U.S. GOVERNMENT PUBLISHING OFFICE

27–228 PDF WASHINGTON : 2018

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON HEALTH

MICHAEL C. BURGESS, Texas 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

JOE BARTON, Texas 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

ANNA G. ESHOO, California 

DIANA DEGETTE, Colorado 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

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. lll, 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 

1Dr. Woodcock did not answer submitted questions for the record by the 

time of printing. 2The information has been retained in committee files and also is available 

at http://docs.house.gov/meetings/IF/IF14/20170913/106396/BILLS115pih-OTCMonograph.pdf. 

(1) 

1The 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. 

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

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 

2 

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 overthe-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-thecounter 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 

3 

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 

4 

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 overthe-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 accommoVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
5 

dating 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 

6 

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 

7 

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-thecounter 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 monoVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
8 

graph 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 underresourced. 

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-thecounter 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. 

9 

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. 

10 

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 simiVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
11 

lar 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:] 

12 


U.S. FOOD & DRUG ADMlN!STRATION 

TESTIMONY 

OF 

JANET WOODCOCK, M.D. 

DIRECTOR, CENTER FOR DRUG EVALUATION AND RESEARCH 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEAL Til AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

HOUSE ENERGY AND COMMERCE COMMITTEE 

U.S. HOUSE OF REPRESENTATIVES 

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

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

\NVI'-N. fda gov 

SEPTEMBER 13,2017 

RELEASE ONLY UPON DELIVERY 
13 


INTRODUCTION 

Good morning Chainnan Walden, Ranking Member Pallone, and members of the Subcommittee. 

I am Janet Woodcock, Director of the Center for Drug Evaluation and Research (COER) at the 

Food and Drug Administration (FDA or the Agency), which is part of the Department of Health 

and Human Services (HHS). Thank you for the opportunity to be here today to discuss potential 

refonns to the over-the-counter (OTC) monograph system and a new OTC monograph user fee 

program. 

OTC drugs have long provided an efficient, low-cost way for Americans to take care of everyday health needs, without the need to visit a doctor and obtain a prescription. OTC regulation is 

considered appropriate for most drugs that can be safely administered without the supervision of 

a health care practitioner. FDA regulates most of the drugs on drug store shelves under the "OTC 

monograph system," though manufacturers do have the option to file a new drug application 

(NDA) in lieu of using the OTC monograph system for OTC products. FDA publishes 

monographs that provide a rulebook for marketing safe and effective products containing 

particular active ingredients for specific OTC conditions. Products that confonn to the 

monograph rules and other relevant requirements are not required to be reviewed by FDA before 

marketing. This contrasts with the NDA system, where sponsors of drugs must submit an 

application to FDA and obtain approval prior to marketing. The OTC Monograph system 

provides lower regulatory burden for industry and helps to keep OTC drug costs low through the 

extensive array of potential products that final monographs can cover. 

2 
14 


When it was first created over 40 years ago, the monograph system was relatively efficient, 

permitting timely monograph development to address safety and effectiveness issues. As product 

innovation unfolded, however, the monograph system has not kept up, leaving a system that does 

not well-serve consumers or industry. FDA still has not been able to complete many monographs 

begun decades ago. Nor has it been able to make timely monograph modifications to account for 

evolving science and emerging safety issues, or to accommodate product innovation or 

marketing changes. Approximately one third of the monographs arc not yet final, and several 

hundred individual ingredients (monographs can include multiple ingredients) do not have a final 

determination of safety and effectiveness. In addition, a number of planned safety labeling 

changes for monograph ingredients have not yet taken place while similar changes have already 

been made to prescription drugs containing the same ingredient. Finally, restrictions in the 

monograph system may discourage manufacturers from innovating. 

Reforms to modernize and support FDA's OTC monograph activities are needed to better serve 

patients, consumers, and industry. Stakeholders from across patient groups, hcalthcare providers, 

public health groups, and industry support reforms to streamline and improve the timeliness of 

review activities, spur innovation on behalf of consumers, and enable the Agency to better 

respond to urgent safety issues. FDA agrees that these changes will better protect the public 

health. 

In addition to structural reforms, the oversight of the OTC marketplace must have more 

resources if FDA is to fully realize the goals of reform and ensure the safety and effectiveness of 

OTC drugs, as well as support innovation by industry. Together with industry, FDA has 

developed a proposed OTC monograph user fee program, modeled on the successful Prescription 

Drug User Fee Act (PDUFA) program which, over the past 25 years, has ensured a more 
15 


predictable, consistent, and streamlined premarket program for industry and helped speed access 

to new safe and effective prescription drugs for patients. Following the success ofPDUFA, 

Congress enacted additional user fee agreements (UFAs), such as those that cover medical 

devices, generic drugs, and biosimilar drug products, as well as animal drug products and generic 

animal drug products. Under a user fee program, industry agrees to pay fees to help fund a 

portion of FDA's drug review activities while FDA agrees to overall performance goals, such as 

reviewing a certain percentage of applications within a particular time frame. As a result of the 

continued investment of UFA resources, FDA has dramatically reduced the review time for drug 

products without compromising the Agency's high standards for demonstration of safety, 

efficacy, and quality of such products. New legislation is needed to allow FDA to establish a 

similar program for OTC monograph drug products that will help ensure a better resourced and 

more streamlined, efficient process. 

BACKGROUND 

OTC Review is one of the Agency's largest and most complex regulatory programs. 

The OTC Drug Review program was created by FDA in 1972 to facilitate the efficient review of 

hundreds of thousands of OTC medicines. Rather than approve each product, as typically is done 

for prescription drugs and certain OTC drugs, the OTC Drug Review develops monographs for 

various therapeutic categories (e.g. internal analgesics, cough/cold products). The monographs 

establish conditions, such as active ingredients, indications, dosage form and labeled directions, 

under which an OTC drug is generally recognized as safe and effective (GRAS E) for usc. There 

are three categories for OTC products: Category I includes products that are GRAS E. Category 

II includes products that are not GRAS E. Category Ill include products for which more data is 

needed to determine whether they are GRAS E. An OTC medication that meets the specific 

conditions contained in the monograph is not required to be approved by FDA before marketing. 

4 
16 


The OTC Drug Review Program has proven to be one of the largest and most complex 

regulatory programs ever undertaken at FDA. It now consists of approximately 88 simultaneous 

rulemakings in 26 broad therapeutic categories that encompass hundreds of thousands ofOTC 

drug products marketed in the United States. Collectively, these monographs cover some 800 

active ingredients for over 1,400 different uses, ranging from antacids to diaper rash creams, and 

from analgesics to cough/cold products. 

The current OTC Review system is slow and antiquated. 

OTC medications play an increasingly vital role in our health care system. Although the current 

system has provided consumers with access to a wide variety of OTC medicines for decades, 

OTC products have become scientifically more challenging to regulate and the regulatory 

framework for OTC monograph products has become increasingly difficult to administer. 

Challenges in the current system include: 

• Burdensome, lengthy, multi-step processes to gather and evaluate data that take many 

years to complete; 

• Limitations on what new products can be marketed under the OTC Review; and 

• Limited resources to carry out the Agency's responsibilities. 

Together, these challenges are responsible for several widely-recognized shortcomings of the 

OTC Review, including: 

• Inefficient and time consuming process for completing safety and effectiveness reviews 

of OTC monographs; 

• Limited speed and flexibility in responding to urgent safety issues; 

• Challenges in keeping pace with evolving science; and 

• Challenges in accommodating innovation. 
17 


Monograph rulemaking takes much too long. 

Rulemaking can be a particularly inefficient process for scientific decisions, where new 

information frequently emerges over time, often requiring FDA to start the rulemaking process 

over to account for evolving science. 

The OTC Drug Review was intended to be a three-step, public notice and comment rulemaking 

process. As originally implemented, the process began with publication in the Federal Register 

of reports from an outside panel of experts. These reports were published in Advance Notices of 

Proposed Rulemakings, or ANPRs. Public comments on these reports were submitted by the 

drug industry, by medical professionals, and by consumers anyone with an interest in the topic 

of the report could submit comments. FDA considered the reports, comments, any new data and 

information, revised the ANPR accordingly, and published the revisions as a proposed rule. The 

proposed rule is also known as the tentative final monograph, or TFM. 

In response to the TFM, a second round of comments was received and evaluated. Following 

submission of comments to the TFM, the last step of the process was for FDA to analyze the 

comments and data that were submitted in response to the TFM, and to revise the monograph 

and publish it as a final rule. Once published, the final monograph would contain the regulations 

that establish the conditions under which a category of OTC drugs is considered GRAS E. The 

final monographs would then be published in the Code of Federal Regulations in Title 21, Food 

and Drugs. 

Although some monographs in the OTC drug review were finalized using this three-step public 

notice and comment rulcmaking process, for many other monographs, the reality has deviated 
18 


this plan to contained the 

to to 
19 


There is a lack of speed and flexibility in responding to urgent safety issues. Using the 

current monograph process to address safety labeling changes and other public health priorities 

limits FDA's ability to address safety issues for OTC drugs in a timely manner. 

Under the current monograph system, FDA is limited in its ability to require safety issues to be 

definitively addressed, unless it goes through rulemaking. While not a substitute for final 

rulemaking, wherever possible FDA has acted to address these public health issues through other 

methods such as consumer education efforts and guidance to industry. A few recent examples 

include: 

• Safety of pediatric cough and cold products 

FDA has published a number of consumer updates (available on FDA's website) to 

inform consumers on the safe and effective use of OTC products due to reports of harm, 

and even death in young children. Examples include: 

o a checklist for choosing OTC medicines for children 

https:llwww.fda.govldownloads!drugs!resourcesforyoulconsumers/buyingusingme 

dicinesafely!understandingover-the-countermedicineslucm094879.pdj; 

o guidance on how to choose medicine for children 

https:!!wwwjda.gov/Drugs!ResourcesFor You/ucm 133419.htm; 

o use ofOTC cough and cold products in children 

https:l!wwwjda.gov!drugs/resourcesforyoulspecialfeatures/ucm263 948. htm; and 

o advice on caring for infants and young children with a cold 

https:l!www.fda.gov/ForConsumers!ConsumerUpdates!ucm422465.htm. 

• Adverse events related to use of codeine for the treatment of cough 

FDA held advisory committee (AC) meetings on December 10,2015, and September 11, 

2017, to review pediatric codeine use. Codeine carries serious risks, including slowed or 

difficult breathing or death, which appear to be a greater risk in children younger than 12 

years ( https:llwww.fda.gov/F orConsumers!ConsumerUpdates/ucm315 497. htm}. These 
20 


meetings followed a number of communications issued by FDA to inform both 

consumers and health care providers about the safe use of codeine in children. 

• Serious skin reactions with acetaminophen 

In 2013, FDA published a drug safety communication alerting the public to serious skin 

reactions with acetaminophen. For prescription drugs marketed under the NDA process, 

FDA was able to take action quickly to have a warning added to the label. For OTC 

monograph drugs, which comprise the majority of the market, the Agency could not have 

generally required the necessary safety changes without undertaking a lengthy 

rulemaking. In order to more quickly encourage appropriate labeling changes, the 

Agency opted to issue a guidance instead, requesting that manufacturers add a warning to 

their labels. 

Although these non-rulemaking approaches have been helpful as alternative ways to effect safety 

labeling changes and to notify consumers of safety concerns, these approaches are far from 

optimal because they do not result in changing the relevant monograph to reflect the new safety 

labeling. 

To address these challenges with the existing OTC monograph system, FDA, industry, and other 

stakeholders have discussed a series of potential reforms with Members of Congress. These 

reforms would: 

• Streamline the process for adopting OTC monographs and for amending existing 

monographs; 

• Provide a special mechanism for rapidly responding to urgent safety issues; 

• Eliminate certain barriers to innovation and provide a more nimble process for their 

review by FDA; and 

9 
21 


• Reduce the backlog of unfinished monographs, for example by finalizing those FDA 

rulemakings that reached the stage of a Tentative Final Monograph. 

Monograph reform can streamline processes, but will not address resource challenges. 

As noted previously, the OTC monograph program is one of the largest and most complex 

regulatory programs ever undertaken at FDA. But FDA has very limited resources to carry out 

the Agency's responsibilities in the OTC monograph program. With current resource levels, 

FDA struggles to meet the requirements of Congressional mandates, keep pace with science, and 

meet public health needs for monograph products in a timely fashion. The OTC monograph 

review does not currently receive user fee funding, and funds from other user fee programs 

cannot be used to support monograph work. 

For a perspective on the resource challenges faced by the monograph program, the Agency 

currently spends approximately 40 times as much budget authority (BA) on the process of 

reviewing PDUF A products as it does on OTC monograph products. In FY20 16, the Agency 

spent $320.9M in BA reviewing PDUFA products and $7.9M in reviewing OTC monograph 

products. Because a user fee program is intended to supplement BA spending and not to supplant 

it, in that year, the Agency had access to additional funds from PDUFA user fees in the amount 

of$836.9M. The total Agency spending on the PDUFA program was therefore $1.16 billion, 

despite the fact that there are far more OTC monograph drug products than there are branded 

prescription drug products (sec Figure 2 below). 

10 
22 


OTC Monograph Resourcing 

Fiscal Year 2014 - 2016 

1.200 $1,157.8 

1,000 

~ 800 

~ ·e 

.5 600 

!!' 

.!!! 

0 

0 400 

200 

2014 2015 2016 

Fiscal Year 

Figure 2 

Note: 

PDUFA resources 

include both budget 

authority and user fee 

funds. 

DPDUFA 

DOTC 

$8.2 

OTC Monograph Reforms and User Fee Program would address these challenges. 

The proposed OTC Monograph Reforms and User Fee Program are designed to address the 

regulatory challenges mentioned above, as well as to provide benefits to the public health and to 

regulated industry. Potential benefits ofOTC Monograph reform with supporting user fees 

include: 

• Timely determination on the conditions for GRASE general recognition of safety and 

effectiveness that would cover thousands of marketed monograph drug products; 

• Ability to address safety issues in a more timely and efficient manner; 

• Ability to consider certain OTC product innovations proposed by industry; 

• Streamlined ability to update monographs to provide for modern testing methods that can 

improve the effectiveness of products available to consumers; 

11 
23 


• Development of information technology infrastructure for submission, review and 

archiving of monograph information; 

• Development of a modern, useful, transparent Web interface; and 

• Increased ability to respond to monograph-related concerns from the public and industry. 

OVERVIEW 

We have worked with numerous stakeholders, including consumer, patient, academic 

research, and health provider groups, and various representatives of industry to get their 

input on the proposed OTC Monograph Reform and User Fee Program. 

At the request of Chairman Lamar Alexander of the Senate Committee on Health, Education, 

Labor, and Pensions in 2015, FDA began discussions with industry to discuss ways to reform the 

OTC Monograph review program. As part of this process, FDA solicited input from and worked 

with various stakeholders, including representatives from consumer, patient, academic research, 

and health provider groups, and engaged in discussions with the nonprescription drug industry to 

help Congress develop authorization language, with user fees, that would launch a reformed 

OTC Monograph drug review program. In addition, FDA held a public stakeholder meeting and 

two public wcbinars to obtain additional feedback and share progress of discussions regarding 

user fees and goals. The final proposed agreement and the goals to which FDA and industry 

agreed to were transmitted to Congress on June 7, 2017. (Please see Appendix for "Goals 

Letter" that details our goals. implementation plan, and time lines.) 

The goals of the OTC Monograph User Fee program are to: 

• Build a basic infrastructure (hiring, training. and IT) to meet the goals of monograph 

reform; 

• Enable industry-initiated innovation (including innovation order requests, development 

meetings, timelines, and performance goals); 

!2 
24 


• Enhance communication and transparency; 

• Enable streamlining of industry and FDA safety efforts; 

• Enable efficient completion of final GRASE determinations for Category III drugs 

requested by industry or initiated by FDA; and 

• Develop and incorporate measures to track successes and Agency accountability. 

FDA estimates that the fees collected under the OTC Monograph User Fee program would start 

at $22 million in Year l and gradually increase to a steady state of $34 million by Year 4. For the 

sake of comparison, in FY 18, the prescription drug user fee program is projected to be over $800 

million per year and the generic drug user fee program is projected to be just under $500 million 

per year; the biosimilar drug user fee program, which is projected to be at around $40 million, is 

much closer in size to the proposed OTC monograph program. 

OTC manufacturers would pay an annual facility fcc under the proposal, and there would be an 

additional fee each time a sponsor submitted what is known as an OMOR- Over-the-counter 

Monograph Order Request (this is analogous to the NDA under PDUFA). The fee amounts 

would be set before the beginning of each fiscal year, and would be set at an amount to generate 

the required level of revenue each year. The per-facility fee will be a function of the number of 

facilities when the program goes live. 

Performance and Procednral Goals 

The performance and procedural goals and other commitments speci tied in the Goals Letter 

apply to aspects of the OTC monograph drug review program that are important for 

implementing the aforementioned policy reforms and for facilitating timely access to safe and 

effective medicines regulated under the OTC drug monograph. FDA is committed to meeting 

13 
25 


the performance goals specified in the goals document under the baseline assumptions described 

and to continuous improvement of its performance. FDA and industry would periodically assess 

the progress of the OTC monograph review program. This would allow FDA and industry to 

develop strategies to address emerging challenges to ensure the efficiency and effectiveness of 

the OTC monograph drug review program. 

Infrastructure Development: Hiring, Training, and Growth of Effective Review Capacity 

The goals document outlines hiring targets for each of the first five years of the proposed 

monograph user fee program. FDA would work toward these hiring goals. An important concept 

is that of the growth of effective review capacity. A newly hired scientist does not come to FDA 

with all the specialized skills and knowledge required to be an effective scientific reviewer. FDA 

scientific review work is highly technical and specialized. It requires knowledge and skills that 

are acquired through training at FDA, and typically takes approximately two years for a new 

staff person to become fully effective in monograph review work. This training process occurs 

simultaneously with assigned review work, with increasing review workload as a new reviewer 

gains experience and training. As these new employees come on board and are trained, total 

FDA effective review capacity for the monograph will increase in a measured fashion. 

During FY 15, FY16, and FYI7, essentially all of FDA's monograph review capacity has been 

dominated by the following three activities: 

• Statutory requirements of the Sunscreen Innovation Act; 

• Court-mandated requirements of the consent decree pertaining to antiseptic drug 

products; and 

• Urgent safety activities. 

14 
26 


During FYI8 and FY19, FDA will continue to have court-mandated obligations under the 

antiseptic consent decree. Congressionally-mandated obligations will also continue under the 

Sunscreen Innovation Act during those years (and perhaps subsequent years as well), unless 

Congress chooses to amend that law as part of the OTC monograph reform process because 

sunscreens are OTC products. Safety activities, for both pressing issues and routine 

pharmacovigilance, are continuous at FDA. 

There will also be numerous implementation activities for monograph reform that would absorb 

additional review capacity in the first three years of a monograph user fee program. Therefore, 

FDA expects to have built sufficient effective review capacity to begin to have time lines and 

performance goals for review activities anticipated to be part of the steady state of a monograph 

review program beginning in years four and five of the program (and to a limited extent in year 

three). 

Development and Implementation of an Information Technology Platform 

The OTC Monograph User Fee program would involve the development of a new IT platform. 

FDA would leverage an existing FDA IT platform to develop an IT system for the OTC 

Monograph User Fee program. FDA would work with industry to develop specifications for a 

public-facing IT dashboard, and would establish a fully functioning IT platform for OTC drug 

monograph review within tivc years of the program. 

In order to maximize the efficiency of the monograph review process, all monograph 

submissions would be electronic. FDA would modify existing guidance regarding the content 

and format of submissions to provide clarity to industry on how to structure its submissions. 

15 
27 


Enabling Industry-Initiated Innovation 

Innovation under the current monograph framework has been difficult. Under monograph 

reform, sponsors would be able to submit data packages (OMORs) to FDA, with requests that 

FDA issue an administrative order for a change to a monograph. There would be two types of 

Innovation OMORs, referred to as Tier One Innovation OMORs and Tier Two Innovation 

OMORs. The Goals Letter provides examples of each type of Innovation OMOR, but basically, 

most Innovation OMORs will be Tier One OMORs, and a few specific types of less resourceintensive OMORs would be Tier Two. 

Innovation OMORs for new active ingredients would require an eligibility determination, to 

show that there is a sufficient marketing history of the drug being safely used in an OTC setting 

under comparable conditions of use, e.g., in other countries. Industry could submit a request for 

an ingredient's eligibility determination well in advance of submission of the OMOR. Minimum 

advance submission periods for eligibility determination requests are specified in the Goals 

Letter. Other types of innovations would not require an eligibility determination. 

In-Review Meeting 

For filed Innovation OMORs and for filed industry-requested GRASE Finalization OMORs, 

FDA would schedule an in-review meeting to be held between the requestor of the OMOR and 

FDA. The Goals Letter details submission requirements and timclines. 

Guidance Development for Innovation 

Under the proposed policy reforms for the monograph, most innovations would occur through 

submission of an OMOR by an industry requestor. However, it is possible that a few types of 

changes could be accomplished through a process that would not require an OMOR for each 

16 
28 


change. One area where such changes might occur is for minor dosage form changes. In order to 

clarify which types of minor changes to solid oral dosage forms might be possible without an 

OMOR (when the monograph does not already specifically provide for these types of changes), 

FDA would issue an administrative order outlining key requirements and guidance providing 

details of what sponsors should do in order to comply with the administrative order. This order 

and guidance are referred to together as an "order/guidance pair". Sponsors would need to have 

data on file, available at FDA request, to support the safety and efficacy of drugs with the minor 

change. 

Tim clines 

Currently, it takes many years to make a change to a monograph, and the goal under monograph 

reform is to shorten that timeframe substantially, while still maintaining a public comment 

process between proposed and final orders, and maintaining FDA's standards for safety and 

efficacy. For example, it took approximately seven years to amend a monograph to require new 

warnings for liver injury for acetaminophen and Gl bleeding for nonsteroidal anti-inflammatory 

drugs. The Advisory Committee meeting was held September 19 and 20, 2002. The proposed 

rule was published December 26, 2006, and the final rule was published April 29, 2009. These 

warnings were very high priorities for the Agency to address urgent safety issues, yet it took that 

long. These substantially shortened timeframes are reflected in the tables in the Goals Letter, and 

would reduce what is currently a years-long process to between 17.5 and 23.5 months, with 

support from user fees (see Figure 3 below). 

17 
29 


Potential Review Timelines for 

Innovation OMORs 

Figure 3 

FDA Receives 

Order Request 

(DayO) 

FDA Issue~ Proposed Order 

(Monthl2) 

Communication and Transparency 

FDA lss~Jes Ftnal Order 

(Month17 

FDA ls.sues Final Order 

(Month2.35) 

FDA is committed to enhancing communication and transparency for the public and regulated 

industry. The Goals Letter details meeting management goals, which include timely responses to 

meeting requests, meeting scheduling. meeting background packages, preliminary responses to 

requestor questions, requestor notifications, anticipated agendas, meeting minutes, number of 

meetings per year. performance goals, and meetings guidance development, and a forecast of 

planned monograph activities. 

Conclusion 

FDA is committed to enhancing its core mission, which includes efforts to ensure and improve 

the safety and effectiveness of OTC Monograph drugs. Americans use OTC drugs every day, and 

18 
30 


these products will become increasingly important as patients take greater control of their own 

health. And yet the existing monograph system no longer functions well. We face significant 

challenges in completing monographs, addressing safety issues, and supporting innovation in the 

OTC marketplace. Reforms of the existing system are needed to promote innovation and choice 

for patients and consumers while also improving FDA's ability to address urgent safety issues in 

a timely fashion and ensure the safety and effectiveness of OTC products. A wide range of 

stakeholders has come together to support these reforms and we hope to continue to work with 

Congress on legislation to make them a reality. 

l9 
31 


APPENDIX 
32 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

Table of Contents 

2 

3 I. Introduction and Background 

4 II. Goals for the First Cycle of an Over-the-Counter Monograph User Fee Program 

5 A. Building the Basic Infrastructure to Enable the Goals of Monograph Reform to be Met 

6 1. Hiring 

7 2. Training and Growth of Effective Review Capacity 

8 3. Development and Implementation of an Information Technology Platform 

9 a. Development of the Information Technology Platform 

10 b. Electronic Submissions 

11 c. Content and Format of Monograph Submissions 

12 d. Cataloging of Pre-OMUFA Paper Documents 

13 B. Enabling Industry-Initiated Innovation 

14 1. Over-the-Counter Monograph Requests [OMORs) for Innovations 

15 a. Tier One and Tier Two Innovation OMORs 

16 b. Innovations May Only be Made to Ingredients that have had a Final Determination of 

17 "Generally Recognized as Safe and Effective" [GRASE) 

18 c. OMOR Packages Expected to be Complete at Time of Submission 

19 d. Timelines 

20 e. Comment Review Extension 

21 f. Performance Goals 

22 g. Assumptions Regarding Expected Numbers of Innovation OMORs in the First Five 

23 Years of OMUFA 

24 h. Major Amendments 

25 i. In-Review Meeting 

26 j. Resubmitted Original OMORs 

27 2. Guidance Development for Innovation 

28 C. Enhancing Communication and Transparency for the Public and Regulated Industry 

29 1. Meeting Management Goals 

30 a. Responses to Meeting Requests 

31 b. Meeting Scheduling 

32 c. Meeting Background Packages 

33 d. Preliminary Responses to Requestor Questions 

34 e. Requestor Notification to FDA Regarding Whether Meeting is Still Needed, and 

35 Anticipated Agenda 

36 f. Meeting Minutes 

37 g. Assumptions Regarding Number of Meetings Industry Expects to Request per Year 

38 h. Performance Goals 

39 i. Conditions for Performance Goals for Meetings 

40 j. Meetings Guidance Development 

41 2. FDA Forecasting of Planned Monograph Activities 

42 D. Enhancing Industry's and FDA's Core Mission Efforts to Ensure and Improve the Safety of OTC 

43 Monograph Drugs 

44 1. Timelines for Industry-Initiated OMORs for Specified Safety Changes to Drug Facts Labeling 

Page 1 of 37 
33 


45 

46 

47 

48 

49 

50 

51 

52 

53 

54 

55 

56 

57 

58 

59 

60 

61 

62 

63 

64 

65 

66 

67 

68 

69 

70 

71 

72 

73 

74 

75 

76 Ill. 

77 

78 

79 

80 

81 

82 

83 

84 

85 

86 

87 

88 

89 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

2. Assumptions Regarding the Number of Specified Safety Change OMORs Industry Expects to 

Submit in the First Five Years of OMUFA 

3. Performance Goals 

4. Timelines for FDA-Requested Safety Changes 

5. Major Amendments 

6. Comment Review Extension 

7. Resubmitted Original OMORs 

E. Enhancing Efficiency in Continuing FDA's Core Mission Work of Completion of Final GRASE 

Determinations of Monograph Ingredients 

F. Enabling Efficient Completion of Final GRASE Determinations Requested by Industry 

1. Timelines 

2. Assumptions Regarding the Number of GRASE Finalization OMORs Industry Expects to Submit 

in the First Five Years of OMUFA 

3. Performance Goal 

4. Major Amendments 

5. In-Review Meeting 

6. Comment Review Extension 

7. Resubmitted Original OMORs 

G. Implementing a New Dispute Resolution System Agreed Upon as Part of Monograph Policy 

Reform 

H. Carrying Out Other Aspects of Monograph Reforms 

1. Consolidated Proceedings Guidance 

2. Administrative Activities for Finalization of Category I Ingredients and other Monograph 

Conditions of Use from Tentative Final Monographs 

3. Conditions that Apply to Over-the-Counter Monograph Order Requests Filed Over Protest 

I. Routine Inspections 

J. Creating a System to Measure the Success of Goals Laid Out in the User Fee Agreement 

1. Summary of Performance Goals for OMUFA 

2. Summary of Timelines for Industry-Initiated Over-the-Counter Monograph Order Requests 

3. Summary of Dates of Specified Activities under OMUFA 

4. Annual Performance Reporting 

Definitions and Explanations of Terms 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

90 

91 

I. Introduction and Background 

92 This draft document contains the performance goals and procedures for the Over-the-Counter 

93 Monograph Drug User Fee Act initial program. If the program is enacted by Congress, the 

94 program will likely subsequently be abbreviated OMUFA. For simplicity, the program will 

95 generally be abbreviated as OMUFA in the remainder of this document. The over-the-counter 

96 drug monograph will generally be referred to simply as the monograph. The document assumes 

97 that the effective date of the OMUFA program will be October 1, 2017, and that it will cover 

98 fiscal years (FYs) 2018-2022. If the program has a different effective date, goal dates in this 

99 document will need to be adjusted accordingly. 

100 

101 For user fee programs, this type of document is commonly referred to as the "goals letter" or 

102 "commitment letter." This goals document represents the product of FDA's discussions with 

103 the regulated Industry, and consideration of input by public stakeholders. 

104 

105 OMUFA discussions ensued from prior discussions of the need for extensive policy reforms in 

106 order to preserve and modernize the over-the-counter drug monograph regulatory system. 

107 These reforms, if enacted by Congress, will result in numerous positive benefits to the public 

108 health, and to regulated Industry. The United States Food and Drug Administration (hereafter 

109 generally referred to as FDA) and regulated Industry have also come to agreement on the 

110 principles of a system of monograph user fees through which regulated Industry will provide 

111 resources to enable the range of review activities necessary to meet the goals of the 

112 monograph reform. 

113 

114 The performance and procedural goals and other commitments specified in this letter apply to 

115 aspects of the over-the-counter monograph drug review program that are important for 

116 facilitating timely access to safe and effective medicines regulated under the over-the-counter 

117 drug monograph, and to implementing the aforementioned policy reforms. While much of 

118 FDA's work is associated with formal tracked performance goals, FDA and Industry mutually 

119 agree that it is appropriate to manage some areas of the human drug review program with 

120 internally tracked timeframes. This provides FDA the flexibility needed to respond to a highly 

121 diverse workload, including unanticipated public health needs. FDA is committed to meeting 

122 the performance goals specified in this goals document and to continuous improvement of its 

123 performance. FDA and the regulated Industry will periodically assess the progress of the over124 the-counter drug monograph review program. This will allow FDA and the regulated Industry to 

125 identify emerging challenges and develop strategies to address these challenges to ensure the 

126 efficiency and effectiveness of the over-the-counter monograph drug review program. 

127 

128 Many aspects of this goals document will be addressed in statutory language. If differences are 

129 noted between the OMUFA goals document and statutory language, statutory language will 

130 supersede this goals document. 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

131 

132 

133 

II. Goals for the First Cycle of an Over-the-Counter Monograph User Fee Program 

134 It should be noted that, when there are very few instances of a given activity, adherence to 

135 performance goals should be interpreted accordingly. For example, if there are so few 

136 occurrences of an activity that missing only one or two goal dates would make it appear that 

137 the performance goal was not met, a qualitative description of performance may provide more 

138 useful data to be used in improving future performance. 

139 

140 A. Building the Basic Infrastructure to Enable the Goals of Monograph Reform 

141 to be Met 

142 

143 1. Hiring 

144 

145 The FDA will target on boarding of the following numbers of new fulltime employee equivalents 

146 (FTEs) in each of the fiscal years (FYs) specified below. 

147 

148 Hiring Onboarding Targets: 

149 

150 FY 2018: 30 

151 FY 2019: 24 

152 FY 2020: 23 

153 FY 2021: 19 

154 FY 2022: 9 

155 

156 2. Training and Growth of Effective Review Capacity 

157 

158 FDA will work toward the above hiring goals, but it is important to note that, although new 

159 scientific reviewers begin review work immediately, new reviewers will not be fully effective 

160 immediately as scientific reviewers, and that effective review capacity will grow slowly at first. 

161 FDA scientific review work is highly technical and specialized, requiring knowledge and skills 

162 that must be taught after onboarding. Typically, two years are required for a scientific reviewer 

163 to take all the necessary training, and acquire all the knowledge and experience needed to be 

164 fully effective. This training process occurs simultaneously with assigned review work, with 

165 increasing review workload as a new reviewer gains experience and training. 

166 

167 Immediately prior to OMUFA, FDA expects to have approximately 35 FTE working on 

168 monograph issues, only 18 of whom work fulltime in the relevant review division. A total of 29 

169 of these 35 FTE are expected be fully trained at the time OMUFA becomes effective, and 6 are 

170 expected to be recent hires who are still training. Given this fact, and the time required for 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

171 training of additional hires under OMUFA, and the above hiring numbers, effective review 

172 capacity is expected to grow as follows: 

173 

174 Mean Effective Monograph Review Capacity, FYs 2018-22: 

175 

176 FY 2018: 31 FTE 

177 FY 2019: 42 FTE 

178 FY 2020: 64 FTE 

179 FY 2021: 88 FTE 

180 FY 2022: 110 FTE 

181 

182 This concept is important, because it illustrates that during the early years of OMUFA, although 

183 FDA will be striving to meet on boarding targets, FDA will actually not begin to see significant 

184 growth in effective review capacity until FY 2020. Also of note is the fact that although hiring is 

185 to be complete by the end of FY 2022, growth in review capacity will continue beyond the end 

186 of FY 2022 as employees hired in FYs 2021 and 2022 continue and complete their training in the 

187 ensuing years. 

188 

189 During FYs 2015, 2016, and 2017 (which began October 1, 2016), essentially all of FDA's current 

190 monograph review capacity has been consumed by the following three activities: 

191 Statutory requirements of the Sunscreen Innovation Act 

192 Court-mandated requirements of the antiseptic consent decree 

193 Pressing safety activities 

194 

195 During FYs 2018 and 2019, FDA will continue to have mandated obligations under the antiseptic 

196 consent decree. As of the writing of this goals document, mandated obligations also continue 

197 under the Sunscreen Innovation Act during those years (and perhaps subsequent years as well), 

198 unless Congress chooses to change that law. Safety activities, for both pressing issues and 

199 routine pharmacovigilance, are continuous at FDA. 

200 

201 In addition, during the first three years of OMUFA, numerous activities will need to occur to put 

202 the necessary infrastructure into place, and to begin to implement the various aspects of the 

203 proposed monograph reforms. Examples of these activities include: 

204 leadership development (particularly important when beginning from such a small 

205 initial staff knowledgeable in the monograph) 

206 Information technology (IT) platform development and implementation (no IT platform 

207 exists for the monograph prior to OMUFA) 

208 Development and posting of a nonbinding list of forecasted monograph activities (see 

209 Section II.C.2) 

210 Activities to reflect finalization of Category I ingredients from Tentative Final 

211 Monograph (TFM) status to Generally Recognized as Safe and Effective (GRASE) 

Page 5 of 37 
37 


212 

213 

214 

215 

216 

217 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

For TFM Category II ingredients, which will be deemed not GRASE (not Generally 

Recognized as Safe and Effective) at time of enactment, Industry requestors may elect 

to submit requests to submit data packages supporting the safety and/or efficacy of 

these ingredients. FDA resources will be required to consider these requests. 

User fee collection system implementation and collection activities 

218 Resource estimates indicate that, in order to implement all these activities and continue 

219 externally mandated activities, FDA will be substantially "net-negative" in terms of effective 

220 review capacity for the first 3 years of OMUFA. There will be performance goals for 

221 implementation activities such as development of guidances and hiring in the first three years. 

222 By Year 3, review resources will grow to the point where limited performance goals can begin 

223 for meetings. In Years 4 and 5, FDA expects to be able to implement timelines and limited 

224 performance goals for OMOR submissions, and will continue progressive performance goals for 

225 meeting management, guidance development, and other activities, although FDA's effective 

226 monograph review capacity will still not be expected to be at the steady state required to 

227 handle the eventual anticipated full workload of OMUFA activities. Training will continue, with 

228 expected continued growth of review capacity beyond the first five years of OMUFA as all 

229 hirees finish their training and reach full review capability. 

230 

231 After establishment of the necessary infrastructure, and based on estimates of review activity 

232 expected numbers provided by Industry, FDA expects that the FTE need for monograph 

233 activities at steady state will be the equivalent of approximately 140 FTE. The steady state 

234 estimate includes those activities that are expected to be part of a continuing program over 

235 time, and does not include activities that are only part of start-up and implementation. Some 

236 examples of activities expected to occur at steady state include: 

237 Industry-requested Over-the-Counter Monograph Order Requests (OMORs) for 

238 innovations and other changes to the monograph 

239 Industry-requested guidances for innovations (and administrative orders that will 

240 accompany these guidances) 

241 Industry-requested meetings with FDA 

242 Industry-requested dispute resolution, up to the Center for Drug Evaluation and 

243 Research (COER) level, and above COER under a new administrative hearing procedure 

244 Industry-requested finalizations of GRASE determinations for nonfinal monograph 

245 ingredients and other monograph conditions of use 

246 Industry-requested safety changes to monograph drug labeling 

247 Industry resubmissions of OMORs for which a previous final order did not result in the 

248 requested change to the monograph 

249 • FDA-requested safety changes to monograph drug labeling 

250 • FDA-requested packages for GRASE determinations 

251 Other monograph review activities 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

252 Other guidance and policy development 

253 Information technology support 

254 • Reporting 

255 • User fee management 

256 • Other activities specified in the OMUFA statute 

257 

258 In summary, during the first three years of OMUFA, essentially all effective review capacity is 

259 expected to be consumed by current external mandates, safety activities, and OMUFA 

260 implementation and infrastructure development activities. Beginning in Years 4 and 5 (and to a 

261 limited extent in Year 3), FDA expects to have built sufficient effective review capacity to begin 

262 to have timelines and performance goals for review activities expected to be part of the steady 

263 state of a monograph review program. 

264 

265 3. Development and Implementation of an Information Technology Platform 

266 

267 Prior to OMUFA, no IT platform exists for the monograph, a lack which greatly hampers review 

268 efficiency. 

269 

270 a. Development of the Information Technology Platform 

271 

272 FDA will develop specifications for a public-facing IT dashboard and award a contract by 

273 October 1, 2018. 

274 

275 FDA will implement the above public-facing IT dashboard by October 1, 2019. 

276 

277 FDA will issue a Request for Proposals for an information technology (IT) platform for receiving 

278 electronic submissions, archiving review work, and generating reports, for over-the-counter 

279 (OTC) drug monograph review, by February 1, 2019. 

280 

281 FDA will award the initial contracts for the above IT platform by April1, 2019. 

282 

283 FDA will establish business requirements for the above IT platform by April1, 2020. 

284 

285 FDA will establish a fully functioning IT platform for OTC drug monograph review by April1, 

286 2022. 

287 

288 

289 

290 

291 

292 b. Electronic Submissions 

Page 7 of 37 
39 


293 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

294 In order to maximize the efficiency of the monograph review process, all monograph 

295 submissions from industry are to be electronic rather than paper. Industry may submit 

296 monograph electronic submissions to FDA starting on October 1, 2017. 

297 

298 FDA will provide additional information regarding electronic submissions for the monograph in 

299 draft guidance to be issued by October 1, 2019. FDA will issue final guidance for electronic 

300 submissions for the monograph by April 1, 2021. 

301 

302 c. Content and Format of Monograph Submissions 

303 

304 Initially (beginning October 1, 2017), Over-the-Counter Monograph Order Requests (OMORs) 

305 are to be submitted using content and format recommendations described in the guidance for 

306 Industry Nonprescription Sunscreen Drug Products- Content and Format af Data Submissions. 

307 The format recommendations of this guidance, although developed for sunscreen drug 

308 products, are generally applicable to all monograph submissions. 

309 

310 FDA will modify the above content and format guidance to clarify its applicability across 

311 monograph drug products. FDA will issue updated draft guidance by Aprill, 2019. FDA will 

312 issue final guidance by October 1, 2020. 

313 

314 OMORs are expected to be complete at the time of submission, and are expected to include all 

315 information, both positive and negative, relevant to the determination of general recognition of 

316 safety and effectiveness for the ingredient or other condition(s) of use under consideration. 

317 OMOR requestors are required to submit a certification that the requestor has submitted all 

318 evidence created, obtained, or received by that requestor that is relevant to whether the 

319 ingredient or other condition of use is generally recognized as safe and effective (GRASE). 

320 

321 d. Cataloging of Pre-OMUFA Paper Documents 

322 

323 Some paper documents that reside with FDA contain information of importance relating to 

324 monograph ingredients and their review. Prior to OMUFA, FDA has not had the resources to 

325 catalog and archive these documents. Many of these documents are old and fragile. It is 

326 important to catalog the content of these documents, and FDA must retain paper documents as 

327 required by established records retention policies. Because of the large volume of these 

328 documents, and the fragility of many of them, the process of sorting, scanning, and archiving 

329 them would be costly and time-consuming. Industry does not support provision of user fee 

330 funds to permit electronic archiving of these documents during the first five years of OMUFA, 

331 but agrees that cataloging them could have value to Industry, because some of the documents 

332 may contain data that Industry requestors could use to support order requests or other 

333 activities of interest to Industry. FDA and Industry have agreed that, among IT-related goals, the 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

334 priority of creating the IT platform is higher than that of cataloging these paper documents, and 

335 therefore IT platform development would be pursued first. Cataloging will have a limited goal of 

336 identifying the monograph ingredient{s) discussed in each document, and creation of a 

337 searchable electronic catalog. Cataloged paper documents will be stored per records retention 

338 policies, but the paper documents themselves will not be scanned and electronically archived. 

339 By February 3, 2020, FDA will award a contract for the cataloging project. By Feb 3, 2022, the 

340 cataloging project will be complete. FDA will be able to initiate GRASE determinations prior to 

341 completion of the cataloging project. 

342 

343 B. Enabling Industry-Initiated Innovation 

344 

345 1. Over-the-Counter Monograph Order Requests {OMORs) for Innovations 

346 

347 Prior to the proposed monograph reforms, innovation under the monograph has been difficult. 

348 Under monograph reform, sponsors {hereafter referred to as requestors when referencing 

349 submission of OMORs) will be able to submit data packages {Over-the-Counter Monograph 

350 Order Requests, or OMORs) to FDA, with requests that FDA issue an administrative order for a 

351 change to a monograph. Hereafter, these packages requesting changes to monographs will be 

352 referred to as "Innovation OMORs." 

353 

354 a. Tier One and Tier Two Innovation OMORs 

355 

356 There will be two types of Innovation OMORs, referred to as Tier One Innovation OMORs and 

357 Tier Two Innovation OMORs. 

358 

359 Most Innovation OMORs will be Tier One OMORs. Examples include, but are not limited to, 

360 requests for the following: 

361 Addition of a new ingredient to a monograph that already has one or more ingredients 

362 that have been found to be GRASE 

363 • Addition of a new indication to a monograph that already has one or more ingredients 

364 that have been found to be GRASE, and the new indication applies to one or more of the 

365 GRASE ingredients 

366 Addition of a new fixed-dose combination of ingredients to a monograph that already 

367 has one or more ingredients that have been found to be GRASE 

368 Addition of a new test method for a monograph that already has one or more 

369 ingredients that have been found to be GRASE, and the new test method applies to one 

370 or more of the GRASE ingredients 

371 Addition of a new route of administration for a monograph that already has one or 

372 more ingredients that have been found to be GRASE, and the new route of 

373 administration applies to one or more of the GRASE ingredients 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

374 Addition of a new dose or concentration for a GRASE ingredient for a particular 

375 monograph 

376 Addition of a new monograph therapeutic category (each ingredient proposed for the 

377 new therapeutic category will be a separate OMOR) 

378 All other Innovation OMORs not covered in Tier Two 

379 

380 Tier Two Innovation OMORs will be limited to requests for the following: 

381 Reordering of existing information in the Drug Facts label (DFL) 

382 Standardization of the concentration or dose of a specific finalized ingredient within a 

383 particular finalized monograph 

384 An ingredient nomenclature change to align with nomenclature of a standards-setting 

385 organization 

386 Addition of an interchangeable term under 21 CFR 330.1(i) 

387 Modification to existing DFL Directions for Use, in order to be consistent with a final 

388 order/guidance pair on minor dosage form changes (see Section II.B.2) 

389 • Addition of information (either required or optional) to be included under the "Other 

390 Information" section of Drug Facts labeling, as limited by 21 CFR 201.66(c)(7) 

391 Other specific items may be added by FDA later as FDA gains experience with Tier Two 

392 OMORs 

393 

394 The decision regarding whether a proposed Innovation OMOR meets one of the above criteria 

395 for a Tier Two OMOR will be made by the review division after receipt of the OM OR. 

396 

397 b. Innovations May Only be Made to Ingredients that have had a Final Determination of 

398 "Generally Recognized as Safe and Effective" 

399 

400 Innovations may only be made to ingredients that have had a final determination of "Generally 

401 Recognized as Safe and Effective", or GRAS E. Under monograph reform, ingredients that are 

402 GRASE are limited to the following: 

403 Ingredients that were GRASE in a Final Monograph at the time of enactment of 

404 monograph reform 

405 • Ingredients that, immediately prior to monograph reform, were proposed as Category I 

406 in a Tentative Final Monograph 

407 

408 

409 

Ingredients that have been found GRASE in a final order after enactment of monograph 

reform 

410 All other ingredients will require a final GRASE determination, with finalization of all relevant 

411 monograph conditions of use for that ingredient for a particular therapeutic use, in order for 

412 FDA to consider an Innovation OMOR relevant to that ingredient. Examples of these types of 

413 ingredients that would require GRASE finalization include, but are not limited to: 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

414 Ingredients that, immediately prior to monograph reform, were Category Ill in a 

415 Tentative Final Monograph 

416 Ingredients that, immediately prior to monograph reform, were proposed Category I in 

417 an Advance Notice of Proposed Rulemaking 

418 Other ingredients that have not had a final GRASE determination 

419 

420 ideally, if a requestor wants to request a change for an ingredient for which a final GRASE 

421 determination has not been made, the requestor would submit an OMOR for the final GRASE 

422 determination for the ingredient and all of the relevant monograph conditions of use first, and 

423 would submit the Innovation OMOR after FDA issues its final order regarding the GRASE 

424 determination for the ingredient. However, a requestor may submit a single OMOR package 

425 that contains both the complete data necessary for final GRASE determination for that 

426 ingredient and all its relevant conditions of use (referred to as a GRASE Finalization OMOR), and 

427 the complete data to support the proposed innovation. Cosubmission of a GRASE Finalization 

428 OMOR with an Innovation OMOR will extend the GRASE Finalization OMOR timeline from 

429 receipt to issuance of the proposed order by six months, with a consequent extension of the 

430 total GRASE Finalization OMOR timeline to final order by six months. If a requestor submits a 

431 GRASE finalization OMOR, and later submits an Innovation OMOR before the final order for the 

432 relevant GRASE finalization OMOR, the time line of the subsequently submitted Innovation 

433 OMOR will be extended by six months. 

434 

435 c. OMOR Packages Expected to be Complete at Time of Submission 

436 

437 OMOR packages are expected to be complete at the time of submission, and FDA will make a 

438 determination of whether each package is acceptable for filing. As described in Section II.A.3.c, 

439 FDA will issue guidance regarding the content and format of OMOR packages. OMOR 

440 requestors are strongly encouraged to request and attend a presubmission meeting (as 

441 described in Section li.C.l} for their proposed OMOR, to discuss the expected content, format, 

442 and tier for a particular OMOR. 

443 

444 d. Timelines 

445 

446 The following table outlines the timelines for Innovation OMOR review, i.e. review of lndustry447 requested changes to finalized monographs, other than Drug Facts label (DFL} specified safety 

448 changes as outlined in Section II.D. 

449 

450 Currently, prior to enactment of proposed monograph reforms, it takes many years to make a 

451 change to a monograph, and the goal under monograph reform is to shorten that timeframe 

452 substantially, while still maintaining public comment between proposed and final orders, and 

453 maintaining FDA's standards for safety and efficacy. These substantially shortened timeframes 

454 are reflected in Table II.B.l.d. 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

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455 

456 Eligibility determination for a new ingredient (a pre-OM OR activity): 

457 

458 Innovation OMORs for new ingredients will require an eligibility determination. Industry may 

459 submit a request for ingredient eligibility determination well in advance of submission of the 

460 OMOR. Minimum advance submission periods for eligibility determination requests are 

461 specified in the following paragraphs. 

462 

463 If the ingredient is currently marketed for the same Use in a drug product under a US OTC NDA, 

464 and the US OTC NDA drug product has documented sales of over 1 million units, the requestor 

465 will submit the eligibility determination request at least 60 calendar days in advance of the 

466 OMOR submission. For US OTC NDA products that meet these specific requirements, FDA will 

467 issue an eligibility determination by 30 calendar days after receipt of the ingredient eligibility 

468 determination request. 

469 

470 For any ingredient eligibility determination request that does not meet the specific 

471 requirements in the immediately preceding paragraph, but that the requestor believes meets 

472 eligibility requirements as stated in the applicable statute, the requestor will submit the 

473 eligibility determination request at least 120 calendar days in advance of the OMOR 

474 submission. For these other types of ingredient eligibility determination requests, FDA will issue 

475 an eligibility determination by 90 calendar days after receipt of the eligibility determination 

476 request. 

477 

478 

479 

480 

481 

482 

483 

484 

485 

486 

487 

488 

489 

490 

491 

492 

493 

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494 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures - Fiscal Years 2018-2022 

~--------

Table II.B.l.d: Timelines for Innovation OMORs (Industry-Initiated Over-the-Counter 

Monograph Order Requests OMORs for Monograph Changes) 

Tier One Innovation: Tier One Innovation: Tier Two Innovation 

Eligible1 New Ingredient Change to a Monograph 

Condition of Use (other 

than a New Ingredient), or 

Request for Other2 

Monograph Change 

Filing determination FDA makes fileabillty FDA makes fileability FDA makes fileability 

determination 60 calendar determination 60 calendar determination 60 calendar 

days after receipt of OMOR days after receipt of OMOR days after receipt of OMOR 

Issuance of If OMOR is filed, FDA issues If OMOR is filed, FDA issues If OMOR is filed, FDA issues 

proposed order proposed order 12 months proposed order 12 months proposed order 10 months 

after receipt of OMOR after receipt of OMOR after receipt of OMOR 

Public comment Begins on the date of Begins on the date of Begins on the date of 

period issuance of the proposed issuance of the proposed issuance of the proposed 

order, and !asts 45 calendar order, and lasts 45 ca!endar order, and lasts 45 calendar 

days I days , days 

Assessment of Begins one calendar day Beglns one calendar day · Begins one calendar day 

volume and after the end of the after the end of the after the end of the 

substantiveness3 of comment period, and lasts comment period, and lasts comment period, and lasts 

comments 60 calendar days. 60 calendar _days 60 calendar days 

Issuance of final 17.5 months after receipt of 17.5 months after receipt of 15.5 months after receipt of 

order OMOR OMOR OMOR 

Abbreviations: OMOR =Over-the-Counter Monograph Order Request 

1 Eligibility determinations will be required for proposals for the addition of new ingredients to a monograph, but not for changes to other 

monograph conditions of use for a finalized monograph. See paragraphs immediately preceding this table. 

2 This includes all proposed changes to the monograph, except for safety changes described in Section ILD, the addition of new ingredients, 

Tier Two Innovation OMORs, and specific changes for which FDA has issued a final guidance stating that an OMOR is not required {see 

Section II.B.2). 

3 Assessment of substantiveness of comments does not involve full review of the comments, but rather is intended to assess whether the 

comments will require substantial time or resources for full review. 

41f comments received are numerous or substantive, there will be a Comment Review Extension of the final order goal date. For Tier One 

Innovations, the eKtenslon will be 5 months; and for Tier Two Innovations, the extension will be 3 months. 

495 e. Comment Review Extension 

496 

497 If comments received during the comment period are numerous or substantive, there will 

498 be an extension of the final order goal date. For Tier One Innovations, the extension will be 

499 5 months; and for Tier Two Innovations, the extension will be 3 months. This extension will 

500 be additive to those generated by any major amendment{s). 

501 

502 f. Performance Goals 

503 

504 The first year in which Innovation OMORs will be associated with timelines and performance 

505 goals will be Year 4 of OMUFA (innovation OMORs received on or after October 1, 2020.) 

506 

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Procedures- Fiscal Years 2018-2022 

507 For Innovation OMOR submissions, the following performance goals will apply: 

508 Year 4: For 50% of OMOR submissions received in Year 4, FDA will issue a final order by 

509 the specified goal date 

510 Year 5: For 75% of OMOR submissions received in Year 5, FDA will issue a final order by 

511 the specified goal date 

512 

513 Although there will not be time lines and performance goals associated with Innovation OMORs 

514 submitted in Years 1-3, requestors may still submit Innovation OMORs in Years 1-3. If resources 

515 permit, FDA intends to review these early OMORs in order of receipt, but timelines and 

516 performance goals will not apply. 

517 

518 g. Assumptions Regarding Expected Numbers of Innovation OMORs in First Five Years of 

519 OMUFA 

520 

521 The assumptions for the first OMUFA cycle were that there would be no Innovation OMORs 

522 submitted by Industry over the first 3 years of OMUFA, that 5 Innovation OMORs would be 

523 submitted in Year 4, and that 10 Innovation OMORs would be submitted in Year 5. 

524 

525 h. Major Amendments 

526 

527 OMORs are expected to be complete at the time of submission, and therefore, unsolicited 

528 amendments are expected to be rare. (Unsolicited amendments are amendments other than 

529 those submitted in response to a specific FDA information request.) Major amendments 

530 (whether solicited or unsolicited) submitted by the original requestor prior to issuance of the 

531 proposed order may extend the time to issuance of the proposed order by three months, and 

532 consequently may extend the final goal date by three months. Major amendments submitted 

533 by the original requestor after the end of the comment period and prior to issuance of a final 

534 order may also extend the final goal date by three months. Major amendments may apply to 

535 Innovation OMORs, Industry-initiated requests for GRASE finalizations (as discussed in Section 

536 II. F), and Industry-initiated requests for certain safety changes to the monograph (as described 

537 in Section II.D). 

538 

539 A major amendment may include, for example: 

540 a major clinical safety or efficacy study that was not previously submitted to the current 

541 OMOR 

542 a major reanalysis of a study or studies previously submitted to the current OMOR 

543 

544 

545 

546 

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547 

548 

In-Review Meeting 

549 For filed Innovation OMORs and for filed Industry-requested GRASE Finalization OMORs, FDA 

550 will schedule an in-review meeting to be held between the requestor of the OMOR and FDA. 

551 This meeting will generally be held between 8 and 9 months after receipt of the OMOR. The 

552 OMOR requestor may request that the meeting be held either face-to-face or via 

553 teleconference. 

554 

555 FDA representatives at the in-review meeting are expected to include: 

556 • The signatory authority for the OMOR review 

557 Discipline review team representatives from discipline areas for which substantive 

558 issues in the OMOR have been noted to date 

559 

560 Not less than 12 calendar days prior to the scheduled in-review meeting, FDA will send a 

561 pre meeting document to the requestor. The premeeting document will include an agenda, a 

562 brief list of substantive issues noted to date, and a brief description of information requests 

563 that FDA will ask of the requestor. The total length of the pre meeting document generally will 

564 not exceed three pages. 

565 

566 Potential topics for discussion at the in-review meeting include: 

567 Substantive issues identified to date 

568 Information requests from the review team to the requestor 

569 Additional data or analyses the requestor may wish to submit 

570 

571 Review of the OMOR will not be complete at the time of the in-review meeting, and thus 

572 definitive information regarding the content of the future proposed order will not be discussed. 

573 

574 j. Resubmitted Original OMORs 

575 

576 A resubmitted original OMOR is an OMOR resubmitted after FDA has issued a Final Order 

577 declining to make the requested change to the monograph. The resubmitted OMOR must 

578 address all of the deficiencies noted in the final order. A resubmitted OMOR pertains only to 

579 the monograph changes requested in the original OMOR; if new changes are requested, a new 

580 OMOR is required. 

581 

582 There will be two classes of resubmitted original OMORs: Class One and Class Two. 

583 

584 

585 

586 

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587 Class One resubmitted original OMORs are limited to the following items, or combinations of 

588 these specified items: 

589 Draft or final labeling 

590 Safety updates submitted in the same format, including tabulations, as the original 

591 safety submission, with new data and changes highlighted. (However, resubmissions 

592 with large amounts of new information including important new adverse experiences 

593 not previously reported for the ingredient(s) will be Class Two resubmissions.) 

594 Assay validation data 

595 • A minor reanalysis of data previously submitted to the OMOR 

596 Other minor clarifying information (determined by the FDA as fitting the Class One 

597 category) 

598 Other specific items may be added by the FDA later as the FDA gains experience with 

599 resubmitted OMORs 

600 

601 Class Two resubmitted original OMORs are resubmissions that include any other items, 

602 including any items that the FDA decides would need presentation to an Advisory Committee. 

603 

604 The FDA and Industry do not expect any resubmitted original OMORs during the first five years 

605 of a user fee agreement. 

606 

607 If any resubmissions of original OMORs occur, the following timelines will apply: 

608 

Table II.B.l.j: Timelines for Resubmitted Original OMORs 

Class One Resubmission Class Two Resubmission 

Issuance of proposed order FDA issues proposed order 4 months FDA issues proposed order 6 months 

after receipt of resubmitted original after receipt of resubmitted original 

OMOR OMOR 

Public comment period Begins on the date of issuance of the Begins on the date of issuance of the 

proposed order, and lasts 45 calendar proposed order, and lasts 45 calendar 

days days 

Assessment of volume and Begins one calendar day after the end Begins one calendar day after the end 

substantiveness1 of of the comment period, and lasts 60 of the comment period, and lasts 60 

comments calendar days. calendar days 

Issuance of final order FDA issues final order 9.5 months after FDA issues final order 11.5 months 

receipt of Class I resubmitted original after receipt of Class! resubmitted 

~' __ OMOR original OMOR 

Abbreviation: OMOR "'Over-the-Counter Monograph Order Request 

1 Assessment of substantiveness of comments does not involve full review of the comments, but rather is intended to assess whether the 

comments will require substantial time or resources for full review. 

2 If comments received are numerous or substantive, there will be a Comment Review Extension of the final order goal date by 5 months, 

for both Class 1 and Class II resubmitted original OMOR:s -

609 

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610 Comment Review Extension: If comments received during the comment period are numerous 

611 or substantive, there will be an extension of the final order goal date by 5 months, for both 

612 Class One and Class Two resubmitted original OMORs. 

613 

614 Performance Goal: 

615 

616 Year 5: For SO% of resubmitted original OMORs received in Year 5, FDA will issue a final order 

617 by the specified goal date 

618 

619 2. Guidance Development for Innovation 

620 

621 Under the proposed policy reforms for the monograph, most innovations would occur through 

622 submission of an OMOR by an Industry requestor. However, it is possible that a few types of 

623 changes to the monograph could be accomplished through a process that would not require an 

624 OMOR for each change. One area where such changes might occur is for minor dosage form 

625 changes. 

626 In order to clarify which types of minor changes to solid oral dosage forms might be possible 

627 without an OMOR (when the monograph does not already provide for these types of changes), 

628 FDA will issue a proposed administrative order outlining key requirements, and draft guidance 

629 providing details of what sponsors will need to do in order to comply with the proposed 

630 administrative order. This order and guidance are referred to together as an "order/guidance 

631 pair". FDA will issue the proposed administrative order and draft guidance by April 1, 2022. 

632 C. Enhancing Communication and Transparency for the Public and Regulated 

633 Industry 

634 

635 1. Meeting Management Goals 

636 

637 Formal OMUFA meetings between monograph sponsors/requestors and FDA will consist of 

638 Type X, Y, and Z meetings. These meetings are further described below. 

639 

640 Type X meetings are those meetings that are necessary for an otherwise stalled monograph 

641 drug development program to proceed, or meetings that are necessary to address an important 

642 safety issue. A meeting requested by an Industry requestor within 3 months after FDA has 

643 taken a refusal-to-file action on an OMOR submitted by that requestor would be a Type X 

644 meeting. A meeting requested by an Industry requestor within 3 months after FDA has declined 

645 to issue an administrative order requested by that requestor would be a Type X meeting. 

646 

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647 Type Y meetings are intended for milestone discussions during the lifecycle of Industry 

648 development programs for monograph ingredients and monograph conditions of use. Examples 

649 of appropriate circumstances for Type Y meetings include: 

650 Overall Data Requirements Meetings: After FDA has stated its intent to make a final 

651 GRASE determination for a particular monograph ingredient or monograph condition of 

652 use, an Industry sponsor may request a meeting to discuss the overall data 

653 requirements to support that GRASE determination. Similarly, an Industry sponsor 

654 interested in initiating an OMOR for an FDA action on a monograph ingredient or 

655 monograph condition of use may request a meeting to discuss the overall data 

656 requirements to support that OMOR. 

657 Presubmission Meetings: When an Industry sponsor is nearing completion of its 

658 development program for an OMOR package, the sponsor may request a meeting to 

659 present a summary of the data supporting the proposed OMOR, and of the proposed 

660 format for the OMOR package, to obtain FDA feedback on the adequacy of the 

661 proposed package. For an Innovation OMOR, the proposed Tier (One or Two) may also 

662 be discussed at the presubmission meeting. The presubmission meeting should be held 

663 sufficiently in advance of the planned submission of the order request to allow for 

664 meaningful response to FDA feedback and should generally occur not less than 3 

665 months prior to the planned submission of the order request. 

666 

667 A Type Z meeting is any other type of meeting. 

668 

669 a. Responses to Meeting Requests 

670 

671 Procedure: FDA will notify the requestor in writing of the date, time, and place for the meeting, 

672 as well as expected FDA participants, following receipt of a formal meeting request. Table 

673 II.C.l.a below indicates the timeframes for FDA's response to a meeting request. 

674 

675 

676 

677 

678 

Table II.C.l.a: Meeting Request Response Time Goals 

Meeting Type Response Time (calendar days) 

~·· 

X 14 

y 14 

z 21 

For any type of meeting, the requestor may request a written response to its questions 

rather than a face-to-face meeting or teleconference. FDA will review the request and 

make a determination regarding whether a written response is appropriate or whether 

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679 a face-to-face meeting or teleconference is necessary. If FDA deems a written response 

680 appropriate, when FDA responds to the meeting request, FDA will notify the requestor 

681 of the date FDA intends to send the written response. This date will be consistent with 

682 the timeframes specified in Table II.C.l.b below for the specific meeting type. 

683 For Type Z meetings, while the requestor may request a face-to-face meeting, FDA may 

684 determine that a written response to the requestor's questions would be the most 

685 appropriate means for providing feedback and advice to the requestor. When it is 

686 determined that the meeting request can be appropriately addressed through a written 

687 response, FDA will, in FDA's response to the meeting request, notify the requestor of 

688 the date FDA intends to send the written response. This date will be consistent with the 

689 timeframes specified in II.C.l.b below for the specific meeting type. 

690 

691 b. Meeting Scheduling 

692 

693 Procedure: FDA will schedule the meeting on the next available date at which all applicable FDA 

694 personnel are available to attend, consistent with the FDA's other business; however, the 

695 meeting should be scheduled consistent with the type of meeting requested. Table II.C.l.b 

696 below indicates the timeframes for the scheduled meeting date following receipt of a formal 

697 meeting request, or in the case of a written response, the timeframes for FDA to send the 

698 written response. If the date requested by the requestor for any meeting type is greater than 

699 the specified timeframe, the meeting date should be within 14 calendar days of the requested 

700 date. 

701 

Table II.C.l.b: Meeting Scheduling or Written Response Times 

Meeting Type Meeting Scheduling or Written Response Time 

X 30 calendar days from receipt of meeting request 

y 70 calendar days from receipt of meeting request 

z 75 calendar days from receipt of meeting request 

702 

703 See Section II.C.l.h for meeting performance goals. 

704 

705 c. Meeting Background Packages 

706 

707 The requestor of the requested meeting will submit the background package for each meeting 

708 type no later than the date specified in Table II.C.l.c below. 

709 

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Over-the-Counter Monograph User Fee Program Performance Goals and 

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Table II.C.l.c: Timelines for Submission of Meeting Background 

Packages 

Meeting Type Receipt of Background Package 

X At the time of the meeting request 

Y 50 calendar days before the date of the meeting or expected 

written response 

47 or expected 

written response 

710 

711 d. Preliminary Responses to Requestor Questions 

712 

713 Procedure: FDA will send preliminary responses to the requestor's questions contained in the 

714 background package no later than five calendar days before the meeting date for Type Y and Z 

715 meetings. FDA will generally not send preliminary responses for Type X meetings. 

716 

717 See Section II.C.l.h for meeting performance goals. 

718 

719 e. Requestor Notification to FDA Regarding Whether Meeting is Still Needed, and 

720 Anticipated Agenda 

721 

722 Not later than three calendar days following the requestor's receipt of FDA's preliminary 

723 responses for a Type Y or Z meeting, the requestor will notify FDA of whether the meeting is 

724 still needed, and if it is, the anticipated agenda of the meeting given the requestor's review of 

725 the preliminary responses. 

726 

727 f. Meeting Minutes 

728 

729 Procedure: FDA will prepare minutes that will be available to the requestor 30 calendar days 

730 after the meeting. The minutes will clearly outline the important agreements, disagreements, 

731 issues for further discussion, and action items from the meeting, in bulleted form, and need not 

732 be in great detail. Meeting minutes are not required if FDA transmits a written response for 

733 any meeting type. 

734 

735 See Section II.C.l.h for meeting performance goals. 

736 

737 

738 

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739 g. Assumptions Regarding Number of Meetings Industry Expects to Request per Year 

740 

741 

742 

743 

744 

745 

746 

747 

748 

749 

Industry has estimated that approximately the following numbers of meetings will be 

requested per year: 

FY 2018: 6 meetings (not under time lines or performance goals) 

FY 2019: 9 meetings (not under timelines or performance goals) 

FY 2020: 12 meetings (see performance goal below) 

FY 2021: 24 meeting requests (see performance goal below) 

FY 2022: 40 meeting requests (see performance goal below) 

750 h. Performance Goals 

751 

752 Requestors may submit meeting requests beginning in FY 2018. However, performance goals 

753 regarding meeting management will become effective October 1, 2019. These goals are: 

754 • Year 3: For the first 12 meeting requests received in Year 3, FDA will meet 50% of the 

755 total of meeting management goal dates (goal dates for response, scheduling, 

756 preliminary responses [Type Y meetings only], and minutes). If more than 12 meeting 

757 requests are submitted in Year 3, the remainder will not be under timelines. 

758 • Year 4: For meeting requests received in Year 4, FDA will meet 60% of the total of 

759 meeting management goal dates (goal dates for response, scheduling, preliminary 

760 responses [Type Y meetings only], and minutes) 

761 • Year 5: For meeting requests received in Year 5, FDA will meet 80% of the total of 

762 meeting management goal dates (goal dates for response, scheduling, preliminary 

763 responses [Type Y meetings only], and minutes} 

764 

765 Performance goals apply to the aggregate of all types of meeting management goals. However, 

766 in FDA's OMUFA performance report, FDA will include information on the various subsets of 

767 meeting management goals. 

768 

769 Conditions for Performance Goals for Meetings 

770 

771 For a meeting to qualify for OMUFA performance goals, all of the following conditions must be 

772 met: 

773 • The meeting must concern issues related to the issuance of an administrative order for 

774 the monograph, issues related to a potential request for a monograph order, or issues 

775 related to FDA-initiated data requests for the monograph. 

776 The requestor of the meeting must be subject to, or potentially subject to, OMUFA fees. 

777 For example, the requestor may be a monograph establishment owner, a requestor of 

778 an OMOR, or a requestor who intends to submit an OMOR. Other entities may request 

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779 meetings to discuss monograph issues, but meetings with these other entities will not 

780 qualify for OMUFA performance goals. 

781 A written request must be submitted to the review division. 

782 • The written request must provide: 

783 o A brief statement of the purpose of the meeting and the requestor's proposal for 

784 either a face-to-face meeting or a written response from FDA 

785 o A listing of the specific objectives/outcomes the requestor expects from the 

786 meeting 

787 o A proposed agenda, including estimated times needed for each agenda item 

788 o A statement of whether the requestor intends to discuss trade secret or 

789 confidential commercial information at the meeting 

790 o A listing of planned external attendees 

791 o A listing of requested participants or discipline representatives from the Center 

792 with an explanation for the request as appropriate 

793 o The date that the meeting background package will be sent to the Center. Refer 

794 to Table II.C.1.c for timeframes for FDA's receipt of background packages. 

795 FDA must concur that the meeting will serve a useful purpose (i.e., the meeting is not 

796 premature or clearly unnecessary). However, requests for Type Y meetings will be 

797 honored except in the most unusual circumstances. 

798 • The requestor of the meeting and any of its affiliates must have no overdue unpaid 

799 OMUFA fee. 

800 

801 j. Meetings Guidance Development 

802 

803 FDA will develop guidance regarding formal meetings between FDA and sponsors or requestors 

804 for OMUFA ingredients and drug products. FDA will issue draft guidance by February 1, 2019. 

805 FDA will issue final guidance by July 1, 2020. 

806 

807 2. FDA Forecasting of Planned Monograph Activities 

808 

809 Procedure: Each year, FDA will publish a nonbinding listing of monograph issues FDA intends to 

810 address in the coming three years. For issues for which FDA anticipates that submission of data 

811 to FDA will likely be needed, FDA will include a date by which it will expect these data to be 

812 submitted. FDA will publish the first list by October 1, 2018; and will publish subsequent lists no 

813 less frequently than annually (by October 1 in each of the years 2019, 2020 and 2021.) 

814 

815 Performance goal: FDA will publish each annual forecasting list within 30 days of the goal date. 

816 

817 

818 

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819 

820 

821 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

D. Enhancing Industry's and FDA's Core Mission Efforts to Ensure and Improve 

the Safety of OTC Monograph Drugs 

822 Prior to the proposed monograph reforms, it has been very difficult and time-consuming to 

823 effect changes to monographs, with changes often requiring many years. The significance of 

824 this difficulty in changing monographs in a timely manner has been especially problematic 

825 when the desired changes have been intended to change the labeling of monograph products 

826 to enhance the likelihood of safe use of the product. As noted in sections on timelines for 

827 Industry-initiated Innovation OMORs and Industry-requested GRASE Finalization OMORs, FDA 

828 intends to reduce the time needed for action on monograph issues, going from the current 

829 reality of many years for each change, to a timeframe of less than two years in most 

830 circumstances, while still maintaining public comment between proposed and final orders, and 

831 maintaining FDA's standards for safety and efficacy. 

832 

833 For certain Industry-requested safety changes to the Drug Facts labeling of monograph drug 

834 products, FDA intends an even shorter timeline, as described below. 

835 

836 The following types of proposed changes to the Drug Facts label of monograph drug products 

837 qualify for the shorter timeline: 

838 

839 Changes to the Drug Facts labeling of a monograph drug that are intended to add or strengthen 

840 any of the following: 

841 a contraindication, warning, precaution, or adverse reaction 

842 a statement about risk associated with misuse or abuse 

843 an instruction about dosage and administration that is intended to increase the safe 

844 use of the monograph drug product 

845 

846 OMORs for these types of changes will hereafter be referred to as "Specified Safety Change 

847 OMORs." These industry-requested Specified Safety Change OMORs will be made through the 

848 ordinary administrative order process proposed under monograph reform (and not through the 

849 interim final order expedited procedure for administrative orders proposed under monograph 

850 reform.) 

851 

852 In order to qualify for the shortened timelines, OMORs for these types of safety changes are to 

853 be submitted as stand-alone packages, and are not to include requests for other types of 

854 changes to a monograph. A filing determination will be made, and if an OMOR that is 

855 represented by the requestor as fitting into one of the above DFL safety change categories is 

856 determined to contain a request for another type of change to the monograph, the applicable 

857 timeline will be consistent with that for the other type of request found in the OMOR. 

858 

859 

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860 1. Time lines for Industry-Requested Specified Safety Change OMORs 

861 

Table II.D.l: Timeline for Industry-Initiated Request for Certain2 Safety-Related Changes to 

the Drug Facts Labeling of Monograph Drug Products ("Specified Safety Change OMORs") 

Filing determination FDA makes fileability determination 60 calendar days after 

receipt of OMOR 

Issuance of proposed order If OMOR is filed, FDA issues proposed order 6 months after 

receipt of OMOR 

Public comment period Begins on the date of issuance of the proposed order, and lasts 

45 calendar days 

Assessment of volume and substantiveness Begins one calendar day after the end of the comment period, 

of comments and lasts 60 calendar days 

Issuance of final order 11.5 months after receipt of OMOR 

Abbreviation: OMOR::: Over-the--Counter Monograph Order Request 

1 Assessment of substantiveness of comments does not involve full review of the comments, but rather is intended to assess whether the 

comments will require substantial time or resources for full review. 

2 Changes to the Drug Facts labeling of a monograph drug that are intended to add or strengthen any of the following: 

a contraindication, warning, precaution, or adverse reaction 

. a statement about risk associated with misuse or abuse 

an instruction about dosage and administration that is intended to increase the safe use of the monograph drug product 

31f comments received during the comment period are numerous or substantive, there will be an extension of the final order goal date by 3 

months, 

862 

863 2. Assumptions Regarding the Number of Specified Safety Change OMORs Industry Expects 

864 to Submit During the First Five Years of OMUFA 

865 

866 Across the first five years of OMUFA, Industry estimates that it will submit a total of two 

867 OMORs for the above types of safety-related changes. 

868 

869 3. Performance Goals 

870 

871 Timelines and performance goals will begin on October 1, 2020. 

872 

873 Requestors may submit OMORs for the above types of safety-related changes in Years 1-3, but 

874 time lines and performance goals will not apply in those years. However, FDA always strives to 

875 review safety data and make appropriate changes in a timely manner. 

876 

877 Performance Goals: 

878 Year 4: For 60% of OMOR submissions that request the above types of safety changes, 

879 and that are received in Year 4, FDA will issue a final order by the specified goal date 

880 Year 5: For 80% of OMOR submissions that request the above types of safety changes, 

881 and that are received in Year 5, FDA will issue a final order by the specified goal date 

882 

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883 4. Timelines for FDA-Requested Safety Changes 

884 

885 The above timelines and performance goals apply to Industry-requested specified safety 

886 changes. Other Industry-requested changes to the monograph, even if possibly related to 

887 safety, will be subject to the same time lines for other OMORs as outlined in Section II.B.l.d. 

888 

889 Under the proposed monograph reforms, two types of FDA-requested safety changes to the 

890 monograph are included. One type will include a proposed order, followed by a comment 

891 period, followed by a final order. Another type, to be used for certain serious safety concerns 

892 defined in the policy reform statutory language, will include an interim final order (that will go 

893 into effect immediately), followed by a comment period, followed by a final order. Once FDA 

894 has issued an FDA-initiated proposed safety order, or an FDA-initiated interim final order for a 

895 safety issue, FDA intends to follow the same timelines outlined in Table II.D.l above regarding 

896 the length of the comment period and lengths of time from the end of the comment period to 

897 issuance of a final order. 

898 

899 5. Major Amendments 

900 

901 Major Amendments will be possible; see Section II.B.l.h for further information. 

902 

903 6. Comment Review Extension 

904 

905 Comment Review Extension: If comments received during the comment period are 

906 numerous or substantive, there will be an extension of the final order goal date by 3 

907 months. This extension will be additive to those generated by any major amendment(s). 

908 

909 7. Resubmitted Original OMORs 

910 

911 See Section II.B.l.j. 

912 

913 E. Enhancing Efficiency in Continuing FDA's Core Mission Work of Completion of 

914 Final GRASE Determinations of Monograph Ingredients 

915 

916 FDA will continue work on finalization of GRASE determinations for ingredients that were 

917 Category Ill in a TFM prior to monograph reform, and for ingredients that were proposed as 

918 Category I in an ANPR prior to monograph reform. FDA will request that Industry submit data 

919 packages to support these GRASE finalizations. 

920 

921 When an FDA-requested complete package for a final GRASE determination (referred to as a 

922 GRASE Finalization Package) is submitted, FDA intends to follow the same timelines as outlined 

923 for Industry-submitted OMORs for GRASE finalizations (see below). 

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924 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures - Fiscal Years 2018-2022 

925 Due to the resource requirements for the many implementation activities for other aspects of 

926 monograph reform, FDA does not expect to begin to request packages until OMUFA Year 4 or 

927 later, and even in Year 4 and the ensuing few years, will likely only have sufficient resources to 

928 review one or two packages per FY while still meeting other OMUFA commitments. Once FDA 

929 begins to request these packages, FDA plans to request packages for up to 6 ingredients per 

930 year. 

931 

932 F. Enabling Efficient Completion of Final GRASE Determinations Requested by 

933 Industry 

934 

935 As discussed above, some GRASE finalization packages will be requested by FDA. Industry can 

936 also initiate a GRASE finalization process by submitting a GRASE Finalization OMOR. All OMOR 

937 packages are expected to be complete at the time of submission. The content and format of a 

938 complete OMOR package are to be discussed at a presubmission meeting as discussed in 

939 Section II.C.l. 

940 

941 1. Timelines 

942 

Table II.F.l: Timeline for Review of Industry-Initiated Over-the-Counter Monograph Order 

Requests for Final GRASE Determinations (GRASE Finalization OMORs) 

Filing determinatioll FDA makes fileability determination 60 calendar days after 

receipt of OMOR 

Issuance of proposed order If OMOR is filed, FDA issues proposed order 12 months after 

receipt of OMOR 

Public comment period Begins on the date of issuance of the proposed order, and lasts 

45 calendar days 

Assessment of volume and substantiveness1 Begins one calendar day after the end of the comment period, 

of comments. and lasts 60 calendar days 

Issuance of final orderz 117,5 mo_!lths after ~-eceipt of OMOR 

Abbreviations: GRASE:: General Recognition of Safety and Effectiveness; OMOR"' Over-the-Counter Monograph Order Request 

1 Assessment of substantiveness of comments does not involve full review of the comments, but rather is intended to assess whether the 

comments wHI require substantial time or resources for full review. 

2 If comments received during the comment period are numerous or substantive, there will be an extension of the final order goal date by 6 

months. 

943 

944 2. Assumptions Regarding the Number of GRASE Finalization OMORs Industry Expects to 

945 Submit in the First Five Years of OMUFA 

946 

947 Based on discussions between Industry and FDA, an assumption was made that no lndustry948 initiated requests for GRASE finalizations for existing nonfinal ingredients are likely during the 

949 first cycle of OMUFA, as Industry is expected to be more likely to submit Innovation OMORs and 

950 Specified Safety Change OMORs in the first cycle. 

Page 26 of 37 
58 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

951 

952 3. Performance Goal 

953 

954 Timelines and performance goals for Industry-requested GRASE Finalization OMORs will begin 

955 in Year 5. 

956 

957 Although there will not be timelines and performance goals associated with GRASE Finalization 

958 OMORs submitted in years 1-4, requestors may still submit them. 

959 

960 Performance Goal: 

961 FY 2022: For 50% of GRASE Finalization OMOR submissions received in Year 5, FDA will issue a 

962 final order by the specified goal date 

963 

964 4. Major Amendments 

965 

966 Major Amendments will be possible; see Section II.B.l.h for further information. 

967 

968 5. In-Review Meeting 

969 

970 An in-review meeting will be scheduled for Industry-submitted G RASE Finalization OMORs. See 

971 Section II.B.l.i. 

972 

973 6. Comment Review Extension 

974 

975 If comments received during the comment period are numerous or substantive, there will 

976 be an extension of the final order goal date by 6 months. This extension will be additive to 

977 those generated by any major amendment(s). 

978 

979 7. Resubmitted Original OMORs 

980 

981 See Section II.B.l.j. 

982 

983 G. Implementing a New Dispute Resolution System Agreed Upon as Part of 

984 Monograph Policy Reform 

985 

986 Under the proposed monograph policy reforms, two (sequential) dispute resolution processes 

987 are specified. The first is the current COER formal dispute resolution request path, referred to 

988 here as the COER FDRR path. If a requestor proceeds through the entire COER FDRR path, but 

989 still wishes to dispute COER's action, the requestor may request to proceed to a second path, 

990 referred to here as the administrative hearing path. 

991 

Page 27 of 37 
59 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

992 The first path is described in the draft guidance for Industry and review staff entitled Formal 

993 Dispute Resolution: Appeals above the Division Level, hereafter referred to as the FDRR 

994 guidance. This guidance will need some modification of its language to encompass actions 

995 covered under OMUFA. If dispute resolution is requested prior to modification of the draft 

996 guidance, FDA and Industry intend to follow applicable general procedures in the above existing 

997 FDRR draft guidance. 

998 

999 Procedure (for FDRR draft guidance development): FDA will revise the draft guidance for 

1000 Industry and review staff Formal Dispute Resolution: Appeals above the Division Level, to state 

1001 the circumstances and procedures under which requestors of OMUFA may use the CDER FDRR 

1002 process. The draft guidance will be revised by February 3, 2020. 

1003 

1004 Performance goal (for time lines described in the FDRR draft guidance): 

1005 

1006 FY 2021: For dispute resolution requests received in Year 4, FDA will meet 50% of the timeline 

1007 dates described in the FDRR draft guidance 

1008 

1009 FY 2022: For dispute resolution requests received in Year 5, FDA will meet 75% of the time line 

1010 dates described in the FDRR draft guidance 

1011 

1012 After a requestor has proceeded through the entire CDER FDRR path, the sponsor may request 

1013 to proceed to an administrative hearing path. The above performance goals will not apply to 

1014 the administrative hearing path. 

1015 

1016 

1017 

H. Carrying Out Other Aspects of Monograph Reforms 

1018 L Consolidated Proceedings Guidance 

1019 

1020 For monograph drugs products, it is common for there to be multiple manufacturers or 

1021 sponsors of a given drug product with the same active ingredient and other monograph 

1022 conditions of use. 

1023 

1024 For Industry-initiated OMORs, it is highly desirable that all Industry sponsors that are relevant 

1025 for a given OMOR consolidate their data into a single well-organized and complete submission 

1026 package. 

1027 

1028 For Industry-initiated appeals of FDA decisions regarding the monograph, FDA intends to 

1029 conduct a single consolidated appeals process for a given appealed FDA decision, with all 

1030 relevant sponsors represented as a group. 

1031 

Page 28 of 37 
60 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

1032 It will be the responsibility of Industry to organize itself for these consolidated processes. 

1033 However, FDA will issue guidance on its views regarding best practices for consolidated 

1034 proceedings for appeals. FDA will issue draft guidance by July 1, 2019, and will issue final 

1035 guidance by February 1, 2021. 

1036 

1037 2. Administrative Activities for Category !Ingredients and Other Monograph Conditions of 

1038 Use from Tentative Final Monographs 

1039 

1040 Under the proposed monograph reforms, TFM Category I ingredients will be treated as GRASE 

1041 under the monograph conditions of use specified in the TFM as it was immediately prior to 

1042 enactment of monograph reform. There will be administrative activities associated with these 

1043 finalizations and the associated public postings. FDA will complete these administrative 

1044 activities by October 1, 2018. 

1045 

1046 3. Conditions that Apply to Over-the-Counter Monograph Order Requests Filed Over 

104 7 Protest 

1048 

1049 Under proposed monograph reforms, FDA may refuse to file certain OMORs. 

1050 

1051 FDA will make a filing determination within 60 calendar days after receipt of an OMOR. FDA will 

1052 issue a letter (a "Day 74 letter") to requestors within 74 calendar days after receipt of an 

1053 OMOR. The Day 74 letter will communicate FDA's filing decision and any filing issues that were 

1054 identified. 

1055 

1056 OMOR requestors may choose to file an OMOR over protest after a refusal-to-file decision by 

1057 FDA. The following conditions will apply to OMORs filed over protest: 

1058 OMORs filed over protest will be subject to the same timelines and performance goals 

1059 outlined in Sections II.J.1 and II.J.2. 

1060 • OMORs filed over protest will not be eligible for in-review meetings with FDA 

1061 FDA generally will not review amendments to OMORs filed over protest 

1062 FDA generally will not issue information requests to requestors of OMORs filed over 

1063 protest 

1064 • The timelines for resubmitted original OMOR reviews will not apply to resubmission of 

1065 an OMOR that was filed over protest. Any such resubmission will be reviewed as 

1066 available resources permit. 

1067 

1068 I. Routine Inspections 

1069 

1070 For routine FDA inspections of monograph drug manufacturing facilities, FDA intends to 

1071 continue to follow a risk-based model for prioritization of inspections. 

1072 

Page 29 of 37 
61 


1073 

1074 

1075 

Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

J. Creating a System to Measure the Success of Goals Laid Out in the User Fee 

Agreement 

1076 1. Summary of Performance Goals for OMUFA 

1077 

1078 As noted earlier, when there are very few instances of a given activity, adherence to 

1079 performance goals should be interpreted accordingly. For example, if there are so few 

1080 occurrences of an activity that missing only one or two goal dates would make it appear that 

1081 the performance goal was not met, qualitative description of performance may provide more 

1082 useful data to be used in improving future performance. 

1083 

1084 As discussed in Section II.A.2, the growth of effective review capacity will be limited in the first 

1085 three years of OMUFA due to the necessary training of newly onboarded hires, and during 

1086 those first three years, much of the effective review capacity will be consumed by current 

1087 mandates such as the Sunscreen Innovation Act and an antiseptic consent decree, and by 

1088 ongoing safety activities. There are also numerous OMUFA implementation and infrastructure 

1089 establishment activities to be accomplished in those years, resulting in a likely "net-negative" 

1090 effective review capacity in Years 1-3. Beginning in Year 4 (and to a very limited extent in Year 

1091 3), FDA expects to have built sufficient effective review capacity to begin to implement 

1092 timelines and limited performance goals. 

1093 

1094 

1095 

1096 

1097 

1098 

1099 

1100 

1101 

1102 

1103 

1104 

1105 

1106 

1107 

1108 

1109 

1110 

1111 

1112 

Page 30 of 37 
62 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

1113 The following table summarizes performance goals for OMUFA activities for the first 5 years of 

1114 OMUFA: 

1115 

Table II.J.l: Summary of Performance Goals for OMUFA 

Activity Performance Goal 

Industry-Submitted Innovation Year 4: For 50% of OMOR submissions received in Year 4, FDA will issue a final 

OMORs order by the specified goal date 

Year 5: For 75% of OMOR submissions received in Year 5, FDA will issue a final 

order by the specified goal date 

Industry-Submitted Specified Year 4: For 60% of OMOR submissions received in Year 4, FDA will issue a final 

Safety Change OMORs order by the specified goal date 

Year 5: For 80% of OMOR submissions received in Year 5, FDA wll! issue a final 

order by the specified goal date 

Industry-Submitted GRASE Year 5: For 50% of OMOR submissions received in Year 5, FDA will issue a final 

Finalization OMORs order by the specified goal date ----·----~-----

Resubmitted Original OMORs Year 5: For 50% of resubmitted original OMORs received in Year 5, FDA will issue 

a final order by the specified goa! date 

Meetings between FDA and Year 3: For the first 12 meeting requests received in Year 3, FDA will meet 50% of 

regulated monograph Industry the total of meeting management goal dates (goal dates for response, 

scheduling, preliminary responses [Type Y meetings only], and minutes). If more 

than 12 meeting requests are submitted in Year 3, the remainder wHI not be 

under time!ines. 

Year 4: For meeting requests received in Year 4, FDA wt!l meet 60% of the total of 

meeting management goal dates (goal dates for response, scheduling, 

preliminary responses [Type Y meetings onlyL and minutes) 

Year 5: For meeting requests received in Year 4, FDA will meet 80% of the total 

of meeting management goal dates {goa! dates for response, scheduling, 

preliminary responses [Ty~~.meetings only], and minutes} -- Issuance of nonbinding annual FDA will publish the forecasting list within 30 days of each goal date (goal dates 

forecasting list of planned are Oct 1 of 2018, 2019, 2020, and 2021)~ 

monograph actions over 

ensuing 3 years 

Dispute resolution Year 4: For dispute resolution requests received in Year 4, FDA will meet 50% of 

the time!lne dates described in the FDRR draft guidance 

Year 5: For dispute resolution requests received in Year 5, FDA will meet 75% of 

the time!tne dates described in the FDRR draft guidance 

"Abbreviations: DFL = Oru8 Facts label; FY:::: fiscal year; FORR =Formal Dispute Resolution Request; .OMOR- Over-the-Counter Monograph 

Order Request 

Page 31 of 37 

1116 2. Summary of Timelines for Industry-Initiated Over-the-Counter Monograph Order Requests 1117 1118 The following table summarizes the timelines for Industry-initiated OMORs. 1119 ---- Table II.J.2: Summary of Time lines for Industry-Initiated Requests for Monograph Actions !---------- Tier One Tier One Tier Two GRASE Specified Safety Class One Cla

Innovation Innovation Innovation Finalization Change OMOR Resubmitted5 Res

OMOR: OMOR: OMOR OMOR Original OMOR Origi

Eligible' New Change to a Ingredient Monograph Condition of Use (other than a New Ingredient), or Request for Other2 Monograph Change Filing FDA makes FDA makes FDA makes FDA makes FDA makes n/a 

determination fileability fileability fileability fileability flleability determination determination 60 determination determination determination 60 calendar days calendar days 60 calendar days 60 calendar days 60 calendar days after receipt of after receipt of after receipt of after receipt of after receipt of OMOR OMOR OMOR OMOR OMOR Issuance of If OMOR is filed, If OMOR is filed, If OMOR is filed, If OMOR is filed, If OMOR is filed, FDA issues FDA is

proposed order FDA issues FDA issues FDA issues FDA issues FDA issues proposed order propo

proposed order proposed order proposed order proposed order proposed order 4 months after 6 mon

12 months after 12 months after 10 months after 12 months after 6 months after receipt of receip

receipt of OMOR receipt of OMOR receipt of OMOR receipt of OMOR receipt of OMOR resubmitted resub

OMOR OMOR Public comment Begins on the Begins on the Begins on the Begins on the Begins on the Begins on the Begins 

period date of issuance date of issuance date of issuance date of issuance date of issuance date of issuance date o

of the proposed of the proposed of the proposed of the proposed of the proposed of the proposed of the 

and lasts order, and lasts order4 and lasts order, and lasts order, and lasts order, and lasts order

45 calendar days 45 calendar days 45 calendar days 45 calendar days 45 calendar days 45 calendar days 45 cal

Page 32 of 37 

Table II.J.2: Summary ofTimelines for lnrh, Requests for Monograph Actions Tier One Tier One Tier Two GRASE Specified Safety Class One Cla

Innovation Innovation Innovation Finalization Change OMOR Resubmitted5 Res

OMOR: OMOR: OMOR OMOR Original OMOR Origi

Eligible 1 New Change to a Ingredient Monograph Condition of Use i (other than a New Ingredient), or Request for Other2 Monograph Change Assessment of Begins one Begins one Begins one Begins one Begins one Begins one Begins 

volume and calendar day calendar day after calendar day calendar day calendar day calendar day calend

substantiveness3 after the end of the end of the after the end of after the end of after the end of after the end of after t

of comments. the comment comment period, the comment the comment the comment ' the comment the co

period, and lasts and lasts 60 period, and lasts period, and lasts period, and lasts period, and lasts period

60 calendar days. calendar days 60 calendar days 60 calendar days 60 calendar days 60 calendar days 60 cal

Issuance of final 17.5 months 17.5 months after 15.5 months 17.5 months 11.5 months 9.5 months after 11.5 m

order4 after receipt of receipt of OMOR after receipt of after receipt of after receipt of 1 receipt of after r

OMOR OMOR OMOR OMOR I resubmitted resub

OMOR OMOR Abbreviations: GRASE =generally recognized as safe and effective; OMOR- over-the·counter monograph order request 1 See Section II.B. l.d regarding eligibility determination 2 This includes all proposed changes to the monograph, except for safety changes described in Section 11.0, the addition of new ingredients, Tier Twa Innovation OMORs, and specific 

which FDA has issued a final guidance stating that an OMOR is not required (see Section 11.8.2). 3 Assessment of substantiveness of comments does not involve full review of the comments, but rather is Intended to assess whether the comments will require substantial time or fu

41f comments received during the comment period are numerous or substantive, there will be an extension of the final order goal date. See Sections !I.B.l.e, II.B.l.j, 11.0.6, and ltf.6. addressed aU deficiencies identified in the previous final order Page 33 of 37 

1125 3. Summary of Dates of Specified Activities under OMUFA 1126 Table II.J.3: Summary of Oates of S!Jccifitu Activities under OMUFA Date Associated with Specified Activity Activity 10ct lOct lFeb !Apr 1 Jul 10ct 3Feb lApr 1 Jul 10ct lFeb !Apr lOct 1 Fe

2017 2018 2019 2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 202

Assumed effective date X Hiring annual goal assessment X X X X Monograph forecast annual X X X X posting TFM Cat I finalization X activities complete Meetings draft guidance X issued - Meetings final guidance X issued Public~facing IT dashboard X contract awarded I Publlc-fadng IT dashboard X functional IT platform for electronic X submission receipt, archiving and reporting: RFP IT platform: initial contracts X awarded I IT platform: business X I requirements established IT platform fully functional 

Content and format draft X guidance issued Content and format final X guidance issued Consolidated proceedings X draft guidance issued Consolidated proCeedings X ~()I gt:fi_~-'!~ce issued - ----- Page 34 of 37 

Table II.J.3: Summary of Dates of Specified1 Activities under OMUFA Date Associated with Specified Activity Activity 10ct 10ct 1 lFeb !Apr lJul !Oct 3 Feb !Apr 1Jul 10ct lfeb 1 Apr 10ct lFe

r.:-- 2017 2018 2019 2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 202

Meeting management TPGs X begin Meeting management TPGs X X annual goal assessment Electronic submission draft X guidance issued Electronic submission final X guidance issued COER-level dispute resolution X updated draft guidance issued Pre-OMUFA paper document X cataloging contract award Pre~OMUFA paper document X cataloging complete ~~ation OMOR TPGs begin X Industry-initiated Specified X Safety Change OMORs TPGs begin Industry-initiated GRASE X Finalization OMOR TPGs begin 1 COER-level dispute resolution X TPGs begin Solid oral dosage forms 

proposed administrative order and draft guidance ~- Page 35 of 37 

Table 11.1.3: Summary of Dates of Specified1 Activities under OMUFA I Date Associated with Specified Activity Activity 

L10ct j 10ct 1Jul I 10ct I 3Feb 11Apr I 1Jul 110ct 1F

I 2o1s 2o19 2<>19 2o19 2o19 202o 2020 2021 2021 2021 20

Abbreviations: ANPR =Advance Notice of Proposed Rulemaking; CAT= category; COER= Center for Drug Evaluation and Resean:h; COU =monograph conditions of use; GRASE =gene

recognized as safe and effective; IT= information technology; OMOR =Over-the-Counter Monograph Order Request; OMUFA = Over¥the¥Counter Monograph User Fee Act; TFM =Te

Monograph; TPGs = timelines and performance goals 

1: These are not all the activities that the FDA monograph review staff will be engaged in, but only those for which goal dates are specified under OMUFA, FDA will continue its many 

monograph activities, such as: addressing ongoing and emerging safety issues; carrying out mandated activities under the Sunscreen Innovation Act and an antiseptic consent decree

numerous other activities described elsewhere in this goals document 

Page 36 of 37 
68 


Over-the-Counter Monograph User Fee Program Performance Goals and 

Procedures- Fiscal Years 2018-2022 

1127 4. Annual Performance Reporting 

1128 

1129 FDA will include in the public annual performance report to Congress an assessment of the 

1130 activities listed in Table II.J.3 "Summary of Dates of Specified Activities under OMUFA." 

1131 

1132 Ill. Definitions and Explanations of Terms 

1133 

1134 (if needed, will be added later to be consistent with statutory language) 

Page 37 of 37 
69 

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 

70 

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 

71 

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? 

72 

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 LattaDeGette-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. 

73 

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. 

74 

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-theCounter 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 

75 

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. 

76 

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 conVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00080 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
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form 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 

78 

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. 

79 

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 mediVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00083 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
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cines 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 

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81 

holders, 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. 

82 

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. 

83 

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 caVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
84 

pacity. 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. 

85 

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. 

86 

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 

87 

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 

88 

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. 

89 

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? 

90 

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? 

91 

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. 

92 

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 offlabel 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. 

93 

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 overthe-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 overthe-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 overthe-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. 

94 

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 

95 

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, effiVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
96 

cient, 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 userfee 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:] 

97 


House Committee on Energy and Commerce, Subcommittee on Health 

Prepared Testimony of Scott Melville, President and CEO Consumer Healthcare Products Association 

September 13, 2017 

Chairman Burgess, Ranking Member Green, and Members of the Subcommittee: 

Thank you for the opportunity to provide testimony today on the over-the-counter (OTC) Monograph 

system and the importance of modernizing regulation to enhance the public health. 

My name is Scott Melville and I am the President and CEO of the Consumer Healthcare Products 

Association (CHPA). 

Since 1881, CHPA has served as the industry association representing leading manufacturers and 

marketers of over-the-counter (OTC) 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. CHPA also shares educational tools and information with partners 

across the globe to ensure the safe and responsible use of OTC medicines. 

Value of OTC Medicines 

More and more consumers are taking their health into their own hands, and they are doing this with the 

help of OTC medicines. For the more than 240 million Americans who use OTC medicines every year, 

these remedies are a trusted and affordable way to get well, stay well, and feel well. 

The availability of OTC medicine provides significant value to the U.S. healthcare system-$102 billion in 

annual savings relative to alternatives and an important increase in access to medicine. This means that, 

on average, every dollar spent on OTC medicines results in $6-7 in value for the U.S. healthcare system. 

In addition to cost savings relative to alternatives, OTC medicines provide value through significantly 

expanded access to treatment for the most frequent and common illnesses. The availability of OTC 

medicines, off-the-shelf, without a prescription, provides symptomatic relief for an estimated 240 

million people, 60 million of whom would not seek treatment if OTC medicines were not available. OTC 

medicines also contribute to increased economic productivity due to less time out of work for physician 

visits or to care for a sick child. 

Commitment to Education and Safety 

With more than 100,000 OTC products widely available, the CHPA Educational Foundation is dedicated 

to helping consumers lead happier, healthier lives through responsible self-care. Through public/private 

partnerships, national educational campaigns, and media efforts, the foundation educates consumers 

on how to safely use, store, and dispose of OTC medicines and dietary supplements. Information and 

materials represent the latest medical and scientific thinking and research and address specific areas 

where we know consumers need guidance and support. 

ljPage 
98 


Up and Away and Out of Sight is an educational program to remind families of the importance of safe 

medicine storage to prevent young children from getting into medicine. It is led by the Centers for 

Disease Control and Prevention (CDC) in partnership with the CHPA Educational Foundation, under the 

umbrella of the PROTECT Initiative. 

Know Your Dose educates patients and consumers about safe and effective use of acetaminophen, the 

most commonly used drug ingredient in the United States. The campaign is organized by the 

Acetaminophen Awareness Coalition-a group of consumer organizations, health organizations, and 

healthcare provider organizations, including the CHPA Educational Foundation. The U.S. Food and Drug 

Administration's Safe Use Initiative and the CDC both serve as coalition advisors. The coalition provides 

information to consumers as they are making healthcare decisions in pharmacies, health clinics, 

physician offices, and online. 

The foundation's Treat with Care program provides parents and caregivers the information they need to 

safely treat their children's cough and cold symptoms with pediatric OTC cough and cold medicines. 

Timed around cold and flu season, "Treat with Care" efforts have included print and radio public service 

announcements; ads and content in popular parenting media; and posters and brochures for doctors' 

offices, clinics and pharmacies. 

Modernizing the Monograph System 

Given the importance of OTC medicines to consumers and our nation's healthcare system, it's essential 

that the regulatory structure that oversees these medicines is one that is efficient, transparent, and 

accommodating to innovation. While some OTC medicines are regulated under new drug applications 

or abbreviated new drug applications, the vast majority of OTC medicines in our homes today are 

regulated under the OTC Monograph system, which our members strongly support. This system 

oversees over 300 active ingredients and more than 100,000 products, ranging from antacids to diaper 

rash creams, from pain relievers to cough and cold products. 

The Monograph system has saved time and other resources for the FDA since there is no need to rereview each individual product with established ingredients, already proven safe and effective. For 

makers of these medicines, it also saves time, resources, and provides for more efficient market access 

stimulating competition, thus providing Americans with a wide array of affordable choices and access. 

While the OTC Monograph system was created more than 40 years ago, 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 time consuming and expensive 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 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 

21Page 
99 


necessary due process protections for dispute resolution and issue escalation. This would empower FDA 

to act quickly when needed to address safety issues or monograph changes, while preserving the 

existing monograph structure- a structure which does not require unnecessary pre-market review 

when manufacturers utilize ingredients that have been found to be generally recognized as safe and 

effective by the FDA. 

We want to thank Chairman Burgess, Congressman Latta, Ranking Member Green, Congressman 

Guthrie, Congresswoman DeGette, Congresswoman Dingell and the entire Committee and its staff for 

working over many months to craft a discussion draft to bring the OTC Monograph system into the 21" 

Century. 

Striking the Right Balance with User Fees 

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 to 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 will, if enacted, 

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 manufacturer 

members. CHPA has some important technical comments on the discussion draft, we look forward to 

continuing 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. !look forward to addressing any questions you might have. 

3IPage 
100 

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, nonprofit 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. 

101 

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:] 

102 


Testimony before the Committee on Energy and Commerce, Subcommittee on Health, United States House of 

Representatives 

Chairman Burgess, Ranking Member Green, members of the sub-committee, thank you for holding this hearing 

and for the opportunity to present testimony. My name is Kirsten Moore; I direct the Health Care Products project 

at The Pew Charitable Trusts. Pew is a nonprofit, nonpartisan research and policy organization with a longstanding 

interest in drug quality and safety. Today I am here to relay Pew's strong support for reforming the regulatory 

framework for over-the-counter (OTC) drug products. Modernizing the OTC monograph system is necessary to 

enhance efficiency, improve safety, promote innovation, and ensure that FDA has adequate resources- all of 

which ultimately help consumers. 

Scope of Problem 

OTC products range from antiperspirant and deodorant to sunscreen to cough and cold medication and 

pain relievers. The OTC drug marketplace includes over 300,0001 unique products and has annual sales of $32 

billion.' FDA's monograph review framework for evaluating OTC ingredients is cumbersome, inefficient, and 

outdated- having not been revised since its inception in 1972. The multi-step rule making process is lengthy, and 

the agency's lack of resources hinders FDA's ability to ensure the safety and effectiveness of OTC products and to 

promote innovation. 

Most over-the-counter drugs are not regulated like prescription medications. Manufacturers of 

prescription drugs must submit clinical data to FDA to show they are safe and effective for their intended use and 

population before marketing them. These data are submitted in the form of a new drug application that FDA can 

approve, deny, or make a request for additional data. The process is drug-product specific, and FDA approves the 

formulation and what goes on the label (for example, intended uses, warnings, and directions for the consumer). 

New OTC products can be reviewed through this process, either as nonprescription drugs or as prescription drugs 

that may be sold over the counter later. Examples include certain allergy medications, antacids, and fluoride 

toothpastes. 

In contrast, the majority of OTCs rely on a "monograph" system, which entails evaluating the safety and 

effectiveness of active ingredients in the product rather than the product itself. A monograph is a published 

"recipe" used by product manufacturers that is typically organized into therapeutic classes or product categories, 

such as topical antimicrobials. The monograph for each category includes active ingredients, dosage form (for 

example, tablet or ointment), doses and dosage instructions, concentration, and mandatory labeling, and is 

published as a final rule in the Federal Register and codified in the Code of Federal Regulations. If a manufacturer 

follows the recipe exactly for an existing monograph, the company ls not required to seek FDA approval for a new 

product. Many ingredients in OTC products have been on the market since before 1962, when Congress first 

required that new drug products be shown to be effective, as well as safe, before they were marketed. FDA, 

recognizing in the 1970s that it needed a way to evaluate the many ingredients in products that were already on 

store shelves, initiated a scientific revlew of all active ingredients in them. Advisory committees, composed of 

physicians, pharmacists, consumers, and industry representatives, recommended that each active ingredient be in 

one of three categories: Category I includes ingredients which have been subject to adequate clinical investigations 

and testing, and experts generally agree that they demonstrate safety and efficacy for intended use. Category II 

includes ingredients that are not generally recognized as safe and effective, but may continue to be marketed until 

a monograph is finalized, which can take years. Category Ill includes ingredients for which there is not enough 

information to determine whether they are generally recognized as safe and effective. Again, the product can 

remain on the market until FDA finds that there is enough evidence to make a final determination. 

1 
103 


Making changes to a monograph is a multi-step process. All proposed changes to monographs are 

reviewed by FDA and the Department of Health and Human Services, and often the White House Office of 

Management and Budget, which estimates the cost and benefit of the change to the economy and consumers. FDA 

also receives and must respond to public comment throughout the monograph revision process. In contrast, new 

drug applications are reviewed solely by FDA on the basis of whether the product is safe and effective. The 

additional review steps for monographs add considerable time1 and they risk prioritizing economic considerations 

over consumer health and safety. There is no deadline by which monographs must be finalized, and several have 

been under review for decades. 

Public Health Implications of Outdated OTC Monograph System 

Approximately 240 million people, including infants and the elderly, use OTC products annually. 3 FDA's 

limited resources and authority to regulate OTC products in a timely and streamlined fashion hinder its ability to 

oversee their safety and effectiveness. This can lead to critical adverse events1 and create unreasonable 

discrepancies between the agency's response to the same risks in OTC products versus prescription drugs. 

In 2002, FDA held an advisory committee meeting to discuss the problem of liver injury related to the use 

of OTC acetaminophen products. 4 The advisory committee recommended a specific liver toxicity warning and 

changes to OTC packages so that products containing acetaminophen could be more easily identified. 5 It took the 

agency seven years to finalize a rule amending the labeling requirements for OTC drugs in order to inform 

consumers about the risk of liver injury when using acetaminophen (and four years even to issue an initial 

proposed rule). 6, 

7 In contrast, it took FDA only two years to convene an advisory committee and require new 

Boxed Warning on all prescription drug products that contain acetaminophen. 8

, 

9 

Similarly, FDA was able much more quickly to address the risks of prescription anti-inflammatory drugs 

compared with the identical active drug sold as an OTC product. In 2002, FDA held an advisory committee meeting 

to discuss the gastrointestinal (GI) and renal toxicity risks associated with the use of OTC nonsteroidal antiinflammatory drugs (NSAIDs). 10 The advisory committee agreed that a change to the current label was necessary to 

address these risks, but again, it took the agency seven years to publish a final rule requiring the change. 11 It took 

the agency less than a year to require a Boxed Warning for prescription NSAIDs. 12 

More recently, in April 2017, FDA required companies to add the strongest form of warning to children's 

prescription cough and pain medications containing codeine, a controlled substance. The agency was responding 

to concerns that the drug can cause potentially fatal breathing problems, especially in children younger than 12 

years. 13 In 2015, an FDA advisory committee identified 24 deaths and 64 cases worldwide of serious breathing 

problems in the previous SO years among children who took medications containing codeine. Twenty-one of those 

who died were children younger than 12. 14 Despite the evidence, FDA has not yet made the change to remove 

codeine from the monograph for OTC children's cough and cold products. 

These examples illustrate the unnecessary delay incorporated into a multi-step rulemaking system, which 

compromises FDA's ability to respond swiftly to address new safety information and protect consumers. This is 

particularly concerning as there is no presumption of a health care professional intermediary in an over-thecounter environment, so consumers lack vita! information about safe or appropriate use of products. FDA, 

industry, and public health stakeholders are united in their conviction that OTC monograph reform is critical to 

protect public health, and are in strong support of this proposed legislation. 

OMUFA Draft Language Improves FDA's Ability to Prioritize Public Health 

2 
104 


Earlier this year, Pew joined with the American Academy of Pediatrics, the American Academy of Allergy, 

Asthma & Immunology, American Academy of Dermatology Association, the American Public Health Association, 

the National Association of County and City Health Officials, Society for Maternal-Fetal Medicine and March of 

Dimes to issue a set of principles for over-the-counter monograph reform.t5 These principles call for: 

(1) replacing the cumbersome rulemaking process with a more efficient mechanism for creating 

and updating monographs; 

(2) allowing FDA to act promptly to address emerging safety issues; providing FDA with sufficient 

resources to accommodate OTC drug innovation; 

(3) creating an efficient data collection system for FDA; and 

(4) establishing FDA as the final arbiter of scientific evidence on the safety and effectiveness of 

ingredients and changes to monographs. 

These principles are broadly reflected in both the House and Senate language which have been circulated. We will 

highlight several significant improvements under the proposed legislation. 

Efficiency 

OTC monograph reform will enhance efficiency by replacing the cumbersome rulemaking process with an 

administrative order process, aligning the decision-making authority FDA has for OTC products with the authority 

the agency already has for prescription drugs. Under the proposed system, agency scientists would be able to 

make important safety and effectiveness decisions about OTC ingredients. Monograph reform would also expedite 

the review process by giving the Secretary authority to standardize the content and format for electronic data 

submissions and set forth a procedure for collecting and analyzing such data. This improves on the current system, 

in which reviewers must sort through and then systematize a volume of disorganized, often fragile, paper 

documents into a package that can be properly reviewed. 

Safety 

Monograph reform will improve FDA's ability to respond to safety threats and ensure the agency has 

complete information about OTC products. Allowing the agency to change the rules for OTC products by 

administrative order would allow it to react rapidly to emerging safety issues regarding the use and misuse or 

abuse of OTC drug products. Currently, products for which FDA has insufficient information remain on the market, 

but OTC reform would allow FDA to complete its review and remove products from the market if sufficient 

evidence of safety and effectiveness is lacking. Furthermore, requiring firms to submit all information in their 

possession, including negative data {as is required for prescription drug submissions), would enhance safety by 

ensuring that FDA is the final arbiter of scientific evidence on the safety and effectiveness of ingredients and 

changes to monographs, as is already the case for prescription drugs and medical devices. To ensure safety, any 

new exclusivity provisions should not apply to safety-related changes, enabling universal adoption of such changes 

and, user fees should not be assessed for adding new safety information, so that firms are likely to update 

products accordingly. 

Innovation 

With an improved regulatory regime, FDA would more quickly be able to accommodate innovation in OTC 

drug products, permitting new ingredients, and new indications and new formulations for existing ones, potentially 

giving patients who are unable to take pill forms to access medications through other routes of administration. 
105 


Resources 

Achieving these potential commercial and public benefits will require additional FDA resources. 

Establishing a user fee program for OTC products will significantly enhance FDA's ability to effectively oversee this 

marketplace. Approximately 18 scientific reviewers oversee about 800 active ingredients for over 1,400 distinct 

therapeutic uses, 16 with more than half of these reviewers dedicated to review of sunscreen ingredients. 17 For 

context, FDA dedicates approximately 18 FTEs to review one application to market a new prescription drug. 18 The 

proposed agreement would provide FDA with the resources required to substantially expand the OTC review and 

oversight capacity- from 31 FTEs (this number includes legal, policy and support staff as well as scientific 

reviewers) in 2018 to 110 FTEs in FY2022, This boost in personnel will enable FDA to clear up the monograph 

review backlog, address safety concerns for products currently on the market, and review future applications for 

innovative products in a timely manner. 

OMUFA is a Compromise 

Pew supports this bipartisan proposed legislation as written, because it will lead to improvements in 

public safety and administrative efficiency. However, it is noteworthy that the new exclusivity provided to certain 

OTC products that do not undergo clinical trials under this measure would exceed the 6-months' additional 

exclusivity that Congress provided to companies that carry out tests of their drugs in a pediatric population. Pew 

also recommends incorporating language authorizing the Secretary to require packaging to be redesigned if 

needed to resolve safety concerns. 

Other concerns with this legislation may be resolvable as stakeholders gain experience in a new system, 

thus Pew recommends incorporating a mechanism that facilitates future negotiations between industry and FDA, 

so that they can resolve remaining inefficienc'1es without the need for new legislation. For example, the proposed 

process for dispute resolution over OTC ingredients requires multiple notifications and potential delays and is 

more complex than the process for resolving disputes over prescription drugs, Industry and FDA should have an 

opportunity to agree to a more streamlined dispute resolution process than is contemplated by the current 

legislation. In addition, the proposed language allows a manufacturer to file an application over protest, even 

when FDA has already reviewed and deemed that file insufficient with regard to evidence. These provisions 

undermine the goal of increased efficiency, both by requiring FDA to use resources on review of insufficient 

applications and by delaying the agency's ability to turn to applications from sponsors who have submitted 

complete files. 

The current monograph system, unchanged since 1972, has had detrimental effects on consumers and 

compromises FDA's ability to ensure the safety and effectiveness of OTC products. We applaud this subcommittee 

for its bipartisan work on the current proposaL The Pew Charitable Trusts urges Congress to capitalize on this 

momentum and pass this legislation as soon as possible. 

1 Food and Drug Administration, "Drug Applications for Over-the-Counter {OTC) Drugs/' accessed Aug. 25, 2017, 

http:Uwww.fda.gov/drugs/developmentaporovalprocess/howdrugsaredevelopedandapproved/approvalapp!ications/over-thecounterdrugs/default.htm. 

2 Consumer Healthcare Products Association, "OTC Retail Sales 1964-2015," accessed Aug. 25, 2017, 

http://www.chpa.org/PR OTCRetaiiSales.aspx. 

4 
106 


3 Approximately 240 million people in the United States use OTC products annually in the seven categories {allergy, analgesics, 

anti~fungals, cough/cold/flu, upper and !ower gastrointestinal, and medicated skin) that represent the significant majority of 

OTC products purchased in the United States. Consumer Healthcare Products Association, "The Value of OTC Medicine to the 

United States," (2012). 

4 U.S. Food and Drug Administration, "Non-prescription Drugs Advisory Committee; Notice of Meeting," 67 Fed. Reg. 161 

(August 20, 2002). 

5 U.S. Food and Drug Administration, "June 29-30, 2009: Joint Meeting of the Drug Safety and Risk Management Advisory 

Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory 

Committee: Meeting Announcement," last modified July 30, 2013, https://wayback.archiveit. orgi7993I20170722143S26Ihttps:l lwww. fda.gov I AdvisoryCommitteesiCalendar lucm 143083.htm. 

6 U.S. Food and Drug Administration, "Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter 

Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other labeling," 71 Fed. Reg. 

77314 (Dec. 26, 2006). 

I 21 CFR § 201.326. 

8 U.S, Food and Drug Administration, "June 29*30, 2009; Joint Meeting ofthe Drug Safety and Risk Management Advisory 

Committee with the Anesthetic and life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory 

Committee: Meeting Announcement," last modified July 30, 2013, https://wayback.archiveit.orgl7993/2017072 2143526lhttps:/ lwww. fda.gov I AdvisoryCommitteesiCa lendar lucm 143083. htm. 

9 US Food and Drug Administration, "FDA Drug Safety Communication: Prescription Acetaminophen Products to be Umlted to 

325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe liver Failure (January 13, 2011)," last modified July 

31, 2017, https:l lwww.fda.gov/Drugs/DrugSafetylucm239821.htm. 10 U.S, Food and Drug Administration, "Nonprescription Drugs Advisory Committee; Safety Issues Related to ASA and NSAIDS, 

September 20, 2002," accessed September 8, 2017, https:/lwww.fda.govlohrmsldocketslacl02/transcriptsi3882T2.pdf. 

H 21 CFR § 201.326. 

12 U.S. Food and Drug Administration, "Public Health Advisory- FDA Announces lmportant Changes and Additional Warnings for 

COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (April 7, 2005)." last modified Aug. 16, 

2013, https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetylnformationforPatientsandProviders/ucm150314.htm. 

13 U.S. Food and Drug Administration, "FDA Drug Safety Communication~ FDA Restricts Use of Prescription Codeine Pain and 

Cough Medicines and Tramado! Pain Medicines in Children; Recommends Against Use in Breastfecding Women" last modified 

April20, 2017, https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm. 

14 U.S. Food and Drug Administration, "FDA Briefing Document: Joint Pulmonary-Allergy Drugs Advisory Committee and Drug 

Safety and Risk Management Advisory Committee Meeting; The Safety of Codeine in Children 18 Years of Age and Younger" 

Dec. 10, 2015, httos://www.fda.gov/downloads/AdvisoryCommittees/CommltteesMeetingMateria!s/Drugs/PulmonaryA!lergyDrugsAdvisoryCommittee/UCM475975.odf. 

The Pew Charitable Trusts, "Pew and the American Academy of Pediatrics Outline Principles for Over-the-Counter Drug 

Regulation Reform," accessed Sept. 11, 2017, http://www.pewtrusts.org/en/research-and-analysis/ana!ysis/2017/05/05/pewand-the-american-academy-of-pediatrics-out!lne-princip!es~for-over-the-counter-drug-regulation. 

16 Renu La I, Pharm.D., "User Fees and the Future of the OTC Monograph System," FDA/CBER SBIA Chronicles, July 6, 2016, 

http:l/www.fda.gov/downloads/Drugs/DevelopmentApprova!Process/SmallBusinessAssistance/UCM510074.pdf. 

11 U.S. Food and Drug Administration, "Report in Response to the Sunscreen Innovation Act (P.l. 113-195) Section 586G," 

accessed Sept. 11, 2017, https:/ /www. fda.gov I downloads/Drugs/Guida nceComplia nceRegulatoryl nformation/UCM503441. pdf. 

18 Renu La!, Pharm.D., "User Fees and the Future of the OTC Monograph System." 

5 
107 

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. 

108 

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:] 

109 


www.passcoalition.com Facebook.com/PASSCoalition 

Testimony of Michael Werner, JD 

Partner, Holland & Knight 

On behalf of 

@PASSCoalition 

The Public Access to SunScreens (PASS) Coalition 

House Committee on Energy and Commerce 

Subcommittee on Health 

September 13,2017 

Summary 

The Public Access to SunScreens (PASS) Coalition is a multi-stakeholder 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. 

According to the U.S. Surgeon General, over 5 million Americans arc treated for skin cancer 

every year, costing American taxpayers $8.1 billion annually. Based on the skin cancer epidemic 

in the U.S., Americans must have access to all available safe and effective sunscreen products, 

especially those that have been available for years in Europe and elsewhere and have been shown 

to offer a public health benefit to the populations that have been using these products. 

In a joint effort to address the skin cancer epidemic, Congress, FDA, the PASS Coalition, and 

other stakeholders came together to enact the bipartisan Sunscreen Innovation Act (SIA; Public 

Law 113-195) in 2014, which included several provisions to improve Americans' access to OTC 

sunscreen ingredients. FDA has met all the time lines required by the SIA. Unfortunately, none of 

the eight pending sunscreen ingredients have yet received a final decision. 

The PASS Coalition supports the efforts to enact reforms to the OTC drug approval process. As 

Congress considers OTC reform legislation, the PASS Coalition has several principles for this 

Committee to consider in drafting your reform legislation. These principles have been developed 

based on feedback f!·om the FDA, Congress, and other public health groups and industry 

stakeholders. 
110 


www.passcoalition.com Facebook.com/PASSCoalition 

PUBLIC 

f?~~§ ACCESS TO SUNSCREENS 

Testimony of Michael Werner, JD 

Partner, Holland & Knight 

On bchalfof 

@PASSCoalition 

The Public Access to SunScreens (PASS) Coalition 

House Committee on Energy and Commerce 

Subcommittee on Health 

September 13,2017 

Good morning, Chairman Burgess, Ranking Member Green, and members of the Subcommittee, 

my name is Michael W crner. I am a partner at the law firm of Holland & Knight and a public 

policy advisor to the Public Access to SunScreens Coalition (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 sunscreens. 

The PASS Coalition is a multi-stakeholder 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. The PASS Coalition's mission is to work 

co!laboratively with all stakeholders, including the FDA, the White House, Congress, health 

providers, consumer organizations, and sunscreen manufacturers, to establish a transparent 

review within a predictable timeframe tor pending time and extent applications (TEAs) for OTC 

sunscreen ingredients. We are also committed to ensuring that FDA has the resources it needs to 

conduct the pre-market review of sunscreen ingredients. 

2 #53601291_vl 
111 


In a joint effort to address the skin cancer epidemic, Congress, FDA, the PASS Coalition, and 

other stakeholders came together to enact the bipartisan Sunscreen Innovation Act (SIA; Public 

Law 113-195) in 2014. By working together and across the aisle, Congress, FDA and 

stakeholders identified a number of regulatory barriers to the consideration of OTC sunscreen 

ingredients and created historic reforms to address these barriers for sunscreen ingredients. The 

SIA was ultimately enacted by both the House and Senate by voice vote. 

The PASS Coalition supports the efforts of the House Energy & Commerce Committee, and 

your counterparts in the Senate, to extend similar reforms achieved for sunscreens to other OTC 

product categories. We also support the establishment of a user fee program to provide FDA with 

the resources to implement these reforms. Based on our experience over the last three years 

implementing the SIA and productive conversations with Dr. Woodcock and Deputy 

Commissioner Anna Abram, we also believe that there are several improvements that are 

necessary to help continue to improve the review process for pending sunscreen ingredients. The 

OTC reform legislation being considered by the Subcommittee provides the opportunity to 

codify these improvements to finally achieve the promise of the SIA. 

Public Health Impact of Skin Cancer 

Mr. Chairman, skin cancer is a public health crisis in the United States. On July 29, 2014, the 

U.S. Surgeon General issued A Call to Action to Prevent Skin Cancer stating: "Even though most 

skin cancers can be prevented, rates of skin cancer, including melanoma, are increasing in the 

United States." According to the U.S. Surgeon General, over 5 million Americans are treated for 

skin cancer every year, costing American taxpayers $8.1 billion annually. 

3 #.13601291 vl 
112 


The alarming rate of skin cancer means that each year there are now more new cases of skin 

cancer than the combined incidence of breast cancer, prostate cancer, lung cancer, and colon 

cancer. Melanoma, attributed primarily to UV exposure, is the deadliest of the skin cancers as a 

result of its ability to move quickly and spread to distant organs in the body and is rising 

dramatically across demographics. In the United States, a patient is diagnosed with melanoma 

every eight minutes and an American loses her life every hour from the disease. Despite recent 

tremendous advancements in treatment science, the melanoma death rate for patients with 

metastatic disease has remained static over the past 30 years, and according to the American 

Cancer Society the incidence of this deadly disease continues to rise at alarming rates. From 

!975-20 II, rates of melanoma in young men and women ages 20-39 years increased by 34% in 

men and by 84% in women. 

These figures show that Americans must have access to all available safe and effective sunscreen 

products, especially those that have been available for years in Europe and elsewhere and have 

been shown to offer a public health benefit to the populations that have been using these 

products. 

The Surgeon General's 2014 Call to Action concludes with this powerful recommendation: "We 

must act with urgency to stop the ever-increasing incidence of skin cancers in the United States." 

United States Sunscreen Backlog 

The last time a new OTC sunscreen ingredient was approved in the United States was the 1990s. 

Since 2002, eight new sunscreen ingredients have been submitted for review under the FDA's 

TEA process. Meanwhile, these ingredients have been widely available in Europe, Asia, and 

Central and South America for decades. That's why the PASS Coalition supported enactment of 

4 #5360129l_vl 
113 


the bipartisan SIA by the Congress. Clearing the backlog of sunscreen applications will ensure 

that Americans have greater access to broad-spectrum sunscreens, which provide better 

protection against both UV A and UVB rays. 

Overview of Sunscreen Innovation Act Reforms 

The SIA represented the culmination of fruitful collaboration between external stakeholders, 

including the PASS Coalition, the FDA, and Congress, who all saw the need to improve 

Americans' access to OTC sunscreen products to reduce the incidence of cancer in this country. 

As a brief reminder, the SIA incorporated several major provisions, including: 

• allowing FDA to make scientific decisions on OTC ingredients with administrative 

orders instead of rulemaking; 

• establishing timelines for FDA review of the safety and efficacy of sunscreen active 

ingredients; 

• allowing robust opportunities for public comment and the submission of safety and 

effectiveness data; 

• ensuring a sunscreen ingredient with at least five years of safe and effective use in a 

comparable jurisdiction is eligible for consideration as under existing FDA regulations; 

• requiring FDA to issue final guidance on the safety and effectiveness data required for 

FDA to review new sunscreen ingredients. 

FDA has met all the timelines required by the SIA. Unfortunately, none of the eight pending 

sunscreen ingredients have yet received a final decision. 

5 #5360! 29!_ \' 1 
114 


In 2016, the PASS Coalition contracted with two independent scientists, Edward Sargent, Ph.D., 

M.P.H., a toxicologist, and Jeffrey B. Travers, M.D., Ph.D., F.A.A.D., a dermatologist, to review 

FDA's draft guidance and examine proposed orders for the eight pending sunscreen ingredients. 

The purpose of the independent scientific review was to provide the Coalition with an analysis of 

FDA's actions and to help the Coalition develop recommendations for an appropriate testing 

regimen based on the risk profile of the pending sunscreen ingredients and the growing incidence 

of skin cancer. The independent scientific review resulted in recommendations with validated 

testing procedures to balance the benefits of additional broad spectrum sunscreen protection 

versus the risk of skin cancer in addition to those described in FDA's draft guidance. The 

conclusions of Drs. Sargent and Travers were peer reviewed and published in the Journal of 

Regulatory Toxicology and Pharmacology in August 2016 and was entitled "Examining the 

differences in current regulatory processes for sunscreens and proposed safety assessment 

paradigm." 

Based on recent conversations with FDA, there is agreement that some changes to the SIA for 

the eight pending ingredients would be beneficial to establish an opportunity for meetings with 

sponsors of new sunscreen ingredients to discuss validated testing procedures that would support 

a determination of general recognition of safety and effectiveness. 

OTC Reform Legislation 

The PASS Coalition supports the efforts to enact reforms to the OTC drug approval process. 

Many of the same structural issues that the SIA sought to address for sunscreens also apply to 

other categories of products, particularly the requirement for FDA to make OTC drug decisions 

through rulemaking and the need for a predictable and transparent review process. 

6 #5360!291 vl 
115 


As Congress considers OTC reform legislation, the PASS Coalition has several principles for 

this Committee to consider in drafting your reform legislation. These principles have been 

developed based on feedback from the FDA, Congress, and other public health groups and 

industry stakeholders. 

First, the eight sunscreen ingredients that already have received proposed sunscreen 

administrative orders should continue to be considered under the SIA. The first of these pending 

sunscreen ingredients was submitted in 2002 and has been under FDA review for IS years. Each 

ingredient was required to be approved for at least 5 years in a comparable jurisdiction, which 

means that some of the pending ingredients have over 20 years of international experience. OTC 

reform legislation should allow sponsors of the eight pending to complete consideration of its 

ingredients under the SIA. New sunscreen ingredients, as with all other OTC drugs, should go 

through the OTC reform framework. 

Second, any new OTC drug approval pathways must be flexible enough to accommodate new 

sunscreen ingredients with U.S. or international experience. The OTC reform process should 

allow sponsors to use U.S. or international safety and effectiveness data as the basis to meet 

FDA's standard for products generally recognized as safe and effective, similar to the framework 

established in the TEA process and codified in eligibility requirements of the SIA. 

Third, any new OTC drug approval pathway should not require the sponsor of a sunscreen 

application to file a New Drug Application (NDA) for its active ingredient to be considered for 

an OTC administrative order. We believe that the NDA process is particularly burdensome for 

new sunscreen ingredients, and the FDA should have alternate pathways at their disposal to 

consider these new applications to maximize the ability of safe and etTective products to come to 

7 #53601291~vl 
116 


market as soon as possible. For instance, the NDA process evaluates only finished products, 

however sunscreen active ingredients are included in a variety of seasonal finished products to 

block UV A and/or UVB radiation from the sun. This is the same rationale used by FDA when it 

established the TEA process. 

Fourth, any OTC reform legislation should authorize FDA to meet individually on a confidential 

basis with sponsors of sunscreen ingredients to allow for open discussions of confidential 

commercial information or trade secrets. FDA has expressed a willingness to consider validated 

alternative testing procedures in support of a determination of general recognition of safety and 

effectiveness outside of what the agency included in its final guidance on safety and 

effectiveness data. An individual meeting will also assist in the establishment of testing protocols 

for tests that have never been performed on a sunscreen ingredients before. 

Finally, given the importance of innovation in the OTC space for getting patients the safe and 

effective products they require, the FDA's testing standards for these products should be 

periodically reviewed and assessed. As I mentioned previously, independent studies have already 

concluded that improvements to the testing regimes for sunscreen ingredients can and should be 

made to incorporate new scientific evidence and appropriately reflect the potential risks of these 

ingredients with the proven public health benefits of skin cancer prevention. 

Ultimately, we believe that the OTC legislation currently being developed by Congress is the 

proper vehicle for these and other changes to be made to the current OTC framework. Inclusion 

of provisions that incorporate these principles will ensure Americans have access to sunscreen 

ingredients that are available across the world. Given the number of new products, labeling 

changes, and other issues pending regarding the tens of thousands ofOTC products in the United 

8 

#5360129] vi 
117 


States, the time is now for Congress to act to improve the way these products are considered and 

approved. 

Thank you for the opportunity to testify before you today. I look forward to your questions. 

9 #53601291_vl 
118 

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 

119 

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:] 

120 


American Academy of Pediatrics 

DEDICATED TO THE HEALTH OJ' ALL CHILDREN'" 

Testimony of Bridgette L Jones, MD, FAAP 

On Behalf of the American Academy of Pediatrics 

Before the U.S. House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

"Modernizing FDA's Regulation of Over-the-Counter Drugs" 

September 13, 2017 
121 


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 (OTC) for America's children. 

My name is Dr. Bridgette L. Jones. I am a practicing pediatrician who specializes in the treatment of 

children with asthma and allergic disease. I also conduct clinical pharmacology research to improve the 

safety and efficacy of drugs for children. I hold a faculty appointment as Associate Professor of Pediatrics 

at the University of Missouri-Kansas City in the divisions of Pediatric Clinical Pharmacology, Toxicology 

and Therapeutic Innovation and Allergy/Asthma/Immunology at Children's Mercy in Kansas City, MO. I 

am board certified in Pediatrics and Allergy/Asthma/Immunology and have completed fellowship 

training in Pediatric Clinical Pharmacology. I am here today in an official capacity to represent the 

American Academy of Pediatrics (AAP). The AAP is a non-profit professional membership organization of 

over 66,000 primary care pediatricians and medical and surgical pediatric subspecialists dedicated to 

health and well-being of children. I serve as the chair of the AAP Committee on Drugs. 

Every day in the United States, pediatricians get urgent calls from anxious parents, often in the middle of 

the night, asking about the best way to treat their sick child. Sometimes the answer is a prescription 

drug, sometimes the answer is non-drug supportive treatment, and sometimes the answer is an OTC 

medicine they can access at their local drug store. 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. Because parents often rely on OTC drugs to treat their children, it is essential that 

they can feel confident in knowing that those products are safe and effective. As a pediatrician advising 

parents, I want to know that the products I recommend have been tested in children and labeled 

appropriately for their use. As such, we must have a process set up to regulate them that is modern and 

responsive to the best and most recent medical science. 

The current OTC regulation process at the Food and Drug Administration (FDA) is antiquated and not 

nimble enough to adapt to emerging evidence and to changes in how pediatricians practice medicine. 

The monograph that dictates how OTC drugs can be marketed was in large part developed based on the 

state of the evidence from over 40 to 50 years ago. Some of these drugs continue to be mainstays of 

pediatric practice, but others provide little or no benefit to children. Much of the pediatric drug labeling 

included in the OTC monograph was based on evidence that no longer meets today's rigorous standards 

for safety and efficacy or was based on incorrect assumptions about how adult data should inform the 

labeling of drugs in children. 

Because we know that children are not just little adults, the AAP believes that drugs used in children 

should be appropriately studied specifically for their use. While we have made great strides in improving 

new prescription drug therapies for children through the Best Pharmaceuticals for Children Act and the 

Pediatric Research Equity Act, we have a long way to go to bring this record of success to OTC drugs. 

The process for revising the OTC monograph is cumbersome and slow, and therefore the FDA cannot act 

quickly to respond to developments in the science, public health and safety concerns, or product 

innovation. The process is resource intensive while being significantly underfunded. It does not serve 

the needs of children and, for that matter, does not serve the needs of the public at large. The only way 

to ensure that consumers are afforded reliable, safe, and quality medicines is to change how the 

monograph system works and provide significant new resources for the endeavor. It is for this reason, 

the AAP supports reforms to the current OTC monograph system and the creation of a user fee program 

to fund FDA's monograph work. Over the past year, the AAP has worked closely with the Pew Charitable 

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Trusts and other public health and medical associations to speak up for the needs of patients as FDA, 

industry, and Congress have worked to develop a modernized approach to OTC regulation. 

OTC Cough and Cold Medicines for Children 

An illustrative example of how the current OTC monograph does not meet the needs of children can be 

found in the case of cough and cold medicines for children. The OTC drug review-the process FDA used 

to review cough and cold drugs and other grandfathered OTC products on the market prior to the 

enactment of FDA's modern standards for safety and efficacy-was a massive and complicated 

undertaking. While FDA reviewers did their best to evaluate the safety and efficacy of these products, 

the data available to them was often extremely limited. And in the case of drugs for children, much has 

changed in the area of pediatric therapeutics since the 1970s. We have moved from an era where drugs 

were seldom studied in children, and pediatric drug studies were often considered to be unethical, to 

today, where failure to study drugs in children can be considered unethical. 

The data that led FDA to label cough and cold medicines for children does not come close to meeting 

today's standards for pediatric data. Not only that, but additional data gathered since that time has 

clearly shown certain cough and cold products to be completely ineffective in the pediatric population. 

Nevertheless, these products are still commonly marketed to children and often in combination with 

other products that can increase the safety risks. The monograph process has proven ineffective in 

ensuring that OTC drugs marketed to children and families have data to justify their use. 

Over a decade ago, numerous pediatric experts submitted a citizen petition to FDA regarding the 

labeling of OTC monograph drugs for the treatment of cough and cold in children. The petition 

highlighted safety concerns but also-in the case of some products-a demonstrated lack of efficacy in 

the pediatric population. FDA held an advisory committee meeting in response to the petition. The 

committee voted unanimously that it was no longer appropriate for adult data on cough and cold 

products to be extrapolated to establish efficacy of the drugs in children under 12. The committee also 

voted to recommend that cough and cold drugs not be used in children under 6 years of age, consistent 

with the AAP's recommendation at the time. After this critical and decisive meeting, FDA embarked on a 

process to revise the pediatric cough and cold monograph to better reflect the current state of the 

evidence. 

Sadly, it's now 2017 and FDA has yet to publish even draft changes to this monograph, despite pleas 

from Congress, pediatricians, and the public. We are convinced that this lack of progress is not for lack 

of effort on the part of FDA. Rather, progress has not been realized because the monograph process 

simply does not work. 

FDA was unable to act decisively in the face of mounting evidence that these products were resulting in 

thousands of pediatric overdose-related emergency department visits each year-all for products with 

modest or non-existent efficacy in children. Currently, for FDA to change a warning in the monograph it 

must go through a lengthy notice and comment rulemaking process to modify federal regulations. This 

unwieldy process comes with numerous bureaucratic steps and layers of review. FDA's only recourse for 

cough and cold drugs was to initiate a rulemaking process that has never concluded. This must change. If 

FDA identifies safety issues associated with a monograph drug, it needs the authority to require prompt 

label changes without going through a prolonged and burdensome regulatory process including the 

lengthy Office of Management and Budget review. Considerations of safety, effectiveness and 

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innovation, not economics, should drive FDA's process for modifying OTC drug monographs. 

Additionally, the agency needs appropriate resources to conduct safety surveillance for monograph 

products and allow quick action when safety issues arise. 

FDA must have the authority and resources necessary to identify monograph products that lack 

appropriate data. Using a risk-based approach, FDA should be able to either require products to 

immediately come off the shelves or to give manufacturers a period of time during which they must 

submit new efficacy data to FDA to justify their continued marketing after which a product lacking such 

data would be removed from the monograph. Today's monograph process is ill-equipped to handle this 

task. Modernizing the monograph process will ensure FDA's ability to address products that do not meet 

appropriate efficacy standards. 

Product Innovation 

While the new drug application (NDA) process is the gold standard for the approval of new and 

innovative drugs, there are certainly instances where industry-initiated changes to the monograph are 

appropriat.e. Such changes can lead to improved drug formulations, increased safety, and other benefits 

for patients. 

For instance, industry has for years been requesting that the monograph be amended to provide 

acetaminophen dosing instructions for children under the age of two. Even though there are wellaccepted guidelines for acetaminophen dosing for children aged 6 to 24 months, the label of "infant" 

and "children's" acetaminophen (oral suspension) still asks parents of children under 2 to "ask a doctor" 

for dosing directions. Parents unable to quickly reach a physician may be tempted to make a guess of an 

appropriate dose, putting their infant at risk. The AAP supports such a change In labeling, and if the 

monograph process worked better, surely this change would have happened years ago. 

Much like the long-delayed FDA action on the cough and cold citizen's petition, the existing backlog of 

industry-requested monograph changes currently awaiting FDA review is unacceptable. The uncertainty 

and complexity of the review process likely also reduces industry's incentive to invest research and 

development resources into monograph products. Congress should act to create a reformed monograph 

system that would add certainty to the evaluation of industry-initiated monograph revisions. 

Safe Packaging for Children 

While we generally support the goal of increasing industry innovation in the OTC drug market, we must 

ensure that this innovation meets the needs and expectations of consumers and does not have 

unintended negative consequences. With a reformed, more responsive, and better resourced system, 

one area where we anticipate greater industry innovation is in the development of novel formulations 

for OTC drug products. It is possible that the industry may work on developing gummy formulations of 

drugs, much like supplement manufacturers have done in recent years with their marketing of gummy 

bear 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 consumed a number of gummy medicines outside the watchful eye of parents, it could lead to 

injury, a trip to the emergency room, or worse. It is therefore vitally important that FDA have sufficient 

authority to regulate the packaging of OTC drugs. 

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Unfortunately, FDA's current authority over packaging is unclear, and as such we believe that this 

legislation must explicitly grant FDA authority to require specific types of packaging to prevent harm to 

children. For instance, if FDA did decide that approving a gummy drug product was appropriate, we 

would insist that FDA have the authority to require that drug to be sold in unit-dose packaging, such as 

blister packs, that would only allow access to one dose at a time. As a hypothetical example, a bottle of 

100 loose, colorful and tasty gummy acetaminophen, if left open by an adult, would be nightmare 

scenario for a pediatrician from a poison prevention perspective. The margin between a therapeutic 

dose of acetaminophen and an amount that could kill a child is small. Without unit dose packaging, that 

open bottle of candy-like acetaminophen could be attractive and potentially fatal to a child. FDA must 

not wait until a product is already on the market and injuries, or even deaths, have occurred in children 

before requiring appropriate packaging. 

Allowing FDA to require unit-dose packaging or other appropriate packaging would not interfere with 

the existing authority the Consumer Product Safety Commission (CPSC) has to require child-resistant 

packaging under the Poison Prevention Packaging Act because CPSC cannot require specific types of 

packaging like blister packs. What CPSC can do, and should continue to do, is to require drugs to be sold 

in what's called "special packaging," or packaging that is tested to ensure that it is sufficiently difficult 

for children to open. However, while CPSC regulations currently require all prescription drugs to come in 

this special packaging-and even requires the same for all prescription drugs that switch to OTC statusCPSC only requires a small handful of specific drugs regulated under the OTC monograph to be sold in 

child-resistant packaging. 

For this reason, it is essential that FDA and CPSC have established processes for communicating about 

their regulatory activities. If FDA, for instance, were preparing to approve a new formulation of a drug 

that CPSC does not currently require come in child-resistant packaging-and this new formulation raised 

concerns about possible child poisoning-it would be important for the FDA to be in communication 

with the CPSC so that the Commission could decide whether updating its packaging regulations would 

be warranted. 

We look forward to continuing to work with you and your staff to ensure that the legislation gives FDA 

the clear authority it needs to require specific types of packaging to prevent harm to children. Similarly, 

we look forward to continuing to work with you to ensure that the FDA and CPSC have established 

processes for notification when the FDA takes regulatory action on an OTC product that might warrant 

CPSC reevaluation of its packaging regulations. 

Thank you for the opportunity to speak here today about the importance of safe and effective over-thecounter medicines for children. We look forward to working with you, FDA and other stakeholders as 

this process moves forward. 

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125 

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. 

126 

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:] 

127 


ONE-PAGE SUMMARY 

TESTIMONY OF GIL Y. ROTH 

PHARMA & BIOPHARMA OUTSOURCING ASSOCIATION 

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

BEFORE THE HOUSE ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH 

SEPTEMBER 13, 2017 

CMO/CDMOs play a key role in the American healthcarc system. What do they do, and 

who is PBOA? 

FDA's current OTC Monograph program is outdated and under-resourced. 

The proposed OMUFA bill should help solve those issues, with greater funding, more 

transparency and commitments, and a path to innovations for established ingredients. 

PBOA's members are pleased that the legislation under discussion includes a fee model 

that ret1ects the differential value ofOTC monograph products to CMO/CDMOs. 

We hope that PBOA and CMO/CDMOs will be included in future FDA user fee 

negotiations. 
128 


TESTIMONY OF GIL Y. ROTH 

PRESIDENT 

PHARMA & BIOPHARMA OUTSOURCING ASSOCIATION 

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

BEFORE THE HOUSE ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH 

UNITED STATES HOUSE OF REPRESENTATIVES 

SEPTEMBER 13, 2017 
129 


Mr. Chairman, Mr. Ranking Member, 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 201 7". 

lam Gil Roth, President of the Pharma & Biopharma Outsourcing Association. PBOA is the 

leading trade association for Contract Manufacturing Organizations and Contract Development 

and Manufacturing Organizations (known as CMOs and CDMOs) in the pharma/biopharma 

space. PBOA 'score mission is to advance the regulatory, legislative and general business 

interests of the CMO/CDMO sector. lam here today to express PBOA's support for the recentlyreleased 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 was greatly 

appreciated, and, PBOA strongly believes, resulted in the release of a better OMUF A draft 

deserving of bipartisan support. 

First, you might be wondering what a CMO/CDMO actually is and how these companies 

contribute to the development of drugs, or in this case, over-the-counter drugs. CMO/CDMOs 

are the true experts in manufacturing. Our members provide manufacturing and other services 

that enable drug companies to develop and commercialize medicines. They account for more 

than one-third of all doses dispensed to patients in America, producing innovator drugs and 

generics, small molecules and biologics, pills and injectables, OTC and biosimilars. 

CMO/CDMOs empower their customers to develop and commercialize life-saving, quality, costeffective medicines for patients. I have been involved in the CMO sector since 1999 and have 
130 


witnessed the industry's rapid growth and the key role it plays in the American hcalthcare 

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 OverThe-Counter (OTC) monographs, work that began in the 1970s. In the current fiscal year, the 

FDA allocated $8 million to such efforts, a sum that can yield only minimal dedicated staffing 

and little progress. Industry, the FDA, and Congress agree that the monograph process is 

outdated. Further, 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 innovations to established ingredients is overdue and could benefit marketers 

and manufacturers alike, particularly 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 includes a fee model that reflects the differential value 

ofOTC monograph products to CMO/CDMOs, and that it provides some relief from the facility 
131 


fees proposed to fund OMUFA. And, again, we are very appreciative of this Committee's role in 

ensuring all stakeholder voices were heard as you developed the OMUFA draft. 

We hope that PBOA and the CMO/CDMO businesses it represents will be included in future 

FDA user fee negotiations, particularly ones that are considering contributions from the 

manufacturing sector, in the form of facility fees. And we look forward to continuing to 

participate in the legislative process relating to OMUFA, and to the day where this good 

legislation is signed into law. 
132 

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 longterm 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 overthe-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 

133 

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 

134 

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. 

135 

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. 

136 

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 preparaVerDate Mar 15 2010 11:38 Nov 14, 2018 Jkt 037690 PO 00000 Frm 00140 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X55OTCDRUGSASKOK102218\115X55OTCDRUGSPDFMADE
137 

tion 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 

138 

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:] 

139 


September 13,2017 

The Honorable Michael Burgess, M.D. 

Chainnan, Subcommittee on Health 

Energy and Commerce Committee 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Burgess and Ranking Member Green: 

Colin I. Mackenzie 

Region Head, Americas 

GSK Consumer Healthcare 

184 Liberty Corner Road 

Warren, New Jersey 07950 

colm.i.mackenzie@?gsk s;om 

www.gsk.com 

The Honorable Gene Green 

Ranking Member, Subcommittee on Health 

Energy and Commerce Committee 

2322A Rayburn House Office Building 

Washington, DC 20515 

On bchalfofGSK and our over 15,000 employees in the United States, thank you for holding today's 

hearing entitled "Modernizing FDA's Regulation of Over-the-Counter Drugs" to consider draft 

legislation updating the Over-the-Counter (OTC) Monograph system. 

As you may know, OTC medicines play a vital role in our nation's healthcare system, providing access, 

affordability, empowerment and trust. OTC medicines allow individuals and families to meet their 

everyday healthcare needs, including 96% of U.S. adults reporting that OTC medicines make it easy for 

individuals to care for minor medical ailments and 93% of U.S. adults preferring to treat their minor 

ailments with OTC medicines before seeking professional care. 

At GSK, our mission is simple. We want to help people do more, feel better, and live longer. GSK 

Consumer Healthcare embodies the company's overall mission by being the largest manufacturer 

globally for OTC products reaching over one billion people and assists in the ability for Americans to 

address these routine healthcare challenges. Our brands are organized into five categories: Pain Relief, 

Respiratory, Oral Health, Nutrition/Gastro Intestinal, and Skin Health. 

OTC Monograph Reform will help foster the growth and availability of these vital medicines. GSK 

believes that policy reforms could make the system even more flexible, responsive, and accommodating 

to innovation. Ultimately, this will broaden choice for consumers so they can better meet their individual 

needs for OTC medicines. 

We thank you for your collective leadership in holding today's hearing, and we hope that the 

Subcommittee moves forward with consideration of this legislation. Ultimately, modernizing the OTC 

Monograph system will ensure that FDA and industry can update products with safe, effective 

ingredients in the market today, and so that FDA has the resources to approve safety labeling changes 

and innovation in the OTC market. 

lfGSK can ever be of assistance to you or your staff, please do not hesitate to contact Michael Calvo, 

Manager, Federal Government Relations, at (202) 715-1041 or via email at michael.j.calvo@gsk.com. 

Sincerely, 

Colin Mackenzie 
140 

[Dr. Woodcock did not answer submitted questions for the record 

by the time of printing.] 


GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Janet Woodcock 

Director 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

(:ongre55 of tbe Wntteb $tate5 

Jt)ou!le o! i\eprc!lentntibe!l 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE 0FFJCE BuiLDJNG 

WASHINGTON, DC 20515-6115 

October 19, 2017 

Center for Drug Evaluation and Research 

Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Dr. Woodcock: 

Thank you for appearing before the Committee on Energy and Commerce on September 13, 

2017, to testilY at the hearing entitled "Modernizing FDA's Regulation of Over-the-Counter Drugs." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on November 2, 2017. Your responses should be mailed to Jay 

Gulshen, Legislative Clerk, Committee on Enerb'Y and Commerce, 2125 Rayburn House Office Building, 

Washington, DC 20515 and e-mailed in Word formal to jay.gulshen@maiLhouse.gov, 

Thank you again for your time and effort pn:paring and delivering testimony before the 

Committee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 
141 


Questions for the Record from Ranking Member Ft·ank Pallone 

House Committee on Energy and Commerce 

Subcommittee on Health 

"Modernizing FDA's Regulation of Over-the-Counter Drugs" 

September 13,2017 

Dr.JanetVVoodcock,M.D. 

Director, Center for Drug Evaluation and Research 

Food and Drug Administration 

FDA Engagement 

There was considerable discussion at the hearing regarding when FDA first identified over-the· 

counter (OTC) drug monograph reform as a priority for the agency, and what steps the agency 

has taken to inform Congress and the public about the need for monograph reform. I would like 

to request further background regarding the agency's prioritization of monograph reform as a 

policy issue and what steps the agency has taken to effectuate monograph reform. 

Ql: Will you please provide more detailed information regarding how the FDA's 

thinking on the OTC drug monograph has evolved over the years, and when the agency 

first identified the need for OTC monograph reform? 

Q2; 1 understand that the agency held public meetings in 2014 and 20 16; as we! I as a 

recent webinar. Will you please further outline the outreach FDA conducted around OTC 

monograph reform, including the time!inc, the types of outreach conducted, and what 

stakeholders the agency engaged? 

Confidential Meetings 

Congress acted back in 2014 to pass the Sunscreen Innovation Act {SIA) with the goal in mind 

of speeding access to over-the-counter sunscreen ingredients. Despite this reform effort, I 

understand that m.cmbcrs of the PASS Coalition, which represents a wide range of stakeholders 

interested in the approval of new sunscreen ingredients, are seeking additional reforms as a part 

of the over-the-counter monograph reform process. 

Ql: How many meetings has FDA held with members of the PASS Coalition or other 

sunscreen manufacutrers since the passage of SIA? Can you explain why sponsors 

of sunscreen ingredients cannot meet with FDA on a confidential basis today? 

Does the agency suppott allowing for confidential meetings for pending sunscreen 

ingredients? 

Q2; Over-the-counter monograph reform also contemplates certain meeting 

management goals for meetings between over-the-counter sponsors and FDA. The 

PASS Coalition has proposed a 90-day timeline for meetings related to pending 

sunscreen ingredients. Would FDA be able to meet this timeline for confidential 
142 


meetings between sunscreen ingredient manufacturers and the agency'! If not, 

please explain why. 

Q3: Would FDA need any additional resources to be able to meet the requirements 

and time frame outlined in the OTC Monograph User Fee Act for confidential 

meetings for sunscreen ingredients? 

2 
143 


GREG WALDEN, OREGON 

CHAfRMAN 

Mr. Scott Melville 

President and CEO 

ONE HUNDRED FIFrEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ctrongress of tbe Wniteb $tates 

;t.lousc o! l'cprc~entatilles 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OrncE BuiLDING 

WASIIINGTON, DC 20515-6115 

M~jM•W 

MJnonty (202)22f>-3fl<11 

October 19,2017 

Consumer Healthcare Products Association 

1625 Eye Street, N.W., Suite 600 

Washington, DC 20006 

Dear Mr. Melville: 

Thank you for appearing before the Committee on Energy and Commerce on September 13, 

2017, to testify at the hearing entitled "Modernizing FDA's Regulation of Over-the-Counter Drugs." 

Pursuant to the Rules of the Committee on Energy and Conm1erce, the hearing record remains 

open for ten business days to pennit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

hold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on November 2, 2017. Your responses should be mailed to Jay 

Gulshen, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office Building, 

Washington, DC 20515 and e-mailed in Word fonnat to jay.gulshen@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attacluncnl 
144 


House hearing record responses 

Exclusivity: Q 1: As you know, in determining appropriate incentives to generate human data in 

the pediatric space, Congress deemed six months of exclusivity to be sufficient. In considering 

how exclusivity would delay patient access to innovative OTC drug formulations, what is the 

public health justification for awarding 24 months of exclusivity? 

A: Exclusivity for OTC monograph drug innovations will provide Americans with a wider range 

of choices and greater competition. For instance, this incentive will encourage development of 

easier to take or apply dosage forms such as a film you could swallow without water or a spray 

that provides easier coverage or application compared to an existing cream. New technology for 

drug delivery has the potential to improve efficacy and safety of OTC products. It provides a 

meaningful path to develop combination therapies where appropriate, which would reduce the 

need to use multiple medicines at the same time or may offer other dosing advantages, including 

for safety. It will incentivize adding ingredients with an established track record of safety and 

effectiveness to a monograph such as ingredients with documented safe experience in other parts 

of the world. Today, that is very challenging. New indications haven't been added to the 

monographs in decades. An incentive will encourage clinical research to identify new 

indications for existing ingredients. 

Innovations such as these require significant investment in generating human data. Innovating 

companies need an incentive to invest in that data before it can be immediately used by their 

competitors. For a product launch to succeed, it requires a sufficient new benefit to breakthrough to the retail shelf. The fact is many launches do not succeed in the marketplace, so to 

take a business risk, the product needs time on the market. This is because developing consumer 

awareness and acceptance takes time. Building acceptance so a retailer will keep the product on 

the shelf requires more than a year. Further, the more successful a new product is, the more 

incentive retailers have to launch their store brand version. For instance, a retailer would 

typically begin store brand planning roughly 6 months before a national brand even launches, 

and set their more precise store brand strategy a few months after the national brand is on shelf. 

That limits the amount of time the innovator has to recoup at least some oftheir R&D investment 

and expenses needed to raise awareness. Finally, new products in monographs will enter 

established categories they are competing with existing options. Consumers have pre-existing 

price expectations, as they shopped the category before. For instance, an average American 

family buys an OTC pain reliever 6 times a year. Ultimately, the individual can see the price of 

the product on the shelf and make a conscious decision on whether the innovative product 

provides sufficient value above the other choices. 

In contrast, 6 month pediatric exclusivity was intended to encourage research in unapproved or 

new pediatric uses of an active ingredient in response to a written request from FDA. The 6 

months is added to existing exclusivity for an active moiety. 

Need for reform: Q 1: Will you discuss why members of your association feel that reform is 

necessary? 
145 


A: Our member companies believe reform is needed to increase the efficiency and 

responsiveness necessary to protect consumer health and to create a pathway for innovation that 

accommodates consumer needs. While the existing OTC Monograph system is a smart, balanced 

framework for regulating OTC medicines containing ingredients with a proven history of safe 

use and efficacy, it relies on notice and comment rulemaking. Rulemaking has become an 

increasingly slow and unresponsive administrative process across government. As a result, the 

Monograph system has become cumbersome. Today, it can take several years or more to 

formally update product labels with new safety information through rulemaking, approve new 

ingredients for monograph eligibility, or make other important changes for consumers. 

Moreover, the current system does not provide a mechanism for innovation. 

Q2: Although some have suggested that user fees should not be necessary for OTC reform as the 

intention is to streamline the monograph process to make it more agile and timely, we heard very 

clearly from Dr. Woodcock about the critical need for additional resources for the OTC 

monograph program. CHPA has been very clear in the association's support for user fees. Will 

you further discuss why the members of your association agree with the need for user fees to 

support monograph reform? 

A: CHPA member companies acknowledge that a reformed and improved monograph system 

requires dedicated resources to operate efficiently. For instance, the discussion draft will 

provide: 

Efficiency: administrative orders will replace notice and comment rulemaking. 

- There will be an accelerated pathway for safety labeling changes. 

- There will be a meaningful innovation pathway, including exclusivity for essential human data. 

- FDA will annual post a projection to preview upcoming monograph work over the next 3 

years, allowing better planning and prioritization. 

- Sponsors will have the opportunity to scheduled closed meetings to discuss research and 

testing plans. 

- As with other user fee programs, FDA, through the Administration, has already transmitted a 

goals letter to Congress outlining items on which they will report and goals they will seek to 

reach during the 5 years of authorization of the program. 

These meaningful improvements will lag, and the goals not be met, without dedicated resources 

provided through user fees. While we would certainly support reform without paying fees, 

precedents in other areas suggest this is simply not likely. Further, even if significantly 

increased appropriations could be provided in a given year, shifting priorities and history suggest 

that would be too unpredictable year on year. Multi-year dedicated resources are necessary to 

meet tJ:te goals of reform. 

It is also important to note that all firms who manufacture, process, and market under the OTC 

Monograph system gain value from it. This system does not require pre-market approval, is 

available to national brand firms, private label manufacturers, retailers under their own brand 

names, packagers, and contract manufacturers. In addition, under the discussion draft, 

companies who choose to innovate with products that require changes in Monograph conditions 

would pay an additional submission fee. 
146 


GREG WALDEN, OREGON 

CHAIRMAN 

Ms. Kirsten Moore 

Project Director 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR .. NEW JERSEY 

RANKING MEMBER 

<trongre55 of tbe 'mlntteb ~tates 

J!)ousr of i'\eptt!l'cntatilles 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE Bu!LOING 

WASHINGTON, DC 20515-6115 Mnjor!ty (l02)225<<'9n 

Minority i.?OZ)225--3\l-11 

October 19, 2017 

The Pew Charitable Trusts 

90 l E Street, N.W. 

Washington, DC 20004 

Dc'llr Ms. Moore: 

Thank you for appearing before the Committee on Energy and Commerce on September 13, 

2017, to testify at the hearing entitled "Modernizing FDA's Regulatioll of Over-the-Counter Drugs." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to pennit Members to submit additional questions for the record, which are 

attached. The fommt of your responses to these questions should be as follows: (l) the name of the 

Member whose question you are addressing, (2} the complete text of the question you are addressing in 

bold, alld (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on November 2, 20!7. Your responses should be mailed to Jay 

Gulshen, Legislative Clerk, Committee on Energy and Conunerce, 2125 Rayburn House Office Building, 

Washington, DC 20515 and eMrnailed in Word format tojay.gulshen@maiLhouse.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee. 

1vbc ' '. Buq, , !.D. fl') 

Cha111an 

Subcommittee 

~~ on Health 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attaclunent 
147 


Responses from The Pew Charitable Trusts to 

Questions for the Record from Ranking Member Frank Pallone 

House Committee on Energy and Commerce 

Subcommittee on Health 

"Modernizing FDA's Regulation of Over-the-Counter Drugs" 

September 13, 2017 

Improving Safetv in OTC Products 

In your testimony, you mentioned several examples in which the FDA process for 

addressing safety issues, such as through updating labeling or inclusion of warnings, was 

far faster for prescription drugs compared to over-the-counter drugs. One such example 

was for the liver toxicity associated with the use of over-the-counter acetaminophen 

products. In this instance, FDA was able to require the inclusion of a new boxed warning 

for all prescription acetaminophen products within two years, whereas it took the agency 

seven years to update the labeling for over-the-counter products. 

QI: Are there other instances where FDA has been able to act on safety issues 

more quickly in the prescription drug space versus the over-the-counter 

space? How will transitioning to a new administrative order procedure, as 

contemplated in the discussion draft, help to hasten label changes compared 

to the current system? 

One example- in addition to the acetaminophen, nonsteroidal anti-inflammatory drug, and 

codeine examples in Pew's testimony is hydroquinone. This drug has been approved as a 

prescription drug for the topical treatment of moderate to severe melasma (skin discoloration) of 

the face. The prescription drug label lists warnings about potential carcinogenicity, birth defects, 

and ochronosis (skin darkening). 

Hydroquinone is also marketed over the counter as a skin bleaching agent, which is a much 

broader usc than the indication for which the prescription drug is approved. There is no 

requirement that the OTC drug bear the same labeling as the prescription drug, including product 

warnings. FDA published a tentative final monograph (TFM) affirming hydroquinone's GRASE 

("Generally Recognized as Safe and Effective") status in 1982. Subsequently, new evidence 

emerged linking hydroquinone to serious side effects such as cancer and ochronosis. In 2006, 

FDA proposed a new rule that would withdraw the TFM and classify the compound as not 

GRAS E. FDA has been unable to finalize this rule and hydroquinone continues to be marketed 

as an OTC. 

When changes need to be made to prescription drug labeling, FDA has the authority, and the 

resources, to work with drug sponsors to make those changes. In contrast, at least three steps are 

needed to create or update a monograph (see Figure I, below). All proposed changes to 

monographs are reviewed by FDA and the Department of Health and Human Services, and often 

the White House Office of Management and Budget, which estimates the cost and benefit of the 

change to the economy and consumers. FDA also receives and must respond to public comment 

throughout the monograph revision process. The additional review steps for monographs add 
148 


considerable time, and they risk prioritizing economic considerations over consumer health and 

safety. There is no deadline by which monographs must be finalized, and several have been 

under review for decades. 

FIGURE 1 

The Monograph Process 

Announcement 

Final 

The first step is often to issue an advance notice of proposed rulemaking. This tells the public, industry, and agencies involved in the 

rule-making process that FDA is planning to change an existing 

monograph or create a new one. This notice is not required, but FDA 

may issue it to invite comments and information about the safety and 

efficacy of the ingredients in a particular product category 

The ~ntatiVe fin~! h1onol)raph isa pr()p~e:C rule outlinlng.the detaifs 

of the •recipe"Jor the pr¥uct cat ciJ.ange.that is bei~gs~g~ested to an e-l<,ist\ng · . . . . . .. · .•. . . .. . . potentlal ingredients .it t,X>ns{4ers to be Category I, ll, orlll: al<:lng witn its 

reasoning. ~he tentative fiAalr:n~nogr~ph is. made availab~ for 

PUblic cofT\"lent .Thi$ stej:) can i:>ecur multiple timel>; as n~w 

·· sc~ntif!(; information er:nerge$ or prOduct usage change~· 

Once the comments have been reviewed and debated, FDA 

publishes a final rule with its conclusions, enabling manufacturers to 

change their products' labeling or ingredients. However, a final 

monograph can be reopened, which begins the process anew. 

Source: Food and Drug Administration 

Complicating the burdensome monograph process are significant resource challenges: FDA has 

fewer than 30 full-time employees working with a budget of less than $10 million annually to 

regulate the $32 billion OTC industry. 1 Most of the agency's resources for over-the-counter 

drug products have been dedicated to fulfilling mandates from Congress (regarding sunscreens) 

and the courts (antibacterial soaps), constraining its ability to prioritize emerging public health 

needs. 

1 Donal Parks, "User Fee Considerations in the Context of Over-the-Counter Monograph Drugs" (presentation at 

FDA public meeting: Over-the-Counter Monograph User Fees, Silver Spring, Maryland, June 10, 2016), 

http://www.fda.gov/downloads/Drugs/UCM510584.pdf. 

2 
149 


The proposed legislation would allow FDA to make changes to monographs outside of the 

notice-and-comment rulemaking process, and would provide the flexibility and resources to 

respond quickly to safety and efficacy concerns. 

Q2: Could you also elaborate on the benefits of requiring firms to submit all 

positive and negative information in their possession would put the OTC 

process on par with prescription drugs in terms of safety and efficiency? 

As a part of a new drug application (NDA), sponsors-of either prescription or OTC drugsmust submit to FDA all data gathered during animal studies and clinical trials. This requirement 

ensures that an NDA sponsor cannot cherry pick the data that it shares with FDA. 

However, under the current system, those OTC drug manufacturers who are not required to 

submit NDA applications are not required to provide the agency with all available data. This 

means that FDA must perform its own review of the literature for publicly-available data and, in 

some cases commission new research, requiring the use of agency resources, and potentially 

causing the delay of agency action in the wake of a new safety concerns. 

Without access to all of the data, FDA is limited in its ability to evaluate the safety and 

effectiveness of these products which are used regularly by millions of Americans 2 

2 Deloitte Center for Health Solutions, "2012 Survey of Health Care Consumers: Key findings, strategic 

implications," https:/ /www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc20 12 -su rvey-of-u s-consu mers-health-ca re. pdf. 

3 
150 


GREG WALDEN, OREGON 

CHAIRMAN 

Mr. Michael Werner 

Partner 

Holland & Knight 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

(!J:ongre55 of tbe Wniteb f$tate5 ~ousr of l\epnsentatibc!l 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority{202t:?l5 

Mu1onty 1202)22536'11 

October 19,2017 

800 17th Street N.W., Suite 1100 

Washington, DC 20006 

Dear Mr. Wemer: 

Thank you for appearing before the Conunittee on Energy and Commerce on September 13, 

20 !7, to testify at the hearing entitled "Modernizing FDA's Regulation of Over-the-Counter Drugs." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to pem1it Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your m1swer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on November 2, 2017. Your responses should be mailed to Jay 

Gulshen, Legislative Clerk, Conunittee on Energy and Commerce, 2125 Raybum House Office Building, 

Washington, DC 20515 and e-mailed in Word format to jay.gulshen@maiLhouse.gov. 

Thank you again .fOr your time and effort preparing and delivering testimony before the 

Con:unittee. 

Subcommittee on Health 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
151 


Questions for the Record from Ranking Member Frank Pallone 

House Committee on Energy and Commerce 

Subcommittee on Health 

"Modernizing FDA's Regulation of Over-the-Counter Drugs" 

September 13, 2017 

Mr. Michael Werner 

Partner, Holland and Knight 

on behalf of the Public Access to Sunscreens (PASS) Coalition 

Confidential Meetings 

In your testimony you noted that Congress acted back in 2014 to pass the Sunscreen Innovation 

Act with the goal in mind of speeding access to over-the-counter sunscreen ingredients. Despite 

this reform effort, I understand that members of the PASS Coalition, which represents a wide 

range of stakeholders interested in the approval of new sunscreen ingredients, arc seeking 

additional reforms as a part of the over-the-counter monograph reform process. In particular, I 

would like to better understand the additional benefits the PASS Coalition is seeking through 

confidential meetings. 

Q 1: You note in your testimony, that over-the-counter reform should authorize FDA 

to meet on a confidential basis with sunscreen ingredient sponsors. Can you 

explain to this Committee why sponsors of sunscreen ingredients cannot meet 

with FDA on a confidential basis today? Further, can you discuss why 

confidential meetings are so critical to your members? 

Response: Currently, FDA's view is that all meetings under the current time and 

extend application (TEA) process under the OTC drug monograph system should 

be public. However, information submitted and considered during this process, 

especially for innovators in the OTC space, may be proprietary and therefore 

inappropriate for public disclosure. Although such data is "confidential until 

publication of a proposed monograph," current regulations still require "published 

and unpublished data and information pertinent to a designated category of OTC 

drugs" submitted to an FDA advisory panel to be eventually released to the 

public, regardless of where that product is in the development process (21 CFR 

330.1 O(a)(2)). This is problematic because sponsors have to be careful in what is 

submitted to FDA and comments that become part of the record (either by FDA in 

providing feedback or by the sponsor) must not include confidential business 

information. 

Thus, it is important that sponsors of sunscreen ingredients are able to participate 

in open discussions with FDA that potentially include the usc of confidential 

commercial information or trade secret~ to ensure the agency has the necessary 

data to make a full and informed decision on the safety and effectiveness of 

sunscreen ingredients. In addition, confidential meetings would allow FDA to 
152 

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have flexibility to consider validated alternative testing procedures in support of a 

determination of general recognition of safety and effectiveness outside of what 

the agency included in its final guidance on safety and effectiveness data. This is 

particularly important since FDA's sunscreen data and testing guidance 

recommends use of tests never before used with sunscreen ingredients. We 

anticipate that sponsors will need to engage in detailed discussions with FDA 

about their clinical protocols designed to meet these new standards. We do want 

to clarify that we believe such non-public meetings do not have to follow New 

Drug Application (NDA) formats. 

Q2: Over-the-counter monograph reform also contemplates certain meeting 

management goals certain meetings between over-the-counter sponsors and FDA. 

Recognizing that the ability of the agency to meet these meeting management 

goals requires resources, do your members support providing FDA with the 

resources necessary to meeting any specified meeting goal timelines for sunscreen 

ingredients? 

Response: Yes, from its inception, the PASS Coalition's mission has included 

working to ensure the FDA has the resources it needs to review sunscreen 

ingredients. The PASS Coalition supports the current proposals to bolster FDA 

resources for OTC product review including the newly proposed user fee 

progran1. The Coalition understands that nearly 20 full time employees (FTEs) are 

required to review a single OTC monograph, and that the agency requires 

additional resources to review the wide range of products that should and need to 

be reviewed in addition to crucial products incorporating OTC sunscreen 

ingredients. 

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