILL FLORES, Texas                   Massachusetts
SUSAN W. BROOKS, Indiana             TONY CARDENAS, California
MARKWAYNE MULLIN, Oklahoma           RAUL RUIZ, California
RICHARD HUDSON, North Carolina       SCOTT H. PETERS, California
CHRIS COLLINS, New York              DEBBIE DINGELL, Michigan
KEVIN CRAMER, North Dakota
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia

                         Subcommittee on Health

                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
TIM MURPHY, Pennsylvania             DORIS O. MATSUI, California
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)

                                  (ii)
                            
                            
                            C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     3
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     5
    Prepared statement...........................................     6
Hon. Frank Pallone, a Representative in Congress from the State 
  of New Jersey, opening statement...............................     7
    Prepared statement...........................................     8

                               Witnesses

Janet Woodcock, M.D., Director, Center for Drug Evaluation and 
  Research, Food and Drug Administration, Department of Health 
  and Human Services.............................................    10
    Prepared statement...........................................    12
    Answers to submitted questions \1\...........................   140
Scott Melville, President and Chief Executive Officer, Consumer 
  Healthcare Products Association................................    95
    Prepared statement...........................................    97
    Answers to submitted questions...............................   143
Kirsten Moore, Project Director, Healthcare Products, The Pew 
  Charitable Trusts..............................................   100
    Prepared statement...........................................   102
    Answers to submitted questions...............................   146
Michael Werner, Partner, Holland & Knight, on behalf of the 
  Public Access to SunScreens (PASS) Coalition...................   107
    Prepared statement...........................................   109
    Answers to submitted questions...............................   150
Bridgette L. Jones, M.D., Chair, Committee on Drugs, American 
  Academy of Pediatrics..........................................   118
    Prepared statement...........................................   120
Gil Y. Roth, President, Pharma and Biopharma Outsourcing 
  Association....................................................   125
    Prepared statement...........................................   127

                           Submitted Material

Discussion Draft, H.R. ___, the Over-the-Counter Monograph 
  Safety, Innovation, and Reform Act of 2017 \2\
Letter of September 13, 2017, from Colin MacKenzie, Region Head, 
  Americas, GSK Consumer Healthcare, to Mr. Burgess and Mr. 
  Green, submitted by Mr. Lance..................................   139

----------
\1\ Dr. Woodcock did not answer submitted questions for the 
  record by the time of printing.
\2\ The information has been retained in committee files and also 
  is available at  http://docs.house.gov/meetings/IF/IF14/
  20170913/106396/BILLS-115pih-OTCMonograph.pdf.

 
                    MODERNIZING FDA'S REGULATION OF
                         OVER-THE-COUNTER DRUGS

                              ----------                              


                     WEDNESDAY, SEPTEMBER 13, 2017

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:15 a.m., in 
Room 2322, Rayburn House Office Building, Hon. Michael C. 
Burgess (chairman of the subcommittee) presiding.
    Members present: Representatives Burgess, Guthrie, Barton, 
Upton, Murphy, Lance, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), 
Green, Engel, Schakowsky, Butterfield, Sarbanes, Schrader, 
Kennedy, Eshoo, DeGette, and Pallone (ex officio).
    Also present: Representatives Latta, Costello, and Dingell.
    Staff present: Mike Bloomquist, Deputy Staff Director; 
Kelly Collins, Staff Assistant; Zack Dareshori, Staff 
Assistant; Paul Edattel, Chief Counsel, Health; Jay Gulshen, 
Legislative Clerk, Health; Elena Hernandez, Press Secretary; 
Edward Kim, Senior Policy Advisor, Health; Alex Miller, Video 
Production Aide and Press Assistant; Jennifer Sherman, Press 
Secretary; Jeff Carroll, Minority Staff Director; Samantha 
Satchell, Minority Policy Analyst; Andrew Souvall, Minority 
Director of Communications, Member Services, and Outreach; C.J. 
Young, Minority Press Secretary.
    Mr. Burgess. The Subcommittee on Health will now come to 
order. I will recognize myself 5 minutes for an opening 
statement.

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

    Today's hearing marks the Health Subcommittee's first 
public discussion on modernizing the current system at the 
United States Food and Drug Administration to review, approve, 
and update over-the-counter drugs. This hearing provides us and 
the American public with an opportunity to better understand 
the Food and Drug Administration's regulatory framework to 
regulate over-the-counter drugs and to consider a proposal to 
reform the monograph system.\1\
---------------------------------------------------------------------------
    \1\ The proposed legislation has been retained in committee files 
and also is available at  http://docs.house.gov/meetings/IF/IF14/
20170913/106396/BILLS-115pih-OTCMonograph.pdf.
---------------------------------------------------------------------------
    Today we will convene two panels of witnesses. First, I 
want to welcome Dr. Woodcock back to our subcommittee this 
morning. Later, we will hear from representatives of other key 
stakeholders and I would to commend all for their efforts 
throughout the negotiation process and for offering their 
insights to the committee.
    Both the Energy and Commerce Health Subcommittee and the 
full committee have a strong record of bipartisanship on 
important public health issues such as 21st Century Cures, the 
FDA reauthorization Act, and I hope to add to that record of 
success with today's hearing.
    Over-the-counter drug products treat a wide variety of 
ailments. Time and again, consumers seek antacids, pain 
relievers, eye drops, cough products as a first line treatment 
option before going to see their doctor and getting a 
prescription. These products also include anti-bacterial soaps, 
hand sanitizers, sunscreens and the sunscreens commonly used by 
many families in the United States.
    Currently, there are more than 300,000 over-the-counter 
products on the market according to the Food and Drug 
Administration. These products go through one of two approval 
processes to reach the store shelf. Manufacturers can one, 
submit a new drug application similar to new prescription 
drugs; or, they may conform to an OTC monograph which is a set 
of specific standards created by the Food and Drug 
Administration that ensures the product's active ingredients 
are generally recognized as safe and effective.
    The vast majority of over-the-counter products rely on the 
over-the-counter drug monograph system. Unfortunately, the 
current system has not had a significant update since the Food 
and Drug Administration first established this in 1972. So that 
is well over 40 years. In addition, this system requires a 
burdensome multistep rulemaking process that can take years to 
resolve. All of this has led to a lack of innovation and an 
inability for timely updates to address safety issues and much 
work unfinished at the Food and Drug Administration. Most of us 
on the committee feel that is unacceptable.
    The good news is, is that there is broad support from the 
Food and Drug Administration, from industry stakeholders, from 
patient groups for significant reform to regulate over-the-
counter products. The Health Subcommittee will examine Over-
the-Counter Monograph Safety, Innovation, and Reform Act of 
2017. The discussion draft was recently released by 
Representatives Latta, DeGette, Guthrie, Dingell, Green and 
myself. This bipartisan proposal establishes the over-the-
counter monograph user fee program that makes a number of 
meaningful modifications to the monograph process. The goal is 
to create a system that is more flexible and more efficient, 
that reflects scientific innovations so that patients and 
consumers have greater access to better and safer over-the-
counter drug products.
    Again, I want to welcome and thank all of our witnesses for 
being here this morning. We certainly look forward to your 
testimony.

             Prepared statement of Hon. Michael C. Burgess

    The subcommittee will come to order.
    The Chair will recognize himself for an opening statement.
    Today's hearing marks the Health Subcommittee's first 
public discussion on modernizing the current system at the U.S. 
Food and Drug Administration (FDA) to review, approve, and 
update over-the-counter (OTC) drugs. This hearing provides us 
and the American public with an opportunity to better 
understand FDA's regulatory framework to regulate OTC drugs and 
to consider a proposal to reform the OTC monograph system.
    Today we will convene two panels of witnesses. First, I 
want to welcome Dr. Woodcock back to this subcommittee this 
morning. Later, we will hear from representatives of other key 
stakeholders. I would like to commend all of their efforts 
throughout the negotiation process, and for offering their 
insights to Congress. Both the Energy and Commerce Health 
Subcommittee and the full committee have a strong record of 
bipartisanship on important public health issues, such as the 
21st Century Cures Act and the FDA Reauthorization Act. I hope 
to add to that record with today's hearing.
    OTC drug products treat a wide variety of ailments. Time 
and again, consumers seek antacids, pain relievers, eye drops, 
and cough products as first-line treatment options before going 
to see their doctor and getting a prescription. These products 
also include antibacterial soaps, hand sanitizers, and 
sunscreens commonly used by many families in the U.S. 
Currently, there are more than 300,000 OTC products on the 
market according to FDA. These products go through one of two 
approval processes to reach store shelves. Manufacturers can 
(1) submit a new drug application similar to new prescription 
drugs, or (2) conform to an OTC drug monograph, which is a set 
of specific standards created by FDA, that ensures the 
products' active ingredients are generally recognized as safe 
and effective.
    The vast majority of OTC products rely on the OTC drug 
monograph system. Unfortunately, the current system has not had 
a significant update since FDA first established it in 1972--
that's over 40 years. In addition, this system requires a 
burdensome, multi-step rule-making process that can take years 
to resolve. All of this has led to a lack of medical 
innovation, an inability for timely updates to address safety 
issues, and much work left unfinished at FDA. That is 
unacceptable. The good news is there is broad support from FDA, 
industry stakeholders, and patient groups for significant 
reform to regulate OTC products.
    The Health Subcommittee will examine the Over-the-Counter 
Monograph Safety, Innovation, and Reform Act of 2017 discussion 
draft recently released by Representatives Latta, DeGette, 
Guthrie, Dingell, Green, and myself. This bipartisan proposal 
establishes the OTC Monograph User Fee Program and makes a 
number of meaningful modifications to the monograph process. 
The goal is to create a system that is more flexible and more 
efficient, and reflects the scientific innovations so that 
patients and consumers have greater access to better and safer 
OTC drug products.
    I again want to welcome all of our witnesses and thank you 
for being here. I look forward to your testimony.

    Mr. Burgess. Before I yield to the ranking member, one 
housekeeping detail. Although this is the premier committee for 
technology in the United States Congress, some of our systems 
are not working this morning. So, I understand Dr. Woodcock had 
a series of slides, so those will be made available to you in 
paper form. We require our doctors to go paperless, but here on 
the committee, we can still deal with paper. And the clock is 
working, but only I can see it, Dr. Woodcock. So the red, 
green, and yellow lights are not working. I will give a brief 
two clicks when we are getting down into the yellow zone so 
that you will know that the time is to wrap up, and we will do 
that obviously for everyone on the committee, just as a gentle 
reminder we are coming to the end.
    So with that, I yield back and recognize the ranking member 
of the subcommittee, Mr. Green of Texas.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman. Thank you, Dr. 
Woodcock, and all of our witnesses here this morning.
    The over-the-counter OTC drugs are routinely used to treat 
a wide variety of ailments. We can go our local Walgreen's, 
CVS, or other retailer and don't even think about that bottle 
of Ibuprofen or sunscreen like we do with a prescription drug. 
OTC drugs provide a low cost, convenient way to take care of 
everyday healthcare needs. We have a growing number of choices 
in our local drugstores.
    According to the FDA and the Consumer Healthcare Products 
Association, the OTC market now includes more than 300,000 
products with annual sales of $32 billion. The items available 
over-the-counter are diverse, ranging from cough and cold 
medications, and pain relievers to sunscreens, and soon, 
hearing aids. The FDA regulates most of these drugs on store 
shelves under the OTC monograph system. The active ingredients 
in these nonprescription products are considered safe and 
effective when the consumers follow their instructions on the 
label without direction from a healthcare provider. While that 
is largely true in theory, many contain ingredients that the 
FDA that is not yet evaluated or known to be misused for 
labels, have not been modified to warn consumers of potential 
harms.
    The current system also poses challenges for consumer 
access to potentially better, safer, innovative products. The 
regulatory framework for FDA oversight of most over-the-counter 
products are put into place in 1972 and has not been updated, 
despite an increasingly diverse and large market. The need for 
reform was brought into sharper focus when this committee 
worked on the Sunscreen Innovation Act in the 113th Congress. 
Under the current system, an OTC drugs monograph is established 
through a three-step public ruling process, with each step 
requiring publication in the Federal Register in the public 
comment period. This antiquated system is overly burdensome and 
time consuming, and, frankly, doesn't work very well. It is 
unable to respond quickly to safety concerns and keep pace with 
scientific discovery, which places consumers at risk and slows 
development of new drugs.
    Today, the FDA has an estimated 88 rulemakings in 26 
therapeutic categories that cover over 100 OTC products. It is 
one of the largest and most complex regulatory schemes and also 
dramatically underresourced. The agency has 30 full-time 
employees for the entire monograph program, and a budget of 
roughly $8 million. For context, 18 full-time employees are 
devoted to the review of one novel drug application. And again, 
the OTC market now includes more than 300,000 products with 
annual sales of $32 billion.
    Recognizing the resource and process, challenges the OTC 
monograph program stakeholders and FDA begin to think about how 
it could work better and value the establishing of the user fee 
program. Congressman Latta and I, along with Representative 
Dingell, DeGette, Guthrie and Burgess have been working on a 
bipartisan fashion to put together a bill that would establish 
and OTC user fee program and reform the monograph system.
    Today, we have a discussion draft that reflects the work of 
the stakeholders, the FDA, and Congress. And I am happy to see 
the committee moving forward. I want to note that we should be 
considering doing the same with cosmetics. There are many 
parallels between cosmetics and OTC products and the way 
consumers use and think about cosmetics and OTC products. And 
also, the challenges the FDA faces in overseeing the category 
of everyday items that impact our health. OTC monograph reform 
will help foster growth in the availability of these medicines. 
Policy reforms can make the system even more flexible, 
responsive and accommodating to innovation and knowledge about 
potential harms for misuse, ultimately modernizing the OTC 
monograph system will ensure that the FDA industry can update 
products with safe, effective ingredients, broad and consumer 
choice, and ensure the FDA has the resources to approve safety, 
labeling changes innovation in the OTC market. I look forward 
to hearing from our witnesses about this. And I would like to 
yield the remainder of my time to Congresswoman DeGette.
    Ms. DeGette. I would like to thank you for working on this 
important bill with us. As the chairman said, it has been 40 
years that we have had this monograph system, but we haven't 
really made any updates to it and as a result, the system does 
not respond to emerging safety issues which creates serious 
problems for consumers. In 2006, for example, the FDA learned 
common cough medication tragically caused several toddlers to 
die. For 10 years, the FDA has been trying to revise the cough 
and cold monograph to warn parents of the risks to young 
children. Their efforts have been unsuccessful due to the 
extremely burdensome process the FDA must use to update and 
change monographs. What this would do is give the FDA new tools 
protect consumers streamline how FDA would use over-the-counter 
medicines.
    Dr. Woodcock, I am extremely glad you are here with us 
today to give us the same kind of guidance you give us in 21st 
Century Cures and other issues. We really have a great 
opportunity to upgrade the regulatory process in a way that 
benefits everybody, the American public, and the Federal 
Government, and the regulated industry alike. I look forward to 
continuing to work with my colleagues to support this bill and 
I thank you very much, Mr. Chairman, for holding this hearing.
    I yield back.
    Mr. Burgess. The gentleman from Texas yields back.The Chair 
recognizes the gentleman from Oregon, the chairman of the full 
committee, Mr. Walden, 5 minutes.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you, Mr. Chairman. I appreciate your 
holding the hearing on these important issues and the long 
overdue reforms needed at the FDA to improve efficiency and 
update their framework for regulating over-the-counter drug 
products.
    Following the successful 5-year reauthorization of several 
of FDA's critical medical device user fee programs, there is no 
better time to continue our work than now and in this space. I 
am pleased with the bipartisan effort that has already begun. 
From cough and cold medicines to antiperspirants an antacids, 
the pharmacy aisles and medicine cabinets are filled with over-
the-counter, or OTC drugs that American consumers rely upon 
daily.
    Unfortunately, the regulatory process as we have heard has 
been the same since the 1970s, and while bell bottom pants I 
see are coming back, we need to--it is remarkable, isn't it? We 
need to innovate in this sector, and safety-related changes 
often take years to implement is simply unacceptable.
    Fortunately, FDA, regulated industry patients, consumer 
groups, all agree that significant reform is something we all 
need to join hands on. For several years now, they have engaged 
in productive conversations about how to substantially improve 
upon the status quo. Informed by this ongoing dialogue, we now 
have bipartisan resolution before us today that will ensure 
Americans have more timely access to innovative, safe and 
effective OTC medicines.
    Consumers will no longer have to wait years for an 
inflexible rulemaking process to wind its way through the 
bureaucracy before benefiting from product improvements. So I 
really want to thank our colleagues Mr. Latta, Ms. DeGette, Mr. 
Guthrie, Mrs. Dingell, as well as Chairman Burgess, Ranking 
Member Green, my colleague, Mr. Pallone, and others who have 
put their shoulder to the wheel on this one. We have proven 
time and again in the committee, we know how to legislate in a 
bipartisan way to get good things done for the American 
consumers, and we are going to do it again here.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Thank you, Chairman Burgess, for holding this important 
hearing to consider long overdue reforms to FDA's inefficient 
and outdated framework for regulating over-the-counter (OTC) 
drug products.
    Following the successful 5-year reauthorization of several 
of FDA's critical medical device user fee programs, there is no 
better time to continue our work in this space.
    From cough and cold medicines to antiperspirants and 
antacids, pharmacy aisles and medicine cabinets are filled with 
over-the-counter, or OTC, drugs that American consumers rely on 
daily. Unfortunately, the regulatory process in place at FDA 
has not been updated since the 1970s. As a result, there has 
been little to no innovation in this sector, and safety-related 
changes often take years to implement. This is simply 
unacceptable.
    Fortunately, FDA, regulated industry, and patient and 
consumer groups all agree that significant reform is necessary. 
For several years now, they have engaged in productive 
conversations about how to substantially improve upon the 
status quo. Informed by this ongoing dialogue, we have a 
bipartisan solution before us today that will ensure Americans 
have more timely access to innovative, safe and effective OTC 
medicines. Consumers will no longer have to wait years for an 
inflexible rulemaking process to wind its way through the 
bureaucracy before benefiting from product improvements.
    I would like to thank my colleagues Bob Latta (R-OH), Diana 
DeGette (D-CO), Brett Guthrie (R-KY), Debbie Dingell (D-MI), as 
well as Chairman Burgess and Ranking Member Green for their 
hard work on getting us to this point. I look forward to 
hearing from our witnesses today about ways we can improve the 
draft legislation being considered, and I yield the balance of 
my time to Rep. ----------.

    Mr. Walden. With that, I am going to yield to the gentleman 
from Ohio, Mr. Latta, the remainder of my time.
    Mr. Latta. Well, I thank the chairman for yielding. And I 
also thank Chairman Burgess for holding today's hearing on this 
very important issue. I also want to thank our witnesses for 
being with us today to provide the insight on this topic and on 
the legislation. It has already been said, over-the-counter 
medicines are in nearly every household in our Nation. Yet 
despite widespread utilization, the system in place to regulate 
these drugs has been outdated for decades. It is time to move 
forward to a more flexible framework that will spur innovation, 
expand consumer choice, and better address potential safety 
concerns.
    I believe the discussion draft before us today will achieve 
these goals and provide predictability to the drug approval 
process. The OTC Monograph Safety, Innovation Reform Act is the 
product of the bipartisan collaboration between myself, the 
chairman of the subcommittee, Mr. Burgess, Ranking Member 
Green, Ms. DeGette, Vice Chairman Guthrie, and Mrs. Dingell, as 
well as significant contributions from the FDA and the 
industry.
    I would like to thank all those involved who worked 
tirelessly on this effort in order to increase consumer choice 
and safety. I appreciate the chairman for allowing the 
opportunity to discuss the monograph reform and improve upon 
the proposed and presented in the discussion draft today. I 
look forward to hearing today's testimony receiving input from 
my colleagues on the subcommittee. I thank the chairman for 
holding today's hearing, and for our witnesses and I yield 
back. I am sorry, and I yield to Mr. Guthrie.
    Mr. Guthrie. Thank you for yielding the chairman's time. I 
appreciate it. Mr. Chairman, I want to thank you for holding 
this important hearing today and examine the review process of 
over-the-counter drugs.
    This important bill would enable greater innovations and 
foster FDA efficiencies within the approval process of over-
the-counter drugs, something that has not been done since the 
1970s. And I want to specifically thank the Congressman Latta 
for his leadership on this issue. I am proud to be a lead 
cosponsor with Congressman Latta and several of my colleagues 
on this important bipartisan bill which industry FDA and the 
committee staff have worked so hard to move forward. I strongly 
believe this legislation help every American as these products 
are the first in the line of defense against common ailments.
    And Dr. Woodcock, I always appreciate you being here, and I 
thank our other witnesses who will follow for being here as 
well today. If there is no one else who is yielding Chairman 
Walden's time, I will yield back.
    Mr. Burgess. The gentleman from Oregon yields back. The 
Chair thanks the gentleman. The Chair now recognizes the 
gentleman from New Jersey, Mr. Pallone, for 5 minutes for an 
opening statement, please.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman. I want to thank you 
also for holding today's hearing on the over-the-counter drug 
monograph reform and establishment of over-the-counter 
monograph user fee program. I also want to commend our Ranking 
Member Green, Representatives DeGette, Latta, Guthrie, and 
Dingell, as well as the chairman of the full committee for your 
work in crafting a proposal that will accomplish these goals.
    The safety and effectiveness of over-the-counter drugs is 
established today through conformance with a monograph, this 
so-called rule book outlines the conditions of use for 
particular drug ingredient that outlines the dosage form, 
patient population, labeling and warnings and other 
requirements. This rule book is established through a three-
phase rulemaking process, but is oftentimes inflexible and 
time-consuming, making it difficult for FDA to quickly revise 
or update monographs in response to safety or other issues. We 
have also heard from FDA and industry that the monograph 
process does not lend itself well to evolving science and 
technology, and may have the unintended effect of discouraging 
the development of new formulation. Not only is it clear that 
regulatory reform is needed, but the current program is 
drastically under-resourced.
    So today, the OTC monograph program oversees more than 
100,000 products with a staff of 30 people, and a budget of 
just over $8 million. It is my hope that through regulatory 
reform and increased predictable resources, we can streamline 
the over-the-counter process to allow for swift finalization of 
current monographs, timely updates, and encourage innovation 
where possible.
    And while we are beginning the process of making 
significant improvements to the review of over-the-counter 
products, I had hoped that we would begin taking action today 
on cosmetics. Millions of Americans use cosmetic products every 
day, but FDA's regulatory authority over cosmetics is woefully 
inadequate. In just the last year, millions of women and 
children have an been exposed to shampoos that can cause 
extraordinary hair loss, lip balm that can cause blistering and 
rashes, and eye shimmer tainted by asbestos.
    Unfortunately, FDA does not have the authority today to 
hold these manufacturers responsible, and has very little 
ability to assure that these cosmetics are safe. And this 
simply can't continue. And as we move forward with this 
process, we should provide adequate resourcing and authority 
for cosmetics as well. And I look forward to continuing to work 
with my colleagues, the FDA industry and other stakeholders to 
accomplish both of these goals and ensure that continued 
availability and safety of the means of drug products and 
personal care products people use every day.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Mr. Chairman. Today we will markup bipartisan 
bills aimed at improving care in the Medicare program. Medicare 
plays a critical role in the lives of our Nation's seniors and 
Americans with disabilities. The committee's efforts to 
continuously improve this program will ensure the highest 
quality care to these beneficiaries.
    First, I'm pleased we're marking up H.R. 1148, the FAST 
Act, introduced by Representatives Joyce and Griffith. Stroke 
telemedicine, also known as telestroke, breaks down barriers to 
care and is a valuable tool for combatting our Nation's fifth 
leading cause of death. The FAST Act would expand coverage of 
telestroke services so that beneficiaries can get the right 
treatment at the right time, no matter where they live. When it 
comes to stroke--every second counts.
    I am also pleased to markup H.R. 3263, to extend the 
Independence at Home Demonstration, which allows seniors with 
complex and expensive chronic conditions to receive team-based, 
primary care in their own home. This model reduces costs and 
barriers to access for vulnerable seniors while also ensuring 
that beneficiaries receive care where they feel most 
comfortable. Improving both the quality and comfort of care for 
seniors suffering from complex conditions is critical to the 
sustainability of Medicare.
    I also look forward to more discussion today on H.R. 3271, 
introduced by Representatives DeGette and Brooks. Medicare 
beneficiaries with diabetes should have a choice in their 
testing supplies. They should be able to access testing strips 
compatible with the blood glucose monitor of their choice. They 
should also be protected by law from coercive practices from 
suppliers. H.R. 3271 would require stronger CMS assurances that 
suppliers carry a greater variety of testing supplies and make 
it easier for beneficiaries to switch testing supplies when 
they want to. This bill will improve the quality of service 
available through the national mail-order program to the 
growing number Medicare beneficiaries living with diabetes.
    We are also marking up four other bills that aim to make 
meaningful changes to the Medicare program by protecting 
beneficiaries, reducing provider burden, and improving program 
integrity. I look forward to working on a bipartisan basis 
today to advance these important bills to the full committee.
    Thank you, I yield back.

    Mr. Pallone. So I would like to yield the time that I have 
left to Mrs. Dingell.
    Mrs. Dingell. I thank my colleague for yielding.
    Americans deserve piece of mind in knowing that all drugs 
they take are safe and effective, whether it is a prescription 
drug or an over-the-counter drug. There are 300,000 over-the-
counter products on the market today, which American's use in 
everyday life. Yet, FDA's regulatory system for OTCs is 
completely broken. The agency has a meager budget of $8 
million, which all of us keep saying over and over in a 
cumbersome process that hinders the agency's ability to both 
address safety risks and let new and innovative products come 
to market.
    The draft legislation creates a new user fee system for the 
OTC products to give FDA the resources it needs do its job of 
ensuring patient safety. It also allows the agency to move 
quickly to update and revise the monograph system through 
administrative orders, rather than noticing comment rulemaking, 
which are similar to the reforms made under the Sunscreen 
Innovation Act.
    We have seen the benefits that user fees have brought to 
the regulation of prescription drugs and medical devices, and 
it is time to bring the system to the OTC space as well. And 
while I am very pleased that we are holding this hearing and 
moving forward with the OTC legislation, I want to commend Mr. 
Pallone for the same comments made about the cosmetic industry, 
which also would desperately benefit from singular reforms, and 
hope the committee soon move forward with legislation 
establishing a user fee program for these products.
    I want to thank my colleagues, Congressman Latta, Green, 
Burgess, Guthrie, and DeGette, for working with me on this 
draft legislation. I look forward to continuing our work 
together to reach consensus on this important issue, and as 
always, our chairman and ranking minority member are 
supportive.
    I yield back the balance of my time.
    Mr. Pallone. And I yield back, Mr. Chairman.
    Mr. Burgess. The gentleman from New Jersey yields back. 
This concludes Member opening statements. And the Chair would 
remind Members that, pursuant to committee rules, all Members' 
opening statements will be made part of the record. We do want 
to thank our witnesses for being here with us this morning, for 
taking the time to testify before the subcommittee.
    Each witness will have the opportunity to give an opening 
statement, followed by questions from Members. Today we will 
start with our first panel and hear from Dr. Janet Woodcock, 
the Director of FDA's Center for Drug Evaluation and Research. 
We appreciate you being here this morning, Dr. Woodcock. You 
are recognized for 5 minutes for your opening statement, 
please.

 STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER FOR DRUG 
    EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, 
            DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Woodcock. Thank you. We are here to talk about 
modernizing the monograph system for OTC drugs. Probably 
everyone in this room has used an OTC drug at one time or 
another, an OTC monograph drug, in fact. I know I have. These 
medicines allow us to manage minor health problems without 
going consulting a health professional, to manage them on our 
own. And millions of Americans use these products every day. 
They are widespread, and I believe there is more exposure of 
Americans to these OTC monograph drugs than there are to 
prescription drugs in this country. The monograph system allows 
manufacturers to come on the market without the burdensome per 
product application process that we use for generics or for new 
drugs. So this is a much-simplified system.
    So why the push for reform? Well, as the Members have 
already said, the monograph process was put in place a long 
time ago to deal with the hundreds of thousands of products on 
the market after Congress passed the 62 amendments to the Food 
and Drug Administration Act requiring drugs on the market to 
show that they were effective. And so FDA had to deal with that 
in some way.
    And since many of the OTC products were a different version 
of the same basic ingredients, FDA decided to deal with them in 
groups. If it was found that X ingredient at Y dose in dosage 
form was effective for Z condition, OK? These facts would be 
put in a regulation and any manufacturer could come on the 
market as long as they conformed to those conditions. Of 
course, these manufacturers were also subject to inspection and 
GMP's for their manufacturing and that is still the case.
    But their problems emerged, as Members have already said. 
The rulemaking process that was put in place has become 
lengthy, burdensome and there are huge delays. There are 88 
monographs that are not finalized. It also means that we can't 
respond rapidly to safety issues. There was perhaps a naive 
thought at the time that science wouldn't evolve, our 
understanding wouldn't evolve, and that new safety issues 
wouldn't come up for the products that have already been 
marketed. But that is by no means the case. We have really been 
hampered in responding rapidly to safety problems. Sometimes 
this leaves consumers unprotected, it may leave manufacturers 
open to liability. And then this process is frozen in 1972 and 
before.
    So it doesn't apply to anything later than that. So this is 
only still trying to deal with those products that were on the 
market at that time. So there is really nothing for innovation 
in this entire process.
    So the reform that we are proposing keeps the features in 
the monograph system that work well, which is products that 
follow the conditions could still be marketed without prior FDA 
approval if they conformed to the conditions for marketing. And 
it is a public process. So the public has input and it is an 
open and transparent process. But it streamlines this process 
by replacing rulemaking with administrative orders. So using an 
order system is very similar to what we do it for new drugs or 
generic drugs, and it is quite appropriate for scientific 
decisionmaking. We would issue a proposed order under the 
discussion draft, allow public comment, and then issue a final 
order, and it provides due process, a healing--an appeal and 
hearing process to permit challenges to FDA decisions. So that 
process is in place.
    But there are fewer requirements that have to do with 
rulemaking so that this can be accomplished in a much speedier 
manner. It also would encourage innovation by expanding 
eligibility for the monograph and no longer limiting it to pre 
1972 type of products.
    So industry can request that we amend a monograph, or they 
could even submit to these kinds of products. And what we 
envision allows for confidential meetings early in the process 
between industry and the FDA before we move into the public 
process, to allow for that innovation to be explored. It also 
would allow, very importantly, FDA to quickly respond to urgent 
safety issues. So we could issue interim final role, and 
definitively get that safety information out. Now that rule 
then would be subject to further public comment and discussion 
and so forth, but it would be in place during that time so that 
people could be protected quickly. And that is something we are 
really missing right now. And it would reduce the backlog of 
unfinished monographs by transferring these pending regulations 
and so forth by statute. And this would allow us to deal in an 
orderly and effective manner with the pending work that has not 
been finalized up to this point.
    The public health, I think, also would be served if there 
were provision to clarify our authority to require certain 
types of packaging, such as unit dose packaging. This can 
protect people from taking too many pills. And we know that for 
our elderly and for children, especially they may mistake 
medicines for candy, they overdose, and so that kind of 
protective packaging is very important. And this clarification 
would complement the authority of the Consumer Product Safety 
Commission, which can require child resistant closures on 
different packages, and we do conform to their standards for 
that.
    So all in all, this modernization proposal, along with the 
user fees that would provide the staff to enable to do it, I 
think would really benefit both the public, most importantly, 
public safety and it would benefit the industry, and the FDA 
has been talking to many stakeholders about this over the last 
3 or 4 years, and we feel the proposals that are on the table 
would really serve the public well.
    Thank you very much.
    [The prepared statement of Dr. Woodcock follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The Chair thanks Dr. Woodcock for your 
testimony and we will move into the question-and-answer portion 
of the hearing. I am going to begin by yielding my time to the 
principal author of the bill, Mr. Latta, recognized for 5 
minutes for questions, please.
    Mr. Latta. Well, thank you very much. And I appreciate the 
chairman for yielding. And Dr. Woodcock, thanks very much for 
being with us today. We appreciate your testimony and the work 
that you have been doing at FDA.
    If I could start with the first question, kind of touching 
on what you were just discussing. As we work together to draft 
this legislation, we are very mindful to ensure that FDA has 
the authority they need to regulate the safe packaging of over-
the-counter drugs to prevent unintended consequences. As you 
were talking, this is children that actually would ingest drugs 
intended for adults. Does the discussion draft--again, just to 
go back into it, does the discussion draft provide FDA with 
sufficient authority? And would you also discuss the 
authorities you would be granted when the monograph reform 
becomes law and it benefits public safety, would you touch back 
into that, please?
    Dr. Woodcock. Certainly. Well, first, we believe the 
language that said an administrative order may include 
requirements for the packaging of a drug, which may include 
requirements for unit dose packaging to encourage use in 
accordance with labelling. Such packaging requirements that we 
could have could include unit dose packaging, special 
requirements for products intended for use by children and 
other appropriate requirements. And we believe that language 
provides us enough authority to require safe packaging.
    Mr. Latta. Thank you. Also--here a lot of us, when you look 
at the dates that we are looking at, in some cases, we are 
going back to 1972, and the FDA began evaluating 26 therapeutic 
categories and had yet to finalize monograph for each of them.
    Could you go into, again, the system that we are looking 
at, especially with the review of the OTC that it is slow, and 
that it is antiquated, and again, speaking to the proposal 
before us today how, especially under the administrative order 
process and procedure, that would be speeded up to get these 
drugs out there?
    Dr. Woodcock. Certainly. So what occurs now, what you have 
in front of you, that first slide, talks about a single role. 
And this is an important one, external analgesic drug products. 
And it shows many of the steps that we have gone through simply 
to try and move a single rulemaking along. And each one of 
those require very large administrative effort, writing, many 
of them publishing in the Federal Register notice going through 
extensive clearances. This would be substituted by a new 
process that would take less than 2 years and would have 
defined timelines under the user fee part of the program. So we 
would commit to finishing things in a timely manner. All right?
    And what we would do for these old ones--some of them would 
transition to legally marketed drugs, and that would, over 
time, go through a process where the industry would submit 
data, the old monograph issues would be taken off the table, 
they would submit current data, and we would have timelines 
within which we would review that, publish a draft, and then 
finalize an order. And the reason we aren't--wouldn't just go 
to an approval like we do for a new drug or generic drug would 
be this is a public process. So if we publish a draft that 
allows anyone who might be interested in commenting and 
participating in that to comment before we finalize.
    So there is a different, slightly additional step compared 
to approving a new drug, because once that order is final, then 
any manufacturer who wishes may enter the market if they 
conform to those conditions. But we do it directly and would do 
it directly instead of through publishing regulations, and the 
current regulations would go off the books.
    Mr. Latta. I wish the slides were working right now because 
what you have given us--obviously, you have the burdensome 
monograph process and the rulemaking. Looking at the first 
December 4th, 1979, and there is it 22 different dates on here. 
We get down to November the 19th, 1997. So we got to get this 
sped up, and we appreciate the work you have been doing, and we 
look forward to getting this bill passed.
    Mr. Chairman, I thank you for yielding and I yield back. 
Thank you very much.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. The Chair recognizes the gentleman from Texas, 
Mr. Green, 5 minutes for questions, please.
    Mr. Green. Thank you, Mr. Chairman. And thank you, Dr. 
Woodcock. You are always--good to see you and we appreciate the 
good work you have done for many years and at the FDA. I want 
to start by asking you about the current OTC monograph system. 
The committee learned a bit about how the system works, or 
doesn't, work during our consideration of the Sunscreen 
Innovation Act. It was clear then and even more clear now that 
reforms are modernized and fund FDA OTC monograph activities 
are needed to better serve patients, consumers in the industry. 
You just elaborated on how monograph rulemaking takes too long 
and is an inefficient process for scientific decisions, and how 
the lack of speed and flexibility poses harm to patient safety. 
How will allowing the FDA to make scientific determinations on 
OTC ingredients through the administrative order process 
improve overall patient safety and allow for new innovations?
    Dr. Woodcock. I brought a little visual aid with me as an 
example, OK? Some time ago, and this relates to the fact that 
with the rulemaking, you assume something is fixed, but there 
is always new scientific knowledge with drugs, right? And we 
need to get it that out there to patients. We discovered that 
acetaminophen, a common pain reliever and fever reducer, some 
people are allergic and have life-threatening skin reactions, 
and we wanted to put a warning on. So what we did, we couldn't 
modify the rule quickly, right? You see that. So what we did, 
we put out a drug safety communication in August of 2013 
discussing 91 cases that had--associated with 12 deaths, and 
the allergy alert for severe skin reaction, we put March 2014. 
So now, if you look at Tylenol, OK, and you look at the label 
of it, it has this allergy statement on there and warning so 
people know.
    If you look at others, that you can get, perhaps smaller 
manufacturers who aren't aware of this, they--we issued 
guidance on how to do this labelling, but they--this does not 
have--this still does not have the safety label on it. And we 
issued a final guidance, a draft guidance in November of 2014, 
a final guidance in January of 2017. Most sponsors voluntarily 
complied, because that is all we could is ask, because it is 
different than the regulation, if you follow me. So this is an 
OTC NDA drug, this is a monograph drug, and it is still out 
there without the warning. And that is the case for many 
products. Most problematically, I think, are the pediatric 
cough and cold where the manufacturers we have had to get them 
to voluntarily comply. We know, and Congress has passed several 
laws around pediatric--studying pediatric drugs, right, and yet 
the monograph system and all the old rules we made assume that 
children are like little adults and that their dosing should 
just be extrapolated. And so to change all that could take 10 
years or more in regulation.
    Mr. Green. Thank you. The monograph reform can and will 
streamline the process, but it won't address the resource 
challenges that the agency faces. You know in your testimony, 
the FDA struggles to meet the requirements of congressional 
mandates to keep pace with the science and meet public health 
needs for monograph products in a timely fashion for current 
resource levels. The FDA has a budget of about $8 million and 
30 full-time employees to oversee a $32 billion industry 
through one of the most complex regulatory frameworks the 
agency has. Can you elaborate on how reform without user fees 
is utterly unworkable?
    Dr. Woodcock. Yes. We have had some reform in the Sunscreen 
Innovation Act that Congress passed several years ago. Even 
right now, our resources are completely taken up by 
implementing the Sunscreen Innovation Act. We are under court 
order for certain deadlines for other monographs, and we have 
to pay attention to that. And then acute safety issues that we 
are dealing with. We literally have no other resources. So even 
where we've given additional authorities or different ways of 
implementing, we would have a great deal of trouble bringing 
that about without additional resources.
    Mr. Green. Mr. Chairman, I only have 12 seconds left, but I 
know the FDA stakeholders and the Members worked together on 
this, and I think we had a good example of this committee, 
subcommittee doing PDUFA over the years since, what, 1992?
    Mr. Burgess. Uh-hum.
    Mr. Green. And to have this funding ability for the FDA to 
not only have the authority, but can actually regulate and 
oversee it. So I yield back my time.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. The Chair recognizes the gentleman from Texas, 
Mr. Barton, for 5 minutes of questions, please.
    Mr. Barton. I thank the subcommittee chairman.
    Dr. Woodcock, how long have you been at the FDA?
    Dr. Woodcock. Thirty years.
    Mr. Barton. Thirty years.
    Dr. Woodcock. Yes.
    Mr. Barton. How many monographs have been approved during 
the time you have been there?
    Dr. Woodcock. Probably seven. Maybe, we don't know, but 
that would be a reasonable ballpark.
    Mr. Barton. I know you are not personally responsible for 
this, but I graduated from college in 1972, 45 years. I have 
had two wives, four children, six grandchildren, been approved 
17 times to be a Member of Congress and disapproved once to be 
a Senator. Do you think seven monographs in 45 years is 
acceptable?
    Dr. Woodcock. No, obviously for each monograph there has 
been a great deal of activity, all right?
    Mr. Barton. I can go outside and yell and scream and cause 
a stir and have a lot of activity, but that doesn't pass a law.
    Dr. Woodcock. Yes.
    Mr. Barton. I know it is not your personal problem. I 
didn't--I wasn't aware of this until I read the briefing. But 
if the system is broken, which obviously as Congressman Latta 
just pointed out--my gosh, does it take 45 years for the FDA to 
say, ``Help, we need help''? I mean--this--when you are trying 
to find a cure for cancer and all the other great things, I 
don't know that this is the most important priority at the FDA, 
I wouldn't say that, but approving a monograph for manufacture 
of over-the-counter drugs shouldn't take a moon shot. Do you 
agree with that?
    Dr. Woodcock. I agree with that. And we could do it under 
the new proposals that have been proposed. We can, I think, do 
this in a more timely manner. It is simply going through 
regulations and doing regulations.
    Mr. Barton. I mean, again, somebody in your agency has 
known for a long, long time this is a problem; a long, long 
time. I mean, I never chaired the Health Subcommittee, but I 
did chair the full committee. I have been on the committee for 
32 years. Nobody ever came to me from the FDA and said, ``Hey, 
we have got a problem here.'' I mean, don't you--Mr. Latta says 
that to approve a specific new drug, you have an average of 18 
FTE reviewers working on that, but to do all of these 
monographs, you have only got 18 people reviewing them.
    Dr. Woodcock. That is right.
    Mr. Barton. Don't you think somebody at some point in time 
in your position, or somebody who reports to you, could have 
said maybe we need a few more people; maybe we need a lot of 
people; maybe we need to change the rules; maybe you don't need 
27-step processes. I would assume that the FDA supports the 
Latta-DeGette-Green bill.
    Dr. Woodcock. That is true. We held a public meeting 3 
years ago to discuss the problem. And we were very clear that 
the system was progressively becoming more unworkable as it was 
more and more difficult to get regulations through.
    Now, the industry is very concerned about these safety 
problems, but earlier, because all these drugs remain on the 
market until the monograph was finalized, and perhaps, some of 
them would be taken off, it wasn't such a problem for the 
industry. But in the modern world, industry, I believe, support 
this.
    Mr. Barton. What, in your mind, is a reasonable time to get 
these monographs approved?
    Dr. Woodcock. I believe for a public process, several 
years, and should be done.
    Mr. Barton. Two years?
    Dr. Woodcock. Yes, sir.
    Mr. Barton. Is that the guideline in the bill, 2 years? Do 
we know? Anybody? OK, if it is not, I will put it in the bill.
    Dr. Woodcock. But we weren't going to be able to do every 
single one at the same time in 2 years.
    Mr. Barton. I understand that.
    Dr. Woodcock. We can talk about that. We will have to build 
up our staff, our infrastructure, our IT systems and so forth.
    Mr. Barton. Well, I appreciate your willingness to testify 
on this, and I commend the subcommittee chairman and the 
sponsors of the bill. Hopefully, it won't take us 45 years to 
move the bill, Mr. Chairman, and we can have a bill-signing 
ceremony, and then hold them to their word that they will start 
approving these in 2 years.
    With that, I yield back.
    Mr. Burgess. The Chair thanks the gentleman. The Chair 
recognizes the gentleman from New Jersey, Mr. Pallone, 5 
minutes for questions, please.
    Mr. Pallone. Thank you, Mr. Chairman. I am not trying to 
denigrate you, Dr. Woodcock or Mr. Barton, and I am certainly 
not going to get it into how many years we have all been here 
and what we have been doing, but I think part of the problem is 
that, you know, you are not allowed to initiate that. I mean, 
you can't write us letters and say you need more resources, you 
want to change the law. That is our oversight obligation. And 
so I would say, whether Democrats or Republicans are in power, 
we still have to do a lot more oversight. It is not really up 
to you to come to us. It doesn't work that way, the way I 
understand it.
    But in any case, one of the most serious constraints of the 
current monograph system is the ability to move quickly to 
revive the monograph to address emerging safety issues and the 
current multistep monograph process requires the FDA to make 
any revisions or updates through a rulemaking process, and that 
is why these safety changes take so long, if they happen at 
all.
    So I just want you, if you could, briefly discuss how 
emerging safety issues are addressed currently through the OTC 
drug monograph process. And what has prevented the agency thus 
far moving swiftly to address safely issues, such as those 
associated with the use of the cough and cold products in 
children, which you mentioned, actually.
    Dr. Woodcock. Well, I believe our thinking has evolved on 
that since the cough and cold issue first came up, because when 
it first came up, the thought was well, the regulation says 
these are generally recognized as safe and effective, including 
for children. That is what it said in Government regulation, so 
what could we say? But it was clear that thinking had changed 
on children, and that children should be specifically studied, 
and their safety evaluated in children. Eventually, what we do 
now is we issue safety communications and issue guidance on 
labeling and so forth, even though it is somewhat different 
than what might be in the regulation, or the draft regulation, 
or whatever state the tentative final monograph--whatever state 
it is in.
    So we can do that and that requires voluntary, as I said, 
participation by the industry. It is not binding on industry 
because it is guidance. And so I think everyone would prefer 
that safety changes we deal with, safety problems are dealt 
with promptly and very definitively, not in guidance or 
something that is voluntary. So we can take care of the 
problem, keep people safe rapidly as we get the information.
    Mr. Pallone. Well, thank you.
    In the discussion draft that we are considering, the 
monograph process will be transitioned from rulemaking to an 
administrative order process, and the FDA would also be given 
expedited authority to update safety labelling information in 
light of serious adverse events. Would you explain how the 
transition to administrative order and to the expedited 
authority for safety labeling will help to respond to these 
emerging safety issues?
    Dr. Woodcock. Well, the expedited safety labelling would an 
interim order whereby the FDA could put out an order rapidly, 
not subject to some of the public comment requirements and so 
forth that most orders would have, all right? And once that was 
out, it would be binding, it would be interim final so it would 
be binding. So we would notify the public, and the 
manufacturers would have to change their label and conform 
their label to the safety problem. Then you could have comments 
after that and we could discuss it more, but the safety issue 
would have been dealt with more definitively so people were 
protected.
    Right now, it may take 8 years or more for us to get a rule 
change so that we can have new safety statements in the 
regulation.
    Mr. Pallone. All right. Thanks.
    I wanted to ask you what lessons have been learned from 
PDUFA, GDUFA, that were incorporated into the Over-the-Counter 
Monogram Drug User Fee Act? And how will user fees benefits the 
OTC program industry in patients, for example?
    Dr. Woodcock. Well, some of the things we learned is, for 
this program, we are going to have what we call ``managed 
growth'' is what we have been discussing with everyone, where 
the program starts sort of small, expectations are clear for 
everyone and it grows over time. And the user fees grow so that 
we can absorb and lay down the foundation. And we learned that 
from the generics program where we had to change like a huge 
number of things at once.
    We also have learned that we should have a simple a fee 
structure as possible, with a few exceptions and tiers and all, 
because this is a very large industry, there are a very large 
number of players here and have all kind of different status, 
and the more exceptions and tiers and everything, maybe it will 
start looking look the Tax Code.
    Mr. Pallone. Thank a lot. Thank you, Mr. Chairman.
    Mr. Burgess. The gentleman yields back, the Chair 
recognizes the gentleman from Kentucky, Mr. Guthrie, 5 minutes 
for questions, please.
    Mr. Guthrie. Thank you, Mr. Chairman. Thank you, Dr. 
Woodcock. Thanks for being here today and discussing this 
important matter. I have heard stories from manufacturers 
trying to do the right thing at risk having a have misbranded 
product because they want to update their label in real time as 
the current process can take years, as Mr. Barton described. In 
order for a label or packaging change currently, manufacturers 
must go through notice and comment rulemaking and bureaucratic 
system of red tape that can take years. So thanks for bringing 
this to us, and us working together to try to move us forward.
    Could you tell me--could you tell the committee how the 
administrative orders will ensure due process is maintained if 
there are differences of opinion since this is a public 
process?
    Dr. Woodcock. Well, there will be administrative order that 
is not final that comes out first, then there will be a comment 
period. And that is because since this is a public issue, other 
manufacturers who may not have been participating, but may want 
to get into that space or the public consumers, advocates may 
want to comment on the order, and so there is that public 
process whereby the comment.
    If we get substantive comments on the proposed order, then 
the time of finalization may be somewhat delayed as we deal 
with those issues, and we can do that in many ways, but that a 
public process. And then, there is a process that has been 
proposed for administrative appeal of decisions through an 
appeal process within the Center for Drugs, and then appeal, 
administrative appeal above that to a party who is third party, 
who is selected to hold a sort of hearing on it, and adjudicate 
any substantive issue that is a material difference that might 
occur. So there are layers of administrative appeal and 
recourse for people.
    Mr. Guthrie. Thank you. And you mentioned sunscreens 
earlier. Could you please expand on how sunscreens will fit and 
can fit into this over-the-counter drug reform? My good friend, 
Ed Whitfield, who was a member of this committee, my former 
colleague from Kentucky who is no longer in Congress, who did a 
lot of work in this space, and I talked about it with him some. 
And so it just seems, with the rise in skin cancer, it seems to 
be difficult to get improved sunscreens on the marketplace. So 
how will this work for sunscreens?
    Dr. Woodcock. My understanding of the contract draft is the 
Sunscreen Innovation Act will continue to operate, all right? 
So what was stipulated by Congress there--and we have met all 
the timeframes that were required under the Sunscreen 
Innovation Act--we have exceeded those timeframes, so those 
will continue to operate.
    Once those sunscreens that are subject to that are done and 
through the process, then they will be folded into the order so 
that then we have a common system. Now one thing that remains a 
question, one of the innovations or improvements that is being 
proposed in this discussion for modernizing the whole monograph 
process is to have confidential meetings with manufacturers and 
an ability to do that. That is not part of the Sunscreen 
Innovation Act, so that could be put in to conform, conform 
that Act if monograph reform is passed. Was I clear?
    Mr. Guthrie. I believe so. I appreciate that. Those are my 
questions. I yield back my time.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back. The Chair recognizes the gentleman from North 
Carolina, Mr. Butterfield, 5 minutes for questions.
    Mr. Butterfield. Thank you, Mr. Chairman. Dr. Woodcook, I 
too would like to thank you for coming back again and giving us 
your testimony today. I am very interested in the potential 
public health benefits of reforming the OTC medicine 
regulations. Your testimony today highlighted several examples 
of safety concerns with OTC medicines, and how they were 
handled by your agency. How frequently--how frequently does the 
FDA encounter adverse events with OTC medicines?
    Dr. Woodcock. I would say fairly frequently, to rise to a 
serious level, maybe once every several years.
    Mr. Butterfield. Infrequently? Frequently or infrequently?
    Dr. Woodcock. Fairly frequently. But given what they are 
and the exposure of the population to them, but once, perhaps, 
every 2 years, we are facing an issue that we would like to get 
out rapidly as public to notify them, and our hands are really 
tied, and we have to use this guidance process.
    Mr. Butterfield. Two of the examples that you highlighted 
in your written testimony were related to pediatric issues with 
certain medicines. Would you say that a disproportionate safety 
concerns with OTC medicines are related to pediatrics?
    Dr. Woodcock. I would say, in the last decade, that is 
true, decade or so, and the reason is starting in the late 
1990s, I think everyone became aware you should study children, 
and not just treat them as tiny adults and just scale down the 
medicines. And so, with that realization came the realization 
that children may be being harmed, because back in the 1970s 
when all of this was started, the doses for children were just 
scaled down adult doses. And so we have been going on a whole 
campaign as you know under BPCA and PREA to study children with 
drugs. Here, it is going back and looking at these medicines, 
particularly, say, the cough and cold, and some of the other 
medicines, and saying, really, is this appropriate for children 
and what do we need to do about this?
    Mr. Butterfield. Can you provide any examples of safety 
improvements that have been made to existing monographs, and 
how long those changes have taken to be implemented? I know we 
touched it on that earlier, but can you illuminate on that?
    Dr. Woodcock. Let me consult my colleagues. Well, most 
recently it took 7 years for to us to get the liver warnings on 
acetaminophen. Acetaminophen is the number one cause of drug-
induced liver failure in the United States. When we 
strengthened the warnings on acetaminophen, we were able to 
rapidly do the NDA acetaminophen and change those warnings very 
fast. In contrast, it took us 7 years for the monograph, and, 
of course, a lot of the acetaminophen use is monograph.
    Mr. Butterfield. And finally, how do you envision the 
special mechanism for rapidly responding to urgent safety 
issues? How do you envision that working?
    Dr. Woodcock. We envision that we could have an interim 
final order that could be issued very rapidly, all right? And 
that order would be in place and therefore manufacturers would 
have to conform to it, so they would have whatever labelling 
statement they would have put on, but subsequent to issuing 
that interim final order, there would be an administrative 
process so people could comment and there could be discussions, 
and it could be modified. However, we could put the interim 
final order in place very rapidly, thus keeping people safe 
while we were discussing the issue.
    Mr. Butterfield. Thank you. Dr. Woodcock, there was a 
discussion earlier that perhaps the FDA has not been proactive 
enough to seek legislation to remedy some of these issues. It 
appears that you are the director for the Center for Drug 
Evaluation and Research of FDA.
    Dr. Woodcock. That is correct.
    Mr. Butterfield. Are you permitted under your rules to pick 
up the telephone and call the chairman of the committee on 
Energy and Commerce and ask for legislation?
    Dr. Woodcock. No.
    Mr. Butterfield. That would be unacceptable in your agency 
or any other agency in the Federal Government?
    Dr. Woodcock. We are not allowed to lobby Congress is my 
understanding.
    Mr. Butterfield. That is what I have learned in my 13 
years. Thank you very much.
    I yield back.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back. The Chair recognizes the gentleman from Virginia, 
Mr. Griffith, 5 minutes for questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman. All right. 
So it seems that we have a problem. Everybody agrees that we 
need to change things. We have a discussion draft in front of 
us. I have looked through it. But I would ask you, as our 
expert who always gives us good counsel, we don't always take 
it, but we always like to hear your opinion: Are there things 
in the bill that concern you, things that we ought to take a 
look at changing the language on? And I know some of it is not 
finalized yet. But as the bill currently exists, is there 
anything in there that causes you concern?
    Dr. Woodcock. No, not serious concern. I think we would 
like to continue to give technical assistance on it, because, 
you know, the devil is in the details.
    Mr. Griffith. Always.
    Dr. Woodcock. But we believe the broad outlines of this are 
where we need to be.
    Mr. Griffith. And likewise, is there anything that you 
would like to see in the discussion draft that is not currently 
in there?
    Dr. Woodcock. I don't have a role in this, as I have told 
this committee before. But I recognize that there are many 
folks who want to talk about exclusivity. I don't believe that 
FDA has a role in those tradeoffs, those societal tradeoffs, 
but I believe that is something that needs to be resolved.
    Mr. Griffith. OK. And I appreciate that.
    And not asking your opinion per se, but have you 
anticipated, or have you felt any, or heard any comments about 
the user-fee portions of this bill? Are there groups out there 
that have told you they really oppose this and that this would 
be an impediment to bringing certain over-the-counter 
medicines, particularly in rural areas?
    Dr. Woodcock. I have not heard that, all right? I recognize 
that some of the contract manufacturers--because the proposed 
fee right now is facility fee, which is the most 
straightforward and simplest way to do this if you are 
producing an OTC drug under the monograph. The issues have been 
raised about the contract manufacturers and their obligation to 
pay a fee.
    Mr. Griffith. OK.
    Dr. Woodcock. I think that is one of the more controversial 
areas.
    We feel that there is tremendous merit in maintaining a 
simple uniform fee. A large number of the OTC manufacturers are 
small business, and so everybody is--there is lots of small 
businesses involved here.
    Mr. Griffith. Right. And I wouldn't want to price them out. 
But at the same time, the other UFAs have been highly 
successful. Isn't that fairly much accepted?
    Dr. Woodcock. Yes. And I believe they have been beneficial 
to industry as well, or they wouldn't have been reauthorized as 
they have been.
    Mr. Griffith. Yes, ma'am.
    Thank you very much. I appreciate your testimony here 
today. And with that, Mr. Chairman, I yield back.
    Mr. Guthrie [presiding]. The gentleman yields. Mr. Schrader 
is recognized for 5 minutes for questions.
    Mr. Schrader. Thank you, Mr. Chairman. I appreciate it. I 
appreciate having you here, Ms. Woodcock. Thank you very much.
    So how many of these steps are we anticipating removing as 
a result of the new process? What would you expect?
    Dr. Woodcock. I would say practically all.
    Mr. Schrader. That is welcome.
    Dr. Woodcock. We want to put this behind us, basically. So 
part of this proposed legislation would put all the monograph 
stuff behind us, transfer all these into a new status, can 
start not over, but start afresh and have a--timelines and 
plans for moving forward.
    Mr. Schrader. So would you be able to establish timelines? 
Is there a rough timeline template, to Mr. Barton's earlier 
question, that you would give us and maybe some benchmark 
performance measures between you start, you get down the road a 
little bit, and then hopefully ultimately get to a decision?
    Dr. Woodcock. Yes. Well, there are goals, and they phase in 
because, as I said, we are talking about managed growth. And in 
the first 2 years of this program, the plan would be to build a 
new system. We also have to deal with those legislatively and 
court-mandated projects, the Sunscreen Innovation Act, and some 
court-mandated things that we have to finish, all right? But we 
would have to hire people. We need to create new standards and 
processes. We need to create a new IT system. We don't have any 
IT system for that.
    Mr. Schrader. But once that is all--I appreciate that.
    Dr. Woodcock. Yes.
    Mr. Schrader. And there is probably a timeline you can give 
us for all that to occur.
    Dr. Woodcock. Right.
    Mr. Schrader. That would help us judge the progress and 
help you with resources and whatever. But once that is all 
established, it would be interesting to know what is the--I 
heard a 2-year, rough-out from start to finish.
    Dr. Woodcock. Right.
    Mr. Schrader. And it is interesting and helpful, I think, 
for the committee and for you to see if we are hitting those 
timelines. I am sure this is a new program. We are going to 
have to make adjustments as we go forward here.
    Dr. Woodcock. Right. Well, we had proposed, or planned to 
have goals, OK, for everything. And so there would be a goal 
for when we do this and when we get that done, just like we do 
for the other user-fee programs. So there would be a structured 
set of goals and timelines and percentage, like, here is the 
timeline, and we would--our goal would be to do 70 percent in 
this time frame this year, and the next year it goes up to 80 
percent, and so on.
    It is pretty complicated, I can't go through it in 5 
minutes. But for the existing monographs, what we would plan to 
do is put forth a dashboard that would be in advance, and that 
would--because the industry is going to have to submit for the 
existing what--what are now existing monographs. They are going 
to have to resubmit something. And then we would have a 
timeline of when we expected that to come in. And then there 
would be an orderly process with timelines for accomplishing 
that.
    Mr. Schrader. Can you share that with us?
    Dr. Woodcock. Absolutely.
    Mr. Schrader. And I assume the industry understands they 
have to resubmit and, in general, they are OK with that, given 
the process?
    Dr. Woodcock. That is the plan, because right now, we have 
this giant, sort of mulch of documents that have been sent in 
over the years. We want to use the current scientific 
information to make the judgment.
    Mr. Schrader. Sure.
    And the last question, all right. You are about 30 FTE, or 
something like that, in this program. With the new revenue 
coming in, what is your initial expectation to gear up to and 
where do you hope to be as a more level employee workforce?
    Dr. Woodcock. Right. Ultimately we would hire 105 new 
employees.
    Mr. Schrader. Wow. Great.
    Dr. Woodcock. So then we would have, then, 135 doing this 
scientific work.
    Mr. Schrader. Very good. Thank you very much. Good luck.
    And I yield back, Mr. Chair.
    Dr. Woodcock. Thank you.
    Mr. Burgess [presiding]. The Chair thanks the gentleman. 
The gentleman yields back.
    The Chair recognizes the gentleman from Missouri, 5 minutes 
for questions, please.
    Mr. Long. Thank you, Mr. Chairman.
    Dr. Woodcock, the over-the-counter monograph program is the 
key regulatory framework at the FDA for oversight of OTC 
medicines which account for the bulk of medication consumed by 
Americans. I understand that the user-fee program you are 
setting up is still relatively small, particularly when 
compared to some of the much larger programs that we have 
approved earlier this year.
    Could you discuss why the user fees are needed?
    Dr. Woodcock. Certainly.
    User fees are needed because we simply do not have enough 
staff to finalize all these, and then deal with innovation 
coming forward. We have 30 staff to deal with more than 100,000 
products that are on the market and, currently, this burdensome 
rulemaking process. Even if we were to move to an order process 
that was streamlined in a very efficient, effective, the 30 
staff could not make substantive progress against that in the 
next 5 years.
    Mr. Long. How are the user fees structured, and how are 
these fees collected?
    Dr. Woodcock. The fees are going to be--for any facility 
that manufactures a monograph drug would have a flat fee. How 
much it would be depends on how many register. We are going to 
use our drug registration enlisting system, which is an 
existing system, to capture all the facilities. It might be 
between, like, $14,000 or a little less or a little more, 
depending on how many facilities participate per annum.
    Mr. Long. OK. Well, you mentioned in your testimony that 
the OTC monograph process is one of the largest and most 
complex regulatory programs ever undertaken by the FDA.
    Could you discuss how OTC monograph reform can address 
these regulatory challenges?
    Dr. Woodcock. Certainly. By simplifying the process that we 
have to go through to finalize a--you know, to finish, in this 
case, it would be an order with the new process, is 
tremendously simpler than what we have to do with the 
monograph. And orders can be amended over time through a simple 
process. So we can keep up with the science. And hopefully with 
the user fees, we will have enough people to do that.
    But I have to be clear, this user-fee program is not large 
enough to get all this done in first 5 years. We will get the 
program set up, and we will begin to work against it, and we 
will be accepting innovation. And that will all be good. And we 
will be dealing promptly with safety issues. But we won't be 
finished with every single one of these, because they do take a 
fair amount of scientific work. But we would never be finished 
with them. We will never finish this process if we do not 
change, do not modernize it.
    Mr. Long. Speaking of process, can you discuss the FDA's 
engagement with stakeholders during the process?
    Dr. Woodcock. Certainly.
    As I said, I think in 2014, we had a public meeting about 
this. And to Representative Barton's point, we did own up to 
the fact that the process was broken, although some people came 
and told us it was simply because we were lazy or whatever. But 
we did ask the public, including advocates, consumer groups, 
and others, you know, how--in the industry--how we could change 
and modernize this process. And we pointed out the different 
problems.
    Since that time, as we have been talking to industry about 
how we might change the process, we have also talked to public 
stakeholders, advocacy groups, consumer groups, professional 
groups, and so forth, to keep people in the loop, although I 
will admit, this is a rather obscure program, and many people 
are unaware of how this program operated and the problems that 
it had.
    We have had several public Webinars, and we have also 
talked extensively to special stakeholders who have a 
particular stake in this, for example, the American Academy of 
Pediatrics.
    Mr. Long. Excuse me. How will FDA address emerging 
challenges to ensure that the OTC monograph program remains 
effective?
    Dr. Woodcock. Well, I think one of the things we need to 
build in, which we have built into every single other user-fee 
program that we have, are assessments. As I said earlier, we 
are going to have goals and objectives. And so we will have put 
forth what we expect our timeliness to be, how much we expect 
to get done. And then we will assess against that. And if we 
are failing on those measures, we will own up to it.
    Mr. Long. OK. Thank you.
    With that, Mr. Chairman, I yield back.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman.
    The Chair recognizes the gentlelady from California, Ms. 
Eshoo, 5 minutes, for question, please.
    Ms. Eshoo. Thank you, Mr. Chairman.
    And I want to commend the authors of the legislation for 
addressing something that evidently has been overlooked for 
decades. I want to start with a question about what you can and 
cannot do. I know that you cannot come to Congress and lobby 
for money. I know that you can't come to Congress and have 
something printed out and say this bill needs to be introduced. 
But I have never heard, in 25 years, that anyone from any 
agency can't meet with Members to discuss a shortcoming within 
the agency policy-wise or anything surrounding what I just 
mentioned.
    So would you clarify this, because I think it changes, for 
me, the complexion of this entire issue; not that it doesn't 
need to be addressed, but it is just stunning to me that it 
hasn't been.
    So would you clarify, please?
    Dr. Woodcock. Well, you know, different administrations 
have different priorities. Administrations basically decide how 
the interactions with Congress are.
    Ms. Eshoo. Well, you need to be more specific about that, 
though. I really want to understand this, because it is 
important.
    Where is the agency precluded from essentially putting a 
spotlight on something that obviously has an effect on the 
population in the country to say there is a shortcoming here 
and we need to work together to address this? I don't think 
that that is something that changes with administrations. I 
think that is just part of the ongoing work of the agency and 
the Congress.
    Dr. Woodcock. We certainly can, as we did, hold public 
meetings. We can write white papers. We can do many things 
depending on----
    Ms. Eshoo. But you are talking about internal to the agency 
and what you do there.
    Dr. Woodcock. Right.
    Ms. Eshoo. I am talking about the relationship between the 
agency and Congress.
    Let me ask this: Is there any statute or rule that is 
written that prohibits the FDA from meeting with any Members or 
chairs of committees or subcommittees to point out that there 
is a shortcoming somewhere, it is troubling to the agency, and 
that we need to work together on whatever the issue might be?
    Dr. Woodcock. No, not to my knowledge. I mean----
    Ms. Eshoo. Well----
    Dr. Woodcock [continuing]. We wish to put forth a 
legislative proposal that is put forward through the A-19 
process by the administration, right.
    Ms. Eshoo. Well, clearly this has really been overlooked, 
and my sense is that it rests more with the FDA than the 
Congress. But I am glad that this is being taken up.
    Now, on the user fees, does 100 percent of the user fees 
that would be coming in fully fund the 130 positions that you 
have goals for?
    Dr. Woodcock. We currently have funding--we currently fund 
30 positions.
    Ms. Eshoo. I know that, but you are anticipating 130.
    Dr. Woodcock. Yes. Yes.
    Ms. Eshoo. So will the user fee----
    Dr. Woodcock. 135. Yes, 105 additional would be funded by 
user fees fully.
    Ms. Eshoo. Fully.
    Dr. Woodcock. Uh-huh.
    Ms. Eshoo. On the risks relative to the incomplete 
monographs, you know, the risks that they pose, does that 
affect the pediatric population?
    Dr. Woodcock. Yes.
    Ms. Eshoo. It does.
    And can you give us an example?
    Dr. Woodcock. Well, in pediatric, cough and cold, in the 
early 2000s, we recognized that there was harm, significant 
harm, to children, OK, due to use of pediatric cough and cold 
medicines, right? But the monograph statements were that they 
were safe and effective. So it is difficult.
    Ms. Eshoo. Were they ever corrected?
    Dr. Woodcock. Well, not fully, not yet. What we have done 
is worked with----
    Ms. Eshoo. I mean, I did BPCA, PREA. But in this area----
    Dr. Woodcock. It doesn't apply.
    Ms. Eshoo [continuing]. It doesn't apply.
    Dr. Woodcock. So what we did, we worked with the industry. 
They voluntarily changed their labeling. But as I showed for 
the acetaminophen example, not every manufacturer voluntarily 
changes their label. And we don't have tools right now, because 
the regulation that is on the books, or the tentative final 
regulation, says ``safe and effective.''
    Ms. Eshoo. My time has expired.
    Thank you.
    Mr. Burgess. The Chair thanks the gentlelady. The 
gentlelady yields back. The Chair recognizes the gentleman from 
New Jersey, Mr. Lance, 5 minutes for question, please.
    Mr. Lance. Thank you very much.
    Good morning to you. It is always a pleasure to be with 
you, Dr. Woodcock.
    Dr. Woodcock. Thank you.
    Mr. Lance. Before I ask questions, I do want to indicate 
that it is my hope that the committee will examine the 
cosmetics issue. This has been discussed in opening statements 
by others. I am involved in that issue with Mr. Pallone, the 
ranking member of the full committee.
    Native Americans use these products, and I have been 
working in a bipartisan capacity to advance consumer safety and 
provide a regulatory framework that furthers growth and 
innovation for American cosmetics manufacturers and small 
businesses. Consumers need to know that the products they are 
using are safe, and businesses need a 21-century FDA that 
responds as quickly as new, great ideas are being developed. 
The statutory scheme governing cosmetics has been unchanged 
virtually for 70 years. This is an area where the committee 
should break ground and find a bipartisan solution for 
consumers and stakeholders.
    Mr. Chairman, on the issue we are discussing this morning, 
I have a letter that I would like to submit into the record 
from Colin Mackenzie, who is the head for all of the Americas 
from GlaxoSmithKline Consumer Healthcare. And I respectfully 
request that that be put in the record.
    Mr. Burgess. Without objection.
    [The information appears at the conclusion of the hearing.]
    Mr. Lance. Thank you very much.
    Dr. Woodcock, off topic, but an issue of acute interest on 
the Hill right now, right-to-try legislation. I have been 
involved in this, and I am interested in hearing your 
perspective on the proposal that recently passed in the Senate.
    Dr. Woodcock. Well, first of all, my personal opinion, 
which I have testified on before, is that the Federal 
Government should not stand between someone who is dying and 
wants to try a medication. However, I feel if I were that 
person, or a relative of that person I would want to know if 
the last several people taking that medication had survived or 
had died quickly or whatever. So I think for protecting people, 
it is important that there be some transparency about the 
outcomes of these uses if something were to pass.
    Now, the FDA, as you know, approves about 99 percent, or 
99.9 percent of all requests for uses of drugs. However, we are 
aware that certainly not all firms are willing to give out 
medicines because they may have a short supply or they may be 
concerned about the situation, or even the safety of the 
treatment for that particular individual. So it is, I believe, 
a complicated scenario. But I believe foremost, we should 
consider not only the rights of patients, but their safety.
    Mr. Lance. Thank you.
    The OTC monograph reform bill we are considering provides 
for significant expansion of FDA's OTC drug review and 
oversight capacity. How will the boost in personnel, which we 
all favor, enable the FDA to resolve the OTC drug review 
backlog and timely consideration of applications for new 
innovate products?
    Dr. Woodcock. Well, what we have envisioned, and what has 
been written down so far is sort of a staged improvement where, 
first, infrastructure and hiring and training and so forth take 
place. Then innovation begins to be taken up as well as early 
cases of finalizing these pending proceedings. And those will 
go overtime with time frames.
    So what we envision is that we would start with the 
innovation along with dealing with the, quote, so-called 
backlog and the safety. Of course, immediately upon having this 
new program, we would be able to deal with safety problems much 
quicker, and we would.
    Mr. Lance. Well, thank you. And I wish you well in that. 
And, certainly, we want to be involved to the greatest extent 
possible.
    Mr. Chairman, I yield back 32 seconds.
    Mr. Burgess. The Chair thanks the gentleman. The Chair now 
recognizes the gentlelady from Colorado, Ms. DeGette, 5 minutes 
for questions, please.
    Ms. DeGette. Thank you, Mr. Chairman. I really want to 
thank you for going through regular order with this bill, 
because I think that this is one of those issues that has 
really been a bugaboo for a long time. The agency has tried to 
deal with it, Congress has tried to deal with it.
    Dr. Woodcock, I just want to ask you a couple of questions. 
The first one is about the process that we have used to come up 
with the discussion draft on which we are having a hearing 
today. All of the group that everybody mentioned, the 
Republicans and Democrats on this committee who have been 
trying to work through this, we have been working with your 
agency for over a year on that. Is that correct?
    Dr. Woodcock. Yes.
    Ms. DeGette. And maybe you can talk a little bit more about 
some of the steps that the FDA took to get input for us on this 
OTC monograph reform bill from the various stakeholders.
    Dr. Woodcock. Certainly.
    Well, as I said, we had a public meeting on this in 2014 
and, at that time, pointed out the fact that the monographs 
were not getting finished and the difficulties we were having, 
the difficulty of safety, and also the problem with innovation. 
And there was a great deal of support for doing something.
    Subsequently with that, we met with the industry numerous 
times, a large number of times, trying to work out what such a 
program would look like so that Congress would have something 
to work with, right, and getting through a lot of the technical 
issues. So there were numerous meetings about both the policy 
changes, the legislative changes, that would enable us to have 
orders and so forth as well as what a user-fee program might 
look like.
    At the same time, we posted meeting minutes of those 
meetings, and we had various public interactions at different 
times. And we met with some of the more involved stakeholders, 
some of whom will testify today as well.
    Ms. DeGette. And in addition, as the bill was being 
drafted, I assume that your staff gave technical assistance to 
the committee staff on this----
    Dr. Woodcock. That is exactly right. Uh-huh.
    Ms. DeGette. So, really, the draft we are looking at today 
is sort of an amalgam of all of those processes that we have 
had up until today.
    Dr. Woodcock. Uh-huh.
    Ms. DeGette. I want to ask you about a specific provision 
of the discussion draft that allows the FDA to include 
requirements for the packaging of a drug to help protect 
children from harm, such as through unit-dose packaging or 
other requirements.
    Does the packaging language include, in the discussion 
draft, give the FDA sufficient authority to require packaging 
information to protect children from risks, or is there more 
that needs to be done?
    Dr. Woodcock. No, we believe this language is adequate.
    Ms. DeGette. And why do you believe that?
    Dr. Woodcock. Because it says other appropriate 
requirements. So it gives us fairly wide scope.
    Ms. DeGette. Thank you very much, and thank you for all of 
your efforts and your agency's efforts.
    I yield back, Mr. Chairman.
    Mr. Burgess. The Chair thanks the gentlelady. The 
gentlelady yields back. The Chair recognizes the gentleman from 
Florida, Mr. Bilirakis, 5 minutes for questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it.
    Dr. Woodcock, in your testimony, you mentioned that roughly 
one-third of the monographs started decades ago are still not 
being finished.
    Can you give us a sense of the size of this backlog? How 
big is it? How long do you think it will take to clear the 
backlog? What types of submissions are in the backlog?
    Dr. Woodcock. Well, first of all, you have to understand, 
this backlog is a little different than, say, what you used to 
talk about the generic backlog, which we have dealt with. These 
products are still on the market, right. All these products are 
on the market. And the process of finalizing the monograph 
would perhaps remove some of those from the market, right, and 
establish the conditions under which they can be marketed and 
perhaps limit those.
    So there are about 100 ingredients, I think--several 
hundred ingredients left out of 800 that haven't been 
finalized. And there are about maybe--many uses--more than--
several hundred uses of those ingredients, because many 
ingredients are used for multiple different uses. It is 
difficult to have a count because, until we get to the final 
monograph, we don't know what will be in or out in each one of 
those. But that is the ballpark. It is about a third.
    Mr. Bilirakis. About a third. And how long do you think it 
will take to clear the backlog?
    Dr. Woodcock. Well, it will definitely, we believe, take 
beyond the 5-year period.
    Mr. Bilirakis. OK. Your testimony shows that funding for 
FDA's monograph products is fairly flat, somewhere roughly 
between $7- and $8 million annually.
    Have submissions being fairly flat year to year, or are 
they increasing?
    Dr. Woodcock. Well, the activity has increased because of 
all the new scientific knowledge. And as I showed you this 
chart earlier, the churn that happens with any given monograph 
as we learn more scientific information. But this was fixed, 
really, in 1972. And so, we don't have any new submissions at 
all to this in the sense of new ingredients added, or whatever, 
except a few that might be foreign ingredients that could come 
within the time and extent pathway, which was what the 
Sunscreen Innovation Act dealt with.
    Mr. Bilirakis. OK. Next question: In your testimony, you 
talked about the slow timeline for changes to the monograph. 
You used the example of a liver injury for generic Tylenol 
taking 7 years to update the warning. My goodness. How would 
monography reform shorten the time frame substantially? What 
changes would be required by statute? And what can FDA do to--
what can they do administratively?
    Dr. Woodcock. Yes. The goal would be that we could have an 
issue, an interim final rule on safety, on specific kind of 
safety changes. And we could issue that rather quickly, and 
then it would be binding. And then the discussion about it and 
any further adjudication could occur after that, and we would 
go to a final rule after we would get public comment. But say 
we find out a safety problem, a serious safety problem, can be 
dealt with with labeling. We issue an interim final rule. All 
the labels change so people are protected, and then we can have 
further scientific discussions and go to a final rule that 
would, you know, have had that chance for people to have a lot 
of discussion.
    Mr. Bilirakis. OK. Very good. Thank you, Dr. Woodcock.
    I yield back, Mr. Chairman. Thank you.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back. The Chair recognizes the gentlelady from Illinois, 
Ms. Schakowsky, for 5 minutes for questions, please.
    Ms. Schakowsky. Thank you very much.
    Dr. Woodcock, let me just say personally, first of all, how 
much I appreciate what you do and your testimony here. I think 
you are always transparent and candid and informed. And I thank 
you very, very much for that. And, you know, we can all look 
back and think, well, maybe we should have moved ahead further 
or faster on this issue. But here we are today, and I know that 
you will be working with us to make sure that we deal with 
over-the-counter drugs.
    I wanted to reaffirm something that has been said a number 
of times, and that is that I am hoping very much that the 
committee moves forward on cosmetics. I have a bill, a Cosmetic 
Safety Act, that I have been working on for a long time. But, 
you know, when we have shampoos that cause people to lose their 
hair, a child to have lost all her hair, or a teen's eye shadow 
is tainted by asbestos, the FDA right now is unable to act. So 
never let it be said that we ignored the issue of cosmetics. 
And I think that is another thing we need to move forward on.
    But back to OTC. We have talked a lot about the 
administrative problems, about how long it takes to regulate 
the cumbersomeness of the process. But I wonder if you could 
just succinctly list the safety issues that we need to address 
that aren't being addressed right now?
    Dr. Woodcock. OK. Well, we could start with the skin 
reactions to acetaminophen. We can add the safety problems with 
pediatric cough and cold medications. We can----
    Ms. Schakowsky. Is that, in part, using the sweet gummy 
kinds of things that might attract children?
    Dr. Woodcock. That is a safety issue related to, you know, 
the dosage form and overdoses in children. That is another 
issue that we would be dealing with. You know, there are quite 
a few. We finally finished the liver warning for acetaminophen, 
but there are other over-the-counter drugs that we probably 
need to move on safety.
    Ms. Schakowsky. So do you think that once this process is 
in place, that there will be over-the-counter drugs that will 
be removed? You alluded to that in the last set of questions.
    Dr. Woodcock. Well, the monograph system itself envisions 
removing, when we have a final monograph, certain ingredients 
out of the monograph. That is kind of how it works. They are 
all on the market, to start with. And as we go through this 
process, they get removed. So as we finalize these monographs, 
certain ingredients be no longer be permissible to be marketed 
in the United States. Most of them don't have serious safety 
issues. Some of them simply don't have any data that show they 
work.
    Ms. Schakowsky. And so some would have to have more 
warnings?
    Dr. Woodcock. They might have to have more warnings, or 
they simply might have to withdraw because they can't produce 
any data that show that they are effective.
    Ms. Schakowsky. So this new process would be a before-the-
fact look at these drugs, or no? Would they still go on the 
market anyway right away?
    Dr. Woodcock. No. No drugs supposedly, since 1972, have 
gone on market. This process now only deals with drugs that are 
on the market in 1972 or before. What we are planning to put in 
place, if Congress, you know, agrees with this, is a process 
where we could move new ingredients into this process and have 
them regulated this way, which is much less burdensome for the 
industry, for products that are OTC products where multiple 
parties can market them.
    Ms. Schakowsky. Let me ask you one more thing. As you know, 
the Consumer Product Safety Commission is charged with 
implementing and enforcing special packaging and child-
resistant package requirements. I am just wondering how the FDA 
work and interact with the Consumer Product Safety Commission 
on these packaging requirements?
    Dr. Woodcock. Certainly.
    We work very closely with them. We recognize their 
standards. They set the standard for child-resistant packaging, 
say, for bottles and how you test for that and so forth. And 
were this to move forward, we could have a memorandum of 
understanding with them on how we would notify them about 
anything we were doing on packaging to make sure that they were 
aware of--you know, if we were making some safety unit of use 
packaging, or whatever. We would let them know.
    Ms. Schakowsky. Thank you.
    I yield back. I appreciate you.
    Mr. Burgess. The Chair thanks the gentlelady. The 
gentlelady yields back. The Chair recognizes the gentlelady 
from Indiana, Mrs. Brooks, 5 minutes for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman. And I want to also 
thank Dr. Woodcock for coming before this committee again and 
explaining to us why it is so necessary to take these long, 
what I am learning, are overdue steps to update our over-the-
counter monograph process.
    I appreciate that you have talked about some of the 
challenges, and you just went through some specific problems, 
but wondered if there were any other examples of how the 
inefficiencies in the existing OTC drug monograph system have 
exposed Americans to risk from potentially unsafe, what you 
just talked about, I believe, or possibly ineffective drug 
products. Are there any specific examples you'd like to 
provide?
    Dr. Woodcock. Well, until we get the monographs finalized, 
it is hard to call them ineffective until they are approved--a 
current system until they are shown by--you know, a regulation 
is published saying they are ineffective. So that is one of our 
conundrums. It fits very well with your question. They aren't 
officially ineffective until they are found ineffective in a 
final regulation.
    Mrs. Brooks. That is what has been so problematic to that 
point.
    Dr. Woodcock. Yes. It is very difficult to get to that 
point, yes. And, you know, people can always submit more data 
and all these types of things. We propose them as ineffective 
and then back and forth. So it can be prolonged very long.
    Mrs. Brooks. Thank you.
    We know that American patients, providers, and 
manufacturers have been benefited greatly from Congress' 
previous authorization of FDA user fees for prescription drugs, 
generic drugs, biologic and biosimilar drugs, animal drugs, 
medical devices. But we know that OTC drugs have--products have 
lagged behind.
    So how do you believe that the user fees authorized in this 
legislation combined with congressional appropriations will 
give you the necessary resources to bring the OTC drug 
regulation on par with other drug and medical products? And 
then, secondly, in addition to the personnel increases, which 
you have talk about going from 30 to 135, what resources will 
this legislation provide FDA to improve the system?
    Dr. Woodcock. Well, we plan to spend about $26 million on 
investing in an IT system so that this becomes paperless 
instead of a paper-intensive process. And that would require 
about $3 million a year ongoing for maintenance once it is 
built. So the $26 million will be spread out over the first 4 
years or so of the program. We would also invest in training of 
our people, developing processes and different matters like 
that.
    But this level of program, as I said, will not result in 
the monographs all being in the new order system and having all 
final orders at the end of 5 years. It is not going to be that 
fast.
    Mrs. Brooks. No, I appreciate that. And you have certainly 
let us know that and have set the expectations.
    Are you saying that right now, the current system relies on 
a paper process?
    Dr. Woodcock. To a great extent, uh-huh.
    Mrs. Brooks. And so the building of an appropriate IT 
system which doesn't exist right now would be incredibly 
helpful?
    Dr. Woodcock. Yes. And since we are going to put what I 
call the mulch behind all this past documentation that we have, 
it is all over the place, we can have an electronic gateway 
like we do for the other user-fee programs, so submissions are 
electronic. There are standardized formats. Many things that 
help everybody in a monograph system be efficient.
    Mrs. Brooks. And just out of curiosity, you talked about 
additional training that would be needed besides the 30 staff 
that are currently on board. Have they been involved in this 
process in a significant way?
    Dr. Woodcock. Yes. Yes. And bracing themselves if they have 
to train all these new people, and try to complete some of the 
work at the same time.
    Mrs. Brooks. Thank you.
    Thanks. I yield back.
    Mr. Burgess. The Chair thanks the gentlelady. The 
gentlelady yields back. The Chair recognizes the gentlelady 
from Michigan, Mrs. Dingell, 5 minutes for questions, please.
    Mrs. Dingell. Thank you, Mr. Chairman.
    Dr. Woodcock, like everybody here, we are a fan and really 
grateful for all the work you are doing and sitting here 
through all these questions, many of which sound the same.
    But I think we are all saying that we think the OTC system 
is broken. I don't think it is working for patients, for 
doctors, for people in the industry who are making innovative 
products. And your testimony said this, and the questions and 
answers we are getting keeps reaffirming that.
    But just for the record, I, again, want to--it is true that 
there are far more OTC monograph products than brand of 
prescription drug products.
    Dr. Woodcock. That is true.
    Mrs. Dingell. And despite this fact, FDA got only $7.9 
million last year to review OTC products while prescription 
drug spending totaled $1.1 billion when user fees were 
included. Is that correct?
    Dr. Woodcock. That is correct.
    Mrs. Dingell. So I do have this question, because when you 
are talking about the 5 years and you are talking about 
creating an IT system that doesn't exist, is it going to--can 
money help accelerate that 5 years? Will getting you more 
money----
    Dr. Woodcock. Well, we can always do more with more. We can 
move faster with more, uh-huh.
    Mrs. Dingell. So it is maybe, at some point, you could give 
us how much you need to create that IT system which will 
accelerate it and maybe give us a little--that is not in any of 
the planned questions, but I think it is a question that is 
really popping here.
    Will the draft legislation we are considering today give 
FDA the resources the agency needs to do a more effective job?
    Dr. Woodcock. Definitely a more effective job, absolutely, 
especially combined--we need the authorities to do a more 
effective job. We can't use these authorities.
    Mrs. Dingell. So as you just said, the lack of funding is 
not the only issue. The draft legislation we are considering 
today also gives FDA the authority to use administrative orders 
to make changes to OTC monographs rather than the current 
notice and comment rulemaking process which has left many 
monographs unfinalized and critical safety issues unaddressed.
    Does FDA believe that these changes in the draft 
legislation would make it easier to allow innovative products 
to make it to the market while also allowing the agency to 
address the safety issues faster?
    Dr. Woodcock. Yes. There is a specific innovation pathway 
that has been built in with timelines and deliverables and so 
forth. And we definitely contemplate that there is innovation 
to be had in this space.
    Mrs. Dingell. Thank you.
    I think this draft bill goes a long way. I want to take a 
step back a bit and give some context.
    In 2014, Congress came together unanimously to pass the 
Sunscreen Innovation Act, because our Nation is facing a skin 
cancer epidemic, and the last time a new OTC sunscreen 
ingredient was approved was in the 1990s, which you know. This 
is a symptom of how broken the OTC system is overall, but it is 
more pressing and it is more urgent because there are 5 million 
Americans being treated for skin cancer every year. And the 
rate of melanoma is on the rise.
    So while OTC reform is going to make it easier for all 
innovative products to safely and quickly get to market, we 
cannot forget the urgent need to ensure that Americans have 
access to sunscreen products that have been used safely for 
decades overseas. This is where the frustration comes from all 
of us.
    Dr. Woodcock, Congress remains concerned about this skin 
cancer epidemic. Can we work with you and other stakeholders to 
ensure Americans have access to the latest sunscreen 
ingredients? And what do we need to do to make sure that is 
here and now?
    Dr. Woodcock. Well, we have, you know, met, as I said, all 
the stipulations, actually exceeded them, in the Sunscreen 
Innovation Act. And what we are waiting for is data--safety 
data to be submitted. What the Sunscreen Innovation Act did not 
do is lower the standards for safety for OTC medicines. And so 
when we receive those data, we will be able to review them 
promptly because, as I said, the Sunscreen Innovation Act is 
one of our highest priorities.
    Mrs. Dingell. So how long is it going to take to get that 
aid up? What is the holdup? Why is this so complicated?
    Dr. Woodcock. Under most of the things that FDA regulates, 
we don't do that research; the research is done by the sponsors 
because they have the medicines, the drugs, the formulations, 
and they submit that research to us. So we wait for them to 
conduct the research. We give them parameters about what the 
research should look like to meet the standards. And then it is 
on their time frames.
    Mrs. Dingell. Do we know their time frames?
    Dr. Woodcock. We certainly are in contact with them about 
their activities. I personally have met with them fairly 
recently.
    Mrs. Dingell. Thank you.
    I yield back the balance of my time, Mr. Chairman.
    Mr. Burgess. The Chair thanks the gentlelady. The Chair 
recognizes the gentleman from Georgia, Mr. Carter, 5 minutes 
for questions, please.
    Mr. Carter. Thank you, Mr. Chairman.
    Dr. Woodcock, thank you for being here. Help me to 
understand something here. And I have been in between 
subcommittee meetings, so please excuse me if I have missed 
this. When you come up with a profile for a certain ingredient, 
does it apply to every product, every manufacturer that has 
that product out there?
    For instance, ibuprofen. If you come up with a profile for 
ibuprofen, didn't you say if you have ibuprofen in your 
product, you have to have this on your monograph?
    Dr. Woodcock. The monograph specifies the ingredient 
ibuprofen if that were in there, which it isn't. But it 
specifies the ingredient. It specifies the dosages that can be 
used, and the regimen. And then it specifies what conditions it 
can be sort of advertised for, right? And if you then market 
using those parameters, then you don't have to send in an 
application.
    Mr. Carter. If you market.
    So tell me, if you find out something, if you find out that 
ibuprofen in a certain dosage causes hepatotoxicity, or is 
eating your stomach up and you want to warn against, so you go 
to every product out there that has a certain amount of 
ibuprofen in it, and you say, You need to add this to your 
monograph?
    Dr. Woodcock. No. The monograph is an FDA regulation.
    Mr. Carter. OK.
    Dr. Woodcock. And so we would have to change if--for an 
ingredient----
    Mr. Carter. But if you change it, do they have to--does 
every product----
    Dr. Woodcock. Yes.
    Mr. Carter [continuing]. Out there have to change?
    Dr. Woodcock. They would have to add the warning, that is 
correct.
    Mr. Carter. They would have to add the warning. So that 
seems simple enough.
    Dr. Woodcock. And only if you didn't--if you got this 
slide. First of all, we have to have a final monograph in 
place. OK. And then we have to change it through rulemaking, 
through notice------
    Mr. Carter. How long does that process take?
    Dr. Woodcock. Six, 8 years.
    Mr. Carter. Oh, please.
    Dr. Woodcock. Here is one. This is the external----
    Mr. Carter. I have seen that. Why does it take that long?
    Dr. Woodcock. Because----
    Mr. Carter. It doesn't take that long with prescription 
medications. They get them off the market quicker than that.
    Dr. Woodcock. Oh, yes. We get them off the market lickety-
split if they are dangerous, right?
    Mr. Carter. Absolutely.
    Dr. Woodcock. Here, the issue is--say we have a final 
monograph in place, the Government has a regulation. The 
regulation states, this drug is generally recognized as safe 
and effective. And now we are saying, ``Oh, it is not safe.'' 
OK. But we have a regulation that says it is safe.
    So for the lawyers in the room, they understand the 
problem, OK? We have to then--what we do now, because of that, 
we issue safety alerts, and we look for voluntary changes to 
the label. But we can't mandate changes until----
    Mr. Carter. Why not?
    Dr. Woodcock. Because it is a regulation.
    Mr. Carter. It is a regulation legislatively or through 
your rules that you promulgated?
    Dr. Woodcock. Rules that we promulgate. And we have to 
promulgate a new rule. That is how the rules work before it 
gets changed.
    Mr. Carter. All right. Let me ask you something. What about 
off-label uses? You know that happens.
    Dr. Woodcock. Uh-huh.
    Mr. Carter. I mean, you know, I practiced pharmacy for over 
30 years, and I did that regularly. Do you ever address that?
    Dr. Woodcock. Well, we address it in the sense that if an 
off-label use is leading to harm, we will send out safety 
alerts and tell people and so forth.
    Mr. Carter. So if a product has been on the market for 
years--let's just take, for example, Diphenhydramine. You know, 
for many years, that was just an antihistamine that you used 
for bee stings or something like that.
    Dr. Woodcock. Right.
    Mr. Carter. And I always recommended it to help somebody 
sleep, you know. And now you have got Benadryl PM, and you have 
got products--and they are marking for that now. So how long 
does that take, to get that new indication there?
    Dr. Woodcock. Well, they are there already part of--right? 
They are already part of the sleep aids.
    Mr. Carter. They are now.
    Dr. Woodcock. They are now.
    Mr. Carter. But initially they weren't.
    Dr. Woodcock. They always were, right?
    Mr. Carter. I am not sure about that. But nevertheless----
    Dr. Woodcock. Yes.
    Mr. Carter [continuing]. You know.
    Dr. Woodcock. OK. To get a new one is what you are asking 
about.
    Mr. Carter. Exactly.
    Dr. Woodcock. There is no way to do that.
    Mr. Carter. An antihistamine. An antihistamine is indicated 
now for sinus drainage. I mean, you know, at one time when I 
was in school, which was just a few years ago. But at one time 
when I was in school, it was--you know, it was a side effect.
    Dr. Woodcock. Right. Right.
    Mr. Carter. That is what we used it for.
    So if a new indication comes out, how long does it take for 
you to get that new indication for them to be able to market it 
that way?
    Dr. Woodcock. Under the monograph, there is no way to do 
that. Unless it was marketed for that purpose before 1972, then 
it isn't eligible for the monograph. They could file an NDA.
    Mr. Carter. Before 1972?
    Dr. Woodcock. Uh-huh. This whole system is fixed in 1972 
and in the past.
    Mr. Carter. I think we have discovered the problem.
    Thank you, Dr. Woodcock.
    Dr. Woodcock. Most welcome.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman.
    Director Woodcock, I deferred my questions until the end, 
and I just have a couple.
    First off, you mentioned at the start that you had 88 
pending monographs; is that correct?
    Dr. Woodcock. Yes.
    Mr. Burgess. Does the committee have that list? Are you 
able to share that with the committee?
    Dr. Woodcock. We certainly could provide that to you.
    Mr. Burgess. And I think it would just provide some context 
of what we are working on.
    And with Mr. Carter's line of questions, there used to be 
an over-the-counter asthma inhaler, and there is not. That was 
prior to 1972----
    Dr. Woodcock. Right.
    Mr. Burgess [continuing]. That that product----
    Dr. Woodcock. Was available.
    Dr. Woodcock. Right.
    Mr. Burgess. So let me just ask the question, because I 
know I am going to get it from other people: Where do we stand 
with providing that active pharmaceutical ingredient that was 
in an over-the-counters asthma inhaler prior to 1972?
    Dr. Woodcock. Right. Well, I can't comment on pending 
applications, so forth. That was not a monograph product. That 
was a new drug application product.
    Mr. Burgess. A new drug application?
    Dr. Woodcock. Product, yes.
    So there are products over the counter, like, say, Cortaid 
or whatever, your vaginal antifungal. Those were all switched 
from prescription drugs, and they still have a new drug 
application. They are not monograph products.
    Mr. Burgess. I see. I see.
    Well, let me just make the plea that asthmatics do need an 
over-the-counter preparation. They shouldn't have to incur an 
emergency room charge in the middle of the night just to get a 
little bit of relief.
    Mr. Carter. Mr. Chairman, would the gentleman yield?
    Mr. Burgess. Briefly.
    Mr. Carter. Briefly.
    I am sorry.What do you do in situations like sudaphedrine 
that has been approved but is being abused? Do you do anything 
in that situation?
    Dr. Woodcock. Well, Congress took the step of moving that, 
restricting its----
    Mr. Carter. Why would Congress need to? I thought that was 
your job.
    Dr. Woodcock. I don't think we have the authority to do 
that.
    Mr. Carter. So if you see that a drug that has been 
approved in the 1972 act is now being abused, you don't have 
the authority to do something about it?
    Dr. Woodcock. We can move against things on safety grounds. 
That is right. But that was being--it was actually being used 
as an ingredient, that one, in manufacturing an abused drug.
    Mr. Carter. Is that not enough?
    Dr. Woodcock. I would not like to give a legal opinion 
here.
    Mr. Burgess. And if the gentleman--reclaiming my time. I 
think there have been various State regulations that have been 
applied, and that is why in different States there is a 
different requirement as to whether or not you need to show a 
driver's license to purchase those products. However, when 
there was a product that was marketed as a weight-loss product 
that contained ephedrine, or some derivative of ephedrine, I 
think you all did move pretty quickly to remove that from the 
market.
    Dr. Woodcock. We did. There were safety events related to 
that, uh-huh.
    Mr. Burgess. Well, I want to thank you for being here 
today. And just to address the comments that were made, 
actually on both sides of the dais. You know, where has the 
committee been? Where has the agency been? I mean, I have just 
been through my third reauthorization of the user-fee 
agreements. This concept was brought to me late in the spring. 
We were pretty far down the road on the user-fee agreements, 
and I made the decision nothing was going to deter us from 
getting the user-fee agreements across the finish line, and we 
did, recognizing that there would be some serious personnel 
repercussions at the agency if we did not do our work, but we 
did. I also committed that we would tackle this problem quickly 
after we got the user-fee agreements put together and 
delivered, and so here we are today.
    I know I personally have made three trips to the Food and 
Drug Administration, your physical campus. And you received 
myself and staff one time when we were worried about the drug 
shortages a few years ago. I think I was there on Dr. Hamburg's 
first day. Dr. von Eschenbach was kind enough to have me out in 
the previous iteration of your headquarters. So the agency, I 
have always found, has been very welcoming to committee 
members. And there has never been, that I have detected, any 
reluctance of the agency to talk to members of the committee. 
Now, maybe there are rules that prohibit the direct 
communication as far as what will be considered as lobbying. 
But generally, the flow of information from the agency to at 
least myself as a Member of Congress, I have always found that 
door to be open, and I have been grateful for that.
    I am grateful for your testimony here today. I think you 
have helped this process. And clearly, it is something that 
needs to be addressed and needs to be fixed, and we will 
continue to pursue it and get it done.
    We will conclude this panel. I am not going to recess in 
the interest of time. We do have another panel to follow. But 
again, thank you, Dr. Woodcock, and we will look forward to 
your next adventure here.
    Dr. Woodcock. Thank you.
    Mr. Burgess. We will now hear from our second panel of 
witnesses. And, again, we do want to thank you our witnesses 
for being here today and taking the time to testify before the 
subcommittee.
    Each witness will have the opportunity to give an opening 
statement followed by questions from Members. Our second panel, 
we will hear from Mr. Scott Melville, the president and CEO of 
Consumer Products Association? Ms. Kirsten Moore, project 
director, Pew Charitable Trust Healthcare Products; Mr. Michael 
Werner, partner, Holland and Knight, on behalf of Public Access 
to Sunscreens Coalition; Dr. Bridgette Jones, chair, Committee 
on Drugs, American Academy of Pediatrics; and Mr. Gil Roth, 
president, Pharma and Biopharma Outsourcing Association. We do 
appreciate you being here today.
    Mr. Melville, you are recognized, 5 minutes for an opening 
statement, please.

  STATEMENTS OF SCOTT MELVILLE, PRESIDENT AND CHIEF EXECUTIVE 
  OFFICER, CONSUMER HEALTHCARE PRODUCTS ASSOCIATION; KIRSTEN 
     MOORE, PROJECT DIRECTOR, HEALTHCARE PRODUCTS, THE PEW 
 CHARITABLE TRUSTS; MICHAEL WERNER, PARTNER, HOLLAND & KNIGHT, 
ON BEHALF OF THE PUBLIC ACCESS TO SUNSCREENS (PASS) COALITION; 
 BRIDGETTE L. JONES, M.D., CHAIR, COMMITTEE ON DRUGS, AMERICAN 
 ACADEMY OF PEDIATRICS; AND GIL Y. ROTH, PRESIDENT, PHARMA AND 
               BIOPHARMA OUTSOURCING ASSOCIATION

                  STATEMENT OF SCOTT MELVILLE

    Mr. Melville. Thank you, Chairman Burgess, Ranking Member, 
members of the subcommittee, thank you for the opportunity to 
provide testimony today on the over-the-counter monograph 
system and the importance of modernizing regulation to enhance 
the public health. My name is Scott Melville, and I am 
president and CEO of the Consumer Healthcare Products 
Association.
    Since 1881, CHPA has served as the industry association 
representing leading manufacturers and marketers of over-the-
counter medicines in the United States. CHPA member companies 
produce the vast majority of OTC medicines in our country, and 
provide millions of Americans with safe, effective, and 
affordable therapies to treat and prevent many common ailments 
and conditions. The availability of self-care treatment options 
saves money, reduces burdens on the healthcare system, and 
keeps consumers active and productive.
    Given the importance of OTC medicines to consumers and our 
Nation's healthcare system, it is essential that the regulatory 
structure that oversees these medicines is one that is modern, 
efficient, transparent, and accommodating to innovation. Now, 
the vast majority of OTC medicines in our homes today are 
regulated under the OTC monograph system, and our members 
strongly support the system. It oversees over 300 active 
ingredients and more than 100,000 nonprescription products 
ranging from antacids to diaper rash creams, from pain 
relievers to cough and cold products.
    While the OTC system was created over 40 years ago, as we 
have heard earlier today from several speakers, the process is 
still not complete. Movement on unfinished items has ground to 
a halt, largely because the system is based on notice-and-
comment rulemaking, a thorough but extremely time-consuming 
process that has slowed across all Government agencies and 
departments in recent years.
    Change is needed to have a regulatory system that accounts 
for advances in science, accommodates innovation, permits 
timely updates to safety information, and creates a workable 
process for completing unfinished monographs.
    CHPA has, therefore, worked with FDA and Members of the 
Congress to provide recommendations for a modernized monograph 
process by which FDA could make scientific determinations for 
these ingredients through an administrative order process 
rather than notice-and-comment rulemaking with necessary due 
process protections for dispute resolution and issue 
escalation. These improvements would empower the FDA to act 
more quickly when needed to address safety issues or other 
monograph changes while preserving the existing monograph 
structure, a structure that does not require unnecessary 
premarket review provided manufacturers utilize ingredients 
that have been determined to be generally recognized as safe 
and effective by the FDA.
    We understand that this new system, if enacted by Congress, 
will require more effort on FDA's part, which is why our 
industry is willing to supplement Government resources with a 
modest user-fee program. We believe the fee agreement strikes 
the right balance and will help achieve a more nimble 
regulatory structure for monograph drugs that would be a win-
win-win for consumers, manufacturers, and regulators.
    In summary, the draft legislation we are discussing today 
is incredibly important, and, if enacted, will impact the 
health of nearly every American for decades to come. It is the 
product of months and even years of consideration and 
compromise between many stakeholders, including CHPA's 
manufacture members.
    CHPA has some important technical comments on the 
discussion draft, and we look forward to continuing to work 
with members of this committee to finalize the text and support 
its introduction and consideration by the Congress in the very 
near future.
    Thank you. I look forward to addressing any questions you 
might have.
    [The prepared statement of Mr. Melville follows:]
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    Mr. Burgess. The Chair thanks the gentleman.
    Ms. Moore, you are recognized for 5 minutes for questions, 
please.

                   STATEMENT OF KIRSTEN MOORE

    Ms. Moore. Thank you very much, Chairman Burgess, Ranking 
Member Green, members of the subcommittee. Thank you for 
holding the hearing and for invitation to testify.
    My name is Kirsten Moore, and I direct the Pew Charitable 
Trusts Healthcare Products project. Pew is a non-partisan, non-
profit research and advocacy center, and I am here today in 
strong support of this legislation that would help update FDA 
regulations of over-the-counter products. By streamlining FDA's 
process, you have the opportunity to improve consumer safety 
and promote innovation.
    My remarks will focus on the problems with the outdated OTC 
monograph system, its public health implications, and the 
benefits of the proposed legislation. Each year, more than 240 
million Americans use OTC products. This marketplace is vast 
and diverse with up to 300,000 products ranging from cough and 
cold to sunscreen to pain relievers. And in theory, the active 
ingredients in these products are considered safe and effective 
when consumers follow the instructions on the label without 
direction from a healthcare provider. In practice, however, 
many contain ingredients that the FDA has not yet evaluated. 
There is no deadline by which FDA's ingredients reviews must be 
finalized, and several of these reviews have lasted decades.
    Two main problems lead us to this point: First, FDA is 
hampered by a cumbersome and inefficient regulatory system in 
evaluating these products. It is a system that has not been 
updated since its introduction in 1972. Second, FDA has only 30 
full-time employees and approximately $8.2 million to oversee 
this growing marketplace. FDA evaluates safety and efficacy of 
OTC ingredients through a monograph system, which is described 
in greater detail in my written testimony. But important to 
note the changing a monograph is a multi-step process involving 
review by FDA, the Department of Health and Human Services, and 
often the White House Office of Management and Budget.
    In contrast, FDA review of prescription drugs relies solely 
within FDA's jurisdiction. The additional steps for review for 
OTC products add considerable time and do not add to the key 
determinations of safety and efficacy.
    Let me provide just one example of the current system's 
effects on public health. This April, FDA required that 
companies add the strongest form of warning label to children's 
prescription cough and pain medications containing codeine. The 
drug can cause potentially fatal breathing problems, especially 
in children under 12. These safety concerns led an advisory 
committee to recommend that FDA remove codeine from OTC 
products in 2015, but FDA has not made this change yet because 
of the inefficient monograph system. When patients are in 
harm's way, we need action, not bureaucracy.
    This spring, Pew and several other public health 
stakeholders issued a set of principles for over-the-counter 
monograph reform. These principles are broadly reflected in 
both the House and Senate language. And the bipartisan 
legislation that you are considering would produce a win-win--I 
will up it win-win-win--reducing regulatory burdens and 
protecting consumers in four key ways: First, by driving 
efficiency. The proposed reforms will replace cumbersome 
rulemaking with an administrative order process, again, 
aligning FDA's decision-making authority for OTC products with 
the authority for prescription drugs. The legislation also 
would expedite the review process by giving the Secretary 
additional authority for data collection.
    Second, improving safety. The proposal will ensure that if 
FDA has reason to believe a product is unsafe, it can take 
swift actions. Currently, products remain on the market when 
FDA has insufficient information about whether or not they are 
safe and effective, because they cannot be removed before a 
final monograph is issued.
    Third, helping innovations. Under this legislation, FDA 
could more quickly accommodate innovation in OTC drug products, 
permitting new ingredients as well as new indications and 
formulations on existing ingredients.
    And lastly, providing resources. The proposed agreement 
would provide FDA with the resources required to clear up FDA's 
review backlog, address safety concerns for products currently 
on the market, and review future applications for innovative 
products in a more timely manner.
    Pew supports the proposed legislation because it will lead 
to improvements in consumer safety and administrative 
efficiency. It strikes a sensible balance and reflects 
thoughtful compromise between stakeholders.
    The current monograph system has had detrimental effects on 
consumers, and hinders FDA's ability to ensure the safety and 
effectiveness of over-the-counter products.
    We applaud this subcommittee for this bipartisan proposal, 
and urge Congress to capitalize on this momentum and pass this 
legislation as soon as possible.
    Thank you.
    [The prepared statement of Ms. Moore follows:]
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    Mr. Burgess. The Chair thanks the gentlelady.
    Mr. Werner, you are recognized for 5 minutes for your 
opening statement, please.

                  STATEMENT OF MICHAEL WERNER

    Mr. Werner. Thank you, Mr. Chairman and Ranking Member 
Green. My name is Michael Werner. I am a partner at the law 
firm of Holland & Knight and a public policy advisor to the 
Public Access to SunScreens Coalition, the PASS Coalition. 
Thank you for inviting me to testify today regarding efforts to 
improve and strengthen the approval process for over-the-
counter OTC products, including sunscreen ingredients.
    The PASS Coalition is a multistakeholder coalition composed 
of public health groups, dermatologists, sunscreen 
manufacturers, and leading advocates for skin cancer patients. 
The PASS Coalition was formed to ensure Americans have access 
to the latest sunscreen technology to curb the skin cancer 
epidemic in the United States. And to address this problem, 
Congress, led by this subcommittee, the FDA, the coalition and 
other stakeholders came together to enact the bipartisan 
Sunscreen Innovation Act, the SIA, in 2014, to ensure Americans 
get access to new sunscreens. And working together, we 
identified regulatory barriers to the consideration of OTC 
sunscreen ingredients, and created historic reforms to address 
them. And the Act was enacted by the House and Senate 
unanimously.
    The PASS Coalition supports the efforts of this 
subcommittee to extend similar reforms to other OTC product 
categories. We also support the establishment of a user-fee 
program to provide FDA with the resources it needs to implement 
these reforms. Based on our experience over the last 3 years in 
implementation of the SIA, and our productive conversations 
with FDA leadership, including Dr. Woodcock, we believe there 
are several improvements needed to continue to enhance the 
review process for pending and new sunscreen ingredients. And 
the OTC reform legislation being considered by this 
subcommittee provides the opportunity to codify these 
improvements and achieve the promise of the SIA.
    Mr. Chairman, skin cancer remains a public health crisis in 
the United States. According to the Surgeon General, over 5 
million Americans are treated for skin cancer every year, and 
each year there are more new cases of skin cancer than breast 
cancer, prostate cancer, lung cancer and colon cancer combined. 
And in the U.S., a patient is diagnosed with melanoma every 8 
minutes and an American loses her life every hour from the 
disease. So clearly, Americans need access to all available 
safe and effective sunscreen products.
    The last time a new OTC sunscreen ingredient was approved 
in the U.S. was decades ago. And since 2002, eight new 
sunscreen ingredients have been submitted for review under the 
FDA so-called time and extend process. And these ingredients 
have been widely available in Europe, Asia and elsewhere for 
decades. Clearing this backlog of applications will ensure that 
Americans have greater access to broad spectrum sunscreens and 
get better protections against both UVA and UVB rays.
    As you have heard this morning, FDA has met all the 
timelines required by the Act. But unfortunately, none of the 
eight pending sunscreen ingredients has yet received a final 
decision, and they are not available in the United States.
    Based on recent conversations with FDA, there is agreement 
that some changes to the SIA for the eight pending ingredients 
are needed, and that any new OTC pathway should accommodate 
sunscreen ingredients.
    So as Congress considers OTC reform legislation, the PASS 
Coalition respectfully submits the following principles for 
consideration. First, eight sunscreen ingredients that have 
already received proposed administrative orders should continue 
to be considered under the SIA. New sunscreen ingredients 
should go to the OTC reform framework. Second, any new OTC drug 
approval pathway should be flexible enough to accommodate new 
sunscreen ingredients with U.S. or international market 
experience and should not require the sponsor to file a new 
drug application for its active ingredient to be considered for 
an OTC administrative order. Third, any OTC reform legislation 
should authorize FDA to meet individually on a confidential 
basis with sponsors of sunscreen ingredients to allow for open 
discussion of commercial confidential information and trade 
secrets.
    And finally, the FDA's testing standards for these products 
should be periodically reviewed and assessed. Inclusion of 
provisions that incorporate these principles will ensure 
Americans have access to safe and effective sunscreen 
ingredients that are available across the world. The draft 
legislation that we have seen contain many of these provisions, 
and we look forward to continuing to working with the 
subcommittee.
    Thank you for the opportunity to testify. I look forward to 
your questions.
    [The prepared statement of Mr. Werner follows:]
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    Mr. Burgess. The Chair thanks the gentleman.
    The Chair recognizes Dr. Jones, 5 minutes for your opening 
statement, please.

              STATEMENT OF DR. BRIDGETTE L. JONES

    Dr. Jones. Thank you. Good morning, Chairman Burgess and 
Ranking Member Green. Thank you for the opportunity to speak 
here today about the importance of modernizing the regulation 
of over-the-counter drugs for America's children.
    My name is Dr. Bridgette Jones. I am a practicing allergy, 
asthma, immunologist and pediatric clinical pharmacologist at 
Children's Emergency in Kansas City, Missouri. I also conduct 
clinical research to improve the safety and efficacy of drugs 
for children. I am here today to represent the American Academy 
of Pediatrics, or the AAP.
    In my practice, I frequently need to discuss with parents 
the risks and benefits of using OTC medicines to treat common 
pediatric ailments, such as allergies and asthma. As a 
pediatrician advising parents, I want to know that the products 
I recommend have been tested in children to ensure that they 
are safe, effective and labeled appropriately for their use. 
Therefore, we must have a process to regulate them that is 
responsive to the most recent medical science.
    The current OTC regulation process at the FDA is not nimble 
to adapt to emerging evidence, safety concerns or product 
innovation. Burdensome regulatory processes cause unnecessary 
delays. The OTC monograph was, in large part, developed based 
on evidence from 50 years ago. Some of these drugs continue to 
be mainstays of pediatric practice, but others we know from 
more recent evidence provide little or no benefit to children. 
Put simply, the current system does not serve the needs of 
children.
    The only way to ensure reliable and safe OTC medicines for 
families is to change how the monograph system works and 
provide significant new resources for the endeavor. Therefore, 
the AAP strongly supports the efforts of Congress to reform the 
process and create a user-fee program to fund FDA's monograph 
work.
    The monograph regulating cough and cold medicines for 
children is a good example of how of process does not work. The 
data that led FDA to label these medicines for children does 
not meet today's standards, and data gathered since then 
clearly shows certain cough and cold products to be completely 
ineffective for children. Nevertheless, these products are 
still commonly marketed to children despite safety risks. While 
FDA agreed to revive the monograph more than a decade ago, 
today, FDA has yet to publish even draft changes despite 
evidence that these products result in thousands of pediatric 
overdose-related emergency department visits each year.
    It is our hope that through a reformed OTC monograph 
system, the FDA will act, at long last, to modernize the cough 
and cold monograph. We also must ensure that innovation made 
possible by OTC reform does not have unintended negative 
consequences. One area where we anticipate greater industry 
innovation is in the development of novel formulations for OTC 
products. It is possible that industry may work on developing 
gummy formulations of drugs, much like supplement manufacturers 
have done in recent years, with their marketing of gummy 
vitamins.
    Gummy formulations of OTC drugs, whether intended for 
children or for adults, would greatly concern pediatricians 
because we know that when a product looks and tastes like 
candy, children will eat it. If a child consumes gummy 
acetaminophen, for instance, outside the watchful eye of 
parents, it could lead to a trip to the emergency room or 
worse. Therefore, FDA must have clear authority to regulate the 
packaging of OTC drugs, including requirements for unit dose 
packaging, such as blister packs to prevent abuse or misuse and 
protect against unsupervised ingestion.
    While the Consumer Product Safety Commission has existing 
authority to require that certain drugs come in child resistant 
packaging, tested to ensure that it is difficult for children 
to open, CPSC cannot require specific types of packaging. 
Therefore, FDA must be able to do so, and since CPSC only 
requires a small handful of OTC monograph drugs to be sold in 
child resistant packaging, greater collaboration between FDA 
and CPSC is critically important.
    Mr. Chairman, the latest discussion draft is largely 
reflective of the AAP's principles for OTC monograph reform. We 
strongly support the packaging language. Additionally, we look 
forward to continuing to work with the committee to ensure that 
the FDA and CPSC establish processes for notification when the 
FDA takes action that might warrant CPSC's reevaluation of its 
own packaging regulations.
    Thank you for the opportunity to speak here today about 
this important issue.
    [The prepared statement of Dr. Jones follows:]
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    Mr. Burgess. The Chair thanks Dr. Jones.
    Mr. Roth, you are recognized for 5 minutes for an opening 
statement.

                    STATEMENT OF GIL Y. ROTH

    Mr. Roth. Chairman Burgess, Ranking Member Green, members 
of the subcommittee, thank you for the opportunity to submit 
testimony today about the proposed Over-the-Counter Monograph 
Safety, Innovation, and Reform Act of 2017. I am Gil Roth, 
president of Pharma and Biopharma Outsourcing Association, or 
PBOA.
    PBOA is a leading trade association for contract 
manufacturing organizations and contract development and 
manufacturing organization known has CMOs and CDMOs in the 
Pharma and Biopharma space. PBOA's core mission is to advance a 
regulatory, legislative and general business interest of the 
CMO and CDMO sector.
    I am here today to express PBOA's support for the newly 
released OMUFA draft, to urge this committee and the Congress 
to advance this draft, and to express my thanks for ensuring 
that this draft takes into account the unique needs of the CMO/
CDMO community. Your willingness to ensure our seat at the 
table greatly appreciated and PBOA strongly believes resulted 
in the release of a better OMUFA draft deserving of bipartisan 
support.
    You may be wondering what a CMO and CDMO actually is and 
how the companies contribute to the development of drugs, or in 
this case, over-the-counter drugs. CMO/CDMOs are the true 
experts in manufacturing. The members, who are predominantly 
domestic, provide manufacturing formulation technology, 
packaging and other services that enable drug companies to 
develop and commercialize medicines. They help make more one-
third of all doses dispensed to patients in America, producing 
both innovator drugs and generics, small molecules and 
biologics, pills to injectables, OTCs and biosimilars. CMOs/
CDMOs empower their customers to bring lifesaving, cost 
effective quality medicines to patients. I have been involved 
with the CMO sector since 1999, have witnessed the industry's 
rapid growth and the key role it plays in the American 
healthcare system.
    I would like to commend the committee for your continued 
focus on the important issues we will examine today. The FDA 
has long outstanding commitments to produce and finalize over-
the-counter monographs worked up again a year after I was born. 
And as has been noted in the current fiscal year, the FDA has 
allocated $8 million to such efforts, some that can yield only 
minimal dedicated staffing, little progress. Industry, the FDA 
and the Congress can agree that the monograph process overall 
is outdated, and further, that there is recognition that 
monograph review cannot expand without additional resources.
    The legislation under consideration should help solve those 
issues. It will provide resources to FDA to finalize long, 
unfinished monographs, giving manufacturers a degree of 
certainty. As with other user fee programs, the transparency 
and goals dictated by the commitment letter should provide 
industry with increased predictability.
    OMUFA's path for innovation to establish ingredients is 
overdue and could benefit manufacturers and marketers alike, 
including CMOs that specialize in unique dosage forms. Although 
PBOA was not included in the negotiations between industry and 
FDA, we are pleased that the legislative text under discussion 
today includes a fee model that reflects a differential value 
of OTC monograph products to CMOs and CDMOs, and that it 
provides a degree of relief from the facility fees proposed to 
fund OMUFA overall. And again, we are very appreciative of this 
committee's role in ensuring that all stakeholder voices were 
heard as you develop this OMUFA draft.
    We hope that PBOA and the CMO/CDMO businesses that it 
represents will be included the future FDA user fee 
negotiations, particularly ones that are considering 
contributions from the manufacturing sector in the form of 
facility fees. We look forward to continuing to participate in 
the legislative process relating to OMUFA, and the day when 
this good legislation is signed into law.
    Thank you, again, for the opportunity, and we are available 
for questions.
    [The prepared statement of Mr. Roth follows:]
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    Mr. Burgess. The Chair thanks the gentleman. I thank all of 
our witnesses for their testimony. We will move into the Member 
question portion of the hearing. I am going to yield to Mr. 
Guthrie of Kentucky 5 minutes for your questions, please.
    Mr. Guthrie. Thank you very much.
    Thank you, Mr. Melville. The issue of new sunscreen 
approvals are important to me and our key component is package. 
I have worked on the Sunscreen Innovation Act in the past and 
have worked to ensure in this package that we work to further 
addressing the continued holdup we see of these products at the 
FDA.
    Mr. Melville, can you outline for us today the positive 
benefits that you see in monograph proposal for sunscreen 
products?
    Mr. Melville. Well, yes, has been mentioned earlier. 
Sunscreens are considered drugs because the health claims that 
are made on sunscreens in the United States. The regulators of 
over-the-counter drugs, they are within the monograph today, 
they are in the monograph system. And over the years, have gone 
through a very long and extensive process with many stops and 
starts. As science has evolved over the years, new ingredients 
have been available elsewhere in the United States. But there 
hasn't been a process, as Dr. Woodcock mentioned, to really 
innovate under the monograph system, with the exception of a 
process called time and extent applications. That has never 
proven to be a very effective approach to market, very time-
consuming. And therefore, the monograph reforms being discussed 
today would open up a new opportunity, bring new ingredients to 
the market through the monograph system, not using notice and 
comment rulemaking as has been traditionally been used, but 
using the administrative order process, which would be a much 
more effective, a much more efficient process.
    So, I think for monograph drugs that are sunscreens, you 
would have two choices today under this law, you could 
continue, as Mr. Werner said, to operate under the Sunscreen 
Innovation Act that Congress passed and implemented 4 years 
ago, or you could elect to operate under the new monograph 
structure. And I think long-term new ingredients would all be 
utilized in the new structure. So it is very positive for 
sunscreens.
    Mr. Guthrie. Thank you. Mr. Werner, I did hear your 
testimony. You mentioned the need for new over-the-counter 
review process to be flexible, enough to accommodate sunscreen, 
and how sunscreen active ingredients are slightly different 
than, say, Advil or Tylenol. Could you explain that?
    Mr. Werner. Sure. Thank you. So first of all, yes, the new 
over-the-counter process has to be flexible enough to 
accommodate sunscreens. A couple of big reasons that those are 
different is number one, the new drug application process isn't 
really feasible for sunscreen products for any number of 
reasons, but not of the least of which is that that would give 
you an approval for a final product and a final formulation. 
And sunscreens, sunscreen ingredients are used in lots of 
different products, number one. And number two, sunscreens 
typically change with the season. They might change their 
scent, they might change their lotion, et cetera. So the 
process has to provide for an alternative pathway to approval 
in the OTC space besides the new drug application, and the 
bill's draft legislation certainly does that.
    The other thing is, just like current law, sunscreen 
manufacturers should be able to use their safety and 
effectiveness data from elsewhere around the world where the 
products are being used as part of their application package to 
demonstrate safety and effectiveness for the FDA purpose. That 
is another way that the products are slightly different, and it 
is another way that this legislation absolutely accommodates 
those products.
    Mr. Guthrie. Thank you. Mr. Roth, in your testimony, you 
mention that contract manufacturing organizations may 
specialize in unique dosage forms. Can you please explain this 
process further, and explain how that process would be affected 
by over-the-counter monograph reform?
    Mr. Roth. Well, some CMOs essentially work in traditional 
dosage form models, and a great portion of the market is 
comprised by those, but other ones do work in unique dosage 
forms and semisolids and other topical delivery systems, et 
cetera. And for some of those types of dosages, it is possible 
that innovations in the monograph might lead to products that 
they would then be open to manufacturing, where just changing 
the type of pill might not be as big an innovation. So for a 
niche technology provider like some of our member companies, 
this could open the door to new OTC monograph products that 
they would produce for their customers.
    Mr. Guthrie. Thank you. Mr. Chairman, I yield back my time.
    Mr. Burgess. The Chair thanks the gentleman. The Chair 
recognizes the gentleman from Texas, Mr. Green, 5 minutes.
    Mr. Green. Thank you, Mr. Chairman.
    Ms. Moore, Mr. Melville, one of the discussed benefits of 
the over-the-counter monograph reform has been potential for 
streamline regulatory process to encourage innovation in the 
OTC drug market. The discussion draft also proposes an 
additional market incentive that would provide 24 months of 
exclusivity to an innovative, over-the-counter product. The 
committee has supported targeted exclusivity in certain product 
areas as a way to create a market where one does exist, such 
as, for instance, antibiotics or in areas where we want to 
engender greater competition, such as with the generic drug 
products.
    Whether or not this incentive was the right incentive in 
these examples, the exclusivity that was crafted was with a 
clear public goal in mind. My question to Ms. Moore as I 
mentioned, the discussion draft would propose awarding 24 
months of exclusivity to innovative over-the-counter products. 
A vastly longer period than the 180 days awarded to the first 
generic market entrants, or are the 6 months provided by the 
pharmaceutical manufacturers who complete the necessary 
pediatric studies.
    In considering marketed activity for all over-the-counter 
products, what public health considerations could Congress have 
in mind to insure that there is a proper balance between that 
innovation and public health? A very long question.
    Ms. Moore. I would--I think--well, first, just to pause and 
reflect that the current draft is really well thought-through 
compromise on the part a lot of parties, so we appreciate that. 
I think that the issue of exclusivity is always one of the more 
sensitive issues in this kind of legislation. And we appreciate 
the fact that different goals and different benefits have been 
evaluated under different types of legislation.
    I think, in this case, for over-the-counter products, 
because we are hoping to spur a fair amount of innovation in 
this marketplace, it would be worthwhile--we understand that 
Congress and industry and other stakeholders have agreed to a 
certain timetable. We think it would be worthwhile to evaluate 
whether that timetable, that 2 years, as you point out, really 
is striking the right balance between spurring innovation for 
products that could improve health, and actually improving 
patient's access to products that could improve their health.
    Mr. Green. Thank you. Much shorter answer than the 
question.
    Mr. Melville, I heard from members in the industry that 
exclusivity is warranted for OTC monograph products in order to 
justify paying user fees are alternatively that regardless of 
the streamlining of monograph's process, that through executive 
order, they would still not be sufficient incentive for 
countries to innovate. Setting aside whether or not exclusivity 
is a proper incentive, what is the public health justification 
for awarding 24 months of exclusivity to an over-the-counter 
product? It seems to me that this long of a period has a 
potential for blocking patient access to new formulations that 
would increase or encourage patient utilization and adherence.
    Mr. Melville. So Mr. Green, I think one of the great 
benefits of the over-the-counter drug industry and the products 
that our members bring to market is it gives consumers a 
choice. They can choose a brand of product, they can chose a 
store brand product. The average price of one of our products 
is $108. So they are very, very affordable products. The 
monograph system is currently enforced. It deals with drugs and 
with ingredients that have been on the market as has been said 
earlier, since 1972. There hasn't been a lot of innovation.
    To spur innovation, a manufacturer would have to come to 
the table with essential human data, data that the drug will 
work on humans, will be safe and effective on humans. That is 
very costly. And if you don't give a period of exclusivity to 
reward the innovator, the next day, there could be a private 
label of that product on the market.
    Mr. Chairman, our association represents both branded 
manufacturers and private label manufacturers. In fact, our 
chairman right now is the business head for the largest store 
brand manufacturer in the United States. They are strongly 
supportive of 2 years of exclusivity, because they recognize 
the investment that it take to innovate, and they recognize 
that that is their future pipeline, and that consumers will 
benefit from that, so they will have a choice.
    Mr. Green. Thank you.
    Like my colleagues, I also want to encourage regulatory 
reform. The over-the-counter drug market is appropriately 
encouraging innovation. However, we consider incentives such as 
marked exclusivity. It is almost like an issue in our 
subcommittee. We must also ensure that our desire for 
innovation does not overtake the need for the patient access.
    Mr. Roth, we work closely with contract manufacturing 
organizations and contract development manufacturing 
organizations, make OTC user fees that are appropriate tailored 
to those specific types of companies. Can you elaborate on how 
the fee model and our discussion draft reflects the deferential 
value of OTC products to CMO and CDMOs?
    Mr. Roth. Certainly. The--it is the result of conversations 
we have had internally within industry, that reflects the much 
lower margins that CMOs have, particularly when it comes to 
working with OTC products, even in relation to the prescription 
and generic products that they manufacture. So in working with 
our industry partners, we developed a tiering model that we 
think would better reflect the respective values that a CMO 
accrues from this, both from the products and from this program 
overall in comparison with the private label and the store 
marketing companies. Does that answer your question?
    Mr. Green. I think that is pretty close.
    Thank you, Mr. Chairman. I have run out of time.
    Mr. Burgess. You are correct.
    The Chair recognizes the gentleman from Virginia, Mr. 
Griffith, 5 minutes for questions, please.
    Mr. Griffith. Thank you, Mr. Chairman. Thank you all for 
being here today. I open up it for whoever wants to jump in 
here. The first question is all pretty simple stuff, is there 
anything that we have in the discussion draft that causes you 
all concern? Anybody? Start which ever end. Whoever is 
passionate and wants to jump in first. Anybody have any 
comments? Dr. Jones?
    Dr. Jones. No.
    Mr. Griffith. Yes, sir. Go ahead.
    Mr. Melville. I do--we strongly support having explicit 
authority for FDA over packaging, and that is in the statute. 
The specific language and how it can be applied, I think, is 
still being discussed. There are three ways that FDA can apply 
some of new authorities that it gets under the statute. It can 
act under an imminent hazard and move very, very quickly to 
remove a product from market. There is some interim order 
authority that it can use to update labelling, as Dr. Woodcock 
mentioned earlier. We strongly support that. Then there is a 
traditional administrative order process, which is a great 
enhancement over current law.
    It allows for a period of public discussion before an order 
would take effect. We believe packaging decisions, because they 
are very complex, require that sort of discussion before they 
would take effect. So we think the packaging authority should 
be limited to the administrative order process.
    Mr. Griffith. All right. That is helpful to know. That is 
why I asked the question. So thank you. And then the second 
half of that question is, is there something that you think we 
ought to have in there that is not in there and part of that 
goes back to what you were saying, Mr. Melville. Does anybody 
else have something that they think we ought to put on the 
table to discuss while we--because it sounds like there is a 
bipartisan agreement by most members of at least the 
subcommittee that we have got do something, so let's make sure 
we cover all the bases that we can.
    Anybody have anything that we should put into the 
discussion draft that is not currently there?
    Mr. Werner. As we said in our testimony, we do think that 
it would be useful if we could incorporate some way to assess 
testing standards in for sunscreens, the FDA has published 
guidance on this, and, certainly, the bill goes a long way 
towards by guaranteeing meetings between sponsors and the 
agency that goes a long way toward the coming to some kind of 
an agreement about what the appropriate standards are, but 
since this is such a new--this is such a new area, we thought 
it would be appropriate for there to be some way, perhaps upon 
reauthorization of the bill, that we could evaluate how that is 
going.
    Mr. Griffith. All right. I appreciate that.
    Dr. Jones, I am going to switch gears and turn to you in a 
slightly different vein. I haven't asked my two questions on 
this subject. I appreciate what you do. I have a now 11-year-
old who has been under an allergists care since he was about 4 
months old, got all kind of issues going on. And so I would 
have to say while in a perfect world, we appreciated your 
comments about making sure things are tested on kids. Every kid 
is a little bit different, as I am sure you are aware. And I am 
sure that at some point, you have off-label drugs because you 
couldn't find something else that would work for that 
particular child. Is that correct?
    Dr. Jones. Yes. That is correct. Although there has been 
significant strides in the ability to study drugs in children 
over the last several years with BPCA and PREA. As 
pediatricians, we still know that 50 to 60 percent of the drugs 
that we currently have to use in children are used off label. 
So we do not have direct evidence that tells us the dosage for 
those medications, and whether those medications are actually 
effective. But when you see a child with a certain condition, 
and you know that this drug has some evidence that it may work 
in adults or other populations, you are somewhat forced to use 
those medications in off-label situations. But I think with 
BPCA and PREA, we are making significant strides, and I hope 
that that will continue.
    Mr. Griffith. And it is always good to get more information 
from whatever source you can to make sure that you are using 
that off-label drug when you have to, in the best way that you 
can. Isn't that also correct?
    Dr. Jones. Yes. I think as any medical provider, it is your 
due diligence to your patients to make sure that you have 
combed the literature and done as much research as you can when 
you have to make that difficult decision in using off label 
medications.
    Mr. Griffith. And I only have time for a yes or no, but 
more information is better than less information, yes or no?
    Dr. Jones. Yes.
    Mr. Griffith. Thank you very much, I yield back.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back.
    I recognize myself for 5 minutes for questions. And Dr. 
Jones, I appreciated your testimony. And I do seem to recall 
maybe 2 or 3 years ago, a difficulty with the labeling of 
infant preparations of acetaminophen, and a child being given a 
child's dose of the infant concentration actually--
paradoxically, it seems the infant preparation was more potent 
or more concentrated than the one that was labeled for 
children. And I believe there were some therapeutic 
misadventures with acetaminophen because of that concentration 
difference. Is that correct?
    Dr. Jones. Yes, yes.
    Mr. Burgess. And one of the things that we might strive to 
avoid in the future would be just that type of confusion that a 
new parent might encounter, this is what I have been giving to 
my infant. Now that they are larger, I will give them a child's 
dose of the infant preparation and it wouldn't be appropriate.
    Dr. Jones. Yes. I think that is a very great example. So 
for acetaminophen, as pediatricians, we know what the correct 
dose is for that medication, but due to limitations with being 
able to add language to the monograph, we cannot put that 
information on the packaging and on the labeling. So if a child 
is less than 2 years of age, it simply says contact your 
healthcare provider to provide how to dose that medication.
    So if you are a parent in the middle of the night and it 
your baby has a fever, and they are less than 2 years of age, 
you do not have any instructions there that tell you how to 
dose that medication. And so that is when you get into safety 
issues where a parent might have to guess the dose if they are 
not able to contact their healthcare provider or they may have 
to take their child out in the middle of the night to an 
emergency room so they can be dosed. So I think those are 
significant safety concerns that hopefully will be addressed 
with this new legislation.
    Mr. Burgess. Yes, that would be my hope as well. Dr. Jones 
and Mr. Melville, you both referenced cross jurisdictions with 
the Consumer Product Safety Commission, I think Dr. Woodcock 
mentioned it as well. And clearly, that is one of the things 
that will have to be taken into account. I had not even 
considered that the dispensing mechanism being a gummy bear 
would pose a special challenge as far as the packaging is 
concerned, and clearly it would.
    So that is--Mr. Melville, it just goes to your point, one 
of the reasons we are here today is we do have to be nimble, we 
do have to be much more agile, the regulatory agency needs to 
be much more agile than is currently capable being at the 
monographs.
    Mr. Melville. If I could follow up. I think Dr. Jones makes 
a great point, and pediatric acetaminophen is a good example. 
Our industry petitioned the FDA to add ``under two'' labeling 
on the label, and FDA wasn't able to move forward quickly on 
that because of the notice and requirement rulemaking 
requirement under the current monograph system. So today it 
does not exist, but our industry did move forward and the two 
concentrations of acetaminophen that Dr. Jones referred to were 
both permitted under the monograph. The industry voluntarily 
withdrew one of those because they saw in real world that there 
was some confusion. So there is only one concentration today, 
and it is the more diluted concentration.
    We also voluntarily added flow restrictors to pediatric 
acetaminophen, so that children if they did get into a bottle 
that was open, was not sealed appropriately they would not be 
able to get a lethal dose of that. So the industry has moved 
forward to innovate to make sure to improve the safety of these 
products. It is a work in progress for sure. And we look 
forward to the authority that FDA would have so we can work 
with them and get some of these improvements and make sure that 
they are applied not just voluntarily, but to all participants 
in the industry.
    Mr. Burgess. Well, then it begs the question because you 
brought up about cumbersome activity of the ruling comment type 
of structure that we are in now. So it made me wonder in the 
future, is there going to be an app for that?
    Mr. Melville. Who knows. Technology is certainly changing 
things. I mean, certainly today consumers have to look at the 
label to get all the information they need to be able to use 
that product safely. And with technology and advances, are 
there uses of technology that can enhance safety, add different 
labels, have a hologram that maybe has multiple languages. 
There are certain--I think the sky is--the options are 
limitless for using technology to enhance the safe use of over-
the-counter medicines. We look forward to working with FDA on 
those initiatives.
    Mr. Burgess. And as every do-it-yourselfer knows, there is 
frequently a YouTube video on just how to provide the 
instruction that you need.
    Mr. Melville. And that concerns us greatly.
    Mr. Burgess. I am sure that it does. It opens another 
avenue.
    Well it has been a fascinating discussion. I do want to 
thank all of our witnesses for being here today. Thank you for 
your testimony. I see no further Members wishing to ask 
questions.
    Pursuant to committee rules, I remind Members they have 10 
business days to submit additional questions for the record. 
And I ask the witnesses to submit their responses within 10 
business days of receipt of those questions.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 12:53 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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    [Dr. Woodcock did not answer submitted questions for the 
record by the time of printing.]
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