[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
__________
U.S. GOVERNMENT PUBLISHING OFFICE
27-228 PDF WASHINGTON : 2018
-----------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].
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:]
[GRAPHIC] [TIFF OMITTED] T7228.058
[GRAPHIC] [TIFF OMITTED] T7228.059
[GRAPHIC] [TIFF OMITTED] T7228.060
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[Dr. Woodcock did not answer submitted questions for the
record by the time of printing.]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]