U.S. GOVERNMENT PUBLISHING OFFICE

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REAUTHORIZATION OF ANIMAL DRUG USER FEES: 

ADUFA AND AGDUFA 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

MARCH 14, 2018 

Serial No. 115–109 

( 

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 

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 

JEFF DUNCAN, South Carolina 

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 

MARSHA BLACKBURN, Tennessee 

ROBERT E. LATTA, Ohio 

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 .......................................................................................... 3 

Hon. G.K. Butterfield, a Representative in Congress from the State of North 

Carolina, opening statement ............................................................................... 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 7 

Prepared statement .......................................................................................... 8 

WITNESSES

Steven Solomon, D.V.M., Director, Center for Veterinary Medicine, Food and 

Drug Administration, Department of Health and Human Services ................ 9 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ...................................................................... 103 

Rachel Cumberbatch, D.V.M., Director, Regulatory Affairs, Animal Drugs, 

Animal Health Institute ...................................................................................... 44 

Prepared statement .......................................................................................... 46 

Answers to submitted questions ...................................................................... 115 

Bill Zollers, Ph.D., Chair, Generic Animal Drug Alliance .................................... 52 

Prepared statement .......................................................................................... 54 

Answers to submitted questions ...................................................................... 122 

Michael J. Topper, D.V.M., Ph.D., President, American Veterinary Medical 

Association ............................................................................................................ 58 

Prepared statement .......................................................................................... 60 

Answers to submitted questions ...................................................................... 127 

SUBMITTED MATERIAL

Discussion Draft, H.R. lll, the Animal Drug and Animal Generic Drug 

User Fee Amendments of 2018 ........................................................................... 75 

Letter of February 26, 2018, from Agricultural Retailers Association, et al., 

to Hon. Lamar Alexander, U.S. Senate, et al., submitted by Mr. Burgess ..... 101 

(1) 

REAUTHORIZATION OF ANIMAL DRUG USER 

FEES: ADUFA AND AGDUFA 

WEDNESDAY, MARCH 14, 2018 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:18 a.m., in room 

2322, Rayburn House Office Building, Hon. Michael C. Burgess 

(chairman of the subcommittee) presiding. 

Members present: Representatives Burgess, Guthrie, Upton, 

Shimkus, Blackburn, Latta, Lance, Griffith, Bilirakis, Bucshon, 

Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), Green, 

Schakowsky, Butterfield, Schrader, Eshoo, DeGette, and Pallone 

(ex officio). 

Staff present: Zack Dareshori, Legislative Clerk, Health; Margaret Tucker Fogarty, Staff Assistant; Ed Kim, Policy Coordinator, 

Health; Milly Lothian, Press Assistant and Digital Coordinator; 

Jennifer Sherman, Press Secretary; Danielle Steele, Counsel, 

Health; Austin Stonebraker, Press Assistant; Hamlin Wade, Special Advisor for External Affairs; Jacquelyn Bolen, Minority Professional Staff Member; Jeff Carroll, Minority Staff Director; 

Samantha Satchell, Minority Policy Analyst; Andrew Souvall, Minority Director of Communications; Kimberlee Trzeciak, Minority 

Senior Health Policy Advisor; and C.J. Young, Minority Press Secretary. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I now call the subcommittee to order and recognize 

myself 5 minutes for the purpose of an opening statement. 

And the Chair would note that today’s hearing marks the Health 

Subcommittee’s fourth hearing to consider reauthorization of vital 

user fee programs at the United States Food and Drug Administration. 

While the bulk of these programs were reauthorized last year 

through the FDA Reauthorization Act, our focus today on reauthorizing the Animal Drug User Fee Act and the Animal Generic Drug 

User Fee Act is equally important for the millions of American 

families and businesses that rely on the critical function of the 

Food and Drug Administration’s Center for Veterinary Medicine. 

With this in mind, I expect us to reach a shared commitment to 

complete our work while reauthorizing these last set of user fees 

2 

and get them to the House floor well in advance of the expiration 

date of September 30 of this year. 

We did so last year with the FDA user fee reauthorization, and 

there is no reason we cannot do so again here. 

This morning, we will have two panels of witnesses before the 

subcommittee. First, I do want to welcome Dr. Steven Solomon, the 

Director for the Center of Veterinary Medicine at the Food and 

Drug Administration. 

Next, representatives from the Animal Health Institute, the Generic Animal Drug Alliance, and American Veterinary Medical Association will share their insights on the current state of the 

United States animal drug market and the significance of reauthorizing the Animal Drug User Fee Agreement and the Animal Generic Drug User Fee Agreement. 

Last month, the Committee on Energy and Commerce and the 

Senate Health, Education, Labor, and Pensions Committee released 

the Animal Drug User Fee Reauthorization Act of 2018, a bipartisan discussion draft to renew the FDA’s authority to collect user 

fees from the manufacturers of brand-name and generic animal 

drugs for another 5 years. 

Among other things, these user fees help the Food and Drug Administration’s Center for Veterinary Medicine in their timely review of animal drug applications, market surveillance of animal 

drug safety and efficacy, and the quality assurance measures for 

animal food as well as food products derived from animals. 

From pet owners and veterinarians to farmers and animal food 

producers, updating these user fee agreements is essential in ensuring that animal drugs are safe and effective for farm animals 

and our pets, while keeping our food supply safe. 

Reauthorizing these agreements also includes the new commitment between the FDA and industry on performance goals and procedures. 

This will be the fourth authorization for the Animal Drug User 

Fee Agreement since its launch in 2004, and we have seen it reviewed several times. 

Under the proposed agreement, funding for the program will increase by approximately $6 million annually. All submissions must 

be electronic. The Center for Veterinary Medicine is required to 

begin implementation of the U.S.-E.U. Good Manufacturing Practice Mutual Recognition Agreement for inspections of pharmaceutical manufacturing facilities, and review time for drug combinations for use in feed is shortened to 60 days if no additional 

data is required. 

The Animal Generic Drug User Fee Agreement is going through 

its third authorization since 2008. The Center for Veterinary Medicine has met or exceeded nearly all of the performance goals in 

each 5-year authorization. 

In addition to increasing funding by approximately $10 million 

annually, the proposed agreement would shorten the review time 

for abbreviated new animal drug applications to 60 days and require all approved drugs to include these applications on the labeling. 

Finally, I would like to commend our fellow Health Subcommittee member, Representative Mark Mullin from Oklahoma, 

3 

for championing the House Animal Drug User Fee Agreement and 

Animal Generic Drug User Fee Agreement reauthorizations. Thank 

you for your hard work on this important measure. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Today’s hearing marks the Health Subcommittee’s fourth hearing to consider the 

reauthorization of vital user fee programs at the U.S. Food and Drug Administration (FDA). While the bulk of these programs were reauthorized last year through 

the FDA Reauthorization Act of 2017, our focus today on reauthorizing the Animal 

Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) 

is equally important for the millions of American families and businesses that rely 

on the critical functions of FDA’s Center for Veterinary Medicine. With this in mind, 

I expect us to reach a shared commitment to complete our work reauthorizing these 

last set of user fees and get them to the House floor well in advance of their expiration on September 30, 2018. We did it last year, so there is no reason we cannot 

do it again here. 

This morning, we have two panels of witnesses before our subcommittee. First, 

I would like to welcome Dr. Steven Solomon, Director of the Center for Veterinary 

Medicine at FDA. Next, representatives from the Animal Health Institute, Generic 

Animal Drug Alliance, and American Veterinary Medical Association will share 

their insights on the current state of U.S. animal drug market and the significance 

of reauthorizing ADUFA and AGDUFA. 

Last month, the Committee on Energy and Commerce and the Senate Health, 

Education, Labor, and Pensions Committee released the Animal Drug User Fee Reauthorization Act of 2018, a bipartisan discussion draft to renew FDA’s authority 

to collect user fees from the manufacturers of brand-name and generic animal drugs 

for another 5 years. Among other things, these user fees help fund FDA’s Center 

for Veterinary Medicine’s timely review of animal drug applications, market surveillance of animal drugs’ safety and efficacy, and quality assurance measures for animal food as well as food products derived from animals. From pet owners and veterinarians to farmers and animal food producers, updating these user fee agreements 

are essential in ensuring animal drugs are safe and effective for farm animals and 

our pets, while keeping our food supply safe. Reauthorizing these agreements also 

includes the new commitments between FDA and industry on performance goals 

and procedures. 

This will be ADUFA’s fourth authorization, and since its launch in 2004, we have 

seen review times reduced significantly. Under the proposed agreement, funding for 

the program would increase by approximately $6 million annually, all submissions 

must be electronic, the Center for Veterinary Medicine is required to begin implementation of the U.S.-E.U. good manufacturing practice Mutual Recognition Agreement for inspections of pharmaceutical manufacturing facilities, and review time for 

drug combinations for use in feed is shortened to 60 days when no additional data 

is required. 

AGDUFA is going through its third authorization since 2008. The Center for Veterinary Medicine has met or exceeded nearly all performance goals in each 5-year 

authorization period. In addition to increasing funding by approximately $10 million 

annually, the proposed agreement would shorten the review time for abbreviated 

new animal drug applications to 60 days and require all approved drugs to include 

these applications on the labeling. 

Finally, I would like to commend our fellow Health Subcommittee member, Representative Mullin, for championing the House ADUFA/AGDUFA Reauthorization 

bill. Thank you for all your hard work on this important measure. 

I again want to welcome all of our witnesses and thank you for being here. I look 

forward to your testimony. 

I yield the balance of my time to Ms. Blackburn of Tennessee, for a statement. 

Mr. BURGESS. I again want to welcome all of our witnesses for 

being here and look forward to your testimony, and I’ll yield to 

Mrs. Blackburn of Tennessee. 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and to our witnesses on each panel, thank you so much for being here. And I am 

so grateful for the chairman’s leadership and the fact that we are 

approaching this in a bipartisan, bicameral manner. 

4 

We know that what you do is important. We are pleased to see 

the amount of progress that is made in animal drugs, whether they 

are for our pets or for livestock that are in the food supply chain. 

We are wanting to focus and get some attention on the innovation side and how we speed the approval process. So we will look 

forward to addressing those issues with you today. 

I yield back. 

Mr. BURGESS. Gentlelady yields back. Chair thanks the 

gentlelady. 

The Chair recognizes the gentleman from North Carolina as the 

substitute ranking member of the subcommittee, and you’re recognized for 5 minutes for the purpose of an opening statement. 

OPENING STATEMENT OF HON. G.K. BUTTERFIELD, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NORTH 

CAROLINA 

Mr. BUTTERFIELD. Thank you, Mr. Chairman. I’ll take it any way 

I can get it this morning. 

[Laughter.] 

Thank you, Mr. Chairman. To the vice chair, Mrs. Blackburn, 

thank you so very much for your opening comments. 

You’re right, I am standing in for the ranking member this morning, Gene Green, who will be here momentarily, I am told. 

Thank you to the Director for your willingness to come forward 

and to share your testimony with us today. This hearing, Mr. 

Chairman, is so very important and so I associate my comments 

with the gentlelady from Tennessee that this is bipartisan, bicameral, and these are two pieces of legislation that we must move 

and do it very quickly. 

The Animal Drug User Fee Act is very important. The Animal 

Generic Drug User Fee Act is very important to all of us on this 

committee. 

These user fee agreements are important to millions of Americans, including those in my home State of North Carolina who live 

with companion animals every day. 

They are also important to the agriculture community. We have 

many stakeholders in this legislation. Some of you may not be 

aware that North Carolina, my State, is the second largest pork 

producer, the second largest turkey producer, and the third largest 

poultry producer in the entire country. 

Our agriculture community and family farms are essential to 

feeding our Nation, and they depend on medicines to keep their 

animals very healthy. 

Mr. Chairman, I support reauthorization of these programs. I 

look forward to hearing about the innovation that’s taking place in 

the animal drugs and how we can support the health of animals 

and human beings, as well. 

Thank you for the time. I yield back. 

Mr. BURGESS. Gentleman yields back. The Chair thanks the gentleman. 

Chair would now like to recognize the gentleman from Oregon, 

chairman of the full committee, Mr. Walden, 5 minutes. 

5 

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

Mr. WALDEN. Thank you very much, Mr. Chairman. Thanks for 

holding this hearing and good morning to everyone. We look forward to yet another ‘‘UFA’’ hearing. 

We have a history of producing bipartisan user fee reauthorizations, most recently as last year, and so I look forward to continuing in those efforts with this one. 

Whether it be livestock or house pets, the owners of these animals rely on the Food and Drug Administration to ensure the 

availability of safe and effective medical products to keep their animals healthy. 

Through the Center for Veterinary Medicine, FDA evaluates new 

drugs to determine if the safety and efficacy of those treatments 

work for their stated use. 

In the case of livestock, CVM must also ensure the drug will not 

impact the food supply and not harm the environment or the 

health of the livestock producer who administers it. 

But the hard work of developing and manufacturing these drugs 

is done by the animal drug industry, and these companies face 

unique challenges that need to be considered, including R&D processes that involve developing and manufacturing drugs for different 

species of animals with different physiologies. 

So, given the success of the human drug user fee programs in expediting approval of treatments by bolstering resources for the 

agency, the FDA and the animal drug industry came together to 

propose the animal drug user fee programs. 

These programs have succeeded in dramatically reducing review 

times by providing the FDA with much-needed additional resources. So it is a win-win scenario where everyone benefits, including farmers, pet owners, and veterinarians. 

Today, we are considering the reauthorization of those programs—the Animal Drug User Fee Act and the Animal Generic 

Drug User Fee Act—both of which will expire at the end of the fiscal year. 

So it is critical that these programs are passed and signed into 

law well before the end of September. Before each reauthorization, 

as set forward in statute, FDA meets with the animal drug industry to reevaluate specific goals for review time lines, solicits comments from stakeholders and members of the public to consider additional enhancements, then the final agreement is delivered to 

Congress for the program to be reauthorized. 

So for this cycle, that process began in May of 2016, and after 

numerous public meetings, the final negotiated recommendations 

were sent to Congress in January of this year. This year’s agreements include increased collections from industry as well as more 

aggressive performance goals for the FDA. They also include several process improvements and other enhancements. We look forward to hearing more about these agreements from our witnesses 

today. 

Encouraging innovation is a top priority of this committee, and 

we want to take this opportunity to examine the animal drug approval process to ensure the incentives are in place to encourage 

6 

innovative treatments to be developed and for generic animal drugs 

to be made available. 

And we don’t often think of the FDA when it comes to animal 

drugs, sadly, but these programs are critical and are important to 

pet owners of America and our farmers and ranchers that we rely 

on to produce food. 

And so we appreciate the witness today. We are actually going 

to get the wisdom of Solomon today, apparently. So we do appreciate that. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Good morning, everyone, and thank you for joining us for yet another ‘‘UFA’’ hearing! We have a history of producing bipartisan user fee reauthorizations, most recently as last year, and I look forward to continuing those efforts today. 

Whether it be livestock or house pets, the owners of these animals rely on the 

Food and Drug Administration (FDA) to ensure the availability of safe and effective 

medical products to keep their animals healthy. Through the Center for Veterinary 

Medicine, FDA evaluates new drugs to determine the safety and efficacy of those 

treatments for their stated use. In the case of livestock, CVM must also ensure that 

the drug will not impact the food supply and not harm the environment or the 

health of the livestock producer who administers it. 

But the hard work of developing and manufacturing these drugs is done by the 

animal drug industry. And these companies face unique challenges that need to be 

considered-including an R&D process that involves developing and manufacturing 

drugs for different species of animals with different physiologies. 

Given the success of the human drug user fee programs in expediting approval 

of treatments by bolstering resources for the agency, the FDA and the animal drug 

industry came together to propose the animal drug user fee programs. These programs have succeeded in dramatically reducing review times by providing FDA with 

much needed additional resources. It’s a win-win scenario where everyone benefitsincluding farmers, pet owners, and veterinarians. 

Today we are considering the reauthorization of those programs-the Animal Drug 

User Fee Act and the Animal Generic Drug User Fee Act-both of which expire at 

the end of this fiscal year. It is critically important that these programs are passed 

and signed into law well before the end of September. 

Before each reauthorization, as set forward in statute, FDA meets with the animal drug industry to reevaluate specific goals for review timelines and solicits comments from stakeholders and members of the public to consider additional enhancements. Then the final agreement is delivered to Congress for the program to be reauthorized. 

For this cycle, that process began in May of 2016. After numerous public meetings, the final negotiated recommendations were sent to Congress in January of this 

year. This year’s agreements include increased collections from industry as well as 

more aggressive performance goals for FDA. They also include several process improvements and other enhancements. We look forward to hearing more about these 

agreements from today’s witnesses. 

Encouraging innovation is a top priority of this committee, and we want to take 

this opportunity to examine the animal drug approval process to ensure the incentives are in place to encourage innovative treatments to be developed and for generic animal drugs to be made available. 

We don’t often think of the FDA when it comes to animal drugs, but these programs are critically important to the pet owners of America and our farmers that 

we rely on to produce the food that feeds our country. 

This is important must-pass legislation and we are committed to getting it done 

on time before these user fee programs expire in September. I’d like to thank our 

witnesses for being here with us today, and Mr. Mullin for leading this legislative 

effort for our committee. 

Mr. WALDEN. And with that, I would yield the remainder of my 

time to Mr. Mullin, I believe, who is seeking time and has been a 

real leader on this effort. 

So Mark, I’ll turn it over to you. 

7 

Mr. MULLIN. Thank you, Mr. Chairman. 

I want to thank you and Chairman Burgess for holding this 

hearing. I am proud to be the sponsor of the legislation to reauthorize the Animal Drug User Fee Act and its generic version. 

ADUFA and AGDUFA will reauthorize user fee agreements between the FDA and the animal drug industry to help speed the approval of new and generic drugs for farmers, ranchers, families, 

and veterinarians so they can keep their animals and pets safe and 

healthy. 

In the last reauthorization, the FDA committed to working with 

industry to complete recommendations for expanding conditional 

approval. I want to reaffirm my commitment to working with the 

FDA and to industry to come to a consensus as early as possible 

so we can continue to drive innovation. 

Thank you to our witnesses for being here today. I look forward 

to hearing your testimony regarding the importance of a clean reauthorization for our farming and ranching communities, and I 

yield back. 

Thank you. 

Mr. BURGESS. Chair thanks the gentleman. The gentleman yields 

back. 

The Chair recognizes the gentleman from New Jersey, the ranking member of the full committee, Mr. Pallone, 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. Today we will be examining the FDA’s animal drug user fee program and the animal generic drug user fee program, and these critical user fee agreements 

have helped to accelerate the development of animal drugs, reduce 

application review times at FDA, and create a more predictable 

and streamlined process for getting animal drugs to market to help 

improve the health of our pets and food-producing animals. 

Last month, this committee, along with the HELP Committee in 

the Senate, released a bipartisan discussion draft that reauthorizes 

FDA’s authority to collect user fees from the animal drug and generic animal drug industries for an additional 5 years, as the current authorization for these programs will expire on September 

30th. 

The discussion draft reflects bipartisan agreement and the recommendations negotiated between FDA and the animal drug industry with input from farmers and ranchers, veterinarians, food 

and feed producers, and other public health stakeholders. 

And these agreements are critically important to pet owners, veterinarians, and farmers so they have access to safe, effective, and 

affordable medications for their animals. And we want our pets to 

have the best are possible, and we must ensure that we keep our 

food supply safe. The animal drug user fee program furthers both 

of these goals. 

I expect we will hear also testimony today on FDA’s work to address antimicrobial resistance from the use of antimicrobials in 

food-producing animals. 

8 

I am very interested in what the Center for Veterinary Medicine 

is doing to ensure the continued effectiveness of antibiotics and 

how we can protect both animals and humans from the growing 

threat of antimicrobial resistance. 

And I look forward to helping to move these agreements through 

Congress in a timely fashion so the Center for Veterinary Medicine 

at FDA can continue its important work. 

I don’t think anyone else wants my time, and if they don’t, I will 

yield back. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Today we will be examining the FDA’s Animal Drug User Fee program and the 

Animal Generic Drug User Fee program. These critical user fee agreements have 

helped to accelerate the development of animal drugs, reduce application review 

times at FDA, and create a more predictable and streamlined process for getting 

animal drugs to market to help improve the health of our pets and food-producing 

animals. 

Last month this committee, along with the HELP Committee in the Senate, released a bipartisan discussion draft that reauthorizes FDA’s authority to collect user 

fees from the animal drug and generic animal drug industries for an additional 5 

years, as the current authorization for these programs will expire on September 

30th of this year. 

The discussion draft reflects bipartisan agreement and recommendations negotiated between FDA and the animal drug industry with input from farmers and 

ranchers, veterinarians, food and feed producers, and other public health stakeholders. 

These agreements are critically important to pet owners, veterinarians, and farmers so they have access to safe, effective, and affordable medications for their animals. We want our pets to have the best care possible, and we must ensure that 

we keep our food supply safe. The animal drug user fee programs further both of 

these goals. 

I expect we will also hear testimony today on FDA’s work to address antimicrobial 

resistance from the use of antimicrobials in food-producing animals. I’m very interested in what the Center for Veterinary Medicine is doing to ensure the continued 

effectiveness of antibiotics and how we can protect both animals and humans from 

the growing threat of antimicrobial resistance. 

I look forward to helping to move these agreements through Congress in a timely 

fashion so the Center for Veterinary Medicine at FDA can continue its important 

work. 

I yield back. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

This concludes the Member opening statements. The Chair would 

remind Members, pursuant to committee rules, all Members’ opening statements will be made part of the record. 

Again, we want to thank all of our witnesses for being here today 

and taking the time to testify before the subcommittee. Each witness will have an opportunity to give an opening statement followed by questions from Members. 

Our first panel today is Dr. Steven Solomon, the Director of the 

Center for Veterinary Medicine, the United States Food and Drug 

Administration. 

We certainly appreciate you being here this morning, Dr. Solomon. You are now recognized for 5 minutes to give a summary of 

your opening statement, please. 

9 

STATEMENT OF STEVEN SOLOMON, D.V.M., DIRECTOR, CENTER FOR VETERINARY MEDICINE, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. SOLOMON. Good morning, Chairman Burgess, the acting 

ranking member, Chairman Walden, and Ranking Member Pallone. I am Dr. Steve Solomon, Director for the Center for Veterinary Medicine at the Food and Drug Administration. 

I thank you for the opportunity to discuss FDA’s proposals for 

the reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. 

I recently returned to CVM as the Director after working extensively in other roles in FDA. This is a very good time to be at CVM 

for a number of reasons, including the fact that we are seeing the 

development of significant and innovative new animal products. 

New animal drugs offer the promise of longer and healthier life 

for our pets and other companion animals. For example, FDA has 

approved new oncology treatments for dogs, targeting canine-specific tumors. 

The drugs represent a significant advance for veterinary medicine, which traditionally relies on human oncology treatments. In 

recent years, FDA has approved innovative therapy options that 

target bone changes to treat a common cause of performance-ending lameness in horses. 

New stem cell therapies offer great promise for future veterinary 

treatments and cures. Meanwhile, approval of the first generic 

version of a vital heartworm treatment has alleviated a shortage 

of this critically important treatment for dogs and provides an alternative to pet owners. 

FDA plays a vital role in animal agriculture by reviewing the 

safety and efficacy of new animal drugs for food-producing animals 

such as cattle, pigs, and chickens. 

For food-producing animals, we also evaluate whether products 

derived from treated animals are safe for human consumption. 

Awareness of the public health challenge created by antimicrobial resistance has led to important changes in animal agriculture. For example, as an alternative to antimicrobials, FDA approved a new treatment to prevent mastitis in dairy cows. At the 

same time, animal welfare awareness has grown, and we have approved the first drug to reduce pain in food-producing animals. 

FDA considers timely review of new animal drug safety and effectiveness to be central to the agency’s mission to protect and promote human and animal health. 

ADUFA and AGDUFA are highly successful programs that enhance the availability of food products for food-producing and companion animals. 

Before their enactment, FDA CVM had a large backlog of overdue submissions, and sponsors had to wait an average 500 to 700 

days for drug review. However, thanks to ADUFA and AGDUFA 

user fees, CVM eliminated the backlog in applications and has dramatically reduced review times. 

Both programs enable FDA to maintain an outstanding scientific 

and technical workforce, improve timely communication with drug 

sponsors, and achieve other efficiencies in the drug approval procVerDate Mar 15 2010 09:57 Oct 11, 2018 Jkt 037690 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\115X109ANIMALDRUGSPDFMADE WAYNE
10 

ess while maintaining scientific standards for drug safety and efficacy. 

Without reauthorization, however, both programs will sunset on 

October 1st, 2018. Timely reauthorization is needed to assure 

FDA’s ability to deliver continued high levels of performance and 

ensure there are no disruptions to these important programs. 

The ADUFA IV proposal built on the success of prior ADUFA 

achievements and proposes changes to current performance goals 

to enhance the review. In it, FDA agrees to maintain current performance goals for most applications and submissions and to add 

four new performance goals to enhance the exchange of scientific 

information. 

FDA would slash the timeframe for reviewing categorical exclusion and Animal Drug Availability Act combination medicated feed 

requests by two-thirds. 

We also establish new goals for presubmission conferences and 

tissue residue method demonstrations. ADUFA IV also includes an 

FDA commitment to work on the implementation of the U.S.-European Union Good Manufacturing Practice Inspection Mutual Recognition Agreement for animal drug facilities. 

The AGDUFA III agreement includes significant additional financial commitments from the animal generic drug industry that 

reflect its growth. These resources will help significantly decrease 

review time for multiple generic submissions and provide greater 

review predictability. 

Both the ADUFA and AGDUFA recommendations require 100 

percent electronic submission starting next year to facilitate efficient review. 

Additionally, both programs include financial recommendations 

to bolster the program’s stability. The ADUFA IV and AGDUFA III 

agreements, produced with considerable input from FDA, industry, 

and other important stakeholders, build on the achievements of 

these highly successful programs. 

They will ensure FDA has the resources needed to conduct timely 

reviews and assist drug sponsors in fostering innovation, enhancing 

access to safe and effective therapies for food-producing and companion animals. 

FDA looks forward to working with the committee to achieve a 

timely reauthorization of these important human and animal 

health programs. 

Thank you for the opportunity to discuss the ADUFA and 

AGDUFA programs, and I’d be happy to answer any questions. 

[The prepared statement of Dr. Solomon follows:] 

11 


30574.001

STATEMENT 

OF 

STEVEN SOLOMON, D.V.M., MPH 

DIRECTOR, CENTER FOR VETERINARY MEDICINE 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

UNITED STATES HOUSE OF REPRESENTATIVES 

"REAUTHORIZATION OF ANIMAL DRUG USER FEES: ADUFA AND AGDUFA" 

MARCH 14, 2018 

RELEASE ONLY UPON DELIVERY 
12 


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Introduction 

Good morning, Chairman Burgess, Ranking Member Green, and Members of the Subcommittee. 

I am Dr. Steven Solomon, Director of the Center for Veterinary Medicine (CVM) 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 discuss FDA's proposals for the 

reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act for 

an additional five years (ADUF A IV and AGDUF A III). 

I recently returned to CVM as the Director after more than 20 years serving in other roles in 

FDA. This is a very exciting time for veterinary therapeutics necessary to protect both animal 

and human health. Advances in biotechnology are leading to the development of innovative, 

new animal drug products and approaches that offer the promise of a safer and healthier future 

for the people and animals we serve. 

According to the American Veterinary Medical Association, more than half of American 

households include pets, most of whom are viewed as part of their families. Overall, this 

includes approximately 70 million dogs, 74 million cats- and a diverse assortment of birds, fish, 

and other animals. Our companion animals are living longer as promising new products are 

being developed to treat chronic and insidious diseases. In recent years, FDA has approved 

innovative treatment options, including two treatments for navicular disease in horses, one of the 

most common causes of lameness. The drugs, for the first time, target bone changes commonly 

caused by the disease. FDA has also approved new oncology treatments for dogs targeting 

canine-specific tumors. The drugs represent a significant advance for veterinary medicine which 

traditionally relies on oncology treatments approved for humans to treat cancer in animals. These 

approved animal drugs contain canine-specific dosing instructions and safety information. Stem 

cell therapies offer great promise for future veterinary treatments and cures. Meanwhile, 

approval of the first generic version of a vital heartworm treatment has alleviated a shortage of 

this critically important treatment for dogs- and provided a safe, effective, and more affordable 

alternative for pet owners. 
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30574.003

FDA plays a vital role in animal agriculture by reviewing tbe safety and efficacy of new drugs 

for food producing animals, such as cattle, pigs, and chickens. When reviewing new animal 

drugs indicated for food producing animals, FDA also evaluates whether edible products derived 

from treated animals (e.g., meat, milk and eggs) are safe for human consumption. Awareness of 

the public health crisis created by antimicrobial resistance has led to important changes in animal 

agriculture- and innovative new products. For example, as an alternative to antimicrobials, 

FDA approved a new treatment to prevent mastitis in dairy cows. Another innovative new 

approval was the first drug to reduce pain in food producing animals. 

FDA considers timely review of the safety and effectiveness of new animal drug applications 

(NADAs) to be central to tbe Agency's mission to protect and promote human and animal health. 

ADUF A and AGDUFA are highly successful programs that facilitate the availability of approved 

products for food-producing and other animals and foster a flexible, risk-based review 

framework to accommodate innovative approaches to drug development. Prior to initiating these 

user fee programs, FDA's CVM had a large backlog of overdue submissions, and sponsors had 

to wait on average 500 days for pioneer drug review responses and 700 days for generic drug 

review responses. As a result of ADUFA and AGDUFA user fees, CVM eliminated the backlog 

in applications and has dramatically reduced the time needed to review animal drug applications 

and other submissions. Both programs help FDA to maintain a stable scientific and technical 

workforce, improve timely communications with drug sponsors, and achieve other efficiencies in 

the drug approval process while maintaining science-based regulatory standards for drug safety 

and efficacy. 

In my testimony today, I will provide the status of FDA's reauthorization activities. I will also 

provide some information about each program, our achievements to date, and our proposed 

changes. 

Status of FDA's Reauthorization Activities 

The ADUFA III and AGDUFA II provisions of the Federal Food, Drug, and Cosmetic (FD&C) 

Act will sunset on October 1, 2018. Timely reauthorization is needed to ensure FDA's ability to 

2 
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deliver continued high levels of performance and help ensure there are no disruptions to these 

important programs. FDA began the reauthorization process on May 16, 2016, with public 

meetings for both programs. These meetings included presentations by FDA and presentations 

and public comment by representatives of different stakeholder groups, including regulated 

industry, veterinary professionals, scientific and academic experts, and representatives of 

consumer advocacy groups. Transcripts and webcast recordings are available on FDA's website 

at https:llwwwjda.gov/Forlndustry/UserFees/Anima/DrugUserFeeActADUF Alucm04289J.htm for 

ADUFA and https:/lwwwjda.gov/Forlndustry/UserFees/Anima/GenericDrugUserFeeActAGDUFAI 

ucm270232.htm for AGDUFA. 

Based on comments to a public docket and the Agency's own analysis of program challenges, 

FDA developed a set of potential proposed enhancements for ADUF A IV and AGDUFA III and 

began negotiations with industry. AGDUF A III negotiations took place between August 2016 

and January 2017; ADUFA IV negotiations took place between October 2016 and April2017. 

Discussions with a broader group of stakeholders also occurred throughout this process. 

Negotiated recommendations were published in the Federal Register in October for public 

comment. 1 Final public meetings were held on November 2, 2017, to discuss the ADUFA IV 

and AGDUFA III recommendations and solicit input from stakeholders. The final 

recommendations were transmitted to Congress in early January, and include, for each program, 

the goals letter outlining performance metrics, proposed legislative language, and a summary of 

public comments. 

ADUFA Background 

The five-year reauthorization cycles for ADUF A- and AGDUF A- have supported continuous 

program innovation, evaluation, and improvement. Through successive reauthorizations, 

program enhancements have evolved and expanded to include extensive communication and 

1 FDA, "Animal Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period," 

Docket No. FDA-2011-N-0656, October 25, 2017, 82 FR 49380-82, available at 

https:!lwww.gpo.gov/jdsyslpkg/FR-2017-l 0-25/pdjl2017-23172.pdf; FDA, "Animal Generic Drug User Fee 

Act; Recommendations; Request for Comments; Extension of Comment Period," Docket No. FDA-2011-N-0655, 

October 25,2017, 82 FR49377-79, available at https:l!www.gpo.gov/fdsyslpkg/FR-2017-10-25/pdjl2017-

23173.pdf. 

3 
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30574.005

consultation between drug sponsors and FDA throughout drug development. ADUFA I enabled 

FDA to increase the number of staff dedicated to animal drug review by approximately 30 

percent. ADUFA II included important measures to enhance communications with industry, 

develop and implement electronic submission capability for applications and submissions, and 

added pre-approval foreign inspection goals. It also supported 10 public workshops on mutually 

agreed upon topics. 

ADUF A III added review flexibility to shorten second-cycle review and included extensive 

information technology enhancements. The early information process has fostered drug product 

innovation and increased the availability of safe and effective products. Early information 

leverages existing data and informs the scope of animal studies required to demonstrate the new 

animal drug's safety and effectiveness, which helps move the project more quickly into clinical 

trials. 

Under ADUFA III, FDA has made multiple enhancements to the chemistry, manufacturing, and 

controls (CMC) technical section of the NADA- one of the most complex components of the 

new animal drug submission - which have reduced overall review time. The Agency now 

permits the submission and review of early completed CMC information, permits comparability 

protocols to be submitted as protocols without substantial data in an investigational new animal 

drug (an IN AD) file, and permits certain prior approval manufacturing supplements to be 

resubmitted as Supplements Changes Being Effected in 30 Days (CBE-30s). 

FDA continues to improve communications, timeliness, and predictability of foreign preapproval inspections. As a result of ADUFA III, sponsors may voluntarily submit a list of 

foreign manufacturing facilities they anticipate including in their applications subject to preapproval inspections for the following fiscal year. Six sponsors voluntarily submitted such lists 

in FY 2016, allowing better planning for all parties involved and timely execution of good 

manufacturing practice (GMP) inspections by FDA. 

Also as part of ADUF A III, FDA agreed to two long-term goals. First, we agreed to explore the 

possibility of pursuing statutory changes to expand the use of conditional approval. FDA is 

4 
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continuing work on the goal of exploring the feasibility of statutory revisions to expand the use 

of conditional approvals to other appropriate categories of new animal drug applications beyond 

the current FD&C Act authority provided under the Minor Use and Minor Species Animal 

Health Act of2004 (MUMS Act). CVM formed a Conditional Approval Working Group that 

has conducted preliminary activities to evaluate the feasibility, practicality, criteria, and potential 

requirements for expanding the use of conditional approval to certain major uses in major 

species. FDA is committed to continuing to explore through a public and transparent process the 

expanded use of conditional approval consistent with the Agency's mission to protect and 

promote public health. In our second long-term goal, FDA agreed under ADUFA III to explore 

the feasibility of statutory revisions that may modifY the current requirement that the use of 

multiple new animal drugs in the same medicated feed each be subject to a separate approved 

application. The Agency held a public meeting on March 16, 2015, to discuss this issue with 

stakeholders. In FY 2016, CVM fulfilled its commitment as outlined in 2the ADUFA III goals 

letter and provided written recommendations concerning the use of multiple new" animal drugs in 

the same medicated feed for consideration through the Federal Register on May 2, 2016. 2 This 

proposal formed the basis for process changes being recommended in ADUF A IV. 

ADUFA Performance 

FDA continues to deliver predictable high levels of performance against ADUF A goal 

commitments for timely review, as shown in Table 1. Final FY 2016 performance data show 

FDA exceeded the 90 percent review performance level for all seven submission types. In 

preliminary FY 2017 performance, FDA is currently exceeding the review-time goal for all 

seven submission types. 

2 FDA, "Recommendations on the Regulation of Combination Drug Medicated Feeds; Availability; Reopening of 

Comment Period; Request for Comments," Docket No. FDA-2014-N-1050, April29, 2016, 81 FR 25677-78, 

available at https:l/www.regulations.gov/document?D;FDA-2014-N-1050-0002; and FDA, "Recommendations on 

the Regulation of Combination Drug Medicated Feeds," May 2, 2016, available at 

https://www.regulations.gov/docket?D=FDA-2014-N-l050. 

5 
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30574.007

Table 1: FDA Review Performance- ADUFA FY 2016: Percent of Submissions Acted on by Goal Date 

Original NADAs and 

Reactivations 

Administrative NADAs 

Non~manufacturing 

Supplemental 

NADAs and Reactivations 

Manufacturing Supplemental 

NADAs and Reactivations 

Qualifying Labeling 

Supplements 

INAD Studies 

INAD Study Protocols 

15 180 days 

18 60 days 

0 180 days 

324 120 days 

6 60 days 

181 180 days 

277 50 days 

NADA = New Animal Drug Application; INAD = Investigational New Animal Drug 

Proposal for ADUFA IV 

14 93% 

18 0 100% 

0 

322 99% 

0 100% 

181 0 100% 

275 99% 

ADUFA IV builds on the success of prior ADUFA achievements. The negotiated 

recommendations propose changes to current performance goals to further enhance review. 

FDA agrees to maintain the ADUF A III performance goals regarding review of most original 

and administrative NADAs, investigational new animal drug studies, non-manufacturing 

supplemental NADAs, and reactivations. To enhance the exchange of scientific information, the 

Agency and industry have agreed on four new performance goals in ADUF A IV: reducing the 

time frame for reviewing Categorical Exclusion requests from 180 to 60 days for certain 

qualifYing submissions; shortening the review time frame for combination medicated feed 

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applications requiring no data; scheduling pre-submission conferences within 60 days upon 

FDA's receiving a complete agenda request; and for a product requiring a tissue residue method 

trial, scheduling the method demonstration within 120 days of receiving a complete request. The 

ADUFA IV recommendations also include a provision requiring 100 percent electronic 

submission starting in FY 2019 and a commitment by FDA to work on implementing the U.S.-

European Union GMP Inspection Mutual Recognition Agreement for animal drug facilities. 

Additionally, ADUFA IV offers the following recommendations: 

• Eliminating the Offset Provision, which will allow any excess collections to be more 

readily available for use by FDA for the process for the review of animal drug 

applications. 

• In conjunction with eliminating the Offset Provision, for any fiscal year the Workload 

Adjuster is invoked in which FDA had excess collections in the second preceding fiscal 

year, provide for FDA to reduce the workload-based fee increase by the amount of excess 

collections. If FDA did not have excess collections in the second preceding fiscal year, 

FDA will collect the full amount of the workload-adjusted fee revenue. 

• Continuing to authorize recovery of collection shortfalls; however, provide for any fee 

increase to recover shortfalls to be reduced by the amount of remaining prior year excess 

collections not already applied for purposes of reducing workload-based fee increases. 

• Modifying the Workload Adjuster base years from ADUF A II (FY 2009 through 

FY 2013) to ADUFA III (FY 2014 through FY 2018) to ensure the adjuster adequately 

captures changes in FDA's workload during ADUFA IV. 

The ADUF A IV recommendations submitted to Congress include total fee revenue estimates for 

FY 2019 of$30,300,000, which includes one-time information technology funding in the amount 

of$400,000. The proposed statutory language specifies base annual fee revenue of$29,900,000 

for each ofFY 2020 through FY 2023; however, this amount is subject to possible adjustments, 

including for inflation, workload, and collections shortfall. 

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AGDUFA Background 

AGDUFA I authorized FDA's first-ever generic animal drug user fee program, launched in 

FY 2009, to provide livestock and poultry producers and pet owners with greater access to safe, 

effective, and more affordable generic animal drugs. Under AGDUFA I, FDA increased the 

number of staff dedicated to generic new animal drug application review by approximately 45 

percent enabling the Agency to accelerate review, eliminate a backlog of 680 applications, and 

create a more predictable, streamlined process, including electronic submission capability. 

Electronic submissions have grown from approximately 3 percent of submissions in FY 2011 to 

58 percent in FY 2017. 

AGDUFA II included further enhancements. FDA added flexibility with a second-cycle 

shortened review process for key submission types, such as protocols, data submissions, and 

applications that significantly impact the generic new animal drug approval timeline. 

QualifYing submissions receive a significantly reduced second-cycle review to shorten approval 

timelines. FDA also made multiple enhancements to the CMC technical section, similar to the 

ADUF A changes noted above. 

AGDUFA II added a pre-approval foreign inspection goal to improve communications, 

timeliness, and predictability of these inspections. FDA also developed question-based review 

(QbR) for bioequivalence submissions, and deployed a QbR for blood-level bioequivalence 

protocol submissions. Additional templates to further enhance the review ofbioequivalence 

submissions are currently under development. 

AGDUFA Performance 

FDA continues to review sponsor submissions and deliver predictably high levels of 

performance against AGDUF A goal commitments for timely review, as shown in Table 2. Final 

FY 2016 performance data show FDA exceeded the 90 percent on-time goal for all five 

submission types. Based on preliminary analysis ofFY 2017 performance, FDA is again on 

track to exceed the review-time goals for all five submission types. 

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Table 2: FDA Review Performance- FY 2016: Percent of Submissions Acted on by Goal Date 

Original ANADAs and 

16 270 days 16 0 100% 

Reactivations 

Administrative ANADAs 100 days 0 100% 

Manufacturing Supplemental 

156 

ANADAs and Reactivations 

270 days 153 98% 

JINAD Studies 63 270 days 61 97% 

JINAD Protocols 22 100 days 22 100% 

JINAD • Generic New Animal Drug 

Proposal for AGDUFA III 

The AGDUF A III negotiated agreement includes a significant, additional financial commitment 

from the animal generic drug industry that reflects the program's growth. The agreement is 

designed to slash review times for generic submissions and increase the predictability of FDA's 

review process by providing CVM resources sufficient to keep pace with actual costs. Review 

times for the following submission types will be cut as indicated in Table 3 below: ANADAs 

(originals, reactivations, and administrative); prior approval supplements; and J!NAD data 

submissions and protocols. Like the ADUF A IV recommendation, AGDUFA III also would 

require 100 percent electronic submission starting in FY 2019. 

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Table 3: AGDUFA Ill Performance Goal Review Times (Complete 90% within the following number of days) 

Prior Approval supplements (Chemistry, Manufacturing, and 

Controls) 

JINAD data submissions (shortened review) 

270 

90 

Additionally, AGDUFA HI offers the following recommendations: 

admin) 

180 

60 

• Eliminating the Offset Provision, which will allow any excess collections to be more 

readily available for use by FDA for the process for the review of generic new animal 

drug applications. 

• In conjunction with eliminating the offset provision, for any fiscal year the Workload 

Adjuster is invoked in which FDA had excess collections in the second preceding fiscal 

year, provide for FDA to reduce the workload-based fee increase by the amount of excess 

10 
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collections. If FDA did not have excess collections in the second preceding fiscal year, 

FDA will collect the full amount of the workload-adjusted fee revenue. 

• Modifying the Inflation Adjuster from a fixed 4 percent in AGDUFA II to a variable 

inflation adjuster in AGDUF A III, matching the inflation adjuster used for the ADUF A 

program. 

• Modifying the Workload Adjuster base years from AGDUFA I (FY 2009 through 

FY 2013) to AGDUFA II (FY 2014 through FY 2018) to ensure the adjuster adequately 

captures changes in FDA's workload during AGDUFA III. 

The AGDUF A III recommendations submitted to Congress include total fee revenue estimates 

for FY 2019 of$18,300,000; in FY 2020 through FY 2023, this amount is subject to possible 

adjustments, including for inflation and workload. 

Conclusion 

The ADUF AIV and AGDUFA III agreements, produced with considerable input from FDA, 

industry, and other important stakeholders, build on the achievements of these highly successful 

programs. They will help ensure FDA has the resources needed to conduct timely reviews and 

assist drug sponsors in bringing more animal drugs to the market. They also will foster 

innovation and provide enhanced access to safe and effective animal therapies. FDA looks 

forward to working with the Committee to achieve a timely reauthorization of these important 

human and animal health programs. 

Thank you for the opportunity to discuss the ADUF A and AGDUF A programs. I would be 

happy to answer any questions. 

11 
23 

Mr. BURGESS. Chair thanks the gentleman, and I do want to 

thank you for taking time to give us testimony this morning. 

We will move into the portion of the hearing where Members’ 

questions are heard. I will begin by recognizing myself for 5 minutes. 

And Dr. Solomon, you referenced the implementation of the U.S.- 

European Union Good Manufacturing Process Inspection. What are 

some of the particular challenges that you face with that? 

Has that been more straightforward or more difficult than you 

would have anticipated? 

Dr. SOLOMON. So thank you for that question. 

We are still in the early stages of doing that. The E.U. GMP Inspection Mutual Recognition Agreement started on the human side, 

and it then will move over to the veterinary side later on. 

So on the human side, it’s been making good progress. Once 

again, lots of countries in the E.U., they need to be assessed. What 

we’ve discovered is that not all the authorities in the E.U. have the 

same authorities on the human side as they do on the animal drug 

side. 

So, as we progress through it and looking at the animal drug 

side, we are going to utilize the information that the human side 

has collected as part of their agreement. But as we move into it we 

are going to need to look at the countries and conduct assessments 

of them that has separate authorities in the E.U. countries for the 

animal side. 

Mr. BURGESS. So there is an increase in funding in the proposed 

legislation that Mr. Mullin has given us. How do you propose that 

the Food and Drug Administration is going to utilize the additional 

resources, and perhaps how is that going to help us improve the 

review process? 

Dr. SOLOMON. So we are going to be hiring additional reviewers 

on both sides to meet the new performance commitments. There 

will be approximately 20 new reviewers in different disciplines on 

the animal drug user fee side and around 30 new people hired on 

the generic drug user fee side, and some of those resources will be 

able to be used for implementation of the E.U. agreement where we 

need to go over to the E.U. and get the assessments of the other 

countries’ regulatory authorities and oversight over GMP animal 

facilities. 

Mr. BURGESS. Just for a point of reference, how large is the 

workforce, currently? 

Dr. SOLOMON. So the current user fees represent around 35 percent of the staff on the animal drug review side and around 60 percent on the generic drug user fee side. Those are covered by user 

fees. 

Mr. BURGESS. OK. So there are more aggressive approval goals 

that are laid out in this—in this reauthorization. You have already 

alluded to it somewhat, but, again, could you just briefly delineate 

the steps the FDA will be taking to meet these goals? 

Dr. SOLOMON. Certainly. So we’ve already been doing planning in 

anticipation of getting this. Part of the process is going to be earlier 

communication. 

24 

We have a phase review process in CVM where we really interact 

with the industry very early in the process, where they’re still in 

developmental stage process. 

We want to enhance that early communication. Before the industry is developing a drug, let’s meet with them early and make sure 

we understand what the data requirements—what type of clinical 

studies are going to need to be done so that we can very quickly 

decide what those are. 

We are also reducing timeframes for some unique aspects of the 

categorical exclusion in some of our environment findings. 

On the generic drug side, we are dramatically reducing the timeframes to be able to get generic animal drugs to the market sooner. 

Mr. BURGESS. So, on the issue of the electronic submissions that 

I believe are going to be required in this reauthorization, obviously, 

there are going to be benefits to electronic submission. Would you 

care to share those with us? 

Dr. SOLOMON. Thank you. 

So electronic submission is a big step in trying to do it. When I 

first started at CVM 28 years ago, there used to be trucks backing 

up with these volumes and volumes of paper that needed to be reviewed. 

Trying to then take those and give them to the different disciplines was quite a challenge. The electronic review process makes 

the review much more efficient. 

Everyone and all the different scientists have access to the data 

in a much more expedient way and makes it a much more efficient 

process of review. 

Mr. BURGESS. Well, again, I thank you for being here this morning. Thank you for your testimony and taking our questions. 

I would now like to recognize Mr. Butterfield from North Carolina for your questions, please. 

Mr. BUTTERFIELD. Thank you very much, Mr. Chairman. 

Dr. Solomon, thank you for your testimony today. Dr. Solomon, 

I’ve heard from some of my colleagues and some of my constituents 

about expanding the use of what is called conditional approval, and 

it’s my understanding that the FDA believes that it needs legislation to provide authority to allow this conditional approval to be 

used for major uses in major species. 

Am I right or wrong about that? 

Dr. SOLOMON. You are correct. 

So Congress gave us statutory authority back in 2004 for use of 

conditional approval in minor species or minor use in major species. 

What that does is, the applicants’ sponsors still need to prove the 

safety, the environmental controls, the human food safety, but allows a 5-year timeframe to demonstrate the efficacy of the product 

while it can be on the market. 

We’ve had discussions with industry that, in order to help spur 

innovation, trying to get this applied to major species under certain 

conditions, the conditions being that it’s got to be for serious illness 

or disease in major species that really have unmet veterinary medical needs or public health needs and for studies that have difficulty in demonstrating efficacy. 

25 

So things that we would envision would be more chronic disease 

conditions, things like congestive heart failure or chronic renal disease, osteoarthritis—things that it would be difficult to do the efficacy studies because you need to measure things over time. 

We think additional approval would be a welcome addition to try 

and get additional products on the market. 

Mr. BUTTERFIELD. Can you describe the safety requirements that 

must be met for conditional approval? 

Dr. SOLOMON. So the safety requirements have to be met exactly 

the same as for any other approval. So there is no difference in the 

safety that needs to be demonstrated before marketing. 

The only difference on conditional approval is the timeframe for 

efficacy requirements, which can be up to 5 years after the product 

starts marketing. 

Mr. BUTTERFIELD. Would any of the drug companies that we deal 

with have an incentive to provide a drug under conditional approval that it does not believe to be effective? 

Dr. SOLOMON. So there’s a requirement in the conditional approval that they need to submit status reports on an annual basis, 

as least as it’s currently applied to minor use, minor species, on the 

progress they’re making on the efficacy requirements. And then, if 

they do not meet it, they need to come in at 5 years for the full 

standard for efficacy, which means substantial evidence of efficacy 

at the end of that 5 period. 

If not, the way the MUMS Act works and what we would hope 

in any future one, is that product is no longer allowed to be marketed. So it gives them time to do the efficacy studies—those challenging efficacy studies that are meeting unmet veterinary medical 

needs. 

Mr. BUTTERFIELD. Dr. Solomon, I appreciate the work that the 

FDA has done to expedite the process of approval for animal drugs, 

and I really appreciate your testimony earlier about how it was 28 

years ago when the trucks would back up to your building. I can 

just envision that now. 

In your testimony, you mentioned that the agreement recommends that 100 percent of the applications be submitted electronically and only 58 percent of applications were submitted in fiscal year 2017 that way. 

Will the FDA provide any support to help with that transition to 

electronic applications, what I call 21st century technology? 

Dr. SOLOMON. Yes. So we recognize that, on the pioneer side, 

most of the submissions are coming in on electronic on the generic 

side. These are generally smaller companies, newer companies. 

We want to provide assistance to try and get there, and it also 

includes some IT enhancements in the funding to help CVM support making that transition over so we can get everyone to the 100 

percent submission goal. 

Mr. BUTTERFIELD. And are the sponsors ready to make that transition, or do they have some anxiety about it? 

Dr. SOLOMON. I think they’re generally anxious to try and do it. 

I think they see the efficiencies in it. But I think it’s a great question for the panel coming up. 

Mr. BUTTERFIELD. All right. All right. Thank you. 

I yield back, Mr. Chair. 

26 

Mr. BURGESS. Gentleman yields back. Chair thanks the gentleman. 

Chair recognizes the gentleman from Kentucky, the vice chairman of the committee, Mr. Guthrie. 

Mr. GUTHRIE. Thank you very much. 

Actually, I can’t let the chairman’s comment of the wisdom of 

Solomon this morning go. I know you probably hear that all the 

time, and I apologize. 

But trying to be a little more disciplined myself, as Solomon 

talked about, and trying to read the proverbs of the day—of the 

chapter of the month, and so today being the 14th Proverbs—and 

if you read Proverbs every day, there’s always something you’re 

going to face. 

So Proverbs 14:4 says, ‘‘Where there are no oxen, the manger is 

empty, but from the strength of an ox come abundant harvests.’’ So 

what we are doing here goes back to understanding we have to 

have a good agriculture, even back in the Bible times—— 

[Laughter.] 

Mr. GUTHRIE [continuing]. And proclaimed by Solomon, which is 

the standard of wisdom. 

And some of the questions they’ve already—I guess some of your 

testimony piqued all of our interest, because I am going to kind of 

touch on it again because I was going to ask that. 

But first, can you please explain ADUFA IV performance goals, 

specifically centered around shortening the review timeframe for 

combination medicated fees? 

Dr. SOLOMON. Sure. 

So this was an agreement that we worked on during the previous 

timeframe. So there’s a number of medicated fees that combine various different drugs, usually for different type conditions. 

So there might be some combination that there might be a need 

for an antiparasitic drug, for, say, Coxidia. At the same time they 

may be treating a bacterial-infection-type area. 

So, in the medicated feed area, we wanted to not subject each of 

them to a separate approval requirement when each drug had already gone through an approval combination. 

When we put these two combinations together, we need to make 

sure that they’re not interfering with each other—the two drugs together. 

Putting drugs in the feed supply is often the most efficient way 

to get it into food-producing animals. 

So we worked with the industry to come up with a shortened 

timeframe to evaluate these drugs when they combine them together in medicated feeds. 

Mr. GUTHRIE. OK. Thanks. 

And the second question, I was going to talk about the electronic 

submission, and it was kind of asked but at the very end you said 

that would be a good question for the next panel, why we haven’t 

gotten a higher percentage from 58 to 100 percent, and we’ll do 

that—ask them that. 

What kind of challenges are you seeing from—for some reason, 

they’re not—obviously, I don’t know if it’s all their issues for not 

getting the 100 percent, but what kind of challenges, from your 

27 

perspective, do you think the next panel should be looking at to address? 

Dr. SOLOMON. So I think my understanding is, this is mainly 

some of the newer companies. Often, we have companies that are 

new on the generic side to this and just simply haven’t developed 

the structure for all the electronic pieces. 

We give lots of guidance on what we expect in a submission, how 

to put it together, how to facilitate the electronic entry. We have 

a pathway for moving it. 

We are going to try and provide, you know, help desk assistance 

for anyone that needs assistance in getting that electronic review. 

So we all benefit from getting the electronic review process, and 

we want to work with the industry to get to that objective. 

Mr. GUTHRIE. Do you think 100 percent is attainable by 2019? 

Dr. SOLOMON. We will work closely with them to try and meet 

that goal. 

Mr. GUTHRIE. That’s a good answer. 

So, and Dr. Burgess talked a little bit about the U.S.-European 

Union good manufacturing practices for animal drug facilities. 

What is the timeframe for this agreement? 

And I know you said they’re doing the human and then the animal. But what’s the timeframe for the agreement, and when do you 

expect to see that? 

Dr. SOLOMON. So, the way the agreement is drafted, the agreement got signed on the human side in March of 2017, and they’re 

still going through the assessment. A number of the E.U. countries 

have already been reviewed and are now part of the agreement. 

In December, we met with the European Union to lay out our 

goals and objectives for trying to move it on the animal side, and 

we have an objective by making a determination by July of 2019 

whether we are going to be successful in moving that agreement 

forward in the timeframe for meeting that assessment so we can 

evaluate the GMP conditions on the animal side of the house. 

Mr. GUTHRIE. OK. Well, thank you very much, and that concludes my questions. I appreciate your testimony. 

I yield back. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

Chair recognizes the gentleman from Oregon, Dr. Schrader, 5 

minutes for questions, please. 

Mr. SCHRADER. Thank you very much, Mr. Chairman. I appreciate it. 

Welcome, Dr. Solomon. 

Dr. SOLOMON. Thank you. 

Mr. SCHRADER. Very impressive, the results you guys have gotten as a result of the previous ADUFA agreements. The performance measures speak for themselves—95 to 100 percent success in 

all the different areas. 

Most agencies would die to have that sort of track record at the 

end of the day, and you’re stepping up and willing to reduce time 

lines and do some more with a little assistance from industry. 

I guess the comment I would make is that it’s just great to see 

these public-private partnerships. I mean, that’s ideally the way 

things are supposed to work. We are in this together. It’s not one 

28 

versus the other, but helping one another get the job done for humans and, in this case, for our animal friends. 

As a veterinarian, I am very interested in the conditional use approval process. Frankly, in the animal field, we are a smaller population, usually not quite as remunerative as it is with our human 

medical colleagues, and as a result the conditional use process is 

critical for us to be able to access some of these medications in a 

more timely manner and make them available to our patients, and, 

frankly, some of the work that’s done on our patients benefits our 

human colleagues at the end of the day. 

So I am very interested in the potential expansion of the conditional use process, you know, when you were before the HELP 

Committee, you indicated that you felt that at least for the minor 

species, minor use, it was working pretty well. But we are getting 

a little behind the time line. It was 2015, I think, at one point, and 

looking at the expansion of the scope, you alluded to it, I think, in 

your comments both to the Chair and to Mr. Butterfield. 

But when do you think we are going to be finishing this expansion and hopefully getting to full conditional use for the major species as well as the minor? 

Mr. SOLOMON. So thank you for your interest in our issues. So, 

once again, it needs statutory language to expand it for the additional approval in major species. 

Once again, this is not for all uses. This is for significant, serious 

disease conditions, unmet veterinary or medical needs. 

We certainly could see this for certain zoonotic diseases that may 

arise where you need to get a drug out. You want to show that the 

product is safe, which needs to be shown beforehand. Some of the 

efficacy requirements may come later, but in critical public health 

issues, which I am sure you recognize, it might be out there. 

So we met earlier this year with the drug industry. We shared 

the interest in moving this forward. Our staffs have been working 

really closely on this issue over the past month and a half. 

And, if Congress is interested in the conditional approval, we 

would love the opportunity to provide some technical assistance on 

that issue. 

Mr. SCHRADER. Great. I would like to see that move forward, because there are unmet needs and there are some difficult processes. 

Neither one of those, I think, would be a good justification for some 

of the changes in the conditional approval process to be very helpful. 

Getting back to the minor-uses-major-species and minor species 

piece, my understanding from the testimony, there’s only been four, 

really, applications and only one been approved. 

Is there a problem in the process here, or do you need some more 

help from us? 

Dr. SOLOMON. So it is a little disappointing. We’d hoped that 

we’d have—that incentive would be more products out there. Of the 

four products, one was an aquiculture product that got approved— 

clearly, a needed area of resources. 

Two of them demonstrate some of the challenges. So two were 

drugs to fight cancer. One drug, simply the firm withdrew it because it was not demonstrating efficacy. They didn’t have the right 

29 

doses, so they determined, ‘‘Let me take this off the market, go do 

some more work and come back.’’ 

One just couldn’t get the efficacy standard and therefore had to 

be withdrawn, and we have another one that’s currently in the 

pipeline that looks promising. 

Mr. SCHRADER. You’re seeing the incentives seem to be OK? It’s 

just maybe a company is getting used to the process or getting familiar with the opportunity? 

Dr. SOLOMON. Once again, firms that are looking for the—usually in the minor species—are generally small firms, and while the 

economic incentives for major species are often a challenge compared to the human side, it’s even more challenging on the minor 

species side. 

Mr. SCHRADER. OK. 

And then ADUFA III accelerated the process quite a little bit, replaced the end review amendment process and shorter secondround reviews. 

Any problems with safety as a result of doing those things? Any 

problems crop up as a result of making the process more efficient? 

Dr. SOLOMON. No. I think safety is always a paramount concern 

and, once again, our process doesn’t just stop with the approval 

process. 

We have postmarketing activities that monitor the safety of 

drugs. We have the largest adverse event database in the world. 

We work with other countries on harmonizing that data, and we 

use that date if we ever have to make adjustments to a product 

and work with industry to continue to ensure the safe use of animal drugs. 

Mr. SCHRADER. Very good. Thank you, and I yield back. 

Mr. BURGESS. Chair thanks the gentleman. The gentleman yields 

back. 

The Chair recognizes the gentleman from Indiana, Dr. Bucshon, 

5 minutes for questions, please. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

This year’s ADUFA includes a new goal for tissue residue method validation. 

First, can you explain what this is, in layman’s terms, and then 

describe how this validation of tissue residue methods may have 

led to delays in the approval of new drugs in the past? 

And then could you walk us through how you plan to meet the 

new review goal of 120 days for this measure? 

Dr. SOLOMON. So thank you. 

So a tissue residue method is for an animal drug that’s going to 

be used in food-producing animals. We need to develop a method— 

industry needs to develop a method and then we need to do validation of the method to make sure that the levels and the determination of the safety in meat, milk, or eggs has been determined and 

this is the method that would be used to evaluate that in the food 

supply once the product’s on the market. 

We have an office of research as part of CVM that does this 

work. This is the first time we actually put a goal time period to 

be able to meet the objective of developing the tissue residue method and validating that method, and because of the agreement we 

are now able to hire additional resources and research scientists 

30 

that can work out in our office of research to be able to support 

the tissue residue method. 

Mr. BUCSHON. So protecting the public health and providing the 

best animal health and welfare can only be achieved through continued advancements in innovation. 

I hear of a need for more innovation in animal health due to the 

unmet medical needs. What are some of the ways the agency can 

spur innovation to meet some of these needs? 

Dr. SOLOMON. So we are doing a lot of different work to communicate with firms early and be able to get new products on the market. 

One of the ways is we do different surrogate end points. One example is, there’s a disease called Addison’s disease, which is a low 

level of cortisol. Cortisol levels are hard to measure because they’re 

a natural hormone in the body, so we’ve used surrogate end points 

to measure sodium and potassium ratios rather than looking at the 

end point. We use different clinical designs. 

So I talked earlier about the use of drugs in food-producing animals. So, if you’re trying to reduce pain you can’t ask the cow, you 

know, ‘‘On a score of zero to 10, how painful are you?‘‘ 

So we actually worked on it in designing a method with the firm 

that the animals have a foot lameness problem and we actually figured out how to use pressure mats to determine how much weight 

they’re putting on it. 

If they’re less painful, these pressure mats will be able to weigh 

the difference about how much weight they’re putting on those 

mats. So we use those methods. 

We use data from foreign countries so we approved a drug for 

noise aversion. Dogs—some animals get very scared when there’s 

thunder or fireworks, and so we use data actually gathered in European studies, transferred that data because we work closely with 

our international colleagues to try and get that data to be able to 

suffice and reduce the number of animals that are used in studies. 

We use other methods such as—we approved a drug for a folliclestimulating hormone, which is a drug for super ovulation. We did 

that review using literature review and meta-analysis without having to use clinical studies. 

We used every technique that we can to try and get innovative 

products to market by early communication with the firm in designing how these studies should look. 

Mr. BUCSHON. Great. Thank you. 

I yield back, Mr. Chairman. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

Chair recognizes the gentlelady from Indiana, Mrs. Brooks, 5 

minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman, and thank you for 

being here. 

Can you talk a little bit about the improved wait times and what 

the average wait times are for pioneer drug review responses and 

generic drug review responses, respectively? 

Dr. SOLOMON. So there’s two ways that a firm can put drugs onto 

the market. One way is to wait and put all their submissions of all 

their technical sections—their target animal safety, their efficacy 

31 

studies, their environmental review, their human food safety if it’s 

for food-producing animals—and submit that. 

We determined a long time, working with industry, a much better way is to do a phase review process where the firms come in 

much earlier in the developmental process, meet with us early, talk 

about those kinds of design of the studies there, and therefore work 

on each section as they have the appropriate resources and they’re 

gathering the data, submit that data to us, and then that technical 

section gets a review. 

So the wait times are a little—it’s not the same way as it is on 

the human side, because most of these are phased review processes. 

We are working with the firm as they’re doing the studies, submitting those pieces, and we are continuing to meet our—that’s the 

way that the performance goals are written to have the timeframes. 

As mentioned now several times, we’ve been very successful in 

achieving our timeframe for each of those actual submission timeframes. 

Mrs. BROOKS. I understand, though, that prior to the ADUFA fee 

process and user fee programs that there used to be, like, 500 days 

average wait time, 700 for generic. What have you gotten those 

down to, on average, now? And I appreciate it’s an average but—— 

Dr. SOLOMON. Right. 

Mrs. BROOKS [continuing]. What kind of timeframe are we looking at now? 

Dr. SOLOMON. So we are getting closer towards these 180-day 

timeframes. You know, it depends how many times—what the work 

looked like, the quality of the submissions. 

But we’ve dramatically reduced the timeframes from where we 

used to be prior to the use fees. 

Mrs. BROOKS. And congratulations. Anything else you need with 

respect to either the process or resources to increase that wait 

time—or, to decrease that wait time, rather? 

Dr. SOLOMON. The user fee agreements and our work with industry are important to get reauthorized. So we are anxious to get that 

done. 

Mrs. BROOKS. Can you talk to us a little bit about what are some 

of the unmet needs in animal medicines? And I am sure there are 

many. 

Dr. SOLOMON. Right. 

Mrs. BROOKS. Some of the most concerning ones to you. 

Dr. SOLOMON. So continued oncology treatment for cancer treatments. As our pets are living longer, we are getting more cancers 

in our companion animals. Right now, a lot of the drugs used are 

human oncology treatments. The veterinarians would greatly appreciate the opportunity to be able to have drugs that have been 

demonstrated for the efficacious—for the canine or equine or the 

horse or the dog or the cat-type tumors. 

The chronic renal diseases, as our pets are living longer, they’re 

getting more care. We are seeing more osteoarthritis, arthritic conditions, the same thing we see at our older ages. 

32 

We’d love to have drugs for renal disease, congestive heart disease problems that we see. There’s no shortage of unmet veterinary 

medical needs out there. 

Mrs. BROOKS. And finally, can you talk to us a little bit about 

the conditional approval process and hearing more about how that 

will impact the industry? 

Dr. SOLOMON. So, once again, we think conditional approval for 

those type diseases I just talked about where, once again, they 

come in with their package as normal for safety. 

They come in for the same package for the environmental controls, human food safety—all those conditions. It’s only on the efficacy. So it changes the requirement from a reasonable—substantial 

evidence of efficacy, too. 

They have to show reasonable expectation and they need to meet 

that standard within the next 5 years and with the current proposals that we are looking at. 

So it gives them time for those diseases that are more chronic, 

insidious diseases that are harder to measure during a clinical trial 

because you’re monitoring these conditions over a much longer period of time. 

Mrs. BROOKS. Thank you. I yield back. 

Mr. BURGESS. Chair thanks the gentlelady. The gentlelady yields 

back. 

The Chair recognizes the gentlemen from New York, Mr. Collins, 

5 minutes for questions, please. 

Mr. COLLINS. Thank you, Mr. Chairman. Thank you, Dr. Solomon. I am going to step back just a second. As we added these 

user fees, I am assuming all that money goes towards personnel in 

your office? 

Dr. SOLOMON. Correct. 

Mr. COLLINS. And whether percentage of your budget or the 

number of folks, how significant is this to your staffing levels? 

Dr. SOLOMON. So on the pioneer side on animal drug, it supports 

28 percent of our animal drug review costs—what our costs are to 

run the program—and on the generic drug, it’s 62 percent. So there 

are significant contributions to our overall—— 

Mr. COLLINS. But absolutely a direct result, this money is what’s 

bringing our wait times down? 

Dr. SOLOMON. Absolutely. 

Mr. COLLINS. So when you mentioned, you know, some veterinarians are using human drugs, is there an approval process they 

have to go through, cancer or otherwise, to take a human cancer 

treatment and use it in an animal? Do they have to come to your 

agency to get approval to do that? 

Dr. SOLOMON. They do not. So there is authorization for extralabel use and veterinarians can use human drugs in animals without a review. That preference would be from the veterinary community, to have drugs that are specifically approved for animals. And 

so that’s why the conditional approval, for example, would be advantageous. 

Mr. COLLINS. If they do this, I mean, I would think it would helpful to the industry if they also compile data at some point so other 

veterinarians could have a better feel whether this drug is working 

or not. 

33 

Is that just option—it’s not mandatory that they do so as they’re 

using—— 

Dr. SOLOMON. So many of these drugs approved in humans may 

have gone through animal studies. So a lot of times veterinarians 

will take a look at those animal studies and, in fact, we’ve had 

drugs that have been approved. 

Much of the work was done during the human approval. We had 

some drugs for pain in animals. We had some drugs for appetite 

stimulation in dogs. Much of the work, when they came in with a 

submission, was done for those drugs when they were approved on 

the human side, and that information was transferred over, submitted to the approval process, and we went through approval. 

Mr. COLLINS. Although I think a lot of the animal portions of 

human drug trials are more for safety issues than efficacy? 

Dr. SOLOMON. That’s correct. 

Mr. COLLINS. So, now, I am very familiar with the human side. 

But on the animal side, is there the equivalent of a phase one, a 

phase two, a phase three, or is it just a lot more data driven—they 

do their work, they come to you with a submission? Or do they 

have to go through anything remotely resembling what we do in 

human trials? 

Dr. SOLOMON. So there are some similarities about the type of 

data that they need to submit. We use a different process than the 

phased process. 

But they do go through those same type of aspects. So they do 

clinical trials on a small number of animals to evaluate safety. 

They look at safety issues by giving various doses of the drug to 

determine the safety. 

Once safety is looked at, then they start doing efficacy trials, and 

that may be both clinical trials and field trials that may be done 

throughout the—— 

Mr. COLLINS. But, I mean, that’s almost exactly the way we do 

human trials. But is it as formalized, or is folks developing animal 

drugs have a lot more latitude in all those areas to bring a drug 

to market and then—is your involvement more of a review of that 

data that they’ve built without being quite under the same scrutiny 

as human trials? 

Dr. SOLOMON. So we don’t put them through the phases in the 

same way the same type data is collected. But we work very closely 

with them on each of those aspects. 

So they come in early in the developmental process, sit down 

with us, what’s it going to demonstrate to show the target animal 

safety? What are we going to need for the clinical efficacy? 

Each drug is unique, because once again we are using different 

approaches. Are we using different surrogate end points? Are we 

using data from human trials? Are we—— 

Mr. COLLINS. Well, my time is almost up. But is the patent protection similar for this development as it is, and then generics can 

come on board after 17 years or whatever it happens to be? 

Dr. SOLOMON. So I need to get back to you on the patent issues. 

We do have exclusivity issues where the drugs are either for 3 

years or 5 years when a pioneer comes on before a generic product 

can come on the market. 

34 

Mr. COLLINS. So significantly reduced time compared to human 

drugs? 

Dr. SOLOMON. On the exclusive marketing, yes. 

Mr. COLLINS. Very good. Well, thank you. This is very informative. 

I yield back. 

Mr. BURGESS. Chair thanks the gentleman. The gentleman yields 

back. 

The Chair recognizes the gentleman from Florida, Mr. Bilirakis, 

5 minutes for questioning. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. Appreciate it. 

Dr. Solomon, would you briefly explain how ADUFA and 

AGDUFA improved FDA regulations as far as the public health is 

concerned and how the most recent proposed changes will benefit 

FDA and public health? 

Dr. SOLOMON. So, by getting new products, new animal drugs to 

the market, many of these drugs are very important for food-producing animals, which directly affects public health. 

When we get a new antimicrobial, for example, for use for treating a disease in food-producing animals, we have the resources to 

try and do the human food safety aspect of that review. 

That review includes all the toxicology review, the residue review, which I talked about before with the tissue residue method. 

But it also looks at the microbial review process. Is this a product 

that could affect humans and is medically important in humans, 

and therefore could cause antimicrobial resistance? So that’s all 

part of the review process that directly affects public health. 

Mr. BILIRAKIS. OK. Very good. 

How has consolidation in the industry impacted the review process? 

Dr. SOLOMON. So, on the pioneer side, there’s been considerable 

consolidation that’s taken place. From our perspective, they become 

more familiar with it and therefore the submissions—they understand better the products out there. 

It also has an effect that sometimes it reduces the number of applications. So when a company has had mergers in several drugs, 

they often look at their portfolio, and it may result in some products being withdrawn from the market. 

Mr. BILIRAKIS. OK. What are the consequences of not reauthorizing these user fee programs? 

Dr. SOLOMON. So I hope no one wants to go down that path, because it’s significant. 

Mr. BILIRAKIS. Tell us why. 

Dr. SOLOMON. Again, we’ve achieved these timely review processes. It would create instability in the industry. We’ve become 

very predictable on the timeframes and the pathways for these 

products. 

It would be significant in terms of our staff. We have 115 staff 

that are currently employed using the user fees. Depending on the 

timing of when reauthorization would look, we would have to give 

notices, and it would make great challenges for our future staffing. 

People would not want to come to work for the Center of Veterinary Medicine, where we have outstanding scientists and reviewVerDate Mar 15 2010 09:57 Oct 11, 2018 Jkt 037690 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\115X109ANIMALDRUGSPDFMADE WAYNE
35 

ers, veterinarians that come on if there was uncertainty about this 

pathway. 

Mr. BILIRAKIS. Well, thank you. 

Mr. Chairman, I yield back the balance of my time. Thank you. 

Mr. BURGESS. Chair thanks he 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. 

All right. So what can we do to help to bring some of these ideas 

that you talked about, the antimicrobials that are being used, and 

trying to make sure that we have drugs for the animals but that 

they don’t affect humans? 

What can we do to move that process along to make it a little 

quicker? 

Dr. SOLOMON. So we are working very closely on the antimicrobial resistance issue. It’s a significant public health issue. 

We work on judicious use policies, both on the human side—my 

counterparts work on the human side, we work on the animal side 

of that issue. 

We work closely with industry to withdraw all the claims for use 

that was production uses for feed efficiency and growth promotion. 

Industry worked over the past 3 years. As of January of last year, 

all those were withdrawn. 

We continue to work at monitoring both sales of antimicrobials 

and monitoring, through our national antibiotic resistance monitoring system, antibiotic usage. 

Our colleagues at the American Veterinary Medical Association 

put out to the veterinary profession principles of good stewardship 

of antimicrobial use and principles about how to apply that and the 

definitions associated with that. Our American Association of Veterinary Medical Colleges has developed curriculum to be able to 

educate the new generation on what judicious use looks like. 

We continue to need to work both domestically and internationally on getting better data to monitor antimicrobial resistance over 

time. 

Mr. GRIFFITH. All right, I am going to shift gears on you, and feel 

free to tell me that it’s not my department, but I had some folks 

come to me recently—and I represent the part of Virginia that has 

Virginia Tech, where a lot of research is being done—and they 

were talking about genetically modified calves. 

And when they finished with their testing on, you know, rearranging the genes in the calf, they have to kill the mother. I am 

trying to figure out why. Do you have any help—can you help me 

there? 

Because why would the mom be affected by a genetically modified calf when the calf is placed there out of a test tube, and it has 

nothing to do with her other than she’s the vehicle in which the 

calf is being—— 

Dr. SOLOMON. So I don’t think I can answer the question on the 

mother. 

Mr. GRIFFITH. And that’s fair. I thought that might be the case. 

Dr. SOLOMON. But in a genetically modified animal, they do need 

to go to a review process to make sure these animals are safe, and 

36 

if someone’s going to eat them that the modification makes it safe 

for people to eat. 

Mr. GRIFFITH. And I recognize it’s not necessarily your field, but 

it’s something we might want to look at at some point, Mr. Chairman, is that they get that with the genetically modified calf, and 

so when they finish their experiment they understand they have to 

kill the calf. But I can’t figure it out. 

Now, you know, it’s not my field. So maybe there’s a small country lawyer—there’s some obvious answer. But if you could maybe 

see if you could find me the right person to answer that question. 

Why does the mother have to be killed because, you know, the 

mama is a valuable asset, and when you’re doing research and you 

suddenly have to start killing off assets that—I can’t figure out nor 

could this individual who brought this to me figure out why the 

mother also has to be killed. 

The calf, I get. You don’t want to put that calf into the marketplace, and maybe you don’t want to put mom in the marketplace, 

but you could use her again if she’s able to have more than one. 

They’re not able to do that right now. But I appreciate it. 

Dr. SOLOMON. We are happy to take a look into the issue. 

Mr. GRIFFITH. And I appreciate that. 

And with that, Mr. Chairman, most of my questions having previously been asked, I yield back. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

Chair recognizes the gentleman from Illinois, Mr. Shimkus, 5 

minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. Sorry I am late. We 

were at another hearing. I am sure you have heard that before, and 

I wish I would have been here for Kurt Schrader’s questions, since 

he’s a veterinarian, and I would have loved to hear. Maybe I will 

check his questions for the record. 

But the last—we started going into this antimicrobial resistance 

discussion, and the only thing I wanted to raise was—and I know 

you have all talked about the conditional approval authority extensively, which is good. 

How might you, in this antimicrobial resistance, can expand and 

improve your antimicrobial resistance provision as we move to—I 

call it AGDUFA—AGDUFA III? 

Dr. SOLOMON. So I think there’s opportunities under—if conditional approval for serious medical conditions that are treating 

public health issues, there’s opportunities for alternatives to antibiotics to be potentially used under conditional approval, and I 

think we’d welcome those opportunities. We have approved a drug 

that’s an alternative to antibiotics. It’s given to dairy cows to try 

and prevent mastitis. It increases the number of neutrophils in the 

bone marrow to be able to fight infections. I think we are looking 

for other innovations that could be used as alternatives to 

antimicrobials, and I think conditional approval may be another incentive to try and get those products to the market. 

Mr. SHIMKUS. Yes, and I should have asked this question first to 

set up the second one, but what are the barriers you have right 

now under current law on this debate? 

37 

Dr. SOLOMON. So the conditional approval Congress approved for 

only minor use in major species or minor species. 

In order to use it in major species under the unique conditions 

that we’ve defined, it needs new statutory authority because it 

was—right now, efficacy needs to be demonstrated at the same 

time as target animal safety, human food safety, the environmental 

review process. 

The conditional approval allows all the human food safety. The 

other pieces—the technical sections to be reviewed allows the product on the market 5 years. Industry can demonstrate the efficacy, 

comes back in and gets the full approval. 

Mr. SHIMKUS. Do you agree with that, Schrader? 

Mr. SCHRADER. Yes. Yes, I do. I mean, he outlined a current 

process and stuff. But we do need to expand the conditional use opportunities for major species. I think—— 

Mr. SHIMKUS. Good enough for me. Yield back my time. Thank 

you. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

The Chair recognizes the gentleman from Oklahoma, Mr. Mullin, 

5 minutes for questions, please. 

Mr. MULLIN. Well, that is good timing. Thank you, Mr. Chairman, and Dr. Solomon, thank you so much for you taking the time 

to be with us. 

A couple questions that I have. Wwhat is the timing? We’ve been 

talking a lot about conditional approvals. What’s the timing on 

this? Do we know what we are looking at, how we can more predict 

in the industry level? 

Dr. SOLOMON. So, once again, I think we’ve worked very hard 

with industry over the long period of time but more expeditiously 

recently to try and get a common understanding of conditional approval. 

I think there’s a good understanding of the scope that we’ve described here about its use for challenging efficacy issues, serious 

medical conditions. 

So we’d be interested in, you know, if Congress wants to take 

this on we’d welcome the opportunity to give some technical assistance to it. 

There may be some remaining issues that would need to be 

worked through, through either a guidance or a regulatory process. 

But getting the statutory authority while ADUFA/AGDUFA would 

be an opportunity. 

Mr. MULLIN. Do you know what you would need from Congress? 

Because I am committed to working with you, and the industry is 

wanting to work with you. 

We are wanting to see this move forward, I mean, because 

under—I mean, as we know, underneath the idea, which passed in 

2004, we’ve only seen, what, four different drugs that’s actually 

been able to come out of it, and I don’t think that was the intent. 

Originally, the intent was to help incentivize the industry on coming up with new ways and new paths to build—to be able to 

produce and enhance the treatment for the animals. 

38 

So what would you need from Congress? How could I work with 

you? Because, in all seriousness, I really want to see this go as far 

as what Congress I think first intended in 2004 for it to go to. 

Dr. SOLOMON. So once again, in 2004, it was for the minor species and minor uses. 

Mr. MULLIN. Right. 

Dr. SOLOMON. We are now having discussions—can we expand 

that to major species under unique conditions? We would welcome 

the opportunity to work on technical assistance to try and—— 

Mr. MULLIN. Who needs to be at the table on that? 

Dr. SOLOMON. The industry is, clearly, at the table. 

Mr. MULLIN. Right. 

Dr. SOLOMON. American Veterinary Medical Association, a lot of 

people that are sitting here today. 

Mr. MULLIN. Are we the ones missing at the table then? I mean, 

you said you’re welcome to work with Congress on this. I am just 

looking for a path. How do we need to inject ourselves into this conversation without confusing it? 

Dr. SOLOMON. I think technical assistance for some language 

that I think has been floating around. Once again, this is a recent 

development. 

We recognize this. We’ve recognized timeframes are challenging, 

but we welcome the opportunity to try and get this important piece 

added. 

Mr. MULLIN. Well, we worked with industry some as far as looking for language that’s needed. Have you had a time to look at it 

yet? 

Dr. SOLOMON. So we’ve had staff working very closely with the 

industry on that piece. 

Mr. MULLIN. But you haven’t got a look at it yet? 

Dr. SOLOMON. We would like the opportunity, sort of taking that 

language if we get requested by Congress and be able to provide 

formal agency review of it. 

Mr. MULLIN. I guess that’s where I am confused. Is it simply me 

saying, ‘‘I want you to look at it,’’ or is there—and I am confused 

here—does it take actual legislation for us to give you—— 

Dr. SOLOMON. I think its only request that if Congress is—which 

sounds, you know, a lot of interest here on conditional approval. If 

you came to us we’d be happy to provide technical assistance to 

give a formal agency position to try and have it in front of you to 

decide to include it in the ADUFA/AGDUFA—— 

Mr. MULLIN. Well, let me talk with the committee so I am not 

stepping in front of the chairman on this and find out for sure what 

the committee wants. 

But I was under the understanding that’s where we are wanting 

to move to. But I will get back to you personally, and then I look 

forward to working with you moving forward with it. 

Dr. SOLOMON. We welcome that opportunity. Thank you. 

Mr. MULLIN. Thank you, sir. 

And with that, Mr. Chairman, I will yield back. 

Mr. BURGESS. Gentleman yields back. 

The Chair would observe that the gentleman might want to work 

with the primary author of the bill. Oh, that is the gentleman. So, 

yes. 

39 

[Laughter.] 

But we will work with you, Mr. Mullin. 

Mr. MULLIN. I don’t want to overstep the committee because you 

have been very gracious to me. 

Mr. BURGESS. We will work with you, absolutely. 

Chair now recognizes the gentleman from Texas, Mr. Green, 5 

minutes for your questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. I apologize for being late. 

Thank you, Dr. Solomon, for being here today, and as you explained in your testimony, over the last 2 years FDA has been 

working to finalize recommendations for reauthorization of the animal drug user fees and has held negotiations with regulated animal drug and generic animal drug industries in order to reach an 

agreement on both financial and performance goals for the next 5 

years. 

These recommendations were finalized and transmitted to Congress for consideration early this year. Dr. Solomon, you noted that 

the FDA is currently delivering predictability—high levels of performance against the ADUFA and AGDUFA goal commitments for 

a timely review. 

Under ADUFA IV and AGDUFA III, do you believe this high 

level of performance will continue? 

Dr. SOLOMON. With the additional resources that have been negotiated and put forward, yes, we are committed to continue to 

meet the high levels of performance. 

Mr. GREEN. Is this why the performance recommendations for 

most of the submission types for pioneer drugs remains consistent 

with the current goals? 

Dr. SOLOMON. That’s correct. 

So once again, we’ve reduced timeframes for most of those submissions. We added four new areas this time, of particular importance to some of those commitments for early communication with 

the industry early in the development process. 

Mr. GREEN. For generic animal drug submissions, FDA’s performance goal review times have been shortened. Can you explain 

how the FDA plans to meet those new timeframes? 

Dr. SOLOMON. So there was significant new resources associated 

with the generic drug. The industry really wanted to be able to get 

the generic drugs to the market sooner, and so they committed additional resources. 

We plan on hiring the scientific support staff to be able to conduct those reviews. There has been a tremendous increase in generic drug submissions over the past couple years. 

The workload has increased tremendously. In fact, we had over 

a 50 percent increase in the last year on generic drug submissions. 

Mr. GREEN. Thank you. 

Can you explain how the financial recommendations in the 

AGDUFA III negotiated agreement have changed from AGDUFA 

II? Additionally, can you explain the rationale for those changes? 

Is it mainly just an increased funding? 

Dr. SOLOMON. So there’s increased funding. We also made the 

funds more readily available. So one of the conditions is, historically there used to be a process where, if there’s excess collections 

40 

of funds, you’d have to wait to the last year of the agreement in 

order to be able to use them. 

We negotiated with industry. They would like and we would like 

to be able to use those funds earlier. There were some changes in 

the inflation index that took place to make it a variable inflation 

index, and there was changing the base years that we were using 

for the negotiations. So all agreed upon. 

Mr. GREEN. Are there any other performance and financial recommendations from the new proposal that should be highlighted? 

Dr. SOLOMON. The tremendous changes on the generic drug side 

dramatically reduce the timeframes associated with those. So I 

think the industry and FDA would be very excited about meeting 

those new timeframes, because they’re significant reductions. 

Mr. GREEN. I want to thank you, Dr. Solomon. These performance and financial goals are critical aspects to the ADUFA and the 

AGDUFA programs and will chart the course for the next 5 years. 

I am pleased that the FDA and the animal health industries 

have reached agreement and look forward to the swift reauthorization of these important programs. 

And Mr. Chairman, I yield back. 

Mr. BURGESS. Chair thanks the gentleman. 

The Chair recognizes the gentleman from North Carolina, Mr. 

Hudson, 5 minutes for your questions, please. 

Mr. HUDSON. Thank you, Mr. Chairman. Thank you, Dr. Solomon, for your time today. 

In my home State of North Carolina, agriculture is the numberone industry. Poultry is the number-one sector, making up 40 percent of our State’s total farm income. 

All told, it’s about $4 billion a year, or 10 percent of our total 

State product. One issue that pops up continually for our chicken 

and turkey farmers is blackhead disease. This highly transmittable 

disease can wipe out an entire turkey flock in weeks, disrupts 

breeding cycles for chickens, causes millions of dollars in damage 

to my farmers back home. 

This disease occurs sporadically but has a high impact every 

time it strikes a farmer’s flock. Unfortunately, no medication exists 

at this moment to treat or cure this disease, meaning that if your 

flock is hit, it’s guaranteed to hurt. 

Because this disease requires a spontaneous biological event to 

occur, it’s almost impossible to create controlled trials to study the 

disease or the efficacy of the drug. 

One thing my colleagues, Markwayne Mullin and Dr. Bucshon, 

noted earlier and I’ve been examining is the conditional approval 

that’s gotten a lot of attention here in this hearing—a pathway for 

major use, major species. 

Blackhead disease is just one disease of many where a conditional approval pathway would help drug makers get medications 

to farmers and pet owners that are currently unviable for the traditional approval pathway. 

So in your testimony you note that the CVM is committed to continuing to explore conditional pathways. Do you agree that the conditional approval pathway for major use in major species would 

help bring innovative therapies that can treat diseases like blackhead disease to market? 

41 

Dr. SOLOMON. I do. We’ve done a lot of work on blackhead. We’ve 

recognized that’s one of those unmet veterinary medical needs out 

there. 

We’ve asked for the industry, in the turkey industry that suffers 

from this the most, that they may be eligible under our minor use, 

minor species, but we need data presented to try and do that. 

If they’re unable to meet that, then this new conditional approval 

proposal would be welcome. It’s a challenging disease to treat because of many of the sporadic conditions, seasonal nature of it. It 

would be one that, you know, demonstrating efficacy over a longer 

period of time could be valuable tool in the arsenal. 

Mr. HUDSON. Right. Well, I appreciate that, and my colleague 

Markwayne Mullin and others have I think clearly established that 

we want to work with you on this and, you know, we welcome any 

feedback you have on any requirements that make conditional approval pathway feasible—you know, what you need from us to 

move forward on this, and rather than continue to beat that dead 

horse, I would just ask do we have your commitment that we’ll 

move as quick as we can together to find a way forward on this? 

Dr. SOLOMON. We are ready, willing, and able to work with you 

on that issue. 

Mr. HUDSON. Great. I appreciate that very much. 

Unrelated to conditional use, but just out of curiosity for me: Off 

the top of your head, what’s the longest amount of time that CVM 

has spent reviewing a single drug? 

Dr. SOLOMON. That’s probably the genetically engineered salmon, 

which went on for a significant period of time for a lot of different 

reasons. 

Mr. HUDSON. What do you think just in general the reasons for 

long review cycles are? 

Dr. SOLOMON. So for that particular review, that was unique— 

the first genetically engineered animal for food-producing animals. 

You need to develop how are you going to evaluate the safety, the 

efficacy of something that’s so new and novel. 

It was one also of great concern from an environmental area, 

which is part of our requirement, you know, what’s the potential 

for a genetically engineered animal to get loose—either get into the 

wild, even though they’re sterile animals—poses lots of different 

challenges, looking at our typical review process with something 

unique. 

Now that we’ve been through those processes, we’ve answered 

many of those questions. 

Mr. HUDSON. Well, just in a more typical review process, you 

know, what are some of the reasons that these sometimes take 

longer? 

Dr. SOLOMON. So data quality is an important issue for us. We 

constantly are working with the industry—the more higher quality 

the data, then we’d have to go back to these issues. 

Efficacy requirements in certain disease conditions can be very 

challenging. We’ve been challenged, for example, on heartworm disease. We try and—as there’s been resistance to various new—some 

of the different parasites—it becomes more difficult to demonstrate 

efficacy over a period of time. 

42 

So it’s kind of, evolution of some of the disease conditions over 

time poses challenges on proving efficacy. 

Mr. HUDSON. Well, I appreciate your testimony very much. 

Mr. Chairman, I will yield back. 

Mr. BURGESS. Chair thanks the gentleman. 

Chair recognizes the gentleman from Georgia, 5 minutes for your 

questions, please. 

Mr. CARTER. Thank you, Mr. Chairman. 

Thank you, Dr. Solomon, for being here. Appreciate that very 

much. 

Let me ask you something. It’s my understanding in a new animal drug application that the drug sponsors are responsible or submitting information, and it’s quite detailed and quite thorough. 

From what I understand, in the application it’s going to include 

information on the drug’s chemistry, the composition, the component ingredients, manufacturing methods, facilities and controls, 

proposed labeling—on and on and on. 

And not only that, but also if the drug product is intended for 

use in a food-producing animal, that it also has to be proven for 

human use, and I am just—and all this burden falls on the drug 

sponsors. 

And it just appears that it’s more than even what—the guidelines for animal drug are more stringent than they are for human 

drug applications. And I am just interested to know, first of all, do 

you think that’s true, and secondly, if it is, why is that? 

Dr. SOLOMON. So, just to take a step back, so with all due respect 

to my human colleagues on review, they have one species to deal 

with. 

Often we have to deal with multiple species. So many of the applications, they don’t want to market it in multiple species at the 

same time. 

And that’s a challenge, because there’s different pharmacology 

versus pharmakinetics in different species out there. We also have 

the responsibility in food-producing animals to make sure that this 

is going to be safe for humans. 

So, once again, I think our safety and efficacy and environmental 

reviews are very similar to the human side. But when it comes to 

either multiple species or the human food safety issues, they’re 

unique to the animal side. But that’s part of our responsibility to 

the American public to make sure that the food is safe. 

Mr. CARTER. Fair enough. Good answer. Thank you. 

I want to talk to you about animal drug compounding. This is 

certainly something that the FDA has—or drug compounding period is something the FDA has been involved in here recently, and 

rightfully so. 

But when it comes to animal drug compounding, it’s my understanding that it’s legal only in very specific circumstances, according to the FDA, and as a result of the Drug Quality Security Act, 

there were some changes that were made and, from what I understand, the FDA rescinded their initial guidelines and that they are 

now looking at and coming up with new guidelines. 

Are you familiar with that, and what kind of time line are we 

looking at here? 

43 

Dr. SOLOMON. So we did have a guidance on compounding. As 

you’re very well aware, it’s a challenging issue to find the right balance. 

There is some need for compounding out there. We don’t want 

that to either prove a safety issue to animals, and we don’t want 

that to undermine the approval of pioneer or generic drugs. 

So compounding within a veterinarian/client/patient relationship 

is something important because veterinarians need access to that. 

So our previous guidance, there was confusion about applying the 

DQSA, the Drug Quality Security Act, which does not apply to the 

animal side of the house. 

Mr. CARTER. Right. 

Dr. SOLOMON. We wanted to clarify that it was never intended 

to apply to that. 

Mr. CARTER. Thank you. 

Dr. SOLOMON. It also—back to my multiple species issues, the 

previous guidance only addressed compounding for companion animals, and as I’ve sort of talked about several times now, we have 

the challenge of compounding for food-producing animals, companion animals, and minor species. 

So we decided to rescind that compounding guidance. We are 

working on it. We expect over the next several months to be able 

to issue a new compounding guidance, where it would be, once 

again, cover the whole spectrum of the species, be clear about not 

applying the DQSA, trying to apply that right balance of where 

compounding is appropriate, and we’d welcome the opportunity 

once that’s out to come brief Congress. 

Mr. CARTER. OK. Are you soliciting the input of the animal drug 

compounders while you’re formulating this? 

Dr. SOLOMON. We are talking to lots of stakeholders and, once 

again, this will be another proposal. So we welcome the opportunity 

when this comes out for a proposal to continue to engage with 

folks. 

Mr. CARTER. Well, thank you for mentioning accessibility, because that’s extremely important. I can tell you, as a practicing 

pharmacist for over 30 years before I became a Member of Congress, this was something we typically worked with our veterinarians and, you know, it was very detailed. 

So the accessibility part of it is very important, as well. Good. 

Thank you very much, and I yield back, Mr. Chairman. 

Mr. BURGESS. Gentleman yields back. The Chair thanks the gentleman. 

I believe that concludes questions from Members for your panel, 

Dr. Solomon. We do, again, want to thank you for being with us 

and providing your expert testimony today, and certainly as we 

work through this we will take what you have shared with us 

today to heart. 

And we are going to have the briefest of transitions to our second 

panel. Dr. Solomon, you’re excused, and we’ll ask our second panel 

to take their places. 

Dr. SOLOMON. Thank you very much. 

[Pause.] 

44 

Mr. BURGESS. So I thank our second panel of witnesses, and I 

want to thank you for being here today, taking time to testify before the subcommittee. 

We are going to give each of you an opportunity to give an opening statement, and that will be followed by questions from Members. 

So today, on our second panel we are going to hear from Dr. Rachel Cumberbatch, the Director of Regulatory Affairs, Animal 

Drugs, at the Animal Health Institute; Mr. Bill Zollers, chairman 

of Generic Animal Drug Alliance; and Dr. Michael Topper, president of the American Veterinary Medical Association. 

We appreciate each of you being here with us today. 

Dr. Cumberbatch, you’re now recognized for 5 minutes to summarize your opening statement. 

STATEMENTS OF RACHEL CUMBERBATCH, D.V.M., DIRECTOR, 

REGULATORY AFFAIRS, ANIMAL DRUGS, ANIMAL HEALTH 

INSTITUTE; BILL ZOLLERS, PH.D., CHAIR, GENERIC ANIMAL 

DRUG ALLIANCE; AND MICHAEL J. TOPPER, D.V.M., PH.D., 

PRESIDENT, AMERICAN VETERINARY MEDICAL ASSOCIATION 

STATEMENT OF RACHEL CUMBERBATCH 

Dr. CUMBERBATCH. Thank you, Mr. Chairman. 

I am a veterinarian here today on behalf of the Animal Health 

Institute, a trade association that represents companies that make 

medicines for animals. 

I am here to ask Congress to reauthorize the animal drug user 

fee program, also known as ADUFA, and to provide a pathway for 

sponsors to meet unmet medical needs by enhancing opportunities 

for innovation. 

The animal health industry makes important contributions to the American economy. Fueled by $9.9 billion in sales of medicine, the 

U.S. animal health industry employs over 21,000 workers and generates more than $1.2 billion in wages. 

It accounts for $1.2 billion in taxes and maintains a positive 

trade balance. Furthermore, animal health products directly contribute to the economy of other industries, including veterinary 

services, animal production, meat and dairy production, and pet 

services. 

Combined, these four industries generated $548 billion in output, 

created more than 1.4 million jobs, and paid over $52 billion in 

wages in 2016 alone. 

These contributions extend to every State, in every congressional 

district where people own pets and families rely on the availability 

of safe food. 

The Animal Health Institute strongly supports the ADUFA program. This new agreement builds on the success of this program. 

Funding will increase from $118 million in ADUFA III to a total 

of $150 million in this 5-year agreement. 

This includes a one-time influx of funds that will be devoted to 

information technology so that CVM can transition to electronic filing of new animal drug submissions and can eliminate all paper 

submissions. 

45 

Current inflation and workload adjustment factors remain as 

they are while AHI has agreed to allow FDA to reinvest surplus 

funds into the program. 

Existing sentinel timeframes will remain the same or be slightly 

reduced, and all current review process changes from the previous 

ADUFA agreement will remain in place. 

There is one important piece of business from ADUFA III which 

we are asking Congress to help us complete. ADUFA III contained 

a provision that FDA and AHI would enter into discussions on how 

to more broadly extend the conditional approval process. 

Conditional approval is currently available only for minor uses 

and minor species products. These efforts aim to find a way to expand a pathway to major species applications. 

Those discussions took place and were productive, bringing each 

side to near agreement on an approach. However, when we got to 

the ADUFA IV, CVM was precluded from discussing this issue as 

part of the agreement. 

More than a year ago, this committee commendably came together and approved the 21st Century Cures Act to spur innovation 

in human therapies. By all indications, it is working, and now we 

ask that you include in this legislation a measure to similarly spur 

innovation in animal health. 

Conditional approval for animal health products exist at the EPA 

as well as the U.S. Department of Agriculture and, as we said, it 

also exists for minor use, minor species at the FDA. 

Expanding the current authority to major species would drive innovation and, most importantly it would lead to the approval of 

new products for serious diseases which there are no available 

treatments and which it is difficult for clinical effectiveness to be 

proven via controlled studies. 

Thank you for holding this hearing on this important piece of 

legislation, and thank you for the opportunity to speak to you today 

about how keeping animals and humans safe using medicines also 

helps with public health. 

Thank you. 

[The prepared statement of Dr. Cumberbatch follows:] 

46 


30574.013

Testimony of Or. Rachel Cumberbatch 

Animal Health Institute 

Subcommittee on Health, Energy and Commerce Committee 

March 14, 2018 

Mr. Chairman and members of the Committee: 

Thank you for holding a hearing on this important piece of legislation, and for the opportunity to speak 

to you today about the important human and animal health benefits that result from using medicines to 

keep animals healthy. 

My name is Dr. Rachel Cumberbatch and I am a veterinarian here today on behalf of the Animal Health 

Institute, a trade association that represents companies that make medicines for animals. 1 am here 

today to ask Congress to reauthorize the Animal Drug User Fee (ADUFA) program and provide a pathway 

for sponsors to meet unmet medical needs by enhancing opportunities for innovation. 

The animal health industry makes important contributions to the American economy. Fueled by $9.9 

billion in sales of medicines, the U.S. animal health industry employs 21,257 workers, accounts for more 

than $1.2 billion in wages and $1.2 billion in taxes and maintains a positive balance in trade. 

Furthermore, animal health products directly contribute to the economic activity of other industries 

including veterinary services, animal production, meat and dairy production, and pet services. 

Combined, these four industries generated $548 billion in output, created almost 1.4 million jobs, and 

paid over $52 billion in wages in 2016. These contributions extend to every state, and every 

Congressional district, where people own pets and where people rely on food to be safe. 

But the contribution of animal health goes far beyond dollars and cents. Over 67% of U.S. households 

own pets, with nearly half owning a dog and over one-third owning a cat. In total, American households 
47 


30574.014

own approximately 393 million pets. These households rely on routine veterinary care and animal health 

products to keep pets healthy. Animal owners can enjoy their companions without the fear of exposure 

to diseases like rabies or pests like fleas and ticks. As pet owners look for solutions to increase the length 

and quality of life for their pets, cutting edge treatments for pet health problems, such as arthritis and 

cancer, are becoming more common. These are the statistics behind what we call the human-animal 

bond, and this bond is strengthened by medicines to both treat and prevent diseases in pets and keep 

families safe by preventing the transfer of disease from pets to humans. 

Animal health products also give veterinarians, and livestock and poultry producers, the necessary tools 

to protect the health and well-being of 9 billion food producing animals annually. A vital first step in 

producing safe meat, milk and eggs is keeping animals healthy. Veterinarians work hard to prevent 

disease in animals, but it is important for them to have medicines available when needed to treat a 

disease or disease threat. 

The statutory standard for Food and Drug Administration (FDA) approval of animal drugs under the 

Federal Food, Drug and Cosmetic Act is the same as that for human drugs: they must be proven to be 

safe and effective. As a result, the animal drug approval process looks much like the human drug 

approval process: animal drug companies submit data packages to demonstrate safety, efficacy, and the 

ability to meet the same stringent FDA manufacturing standards. It is a costly process, requiring as 

much as $100 million and 7-10 years to bring an animal drug to market. In the case of food animals, the 

standard to ensure that meat, milk, and eggs are safe for human consumption adds an additional set of 

requirements that increases the cost and time to market. 

The market for animal drugs, however, is nothing like the market for human drugs. Our products are 

used to treat seven different major species of animals and many more minor species. A blockbuster 

animal drug will have sales of $100 million, and the vast majority of animal health products have a 
48 


30574.015

market size of around $1 million. There is no Medicare or Medicaid and, except in rare cases, no 

employer supported health insurance-- the cost of animal drugs is borne in full by the animal owner. 

Animal health companies rely on a rigorous, efficient, predictable and science-based review process at 

the FDA's Center for Veterinary Medicine (CVM) to provide these products that are not only safe and 

effective, but also affordable. The Animal Drug User Fee Act, first enacted in 2003, made it possible for 

our companies to bolster funding at CVM so that the agency can meet performance standards to 

improve the efficiency and predictability of the animal drug approval process. 

This new ADUFA agreement builds on the success of this program. Funding will increase from a total of 

$118 million in ADUFA Ill to a total of $150 million over the five years, including a one-time influx of 

funds that will be devoted to information technology so that CVM can transition to electronic filing of 

new animal drug submissions and eliminate all paper submissions. Current inflation and workload 

adjustment factors remain as is while AHI has agreed to allow FDA to use over collection of funds from 

one year for program needs in subsequent years. Existing sentinel timeframes will remain the same or 

be slightly reduced, and all current review process changes from the previous ADUFA agreement will 

remain in place. 

In addition to reducing the time for combination clearances, FDA agreed to work on three important 

efforts. 

1. CVM agreed to work towards implementing the US/EU agreement on mutual recognition of 

Good Manufacturing Practices inspections, which were negotiated during the last months of the 

previous Administration. 

2. FDA will implement a new performance metric of 120 days for FDA validation oftissue residue 

methods with additional dedicated funds to accomplish this metric. This process has taken 

considerable time in the past and delayed approval of new drugs. 
49 


30574.016

3. CVM will institute an expedited meeting schedule for critical pre-NADA submission conferences. 

The agreement contains some technical corrections in the Act to permit user fees to apply to Minor 

Use/Minor Species Drug Application reviews, as well as a change in a label requirement on indexed 

minor species products. It also provides an amendment to legally require the NADA number be placed 

on the labels of all approved products. While identification of the NADA on labels has been voluntarily 

adopted by most AHI member for many years this requirement for all sponsors of approved products 

will differentiate -for the producer and veterinarian - legally approved versus unapproved or illegally 

manufactured products. 

There are also a number of minor changes made to the performance standards in an effort to create 

new efficiencies. 

Passage of this important legislation will have several benefits: 

1. FDA/CVM benefits by having additional resources to meet its mission of protecting public 

health. 

2. Animal health sponsors benefit from a stable and predictable review process, allowing them to 

make informed decisions about the investment risks of research and development dollars. 

3. Veterinarians benefit from having new and innovative medical advances available to treat, 

control and prevent diseases in their patients. 

4. livestock and poultry producers, and the veterinarians on whose advice they rely, also have the 

tools needed to keep food animals healthy. 
50 


30574.017

5. Pet owners benefit by having their animals live longer and healthier lives, increasing their 

enjoyment of these companions. 

6. Consumers reap the food safety benefits that come as a result of the availability of additional 

tools to keep food animals healthy. 

There is one important piece of unfinished business from ADUFA Ill which we are asking Congress to 

help complete. ADUFA Ill contained a provision that FDA and AHI would enter into discussions on how 

to more broadly extend the conditional approval process currently available only to minor use/minor 

species products to major species applications. Those discussions took place and were productive, 

bringing each side to near agreement on an approach. However, when negotiations began for ADUFA 

IV, FDA/CVM was precluded from considering this issue as part of the agreement. 

More than a year ago, this committee commendably came together and approved the 2151 Century 

Cures Act to spur innovation in human therapies. By all indications, it is working, and now we ask you to 

include in this legislation a measure to similarly spur innovation in animal health. 

This is a tool that exists in other areas of animal health. Conditional approval exists at the 

Environmental Protection Agency which reviews flea and tick products. It exists at the U.S. Department 

of Agriculture that reviews veterinary vaccines. It even exists at FDA, where Congress in 2004 

authorized conditional approval for minor uses and minor species. Expanding this current authority to 

major species would drive innovation and approval of new products for serious diseases for which there 

are no available therapies and for which it is difficult to establish clinical effectiveness via controlled 

studies. This is often the case where a long term progressive condition takes time to manifest, or where 

there is a lack of effective disease models for use in controlled studies. Conditional approval could also 

aid in the research and discovery in pursuit of alternative therapies to antibiotics. 
51 


30574.018

Authorizing conditional approval in no way reduces safety. Conditional approval requires sponsors to 

provide safety and meet all technical packages but changes the efficacy standard from "substantial 

evidence" to "reasonable expectation" of efficacy. Sponsors can then market the product while 

continuing to collect effectiveness data to satisfy the "substantial evidence" requirement and gain full 

approval. A case can be made that conditional app~oval authority could improve animal safety. 

Providing a veterinarian with a product that has been proven to be safe and has a reasonable 

expectation of efficacy would provide that veterinarian with a better-defined expectation for the 

product than the unapproved drug and off-label human drug now currently used to address unmet 

medical needs. 

Mr. Chairman, CVM has a rigorous, science-based approval process that provides to the American public 

the products necessary to protect public health by protecting animal health. Every year scientists 

uncover new diseases in animals, some of which potentially pose a threat to human health. As more 

animals are raised to feed the planet and as animals are reared closer to people, we will continue to 

need new medicines to protect animal and human health. 

The reauthorization of ADUFA will continue to provide the agency the resources necessary to maintain 

and improve this approval process, provide new and innovative products to allow our pets to live longer 

and healthier lives, and contribute to food safety by keeping food animals healthy. I urge you to pass an 

enhanced ADUFA that improves upon the agreement by authorizing the Agency to extend the 

conditional approval pathway to spur innovation in animal health. 
52 

Mr. BURGESS. Thank you for your testimony. 

Dr. Zollers, you’re recognized for 5 minutes for a summary of 

your opening statement, please. 

STATEMENT OF BILL ZOLLERS 

Dr. ZOLLERS. Thank you. 

Good morning. My name is Bill Zollers, and I serve as the chairman of the Generic Animal Drug Alliance, also known as GADA. 

We are an independent professional trade organization that represents the interests of the generic animal drug industry. We represent sponsors, manufacturers, distributors, suppliers, and service 

providers of generic animal drugs. 

Our products and processes are regulated by the FDA Center for 

Veterinary Medicine. Our members are focused on the development, regulatory approval, and marketing of high-quality generic 

drugs to livestock and pets. 

I would like to thank the committee for inviting me to testify 

today on behalf of GADA in support of the reauthorization of the 

Animal Generic Drug User Fee Act. 

The GADA has previously provided testimony to this subcommittee in support of AGDUFA I in 2008 and AGDUFA II in 

2013. 

Just like with human generic drugs, generic animal drugs provide cost-effective alternatives to pioneer drugs. Lower-cost generic 

animal drug options help contribute to the safety of the Nation’s 

food supply, the treatment of diseases in animals, and the ability 

of owners to provide care to their pet family members. 

However, the potential cost savings from generic animal drugs 

cannot be achieved without broad availability. It is critical that the 

CVM regulatory review and approval process for generic drugs is 

both efficient and predictable. 

Prior to the implementation of AGDUFA I, a CVM review cycle 

of a generic application could take as long as 2 years. In most 

cases, multiple review cycles are needed. So if an application required three review cycles, it could easily take more than 6 to 8 

years to receive approval. 

In the time it took to get an application approved, the market for 

a generic drug could change, making it no longer cost effective. 

This created a disincentive for companies to pursue generic animal 

drug approvals and denied the public cost-effective generic drugs. 

The industry remembers this time in our history. No one involved in the approval process for generic drugs wants to see these 

conditions return. Therefore, the industry is stepping up again to 

support reauthorization of AGDUFA. 

Since AGDUFA began, CVM has reduced the review time of an 

application to a more predictable 270 days. We believe the shorter 

review times are helping contribute to the growth of our industry. 

As part of the current reauthorization of AGDUFA III, the industry has agreed to significantly increase our financial contributions 

so that generic submissions could receive even shorter review periods that are equivalent to pioneer drug submissions. 

As currently written, AGDUFA III will further shorten some critical submission review times from 270 days to 180 days. 

53 

The industry is comprised of many small companies and product 

markets that are much smaller than those for human generic 

drugs. Therefore, it remains vital that congressional appropriations 

continue to be provided to the Center for Veterinary Medicine to 

significantly support the review of generic drug applications. 

Appropriations must continue at an increased level that enables 

CVM to meet its public health mission and the important public 

policy goal of providing generic drug options for farmers and pet 

owners. 

We believe AGDUFA III provides the review time targets that industry requires to counterbalance the financial investment being 

made in support of CVM’s needed resources to build capacity and 

balance the realities of a small but growing generics industry. 

The proposed AGDUFA III enhancement concerning e-submissions should make the approval process more efficient. Also, the 

proposed revisions to the overcollections that offset provisions will 

more immediately reduce the financial burden if overpayments are 

made by the industry. 

Overall, we are hopeful that the reduction and review times will 

lead to a shortened time from project initiation to approval, allowing generic products to come to market sooner. 

In conclusion, the GADA supports the proposed legislation for reauthorization of AGDUFA. 

Thank you. 

[The prepared statement of Dr. Zollers follows:] 

54 


30574.019

GADA 

r'I'L't: 

GENEIIIC IINIMM. DRUG IIU.INKI! 

March 14,2018 

US House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

Dear Honorable Members: 

The Generic Animal Drug Alliance (GADA) is providing testimony to the Subcommittee on 

Health of the Committee on Energy and Commerce in support of the re-authorization of the 

Animal Generic Drug User Fee Act of2018 (AGDUFA). The GADA has previously provided 

testimony to this Subcommittee in support of AGDUFA I in 2008 and AGDUFA II in2013. 

The GADA is an independent professional trade organization that represents the interests of 

generic animal drug companies. We are the only trade organization that represents the interests 

of sponsors, manufacturers, distributors, suppliers and service providers of generic animal 

drugs. Our products and processes are regulated by the Food and Drug Administration, Center 

for Veterinary Medicine (FDAJCVM). Our members are focused on the development, 

regulatory approval and marketing of high quality generic drugs for livestock and pets. 

Just like with human generic drugs, generic animal drugs provide significant benefits to the 

public by providing cost-effective alternatives to their pioneer drug counterparts. Lower cost 

generic animal drug options help contribute to the safety of the nation's food supply, the 

treatment of diseases in animals that can be transmitted to humans, and the ability of owners 

to provide care to their pet family members. However, the potential cost savings to famers 

1 
55 


30574.020

and pet owners from generic animal drugs cannot be achieved without broad availability. 

Therefore, it is critical that the CVM regulatory review and approval process for generic 

drugs is both efficient and predictable. 

AGDUF A was a successful first step in achieving these goals. Prior to the implementation of 

AGDUFA I, a single CVM review cycle of a generic application could take longer than two 

years. In most cases, multiple review cycles are needed, so if an application required three 

review cycles, it could take more than six to eight years to receive approval. In the time it took 

to get an application approved, the entire market for a generic drug could change, making it no 

longer cost-effective to market. This created a disincentive for companies to pursue generic 

animal drug approvals and denied the public cost-effective veterinary generic drugs. The 

industry remembers this time in our history. No one involved in the approval process for 

generic drugs wants to see these conditions return. Therefore, the industry is stepping up again 

to support the reauthorization of AGDUFA. 

Since AGDUFA began, CVM has reduced the review time of an application to a more 

predictable 270 days. In addition, CVM implemented several process enhancements and 

increased communications with industry. We believe the shorter more predictable review times 

are helping contribute to the growth of our industry. As part of the current reauthorization of 

AGDUF A III, the industry has agreed to significantly increase our financial contributions so 

that the generic industry could receive even shorter review periods that are equivalent to those 

experienced by the sponsors of pioneer drugs. As currently written, AGDUFA III will further 

shorten some critical submission review cycle times from 270 days to 180 days. 

2 
56 


30574.021

The industry is comprised of many small companies and product markets that are much smaller 

than those for human generic drugs. Therefore, it is vital that Congressional appropriations 

continue to be provided to the Center of Veterinary Medicine to significantly support the 

review of generic drug applications. For this to be achieved, appropriations must" continue at an 

increased level that enables CVM to meet its public health mission and the important public 

policy goal of providing generic drug options for farmers and pet owners. 

We believe AGDUFA III provides the review time targets that industry requires to 

counterbalance the financial investment being made in support ofCVM's needed resources to 

build capacity and balance the realities of a small but growing generics industry. In addition, 

the proposed AGDUF A III enhancement concerning e-Submissions should make the approval 

process more efficient. Also, the proposed revisions to the overcollections and offset 

provisions will more immediately reduce the financial burden if overpayments are made by the 

industry. This will also make funding more efficiently ready for use by CVM to continue to 

improve the generic drug review process. Overall, we are hopeful that the reduction in review 

times will lead to a shortened time from project initiation to approval allowing generic 

products to come to market sooner. 

In conclusion, the GADA supports the proposed legislation for re-authorization of AGDUFA. 

Without timely reauthorization, we will return to the untenable situation pre-AGDUFA when 

lengthy application reviews served as a disincentive to companies pursuing generic animal 

drugs. It remains critical for the continued viability of the veterinary generic drug industry that 

3 
57 


30574.022

the FDA/CVM review process maintains and improves predictability and efficiency. 

Reauthorization of AGDUF A is critical to continuing to make the pursuit of generic animal 

drug approvals viable and to increase the number of safe and effective generic animal drugs on 

the market. 

Sincerely, 

The Generic Animal Drug Alliance 

4 
58 

Mr. BURGESS. Chair thanks the gentleman. 

Dr. Topper, you’re recognized for 5 minutes for a summary of 

your opening statement, please. 

STATEMENT OF MICHAEL J. TOPPER 

Dr. TOPPER. Thank you, and good morning. 

Like was stated, I am Dr. Mike Topper. I have the privilege of 

being the president of the American Veterinary Medical Association, and on behalf of the AVMA I appreciate the opportunity to 

discuss the importance of reauthorizing the Animal Drug User Fee 

Act and the Animal Generic Drug User Fee Act. 

The AVMA was founded in 1863, and we represent over 91,000 

individual member veterinarians engaged in the many segments of 

professional veterinary medicine, including private practice, public 

health, biomedical research, and many others. 

The FDA Center for Veterinary Medicine’s collection and effective utilization of user fees are important to veterinarians. 

By providing new animal drugs with a predictable pathway to 

market, these fees help provide veterinarians with access to new 

and additional tools that can potentially improve treatment outcomes, provide alternatives to existing therapies, fill unmet medical 

needs in veterinary medicine, and ultimately improve patient care, 

which is the center of veterinary practice. 

The AVMA supports user fees for new animal drug applications 

when the fees are supplemental to appropriations and directed toward expediting the review process for new animal drug products. 

There simply are not enough approved drugs for use in animals. 

Comparisons of FDA data show there are 23 times the number of 

approved labeled indications for human use as there are for animal 

use, and when comparing animal drug products approved for minor 

use and minor species to its human model, which is the orphan 

drug program, that number increases to 26 times. 

Thankfully, through the Animal Medicinal Drug Use Clarification Act of 1994 and its extra-label drug use provision, veterinarians are provided with greater treatment options. 

Of course, there are necessary and appropriate restrictions of 

extra-label drug use in food-producing animals. 

In instances where extra-label drug use is allowed in food and 

companion animals, it is a vital tool that allows veterinarians to 

use animal and human medications labeled for certain indications 

for other clinical instances in which that therapy may be effective 

but for which it is not labeled. 

Our veterinary medical education, clinical training, and understanding of the pharmaceutical products we use enable us to navigate these uncertain waters. But driving innovation and increasing 

the number of improved medications will ultimately lead to better 

patient care, especially in instances where extra-label drug use is 

prohibited. 

Some diseases and conditions lack treatment options due to the 

extended course of the disease or the difficult nature of study. 

Examples in which human drugs are used in an extra-label manner in animals include treatments for heart disease, pain management, gastrointestinal disorders, diabetes, immune-mediating diseases, and cancer. 

59 

While university studies, data collected in foreign countries, anecdotal evidence, and other alternative information all assist in selecting appropriate extra-label therapies, the knowledge that a 

drug used for therapy has been fully evaluated by the FDA and 

shown to be safe and effective is invaluable. 

We have also been encouraged by recent attention given to the 

topic of expanding conditional approval beyond minor use and 

minor species. Extending its applicability to major uses and major 

species would increase the tools in a veterinarian’s pharmaceutical 

tool box. 

A greater number of approved animal drugs helps to ensure that 

veterinary patients receive the best care, and this is the goal of 

clinical veterinarians across the country. 

So thank you for the opportunity to speak on this important topic 

today. We appreciate the attention the subcommittee is giving to 

this issue and the commitment to addressing the unmet needs in 

veterinary medicine. 

Timely passage of this legislation is needed to continue programs 

that increase the availability of pharmaceutical resources in the 

treatment of animal diseases. 

We look forward to working to increase the number of approved 

animal drugs for the benefit of our patients, their owners, and our 

communities. 

Thank you again, and I am happy to answer any questions. 

[The prepared statement of Dr. Topper follows:] 

60 


30574.023

United States House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

Hearing 

"Reauthorization of Animal Drug User Fees 2018: 

ADUF A and AGDUF A" 

March 14,2018 

Testimony of 

Michael J. Topper, DVM, PhD, DACVP 

President, American Veterinary Medical Association 
61 


30574.024

Introduction 

Thank you, and good morning Chairman Burgess, Ranking Member Green, and Members 

of the Subcommittee. I am Dr. Mike Topper, President of the American Veterinary 

Medical Association. On behalf of the A VMA, I appreciate the opportunity to discuss the 

importance of reauthorizing the Animal Drug User Fee Act (ADUFA) and the Animal 

Generic Drug User Fee Act (AGDUFA). 

Founded in 1863, the AVMA represents over 91,000 individual member veterinarians 

engaged in the many segments of professional veterinary medicine, including private 

practice, public health, biomedical research, and more. As an association, we are devoted 

to advancing the science and art of veterinary medicine and advocating on behalf of the 

veterinary profession. 

Background and Support 

The U.S. Food and Drug Administration Center for Veterinary Medicine's (FDA CVM) 

collection and effective utilization of drug sponsor user fees are important to 

veterinarians. By providing new animal drugs with a predictable pathway to market, these 

fees provide veterinarians with access to new and additional tools that can potentially 

improve treatment outcomes, provide alternatives to existing therapies, fill unmet medical 

needs in veterinary medicine, and ultimately improve patient care, which is the center of 

veterinary practice. 

A drug that is approved by the FDA has been shown through rigorous studies to be safe 

and effective for its labeled indication. This gives the veterinarian confidence when 

selecting the drug for use in their patients. Unfortunately, there simply are not enough 

FDA approved drugs for use in animals. In fact, there are far fewer than there are 

approved for use in human medicine. With seven major species and innumerable minor 

species, all of which have many varied diseases and conditions to treat, veterinary access 

to FDA-approved medications for use in numerous diverse species is critical. 

Each animal is different, and therapeutics that are used to treat dogs do not act exactly the 

same in cats, nor in horses, cattle, turkeys, parakeets, koi fish, or any other animal 

species. The inherent pharmacokinetic and pharmacodynamic differences in each species 
62 


30574.025

provide very real hurdles to overcome in the treatment of our patients when there are few 

options with which to help them. Our veterinary medical education, clinical training, and 

understanding of the pharmaceutical products we use enable us to navigate these 

uncertain waters, but driving innovation and increasing the number of approved 

medications will ultimately lead to better patient care, especially in instances where 

extralabel drug use (ELDU) is prohibited. 

The FDA defines "major species" as horses, dogs, cats, cattle, pigs, turkeys, and 

chickens. "Minor species" are all remaining animal species. A "minor use" in a major 

species is defined by FDA in regulation as a drug for a condition that occurs infrequently 

or in a limited geographic area and in only a small number of animals each year. 

A small number of animals is defined by FDA in regulation as fewer than 50,000 horses; 

70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 turkeys; and 

72,000,000 chickens. These numbers translate to very small populations, and the 

availability of animal drugs to treat rare diseases in these limited populations is low. 

A January 2018 review of FDA CVM' s Green Book and Orange Book that list approvals 

of animal drug products and human drug products, respectively, revealed the difference 

between the two is staggering. In fact, comparisons show there are twenty-three times as 

many approved labeled indications for human use than there are for animal use. The 

picture is equally dire for animal drug products approved for Minor Use and Minor 

Species (MUMS), a program modeled after the Orphan drug program. There have been 

approximately twenty-six times the number of approved label indications through the 

Orphan Drugs process as through the MUMS program. For all species treated by a 

veterinarian, most approved indications are for use in one of the seven major species, but 

these disparities highlight the need for more approved drug products for major uses, 

minor uses, and minor species. The lack of approved animal drug products limits 

treatment options in these patients. 

Thankfully, through the Animal Medicinal Drug Use Clarification Act of 1994 

(AMDUCA) and its ELDU provision, veterinarians with a valid existing veterinarianclient-patient relationship (VCPR) are provided with greater prescribing options so that 

animals may receive treatment with therapeutics that are not labeled for that indication. 
63 


30574.026

However, this is not a panacea for the lack of options that are labeled for use in animals. 

Veterinarians must use the safety and efficacy data available to them from veterinary 

literature, alternate sources, and extrapolate data from other studies, data from other 

medications, and data from human medicine. 

To understand the unique needs of veterinarians and complicated nature of veterinary 

therapeutic options when there is no labeled drug available, an understanding of 

extralabel drug use is beneficial. Under the Federal Food, Drug, and Cosmetics Act, the 

FDA has the authority to regulate human and animal drugs. If a use is not indicated on 

the animal drug label, it is deemed unsafe by the FDCA unless it meets specific criteria 

for use under AMDUCA. ELDU is the term that describes the use of an approved drug in 

a manner that differs in any way from the drug's approved labeling. This includes 

deviations from FDA-approved labeling such as: 

• In a species not listed on the label; 

• For an indication not listed on the label; 

• At a different dose or frequency than listed on the label; or 

• Via a different route of administration than listed on the label. 

It is easy to see that drug labels provide essential information to veterinarians. 

AMDUCA appropriately allows ELDU only on the lawful order of a licensed 

veterinarian in the context of a valid VCPR. ELDU is also limited to circumstances when 

the health of the animal is threatened, or suffering or death may result from failure to 

treat. Further, many drugs are prohibited from ELDU for food-producing animals, and 

ELDU is prohibited in the feed offood-producing animals. 

Because of the relative lack of approved animal drug products, ELDU as allowed under 

AMDUCA is a vital tool in veterinary medicine. It allows veterinarians to use 

medications that are approved for use in one species in another, or to use the treatment 

for one disease to treat a different or similar disease. Veterinarians often look to ELDU of 

approved animal drug products or approved human drug products to fill a void where 

there is no appropriate medication approved for that indication. 
64 


30574.027

Understandably, there are necessary and appropriate restrictions on ELDU in foodproducing animals that further limit treatment options. The production of safe and 

wholesome food from healthy animals raised in a healthful environment is part of a 

science-based food safety system, and some drugs are prohibited from use in these 

species entirely. In non-food animals, veterinarians are understandably allowed more 

flexibility and ELDU is permitted ifthere is no appropriate approved animal drug labeled 

for that indication. However, in these circumstances, veterinarians are still often left with 

minimal options to choose an appropriate medication. 

For instance, there are few drugs approved for use in cats. In some circumstances, 

medicines that may be used freely in dogs cannot be used in cats because they are 

metabolized differently. Non-steroidal anti-inflammatory pain medications are one 

example. These medicines, while approved and commonly used in long-term treatment of 

our canine patients for osteoarthritis and other conditions, may have dire consequences 

when given long-term to our feline patients due to potentially harmful side effects. 

Theoretically, human pain medications could be used for pain management in an 

extralabel manner, except this is often medically inappropriate due to toxicity in both 

feline and canine species. This leaves many feline patients with no approved medication, 

and limited options for treatment via ELDU due to the dangerous side effects of these 

medications. 

Many diseases and conditions, due to the extended course of disease, difficult nature of 

study, or difficulty in enrolling patients in clinical studies, also lack treatment options. 

There are many examples in which human drugs are used in an extralabel manner in 

animals, including treatments for heart disease, pain management, gastrointestinal 

disorders, diabetes, behavioral conditions, immune-mediated diseases and disorders, and 

neoplasia. While university studies, anecdotal evidence gathering, and other alternative 

information all assist in selecting appropriate extralabel therapies, the knowledge that a 

drug used for therapy has been evaluated by the FDA and shown to be safe and effective 

is invaluable. 

For these reasons, the A VMA supports user fees for new animal drug applications when 

the fees are directed toward expediting the review and approval process for animal drug 
65 


30574.028

products. The bipartisan and bicameral discussion draft text circulated by the Committee 

would accomplish this objective. 

To ensure adequate availability of veterinary drugs, the A VMA prefers to see 

Congressional funding of the FDA Center for Veterinary Medicine for the New Animal 

Drug Application approval process indexed to keep pace with cost increases. However, 

we recognize that user fees are a valuable tool to expedite the review of new animal drug 

applications, which ultimately puts new animal drugs in the hands of veterinary 

practitioners to apply to their daily practice. 

We appreciate the attention Congress is giving to this legislation to reauthorize user fees 

and provide veterinarians with more important tools with which to treat their patients. We 

feel that more work is needed to attain the program's ultimate goal of more and expedited 

drug approvals. 

Further, we have been encouraged by recent attention given to the topic of expanding 

Conditional Approval beyond minor uses and minor species. Extending its applicability 

to major uses and major species would increase the number of tools in a veterinarian's 

pharmaceutical toolbox. A greater number of approved animal drugs helps to ensure that 

veterinary patients receive the best care, which is the ultimate goal of clinical 

veterinarians across the country. 

Conclusion 

Thank you for the opportunity to provide testimony on this important topic today. We 

appreciate the attention the Subcommittee is giving to this issue and the commitment to 

addressing the unmet needs in veterinary medicine. We look forward to working with the 

Committee and FDA CVM to increase the number of approved animal drugs for the 

benefit of our patients, their owners, and our communities. Thank you again, and I am 

happy to answer any questions. 
66 

Mr. BURGESS. Thank you, Dr. Topper, and I want to thank each 

of you for your testimony, and we’ll move into the second round of 

questions from Members. Let me begin by recognizing myself for 5 

minutes. 

And let me just ask in a very general sense—and I will ask it 

to each of you—how the adoption of the user fees, going back to 

their initiation, how does it fundamentally change the industry? 

So I realize that’s pretty broad, and you have already addressed 

that to some degree. But give me the sound bite, and Dr. 

Cumberbatch, we’ll start with you and then we’ll come down the 

line. 

Dr. CUMBERBATCH. Thank you very much for the question. 

The user fee programs has helped with consistency. Sponsors 

now know when they will hear back from FDA. Also, as Dr. Solomon mentioned, it has allowed them to hire and to increase the 

number of reviewers, which has been very important for helping 

them meet the goals of the time lines. 

Thank you. 

Mr. BURGESS. Yes, Dr. Zollers. 

Dr. ZOLLERS. Yes. As Dr. Solomon indicated, on the generic side 

of things, we’ve seen a tremendous increase in workload on the 

CVM side, and I think that in itself talks to the success of the user 

fee program. 

Ten years ago, when we had 2-year review cycles and we had 12 

or 14 members of GADA at that time, and now today we have 270- 

day review cycles, an increased workload, and over 30 members of 

GADA. So that is all indicative of the growth of our industry. 

Mr. BURGESS. Dr. Topper. 

Dr. TOPPER. Yes, sir. I agree with my colleagues. It has really 

helped in bringing new animal drugs to the market faster, and we 

need to continue with this because that’s what our patients need. 

Mr. BURGESS. So, now, we’ve been through—I guess this is the 

fourth iteration for the animal drug user fee and the third for the 

generic animal drug user fee. 

How has that evolved over time? Do you think that is something 

where we’ve been able to build on the previous levels and increase 

the availability and timeliness of products? 

And, again, Dr. Cumberbatch, we’ll start with you and then come 

down the line. 

Dr. CUMBERBATCH. Thank you. 

In ADUFA I we began with decreasing the backlog, and now we 

are moved on to looking at how we can improve efficiency. From 

here, we will look at how communication can be improved and 

work towards ADUFA goals not just during negotiations for this 

agreement but all through the 5-year agreement and able to work 

together to look at how do we best review products and ultimately 

get additional tools for veterinarians onto the market. 

Mr. BURGESS. Yes, Dr. Zollers. 

Dr. ZOLLERS. Yes, I would agree with a lot of what Rachel just 

said. 

Again, for AGDUFA I, getting through that shock and awe of the 

2-year review cycle and now getting it down to something manageable, now we are focused on how do we reduce the timeframe from 

the time we initiate the project until it’s actually approved. 

67 

And we are having very good conversations and good communication with CVM throughout this process, and we’ll continue to so we 

can try to improve this process even more before we get to 

AGDUFA IV 5 years from now. 

Mr. BURGESS. Yes, sir. Dr. Topper. 

Dr. TOPPER. And, yes, sir, we have been building up all along, 

and we look forward to this new one building even better, moving 

things faster, and if we build different things into this, as we heard 

earlier, it’ll just make it better. 

Mr. BURGESS. To that end—and we’ll start with you this time, 

Dr. Topper, and move back the other way. The electronic submission—do you see that as being—ultimately that’s going to be helpful, correct? 

Dr. TOPPER. Yes, sir. It should speed it up. It should decrease the 

cost to somebody who’s providing, because it’s electronic and they 

don’t have to back up that truckload or send a computer or a hard 

drive in. 

So it will be readily available to the reviewers, and they will not 

have to transcribe it from paper to their own electronic means. 

Mr. BURGESS. Dr. Zollers. 

Dr. ZOLLERS. Yes. We are totally in favor of the electronic system. 

Mr. BURGESS. Dr. Cumberbatch. 

Dr. CUMBERBATCH. As Dr. Solomon mentioned, a majority of 

sponsors of pioneers drugs use the electronic submission system already. 

What we do see is a need to look at the efficiency—how much 

data are we putting in. Electronic submissions are very helpful for 

CVM in getting those to the reviewers. 

What we are trying to find is a good way for sponsors to be able 

to get this information in an efficient way. 

Mr. BURGESS. Well, I want to thank each of you for your testimony today, and Dr. Topper, in your testimony you talked about, 

you know, kind of the differences between humans and animals, 

having spent a lifetime in practicing medicine, to think that you 

have got those—both the major and minor classes of animals to 

consider. 

You give the anti-inflammatory that you gave to your dog to your 

cat, and you’re in big trouble. I am sensitive to the problems that 

you face, and we want you to be able to do your best work. So 

thank you each for testifying today. 

Mr. Green, I will recognize you for 5 minutes for questions, 

please. 

Mr. GREEN. Thank you, Mr. Chairman. I hope you didn’t have 

any patients that would bite you. 

[Laughter.] 

Mr. BURGESS. How much time do you have? 

[Laughter.] 

Mr. GREEN. He was an OB/GYN. Thank you, Mr. Chairman. 

Dr. Topper, I am interested in your perspective as a veterinarian 

on the use of antimicrobials in food-producing animals and the 

growing public health concerns regarding antimicrobial resistance. 

I understand that the use of the medically important antimicrobial drugs in treating food-producing animals is necessary, 

68 

but I also have concern over the overuse and what steps both the 

FDA and the animal health providers should be taking to reduce 

the risks of resistance. 

Can you explain how these antimicrobial resistance happens and 

what impact it can have on both the animal and human health? 

Dr. TOPPER. Yes, sir. I can talk to the first part, for sure, about 

how the AVMA along with other of our colleagues are very much 

concerned about antimicrobial resistance, and we are taking as 

many steps for our members and providing them with information 

about the judicious use of antimicrobials, as you heard Dr. Solomon 

talk about, and we have just developed a stewardship for our members to follow in looking at these. 

So we have been taking an active role in working with the Centers for Veterinary Medicine for the veterinary fee directive so that 

all antimicrobials that are put in food have to be under the direction of a veterinarian-client-patient relationship and they have to 

have that fee directive. 

Most of the other veterinarians, we know through their judicious 

use of the antimicrobials, they are working to reduce the number 

that are being used. So we support that. 

To talk about how antimicrobial resistance happens would probably be a lot longer than we would have here. And so we can probably provide you with plenty of literature as to how that antimicrobial resistance occurs. But I am not ready to talk about it at 

this time, if that’s OK. 

Mr. GREEN. How has greater data collection improved veterinarian awareness regarding the overuse of the antimicrobial drugs, 

and what additional steps should the FDA be taking to address the 

concerns? 

Dr. TOPPER. Well, the FDA is monitoring. We we do the residue, 

like Dr. Solomon talked about, during the formulation and the approval process of the drug. They have to be able to detect it in the 

meat products. And so, as they approve those methods, that will 

help detect the antimicrobial uses, as they go forward. 

Mr. GREEN. OK. Do you know what the American Veterinarian 

Medical Association is doing to educate its members on the importance of addressing these antimicrobial resistances, and how can 

veterinarians be good stewards of antimicrobials when treating 

food-producing animals? 

Dr. TOPPER. Yes, sir. Like I said, we do have and along with our 

industry partners—that’s the bovine practitioners, the swine veterinarians, and the avian pathologists—have developed therapeutic 

guidelines for the judicious use of antibiotics, and we have just approved in our AVMA’s house of delegates our stewardship policy 

and the core principles of antibiotic use. 

So we are very much educating our members, and they do understand that there is this great need in public health. 

Mr. GREEN. Well, part of our other jurisdiction on this committee 

is the need to do medical research and looking at the next, you 

know, vaccinations, the next treatment, because we do have a 

growing resistance of—both in humans and I was going to see if 

that happens with animals—that you use these antimicrobials and 

then over a period of time they develop a resistance to them. Does 

that happen in animals as well as we see in humans? 

69 

Dr. TOPPER. Yes, sir, it does happen in animals also. Again, as 

we talked about, different species react to different antibiotics in 

different ways. So it is a problem in animals also. 

Mr. GREEN. And the concern about growing antimicrobial resistance is a real one and further compounded by the need for the development of new antibiotics and will still be effective in the face 

of the resistance, and I hope we continue to work closely with the 

CVM and the CDR to ensure that safe and effective antibiotics are 

available when needed. 

Dr. TOPPER. Yes, sir. 

Mr. GREEN. Mr. Chairman, I will yield back my time. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

Chair recognizes the gentleman from Oklahoma, 5 minutes for 

your questions, please. 

Mr. MULLIN. Thank you, Mr. Chairman, and I want to thank the 

panel for the great work and the time and dedication you have 

spent to bring us to this point. 

Working with the agency and industry I know is no easy task. 

But that’s how we—as you can see, that’s the best way, the easiest 

way for us to move forward with any type of legislation. So thank 

you both—everybody for being here. 

Dr. Cumberbatch, I want to ask you a question. Can you explain 

the difference between the animal market and the human drug 

market and elaborate on some of the differences and the challenges 

that we face? 

Dr. CUMBERBATCH. Absolutely. Thank you. 

You know, as Dr. Solomon said, size is one of the differences in 

the animal market and the human market. Also, as a veterinarian, 

when I talk about a treatment protocol, price has to be one of the 

topics that we talk about and what the availability is of the medication and what my expectation is as a veterinarian that this is 

going to work for your particular situation. 

And it is important to have very good data so that I can share 

that with an animal owner, and that is why it’s important to have 

new, innovative, well-studied drugs on the market for veterinarians 

to use. 

Mr. MULLIN. So what do you think are some of the unmet needs 

that are in the animal market that we need to try to address? 

Dr. CUMBERBATCH. We’ve had the opportunity to hear about a 

number, but osteoarthritis is one that I know we see every day. I 

hear stories where the cat’s hiding under the bed or ‘‘My dog 

doesn’t want to play ball anymore—he seems more tired,’’ or ‘‘My 

horse won’t jump.’’ 

You know, these seem like changes in behavior, but that’s sometimes pain, and it’s—osteoarthritis can happen over a period of 

time, and it’s difficult to study because it does take that time. 

In cattle, we have chronic diseases as well like Johne’s disease 

that eventually is fatal, and most importantly, it decreases production and can spread throughout a herd, and that’s devastating to 

our small farmers. 

Mr. MULLIN. Well, as a cattle owner, which—you know, I don’t 

think we could quite make a living off our cattle because I still 

70 

think the fastest way to become a millionaire running cattle is 

start with two million—you will get to a million. 

[Laughter.] 

But I am glad I have other things that can help offset the ranch. 

But it’s still a way of life. It’s the way I was raised. It’s the way 

we raise our kids. 

You know, the biggest traffic jam coming out of our house is usually the cattle that want to, for some reason, hang around the 

driveway and use the bathroom on it. But that’s a whole another 

thing. 

But there are issues that we run about—my colleague from 

Texas was talking about the antibiotics and the overuse of it. 

But there has to be a common area that’s reached here, because 

I can tell you personally in our experience—and I am surrounded 

by other cattle owners—when we took away the ability to actually 

buy medicated feed, it actually cost the consumers more and, in my 

opinion, can be even more devastating, moving forward, because 

unlike children, you’re not out there watching your cattle necessarily every day on a one-on-one basis. 

When you buy cattle out of a stockyard or a sale barn, you buy 

a trailer full of them. Before you mix them into your herd, you 

want to be able to make sure that they’ve not carrying something 

that is going to infect the herd. 

We’ve seen an increase, especially in my area this year, because 

we have such high swings with temperatures from low to high, 

with pneumonia coming in. 

And used to, when we would bring our cattle back from the 

barns, which it is very common for them to develop a cough, as you 

guys are aware of, or a runny nose, we could catch a lot of that 

before we’d turn them out into the pastures, because we would feed 

them some medicated feed. 

Now we are running into a situation where we have a choice. Instead of sending them just medicated feed, which we are not going 

to overuse because it’s too expensive to use all the time, we have 

to vaccinate them to be preemptive on this by having to give them 

a shot that they may not need or we take the chance of infecting 

the entire herd. 

So which one is—as us, which one do we decide to do? It’s very 

expensive to sit there and time consuming to give everybody a shot 

when you’re buying them in pot bellies—which pot bellies, by the 

way, for us are those big trailers—and you’re dumping them to the 

lot. 

So when we are having this conversation about overmedicating, 

I understand the concerns—me too. But there has to be some common area to work with. And so, while we’ve been working with the 

panel, make sure you’re not leaving out the stakeholders like myself or other cattle producers or the stockyards, because I know you 

have been hearing from the stockyards on this, too. 

So I want to work, moving forward, with this. But I don’t know 

that what we’ve done right now is the right approach. 

So with that, Mr. Chairman, I will yield back. 

Mr. BURGESS. Gentleman yields back. Chair thanks the gentleman. 

71 

Chair recognizes the gentleman from Oregon, Dr. Schrader, 5 

minutes for your questions, please. 

Mr. SCHRADER. Thank you very much, Mr. Chairman. 

I will kind of jump on Markwayne’s discussion a little bit, because I think there’s a lot of misinformation out there over the use 

of antimicrobials and their contribution to human resistance to 

drugs. 

There certainly could be a factor. I spent a lot of time reading 

a lot of the studies that have been generated since the ’70s, and 

there’s lots of inference but no study that I’ve seen there’s any direct causation. 

That doesn’t mean we shouldn’t be judicious or smart about how 

we use antimicrobials in veterinary medicine or on the ranch. 

I think every one of us wants to do the right thing, and I would 

applaud the CVM’s recent suggestions that, you know, in certain 

situations when there is the right climatic conditions or whatever 

that, under proper veterinary supervision, that certain therapeutic 

uses of antimicrobials could be used on a mass basis to prevent 

more disease and, frankly, suffering to these animals that 

Markwayne and others raise on our farms and ranches. 

So I just want us to be cognizant of that, and I will tell you this: 

In my veterinary practice there were times when, if I did not use 

an antimicrobial at the appropriate time, that the disease spread 

would have been much bigger, and there was also a chance for a 

virulence to increase and these animals—or these bugs, if you 

will—to mutate and go stronger yet. 

And to my good colleague from Texas, the real world of resistance is called biology. You know, if you ever watched ‘‘Jurassic 

Park’’—might have been a fun movie, but one thing that is absolutely true there is the real-world plants and animals mutate over 

time. That could be for good things, and it could also be for bad 

things. 

So whether or not we get engaged at all in trying to prevent that, 

things are still going to change. We should do our best to, you 

know, fight resistance in the ways we can. 

But it’s going to happen anyway, and that’s why drug innovation—the whole hearing we are having here today for our animal 

friends—speed these things to marketplace, because we are going 

to need ever newer and smarter ways to treat these animals, 

whether it’s on an anti-inflammatory, antimicrobial side. 

So ending my soliloquy here, Dr. Topper, do you see expanding 

conditional approval as negatively affecting FDA safety and efficacy standards in any way? 

Dr. TOPPER. No, sir, because, like Dr. Solomon said, they will be 

doing this all along, and it will just get some of these drugs that 

are right now maybe out on extra-label drug use. But we still have 

that great unmet medical need, and this will help very much if this 

is added to the bill. 

Mr. SCHRADER. I would agree. 

Talking about extra-label use, a little different than conditional 

use. How do the two processes work in synergy, or how are they 

different? 

Dr. TOPPER. I will do my best, to my knowledge of them. The 

extra-label drug use, again, are approved drugs that are already on 

72 

the market. They have met FDA efficacy. They may be for humans 

or they may be for another animal species. So, hopefully, they were 

safe in that species. 

This conditional would be specific for the species intended for 

use. So it would then have the same safety studies done for that 

species, and the efficacy would be increased upon as time goes 

along. 

So the difference would be that it will be—in my knowledge that 

it would be for the species intended for use and not just using 

something approved for a different—— 

Mr. SCHRADER. And to your earlier comments, it’s just another 

tool in the toolbox for enabling veterinarians who, again, the market—real-world marketplace—cost matters. Dr. Zollers, say, can’t 

yet take advantage of all these great new drugs necessarily that 

are coming out. 

I think it was the chairman and others indicated or you had indicated earlier, you know, 23 human products for every veterinary 

product that’s developed out there. 

So this is just a great way, a safe way, an efficacious way for veterinarians to have access, hopefully, to some of the same opportunities that we do in the human field, and I would argue that our food 

safety is critical to human safety—the whole public health aspect 

that Dr. Cumberbatch talked about. 

Dr. Cumberbatch, if I could come to you. You know, again, we 

talked earlier about very few conditional approvals have even been 

requested, much less granted at this time. 

From your standpoint—maybe Dr. Zollers, if you have an opinion 

on this—you know, what are the barriers? Is it just familiarity 

with this new process, or are there some barriers, given some of 

these companies are pretty small? 

Dr. CUMBERBATCH. Thank you, Dr. Schrader. 

You know, right now conditional approval is for minor use, minor 

species, and by definition that is a very small market. 

And so, by expanding this, it would allow companies to bring forward products to a bigger market for that unmet need and in no 

way would this be taking away or preventing companies from coming forward and still utilizing MUMS as it currently is. 

Mr. SCHRADER. All right. Dr. Zollers, if I may, real quick. 

Dr. ZOLLERS. Yes. I would just say right now small companies— 

it comes down to how much money can they make in revenue, can 

they make with this process, and a lot of them, a lot of times these 

just don’t pan out. 

Mr. SCHRADER. Got you. 

Thank you, and I yield back, Mr. Chairman. 

Mr. BURGESS. Chair thanks the gentleman. Gentleman yields 

back. 

Chair recognizes the gentleman from Georgia, 5 minutes for your 

questions, please. 

Mr. CARTER. Thank you, Mr. Chairman, and thank all of you all 

for being here. 

Dr. Cumberbatch, I will start with you. Earlier, when Dr. Solomon was here, they asked him about the process by which the 

new animal drug application process and how thorough it was and 

73 

how much information that the drug manufacturers had to submit 

along with a new animal drug application. 

And I just wanted to ask you, from your perspective, do you 

think that’s an impediment for new animal drug breakthroughs in 

any way, that it’s so detailed and so, for lack of a better word, so 

laborious? 

Dr. CUMBERBATCH. Bringing a new product to market takes time. 

It takes investment. In fact, we have a survey that shows that it 

can take up to 10 years and $100 million to bring a product to market. 

Now, as we were talking about with Congressman Mullin, as 

well, at the end of the day it comes down to what can an animal 

owner pay for this. These products need to be at a reasonable price 

point, as well. 

And so, yes, having a long review, an expensive review, ultimately can hinder our ability to get new products onto the market. 

Mr. CARTER. So you do believe that perhaps just a different level 

of data might be sufficient and still provide the protection that we 

need and—because there is a balancing act, we all know there, 

and, quite honestly, from my perspective, FDA, a lot of times, 

has—not just FDA but all of Federal agencies have the tendency 

to overreact sometimes and overrequire. 

So is it your feeling that it could be done safely with less information? 

Dr. CUMBERBATCH. We are committed to working with FDA to 

look at those efficiencies while making sure that we maintain safety and quality in the products. 

Mr. CARTER. Mr. Chairman, we don’t have any kind of abbreviated like we do with the drug approvals—we don’t have any kind 

of abbreviated application in this area, do we? 

Mr. BURGESS. In the generic space, you certainly do. 

Mr. CARTER. In the generic space for animal control? 

Mr. BURGESS. Yes. 

Mr. CARTER. We do? OK. But not for the new drugs, and obviously that wouldn’t work as well. 

Let me ask you, Dr. Cumberbatch—I will start with you. From 

what I understand, the electronic submission that the applications 

are going to have to be submitted electronically starting on October 

of 2018—do you think you’re all going to be prepared for that? Are 

you ready for that? Is that sufficient time? 

Dr. CUMBERBATCH. The pioneer companies have been utilizing 

the e-submitter, and so I am confident, yes, AHI members will be 

ready for that transition. 

Mr. CARTER. Any recommendations in that process that, you 

know, thus far you having input into that process? 

Dr. CUMBERBATCH. The communication is key. Developing the 

templates that they use for the e-submission. The time that it 

would take for a sponsor to put the data in that they collect is important. It adds to that time and that administrative burden. 

And so increased communication, working together on what 

those templates look like. They have also hoped to provide 

webinars and training. These are all very important. 

Mr. CARTER. Great. 

74 

Dr. Topper, just very quickly I wanted to ask you—you know, one 

of the concerns and certainly one of the experiences I had as a 

practicing pharmacist was the price of some of these medications, 

particularly for the companion animals and, you know, unlike 

human patients where you have insurance and have a co-pay, you 

know, there is no insurance or co-pay for these animals and for 

these types of drugs particularly. 

Is there anything that you can really recommend that manufacturers might be able to do to lower the cost of some of these medications besides take a cut in profit? 

Dr. TOPPER. Well, you raise a very difficult issue, and it’s a complex issue. To ensure that the drugs are safe and efficacious, then 

they have to go through this process. 

So anything we can do to speed up the process and make it more 

efficient, hopefully, will result in drug-lowering costs and, especially as the drugs move to generic types, then that should lower 

the cost also. But it’s complicated, as we know, even in human 

medicine. 

Mr. CARTER. Great. Well, I thank all of you for being here. It’s 

been a very interesting hearing today. 

Thank you, Mr. Chairman. I yield back. 

Mr. BURGESS. Gentleman yields back. The Chair thanks the gentleman. 

Seeing no additional Members wishing to ask questions, Mr. 

Green, did you have anything on redirect? 

Mr. GREEN. No, Mr. Chairman. I think the job’s been done, but 

I do have some concerns because our next half will be trying to 

find, you know, some of the solutions for the drug resistance we 

have. But appreciate the efforts. 

Mr. BURGESS. Very well. 

Again, seeing no further Members wishing to ask questions, I 

want to thank our witnesses for being here today. I would like to 

submit statements from the following for the record: the Agriculture Value Chain Coalition. 

Pursuant to committee rules, I remind Members they have 10 

business days to submit additional questions for the record. I ask 

that witnesses submit their response within 10 business days upon 

receipt of those questions. 

And without objection, the subcommittee is adjourned. 

[Whereupon, at 12:20 p.m., the committee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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115TH CONGRESS H R 

2D SESSION • • 

(Original Signature of Member) 

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 

fee programs relating to new animal drugs and generic new animal drugs. 

IN THE HOUSE OF REPRESENTATIVES 

M_. introduced the following bill; which was referred to the 

Committee on __________ _ 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Aet to 

reauthorize user fee programs relating to new animal 

drugs and generic new animal drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the "Animal Drug and Ani5 mal Generic Drug User Fee Amendments of 2018". 

6 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

7 (a) TABI,E OF CONTENTS.-The table of contents for 

8 this Act is as follows: 

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2 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I-FEES RELATING TO ANEVlAL DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use animal dmg fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Savings clause. 

Sec. 106. Effective date. 

Sec. 107. Sunset dates. 

TITI,E II-FEES RELATING TO GENERIC ANIMAL DRUGS 

Sec. 201. Short title; finding. 

Sec. 202. Authority to assess and use generic new animal dmg fees. 

Sec. 203. Reauthorization; reporting requirements. 

Sec. 204. Savings clause. 

Sec. 205. Effective date. 

Sec. 206. Sunset dates. 

TITLE III-MISCELLAi'<EOUS PROVISIONS 

Sec. 301. Electronic submissions. 

Sec. 302. Iudex of leg-ally marketed unapproved new animal drugs for minor 

species. 

Sec. 303. Misbranded drugs and devices. 

1 (b) REFERENCES IN AC'l'.-Except as otherwise spec2 ified, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.). 

6 TITLE I-FEES RELATING TO 

1 ANIMAL DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

9 (a) SHORT TrrLE.-This title may be cited as the 

10 "Animal Drug User Fee Amendments of 2018". 

11 (b) FINDING.-Con!,'Tess finds that the fees author12 ized by the amendments made in this title will be dedi13 cated toward expediting the animal drug development 

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3 

1 process and the review of new and supplemental animal 

2 drug applications and investigational animal drug submis3 sions as set forth in the goals identified for purposes of 

4 part 4 of subchapter C of chapter VII of the Federal Food, 

5 Drug, and Cosmetic Act, in the letters from the Secretary 

6 of Health and Human Services to the Chairman of the 

7 Committee on Energy and Commerce of the House of 

8 Representatives and the Chairman of the Committee on 

9 Health, Education, Labor, and Pensions of the Senate as 

10 set forth in the Congressional Record. 

11 SEC. 102. DEFINITIONS. 

12 Section 739 (21 U.S.C. 379j-ll) is amended13 (1) by amending paragraph (1) to read as fol14 lows: 

15 "(1)(A) The term 'animal drug application' 

16 means17 "(i) an application for approval of any new 

18 animal drug submitted under section 512(b)(1); 

19 or 

20 "(ii) an application for conditional ap21 proval of a new animal drug submitted under 

22 section 571. 

23 "(B) Such term does not include either a new 

24 animal drug application submitted under section 

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4 

1 512(b)(2) or a supplemental animal drug applica2 tion. "; and 

3 (2) in paragraph (8), by adding at the end the 

4 following: 

5 "(I) The activities necessary for implemen6 tation of the United States and European 

7 Union Good Manufacturing Practice Mutual In8 spection Agreement with respect to animal drug 

9 products subject to review, including implemen10 tation activities prior to and following product 

11 approval.". 

12 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

13 FEES. 

14 (a) FEE RE'lENUE Al\fOUNTS.-Section 740(b) (21 

15 U.S.C. 379j-12(b)) is amended16 

17 

18 

19 

20 

21 

22 

23 

24 

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February 6, 2018 (5:03p.m.) 

(1) in paragraph (1)-

(A) in subparagraph (A)-

(i) by striking "2014" and inserting 

"2019"; and 

(ii) by striking "$23,600,000" and inserting "$30,331,240"; and 

(B) in subparagraph (B)-

(i) by striking "2015 through 2018" 

and inserting "2020 through 2023"; and 

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5 

1 (ii) by striking "$21,600,000" and in2 serting "$29,931,240"; and 

3 (2) in paragraph (2), in the matter preceding 

4 subparagraph (A), by striking "determined" and in5 serting "established". 

6 (b) A.'lNUAl; FEE SET'l'ING; ADJUSTMENTS.-

7 (1) lNFlu\TION ADJUSTMENT .-Section 

8 740(c)(2) (21 U.S.C. 379j-12(c)(2)) is amended9 (A) in the matter preceding subparagraph 

10 (A)-

11 (i) by striking "For fiscal year 2015" 

12 and inserting "(A) For fiscal year 2020"; 

13 and 

14 (ii) by inserting "multiplying such 

15 revenue amounts by" before "an amount"; 

16 (B) by redesignating subparagraphs (A), 

17 (B), and (C) as clauses (i), (ii), and (iii), re18 spectively; 

19 (C) by striking the flush text at the end; 

20 and 

21 (D) by adding at the end the following new 

22 subparagraph: 

23 "(B) COMPOUNDED BASIS.-The adjustment 

24 made each fiscal year after fiscal year 2020 under 

25 this paragraph shall be applied on a compounded 

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6 

1 basis to the revenue amount calculated under this 

2 paragraph for the most recent previous fiscal year.". 

3 (2) WORKW.AD ADJUSTMENTS.-Paragraph (3) 

4 of section 740(c} (21 U.S.C. 379j-12(c)) is amended 

5 to read as follows: 

6 "(3) WORKLOAD ADJUSTMENTS.-

7 "(A} IN GENERAL.-1.<-,or fiscal year 2020 

8 and subsequent fiscal years, after the fee rev9 enuc amounts established under subsection (b) 

10 are adjusted for inflation in accordance with 

11 paragraph (2), the fee revenue amounts shall be 

12 further adjusted for such fiscal year to reflect 

13 changes in the workload of the Secretary for 

14 the process for the review of animal drug appli15 cations, subject to subparagraphs (B) and (C). 

16 With respect to such adjustment17 "(i} such adjustment shall be deter18 mined by the Secretary based on a weight19 ed average of the change in the total num20 ber of animal drug applications, supple21 mental animal drug applications for which 

22 data with respect to safety or effectiveness 

23 are required, manufacturing supplemental 

24 animal drug applications, investigational 

25 animal drug study submissions, and invesg:\VHLC\020618\020618.241.xml 

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1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

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February 6, 2018 (5:03 p.m.) 

7 

tigational animal drug protocol submissions submitted to the Secretary; and 

"(ii) the Secretary shall publish in the 

Federal Register the fees resulting from 

such adjustment and the supporting methodologies. 

"(B) REDUCTION OF WORKLOAD-BASED 

INCREASE BY AMOUNT OF CERTAIN EXCESS 

COLLECTIONS.-For each of fiscal years 2021 

through 2023, if application of the workload adjustment under subparab"''aph (A) increases the 

fee revenue amounts otherwi.se established for 

the fiscal year under subsection (b), as adjusted 

for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of 

any excess collections, as described in subsection (g)(4), for the second preceding fiscal 

year, up to the amount of such fee revenue increase. 

"(C) RULE OF APPLICATION.-Under no 

circumstances shall the workload adjustments 

under this paragraph result in fee revenues for 

a fiscal year that are less than the fee revenues 

for that fiscal year established under subsection 

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1 

2 

3 

8 

(b), as adjusted for inflation under paragraph 

(2).". 

(3) FINAL YEAR ADJUSTMENT.-Section 

4 740(c)(4) (21 U.S.C. 379j-12(c)(4)) is amended5 (A) by striking "2018" each place it ap6 pears and inserting "2023"; and 

7 (B) by striking "2019" and inserting 

8 "2024". 

9 (e) EXEMPTION FROM FEES.-Section 740(d) (21 

10 U.S.C.379j-12(d)) is amended11 (1) in the subsection heading, by inserting " 

12 EXEMPTION FROM FEES" after "REDUC'riON"; 

13 (2) by striking the heading of paragraph (1) 

14 and inserting "WAIVER OR REDUCTION"; and 

15 (3) by adding at the end the following: 

16 "( 4) EXEMPTIONS FIWM FEES.-

17 

18 

19 

20 

21 

22 

23 

24 

25 

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"(A) CERTAIN LABEioiNG SUPPLEMENTS 

TO ADD NUMBER OF APPROVED APPUCATION.-Fees under this section shall not apply 

with respect to any person who--

"(i) not later than September 30, 

2023, submits a supplemental animal drug 

application relating to a new animal drug 

application approved under section 512, 

solely to add the new animal drug applica-

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9 

1 tion number to the labeling of the drug in 

2 the manner specified in section 502(w)(3); 

3 and 

4 "(ii) otherwise would be subject to 

5 fees under this section solely on the basis 

6 of such supplemental application. 

7 "(B) CERTAIN ANIMAI1 DRUG APPLICA8 TIONS.-Fees under paragraphs (2), (3), and 

9 ( 4) of subsection (a) shall not apply with re10 spect to any person who is the named applicant 

11 or sponsor of an animal drug application, sup12 plemental animal drug application, or investiga13 tional animal drug submission if such applica14 tion or submission involves the intentional 

15 genomic alteration of an animal that is in16 tended to produce a drug, device, or biological 

17 product subject to fees under section 736, 738, 

18 744B, or 744H.". 

19 (d) CREDITING AND AVAILABILI'rY OF FEES.-

20 (1) AU'niORIZATION OF APPROPRIATIONS.-

21 Section 740(g)(3) (21 U.S.C.379j-12(g)(3)) is 

22 amended23 (A) by striking "2014 through 2018" and 

24 inserting "2019 through 2023"; 

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10 

1 (B) by striking "determined" and inserting 

2 "established"; and 

3 (C) by striking "paragraph (4)" and m4 serting "paragraph (5)". 

5 (2) EXCESS COLLECTIONS.-Seetion 740(g) (21 

6 U.S.C.379j-12(g)) is amended by striking paragraph 

7 ( 4) and inserting the following: 

8 "(4) EXCESS COLLEC'fiONS.-lf the sum total 

9 of fees collected under this section for a fiscal year 

10 exceeds the amount of fees authorized to be appro11 priated for such year under paragraph (3), the ex12 cess collections shall be credited to the appropria13 tions account of the Food and Drug Administration 

14 as described in paragraph (1). 

15 " ( 5) RECOVERY m~ COLI,ECTION SHORT16 FALLS.-

17 "(A) IN GENERAL.-Subject to subpara18 graph (B)-

19 "(i) for fiscal year 2021, the amount 

20 of fees otherwise authorized to be collected 

21 under this section shall be increased by the 

22 amount, if any, by which the amount col23 lected under this section and appropriated 

24 for fiscal year 2019 falls below the amount 

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2 

3 

4 

5 

6 

7 

8 

9 

10 

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12 

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14 

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17 

18 

19 

20 

21 

22 

23 

24 

25 

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Februa.y 6, 2018 (5:03 p.m.) 

11 

of fees authorized for fiscal year 2019 

under paragraph (3); 

"(ii) for fiscal year 2022, the amount 

of fees otherwise authorized to be collected 

under this section shall be increased by the 

amount, if any, by which the amount collected under this section and appropriated 

for fiscal year 2020 falls below the amount 

of fees authorized for fiscal year 2020 

under paragraph (3); and 

"(iii) for fiscal year 2023, the amount 

of fees otherwise authorized to be collected 

under this section shall be increased by the 

cumulative amount, if any, by which the 

amount collected under this section and 

appropriated for fiscal years 2021 and 

2022 (including estimated collections for 

fiscal year 2022) falls below the cumulative 

amount of fees authorized for such fiscal 

years under paragraph (3). 

"(B) REDUCTION OF SHORTFALL-BASED 

FEE INCREASE BY PRIOR YEAR EXCESS COLLECTIONS.-

"(i) IN GENERAL.-Subject to clause 

(ii), the Secretary shall, in such manner as 

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1 

2 

3 

4 

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17 

18 

19 

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22 

23 

24 

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February 6, 2018 (5:03p.m.) 

12 

the Secretary determines appropriate, reduce any fee increase otherwise applicable 

for a fiscal year under subparagraph (A) 

by the amount of any excess collections 

under this section for preceding fiscal 

years (after fiscal year 2018). 

"(ii) WORKLOAD-BASED FEE ACCOUNTING.-ln applying clause (i), the 

Secretary shall account for the reduction of 

workload-based fee revenue increases by 

excess collections under subsection 

(c)(3)(B), in such manner as needed to 

provide that no portion of any excess collections described in clause (i) is applied 

for purposes of reducing fee increases 

under both such subsection (c)(3)(B) and 

this paragraph. 

"(C) RUIJE OF APPLICA'fiON.-Under no 

circumstances shall adjustments under this 

paragraph result in fee revenues for a fiscal 

year that are less than the fee revenues for that 

fiscal year established in subsection (b), as adjusted or otherwise affected under subsection 

(c).". 

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13 

1 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 740A (21 U.S.C. 379j-13) is amended3 (1) in subsection (a), by striking "2013" and 

4 inserting "2018"; 

5 (2) by striking "2014" each place it appears in 

6 subsections (a) and (b) and inserting "2019"; and 

7 (3) in subsection (d), by striking "2018" each 

8 place it appears and inserting "2023". 

9 SEC.105. SAVINGS CLAUSE. 

10 Notwithstanding the amendments made by this title, 

11 part 4 of subchapter C of chapter \lii of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 379j-ll et seq.), as 

13 in effect on the day before the date of enactment of this 

14 title, shall continue to be in effect with respect to animal 

15 drug applications and supplemental animal drug applica16 tions (as defined in such part as of such day) that on or 

17 after October 1, 2013, but before October 1, 2018, were 

18 accepted by the Food and Drug Administration for filing 

19 with respect to assessing and collecting any fee required 

20 by such part for a fiscal year prior to fiscal year 2019. 

21 SEC. 106. EFFECTIVE DATE. 

22 The amendments made by this title shall take effect 

23 on October 1, 2018, or the date of the enactment of this 

24 Act, whichever is later, except that fees under part 4 of 

25 subchapter C of chapter VII of the Federal Food, Drug, 

26 and Cosmetic Act, as amended by this title, shall be asg:\VHLC\020618\020618.241.xml 

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14 

1 scssed for animal drug applications and supplemental ani2 mal drug applications received on or after October 1, 

3 2018, regardless of the date of the enactment of this Act. 

4 SEC. 107. SUNSET DATES. 

5 (a) AUTHORIZATION.-Section 740 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12) shall 

7 cease to be effective October 1, 2023. 

8 (b) REPORTING REQUIREMENTS.-Section 740A of 

9 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 379j-13) shall cease to be effective January 31, 2024. 

11 (c) PREVIOUS SUNSET PROVISION.-Effective Octo12 her 1, 2018, subsections (a) and (b) of section 107 of the 

13 Animal Drug User Fee Amendments of 2013 (Public Law 

14 113-14) are repealed. 

15 TITLE II-FEES RELATING TO 

16 GENERIC ANIMAL DRUGS 

17 SEC. 201. SHORT TITLE; FINDING. 

18 (a) SHORT TITLI<J.-This title may be cited as the 

19 "Animal Generic Drug User Fee Amendments of 2018". 

20 (b) FINDING.-Congress finds that the fees author21 ized by the amendments made in this title •vill be dedi22 cated toward expediting the generic new animal drug de23 velopment process and the review of abbreviated applica24 tions for generic new animal drugs, supplemental abbre25 viated applications for generic new animal drugs, and ing:IVHLC\020618\020618.241.xml 

February 6, 2018 (5:03 p.m.) 

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15 

1 vestigational submissions for generic new animal drugs as 

2 set forth in the goals identified for purposes of part 5 of 

3 subchapter C of chapter VII of the Federal Food, Drug, 

4 and Cosmetic Act, in the letters from the Secretary of 

5 Health and Human Services to the Chairman of the Com6 mittee on Energy and Commerce of the House of Rep7 resentatives and the Chairman of the Committee on 

8 Health, Education, Labor and Pensions of the Senate as 

9 set forth in the Congressional Record. 

10 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

11 ANIMAL DRUG FEES. 

12 (a) FEE REVENUE At'VIOUNTS.-Subsection (b) of sec13 tion 741 (21 U.S.C. 379j-21) is amended to read as fol14 lows: 

15 "(b) FEE REVENUE Al\10UNTS.-

16 "(1) IN GENERAL.-Subject to subsections (c), 

17 (d), (f), and (g), for each of fiscal years 2019 

18 through 2023, the fees required under subsection (a) 

19 shall be established to generate a total revenue 

20 amount of $18,336,340. 

21 "(2) TYPES OP PEES.-Of the total revenue 

22 amount established for a fiscal year under para23 graph ( 1 )-

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1 "(A) 25 percent shall be derived from fees 

2 under subsection (a)(1) (relating to abbreviated 

3 applications for a generic new animal drug); 

4 "(B) 37.5 percent shall be derived from 

5 fees under subsection (a)(2) (relating to generic 

6 new animal drug products); and 

7 "(C) 37.5 percent shall be derived from 

8 fees under subsection (a)(3) (relating to generic 

9 new animal drug sponsors).". 

10 (b) .A..'!NUAL FEE SETTING; ADJUSTMENTS.-

11 (1) INFLATION ADJUSTMENT.-Section 741(c) 

12 (21 U.S.C. 379j-21(c)) is amended13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

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February 6, 2018 (5:03 p.m.) 

(A) by redesignating paragraphs (2) 

through (4) as paragraphs (3) through (5), respectively; and 

(B) by inserting after paragTaph (1) the 

following: 

"(2) INFLATION ADJUSTMENT.-

"(A) IN GENER.Al".-For fiscal year 2020 

and subsequent fiscal years, the revenue 

amounts established under subsection (b) shall 

be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, 

by multiplying such revenue amounts by an 

amount equal to the sum of-

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17 

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19 

20 

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24 

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February 6, 2018 (5:03p.m.) 

17 

"(i) one; 

"(ii) the average annual percent 

change in the cost, per full-time equivalent 

position of the Food and Drug Administration, of all personnel compensation and 

benefits paid with respect to such positions 

for the first 3 of the preceding 4 fiscal 

years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to 

total I<~ood and Drug Administration costs 

for the first 3 of the preceding 4 fiscal 

years for which data are available; and 

"(iii) the average annual percent 

change that occurred in the Consumer 

Price Index for urban consumers (Washington-Baltimore, DC-l\1D-VA-WV; not 

seasonally adjusted; all items less food and 

energy; annual index) for the first 3 of the 

preceding 4 years for which data are available multiplied by the average proportion 

of all costs other than personnel compensation and benefits costs to total Food and 

Drug Administration costs for the f1rst 3 

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18 

1 of the preceding 4 fiscal years for which 

2 data are available. 

3 "(B) COMPOUNDED BASIS.-The adjust4 ment made each fiscal year after fiscal year 

5 2020 under this paragraph shall be applied on 

6 a compounded basis to the revenue amount cal7 culated under this paragraph for the most re8 cent previous fiscal year.". 

9 (2) WORKLOAD AD.TUSTMENTS.-Paragraph (3) 

10 of section 741(c) (21 U.S.C. 379j-21(c)), as redesig11 nated, is amended to read as follows: 

12 "(3) WORKLOAD ADJUSTMENTS.-

13 "(A) IN GENERAL.-For fiscal year 2020 

14 and subsequent fiscal years, after the fee rev15 enue amounts established under subsection (b) 

16 are adjusted for inflation in accordance with 

17 paragraph (2), the fee revenue amounts shall be 

18 further adjusted for each such fiscal year to re19 fleet changes in the workload of the Secretary 

20 for the process for the review of abbreviated ap21 plications for generic new animal drngs, subject 

22 to subparagraphs (B) and (C). With respect to 

23 such adjustment24 "(i) this adjustment shall be deter25 mined by the Secretary based on a weightg:IVHLC\020618\020618.241 .xml 

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2 

3 

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February 6, 2018 (5:03 p.m.) 

19 

ed average of the change in the total number of abbreviated applications for generic 

new animal drugs, manufacturing supplemental abbreviated applications for generic 

new animal drugs, investigational generic 

new animal drug study submissions, and 

investigational generic new animal drug 

protocol submissions submitted to the Secretary; and 

"(ii) the Secretary shall publish in the 

Federal Register the fees resulting from 

this adjustment and the supporting methodologies. 

"(B) REDUCTION OF WORKLOAD-BASED 

INCREASE BY A..'VIOUNT OF CERTAIN EXCESS 

COLLECTIONS.-For each of fiscal years 2021 

through 2023, if application of the workload adjustment under subparagraph (A) increases the 

fee revenue amounts otherwise established for 

the fiscal year under subsection (b), as adjusted 

for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of 

any excess collections, as described in subsection (g)(4), for the second preceding fiscal 

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20 

1 

2 

3 

4 

year, up to the amount of such fee revenue increase. 

"(0) RULE OF APPLICATION.-Under no 

circumstances shall workload adjustments 

5 under this paragraph result in fee revenues for 

6 a fiscal year that are less than the fee revenues 

7 for that fiscal year established under subsection 

8 (b), as adjusted for inflation under paragraph 

9 (2).". 

10 (3) FINAL YEAR ADJUSTlVlKNT.-Paragraph (4) 

11 of section 741(c) (21 U.S.C. 379j-21(c)), as redesig12 nated, is amended by13 (A) striking "2018" each place it appears 

14 and inserting "2023"; and 

15 (B) striking "2019" and inserting "2024". 

16 (c) FEE WAIVEH OH REDUCTION; EXElVIPTION FHOM 

17 FEES.-Subsection (d) of section 741 (21 U.S.C. 379j18 21) is amended to read as follows: 

19 "(d) FEE WAIVEH OH REDUCTION; EXEMPTI0:-.1 

20 FHOM FEES.-

21 "(1) FEE WAIVEH OH REDUCTION.-The Sec22 retary shall grant a waiver from or a reduction of 

23 1 or more fees assessed under subsection (a) where 

24 the Secretary finds that the generic new animal drug 

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1 is intended solely to provide for a mmor use or 

2 minor species indication. 

3 "(2) EXEMPTION FROM FEES.-Fces under this 

4 section shall not apply with respect to any person 

5 who6 "(A) not later than September 30, 2023, 

7 submits a supplemental abbreviated application 

8 for a generic new animal drug approved under 

9 section 512, solely to add the application num10 ber to the labeling of the drug in the manner 

11 specified in section 502(w)(3); and 

12 "(B) otherwise would be subject to fees 

13 under this section solely on the basis of such 

14 supplemental abbreviated application.". 

15 (d) CREDITING AND AVAILABILITY OF FEES.-Sec16 tion 741(g) (21 U.S.C. 379j-21) is amended by striking 

17 paragraph (3) and inserting the following paragraphs: 

18 "(3) AUTHORIZATION OJ;" APPROPRIATIONS.-

19 For each of the fiscal years 2019 through 2023, 

20 there is authorized to be appropriated for fees under 

21 this section an amount equal to the total revenue 

22 amount established under subsection (b) for the fis23 cal year, as adjusted or otherwise affected under 

24 subsection (c). 

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22 

1 "(4) EXCESS COLI;ECTIONS.-If the sum total 

2 of fees collected under this section for a fiscal year 

3 exceeds the amount of fees authorized to be appro4 priated for such year under paragraph (3), the ex5 cess collections shall be credited to the appropria6 tions account of the Food and Drug Administration 

7 as described in paragraph (1).". 

8 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

9 Section 742 (21 U.S.C. 379j-22) is amendedto (1) in subsection (a), by striking "2013" and 

11 inserting "2018"; 

12 (2) in subsection (b), by striking "Committee 

13 on Health, Education, Labor, and Pensions" and in14 serting "the Committee on Health, Education, 

15 Ijabor and Pensions"; 

16 (3) by striking "2014" each place it appears in 

17 subsections (a) and (b) and inserting "2019"; and 

18 (4) in subsection (d), by striking "2018" each 

19 place it appears and inserting "2023". 

20 SEC. 204. SAVINGS CLAUSE. 

21 Notwithstanding the amendments made by this title, 

22 part 5 of subchapter C of chapter VII of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), as 

24 in effect on the day before the date of enactment of this 

25 title, shall continue to be in effect with respect to abbreg:IVHLC\020618\020618.241.xml 

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23 

1 viated applications for a generic new animal drug and sup2 plemental abbreviated applications for a generic new ani3 mal drug (as defined in such part as of such day) that 

4 on or after October 1, 2013, but before October 1, 2018, 

5 were accepted by the Food and Drug Administration for 

6 filing with respect to assessing and collecting any fee re7 quired by such part for a fiscal year prior to fiscal year 

8 2019. 

9 SEC. 205. EFFECTIVE DATE. 

10 The amendments made by this title shall take effect 

11 on October 1, 2018, or the date of the enactment of this 

12 Act, whichever is later, except that fees under part 5 of 

13 subchapter C of chapter VII of the Federal Food, Drug, 

14 and Cosmetic Act, as amended by this title, shall be as15 sessed for abbreviated applications for a generic new ani16 mal drug and supplemental abbreviated applications for 

17 a generic new animal drug received on or after October 

18 1, 2018, regardless of the date of enactment of this Act. 

19 SEC. 206. SUNSET DATES. 

20 (a) AUTHORIZA'l'ION.-Section 741 of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) shall 

22 cease to be effective October 1, 2023. 

23 (b) REPORTING REQUIHEMENTS.-Section 7 42 of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j25 22) shall cease to be effective January 31, 2024. 

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1 (c) PREVIOUS SUNSET PROVISION.-Effective Octo2 her 1, 2018, subsections (a) and (b) of section 206 of the 

3 .Animal Generic Drug User Fee Amendments of 2013 

4 (Public !.Jaw 113-14) are repealed. 

5 TITLE III-MISCELLANEOUS 

6 PROVISIONS 

7 SEC. 301. ELECTRONIC SUBMISSIONS. 

8 (a) NEW ANIMAL DRUG APPLICATIONS AND ABBRE9 VIATED APPLICATIONS FOR A GENERIC NEW ANIMAL 

10 DRUG.-Section 512(b) (21 U.S.C. 360b(b)) is amended 

11 by adding at the end the follov;ring: 

12 "(4) Beginning on October 1, 2018, all applications 

13 or submissions pursuant to this subsection shall be sub14 mitted by electronic means in such format as the Sec15 retary may require.". 

16 (b) CONDITIONAL APPROVAl; OF NEW ANIMAL 

17 DRUGS FOR MINOR USE AND MINOR SPECIES.-Seetion 

18 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at 

19 the end the folloViring: 

20 "(4) Beginning on October 1, 2018, all applications 

21 or submissions pursuant to this subsection shall be sub22 mitted by electronic means in such format as the Sec23 retary may require.". 

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25 

1 SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED 

2 NEW ANIMAL DRUGS FOR MINOR SPECIES. 

3 Effective on October 1, 2018, section 572(h) (21 

4 u.s.a. 360ccc-1(h)) is amended5 (1) by amending paragraph (1) to read as fol6 lows: 

7 "(1) 'LEGAL STATUS-In order to be legally 

8 marketed, a new animal drug intended for a minor 

9 species must be Approved, Conditionally Approved, 

10 or Indexed by the Food and Drug Administration. 

11 THIS PRODUCT IS INDEXED-MIF.' (followed 

12 by the applicable minor species index file number 

13 and a period) 'Extra-label use is prohibited.';"; and 

14 (2) in paragraph (2), by striking "other ani15 mals" and inserting "food-producing animals". 

16 SEC. 303. MISBRANDED DRUGS AND DEVICES. 

17 (a) IN GENERAL.-Section 5.02(w) (21 U.S.C. 

18 352(w)) is amended19 (1) in subparagraph (1), by striking "; or" and 

20 inserting ";"; 

21 (2) in subparagraph (2), by striking the period 

22 and inserting"; or"; and 

23 (3) by adding at the end the following: 

24 "(3) for which an application has been ap25 proved under section 512 and the labeling of such 

26 drug does not include the application number in the 

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26 

1 format: 'Approved by FDA under (A)NADA # xxx2 xxx', except that this subparagraph shall not apply 

3 to representative labeling required under section 

4 514.l(b)(3)(v)(b) of title 21, Code of Federal Regu5 lations (or any successor regulation) for animal feed 

6 bearing or containing a new animal drug.". 

7 (b) APPLICABILITY.-Section 502(w)(3) of the Fed8 eral Food, Drug, and Cosmetic Act, as added by sub9 section (a), shall apply beginning on September 30, 2023. 

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30574.055

... 

American Farm Bure.u Federation• 

··~ \l!:.r.lA aSta 

filll-lhe seed" 

All ANIMAL 

HEALTH 

INSTITUTE 

0NGFA 

Ill ~~NORTH AMERICAN .... MEATINSTITUTE 

NASDA 

... 

!171) 

~!.~ 

--

N Ap~N A ty() 

FE~ONl{/ 

February 26, 2018 

The Honorable Lamar Alexander 

Chairman 

Committee on Health, Education, Labor 

and Pensions 

U.S. Senate 

Washington, D.C. 20510 

The Honorable Greg Walden 

Chairman 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, D.C. 20515 

The Honorable Patty Murray 

Ranking Member 

Committee on Health, Education, Labor 

and Pensions 

U.S. Senate 

Washington, D.C. 20510 

The Honorable Frank Pallone 

Ranking Member 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, D.C. 20515 

Dear Chairman Alexander, Ranking Member Murray, Chairman Walden, and Ranking Member 

Pallone, 

As representatives of the U.S. food value chain, we urge you to reject any amendments to the 

reauthorization of the Animal Drug User Fee Act (ADUFA) that could undermine or conflict 

with the National Bioengineered Food Disclosure Standard Act (the Disclosure Act or the Act). 

Congress passed the Disclosure Act in 2016 with overwhelming bipartisan support, and 

President Obama signed it into law. The Act provides the framework for the United States 

Department of Agriculture (USDA) to provide consumers with consistent, truthful, and nonmisleading information they may wish to have about their food in a way that does not stigmatize 

the use of technology to produce that food. USDA is currently implementing the Disclosure Act 

through rulemaking. 

When considering the Disclosure Act, Congress was explicit that the Act must prevent a 

patchwork of bioengineered food disclosure regulations, as the existence of such would likely 
102 


30574.056

cause widespread consumer confusion. Consequently, Congress set the definition of 

"bioengineered" food, thus establishing the scope of the uniform mandatory disclosure standard. 

Those foods that meet the definition of a "bioengineered food" fall within the uniform disclosure 

mandate. The Act sets out a number of options for compliance and recognizes the 30-plus years 

of proven safety of bioengineering in food and agriculture. 

It is important for Congress to fully support the framework set out in the Disclosure Act and the 

authority vested in USDA to implement that framework. To do that, Congress must reject any 

attempts to undermine the Act. We are extremely concerned that a proposed amendment to S. 

2434, the Animal Drug and Animal Generic Drug User Fee Amendments of2018 would do just 

that. The proposed amendment would require a separate and conflicting mandated label for a 

specific bioengineered food product that is already covered by the Disclosure Act. If this 

provision becomes law, it will undermine the congressionally-mandated USDA uniform 

disclosure standard and generate consumer confusion as the proposed FDA label would mandate 

different disclosure language from that required by the Disclosure Act. Consumers would likely 

be left wondering as to the differences in disclosures. 

As you work over the next few weeks to finalize the reauthorization of ADUF A, we ask that you 

oppose inclusion of this harmful bioengineered food labeling provision from any final bill. 

Sincerely, 

Agricultural Retailers Association 

American Farm Bureau Federation 

American Feed Industry Association 

American Seed Trade Association 

American Soybean Association 

Animal Health Institute 

Biotechnology Innovation Organization 

Corn Refiners Association 

Enzyme Technical Association 

National Association of State Departments of Agriculture 

National Association of Wheat Growers 

National Black Growers Council 

National Cattlemen's Beef Association 

National Com Growers Association 

National Council of Farmer Cooperatives 

National Grain and Feed Association 

National Milk Producers Federation 

National Oilseed Producers Association 

National Pork Producers Council 

National Renderers Association 

National Turkey Federation 

North American Meat Institute 

North American Millers' Association 
103 


30574.057

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

€:ongreS'S' of tbt Wniteb ~tateS' 

~oust of l\tprtscntatibt5 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House 0FACE BuiLDING 

WASHINGTON, DC 20515-6115 

Dr. Steven Solomon 

Director 

Center for Veterinary Medicine 

U.S. Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Dr. Solomon: 

Majority 12021225-2927 

Minority (202)225-3641 

AprilS, 2018 

Thank you for appearing before the Subcommittee on Health on March 14, 2018, to 

testify at the hearing entitled "Reauthorization of Animal Drug User Fees 2018: ADUFA and 

AGDUFA." 

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. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close ofbusiness onAprill9, 2018. Your 

responses should be mailed to Zack Darcshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
104 


30574.058

The Honorable Greg Walden 

Chairman 

Dear Chairman Walden: 

Thank you for nrc>vidlmJJ the Food and Drug (FDA or the 

op:portuntity to March 14, 2018, heating before the Committee on 

Ccrmrrrerc:e. entitled of Animal Fees: ADUFA and 

letter is a response for the record to ll'""'n'cm~ 

Ifyouhave 

"This 
105 


30574.059

Page 2 -The Honorable Greg Waideii 

The committee·~ questions are restated below in bold, followed by FDNs.resp(lnse. 

The ilonor;ible Gus M: Bili•·akis 

1. Would you walk us through lvhat actions FDA has taken overthe pastfew·years 

aud is currently undertaldngwitb regard to antimicrobial resistance in animals -

specifically those for consumption? · 

Antlmicrobi~ resisiance (AMR) is a.sedous global. puhlic health thre&t. FDA, in close 

coordinationwith other government aiid. public health stakeholders; including the U.S. 

Department of Agriculture (USDA)~ has taken a leading role in addressing this critical threat 

by implementingj:O:dicious use policies to promote antimicrobial stewardship aiid by 

eiiliancing surv<:11lance through systems such as the National Antimicrobial Resistance 

Monitoring System. 

Over the past few years, fDA has made a number of important changes wlthregard to 

antimicrobial use itt animals. 

In December 2013, FDA requested througl1 gtiidance for industry (GFI) .#213 t]lat animal . 

dmg sponsors of meciicafly-importantantimicrobials used in animal feed .and water revise the 

labels of these. prpdu.cts to remove indioati~ns for groWtl1 promotion and to require v~erinary 

oversight for theremalning therapeutic uses. The policy outlined in GFI.#213 was fuily 

jmplemented in Jimu~)' 2017, whh all affected animal drug sponsors making t!)erequested 

changes to their labelS; It is important to note that the cooperation of fhe.affected animal dtug 

sponsors was voluntary; however; because they have now revised their labeling consistent 

with tb,e teeommendatidn$ in GFI #2 l~, the use of these products in the feed or drinking 

water'offood,ptodudng animals fot production (e,g., growtb pr01notioh) :Pl!rposes is now 

illegal in the~ ~S .. ood their use for therapeutic purposes require~ auih9rization frotn a 

licensed veterinarian. · 

To build on the pr(igi'ess made by GFI #213; FDA $ougl1t public input on establishing . 

ap.propriately"targeted durations of therapeutic .use ·of medically, important arttli11icrobia1 

drugs in food-producing animals .. FDA has evaluated the CO!lllnents. received and is in the 

·process ofdeveiop!ng a specific sttategy for addressing this issue. The strat<:gy developed wilt need to. c.onsider the approved use conditions of these products on a product-by-product 

basis and any changes to such use conditions will need to be bas.ed on sound seietice !lnd 

available evidenc.e. · 

FDA also has issued a final rule revising the annual reporting requirements fotdrug.sponsots 

of antimicrobia1s sold or distributed for 1.!Se in food•produci.ng 11nimals~ The additional data 

FDA willgather as a result of tbat ruletnaking will improve our uri9erstandh1g of how 

antimi<;robials are sold or distn'buted for use i11 major foQd-producing specieS and help 

further target efforts to ensure J~;!dicioi;IS use of medically~irilporlant antimicrobiliJs. 

FDA iS, also ful~di!lg two gnmis for at'ltllllicrobial use .data collection. These ,collection efforts 

are intended to 'provide part Of the baseline infc.mnation on :antimicrobial use practices .in tl1e 
106 


30574.060

Pl\ge3- The Honorable Grc:g Walden: 

four major foud·producili,g animal. species ( cal:tle, swine, chickens, turkeys), which is a 

critical element in measuring the overall impact ofFDA'sjudi:cioiis use strategy. We,also 

expect these d11ta collection efforts 1o provideimportantinfonnation on metltodoh>gies to 

help optiinizelong.terin strategies to collect arid report sucharttimiero\:lial use data. 

Finally; FDA has atso been wbrking iii close collabQrationwith the USDA.Anh:nal and Plant 

Health Inspection Service (APHIS) Centerfor .Epiderriiology. and Aniniai Health, and has 

ptovided.input on surveys they l1ave conducted on anth:rti.erobial use in certain anim.al 

agriculture settings. We also eiq)ectthe results of these surVeys to provide uSeful 

infonnation for assessing antimicrobial Use practice)! .in veterinary settings. 

2. How 9o 'these user fce.pr()gr~ms foster innovation ~n dr!lg deve!llpment? 

ADUFA a11d AG0l)FA~re highly successful programs thatJ1ave accele.rated the revrew ·of 

innovative new animal drugs - and more affurdabie gf;lneoc alternatives - advancigg botll 

.animal and lwman heaUh. The programs have enabled FDA to dramatically redtice the. time 

needed to. te'\liew pioneer and g;;:neric anirh!ll products for preptarket approval, improve 

tilnely communications wlduponsors, and acliieve other efficiencies in tlle drug re:View 

process, while belping ensure that the drugs are ~fe and f;lffective. 

lnnovati'l'e new anim.al produ<::ts .. and approaches are being developed that .offer tlle promise. 

of a longer imd healthier life for our pets and oilier anilnals. Jn recentye~r,s,. Fl)Ahas. . 

approv~ new oncology treatments for dogs tar,geting cimine-speoific tumors imdirlilOV'ative 

therapies targeting :Pone changes in horses to tre.at a comll)on 'CaUse ofperformance-ending 

lameness. We also approved the first generic version of a vital heartwonn treatment that 

alleviated a'shortage of this critically important treatment for dogs. And promising new stem 

cell therapies offer future veterinary treatments and cures. 

FDA employs cutting edge methods ofima!ysis and approaches to arrive at ~ety and 

efficacy condusions including tlle following: · 

• Use of phannacokinclic/pharmacodyhap1ic infimnation 

In vitro testing ofproduct characteristics 

• Metii-lll1a1ysis ofbroad sources of h1fuonation such as published literature 

• New statistical analyses and presentations ofdata 

• Ri~k analysis methodologies 

The Honorable Frank Palli)QC;.Jt. 

J)r. ~OJOIDOB1 it'S Clear that the user fee program$ for aJijmaJ drug~~ have been a SUCCI:$S1 

just as the other user fee programs at FDA have .been. I'm pleased that .FDA; the animal 

drug industry, and other stal{eholdcrs have once again worked togethcr·to reach agreement 

on a path fonvatd. · ' · 
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Page 4-The H:onorable Greg. Wal;!~n 

L Since the implementati(in of the animal drug usei· fee programs, how has FDA's new 

animal drug review process improved? 

Before these pl'ograms were initiated, FDA's Center for Veterinary Medicine had a hirg¢ 

backlog of ovenlue submissions, and sponsors had to wait, on i!Ve!'age, 500 days for pioneer 

drug review responses aild 700 days for.generic drug review respofllle$. Because.of · . 

additional resources provided through the animal drug .user fee programs, FDA maintains a 

stable scientific and teclu1ichl. 'YOrkforce and provides the animal drug iildustrywith more 

timely and pl'edictable ptematket product review. Thes¢ prograrris have been l)ighiy 

successM and have. enabh:d CVM to eliminate the backlog .in applications, dramatically 

reduce the time needed to review animal drug applications and other submissions, improve 

time}y communications with drug sponsors, and achieve.otherefficiencies in the drug 

approval process. FDA has met or exce.eded virtually aJ.l perfonnance goals establishe.d 

und.er ho.th programs, without sacrificing sCientific standards for safety and efficacy. 

2.. What has FDA Ieari1ed since the first authorization. of the animal drug use!' fees and 

how have.the ag1•eements evolved over time to furthl!r streaniline the review ,proce$s 

since the fil'st authorization? . 

The :five-ye!!f reautlwriZation cycles for AnOFA- andAGD:UFA- have supported 

continuous program innovation, evaluation, and improvement. Through successive 

reauthorizations, program enhancements hav!'l evolved and expiUlded to inClude extensive 

eommunication and consultation between drug sponsors and FDA throughout drug 

dev~Jlopment. 

Under the currllht .ADU.F Ant agreement,. FDA has made multiple enllm~cements to the 

chemistry, manufacturing,. am,! cqntrols (CMC) technical sec~ion of the new animal.drug 

appiication (NADA)- one of the rriost complex coinpone11ts of the new animal drug 

sul>mission -which have reduced overall review time. The. Agency now permits the 

submission and review of early completed CMC irtfonnation, permits comparability 

p.rotocols to be submitted as pi:otocois Without substantial !lata in an investigalional new 

animal drug (INAD) file, and permits certain prior approval manufacturing supplements to be 

resub!'nitted as Supplements-Changes Being Effected in 30 Pays (CBE-3Qs). 

FDA continues to improve commuh:lcatlons, tirneHness, and predictability offoreign pre;. 

approval ins})(lCtions. Sponsors.may how voluntarily subinit a. list of foreign nianufacb.iting 

facilities t)wy anticipate including in their applic~tions sqbject to pre-approval inspections for 

the following fiscal yea!', perrnittii1g:better planning and ti:rriely e~ec!ltion of FDA good 

manufacturing practice (GMP) inspections. 

Under the cun-ent AODUFA II agreemen~ FDA added flexibility with asecond-cyde 

shortened review proce$8 for key SJ.lbmiss\qntypes, suc)1 as protocols, .data submissions, and 

applications that significantly impact the generic new.animal drug approval timellne. 

Quhlifyi11g submissions receive a significantly reduced second-cycie review to shorten 

approvaltiinelines. FDA aiso made multiple enl1\lntements to the q,1Ctechnica1 section, 

similar to. the ADUF A changes noted abo vee 
108 


30574.062

PageS-Tbe flonorable Greg Walden 

FDA ah;o added a pre-approval foreign inspection.goal to improve con'nm:mlcations, 

timelim:$,S:, and p~edictability of these inspections .. FDA l!lso: developed question-bl\l>ed 

review (QbR) for bioequivalence submissions, .and. deployed aQbR for blood-1iwel 

bioequjvaleriee protocol submissions. Additional templates to further enhance the review of 

bioequivalence stibmissiohs.ate currentlytu'ider development. 

The ADUF A IV and AGDUF A III agreements b1.tild on the achievements of these highly 

succ.essfuf programs. TI1ey will help ensure .FDA has the resources needed to conduct timely 

reviews lind a~sist drug spopsors:inbringing more animaL drugs to the market. They also will 

fostetinhovatioh and provide .enhanced access to safe arid effective aniinal tl'!etapies. 

3. Without the animal drug user fee programs, would animal drug development 

suffer'? · 

The animal drug user fee programs have enabled FDA to dramatically reduce the time 

needed to review pioneer and ·generic animal produ<;ts riirptemarket appi:oval; improve 

timely commurucatiohs w:itb spQnsors, and achieve other efficiencies in the drug review 

process, whlle,he'Iping ensure that the drugs are safe and effective. 

In the absence of these programs, FDA would be forced to.lay off a significf!Dt share of o.ur 

SCi\lnti:fic Wotkforce, delaying the. review.ofneW animal drugs, creating unCertainty and 

frustration fot ii1dustry, a:nd delayjng the availability of new safe 11nd effectiye treatments. In 

'the.AGDtJF A progTllm, approxJmately 60 percent of oU1' staff are funded .by user feeil •. In the 

ADUFA progta:in, approximately35 percent ofCVM's workforce is fi)nded by user fees. 

·The loss ofstich a large number ()f staff would be devastating: 

4. In yow· opinion, wluit are the most sigilificant ne\V propo~als in ADUFA IV and 

AGD.UFA lll and bow do they further improve the aliimal drug review process at 

FDA? . 

Both agreenienis build oil the success of prior progr~~tn.achieveme!1ls, propose addition& to 

current perfo1'tnance goals to .further enhance review,. and ii1clnde financial recoinmeridati(;)11S 

to enhance program stability. 

In ADUFAIV, FDA adds 1111 additional four.new performance goa:ls to enhance the :exchange 

of scientific infol'ffiatiqn. FDA Will reduce timeframes for certain ll.ledica:ted feed 

applications and environmentalimpact submissions from· 1.80 days. to 60 day$. We also 

establi.sh new goals for timely pre-submission conferences (l!ld tissue l'esidue method 

demonstratiot1s. · 

TI1e ADUFA IV recotnmendatiC;>ns. pl$o requite 100 percent elect\~Oruc suJJmission starting in 

FY 2019 to help facilitate efficient review and an FDA coinmittnent to wo.rk on · 

implemllnth1g the U .~.-EUitlpean Union Good Manufacturing Pi:;lctices Inspectiort Mutual 

Recognition .Agreement for animal drug facilities .. 
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30574.063

Page <i-The Honot;~bJe, Gteg Walden 

The AGDUFA ni m':gotiate(l.agreeinent incl1.1des a significa,nt, i!dditional financial 

commitment from theat1imal genericdtug h'ldusuy that reflects the industry's growth. 

1Jlese resourc~ will help support, significantly decreased review times tb.r generic 

Sl.)brnissiorts and proVide greater review predictability. Like the A.DUFA1V 

recommendation, AGDUFA nr alsotequites 100 percent electtoni<: subrnission,startirtg next, 

year; 

Dr. So,l,omon as you have previously e:l(J}bdned, tnese animal drug user fee agreement' are 

critical to ensur'ing ariimld health and safety alid strl)amliriing FDA's animal drug approval 

process; 

These user fee programs help to maintain a stable workforce at th,e agency to reView new 

animal drug l!pplications, whil,e cutting down on review times and improvirtg FJ)A. 's 

efficiency. In additiort,,the agreements also help to bring, cettafu.'ty to industry nigarding 

the review ,and approval of Innovative and generic animal drug5,' provide necessary 

treatments for,animaJ healt~providets, and eJJ.SUte tQe heal.th and Well-being of our 

aniinals. 

5. Can you explain why it is so criticai that the animal drug user fee.and animal 

generic drug user fee programs 11re reauthorized bdor-e the sunset date? 

6. What willllappen ifthe animal drug use)· fee agreements .are not reauthoriZed in a 

timely manner? Could there be disr11ptiolis in. the approvai process? 

1. WQuld delays impact t~e agency's ability to retain subject matter experts to nvfew 

new animal drug applications? 

If reauthorization is delayed, .we could risk having to lay off many employ~s .. As a longertetm consequence, a delaY will.make it more difficult fot' FDA to attract and retain skilled 

scientists and medical reviewers, and qndennine product innovation. 

The loss of large nUJIIb.ers ofdedicated staffwouid be devastating. In 'the AGDUFA 

progranr, approximately 60 percent of our staffare fi.mtied by user fees. In the ADUF A 

program, .approximlltely 35 percent of the FTE are funded by userfees. With the loss of 

FTE, review til'l)es would retum to the pre-user fee. timefhunes. whiCh exceeded SOQ days for 

pioneer products and 700 days for ~~enerlc products. 

lfthere's a reastmable expectation that ADUFAand AGDUf A will not be reauthorized by 

September 30th, FPA wotJld have to.notify those employees affected no later than 60 days 

prior to their ex;pectedtelease tiate. Ute Agency, however, would .have· to perform a · 

substantial analysis ptior to sendil1g out the RIF notices to determine what steps would be 

lleces-sary to adjust ·drug review and. the personnel e)1gagGd in those activities. 

A topic that of({.ln comes "Pin ~Celation to th.e reauthorization of animal drug user fees is 

antimicrobial resistance given that the Center for Vciterinary Me()icbte. at FDA is also 

~barged with evaluating antimicrobial animai drugs. Dr. Solomon, as you know; antibiotic 
110 


30574.064

Page 7-'l1u; Honorable Greg Walden 

resistance is .a grave public health threat as the use ofantimicropials in food-producing 

animals .can.rcsult. in the emergence of antimicrobial resistance in bacteria that can be 

l;ransfcrr~ to ltnmans and can pltimately reduce the effe~:tiveness of antibioti.!!S in human$ • 

. 6. Can you discus,s the steps. FDA has taken recently to addr.ess the p.ubiic health 

concem.s related to ailtiinicrobial resistance and help r.educe or limit th!il use of 

antimic.-obials in 

.fooJi-producing animal~? 

Antimicrobial resisttmce (AMR) is a serious global public health threat. FDA, in close 

coordination with other governn1ei1t and public l1ealth stakeholders,includingUSI>A,. ha13 

taken a leading role in addressir!g this. Critical threat.by impleinentingjudicious use poliCies 

to pl:()mote anti.microbial stewardship and by enbancing surveillance through systems snch 

as the Nationai AntimiCrobial Resistai1ce Monitoring System. 

Over the past few yea.rS FDAhascmade a number Of lmportimt changes with regard to 

antimicr:qbial use in r~nimals.. 

1n Dece~"riber 2013, FDA relJ_uested through guidance GFI #213 that animaf drug. sponsors of 

riledically important .antiinierobials us.ed in an1mal feed and w~fer revise the labels of th~e 

products to remove indications· for growth promotion .and to require. v¢tetinary oversight for 

.!he re1llainingtherapeutic uses. The policy outlfued in GFI #213 was fuilyimplemented in 

Janu11fY 2017, with all affected animal dh\gsp6nsprs inakingt!le request~.changes to. their 

labels. It is important to note that the cooperation of the affected animal drug sponsors was 

voluntary; .however, because they have now revised their labeling consistent with the 

recommendations irt GFI #213, theuse·oftheseproducts i11 the feed or drinking wate~· Of 

food-producing. at;1imals for produc;:tion (e.g., growth promotio11) purposes is now illegaliri 

the U.S. and their use for therapeutic purposes.requires authoriza~on from a licensed 

veterinari811. 

To build on the progress made by GFI #213; FDA smtght public inputon establishing . 

appropriately-targeted, durations ofth1;1rapeutle use ofmedically•important antimicrobial 

drugs in food"J)rodueing a:trimajs. FDA has evaluated the comment~ received and is in the 

process of ~eve! oping- a.specific strategy for addressing this issue. The strategy developed 

will 11eed to c9nsider the approved use conditions of these products on a product-by-product 

I;Jasis and any Cl1anges to such use cond]tiorts will need to. be based on sound science and 

available evi<ienee. 

FDA also has issued annal rule revising the· annual reporting requirements for drug 

sponsors of antimicrobial$ sold or distlibrited fo1· use i!l food-producing a11im.als. t!J.e 

additional data FDA will gather .as a result of that rulemaking. will improve. our 

underStanding of how antimicrobials are so1<i or distributed for use. in majorfood-producing 

species. and help further targef efforts tO. ensure judicious use of medically-import811t 

arttimicro)Jials. · 
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Page 8 - Tl~e Honorable On:g Walden 

FDA is. aiso funding two g~•ants for antimicrobial u~e data collection. These collectic;m 

efforts. are intended to provide part of the baseline lnfol'matiort on antimicrobial use 

practices iil the fopr major food·produqing animal species (cattle, s\',li11e, chickens, turkey!l), 

which is.a cdtical element in measuring the overall impact of FDA's j_udicioususestr{liegy. 

We also expect these data co)leclion efforts. to provide important inf'onnation on 

methodologies to help opthrtize Jong-tetm strategies to collect and report:s\lch antitrticrbbial 

use da~a. 

Finally, FDA has also been working in close collaboration with the USDA APHIS Center 

for Epidemiology and Animal Health, ap.d.has provided input on surveys they h<1ve 

conducted on antimicrobial use hi ceiiajn apimal agriculture. settings. We. also expect the 

results oftlleSe surveys to provide useful information fot assessing.antiniicrobial Use 

practiceS in veterinary setting&; 

9. tiow do we balance the need for medically important U:ses of antimicrobials in food 

producing a11i'mal.s with .efforts to limit or .reverse resistance @nccrns? 

FDA believes thatthe concept.of"antin1ictobial stewatdship" in the aninlal agricuiture 

setting el,lcompasses a number of important principl~, including the following judicious use 

prillciples: i) Antimicrobial. drugs should only be used in food-producing animals When 

necessary to treat; prevent, o;r control <:lisea&e,. !md not for production (e.g., g~·owth 

promotion) purposes; a1:id 2) when antimicrobial u8e is necessary, they should be used ir\_ai1 

optimal miumeru.nder the supervi$ion of a licensed veterinarian. 

lO,.How has ac.cess to antimicrobial drug sales.and distribution data helped to iinprove 

·FDA's efforts to addres.s antimicrobial resistance? 

FDA believe8 this information enhances the Agency's understanding of antimicrobials 

entering fue marketplace and supports the assessment of FDA's ongoing efforts to encourage 

thejt[diciou8 use of antirnicrQbials in food~producipg animals to heip ensure the continued 

!lVailability ofsafe and. effective antimicrobials fot ilniinal!l arid htimiln~, 

While sales data.provide insight regar<:ling antimicrobial drugs being sold and distributed, 

F,DA believes !iclditional data should be considered when assessing the progtess·ofefforts to 

fOster judicious antimicrobial use, including acrual1,1se data, animal den1ographi~ and 

animal health data, anddata·on .resistance; FDA .continue& to work with Pe4eral, academic, 

and industry Pllriners to obtain more information about how, when; and why animal · · 

producers and veterinarians use medically important ai1tim;ict"Qpial drugs: 

il .. For the first time this past year FPA's summary re(iort on antimiCrobials sold or 

. distributed for use in food, producing animals Included species-specific estimates. 

How did FDA determine thes.e estimates and wh11t 11dvant11gedoes Inclusion of 

specific estimates have In data collection efforts? 
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Page 9- The Horioi'l!ble Greg Wal~(l!J 

Since 2008, sponsors of approved or conditionally approved new animal dl'ug applications 

for a drqg containing an atltimicrohial.activ!l ingredient; m!lst annually report to FDA on the 

ainol.int·ofeach such ingredient'inthese drug products sold 9r distributed for use ill food" 

producing anii:nals .. FDA summarizes this infontlation and.tnakes itavai1able'to the public in 

its ru:mUlil.~UilltllatY .reports. 

The species-specific estimates were reported for the first time. as part.of1he2016 annual 

·summary report FDAestablished1 through notice li!ld co1nment rulemaking,.the additional 

requirement that drug .sponsors subm1t species-specific estimates as part of their annual 

tepoi't on the quantity o,fantirl:iicrobials sold or distributed for use in food-producing animals. 

·orug sponsors are required to :proVide a spedes-specificestiinate of the percentage of each 

producfthat was so!p or di!rtribpted domesticaily il1 the reporting yeatfor use in any ofthe 

foilowing animal ~ecies categories, but only for such spe<.;les that appear on the l\pproved 

label; cattle, swine, chickens, twk;eys. The total ofthe .species"speci:tie percentages tepo1ted 

for each product niust account for 100 percellt of its sales aiJ.d d~stribrition;. therefore, a fifth 

category of"other species/unknown;' must also be reported. Sponsors m\jst submit eaCh 

year's report to FDA.no l&terthan iylarch 3.1. 

Given th!it.many anti~icrobialnew animal drug products are approved arid labeled for use in 

more than one animal species, the additional species,specific data improv~ our . . 

understanding ofhow antimierobilils are sold <rr distributed for use,in l'najot food-producing 

species ai!d will help further target effo1is to en$urejudicious use ofm,edically impmtant 

antimicrobials. 

Dr. Solomon, the public health crisis resulting from alttiniicrobinl resistance. is ve1-y 

concerning and I'm interested in FDA's guidance on judicious use ofantbnict•obials for 

food-p1·oduclng ani,mals and whether FDA's policy has improved veteri11ary practice In this 

·area. 

There is wide agreement that antibiotics should only be usell when necessary. As yon 

discussed brieny In your tesfimqny, greater .awareness of the harms of antibiotic resistance 

shouJd result in changes to how ant~bloties are utilized In animai jlgriculttJre, an4 how FDA 

is monitoring !lntimicrobial usage in food-producing animals. 

12. Will you furthe1· discuss FDA's policy on judicious use ofliiltimicr~bials in food 

producing aliimab, which aims tl;. m3~n:dze therapeutic efficacy while also 

n'tinimi:ting the selection of resistant microorganiSms1 

T):le goal ofFDA ·~.judi<;ious use strategy is fo~used on mitigating antl.microbhll resistance 

bey eliminating the use of medically important anthnicrobials in food•producing.aniina:ls.for' 

pl;o<').uction{e.g., growth promotion) p\lrpose,s and limiting thempeuticuse to. legitimate 

animal healtlmeeds (he., diseasetniatmertt; 'coiltrol; and prevention) that are \lllder 

veterinary oversight. 
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Page 10 -111e Hoi1<irable ~reg Walden 

It's essentialthat we take steps to ensure that all uses of.authuicrobials, in both veterinary 

and l1uman healthcare.settings, are judicious!lnd cons.istent with the principles of ruttibidtic 

stewardship. FDA conthiues to weir]<. WithFed~ral, aqademic, and iudusti"yprutners to obtain 

more :information about how,. when, and why animal producers and veterimiriatJs use 

medicallyjt'PJlOrtant atithnicrobial dJ;Ugs. Additional information about how these 

antimicrobials are.beingused 011 the fannwillhelp the agency to assess associations 

between atitibiotic use practi~ atJ.d antimicrobial resistance. 

13. Why is .It so important (o have vetet·~ary ovcr~igbt or .cons11ltatiC!n when !ltllizing 

medicaliy tmportant .antimicrobials .in food-producing animals? 

Veterinarians play a critical role in diagt1osing disease and in the decision-making prcicesa 

related to instituting measQres to treat, control; or prevenfdisease~ Veterinary oversight of 

medically i:mportatit all,ti:mictobials. ensure!\ that pre~cri]>ing d~cisio;ns are based on 

·professional judgements about the risk of a specific bacterial disease atJd whether'it would be 

appropriate in a partiCl.Jllu· situation to tiS.e medic;illy important antimicrol?ials.for prevention 

purposes, ·Such factotsii1c!udewhether: (!) thereis evidence that the drug wi.ll b~ eff~c.tiye 

in treating the ParticUlar dis~!le;. (2) such preventive use ls consi$tent with accepted 

veterimiry practice; (3) the use is Intended to address particular bacteria; (4} the 1,1seis 

appr9priately targeted to atJimalJ> at risk of developing.a specific disease; arid (5) there are no 

reasoiJable altemative.s forirttetvet1tion. . 

14. What is.tbe status ofimplementation 011 FDA's judicious use poiicy;and how has 

implementation. progressed since the guidance was first Pllb~shed fu 20131 

In January 2017,FDA completed its thre¢-year initiative tQ eliminate the use ofmedica,Jiy 

important antimicrobial. drugs for production purposes (e.g., growth promotion) '!itid require 

veterinary oversigh_tfor the rC1lJaming therapeutic uses of these drugs in the feed ot drinking 

water of food producing animals, All affected animal drug sp<msors voluntarily worked 

with FDA to make the requested chl;!t1ges to their product labels. A11292 affected atJimal 

drug .applications were eithet aligned with the Agencis reeommendations or, in some east;s, 

were voluntarily withdrawn by the drug sponsor. As a, result ofthe ohimges: tnade by at1imal 

drug sponsors to ali&ll their products with FDA's recommendations i11 GFI #213, medicallyimporlantantlmicrobials can no longer legally be used hi the·feed.pr drinking water offoodproducing animals for production (e.g., growth promotion) purp.oses and can ortly be· used 

for therapeutic purposes m the feed or water of food-producing atlimal.s with the oversight 

of a-licensed veterinaria.n. · 

FDA finallze.d updated Veterinary Feed Directive (VFD)regulations in June 2015 to 

facilitate veterinary over&ight gf feoo-use ru)tibiotics. These regulations wentinto effect 

October 1 ,20 15. The updated VFD regulations provideveterinatiatls 11 framework for 

authorizi11g the use qfmedically important antimicrobials in feed. 

Based on inspection activiiies carried oilt by FDA's office of Regulatory Affliifs (ORA) and 

state feed regulatory pi:ogrl!n'is, itnplementation .of the VFD Final Rule has generally gone 
114 


30574.068

Page 11-TIJe.HonorableGreg Walden 

welL Ofthe approxhnately 19Q VFD orders.inspooted during the2Ql7 VFD Inspection 

Assignmen~ nearly 100% have been signed by a veterinarian aware of t4e state or federal 

veteliilarian-client~patient relationship (VCPR) requirements.that apply in the state where 

they ate issning the VFD order. Based on this observation, we l;lelieve affected .stakeholders 

have bee~tlearning and adopting the prnctices necessary fqr ensuring co.mpllance with the 

VFDtegniation and supporting antiniicrobiarstewi!Idship. 

15. Wltat additional steps do you believe FDA and industry should be taking to further 

addl'ess the harms of antimi~obial resistance? Are, there additionaUools that FDA 

needs to· better address antimicrobial r.esistance? 

Last Jatiuary, .FDA published its key initiatives for the nex,t five:years,·which include the 

following: 

• Align antirnicrol;Jial di:ug products with the principles ofantimicrol:Jial stewardship in 

veterinary setting~. 

• Support efforts to foster stewardship of antimicrobials in veterinary .setting$. 

• Assess the impact of strategies inte11ded to curb the eme~·.gence ofantimietobial resistance 

ass<Jei!lted with the us!l ohntimicrobial dtu~ in veterinary s\'lttings. 

FDA CQntinues to work with Federal~ academic, and Industry partners to obtain mote 

ipfonnatioJ1.about how:, when,. and. why animal producers apd vetepnariims use medically 

important antimicrobial drugs. Shouid FDA identify further steps that a.re i1ecessw.;y td 

address the potential ham'! of antiinicrobial resisiaqee, we will work with our Congressional 

. partners to request additional tools or authorities, as apprqpriate. · 
115 


30574.069

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

€ongressss of tbe Wniteb ~tatess 

~oust of i\epresentatibes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority (202)225-2927 

Minority (2021 225-3S41 

AprilS, 2018 

Dr. Rachel Cumberbatch 

Director, Regulatory Affairs, Animal Drugs 

Animal Health Institute 

1325 G Street, N.W.; Suite 700 

Washington, DC 20005 

Dear Dr. Cumberbatch: 

Thank you for appearing before the Subcommittee on Health on March 14, 2018, to 

testify at the hearing entitled "Reauthorization of Animal Drug User Fees 2018: ADUFA and 

AGDUFA" 

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. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on Apri119, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov, 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
116 


30574.070

Attachment- Additional Questions for the Record 

The Honorable Gus M. Bilirakis 

1. Would you walk us through the benefits of ADUFA and AGDUFA to industry and why 

these programs have a track record of success? 

The Animal Drug User Fee Act (ADUFA) has been successful in providing additional resources 

to the Food and Drug Administration (FDA) to enable the agency to meet agreed-upon 

performance goals. ADUFA provides about 44% of the funding for the animal drug review 

process at FDA. The program has provided stability and predictability for sponsors and has 

helped modernize the review process through items such as electronic submissions and 

communications and the scheduling of conference calls and meetings. This stability allows 

sponsors to make informed decisions about the investment risks of research and development 

dollars. Pet owners benefit by having their animals live longer and healthier lives, and livestock 

and poultry producers have the tools needed to keep food animals productive and healthy. 

Looking forward, AHI hopes to engage FDA's Center for Veterinary Medicine (CVM) on 

potentially more meaningful improvements for ADUF A V to incentivize innovation and 

streamline the review process. Such improvements could include increased market exclusivity to 

encourage more innovation and new technologies; implementation of a concurrent two cycle 

chemistry, manufacturing and control review process; and using a risk-based approach to 

determine the need for submission of raw data from laboratory and clinical studies and 

simplifYing the drug review process and associated requirements. 

2. You mention in your testimony that conditional approval authority exists in other areas 

of animal health with the exception of major species. Why is that and how does not 

having this authority in major species ultimately affect public health? 

There are several urunet medical needs where veterinarians, livestock and pet owners have no or 

limited treatment options necessary to address disease threats. These unmet needs can lead to 

illness and death among animals. There are well-defined public health benefits to keeping all 

animals healthy, largely due to the number of zoonotic diseases which can pass back and forth 

between animals and humans. Authorizing the agency to extend conditional approval status for 

animal drugs would modernize the FDA approval process and allow faster access to new animal 

drugs that can treat or potentially prevent serious diseases. We have seen success of licensing of 

vaccines and biologics at USDA and believe that the program, expanded to a similar market in 

animal drugs, would also be successful. 

Conditional approval does not currently exist for major species because it has not been 

authorized in law. The Food and Drug Administration would like to offer this pathway but has 

made it clear they need Congressional authorization. Congress last addressed the issue of 

conditional approval in animals when it passed the Minor Use/Minor Species Act in 2003. The 

ability to treat more diseases in food animals will contribute to a safer food supply. The ability 

to treat more diseases and conditions in companion animals will allow animal owners to enjoy 

the companionship and health benefits of pet ownership without fear of disease spread. 
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30574.071

The Honorable Frank Pallone, Jr. 

1. Dr. Cumberbatch, can you briefly summarize why you believe the ADUF A and 

AGDUFA programs, respectively, are critical to the development of animal drug 

products? 

The chief benefit from ADUFA is ensuring an efficient and predictable review process by which 

the industry can effectively plan a project timeline, therefore providing a greater incentive to 

invest in new technologies. The dedicated resources provided for by the user fee program enable 

FDA to have qualified staff to review submissions in a timelier manner. Because of this, 

sponsors can better plan their research projects since they can better estimate when the FDA 

review will be completed for certain technical sections, allowing for better informed decisions 

about research and development investments. Increased predictability and communication is 

critical to the development of animal drug products because it encourages increased research in 

new therapeutic areas and fosters opportunities for new entrants in the animal health industry. 

2. How has the animal health industry evolved since the implementation of ADUFA and 

AGDUFA and how have the animal drug user fee programs improved the animal drug 

application review process at FDA? 

The primary aim of ADUFA was to establish a degree of predictability as to when FDA would 

render a decision on a new animal drug application or technical section leading to the filing of an 

application under the phased review process. Prior to ADUFA, animal drug sponsors had no 

assurance when the agency would respond to a submission even though the statutory time frame 

of 180 days was required. The timeframe was often exceeded, generating a backlog of 

applications and submissions. The dedicated resources provided for by the user fee program has 

enable FDA to have qualified staff to review submissions in a timelier manner. User fees 

collected under ADUFA have fixed some of the problems related to unpredictability by 

eliminating the backlog within the first year of ADUFA I and establishing sentinel submission 

time frames in which the agency is required to render a response whether positive or negative. 

Because of this, sponsors can now better plan their research projects since they can better 

estimate when the FDA review will be completed for certain technical sections, allowing for 

better informed decisions about research and development investments. 

Increased predictability and communication has encouraged increased research in new 

therapeutic areas and fostered opportunities for new entrants in the animal health industry. 

3. Can you provide examples of how the ADUFA and AGDUFA programs, respectively, 

have helped your industry to innovate and have resulted in bringing more products to 

the market? 

The chief benefit from ADUFA is ensuring an efficient and predictable review process by which 

the industry can effectively plan a project timeline, therefore providing a greater incentive to 

invest in new technologies. In ADUFA II the FDA agreed to sponsor a series of technical 

workshops to explain the current thinking on requirements for safety and efficacy testing, 

manufacturing, and for other data requirements under the Act. These workshops were important 
118 


30574.072

for sponsors to better understand what FDA would expect for study designs and outcomes. CVM 

also instituted an iVET program with CVM teams dedicated to new technology platforms 

supporting both small and large companies. Overall, the communication aspect under ADUF A 

has enabled industry to better understand the FDA expectations, allowing sponsors to invest in 

the development of new and innovative technologies. 

4. In your opinion, what are the most significant new proposals in ADUFA IV and 

AGDUFA III and how do they further improve the animal drug review process at FDA? 

An important goal for FDA to act on is implementation of the US/EU mutual recognition 

agreement on Good Manufacturing Practice inspections. Due to globalization, many FDA 

approved animal drugs are also sold and manufactured in the European Union member countries. 

Inspections are required before a product can be approved and marketed. Regulatory GMP 

inspections continue to be done as long as the drug is being manufactured. FDA has traditionally 

required inspectors to conduct on-site inspections of those foreign facilities. Due to scheduling 

priorities and logistical considerations, these inspections can be a lengthy process and may cause 

significant delays in approval. Though FDA has agreed in prior ADUFA agreements to speed the 

process of foreign inspections, delays remain in certifying foreign manufacturing sites. The 

ability for FDA to accept the inspection reviews of competent authorities in the EU without 

having to conduct their own inspections will improve the timing of these decisions and 

potentially accelerate the approval of important new products. This effort is already underway 

for human drugs and it is important that FDA work to leverage that effort to include animal 

health products as well. Inspections of animal drug manufacturing sites are usually scheduled at 

foreign sites when there are associated human drug inspections in the region. If mutual 

recognition of foreign authority inspections is only implemented for human drugs, the site 

inspections for animal drugs will likely suffer further delays because the coordination between 

human and animal drug inspections will no longer be possible. 

5. Can you explain why it is so critical that these programs are reauthorized before the 

sunset date of September 30, 2018? 

As with consideration of other user fee programs, if Congress does not reauthorize the ADUFA 

program by the sunset date the program will cause the initiation of sunset procedures, including 

the layoffs of some 120 FDA employees. Even a temporary disruption would cause harm to the 

drug approval process at the operational level and thus slow the momentum within CVM for 

reviewing submissions and the overall approval process. This unpredictability would inhibit 

companies from moving forward on projects where timelines and costs could not be accurately 

forecast. Overall this would lead to a setback in bringing much-needed animal health products to 

the market. 
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30574.073

6. Given the lack of robust utilization of the conditional approval pathway under the minor 

use/ minor species approach, why does industry believe this process might be more 

successful for other types of animal drug products? 

Since 2004 FDA has conditionally approved four animal drugs through MUMS- one to control 

mortality in catfish due to bacterial disease and three to treat specific cancers in dogs. 

Unfortunately, the program is underutilized because the definition of minor use in a major 

species is narrow in scope. Developing a product that costs millions of dollars for a small market 

is unfeasible. The current limits of 50,000 horses and 70,000 dogs, for example, are small 

considering the fact there are 7.6 million horses and nearly 90 million dogs in the U.S. The final 

cost of the product would be higher than the market could bear because animal owners pay the 

full cost of medical treatment out of pocket. 

A key reason to expand the conditional approval process is to drive innovation and approval of 

new molecular entities for serious diseases for which there are no available therapies and for 

which it is difficult to establish clinical effectiveness via controlled studies. This is often due to 

the time needed for a long term progressive condition to manifest or lack of effective disease 

models for use in controlled studies. Expanding the pathway to major uses in major species 

changes that equation and allows companies to consider a fuller range of opportunities. There 

are several unmet medical needs where veterinarians, livestock and pet owners have no or 

limited treatment options necessary to address disease threats. Authorizing the agency to extend 

conditional approval status for animal drugs would modernize the FDA approval process and 

allow faster access to new animal drugs that can treat or potentially prevent serious diseases. We 

have seen success of licensing of vaccines and biologics at USDA and believe that the program, 

expanded to a similar market in animal drugs, would also be successful. 

7. Should conditional approval be expanded in certain cases for other animal drugs 

applications, what are some examples of conditions or potential therapies that could 

improve animal health and could be an effective use of this process? 

CVM and AHI held two years of discussion to determine the need for expansion of conditional 

approval to other categories of new animal drugs and agreed to a set of criteria for products that 

would qualify: 

o Unmet medical needs (including new disease outbreaks) 

o Life threatening, emerging, sporadic and/or chronic disease conditions 

o Delayed onset or delayed progression of disease. 

o Diseases which would require an extended time period of evaluation in order to 

euroll enough animals to adequately power the study. 

AHI has developed a list ofunrnet medical needs in different animal species that are examples of 

the diseases and conditions that could be addressed, and that list is attached as Appendix A. 

While this list is not comprehensive, it illustrates the diversity and seriousness of the need across 

animal health. 
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30574.074

8. FDA's gold standard of safety and efficacy is the cornerstone by which the agency 

reviews new drug applications. Do you believe that by expanding conditional approval and 

permitting sponsors to keep products on the market while gathering effectiveness data 

there will ultimately be more fully approved products on the market in the long-term? 

Yes. For certain products that treat conditions that meet the definition of an unmet medical need, 

this new pathway would address situations where it is difficult to establish clinical effectiveness 

via controlled studies. By providing flexibility in the timeline for gathering this data, expanding 

conditional approval creates a greater incentive for sponsors to consider these innovative 

therapies. Conditional approval also requires sponsors to demonstrate annual progress toward 

substantial evidence of efficacy and full approval. The availability of more approved drugs may 

improve animal safety by reducing the current use of unapproved or human drugs off-label with 

therapies that have been tested in the target animal and have full data packages that support their 

safety and efficacy. As in the traditional approval pathway, sponsors would be required to 

complete all safety testing prior to receiving conditional approval. FDA would also maintain 

control and oversight of the drug, thus upholding FDA's gold standard of safety while allowing 

the sponsor to prove efficacy. 

9. What are some of the major improvements this proposal makes from the current goals 

and how will these proposals create new efficiencies for FDA? 

In ADUFA IV, FDA has agreed to allow for a reduced review time for medicated feed 

combination drugs and establish a new performance standard for validating tissue residue 

methods and implement a mutual recognition process for GMP inspections of manufacturing 

facilities within the European Union. 

There have been considerable delays for sponsors that gain approval of a new animal drug 

intended for medicated feed to be able to market that product since food animal producers 

frequently use two or three drugs in combination in medicated feeds. FDA must ensure that the 

combinations are safe and effective, so each combination must be separately approved. FDA has 

agreed to substantially shorten this process which will allow important new food animal products 

to be marketed sooner. 

All new animal drugs used in food-producing animals are tested for residue potential, and FDA 

establishes a tolerance, or maximum residue level, permitted in food animal products. The 

agency requires the sponsor to submit for validation by FDA and USDA a suitable laboratory 

testing method that regulatory authorities can use to monitor the safety of meat, milk and eggs. 

Because these validation procedures have not been part of the ADUFA program, timing of this 

process has been uncertain and has been a cause for significant delays in FDA approval of 

products. FDA has now agreed to establish a 120-day performance timeframe for rendering a 

decision on the residue method. 

FDA has agreed to work towards the USIEU mutual recognition agreement on Good 

Manufacturing Practice inspections. FDA has always required that their inspectors conduct onsite inspections of foreign facilities, such as those in the EU. These inspections can delay 

approvals if scheduling or logistical complications occur. Efforts to streamline inspections are 
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30574.075

already underway for human drugs and it is important to FDA work to leverage current efforts to 

include animal health products as well. 

lO.Dr. Cumberbatch- do you believe the electronic submission requirements included in 

this discussion draft will improve the efficiency of the animal drng approval process at 

FDA? 

Yes. eSubmitter has already been widely used by CVM and has improved the ease with which 

information can be shared among reviewers and sent from sponsors to CVM. In short, electronic 

submission is more efficient than large amounts of physical documents, for industry and agency 

alike. In addition to eliminating a significant amount of paper, eSubmitter reduces the time 

needed to copy and assemble paper submissions. It also allows for complete electronic 

archiving and storage of documents. 

While eSubmitter is an important step forward, inputting information into the system and 

understanding what is required for different sections within the template continues to require 

significant industry time because of tight restrictions on acceptable file types. AHI is working 

with CVM to improve the eSubmitter program. Most AHI members currently use electronic 

submissions and work closely with CVM when troubleshooting issues. 
122 


30574.076

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Bill Zellers 

Chairman 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

~ongrt55 of tbt Wntttb ~tatts 

1$oul3e of l\tprel3entatibtl3 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 M<!]Orlty !2<12)225-2927 

Minority {202) 225-3641 

AprilS, 2018 

Generic Animal Drug Alliance 

9 Newport Drive; Suite 200 

Forest Hill, MD 21050 

Dear Dr. Zollers: 

Thank you for appearing before the Subcommittee on Health on March 14,2018, to 

testify at the hearing entitled "Reauthorization of Animal Drug User Fees 2018: ADUFA and 

AGDUFA." 

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. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business onApri119, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thaok you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
123 


30574.077

Attachment Addjtional Questions for the Record 

The Honorable Gus M. Bmrakis 

Would you briefly explain the importance to industry and public health of efficient and 

predictable review periods for generic animal drugs? 

For public health, A GDUF A has provided additional resources for FDA -CVM to make the 

thorough review process more efficient and predictable in terms of timing. This capacity leads to 

sustainability of the regulatory review process for generic veterinary drugs. The benefit of 

AGDUFA to the FDA-CVMreview process further protects the public health by resulting in the 

approval of safe and effective veterinary generic drug products. This ultimately leads to a longer, 

healthier lifespan for our family pets and a safer food supply for the public. 

For industry, efficient and predictable review cycles allow Sponsors of veterinary drugs to plan 

more effectively and to choose generic drug development projects that will lead to a positive 

financial outcome. As mentioned in the GADA testimony on March 14, 2018, prior to the 

implementation of AGDUFA, a CVM review cycle of a generic drug application could take 

longer than 700 days. In many cases where the regulatory process required multiple review 

cycles, it could easily take 6 to 8 years to receive an approval for a generic drug. This was a 

major disincentive to the generic drug Sponsors. Without the re-authorization of AGDUFA, we 

fear that a lack of fimding will result in a number of CVM reviewers losing their jobs, and a 

return to the longer and unsustainable timeframes for regulatory review cycles. This is the main 

reason industry is stepping forward again to support the reauthorization of AGDUFA Ill Ideally, 

industry would like to see increases in Congressional budget appropriations to the veterinary 

generic drug approval process. 

The Public and the Sponsors of generic drugs have a financial interest in an efficient and 

predictable regulatory process. For the Public, the financial interest is that generic animal drugs 

provide a cost-effective alternative to pioneer drugs. For the Sponsor, a predictable regulatory 

review and approval process ultimately leads to a better financial position. When a veterinary 

drug company sells high-quality, safe generic drugs, this not only leads to better lives for our 

family pets and a safer food supply, but it also helps to stimulate the economy, create and/or 

sustain jobs, and provide a return on investment to shareholders. 

The Honorable Frank Pal!ope .. Jr, 

Since the first iteration ofthe ADUF A and AGDUFA programs, these agreements have worked 

to streamline the animal drug approval process at FDA while also ensuring that animal drugs for 

both pets and food-producing animals are safe and effective. 

I'm interested in hearing GADA's perspective on why the animal drug user fee programs are so 

important and why we must ensure the timely reauthorization of these programs. 

1. Dr. Zollers, can you briefly summarize why you believe the ADUFA andAGDUFA 

programs, respectively, are critical to the development of animal drug products? 

The ADUFA and AGDUFA programs provide key funding to assist the FDA-CVM 

in protecting the public health by ensuring the safety, efficacy and security of 

veterinary drugs and by ensuring the safety of our nation's food supply. Without 
124 


30574.078

these additional ADUFA and AGDUFA resources provided by the industry, the 

FDA -CVM has told us that review times would increase significantly and therefore 

the review process would lose efficiency and increase the time to approval for 

generic animal drugs. The uncertainty created due to the lack of ADUFA and 

AGDUFAfunding would set back the ability to bring new pioneer and generic 

drugs to the Public to promote advances in health for veterinary medicine. 

2. How has the animal health industry evolved since the implementation of ADUF A and 

AGDUFA and how have the animal drug user fee programs improved the animal drug 

application review process at FDA? 

The ADUFA and AGDUFA programs have created a predictable review cycle 

allowing the Sponsor to plan and anticipate better. To speak specifically to the 

AGDUFA program, part of the evolution of the generic veterinary drug industry over 

the last 9 years has included new CVM interpretations oft he requirements for a 

veterinary generic drug. There is some debate as to whether all the new requirements 

effictively lead to safer drug products. It is a struggle for industry to balance the 

support/or AGDUFA as we know that growing the FDA-CVM capacity is likely to 

lead to additional drug development requirements that may not contribute to the 

safety of drugs in a measurable way. 

Upon evaluation of the FY2017 AGDUFA Performance Report and the FY2017 

AGDUFA Financial Report, GADA notes that over the last 9 years there are more 

sponsors and interest in seeking approval of generic animal drugs. This is evidenced 

by the reported increase in sponsors and based on the increase in the JINAD sentinel 

submissions, which are indicative of a significant increase in workload. However, 

there is not a corresponding significant increase in generic drug approvals by FDACVM The output of approvals does not follow the same increased trajectory as the 

workload involved in the process to approval. GADA is hopeful that this increased 

workload, which is reflective of significant interest by the Sponsor, will show up in 

the number of approvals in the coming years. 

3. Can you provide examples of how the ADUFA and AGDUF A programs, respectively, 

have helped your industry to innovate and have resulted in bringing more products to the 

market? 

Given that GADA's testimony on March 14, 2018 was focused onAGDUFA, we will 

speak to that User Fee program. The focus of the generic industry through the 

AGDUFA program has been to eliminate the backlog of submissions under review in 

2008 and decrease the review cycle from greater than 700 days down to the proposed 

180 days in AGDUFA Ill There have been great strides in accomplishing these goals. 

However, this has not translated into a significant increase in the number of generic 

drug products approved over the last 9 years. 

There are really no good specific examples of innovative generic approval regulatory 

pathways that have resulted directly from the AGDUFA program. GADA continues to 

support innovative ways that might improve the efficiency of the review process and 

lessen the burdensome requirements without sacrificing safety. 

4. In your opinion, what are the most significant new proposals in ADUFA IV and 

AGDUFA III and how do they further improve the animal drug review process at FDA? 
125 


30574.079

The GADA testimony on March 14, 2018 was focused onAGDUFA Ill The most 

significant improvement in AGDUFA III is the reduction in the submission review 

cycles. For Phased submissions, the review goes from 270 days to 180 days and the 

reduction in the administrative AN ADA review cycle goes from I 00 days to 60 days. 

These reductions put generic drug application review cycles on par with the pioneer 

drug applications. These reductions in review cycle timeframes come with a very high 

cost to industry, as the total cost of AGDUFA III (-$95 million) will approximately 

double from the total cost of AGDUFA II (-$47 million to -$50 million). 

Industry willingly supports AGDUFA Ill. However, industry will be unwilling to increase its 

contribution in the fUture if we do not see an increase in product approvals. It will simply get 

to a point where it does not make financial sense. As industry has doubled our dollars going 

from AGDUFA II to AGDUFA III, we have not seen a similar increase in generic drug 

products approved. In addition, we have seen little or no increases in Congressional budget 

appropriations allocated to the veterinary generic drug approval process. 

5. Can you explain why it is so critical that these programs are reauthorized before the 

sunset date of September 30, 2018? 

Upon sunset of the AGDUFA III User Fee program, the review cycles for generic drug 

applications would likely go from the current 270 days to in excess of700 days, as was 

the review cycle time frame before A GDUFA. A number of reviewers at FDA -CVM would 

lose their jobs because no funding would be available unless additional Congressional 

budget appropriations were provided This would be a lose-lose-lose situation for FDACVM, industry and the public. 

For public health, AGDUFA has provided additional resources for FDA-CVMto make 

the thorough review process more efficient and predictable in terms of timing. This 

capacity leads to sustainability of the regulatory review process for generic veterinary 

drugs. The benefit of AGDUFA to the FDA-CVM review process further protects the 

public health by resulting in the approval of safe and effective veterinary generic drug 

products. This ultimately leads to a longer, healthier lifespan for our family pets and a 

saftr food supply for the public. 

For industry, efficient and predictable review cycles allow Sponsors of veterinary drugs to 

plan more effectively and to choose generic drug development projects that will lead to a 

positive financial outcome. As mentioned in the GADA testimony on March 14, 2018, 

prior to the implementation of AGDUFA, a CVM review cycle of a generic drug 

application could take longer than 700 days. In many cases where the regulatory process 

required multiple review cycles, it could easily take 6 to 8 years to receive an approval for 

a generic drug. This was a major disincentive to the generic drug Sponsors. Without the 

re-authorization of AGDUFA, we fear that a lack of funding will result in a number of 

CVM reviewers losing their job and these longer and unsustainable time frames for 

regulatory review cycles will return. This is the main reason industry is stepping forward 

to support the reauthorization of AGDUFA Ill Ideally, industry would like to see 

increases in Congressional budget appropriations to the veterinary generic drug approval 

process. 

The Public and the Sponsors of generic drugs have a financial interest in an efficient and 

predictable regulatory process. For the Public, the financial interest is that generic 
126 


30574.080

animal drugs provide a cost-effective alternative to pioneer drugs. For the Sponsor, a 

predictable regulatory review and approval process ultimately leads to a better financial 

position. When a veterinary drug company sells high-quality, safe generic drugs, this not 

only leads to better lives for our family pets and a safer food supply, but it also helps to 

stimulate the economy, create and/or sustain jobs and provide a return on investment to 

shareholders. 

FDA has been working since May 2016 to finalize recommendations for the reauthorization of 

the animal drug user fee programs and as part of this process FDA held negotiations with the 

regulated animal drug and generic animal drug industries to reach agreement on both financial 

and performance goals for ADUF A IV and AGDUF A III. 

6. What are some of the major improvements this proposal makes from the current goals 

and how will these proposals create new efficiencies for FDA? 

In AGDUFA III, the most significant improvements for industry are the reduction in 

the Phased submission review cycle from 270 days to 180 days, and the reduction in 

the administrative AN ADA review cycle from 100 days to 60 days. This puts generic 

drug application review cycles on par with that of the pioneer drug applications. In 

AGUFA Ill, the overcollections and offiet provisions have been refined and improved 

to allow funding to be more effectively and efficiently ready for use by FDA-CVM to 

continue to improve the generic drug review process. 

GADA is cautiously optimistic that these shorter review times will not result in 

multiple review cycles. Overall, we are hopeful that the reduction in review times will 

lead to a shortened time from project initiation to approval, allowing generic 

products to come to market sooner. 

7. Dr. Zollers- do you believe that the electronic submission requirements included in this 

discussion draft will improve the efficiency of the animal drug approval process at FDA? 

The electronic submission process has already been available to Sponsors for a number 

of years. According to the FY 2017 Performance Report to Congress for AGDUFA, in 

FY20 13, 48% of generic product related submissions were via the electronic pathway. In 

FY20 17, 58% of generic product related submissions were via the electronic pathway. 

Each year, adoption of the electronic submission process increases. CVM has told 

industry that e-Submissions improve the efficiency of the generic drug review process. 

FDA-CVM requested that AGDUFA III include the provision that 100% of submissions 

be electronic. Industry has accepted this proposal, although we realize there will be an 

initial burden on Sponsors not currently using the e-Submission pathway. FDA-CVM is 

providing a webinar training series to allow Sponsors the opportunity to learn how to 

establish and utilize the e-Submission process. GADA is also reaching out to all of its 

member companies and associates to assist in connecting them to the resources needed 

to establish the e-Submission pathway. 

This will allow CVM to eliminate the "paper" process submission system; essentially 

allowing FDA-CVM to move to one system: electronic. This will save time, money and 

effort and CVM can invest these efficiencies in other aspects of regulatory review. 

GADA understands that potential efficiency gains that can be made. GADA supports the 

transition to 100% electronic submissions. 
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30574.081

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

€ongrt~~ of tbt Wnfttb ~tatt~ 

T!>oulie of 1\eprelientattbeli 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Dr. Michael Topper 

President 

Majority {202) 225-2927 

Minority 1202) 225-3641 

AprilS, 2018 

American Veterinary Medical Association 

1910 Sunderland Place, N.W. 

Washington, DC 20036 

Dear Dr. Topper: 

Thank you for appearing before the Subconunittee on Health on March 14, 2018, to 

testify at the hearing entitled "Reauthorization of Animal Drug User Fees 2018: ADUF A and 

AGDUFA." 

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. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on April19, 2018. Your 

responses should be mailed to Zack Dareshori, Legislative Clerk, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and e-mailed in Word 

format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attacinnent 
128 


30574.082

Govemml!llt Relations 

Aprill9,20l8 

The Honorable Michael Burgess, Chair 

The Honorable Gene Green, Ranking Member 

U.S. House Committee on Energy and Commerce 

Subcommittee on Health 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Answers, Questions for the Record for the Marcill4, 2018 hearing entitled 

"Reauthorization of Animal Drug User Fees 2018: ADUFA and AGDUFA" from AVMA 

President Dr. Mike Topper 

Dear Chairman Burgess and Ranking Member Green, 

Thank you for the opportunity to testify al the March 14, 2018 

of Animal Drug User Fees 2018: ADUFA and AGDUFA." On President Dr. 

Mike Topper, please find attached the answers to submitted questions for the record. If you have 

questions or further information, please do not hesitate to contact Dr. Lauren Stump at 

lstump@avma.org or 202.289.3211. 

Sincerely, 

Kent McClure, DVM, JD 

Chief Government Relations Officer 

The AVMA is the nation's leading representative of the veterinary profession, speaking jar mare than 

9.1,000 member veterinarians across the United States who care passionately about protecting animal 

health, animal welfare and human health. Informed by its members' unique scientific training and 

knowledge, the AVMA advocates for policies that advance the practice of veterinary medicine and 

support the crucial work of veterinarians nationwide. 

1910 Sunderland Place, NW I Washington, DC 20036-16421 p: 800.321.1473 1 

www.avma.org 
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30574.083

Aprill9, 2018 

The Honorable Michael Burgess, Chair 

The Honorable Gene Green, Ranking Member 

U.S. House Committee on Energy and Commerce 

Subcommittee on Health 

Answers to Questions for the Record, hearing entitled "Reauthorization of Animal Drug 

User Fees 2018: ADUFA and AGDUFA" from AVMA President Dr. Mike Topper 

The Honorable Gus M. Bilirakis 

Question 1: In your testimony, you mentioned the need for new and innovative 

medicines to fulfil unmet needs for veterinarians. Would you walk us through some of 

the unmet needs your members see in their practices? 

Answer 1: There are numerous examples of unmet animal drug needs in veterinary 

medicine given the number of different animals that we treat. It is not economically 

feasible for a drug company to develop a treatment for a disease or condition that occurs 

uncommonly or in only one species. Further, it is not economically feasible for drug 

companies to go through the development and approval process for a drug for each of 

seven major species of animals, much less each of innumerable minor species of animals. 

Nor is it practical for drug companies to go through the same approval process for 

different, but similar, indications. Certain diseases are difficult to study due to inherent 

difficulties in constructing long-term studies, enrolling the required number of patients, 

and in studying people's pets or other owned animals, among other factors. Specific 

examples include a lack of commercial eye drops to treat common herpesvirus eye 

infections in cats, immune-modulating or gene-targeted therapies to decrease the severity 

of a fatal condition called degenerative myelopathy in dogs, local analgesics for use 

during procedures such as castration or dehorning in food animal species, and drugs to 

treat or prevent a fatal infection called blackhead in turkeys. More generally, targeted 

therapies for immune-mediated conditions would improve treatment outcomes and 

decrease potential side effects, and the development of more selective antiinflammatories or other pain medications for arthritis in cats, for which there is no proven 

safe drug for long-term treatment, would also be a great step forward. Not only is the 

development of therapies for use for their labeled indication important, but the safety and 

efficacy data they provide is enormously beneficial when extralabel drug use (ELDU) 

provisions in the Federal Food, Drug, and Cosmetic Act apply. ELDU allows 

veterinarians to legally use a drug approved for one species or condition to treat a 

different species or a different condition in which that therapy is effective, but not 

labeled. Development of additional therapies and the generation of additional safety and 

efficacy data will benefit both approved uses and ELDU and are critical for improving 

the health and well-being of our pets, and through food animals, the quality and safety of 

our food supply. 

Question 2: Would you explain some ofthe challenges that exist for veterinarians and 

veterinary therapeutic options in the context of extralabel drug use? 
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Answer 2: Extralabel drug use (ELDU) is a vital provision in the Federal Food, Drug, 

and Cosmetic Act that allows veterinarians to effectively treat their patients despite a lack 

of a drug specifically labeled for that condition. Veterinarians do not enjoy access to the 

same number of approved therapies as human physicians and practitioners, as there are 

roughly 25 times the number of approved drugs for use in humans as there are for use in 

all animal species. Even in human medicine, where there is much greater access to 

approved drugs, there is often the need to use them in a manner that differs from their 

approved labeling. In many cases there is no financial incentive for manufacturers to 

develop animal-specific products or to go through an approval process in each species of 

animal for which a drug may have use, and an understanding ofELDU becomes critical. 

Under ELDU provisions, veterinarians may use a drug approved for one animal or 

purpose in a different animal or for a different purpose when a more appropriate therapy 

does not exist. For example, many anesthetics and pain medications used daily by 

veterinarians in hospital or clinic procedures are approved only for use in humans, but 

they are no less vital to our animal patients for the same purposes. Veterinarians regularly 

perform the complex task of interpreting multiple sources of data including labeled 

animal and human drug data, independent studies, foreign research and data, and 

historically successful clinical endpoints to choose the most appropriate therapy for their 

patients. Conditional approval is a process through which a manufacturer is able to 

market their product after proving full safety data and a reasonable expectation of 

efficacy, but while still gathering final efficacy data. Currently this process is only 

allowed in the approvals process for minor uses and minor species, and it would be a 

transformative improvement to the user fee agreements if this were expanded to major 

uses in major species, and if this improvement included allowing ELDU of these 

conditionally approved drugs. Allowing ELDU of these drugs, within the current legal 

and regulatory framework, would further increase options available for treating animal 

patients, especially for all those species that are not one of the seven major species and 

for more uncommon conditions. Expanding this under the existing legal and regulatory 

framework would keep existing prohibitions on uses of antimicrobials and certain other 

drugs in food producing animals, and continue to prohibit ELDU of medicated animal 

feed. Allowing for ELDU of conditionally approved products would have no impact to 

any FDA policy to address antimicrobial resistance. 
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30574.085

The Honorable Frank Pallone, Jr. 

I'm interested in your perspective on how the ADUFA and AGDUF A programs have 

improved animal health, as well as the nation's food supply. Animal drug development 

and approvals are critical to ensuring that our companion pets lead longer and healthier 

lives and that our foodproducing animals are safe for human consumption. 

Question 1: Can you explain how the animal drug user fee agreements have improved 

animal health, both for pets and food-producing animals? 

Answer 1: Animal drug user fee agreements and animal generic drug user fee 

agreements have improved animal health for pets and food-producing animals by 

providing veterinarians with additional tools with which to treat their patients. In recent 

years, the veterinary community has seen the approval of several new animal drugs, 

partly in thanks to the streamlined and predictable pathway provided by ADUF A and 

AGDUF A. Examples of improvements include a transdermal solution for cattle to treat 

pain in cases of a debilitating and painful disease called footrot, and which also treats the 

fever associated with pneumonia. In pigs, a first-in-class, animal-only antimicrobial that 

is not considered medically important in human medicine, A vilamycin, was developed to 

reduce a disease called scours that causes devastating diarrhea in weaned pigs. We have 

seen approval of a drug for use in horses to relieve certain types of a condition called 

colic, which can cause significant pain in the gastrointestinal tract and be fatal. These 

user fee agreements have also contributed to the approval of many therapies that improve 

the comfort and well-being of our pets. For example, a new drug was developed to target 

and inhibit a step in the pathway in a dog's response to allergens, and provides them 

more effective relief from allergies. An insulin product approved for use in both dogs and 

cats also allows for improved management of diabetes mellitus in many instances. In 

addition to these, there are many other examples of improvements that have been made, 

leading to improved animal health for pets and livestock. 

Question 2: As a veterinarian, what are the benefits of increasing the efficiency of the 

animal drug approval process? Does ADUF A and AGDUF A help bring new and 

innovative products to the market faster in order to help treat animal patients? 

Answer 2: By increasing the efficiency of the animal drug approval process and 

providing a predictable path to market, veterinarians have been provided with new and 

more efficacious therapies for some conditions in animals. This would not have been 

possible without user fee agreements. In an ideal scenario, there would be both robust 

pioneer and generic industries providing veterinarians and their patients with approved 

products for multiple uses and all species. However, the costs associated with developing 

this number of approved products and the every-day realities of veterinary practice that 

require cost-efficiencies and effectiveness make this unlikely. ADUF A and AGDUF A 

have helped bring new and state-of-the-art products to market, and there are 

improvements that can be made to the conditional approval process to further increase the 

number of approved drugs to both major species and minor species under the existing 

legal and regulatory framework surrounding extralabel drug use. 
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Question 3: Can you discuss why the FDA gold standard of safety and efficacy is so 

critical when treating animal patients? 

Answer 3: The FDA review process provides veterinarians and animal owners with 

assurances in regard to the use of drug products in animal patients. It provides 

veterinarians with safety and efficacy data that would not otherwise be available to them. 

When an animal drug is FDA-approved to treat a specific condition, a veterinarian must 

choose that drug to treat the patient unless circumstances that warrant extralabel drug use 

(ELDU) apply, as defined in statute in the Animal Medicinal Drug Use Clarification Act 

of 1994 and in FDA regulations. However, for the majority of conditions that 

veterinarians must treat in numerous animal species, there are no drugs specifically 

labeled for that use. ELDU is a vital provision within the Federal Food, Drug, and 

Cosmetic Act that allows veterinarians to treat their patients despite a lack of a labeled 

therapy, protecting both animal and human health. For example, many analgesics and 

other drugs used daily by veterinarians are approved only for use in humans, but they are 

no less vital to our animal patients in those instances. Even in human medicine, where 

there is much greater access to approved drugs, there is often the need to use them in a 

manner that differs from their approved labeling. Legal restrictions on use in food 

animals are in place to safeguard human health, such as harming ELDU of medicated 

animal feed, and appropriate restrictions on the use of medically-important antimicrobials 

and certain other drugs. In both food and companion animals, veterinarians regularly 

perform the complex task of interpreting multiple sources of data including drug labels, 

independent studies, foreign research data, and historically successful clinical endpoints 

while applying their medical knowledge of unique pharmacokinetic and 

pharmacodynamic principles for many drugs and species in order to choose the most 

appropriate therapy for each specific patient. To determine the best course of action when 

ELDU is required, as in cases when no appropriate labeled therapy exists, veterinarians 

use their medical knowledge and training to analyze existing sources of safety and 

efficacy data, including data from FDA-approved animal drugs. When full approval is 

possible, feasible, and practical, a fully approved-drug can yield an abundance of 

information to veterinarians for both its labeled indication and in cases when ELDU is 

required. Drugs conditionally approved for use in animals provide full safety data and 

preliminary efficacy data in at least one animal species, and that data can be translated to 

other uses in that same species and across species as well. FDA safety and efficacy data 

is the gold standard, and ADUFA and AGDUFA's capability to provide veterinarians 

with an increase in this data can improve the health of animals regardless of the labeled 

indication when ELDU is legally allowed. Improving both the conditional approvals 

process through expansion to major species and allowing ELDU of conditionally 

approved drugs would be a transformative improvement to the user fee agreements. 

Allowing for ELDU of conditionally approved products would have no impact to any 

FDA policy to address antimicrobial resistance.