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



 
       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
                           
                           
                           
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                           

                           


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                        
                              _________ 

                  U.S. GOVERNMENT PUBLISHING OFFICE
                   
 30-574 PDF                 WASHINGTON : 2018                              


                    COMMITTEE ON ENERGY AND COMMERCE

                       GREG WALDEN, Oregon
                             Chairman

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

                         Subcommittee on Health

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

                                  (ii)
                                  
                                  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     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. ___, 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


       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 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, 
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.
    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.

  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 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 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 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.
    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.
    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.

   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 process 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:]
    
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    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.
    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.
    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.
    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 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 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 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 
second-round 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 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 
follicle-stimulating 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 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.
    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 
extra-label 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.
    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.
    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 
reviewers, 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 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?
    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.
    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.
    [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 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 
number-one 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?
    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.
    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?
    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.]
    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.
    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:]
    
    
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    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.
    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:]
    
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   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.
    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:]
    
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    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.
    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, 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?
    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 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.
    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 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 
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.
    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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