[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]


                    REAUTHORIZATION OF THE ANIMAL DRUG USER 
                                  FEE PROGRAMS

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 30, 2023

                               __________

                           Serial No. 118-20
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


     Published for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov
                        
                                __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
54-663 PDF                  WASHINGTON : 2024                    
          
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                    COMMITTEE ON ENERGY AND COMMERCE

                   CATHY McMORRIS RODGERS, Washington
                                  Chair
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio                  Ranking Member
BRETT GUTHRIE, Kentucky              ANNA G. ESHOO, California
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
GUS M. BILIRAKIS, Florida            JAN SCHAKOWSKY, Illinois
BILL JOHNSON, Ohio                   DORIS O. MATSUI, California
LARRY BUCSHON, Indiana               KATHY CASTOR, Florida
RICHARD HUDSON, North Carolina       JOHN P. SARBANES, Maryland
TIM WALBERG, Michigan                PAUL TONKO, New York
EARL L. ``BUDDY'' CARTER, Georgia    YVETTE D. CLARKE, New York
JEFF DUNCAN, South Carolina          TONY CARDENAS, California
GARY J. PALMER, Alabama              RAUL RUIZ, California
NEAL P. DUNN, Florida                SCOTT H. PETERS, California
JOHN R. CURTIS, Utah                 DEBBIE DINGELL, Michigan
DEBBBIE LESKO, Arizona               MARC A. VEASEY, Texas
GREG PENCE, Indiana                  ANN M. KUSTER, New Hampshire
DAN CRENSHAW, Texas                  ROBIN L. KELLY, Illinois
JOHN JOYCE, Pennsylvania             NANETTE DIAZ BARRAGAN, California
KELLY ARMSTRONG, North Dakota, Vice  LISA BLUNT ROCHESTER, Delaware
    Chair                            DARREN SOTO, Florida
RANDY K. WEBER, Sr., Texas           ANGIE CRAIG, Minnesota
RICK W. ALLEN, Georgia               KIM SCHRIER, Washington
TROY BALDERSON, Ohio                 LORI TRAHAN, Massachusetts
RUSS FULCHER, Idaho                  LIZZIE FLETCHER, Texas
AUGUST PFLUGER, Texas
DIANA HARSHBARGER, Tennessee
MARIANNETTE MILLER-MEEKS, Iowa
KAT CAMMACK, Florida
JAY OBERNOLTE, California
                                 ------                                

                           Professional Staff

                      NATE HODSON, Staff Director
                   SARAH BURKE, Deputy Staff Director
               TIFFANY GUARASCIO, Minority Staff Director
                         Subcommittee on Health

                        BRETT GUTHRIE, Kentucky
                                 Chairman
MICHAEL C. BURGESS, Texas            ANNA G. ESHOO, California
ROBERT E. LATTA, Ohio                  Ranking Member
H. MORGAN GRIFFITH, Virginia         JOHN P. SARBANES, Maryland
GUS M. BILIRAKIS, Florida            TONY CARDENAS, California
BILL JOHNSON, Ohio                   RAUL RUIZ, California
LARRY BUCSHON, Indiana, Vice Chair   DEBBIE DINGELL, Michigan
RICHARD HUDSON, North Carolina       ANN M. KUSTER, New Hampshire
EARL L. ``BUDDY'' CARTER, Georgia    ROBIN L. KELLY, Illinois
NEAL P. DUNN, Florida                NANETTE DIAZ BARRAGAN, California
GREG PENCE, Indiana                  LISA BLUNT ROCHESTER, Delaware
DAN CRENSHAW, Texas                  ANGIE CRAIG, Minnesota
JOHN JOYCE, Pennsylvania             KIM SCHRIER, Washington
DIANA HARSHBARGER, Tennessee         LORI TRAHAN, Massachusetts
MARIANNETTE MILLER-MEEKS, Iowa       FRANK PALLONE, Jr., New Jersey (ex 
JAY OBERNOLTE, California                officio)
CATHY McMORRIS RODGERS, Washington 
    (ex officio)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Brett Guthrie, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     1
    Prepared statement...........................................     3
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     5
    Prepared statement...........................................     6
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     8
    Prepared statement...........................................     9
Hon. Cathy McMorris Rodgers, a Representative in Congress from 
  the State of Washington, opening statement.....................    10
    Prepared statement...........................................    12
Hon. Greg Pence, a Representative in Congress from the State of 
  Indiana, opening statement.....................................    15

                               Witnesses

Tracey Forfa, Director, Center for Veterinary Medicine, Food and 
  Drug Administration, Department of Health and Human Services...    16
    Prepared statement...........................................    18
    Submitted questions for the record \1\.......................   120
Rachel Cumberbatch, D.V.M., Director, Regulatory Affairs, Animal 
  Drugs, Animal Health Institute.................................    56
    Prepared statement...........................................    59
    Answers to submitted questions...............................   123
Stephanie Batliner, Chair, Generic Animal Drug Alliance..........    65
    Prepared statement...........................................    67
    Answers to submitted questions...............................   125
Lori Teller, D.V.M., President, American Veterinary Medical 
  Association....................................................    75
    Prepared statement...........................................    77
    Answers to submitted questions...............................   128

                              Legislation

H.R. ___, the Animal Drug User Fee Amendments of 2023............    93
H.R. ___, the Generic Animal Drug Advancement Act................   116

                           Submitted Material

Inclusion of the following was approved by unanimous consent.
Letter of March 21, 2023, from Stephanie Batliner, Chairperson, 
  Generic Animal Drug Alliance, to Mr. Pence and Ms. Schrier.....   119

----------

\1\ Ms. Forfa did not answer submitted questions for the record by the 
time of publication. Replies received after publication will be 
retained in committee files and made available at https://
docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=115630.

 
          REAUTHORIZATION OF THE ANIMAL DRUG USER FEE PROGRAMS

                              ----------                              


                        THURSDAY, MARCH 30, 2023

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:01 a.m., in 
the John D. Dingell Room 2123, Rayburn House Office Building, 
Hon. Brett Guthrie (chairman of the subcommittee) presiding.
    Members present: Representatives Guthrie, Bucshon, Latta, 
Griffith, Bilirakis, Johnson, Carter, Dunn, Pence, Joyce, 
Harshbarger, Obernolte, Rodgers (ex officio), Eshoo 
(subcommittee ranking member), Sarbanes, Ruiz, Kuster, Craig, 
Schrier, and Pallone (ex officio).
    Staff present: Kate Arey, Digital Director; Jolie Brochin, 
Clerk, Health; Corey Ensslin, Senior Policy Advisor, Health; 
Grace Graham, Chief Counsel, Health; Jack Heretik, Press 
Secretary; Tara Hupman, Chief Counsel; Peter Kielty, General 
Counsel; Emily King, Member Services Director; Chris Krepich, 
Press Secretary; Clare Paoletta, Professional Staff Member, 
Health; Lydia Abma, Minority Policy Analyst; Hannah Anton, 
Minority Staff Assistant; Waverly Gordon, Minority Deputy Staff 
Director and General Counsel; Tiffany Guarascio, Minority Staff 
Director; Perry Hamilton, Minority Member Services and Outreach 
Manager; Stephen Holland, Minority Senior Health Counsel; and 
Una Lee, Minority Chief Health Counsel.
    Mr. Guthrie. The subcommittee will come to order, and the 
Chair recognizes himself for an opening statement.

 OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Today, we take the first step to reauthorizing the Animal 
Drug User Fee Agreements through 2028. These must-past 
agreements play important roles in keeping our pets and farm 
animals healthy and happy. This process gives Congress the 
unique ability to help ensure brand-name animal drugs and their 
generic equivalents are able to reach the market as quickly and 
as safely as possible. Animal health is also important to human 
health.
    For example, there is currently a severe bird flu outbreak 
going around the world. One way to prevent that virus from 
potentially mutating and becoming potentially infectious in 
humans is to prevent it or cure the disease in animals. 
Originally established in 2004, the first Animal Drug User Fee 
Agreement transformed the review process for these drugs.
    Before the establishment of these agreements, it took 
roughly 7 to 10 years to get new animal drugs approved. This 
backlog made it more difficult for veterinarians to treat house 
pets for treatable and nonlife-threatening conditions. Food was 
also delayed getting to the grocery store shelves because of 
delays in determining that antibiotics given to food-producing 
animals did not jeopardize the safety of that food for human 
consumption.
    The first ADUFA agreement eliminated the backlog of 
applications sitting with the FDA Center for Veterinary 
Medicine and decreased the review times for new animal drug 
applications from over 600 days to 180 days. The ADUFA 
agreement we are considering today will allow the agency to 
collect 174 million in fees from the industry from 2024 to 2028 
and make critical program enhancements to streamline the review 
process for both regulators and industry.
    These include more stringent reporting requirements for the 
FDA and review times and outcomes of investigational new animal 
drug applications. The agreement also includes a third-party 
review process of these applications to increase oversight and 
help identify ways this process can be more predictable for 
drug sponsors.
    Today, we are also considering the Animal Generic User Fee 
Agreements, AGDUFA. Since Congress backed AGDUFA in 2009, these 
agreements have been instrumental in reducing long wait times 
for drug reviews and getting more lower-cost generic drugs on 
the market. The AGDUFA agreement we are examining would permit 
the FDA to collect up to 130 million end-user fees through 2028 
on review of the generic animal drugs. This also includes 
improved transparency requirements for FDA, who will help 
sponsors more effectively work with regulators to address 
outstanding issues with the file for which sponsors use to 
share information about an abbreviated new animal drug 
application.
    It also includes a commitment from the FDA to take action 
on 90 percent of these requests within 100 days of submission. 
Overall, both of these agreements will significantly enhance 
our ability to keep household pets and farming animals healthy 
while continuing to promote human health in the process. I 
would like to thank my subcommittee colleagues, Representatives 
Pence and Schrier, for their work in introducing the 
legislation before us today that reauthorizes these programs.
    As subcommittee Chair, I want to ensure we are taking care 
of business by getting this legislation to the President's desk 
well before its September 30 deadline. Thank you, and I yield 
back.
    [The prepared statement of Mr. Guthrie follows:]
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    Mr. Guthrie. The Chair now recognizes the Gentlelady from 
California, Ms. Eshoo, the ranking member, for an opening 
statement.

 OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Ms. Eshoo. Thank you, Mr. Chairman, and good morning 
colleagues.
    Today, we consider the reauthorization of the Animal Drug 
User Fee programs. A source of pride of this subcommittee is 
our history of bipartisan work to advance user fee agreements 
that enable the U.S. to lead the world in innovation and drug 
development. I voted for the initial Animal Drug User Fee Act, 
known as ADUFA, in 2003 to authorize the FDA to collect fees 
for animal drug applications, as well as the Animal Generic 
Drug User Fee Act, known as AGDUFA, in 2008 to expand these 
authorities to generic animal drugs.
    These programs are reauthorized every 5 years to ensure the 
center for veterinary medicine can continue to meet the needs 
of the animal drug industry as it evolves. Today, we are 
considering a new set of agreements negotiated by the FDA and 
stakeholders in the animal drug industry. These agreements will 
lead to increased transparency, additional pathways for animal 
drug approvals, and reduced review times for pioneer and 
generic drug applications while maintaining high standards for 
safety and efficacy.
    Everyone on this subcommittee has a vested interest in 
moving these reauthorizations because they are critical to 
animal and human health. Millions of American pet owners and 
veterinarians rely on the robust animal drug pipeline to keep 
their companions safe and healthy. Livestock and poultry 
producers also rely on animal health products to protect food-
producing animals from diseases that threaten the safety of our 
food supply.
    FDA continues to make progress to mitigate the growth of 
antimicrobial resistance in food-producing animals, including 
ending over-the-counter access to medically important 
antibiotics, which are used in both human and animals, but more 
needs to be done. ADUFA V and AGDUFA IV are the latest 
evolutions to further strengthen the review process for animal 
drugs and ensure robust funding for the Center for Veterinary 
Medicine. We are also considering Congresswoman Nancy Mace's 
legislation, the Generic Animal Drug Advancement Act to allow a 
generic animal drug manufacturer to seek approval for fewer 
species than were on the original pioneer drugs labeling.
    So thank you to Director Forfa for being with us today. I 
look forward to hearing from you and our other expert witnesses 
about the negotiated animal user agreements, and I remain fully 
committed to moving ADUFA and AGDUFA--how do we come up with 
all of this; the Federal Government wins the prize for all of 
this alphabet soup--and a swift reauthorization as the chairman 
of our subcommittee just stated before the programs expire on 
September 30.
    With that, I yield back, Mr. Chairman.
    [The prepared statement of Ms. Eshoo follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you. The gentlelady yields back. So the 
gentleman from New Jersey, you are recognized for 5 minutes for 
your opening statement.

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

    Mr. Pallone. Thank you. Thank you, Chairman Guthrie.
    The two animal user fee programs we are reviewing today 
support the timely review of both pioneer and generic drugs at 
the Food and Drug Administration while supporting the agency's 
public health mission and gold standard for safety and 
efficacy. Today's hearing and these user fees highlight, of 
course, the importance of medicine for our four-legged friends 
at home. At the same time, we have to stress that animal drugs 
support a healthy agricultural economy and protect the Nation's 
food supply.
    User fees are--I am sorry. We have to also remain vigilant 
in supporting animal health due to its known impact on human 
health. As we have repeatedly seen through outbreaks like 
Ebola, Zika, coronavirus, avian influenza, or bird flu, 
infectious diseases can be transmitted between species, and 
scientists have also drawn a direct connection between our 
changing environment and the heightened risk of interspecies 
transmission of disease.
    And similarly, the careful and responsible management of 
animal or antimicrobial use in animals is of critical 
importance in our fight against antimicrobial resistant 
pathogens that could infect humans. So animal drug user fees 
provide critical supplemental funding for the FDA and have 
helped ensure faster, more predictable review timelines for new 
drugs and generic competition.
    But I do want to highlight that user fees are intended to 
be supplemental to FDA's appropriated budget allocations. Our 
reauthorization of user fees should not be seen by the majority 
or anybody as a justification to cut FDA's budget in the 
Republican quest to dramatically slash funding across the 
Government. So I am committed to seeing these programs 
authorized on time well ahead of the September deadline. Of 
course, we will see what the Senate does to support the FDA's 
mission. I am sure everyone remembers when we did everything 
quickly, and then the Senate took like another year to get it 
done, so that is why I mentioned that.
    But after successfully reauthorizing human drug user fee 
programs and enacting the Food and Drug Omnibus Reform Act in a 
bipartisan way last year, I am confident that we can come 
together and get this done. So I look forward to learning more 
today about the new user fee agreements as well as additional 
policy proposal that can improve animal health. And welcome to 
our witnesses.
    Thank you, Mr. Chairman. Yield back.
    [The prepared statement of Mr. Pallone follows:]
    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you. The gentleman yields back. And the 
Chair recognizes the Chair of the full committee, Chair 
McMorris Rodgers.

      OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON

    Mrs. Rodgers. Good morning. Whether or not you know it, 
almost everyone in the room relies on animal drugs approved by 
the FDA, whether you have a pet, drink milk, eat meat, the FDA 
plays a very important role in making sure the drugs we give 
animals work and are safe. This is especially important to make 
sure food is safe for humans to eat. The Center for Veterinary 
Medicine at FDA is responsible for regulating animal drugs and 
is funded in part by congressional appropriations and in part 
by user fees paid by industry.
    If we don't reauthorize this legislation on time, FDA can 
no longer collect fees, and the drugs that farmers and pet 
owners rely on may not come to market. It is important that we 
get this done on time and work in a bipartisan way to keep any 
controversial policies from slowing this down.
    We are off to good start. I am glad that industry and FDA 
submitted recommendations for this reauthorization ahead of the 
January 15 deadline, and today we will be considering 
legislation that reauthorizes the Animal Drug User Fee 
Amendments and the Animal Generic Drug User Fee Amendments. The 
agreements before us reflect nearly 2 years of negotiations 
between FDA and industry. We appreciate the hard work from 
those involved in those discussions.
    This will be the fifth ADUFA reauthorization, and fourth 
reauthorization of AGDUFA. And in the 20 years since these 
authorities were established, we have seen significant 
improvements to review times for new animal drug applications 
and continued progress towards getting safe and cost-effective 
products to the market faster. Over the course of the 
negotiation process, we have heard industry and stakeholders on 
current challenges within the animal health market, including 
rising cost of pet care and limited options available for 
treatment.
    We are also hearing how the significant growth in new drug 
application fees are limiting participation in the Animal Drug 
User Fee programs. This ultimately leaves us with fewer and 
less-affordable options to treat our country's animals. It is 
clear that we need more innovative and affordable medicines on 
the market, and I look forward to discussing FDA's plans to 
better utilize existing processes to expedite the review and 
approval of animal drugs.
    The agreements contain several proposals that address 
supply-chain issues, funding for preapproval foreign inspection 
capabilities, and commitments to exploring additional EU and 
U.S. good manufacturing agreements. FDA will also commit to a 
third-party evaluation of CVM's utilization of review processes 
of animal drug applications.
    Independent assessments such as these are critical as this 
committee conducts oversight over the agency's mission and 
fulfilling its regulatory and public-health responsibilities. 
We look forward to reviewing the findings from this assessment. 
The proposed agreement for the Animal Generic User Fee Program 
should help get more lower-cost animal drugs to farmers and pet 
owners. FDA is committed to providing increased engagement with 
generic drug sponsors through new meeting processes.
    These meetings will provide additional opportunities for 
sponsors to engage with the agency's scientific staff to better 
understand what data is needed to support new animal drug 
applications. I am also looking forward to discussing CVM's 
plans to transition staff and resources back to in-person 
operations as we continue the corner on 3 years since the 
beginning of the pandemic, and as the COVID-19 public health 
emergency is set to end May 11.
    In addition to the user fee agreements, we are also 
considering legislation introduced by Representative Nancy 
Mace, the Generic Animal Drug Availability Act. This bill would 
improve pathways for generic animal drugs seeking approval for 
a single species and as combination products.
    I look forward to today's discussion. I believe there is a 
bipartisan commitment to reauthorizing these agreements on 
time. Thank you. I yield back.
    [The prepared statement of Mrs. Rodgers follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you. The Chair yields back. The Chair 
reminds Members that, pursuant to the committee rules, all 
Members' opening statements will be made part of the record.
    Are there any Members seeking for an opening statement?
    Mr. Pence, you are recognized for 3 minutes for an opening 
statement.

   OPENING STATEMENT OF HON. GREG PENCE, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF INDIANA

    Mr. Pence. Thank you, Chairman Guthrie, and Ranking Member 
Eshoo and Director Forfa for being here. I am proud to champion 
the fifth reauthorization of the Animal Drug User Fee Act with 
my colleague, Congresswoman Schrier. This important legislation 
is critical to ensuring safe and effective drugs for our 
Nation's livestock industry and farm animals for the next 5 
years. Farmers, ranchers, and rural communities across southern 
Indiana rely on veterinary medicines and therapeutics produced 
by animal drug manufactures.
    Innovators in the Hoosier State, like Elanco Animal Health, 
are leading the charge to keep America's farm animals safe and 
healthy. The fees associated with this legislation is a 
collaborative investment between the FDA and America's animal 
health companies. In addition to providing the FDA with 
resource to expedite reviews and approvals, my legislation 
would ensure the agency is transparent and held accountable for 
performance goals.
    This legislation would preserve security of our Nation's 
food supply by making certain the medications administered to 
food-producing animals are safe for animal and human health. I 
look forward to working with my colleagues on the Energy and 
Commerce Committee to get this legislation across the finish 
line. Since 2004, fees paid to the Center for the Veterinary 
Medicine at FDA have increased exponentially across both 
programs while the workload and number of animal drug approvals 
have declined.
    Within the ADUFA program, supported full-time equivalents 
at CVM have also increased. However, approval timelines are 
still far behind our counterparts around the world, such as the 
European Medicines Agency. This places the United States at a 
competitive disadvantage as foreign producers gain access to 
cutting-edge medicines before producers here in the United 
States.
    Director Forfa, I hope today that you will answer a few--
give us some thoughts on some of the issues involved here going 
forward, and I hope you will commit to executing the 
independent third-party assessment of the program. And I hope 
that you will explain what the timeline for when CVM plans to 
begin this assessment and the process to keep industry 
stakeholders is formed. And then I hope you can share your 
thoughts in how the negotiated goals and authorized fees in my 
legislation could reverse this trend of approval delays at the 
FDA.
    And with that, Mr. Chairman, I yield back.
    Mr. Guthrie. The gentleman yields back.
    Any opening statements from the Democrat side?
    No opening statements. Seeing none, I will introduce--we 
will move into witness testimony. I will introduce our witness. 
Our first witness today is Tracey Forfa, Director for the 
Center for Veterinary Medicine at the U.S. Food and Drug 
Administration.
    You are recognized 5 minutes for your opening statement.

  STATEMENT OF TRACEY FORFA, DIRECTOR, CENTER FOR VETERINARY 
 MEDICINE, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH 
                       AND HUMAN SERVICES

    Ms. Forfa. Good morning, Chairman Guthrie. Thank you, 
Ranking Member Eshoo and members of the subcommittee. I am 
Tracey Forfa, the Director of the Center for Veterinary 
Medicine, or CVM, of the FDA. Thank you for this opportunity to 
discuss FDA's proposals for reauthorization of the Animal Drug 
User Fee Act and the Animal Generic Drug User Fee Act, ADUFA V 
and AGDUFA IV.
    The enactment of ADUFA and AGDUFA enabled CVM to resolve a 
longstanding backlog of animal drug applications and created 
predictability in the review process. Both programs help FDA 
maintain a stable, scientific, and technical workforce, reduce 
review times, and improve communication with drug sponsors. 
Since then, FDA has approved over 360 new animal drugs and over 
227 generic drugs.
    These medicines in our larger American health systems 
impact Americans' lives every day. They make a difference for 
the pets that live in over two-thirds of American households 
and support food-producing animals, a critical part of the 
American agricultural economy.
    With this reauthorization, we have several proposals that 
we believe will advance CVM's highly successful animal health 
programs. I will highlight just a few. Building on the ADUFA IV 
performance goals, FDA and industry have agreed to report 
certain programmatic metrics and participate in an independent 
third-party assessment of first-cycle reviews. We will offer a 
new virtual option for presubmission meetings so industry can 
receive feedback from CVM on development plans without 
logistical delays or travel costs and will work with industry 
to host annual public education conferences.
    We have agreed to form FDA industry work groups to explore 
potential program enhancements, including tools to improve 
review efficiency, the drug residue analytical method trial 
process, and the policies and procedures on Animal Drug 
Availability Act drug combinations.
    We also offered financial recommendations, including 
implementing and operating reserve adjustment, modifying the 
workload adjustor, and establishing an annual financial plan.
    AGDUFA IV proposals include agreements on several program 
enhancements, formalizing the bioequivalence meeting process, 
creating a dosage-form-specific template letter, adding the 
request to open a generic investigational animal drug file as a 
sentinel submission, implementing U.S./U.K. and U.S./EU mutual 
recognition agreements, and potentially establishing MRAs with 
other countries.
    Financial recommendations include modifying the workload 
adjustor, updating the fee structure, and adding a shortfall 
provision. The negotiations are positive and cooperative, and 
the proposals put forward serve mutual goals of continuous 
process improvement, transparency, and the protection of public 
health.
    I have been with the Center for 21 years and have seen many 
dedicated public servants come and go. I truly respect and 
admire the people I work with and their commitment to public 
health. I did not say animal health. Human health, animal 
health, environmental health, and other aspects of societal 
health do not exist in a vacuum. At CVM, we take a 
collaborative, multisectoral, and transdisciplinary approach 
called the One Health approach.
    When we review drugs for food-producing animals, for 
example, we consider the safety of people consuming meat, milk, 
or eggs from those animals, the safety of people handling the 
drugs, and the impact on the products on the environment. Our 
drug review teams house a wealth of experience, and I commend 
their dedication. The international public health community 
increasingly recognizes the value of One Health. CVM has led 
FDA and HHS to recognize this utility.
    CVM is often deeply engaged in unexpected crossdisciplinary 
issues. We have seen a recent explosion of products that cut 
across human, animal, and environmental health, advancement in 
technologies like gene editing and cell- and tissue-based 
therapies, and innovative chemical uses like the potential 
cattle food ingredients to cut emissions of greenhouse gases. 
Such innovations challenge us to assess whether the study data 
legally required for approval are scientifically necessary or 
appropriate to protect public health.
    We maximize flexibility to get safe and effective products 
into the market without undue burden on sponsors. In addition, 
we have issued guidances on expanded conditional approval and 
alternative data sources. Our Veterinary Innovation Program 
established in 2019 gives sponsors of animal cellular products 
and intentional genomic alterations more opportunities to 
consult. Fifty-two product developers have enrolled in the 
program so far.
    In closing, I appreciate your consideration of our 
recommendations and hope for a timely reauthorization. I also 
hope to work with you to examine our animal product safety 
system for opportunities and to break down barriers to 
innovations that will advance human and animal health.
    Thank you for your time.
    [The prepared statement of Ms. Forfa follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you. I thank for your opening statement, 
and we will now move into Member questions. I will recognize 
myself 5 minutes for that purpose.
    Ms. Forfa, the ADUFA I eliminated a significant backlog of 
680 submissions and reduced review times from 700 days to 270 
for these products. And the question is, how will this 
agreement further reduce these backlogs and reduce review times 
and likewise ADUFA work to address significant backlogs and 
long waits? So how will this agreement accelerate development 
of pioneer drugs? So what is going to be the improvement? You 
all have done a good job. So what is the improvement that we 
are looking for?
    Ms. Forfa. I thank you very much for the question, and we 
thank you for your support.
    So, as you said, the animal drug user fees provide 
predictability. We have all set goals, and we have met and 
succeeded all of those goals a hundred percent of the time. We 
have moved to a hundred percent electronic submissions, which 
has really sped up the process for both the sponsors providing 
us with the information and for us reviewing it.
    We want to continue to increase our response times and 
increase the enhancements to both programs. We also want to 
ensure that our reviews are timely and flexible, as I said in 
my opening statements. And we are going to continue to work 
with the industry to build in as many flexibilities as we can 
to make sure that drugs come to the market in the most 
expeditious manner possible.
    Mr. Guthrie. All right. Thank you. I appreciate that. And 
how has FDA worked with drug sponsors to develop new 
antimicrobials in food-producing animals that are also safe for 
humans?
    Ms. Forfa. The antimicrobial resistance is a huge priority 
for CVM and FDA and the Government overall. We are in the final 
year of a 5-year plan. We have made significant progress in 
implementing that plan, and we have provided a report in fiscal 
year 2022 that provided the data elements and identified gaps 
and places where we still need to work harder on antimicrobial 
resistance. We have also engaged the Reagan-Udall Foundation, 
who has spoken to 30 stakeholders from various Ag associations, 
producers, researchers and academics, and consumer advocacy 
groups on next steps in our next 5-year plan, which we will be 
putting out shortly. We really are looking forward to 
developing potential public/private partnerships, and we 
continue to want to work with the agriculture sector and other 
interested stakeholders to make sure our antimicrobial 
resistance policy addresses this very critical issue.
    Mr. Guthrie. Thank you very much. That concludes my 
questions. So I will yield back the time. And I will recognize 
the gentlelady from California, Ms. Eshoo, for 5 minutes for 
questions.
    Ms. Eshoo. Thank you, Mr. Chairman. And thank you for your 
opening statement.
    Does the FDA know where most animal drugs are manufactured? 
The United States? China? India?
    Ms. Forfa. I don't have that information right off the top 
of my head, so we would be happy to get back to you on that.
    Ms. Eshoo. All right. I think it would be interesting to 
know that. Are you facing similar delays and barriers to 
inspecting foreign manufacturers as the human drug side of FDA 
has?
    Ms. Forfa. During the pandemic, we did face similar 
challenges. Some of the companies are the same, and some of the 
companies are the same ones to be inspected. So we leverage our 
inspectional force wherever we can. We are working with our 
foreign counterparts on mutual recognition agreements and other 
tools to help speed up those inspections. But during the 
pandemic we faced similar challenges.
    Ms. Eshoo. But what is the state now?
    Ms. Forfa. It is gradually improving, and we are hoping 
that, you know, it will continue to improve at a faster pace.
    Ms. Eshoo. I have been a critic of foreign inspections 
relative to FDA, and that is why I asked the question. I think 
that, you know, heightened inspections are really so very 
important. So if you have anything to add to that, you can get 
it to me in writing.
    During the last ADUFA and AGDUFA reauthorization, this 
subcommittee spent a great deal of time on the important issue 
of antibiotic use in animals. Overuse of antibiotics in animals 
can contribute to the emergence of antimicrobial resistance 
that can then be transferred to humans through food-producing 
animals, which your center regulates. In the U.S. alone, the 
CDC estimates there are more than 2.8 million antimicrobial-
resistant infections each year killing more than 35,000 
Americans. Those are pretty stunning numbers.
    Can you describe the actions that the FDA has taken 
regarding antibiotic use in animals since the last two 
reauthorizations, and has the CVM measured whether antibiotic 
stewardship in food-producing animals have improved, and what 
steps do you plan to take in the future to encourage that 
stewardship?
    Ms. Forfa. Thank you for that question. As I said earlier, 
antimicrobial resistance is a huge priority for CVM. It has 
been. There's a number of steps that we have taken.
    I will answer your second question first. We continue to 
monitor antimicrobial resistance progress through a number of 
different ways. One is through our national antimicrobial 
resistance monitoring system, where we monitor the resistance 
factors.
    We put out annual reports on whether we are making progress 
in the number of antimicrobial-resistant bacteria reported. We 
continue to work with other Government agencies, including USDA 
and CDC, to implement that program. Also, we are working, as I 
said earlier, with the Reagan-Udall Foundation to ensure that 
our antimicrobial resistance strategy is strong and robust and 
is taking the right steps and measures.
    We also have a reporting requirement where we report out 
the number of antimicrobials sold during the course of the 
year, and we monitor either the increase or the decrease in 
actual sales.
    So we have a number of tools at our disposal. I think that 
we recognize there have been additional requests for more data. 
And we certainly are looking at that, and hopefully we can 
figure out the best way to continue to assure the American 
public that we are indeed attacking this very, very serious 
problem.
    Ms. Eshoo. So in the proposals that you are presenting to 
us in these reauthorizations, do you have new steps included to 
address these numbers, the 2.8 million antimicrobial-resistant 
infections and the deaths of Americans as a result of it?
    Ms. Forfa. So not in the proposal specifically, but this 
work is going on at the--this work is continuing to be going on 
in the Center. It is part of our priorities and our strategies 
for--our key strategies for the year each year, and we devote a 
significant number of resources to that particular work.
    Ms. Eshoo. Thank you. I yield back. Thank you.
    Mr. Guthrie. Gentlelady yields back.
    The Chair recognizes the Chair, Chair McMorris Rodgers for 
5 minutes of questions.
    Mrs. Rodgers. Good morning.
    Ms. Forfa. Good morning.
    Mrs. Rodgers. Director Forfa, I wanted to start--I had 
mentioned in my opening remarks about the importance of getting 
everyone back to the office and returning--the return-to-office 
plans as we approach the end of the COVID pandemic, the public 
health emergency ending on May 11. In January, Dr. Califf 
announced that the FDA Centers for Drug and Biologics would 
resume in-person, face-to-face meetings beginning February 13 
of this year.
    So we have had over 3 years now of virtual work across 
Federal agencies, and I have heard a lot of concerns especially 
from the regulated industry on how that has impacted fulfilling 
critical agency duties, granting sponsor meeting requests, 
conducting necessary facility inspections, and ultimately 
getting new products to the market efficiently.
    That being said, I just wanted to ask you: Can you share 
the status of your Center's plans to resume in-person 
operations and transition towards granting face-to-face 
meetings?
    Ms. Forfa. Sure. I would be happy to. Thank you. So we are 
working right now under what we call a business hybrid model--
and so--driven by business needs. So if a sponsor requests an 
in-person meeting, we are happy to grant that. My very first 
in-person meeting with a large group was with the Animal Health 
Institute not that long ago. And so we certainly are very, very 
open to having requests. I have had a number of requests for 
in-person meetings. And I am always happy to entertain those 
and come in to meet.
    Many of my staffs actually want to come back to the office. 
They want to be together with their teams. They have felt 
disconnected. So they are coming back, and we are ensuring that 
the facilities are safe for their return. But we are--again, 
any time that we get a request, we do it on a business-needs 
basis. And again, happy to--we have had several of those 
meetings, both some with our foreign counterparts, with the 
regulated industry, individuals. So we with are certainly happy 
to do that.
    Mrs. Rodgers. Great. Can you give me an estimate, like a 
percentage of how many you believe of the staff are back to in-
person, being in the office every day?
    Ms. Forfa. On an everyday basis, I can't really estimate 
that. It varies. But people are looking forward to coming back.
    Mrs. Rodgers. Is there a reason that Dr. Califf did not 
include the Center for Veterinary Medicine as one of the 
Centers to resume in-person meetings starting February 13 in 
his announcement earlier this year?
    Ms. Forfa. I don't know. I haven't discussed that with him. 
But again, we are following the rest of the agency, what the 
agency is doing. We follow their guidance, and we follow the 
Department's guidance. And so we don't do anything really 
different than the rest of the agency is doing.
    Mrs. Rodgers. Thank you.
    Ms. Forfa. Thank you.
    Mrs. Rodgers. It remains a concern, and so I am--you are in 
front of us today. I have had this conversation with Dr. Califf 
too. We need to get people back to work.
    Dr. Forfa, this year's ADUFA agreement includes a million-
dollar investment, an independent third-party assessment of how 
efficiently CVM is utilizing existing review processes for new 
animal drug applications. What will be the scope and timeline 
of this assessment, and how does CVM plan on implementing the 
findings of this independent evaluation?
    Ms. Forfa. Since I don't have all the granular details on 
that, I would more than happy to get back to you with a more 
robust answer on that.
    Mrs. Rodgers. OK. OK. Well, I look forward to hearing the 
outcome of that evaluation. Thank you for being here.
    Ms. Forfa. Thank you.
    Mr. Guthrie. The gentlelady yields back. The Chair now 
recognizes the gentlelady from Washington State, Dr. Schrier. 
You are recognized for 5 minutes.
    Ms. Schrier. Thank you, Mr. Chairman. The other lady from 
Washington State.
    Thank you, Director Forfa, for coming to speak to the 
committee today about this important issue. I want to begin by 
setting the stage for the bill that my colleague Representative 
Pence and I have been working together to reauthorize ADUFA. 
And I want to thank Representative Pence also for working with 
me on this important issue.
    It is incredibly important that this process and 
relationship works for both the Government and for the industry 
so that we ensure that animal health and human health are 
protected, and we do it in an expedient fashion. I think it is 
just a matter of good governance to ensure that we put 
guardrails in place to protect animal health and safety, which 
translates to our health and safety. That starts with ADUFA, an 
Animal Drug User Fee Agreement.
    Animal safety is incredibly important for my district. I 
think in every district. So many of us have found ourselves in 
situation with a sick pet at home and have turned to trusted 
veterinarians who depend on the availability of safe drugs that 
ADUFA ensures get to market.
    In my district, we have farmers and ranchers and dairymen 
who need healthy livestock and poultry and dairy production. 
And having timely access to affordable, effective medicines is 
a key part of their economy and our domestic food chain. I want 
to note that the FDA is in the process of reviewing the use of 
feed additives to reduce methane emissions from cattle, which 
would go a long way to eliminating greenhouse gas emissions 
from the agriculture sector. I want to thank you for that, 
ensuring that the FDA has appropriate staff and resources to 
review these applications and products will help, again, 
animals and food remain safe and help us cut emissions.
    Director Forfa, can you just take a moment to expand on why 
having ADUFA pass in a timely manner is important for animal 
health?
    Ms. Forfa. Thank you very much for the question. So if the 
agreements aren't passed in a timely manner, there may be 
delays in our ability to improve the important drugs for pets 
and food-producing animals that you mentioned. These agreements 
ensure that there are enough staff to adequately review animal 
drug submissions and applications. It supports the 
infrastructure as well as increase the transparency of our 
approval requirements through guidance documents and other 
documents that we put out to help industry.
    Ms. Schrier. And speaking of important medications, I want 
to just touch on antimicrobial resistance, something that is 
top of mind for us, something that I am concerned about as a 
pediatrician. And I think that is a place where veterinarians 
and physicians, in addition to sometimes having nonverbal 
patients, where veterinarians and pediatricians know that 
judicious use of antibiotics is critical to reducing the 
emergence of antibiotic-resistant bacteria.
    At the same time, we say that the bacteria are smarter than 
we are, and eventually there will be resistance. That is why we 
need to incentivize the industry to do research in this area, 
which is not necessarily an area where there is economic 
incentive otherwise to do it. In September of 2018, the FDA 
Center for Veterinary Medicine issued a 5-year stewardship 
action plan intended to combat antibiotic resistance and 
preserve the future effectiveness of these medications.
    I was wondering if you could describe some of the goals of 
that action plan, the progress FDA has made, and maybe some of 
the challenges that you have found along the way.
    Ms. Forfa. Thank you for that. I will touch on that 
briefly. I think the--there has been significant progress in 
reducing antimicrobial resistance. I think one thing that comes 
to the top of the mind is the transition from the over-the-
counter antimicrobials to vet prescription only, so that a 
veterinarian--there has to be a veterinarian involved. This 
promotes judicious use of these antimicrobials and helps 
preserve them for both animal and human health.
    So I think that was one of the significant accomplishments. 
That work is continuing. We are also continuing to work with a 
wide variety of stakeholders on next steps in our next 5-year 
plan.
    Ms. Schrier. Just to touch on--I am going to make a comment 
here about One Health and the intersection of human health and 
animal health some of my colleagues have referred to, and I 
just wanted to kind of put an exclamation point on how 
important it is FDA has the resources to do surveillance 
monitoring of animals to prevent the next pandemic.
    Thank you, and I yield back.
    Mr. Guthrie. Gentlelady yields back.
    The Chair recognizes from Mr. Latta for 5 minutes for 
questions.
    Mr. Latta. Thank you, Mr. Chairman, and thanks for holding 
this very important hearing today. And Director, thanks so much 
for being with us today.
    Question: How is the agency prioritizing reviews of new 
animal drugs for treatment of severe and/or prion diseases that 
may also pose serious risk to humans, such as chronic wasting 
disease?
    Ms. Forfa. So when we--when we get an application in house, 
we have a process set up to triage it, to look at--we meet with 
sponsors early in the process even before their applications 
come in. And so we can look at products across and kind of 
triage them in a way so that we know which ones are amenable to 
our Veterinary Innovation Program and some of the other 
flexibilities that we built into the new animal drug process 
over the years. And so we do--there are procedures in place so 
that if a critical drug comes in, we don't have all of the same 
authorities that our human colleagues do, but we have recently 
gotten emergency use authorization authorities that we can use, 
and it is based on public health--declaration of a public 
health emergency. So there are things that we can do to help 
prioritize the review and approval of those type of products.
    Mr. Latta. Well, you know, I am following up on that. What 
are the challenges, then, when you are conducting the necessary 
research on diseases like chronic wasting disease that would an 
effective treatment in an expedited manner?
    Ms. Forfa. Well, we always face a number of challenges in 
the animal drug space. Very often, we don't--we can't find a 
sponsor who is willing to, you know, bring a product forward. 
Sometimes there is limited research. Sometimes there is just 
not enough data out there to be able to, you know, do a robust 
review. So there are a number of factors that actually sort of 
limit the ability to move things quickly through the process. 
We try to do the best we can on a case-by-case basis with each 
particular product. And I think over the years, we have shown 
that we can actually get products on the market relatively 
quickly. But, you know, it certainly depends on what comes in 
the door.
    Mr. Latta. When you say about getting all the necessary 
data, and then also, you know, having that information and make 
that and getting those products to market quickly, do you have 
any kind of idea generally what timelines are on some of these 
things? How long it takes to get maybe a product out there?
    Ms. Forfa. It varies so widely that I would, you know, I 
would hate to you give an exact number. Much depends, again, on 
the data that we receive initially and how robust it is. And 
that often determines how quickly we can get a product reviewed 
and approved.
    Mr. Latta. And you know, as we look into the future, are 
there many opportunities for a bipartisan collaboration in the 
ADUFA space?
    Ms. Forfa. Absolutely. And lots of opportunities for us to 
continue to work with industry, to work with you all in this 
space, yes. Lots of good opportunities.
    Mr. Latta. Thank you very much. Mr. Chairman. I am going to 
yield back the balance of my time.
    Mr. Guthrie. Gentleman yields back.
    The Chair now recognizes Mr. Sarbanes for 5 minutes for 
questions.
    Mr. Sarbanes. Thanks very much, Mr. Chairman. Thank you, 
Director Forfa, for being here. This is an important function 
that our committee plays. We take it seriously. I just wanted 
to talk a little bit more about this One Health initiative. And 
you know, that is an effort that acknowledges that we are all 
connected, the health of people, animals, and environment are 
intertwined, interdependent. And not only can these zoonotic 
diseases pose a great threat to human health, but the drugs we 
give to animals to ward those off, a treated disease can also 
affect our food supply, individual health, our environment, and 
so forth.
    And the initiative I know aims to promote total ecosystem 
health by building bridges between physicians and 
veterinarians, public health officials, and so forth, as well 
as environmental scientists. As part of our comprehensive 
efforts to restore the Chesapeake Bay, which I am very focused 
on, as you can imagine, we have worked with farmers to reduce 
the impacts their operations have on the Bay's health. I am 
glad that promoting environmental health broadly through things 
like the One Health initiative is a guiding imperative at FDA 
as well.
    So could you speak, again, on how reauthorizing the Animal 
Drug User Fee program, providing FDA with a strong budget 
through the appropriations process, all of those things can 
support the One Health initiative, and what impacts in turn 
will have on the health of the environment and all the people, 
species that occupy it? Thank you.
    Ms. Forfa. Thank you for that question. It is one of my 
favorite topics, so I am happy to talk about it. So CVM has 
taken a very strong lead at One Health at FDA. We are working 
across the agency. I cochair the One Health steering committee 
across FDA that includes all of the component Centers. I also 
sit on an intergovernmental group formed by CDC as part of the 
fiscal year 2023 consolidated appropriations, the One Health 
coordination unit with Dr. Casey Barton Behravesh.
    So we see, as you said, that it is a critical intersection 
of human health, animal health, and the environment. And we try 
to say and help our colleagues across the agency understand 
that everything we do pretty much at FDA every day is in the 
One Health space. And so, when we have an approval, we look 
at--of animal drug, we look at what are both the environmental 
and the human health consequences of that particular approval.
    And so that is just built into our approval process. We 
have a target animal safety, human user safety, and an 
environmental safety review when an animal drug is presented to 
us. It is the same on the food side. And so we see that One 
Health is just critical to the work that we do every single day 
in every single aspect of the Center.
    Mr. Sarbanes. Let me ask you a question slightly related, 
but I was listening to a piece the other day about, you know, 
this concern of viruses jumping from animal population into 
human population and whether the research that I guess up until 
now has been focused on sort of trying to look at all these 
millions of viruses in the animal population as opposed to 
focusing on the ones that are already made to jump into human 
population, where should the focus be particularly as we think 
about the potential for pandemics and other kinds of public 
health threats that come when you see that jump.
    Do you have any perspective on that discussion or the 
research on how we monitor the relationship between viruses in 
animals and in humans?
    Ms. Forfa. As we move forward, I think that we have to keep 
the three pieces deeply connected. I think we have to keep 
animal health, human health, and environmental health 
connected, and I think we have to look at all three at all 
times. I think that there is--we are very concerned about 
zoonotic diseases and we are concerned about transmission. 
There is also all of the potential that humans can transmit 
viruses to their animals, to their pets, which we saw during 
COVID. And so I don't think there is any way that we can do our 
work on a daily basis without thinking about all three 
components.
    Mr. Sarbanes. Great. Thank you. Yield back.
    Mr. Guthrie. The gentleman yields back. The Chair now 
recognizes the gentleman from Florida, Mr. Bilirakis, for 5 
minutes.
    Mr. Bilirakis. Thank you. I appreciate it, Mr. Chairman.
    Ms. Forfa, welcome. I want to briefly discuss the unique 
instance of an animal drug approved for use in veterinarian 
medicine by the FDA that has no human use, xylazine. Right now, 
xylazine is at the center of a rapid shift in the drug overdose 
epidemic with its use as an adulterant to fentanyl. This drug 
has mirrored the geographic patterns of fentanyl when it first 
infiltrated the drug market. Illicit fentanyl that is cut with 
xylazine is a street drug referred to as tranq dope--I think 
you probably know that--and its use has been found in all 50 
States, unfortunately. It has never been approved for human 
consumption, and it is sedative to induce a state of 
unconsciousness. There is no doubt we need to be working 
together to address this, and we need to be out in front of 
this, to tell you the truth.
    I am coleading a bipartisan bill with several of my 
colleagues--some are on this committee, including Mr. Fulcher, 
that looks to address this issue. I welcome the opportunity to 
move this bill through committee as soon as possible.
    Ms. Forfa, the FDA has also spoken out about this drug. We 
are well aware of its legitimate and safe use within the 
veterinary space and how important it is to veterinarians, 
cattlemen, and ranchers. The FDA has put out guidance in an 
attempt to stop illicit opioids coming into the country through 
the mail. Could you please elaborate on this?
    Ms. Forfa. Thank you very much. And I am equally concerned 
as you are about this development. Early on in my tenure as the 
Center Director, I was faced with this issue. And so we moved--
as an agency, we moved quickly to put in an import alert in 
place to make sure that all xylazine coming through the borders 
would be screened to make sure it was going to a legitimate 
manufacturer. We have been working with the Drug Enforcement 
Administration on the tools that they have to be able to 
address the issue. We have also been working with our 
colleagues in the Center for Drug Evaluation and Research, 
which is the liaison to the Drug Enforcement Administration at 
FDA. We are using every tool we have in our toolbox to be able 
to try to address this. And so we are--again, at this point I 
cannot speak to your legislation because I haven't had a chance 
to read it.
    Mr. Bilirakis. Please review it and get back to me on that. 
Very important.
    Ms. Forfa. I will. But we certainly--again, I think you 
articulated it very well about striking the balance between the 
need for the veterinary community and the stopping of the 
illicit use of it because it is--I agree with you, the side 
effects are horrifying.
    Mr. Bilirakis. This is what I hear. Now, the FDA has put in 
place similar guidance around fentanyl in the past, but it was 
not found that FDA encountered very little fentanyl, so--it was 
found they found very little fentanyl in this instance, but 
rather the vast majority of packages seized contained 
uncontrolled drugs purchased by individuals for personal use.
    Does the FDA have a sense of how much illicit xylazine is 
being shipped into the country? If you could give me an 
estimate on that, I would appreciate it. What steps are being 
taken to ensure a strategic target approach for these efforts 
so that illicit drugs rather than legal ones are being seized? 
If you can elaborate a little bit in the time I have left, I 
would appreciate it.
    Ms. Forfa. Certainly. I don't have the statistics about how 
much we have actually stopped to our import alert. I would be 
happy to get back to you on that. We are using every single 
tool we have to be able to stop the elicit use of the product, 
and we are working--there are a number of different components 
of the agency, including the Office of Regulatory Affairs, who 
we are working very closely with to be able to leverage their 
inspectional tools and their import alert tools to be able to 
stop things at the border.
    Mr. Bilirakis. This is a very serious issue, as you know. 
You know what is happening in our communities. Our kids are 
dying.
    Ms. Forfa. I agree.
    Mr. Bilirakis. The combination of fentanyl and xylazine, it 
is just awful. So we got to do everything we possibly can.
    I do have other questions, but I ran out of time. I will 
yield back, Mr. Chairman.
    Mr. Guthrie. The gentleman yields back.
    The Chair recognizes Dr. Ruiz for 5 minutes for questions.
    Mr. Ruiz. Hi. Good morning. Thank you for being here.
    Ms. Forfa. Thank you.
    Mr. Ruiz. Ms. Forfa, as you discussed in your testimony, 
the work of the Center for Veterinary Medicine affects human 
health, animal health, and also can affect the health of our 
environment. And, of course, the health of our environment is 
directly linked to the health of our communities. And as a 
doctor, I have seen firsthand how poor environmental conditions 
lead to poor health statuses and outcomes.
    As my colleagues have all heard before, one of the greatest 
sources of greenhouse gas emissions comes from livestock. This 
committee has been focused on innovative new ways to address 
the climate crisis, and I would like to know more about how 
innovative products for animals might help us combat climate 
change. So is there anything we can do in the animal food or 
drug space to address the emissions caused by livestock? And if 
so, how would FDA be able to regulate a claim on a food 
product, for example, that claimed to reduce emissions from 
that animal?
    Ms. Forfa. Thank you for the question. We do see a big 
benefit in some of the new and innovative products that have 
been coming out to address climate change and greenhouse gas 
emissions. It--we call it One Health in action, as you have. So 
we are working with stakeholders, including Congress, on a 
pathway. There is legislative language that we have been 
working with you all on. And as developers come to us, we work 
with them on a case-by-case basis to build in as many 
flexibilities as we can to get these products on the market as 
quickly as possible. There is one approved product out there. 
It was approved under the animal drug paradigm, but we 
recognize that a lot of these are animal food ingredients. And 
so we are looking for new authorities in that space to be able 
to bring them--the products to market under the animal food 
ingredient paradigm.
    Mr. Ruiz. Can you give me an example of a product and how 
it works? I am curious.
    Ms. Forfa. So they work a number of different ways. They 
work mostly on the microbiome of the animal itself, and they 
change the microbiome to be able to reduce the emissions.
    Mr. Ruiz. The amount of CO2 and methane and all 
that?
    Ms. Forfa. Yes.
    Mr. Ruiz. Great. So what tools would be helpful for FDA and 
innovators to inform consumers about this products?
    Ms. Forfa. The thing that would be the most helpful for us 
is consistent with some of the legislative language that we 
have proposed, which allows us to review this in a slightly 
different paradigm than our animal drug. Because mostly these 
products need our animal drug definition because they affect 
the structure of function of the animal. And so this new 
legislation that we--legislative language that we have put 
forward allows us to review it more in the animal food 
ingredient and give it a little bit of flexibility. We still 
look at safety very closely, but it allows us some new tools to 
be able to move these innovative products forward more quickly.
    Mr. Ruiz. Look, as a forever family of a rescued husky--the 
best husky ever that has ever walked this Earth, his name is 
Blues, white Siberian--and a father of a young daughter who 
wants to be a veterinarian, I want to say thank you for the 
work you do.
    Ms. Forfa. Thank you.
    Mr. Ruiz. I yield back my time.
    Mr. Guthrie. Thank you. The gentleman yields back.
    The Chair now recognizes Mr. Carter for 5 minutes for 
questions.
    Mr. Carter. Thank you, Mr. Chairman.
    And thank you, Director, for being here. This is important, 
particularly to our world in pharmacy because we are obviously 
very involved in a number of different ways, including and 
certainly not the least of which is with compounding.
    And I know that you all have been very involved in this, 
and I really do want to commend you for that. I want to commend 
you for the open line of communication. And I think it has been 
good between your agency and between some of the organizations 
that have represented pharmacists and veterinarians as your 
agency has finalized and now, I assume, will begin implementing 
256, the compounding animal drugs from bulk substances.
    You know, the agency, in 256, has taken it upon itself to 
create a Federal regulatory framework over animal drug 
compounding that somewhat resembles the statutory framework 
Congress gave the FDA to regulate human drugs, and I think that 
is a good thing as well.
    And the drug compounding--Congress gave the FDA to regulate 
human drug compounding by 503A, traditional State-registered 
regulated pharmacies, and by FDA register 503B, outsourcing 
facilities. And that was in the Food, Drug, and Cosmetic Act.
    So, you know, I feel strong, very strongly that compounded 
drugs, including those from bulk substances, are an integral 
part of animal healthcare. And I know that this is practiced 
quite often, and particularly in our rural areas, the 
compounding with a lot of the farmers and a lot of the ag 
community is extremely important, but--because there are times 
when, you know, there is a shortage of something or when there 
is a lack of access to something.
    And I just wanted to ask you, first of all, will you commit 
today that you will continue working with veterinarians and 
with pharmacists to provide further clarification and education 
to all the stakeholders, including the veterinarians, 
pharmacists, and the State boards of pharmacy? That is going to 
be important too. I have actually got some calls from the State 
board of pharmacies about this.
    Ms. Forfa. Yes, sir, I certainly can commit to that.
    Mr. Carter. Good, good.
    Can you tell me where you are at in the implementation? I 
mean, can you just give me an update about how you intend to 
enforce the components of this?
    Ms. Forfa. Certainly. So we are taking a very balanced 
approach as we move forward. And as you requested and we have 
done, we are working with all affected entities to try to 
provide as much clarity as we can. I think you mentioning of 
outsourcing facilities, we recognize that we have to provide 
additional clarification in that space as well.
    In April--we have announced that, in April, we are shifting 
some of our resources more to inspections, but those 
inspections are going to be--it is a limited inspection. It is 
not going to be some sort of wholesale inspectional blitz. It 
is still going to be working--we would be working with State 
licensing authorities. And it is not going to be--it is not 
going to be a huge--as I said, there is just going to be a 
limited number of those.
    You know, our policy, we just--we want to make--we want to 
strike that balance that you spoke. We want to give 
veterinarians and their patients access. We want to make sure 
that the integrity of the approval process gets preserved, and 
we want to make sure that, you know, all drugs are safe and 
effective, whether compounded or approved.
    Mr. Carter. Good. Let me ask you this. I know you mentioned 
earlier in your statement that you have approved over X number 
of drugs. But still, if you look at the approvals over the last 
few years, the number of animal drugs has really not kept up 
with what some other countries have approved.
    Why has ADUFA not stimulated an increase in product 
approvals like on the human side it has?
    Ms. Forfa. So it is multifactorial. You know, certainly we 
work very hard to approve the products that are brought to us. 
I do think that in the animal--particularly in the pioneer 
animal drug industry, we have seen a consolidation of 
companies, and I think that, in some ways, has decreased the 
number of products that are on the market. I think it is an 
economically driven situation.
    And so, you know, we are working very closely with the 
animal health industry and the animal generic industry to try 
to address, you know, shortages where there's not enough 
approved products.
    Mr. Carter. Right. Well, I am out of time. But, again, I 
want to compliment you and thank you for the line of 
communication. I have been very impressed, and we really do 
appreciate it. It is extremely important. So thank you.
    And I yield back.
    Mr. Guthrie. Thank you. The gentleman yields back.
    And the Chair recognizes Mr. Pence from Indiana, for 5 
minutes.
    Mr. Pence. Thank you, again, Mr. Chairman.
    And I am going to kind of go off my opening remarks, if 
that is OK, Director, reread something that I said at the 
beginning.
    Since 2004, fees paid at the Center for Veterinary Medicine 
at FDA have increased exponentially across both programs, while 
the workload and number of animal drug approvals have declined. 
And that is 2004.
    You know, when Chair Rodgers mentioned that not everybody 
is in working while, in fact, your constituents are, I found 
that a little troubling.
    Has that contributed to that, the delay in approvals over 
the last 3 years?
    Ms. Forfa. No, sir. I believe that our workforce is 
continuing to work as well or maybe even slightly better than 
they did before, and we have met all of our ADUFA goals.
    Mr. Pence. Sure. And I understand that that is something 
that you are adhering to. You made that a little bit clear. But 
I always think people working together, face to face, is always 
a little better than not.
    So let me ask just a few questions, kind of a commitment 
going forward. Let's not look back. Let's look forward.
    Will you commit to executing the independent third-party 
assessment of the program outlined in the goals agreement?
    Ms. Forfa. Certainly, yes.
    Mr. Pence. OK. Thank you.
    Is there a timeline for when CVM plans to begin this 
assessment and the process to keep industry stakeholders 
informed?
    Ms. Forfa. I will have to get back. I don't have the 
details at my fingertips, so I would be happy to get back to 
you on that.
    Mr. Pence. OK. I would appreciate that. Thank you.
    Can you share your thoughts on how the negotiated goals and 
authorized fees in my legislation--our legislation--will 
reverse this trend of approval delays at the FDA?
    Ms. Forfa. Certainly. And we are--you know, thank you very 
much for your support of the program. We think it is a very 
critical program to be able to give us the tools necessary to 
approve animal drugs that are brought to us in a timely manner 
to ensure that they are safe and effective, that we can hire 
the staff, build the infrastructure, and do everything we need 
to do for the American public.
    Mr. Pence. OK. Thank you, Mr. Chair. I yield back the 
balance of my time.
    Mr. Guthrie. The gentleman yields back.
    The Chair now recognizes the gentleman from Indiana, Dr. 
Bucshon, for 5 minutes for questions.
    Mr. Bucshon. Thank you, Mr. Chairman.
    I heard one of my colleagues raise the question about CVM's 
work on antimicrobial resistance. Was the topic raised by CVM 
or industry during the negotiations?
    Ms. Forfa. I was not at the table during the negotiations, 
so I would have to get back to you.
    Mr. Bucshon. OK. So, I mean, I understand CVM published or 
will publish a strategic plan on this for the years 2019 to 
2023. Is that publicly available yet?
    Ms. Forfa. No, not yet.
    Mr. Bucshon. No. And so do you have any idea when that 
would be available?
    Ms. Forfa. It is under development, and we would be happy 
to keep you informed as it moves forward.
    Mr. Bucshon. Yes. OK. That would be great. Keep the 
committee and myself informed about how that is going along. I 
was a doctor before. This is an important issue.
    So I wonder if it is necessary to go ahead with a new 
study. I guess people are mentioning a potentially new study 
while we are still wrapping our heads around this one.
    Ms. Forfa. You know, I think our engagement with the 
Reagan-Udall Foundation and their engagement with over 30 
stakeholders, I think will--we are still waiting for that 
information to come in. And I think that will be dispositive 
about, you know, maybe where some of the gaps are and where we 
can fill in some of the--you know, the gaps moving forward.
    Mr. Bucshon. OK. And maybe this had been asked. Sorry, I 
had so many things going at the same time here.
    I understand that these user fee agreements include many 
important tactics related to performance evaluations and 
closing performance gaps. One stands out as very promising to 
me, the independent third-party assessment. This has been part 
of the PD--you know, the PDUFAs for years.
    Will you, Director Forfa, commit to the agency's full and 
timely participation in this assessment?
    Ms. Forfa. I can commit to that, yes.
    Mr. Bucshon. Great. It is also my understanding the CVM 
works with animal drug sponsors to change labels when necessary 
to reflect changes or new revelations about the safety of a 
product. But I am also understanding that during ADUFA 
negotiations, CVM asked for additional postmarket authorities, 
including requiring safety labeling changes.
    Why would CVM need additional authorities if industry has a 
proven record of updating their labels upon new safety data?
    Ms. Forfa. So thank you for that question. Currently, CVM 
does not have a broad range of authorities to be able to 
address adverse events raised during postmarketing.
    So, for example, CVM approved 85 pioneer animal drugs 
products in a 10-year period between 2011 and 2021. We 
recommended safety-related labeling changes for 35 of the 85 
products. That is 40 percent. And the average time for 
negotiation of a labeling change during this period was 2.4 
years, with a range of 4 months to 10 years.
    So we really hope that we could get additional authorities 
to speed up and reduce that time.
    Mr. Bucshon. OK. Great. Thank you.
    Mr. Chairman, I yield back.
    Mr. Guthrie. The gentleman yields back.
    The Chair now recognizes the gentlelady from Tennessee, 
Mrs. Harshbarger.
    Mrs. Harshbarger. Thank you, Mr. Chairman.
    Thank you, Ms. Forfa, for being here.
    And compounding has been a big part of my life, especially 
vet compounding. So this is good to be able to talk to you 
today.
    Now, we know that the animal health drug approval process 
is not the same as the human process. Instead, it is done on a 
rolling basis. So my question is: How many full-time equivalent 
hours does it take to review each of the technical sections?
    Ms. Forfa. I can get back to you with more specificity, but 
I do think it varies from product to product.
    Mrs. Harshbarger. OK. Has the time spent reviewing each 
technical section changed over time?
    Ms. Forfa. I certainly think that we have worked very hard 
to build in efficiencies and also provide additional clarity to 
sponsors who are coming to us, so that when they do come to us, 
it is--the data that they bring to us is more robust and that 
the applications are--there isn't so many back and forth 
between our reviewers and sponsors.
    Mrs. Harshbarger. OK. Are there areas where more staff or 
different expertise is needed when it comes to that?
    Ms. Forfa. I think that we, you know, certainly are 
staffing up. We have a great cadre of experts who review animal 
drugs. Certainly, I think we could always use more staff, but 
we make due. Since we are still the smallest center at FDA, we 
have learned to make due. With the broadest portfolio, we have 
learned to make due with what we have to.
    Mrs. Harshbarger. Well, you know, we see a lot of drug 
shortages. Things are on long-term back order. You see it on 
the human side. You especially see it on the animal side.
    And talking about--going a little further with Mr. Carter's 
comments about that GFI 256. You know, and I have talked to 
different veterinarians and compounders that, you know, 
compound for animal use and, you know, I guess there are some 
reservations about that nominating process for bulk, to use 
bulk chemicals, basically. It is missing specifics around the 
process to nominate those ingredients for review and possible 
inclusion on a list of preps that could be used for office use.
    And they go on to say--also concerning, he said, in human 
health, the bulk ingredient list is an ingredient list; 
however, the construct of the FDA's list includes the specific 
dosage form, strength, species, and doesn't allow the type of 
flexibility generally required to meet the variety and needs 
around animal patients.
    And, you know, I have done compounding for, you know, not 
animal--food animals, but pets, you know, a lot of expensive 
animals. But there needs to be clarity there on that bulk 
ingredient list. Because you said earlier that you did not know 
where the drugs were coming from or their country of origin, 
where some of these bulk chemicals are coming from or final use 
product?
    Ms. Forfa. So that was for xylazine specifically.
    Mrs. Harshbarger. OK.
    Ms. Forfa. We are, you know, certainly concerned about the 
flow of illicit xylazine into the country, and that is what our 
import alert was very specific for, xylazine.
    Mrs. Harshbarger. OK. Well, you said something a minute ago 
too about you are putting funding into inspections. Is that 
going to be more funding for 503B? 503A? Can you elaborate on 
that?
    Ms. Forfa. So if I wasn't clear, I apologize. Let me 
clarify. So we are shifting our resources. Previously, we had 
been doing a lot of education and outreach, and now we are 
really shifting resources into more traditional inspectional 
activities into the State-licensed compounding pharmacies.
    Mrs. Harshbarger. So is that traditional, the 503A? Because 
they do a lot of patient-specific.
    Ms. Forfa. Yes. What we really want to do is just provide 
that balance so veterinarians can have access, the appropriate 
access while we make sure that, you know, the products that 
they are getting for individual patients are safe and 
effective.
    Mrs. Harshbarger. What do you do with the veterinarians 
that compound in their practices?
    Ms. Forfa. We don't regulate the practice of veterinary 
medicine.
    Mrs. Harshbarger. OK. But, yes, I just would like a little 
more clarity on where the funding on those inspections are 
going. 503A traditional? 503B outsourcing? If you could do 
that----
    Ms. Forfa. Yes. Certainly.
    Mrs. Harshbarger [continuing]. Get me a breakdown, that 
would be--and is it allocated.
    And, with that, I know my time is up, but I appreciate you 
answering the questions.
    And I yield back.
    Mr. Guthrie. Thank you. The gentlelady yields back.
    The Chair recognizes Mr. Griffith from Virginia for 5 
minutes for questions.
    Mr. Griffith. Thank you very much. And I apologize. I had 
to step out for a few minutes to take care of another matter.
    But let me associate myself with remarks of Ms. Eshoo 
earlier in relationship to the active pharmaceutical 
ingredients. We need to, whether it be human medicines or 
animal medicines, we need to be producing those more in the 
United States. And if we cannot produce them more in the United 
States, we need to make sure that we have FDA inspectors 
overseas, robust, on the ground, looking at these facilities. 
Because in many cases, the active pharmaceutical ingredient is 
going to go sometimes into medicine for humans and sometimes 
into medicine for animals, and we need to make sure that we are 
getting the best quality products that we can for our citizens.
    All right. That being said, let me move on to another one 
that was raised also by Ms. Eshoo, and that was the antibiotic-
resistant bacteria and microbes. I am hopeful that FDA on both 
sides--but you are here, so I get to bring it up with you--is 
working on making sure we have a proper and fast way to approve 
viruses used in phase therapy, which is, outside of 
antibiotics, is the best known way to deal with bacteria that 
are causing problems. But you have got to find the right mix, 
and you have got to move fast.
    And so I would hope that you all would have some--do you 
have anything on that you would like to say about how quickly 
you can move? Because whether it is a herd of cattle or a human 
being, we want to move quick to knock those things out.
    Ms. Forfa. I appreciate that. And one of the things that I 
have seen in the 6 to 7 weeks that I have been sitting in the 
Director's chair is there are many, many innovative products 
coming forward in the future to address many, many of the 
challenges that we face--you know, antimicrobial resistance, 
climate change, all of those things that we are facing. I 
recognize that we have to be very flexible with the authorities 
that we have to be able to get these products, to not be the 
delay that stops these products from coming to market.
    Mr. Griffith. All right. Now, let me switch to 
telemedicine.
    Ms. Forfa. OK.
    Mr. Griffith. I have a district that stretches from what is 
known as central Virginia, just barely outside of the city of 
Lynchburg, all the way to Ewing, Virginia, which is west of 
Detroit, Michigan. It is a huge district.
    The 800,000, roughly, people that live in the Ninth 
District are in a territory, an area that is larger than the 
State of New Jersey, and we don't have enough vets, and as a 
result of that, using telemedicine during COVID was extremely 
helpful. Most of the time--I would say at least 98 percent of 
the time--my farmers know the vet. The problem is the vet might 
live on the other side of the mountain. They might live, you 
know, by car, an hour, 2 hours away.
    We don't have enough vets is one problem, but you can't 
solve that. But FDA changed the rules on my farmers, and the 
rule went into effect in February, making it much harder for 
them to use telemedicine.
    And, look, farmers are savvy. They want their animals to be 
healthy. I mean, I am not going to say there isn't a rogue 
person out there somewhere, but if you get a rogue farmer 
working with a rogue vet, we already have other, bigger 
problems.
    They can use a telephone, use that camera on the phone they 
have in their pocket. Now, they might have to go back to the 
house to get a signal or drive down the road to get a signal, 
but they can take a picture of something that is going on on 
one of their animals, send it to their vet. The vet can call 
the prescription in and they can go get it.
    We are making it hard on farmers by not updating 
telemedicine. We know it works. We know it works for the 
farmers. We know it helps the large animal vets in particular.
    And I say that and, you know, we talk about the shortage, 
but I have the distinction, I think, of being the only 
Congressman in the country who has two vet schools physically 
located in his district. I have the Virginia Tech school and 
then I mentioned Ewing earlier, and there is a vet school. It 
is licensed to Harshbarger's district. I think it might be even 
further west than Harshbarger, but it is licensed in Harrogate, 
Tennessee, but it is physically in my district in Ewing, 
Virginia. And we are putting out some great vets, but a lot of 
times they are going elsewhere or they choose, for obvious 
reasons, to go into small animal veterinary.
    But my farmers, whether they be sheep or cattle, and mostly 
cattle in my district--we don't have a lot of chickens outside 
of Abingdon where we have a big egg facility--but they need the 
telemedicine rules to be more flexible so that they can provide 
food for us and livelihoods for their families.
    What say you?
    And I am over my time, but if you would give me 30 seconds, 
Mr. Chairman.
    Ms. Forfa. We are working really closely with the AVMA on 
this. We recognize there is a shortage of veterinarians. I 
think the key factor for us is the veterinary-client-patient 
relationship. Once a veterinary-client-patient relationship is 
established, I think, you know, we are continuing to work with 
AVMA on what makes the most sense.
    Mr. Griffith. All right. So here is what I want you to do. 
Work with them. Get me language. Let's put a bill in. I mean, 
that makes it easy. I agree there should be a relationship, but 
once that relationship is established, let's stop making vets 
drive 2 hours and farmers have to wait for their animal to be 
seen, particularly if it is something that could be contagious 
and could affect the whole herd.
    I yield back, Mr. Chairman.
    Mr. Guthrie. Thank you. The gentleman yields back.
    The Chair recognizes the gentleman from Pennsylvania, Dr. 
Joyce, for 5 minutes.
    Mr. Joyce. Thank you for yielding, Mr. Chairman, and thank 
you for holding this hearing today.
    It is very important that we complete our work on time 
reauthorizing the Animal Drug User Fee Act, to ensure that we 
are supporting advancements and safety in animal health.
    In my district, state-of-the-art laboratories, like Lampire 
Biological Laboratories, provide high-quality products and 
services to the life science industry.
    Dr. Forfa, thank you for appearing with us today. What are 
some of the major improvements that this agreement makes from 
the current goals? And how will it create new efficiencies for 
the FDA CVM?
    Ms. Forfa. So thank you for that. This new agreement really 
does help us continue to build on the successes that we have 
had, maybe fill in the gaps where we have identified gaps in 
previous agreements. We want to continue our 100 percent goals, 
meeting our objectives and goals. I think it allows us to do 
the third-party review that has been talked about. It allows us 
to build in new efficiencies where we see innovative products. 
So this is critically important to continuing to, as I said, 
build on the successes that we have had previously.
    Mr. Joyce. Thank you. The ADUFA agreement increases user 
fee funding from $156 million to $174 million over the next 5-
year cycle.
    Dr. Forfa, how will CVM utilize these additional resources 
across the two user fee programs?
    Ms. Forfa. We have seen actually--I am going to start with 
our generic--generics first.
    We have seen an exponential increase in generic products 
coming to the market, and so I think the additional revenue 
will help support those. And when those particular products 
come to the market, it provides additional choices for animal 
owners. So in that space, it will help really bolster that 
program.
    In our pioneer space, we are hoping to be able to, as I 
said, build in efficiencies, but I am also hoping that it will 
help enhance the sponsors coming to work with us. We are seeing 
shortage--I mean, we don't have as many products on the market 
as we would like to have. And we would like to continue to work 
with the industry to bring products to us to approve.
    So we are committed to continuing to work with both 
industries on the vital work that we all do collectively.
    Mr. Joyce. And the advancement of lower-cost generics, safe 
and effective generics are important to me and to my district 
as well.
    The ADUFA and AGDUFA agreements both contain provisions to 
enhance agency engagement with sponsors throughout the drug 
review process. Namely, AGDUFA V would establish a new meeting 
process to provide opportunities for the aforementioned generic 
drug makers to seek discussion of bioequivalent status 
submissions.
    Could you speak to why this new meeting process was added 
to the agreements? And will these meetings occur in person or 
will they occur virtually?
    Ms. Forfa. So, as I said earlier, if a sponsor requests an 
in-person meeting, we certainly honor--we have certainly 
started honoring those requests. So sponsors--and we have 
honored them, and so sponsors are more than--are free to 
request coming in and meeting with us in person. We are happy 
to do that.
    So the bioequivalence meeting helps to determine what 
requirements are going to be necessary to prove bioequivalence. 
We know that there is a generic proposal that will allow 
sponsors to get single species, as opposed to multiple species 
in the pioneer, and we are supportive of that. And so we just--
we want to build in flexibilities in the generic space to, as 
you said, you know, provide greater access in the marketplace.
    Mr. Joyce. And I encourage you to continue to offer those 
in-person meetings. As we put the pandemic in the rearview 
mirror, it is time to resume that person-to-person contact.
    Thank you for being here today.
    And thank you, Mr. Chairman. I yield back.
    Mr. Guthrie. Thank you. The gentleman yields back.
    And that concludes all Members seeking questions for the 
first panel. We appreciate you for being here.
    Ms. Forfa. Thank you.
    Mr. Guthrie. We appreciate your answers, and I know you 
will respond--I think there were some things that needed to 
respond back to. I know we will get that in a timely manner. So 
we appreciate your time. So thank you.
    Ms. Forfa. Thank you.
    Mr. Guthrie. And now we will move to the second panel and 
kind of quickly because we are kind of facing votes. We are 
trying to get as much of this hearing in as we can. So if the 
third panel will take their seats.
    Thank you all very much. We appreciate having you here 
today. We appreciate all of you agreeing to testify.
    I will introduce our witness. Our first witness will be Dr. 
Rachel Cumberbatch, director of Regulatory Affairs for Animal 
Drugs at the Animal Health Institute. We also have Stephanie 
Batliner, Chair of the Generic Animal Drug Alliance. And we 
also have Lori Teller, president of the Animal Veterinary 
Medical Association.
    And so the first witness today will be Dr. Cumberbatch. You 
are recognized for 5 minutes for your opening statement.

STATEMENTS OF RACHEL CUMBERBATCH, D.V.M., DIRECTOR, REGULATORY 
   AFFAIRS, ANIMAL DRUGS, ANIMAL HEALTH INSTITUTE; STEPHANIE 
BATLINER, CHAIR, GENERIC ANIMAL DRUG ALLIANCE; AND LORI TELLER, 
   D.V.M., PRESIDENT, AMERICAN VETERINARY MEDICAL ASSOCIATION

            STATEMENT OF RACHEL CUMBERBATCH, D.V.M.

    Dr. Cumberbatch. Thank you, Mr. Chairman. Thank you, 
Ranking Member, and thank you, members of the committee. Thank 
you for holding a hearing on this important piece of 
legislation and for the opportunity to speak with you today.
    My name is Dr. Rachel Cumberbatch. I am a veterinarian, and 
I am here on behalf of the Animal Health Institute, a trade 
association that represents companies who make animal 
medicines.
    I am here today to ask Congress to reauthorize the Animal 
Drug User Fee Act, or ADUFA. This program is important to 
ensure Americans have an efficient and flexible regulatory 
system capable of evaluating innovative solutions to unmet 
medical needs and to meet the challenges of the future.
    This legislation is important for the simple reason that 
keeping animals healthy provides economic and social benefits 
that touch everyone. In fact, some 70 percent of U.S. 
households have at least one pet, and every U.S. household 
benefits from a safe and available food supply.
    Animal health products protect the health and welfare of 
companion animals. These animals improve the mental and 
physical well-being of their human caretakers, work alongside 
many of our public servants, and assist with therapy for those 
in need.
    The pandemic highlighted the importance of pets when stress 
and isolation contributed to the prevalence of mental health 
issues and the need for companionship.
    Animal health products also protect food-producing animals 
from diseases that affect food availability and the safety of 
consumers. These important medicines give veterinarians, 
producers, and the tools necessary to care for the 9 billion 
food-producing animals annually.
    Animal medicines also help farmers operate more sustainably 
and profitably. Healthy animals are simply more productive.
    Since animals struggle with disease, they require more 
resources, and many of them will never produce as much as if 
they remained disease free. The ADUFA program is designed to 
provide supplemental funding to the FDA Center for Veterinary 
Medicine and to meet agreed-upon performance goals to 
accomplish the congressional mandate of expediting the review 
process of drug applications.
    As we prepared for this reauthorization, we spent time 
examining the public data available on the program's 
performance over its nearly 20-year history. It became apparent 
that a gap has developed between program capacity and 
performance.
    Over the life of the program, fees have increased 600 
percent, and staff at CVM have also increased, yet the sentinel 
workload has declined by 12 percent and the number of products 
approved has remained flat.
    Perhaps most concerning, products are becoming available in 
the European Union before they are being approved in the United 
States, and that puts the U.S. animal health industry and U.S. 
pet owners and farmers at a disadvantage.
    The compromise agreement before you today takes some 
immediate steps to close that gap and proposes further 
collaboration and data collection that will help lead to an 
improved ADUFA VI. Highlights of this agreement include 
appropriate funding, program enhancements, a focus on metrics, 
and financial sustainability. The agreement includes base 
funding of $33.5 million per year as well as one-time 
allowances from carryover.
    ADUFA fees fund about one-third of the new animal drug 
review budget, which we believe meets the congressional intent 
that these fees are supplemental.
    Several technical improvements are also included, such as 
opportunities for earlier feedback for presubmission 
conferences, updating policies and procedures, and, 
importantly, an annual face-to-face meeting between the FDA and 
industry, and able to provide education.
    We highly value face-to-face interaction. It is necessary 
when talking about these complex scientific issues and finding 
solutions to important regulatory decisions.
    Additionally, some new metrics will be implemented 
immediately, and more will be explored for the future. For 
example, we will work together to find a way to measure time in 
agency and time in industry. Under the current process of 
phased review, it is very difficult to measure that total time 
to approval. Yet that is the key metric that is going to be a 
perfect measure to the ADUFA success going forward.
    Lastly, the agreement provides for a third-party 
assessment. This is a tool that has been successfully used in 
other fee programs to identify new efficiencies and develop new 
metrics. It is going to be a first for the ADUFA program.
    Mr. Chairman, Ranking Member, we believe this ADUFA 
agreement sets the program on a more sustainable path. It will 
continue to provide the agency with resources necessary to 
maintain the program and will institute enhancements to improve 
the animal drug approval process.
    We support this investment because a modern and flexible 
regulatory program is necessary for innovative solutions to 
reach veterinarians, producers, and animal owners. Those are 
the people that need them to help keep their animals healthy 
and live longer and more productive lives.
    We urge the committee to pass this agreement without 
amendments or modifications.
    Thank you.
    [The prepared statement of Dr. Cumberbatch follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you. I appreciate your testimony.
    The Chair now recognizes Ms. Batliner for 5 minutes for 
your opening statement.

                STATEMENT OF STEPHANIE BATLINER

    Ms. Batliner. Hello. And I appreciated your comment earlier 
about alphabet soup. So bear with me as we get through this.
    Chairman Guthrie, Ranking Member Eshoo, and members of the 
subcommittee, on behalf of the Generic Animal Drug Alliance, 
GADA, thank you for the opportunity to testify today.
    I am Stephanie Batliner, currently serving as chair of 
GADA. We support the reauthorization of the user fee program 
and, more specifically, support the Animal Generic Drug User 
Fee Act of 2023, or AGDUFA IV.
    GADA is the only U.S.-based independent professional trade 
organization that represents the interests of generic animal 
drug sponsors and industry stakeholders.
    Generic animal drugs provide significant benefits by 
providing cost-effective alternatives to their pioneer drug 
counterparts and by providing supply, security, and access to 
pharmaceutical treatments that would otherwise be unavailable. 
These treatments contribute to the safety of the Nation's food 
supply, the treatment of diseases in animals that can be 
transmitted to humans, and the ability of owners to provide 
care to their pet family members. However, the potential cost 
savings and supply advantages from the use of generic animal 
drugs cannot be fully achieved without broad availability.
    For the AGDUFA IV program, the key GADA objectives were to 
establish a functional user fee program that supports an 
efficient, predictable, and timely FDA review and approval 
process while employing a cost-effective and equitable payment 
structure.
    While the proposed AGDUFA IV program does not include 
significant review program enhancements, such as reduced review 
timelines or increased metrics around efficiency of the 
program, we do support the proposed fee structure revisions. 
These changes will bring some relief to the application fee, 
which has increased to the point that it has become prohibitive 
for the development of smaller-market but medically important 
generic drugs.
    The proposed user fee program is not perfect, however. A 
fundamental concern for GADA is the disparity between how the 
generic and pioneer animal drug programs are funded. The ratio 
of appropriations to user fee funding between these two review 
programs is radically different.
    On the generic animal drug side, industry user fees fund 
roughly two-thirds of the total CVM review program cost; 
whereas on the pioneer side, as my colleague Rachel pointed 
out, the animal drug industry user fees fund roughly one-third 
of that review program cost.
    GADA appreciates that CVM proposed additional moneys for 
generic animal drug review in the President's fiscal year 2023 
budget; however, this does not significantly close the gap 
between the two programs.
    CVM reports significant growth in generic animal drug 
workload, but there appears to be a disconnect, as the number 
of generic animal drug approvals are not increasing 
accordingly. In 2021, generic animal drug sponsors overall made 
nearly twice as many submissions to CVM than they did in 2017. 
However, the number of generic animal drug approvals per year 
has remained relatively stable.
    The program's focus should remain on ensuring the program 
is cost-effective, efficient, predictable, and geared toward 
expediting the availability of FDA-approved generic animal 
drugs based on sound science. Additionally, the industry should 
be protected from unfair competition from illegal pharmacy 
compounding. And we do not support the user fee funding for 
surveillance or enforcement activities but believe these funds 
should come from appropriations.
    While generic animal drugs are in the spotlight, we also 
support and call for the passage of the Generic Animal Drug 
Advancement Act, H.R. 1683, introduced by Representative Nancy 
Mace. This legislation adjusts decades-old legislative language 
that have left generic animal drug sponsors at a significant 
disadvantage. The legislative fixes would allow generic animal 
drug approval for only the targeted species as well as expand 
pathways for generic animal drug products to be approved as 
combination products.
    We thank the committee for including H.R. 1683 in today's 
discussion.
    It should be noted there is a significant overlap between 
ADUFA and AGDUFA programs. Many generic animal drug sponsors 
pay fees into both programs. As AGDUFA fees grow, the range of 
medically important generic drug targets decrease due to the 
lack of profitability.
    In conclusion, GADA supports the proposed legislation for 
the timely reauthorization of AGDUFA IV. It remains critical 
for continued viability of the veterinary generic drug industry 
that the FDA CVM review process maintains predictability and 
improves efficiency.
    Thank you for the opportunity.
    [The prepared statement of Ms. Batliner follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you.
    I just want to make the committee--or subcommittee--aware 
that votes are on the floor, but we are going to finish opening 
statements, and then we will recess and then come back for 
questions. So to let everybody know what the plan is.
    So we are going to finish your opening statement, Dr. 
Teller, then we will recess, and that will give you guys some 
time to get something to eat. But make sure you coordinate with 
staff because we are not sure when we will finish. And we will 
come straight back when we finish, but I think there are 
several votes on the floor. So you should have time.
    But, Dr. Teller, you are now recognized for 5 minutes.

                STATEMENT OF LORI TELLER, D.V.M.

    Dr. Teller. Thank you.
    And good morning, Chairman Guthrie, Ranking Member Eshoo, 
and members of the subcommittee.
    I am Dr. Lori Teller, president of the American Veterinary 
Medical Association. And on behalf of the AVMA, I appreciate 
the opportunity to emphasize the importance of reauthorizing 
the Animal Drug User Fee Act and the Animal Generic Drug User 
Fee Act for our more than 101,000 members.
    The AVMA supports collection and effective utilization of 
user fees to enhance the U.S. Food and Drug Administration 
Center for Veterinary Medicine's review of pioneer and generic 
animal drugs. Access to new FDA-approved animal drugs has the 
potential to improve treatment outcomes, provide better 
alternatives to existing therapies, fill unmet medical needs in 
veterinary medicine, and ultimately improve patient care.
    The needs of veterinarians are unique because we treat a 
multitude of species across an incredible range of sizes for a 
variety of diseases and conditions. Despite this vast range of 
needs, veterinarians have far fewer FDA-approved animal drugs 
available than our colleagues who treat human patients.
    Also, for food-producing species, our veterinarians take 
care to ensure food derived from these animals is safe for 
human consumption.
    Veterinarians need more new and innovative animal drugs 
demonstrated to be safe and effective for optimal patient care 
and the protection of public health. Effective utilization of 
user fees under ADUFA and AGDUFA is of keen interest to 
veterinarians, as we are the primary prescribers and purchasers 
of FDA-approved animal drugs.
    Ultimately, however, it is our clients who pay the cost of 
FDA-approved animal drugs. Drug costs directly impact our 
clients' ability to care for their animals. Animal owners 
thereby rely on animal drugs to not only be safe and effective 
but also reasonably priced.
    We urge FDA CVM to ensure the review process is efficient 
in bringing new animal drugs to market to safeguard the 
public's access to affordable treatment for animals.
    Under previous animal drug user fee agreements, FDA CVM 
committed to utilizing user fees to improve efficiency of the 
animal drug review and approval process. However, we believe 
additional work is needed to attain the program's goals.
    The AVMA suggests, where appropriate, that FDA CVM consider 
adopting processes used by other similar regulatory agencies 
that may streamline and shorten the time needed to approve 
animal drugs for the U.S. market. Our understanding is U.S. 
approvals lag behind Europe and Canada by up to a year. The 
U.S. is the largest animal drug market in the world, and we 
should be the leader in bringing innovative products to market.
    With respect to the AGDUFA program, veterinarians need 
access to more generic animal drugs that have been demonstrated 
to be bioequivalent to pioneer drugs, are properly 
manufactured, accurately labeled, are subject to postmarket 
approval requirements, and are available at a reasonable cost. 
We need more generic drugs for new areas where there is 
currently no generic competition, as well as multiple generic 
approvals to provide stability in the market.
    We recommend FDA CVM prioritize those applications for 
which a generic animal drug is not currently available. Having 
more new generic drug approvals when a pioneer drug comes off 
patent or an exclusivity period expires would signal to 
manufacturers that their time and investment in generic drugs 
is worthwhile, leading to increased competition and, 
ultimately, reduced costs borne by our clients.
    However, having multiple generic animal drug approvals for 
the same pioneer drug can also be beneficial. The supply chain 
volatility and vulnerability experienced over the past several 
years has demonstrated the need for multiple sources of 
important animal drugs. In such instances, access to another 
FDA-approved generic animal drug with demonstrated 
bioequivalence that is manufactured under FDA's good 
manufacturing practices is preferred to alternatives such as 
compounded drugs.
    Ultimately, in order to provide the best care, we need a 
robust pipeline of innovative new animal drugs and a strong 
generic industry.
    Thank you for the opportunity to provide testimony on these 
important programs. The AVMA appreciates the attention the 
subcommittee is giving to this issue to addressing unmet needs 
in veterinary medicine, and we look forward to working with the 
committee and the FDA CVM to increase the number of improved 
animal drugs for the benefit of animals under our care, their 
owners, and the public.
    Thank you very much.
    [The prepared statement of Dr. Teller follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Guthrie. Thank you, Dr. Teller.
    The committee will now recess for the purpose of votes on 
the floor. And our staff will get with you and make sure you 
guys go do what you need to do, but we will be available when 
we get back. We don't know exactly when that will end.
    So the committee is now in recess.
    [Recess.]
    Mr. Griffith [presiding]. I call this meeting to order.
    Chair Guthrie will be back in a couple of minutes, but we 
want to respect as much of the time as we can.
    That being said, I will now recognize Mr. Bucshon for 5 
minutes.
    Mr. Bucshon. Thank you very much.
    First of all, I want to let everybody know everybody has 
written statements that their staff and Members take seriously. 
So I just want to--but I want to let you know that.
    Dr. Cumberbatch, as I discussed with Director Forfa 
previously, FDA Center for Veterinary Medicine, CVM, has 
postapproval authority that protects human and animal health.
    Could you speak from the drug sponsor perspective and tell 
us how CVM works with drug sponsors to change labels to reflect 
what is known or learned about the safety of a product?
    Dr. Cumberbatch. Thank you very much for the question. 
Currently, there is a lot of engagement. What happens is that 
data comes from both FDA and the sponsors in the 
pharmacovigilance, and when there is a need for a conversation, 
they come together and able to debate the scientific data 
behind those decisions. That provides greater rigor to the 
process.
    From AHI's perspective, this process is very important 
because it allows for any label changes to make sure that what 
is going on the label is scientifically sound.
    And I would also like to add, one of the differences 
between animal health and human health is, on this 
postapproval, they are not looking for causation. It is 
association. And our customers, the veterinarians, they want 
causation.
    Mr. Bucshon. OK, great. She testified they wanted a little 
more authority on the subject because of the turnaround time on 
label changes. But I wanted to get the perspective from the 
other--the other perspective on that.
    Has this approach been prove--you mentioned it. It has been 
proven successful, though, right?
    Dr. Cumberbatch. Yes, it has. It has been successful. And 
you can see publicly the label changes that are in place, and, 
importantly, label changes that are backed by data.
    Mr. Bucshon. Yes. All right. That is what I thought.
    I just have a comment, no more questions, but I agree with 
Dr. Teller and your statement that the process in the U.S. 
should be the best in the world.
    I was a surgeon before I was in Congress. So on the human 
side of the situation, and the frustration that all of us feel 
sometimes about this slow process through FDA and, honestly, 
all Federal agencies is real. And so, you know, I--and the same 
thing is true with generics.
    So I just wanted to say I think you have a lot of--a lot of 
people on both sides of the aisle agree with you on that, and 
we are constantly looking at ways to streamline the process, 
make it better and more efficient because, you know, we do have 
the largest market for what you are talking about in the world 
and probably the largest human drug market in the world also, 
and we need to do better.
    With that, Mr. Chairman, I yield back.
    Mr. Griffith. I thank the gentleman.
    And now recognize Ms. Eshoo, the ranking member of the 
subcommittee, for her 5 minutes of questioning.
    Ms. Eshoo. Thank you, Mr. Chairman.
    And thank you to the witnesses for being patient, but, you 
know, votes are votes. So thank you.
    First an observation, and I think that--obviously, I think 
it is an important one, to have three women testifying and that 
we have leaders of organizations, doctors. It is a real source 
of pride to me and I think to my colleagues as well because 
this hasn't always been the case. So I am proud of you.
    I asked Director Forfa about where animal drugs are 
manufactured. I think this is a very important issue for our 
country.
    And so, Dr. Cumberbatch and Ms. Batliner, can you tell us 
where animal drugs are manufactured?
    Dr. Cumberbatch. Thank you for the question. And it really 
gets to the heart of, is our supply chain resilient? That is a 
space where we share your----
    Ms. Eshoo. Or do we have a supply chain?
    Dr. Cumberbatch. Because there's multiple components. You 
bring up a good question. There's multiple components, and we 
need a resilient supply chain.
    In the pandemic, the animal health industry was quite 
resilient. We did not see a significant number of shortages, 
but in able to make sure that flexibility is there, this 
flexibility is key when you are talking about finding new areas 
to manufacture. That is one of the goals under ADUFA, because 
that manufacturing section needs to be in place in able for the 
companies to manufacture where it is best. And right now, that 
manufacturing, that supply chain is global.
    Ms. Eshoo. And predominantly from any foreign country?
    Dr. Cumberbatch. Ranking Member, I am not able to give the 
specifics right now because what we know is that it comes from 
many places.
    Ms. Eshoo. Do you know what the percentage of foreign 
versus domestic are?
    Dr. Cumberbatch. Ranking Member, I do not.
    Ms. Eshoo. OK. Ms. Batliner?
    Ms. Batliner. I also don't have specifics in terms of 
percentages. I can speak a bit to the supply chain. And I think 
for the finished dosage form, the actual, you know, FDA-
approved product that is given to the end user here, many of 
them are manufactured in the United States. Many of them are 
also manufactured elsewhere. But manufacturing for that 
finished dosage form in the United States is much more common 
than if we look at the active ingredient that goes into that 
finished dosage form.
    And so I think if you really want to look at where we are 
not predominantly supplied by manufacturers within our own 
boundaries, then the active ingredients are majority from 
China, with India becoming a second source in that category.
    Ms. Eshoo. Still, that is the case that remains, which I 
find deeply troubling.
    Is there an effort that you see that would move animal drug 
manufacturing to the United States?
    Ms. Batliner. Those types of discussions are not something 
that our member companies really talk about within the Generic 
Animal Drug Alliance.
    For a company that I work for in my day job, we have two 
manufacturing sites in the United States--one in Canada that 
served the U.S. market--and we are not currently exploring 
bringing additional manufacturing to the United States.
    Ms. Eshoo. And what company is that?
    Ms. Batliner. Bimeda Incorporated.
    Ms. Eshoo. Well, I think, Mr. Chairman, this continues to 
be not only a deep concern of mine, but I think on a bipartisan 
basis this is an area that we need to really thoroughly examine 
and address. I think it is a serious one.
    Thank you to the witnesses.
    I yield back.
    Mr. Guthrie [presiding]. Thank you. The gentlelady yields 
back.
    And the Chair recognizes Mr. Griffith for 5 minutes for 
questions.
    Mr. Griffith. Ms. Batliner, the company you work for in 
your day job manufacturers medicines. Do they get their active 
pharmaceutical ingredients from overseas and manufacture them 
here, or do they get their active pharmaceutical ingredients in 
the U.S. or North America?
    Ms. Batliner. Our primary source for active ingredients is 
China. We also have suppliers in India, Latvia, elsewhere. But 
predominantly, active ingredients are not coming from the 
United States.
    Mr. Griffith. What can we do--and you may not have an 
answer for me today, but what can we do to bring more of the 
production of the active pharmaceutical ingredients onto the 
shores of the United States or at least our allies in North 
America?
    Ms. Batliner. I think that is an excellent question, and I 
would love to help you solve it.
    Mr. Griffith. All right. And I look forward to, you know, 
as you all think of--any of you all think of ideas.
    I think that this is a bipartisan concern in this 
subcommittee, at least, if not elsewhere, and we should be 
trying to solve this issue. And that is not to say that it 
should all be brought back to the United States, but we need to 
have a good enough supply that, in a crisis, we can ramp up 
production at facilities that are located here that already 
know what they are doing.
    All right. Thank you.
    Dr. Teller, you knew I had to be coming to you.
    Dr. Teller. I did.
    Mr. Griffith. You heard my questions in the previous panel 
and know of my concerns with my large district and the fact 
that we need telemedicine.
    What say you? What are your folks saying?
    Dr. Teller. I say we have telemedicine, and we are happy to 
work with you more.
    The scenario that you laid out for Ms. Forfa this morning 
is actually currently legal under both FDA and the State of 
Virginia laws.
    Mr. Griffith. Then how come my farmers don't know that?
    Dr. Teller. That is the problem.
    Mr. Griffith. Because they think they have to have the vet 
show up even if they have got something they can show them on 
the phone.
    Dr. Teller. So they need to have a veterinarian to 
establish their veterinarian-client-patient relationship, and 
once that is established, they can use telemedicine and send 
them a picture, show it to them. The veterinarian can make the 
appropriate treatment recommendations. If a prescription is 
needed, they can authorize the prescription for the medication.
    So we are happy to work with you to improve the education 
of both the veterinarians in your district and the farmers.
    Mr. Griffith. Yes. No, I look forward to that because this 
is--I mean, if I had just gotten it from one farmer, I might 
think, yes, maybe this is not a districtwide problem. But 
across the board, I have gotten this question on at least three 
or four different occasions in different parts of the district, 
which is why I went after it.
    Dr. Teller. Absolutely.
    Mr. Griffith. Because I want our folks to be served because 
they are part of the food chain, and we want to make sure that 
we have an abundant supply and a healthy supply.
    Dr. Teller. Absolutely. I eat steak. I had one last night, 
and I want that steak to be healthy and tasty and be safe.
    Mr. Griffith. And hopefully it was, you know, raised right 
there in the foothills of the Appalachian Mountains, maybe even 
on top.
    Dr. Teller. I will ask that next time, yes.
    Mr. Griffith. Yes. All right. I appreciate that.
    Is there anything else that we should be doing in that 
regard to make telemedicine easier for the farmers to access?
    Dr. Teller. So the AVMA has a tremendous coalition of 
several State organizations and ally groups as well as industry 
partners in the pharmaceutical world, and we are working very 
hard to educate our stakeholders. And whatever you can do to 
help us amplify that message would be quite welcome.
    Mr. Griffith. All right. And then let's talk phase therapy. 
I have got about 1 minute and 15 seconds. Is this something 
that--and anybody can answer it, but is this something that you 
all are looking at? Is it something that you have even thought 
about?
    Because I think it is an area--because it hasn't been 
explored heavily, even for human being usage, it is an area of 
medicine that we need to be exploring because it may be the 
answer to bacterial infections that do not respond to 
antibiotics.
    Anybody want to take it?
    Dr. Teller. I will say, as the end user, we would love 
anything new and innovative that is safe, that helps alleviate 
the concerns around antimicrobial resistance. We are happy to 
use that as long as it is safe and efficacious. I will defer to 
the industry folks over here to make that happen.
    Mr. Griffith. Yes. Dr. Cumberbatch?
    Dr. Cumberbatch. Thank you for the question. Specifically, 
we need more tools in this toolbox. And so certainly when 
products, innovative products come forward, there is both the 
FDA and the USDA in able to determine the best jurisdiction for 
those. But the important thing is let's bring innovation 
forward so that it can be approved and used appropriately by 
the veterinarians.
    Mr. Griffith. And, Mr. Chairman, what we need are kids 
that--you know, the kids that always love to get their hands 
dirty, because to find the viruses that attack the bacteria, 
you usually find those. So it is treatment plan.
    I yield back.
    Mr. Guthrie. The gentleman yields back.
    The Chair recognizes Dr. Schrier for 5 minutes for the 
purpose of questions.
    Ms. Schrier. Thank, you Mr. Chairman.
    First, let me thank the witnesses for being here today. It 
is nice to see you again, Dr. Teller. I also want to associate 
myself with Mr. Griffith's remarks about the importance of 
having a robust supply chain for pharmaceuticals, not putting 
our food's health at risk, about--comments about innovation in 
pharmaceuticals and antibiotics and treatment of infections. So 
thank you.
    I wanted to just start by saying that of course this 
reauthorization is critical for animal and human health. And I 
wanted to start with you, Dr. Cumberbatch. In your testimony, 
you discussed how ADUFA, its reauthorization, has a robust 
focus on metrics, new metrics, including the metric of time. 
And I was wondering if you could just talk about these new 
metrics, including time, and how they will make a difference 
and get drugs to market?
    Dr. Cumberbatch. Yes. Thank you. One of the challenges that 
we saw going into this negotiation is that, while CVM was able 
to respond by the ADUFA goal, we were seeing more and more 
cycles. And remember in the phased approach, with more and more 
cycles means longer and longer time. And so we were measuring 
activities. The metric of measuring time is going to help us 
measure outcomes, but it is not easy. And so there is a 
commitment to work towards that. But it is when that commitment 
is finally implemented that we will really be able to see a 
return focused on the outcome.
    Ms. Schrier. Thank you for that clarification. I want to 
turn my attention, now, to Dr. Teller. Again, it is very nice 
to see you again.
    You mentioned in your testimony that, where appropriate, 
the FDA Center for Veterinary Medicine should consider adopting 
processes used by other similar regulatory agencies that may 
streamline and shorten the timeline needed to approve drugs for 
animals in the U.S. market. In fact, just yesterday, you 
mentioned that medications were getting approved much more 
rapidly in Europe, and some frustration with our system.
    Could you talk a little bit more about that and why it is 
so important to veterinarians?
    Ms. Teller. It is really important. There are over 20,000 
FDA-approved medications for humans. There are approximately 
1,600 available for veterinarians to use across a wide variety 
of species. And we need more drugs, and if there is a way to 
streamline that process, learn from what is happening in 
Europe, Canada, Australia, those places, that would benefit our 
animals, our patients so much better.
    Ms. Schrier. It seems like there's good opportunities for 
collaboration there.
    Ms. Teller. Absolutely.
    Ms. Schrier. In the realm of human medicine, we came upon 
some of these frustrations with the approval of rapid COVID 
tests that people could use at home that were approved much 
more rapidly in other countries before they were available on 
our drugstore shelves.
    Dr. Teller, I have another question about antimicrobial 
resistance. Pediatrician, I have long worried about this. I 
have seen with my own eyes the evolution of drug resistance and 
the limitation on which antibiotics we can use to treat 
diseases. It is getting very scary. So we try to prevent it 
with very judicious use of antibiotics only where absolutely 
needed. And I was wondering if you could expand a bit on 
judicious use of antimicrobials, why it is so important for 
veterinarians to consider treating your patients, and if you 
could talk about this with respect to ADUFA.
    Ms. Teller. Absolutely. Judicious being the keyword there, 
and it is something the AVMA believes very strongly. And we 
have a committee dedicated just to antimicrobials, experts from 
across the veterinary profession, and they spend a lot of time 
focused just on this. We provide guidelines to our members, the 
prescribers, also across the species and for certain disease 
conditions. And we work with our clients, whether these are 
companion animal veterinarians, are there other ways to prevent 
the problems that the antibiotics are using to treat? So 
preventive care, wellness care, other treatment modalities that 
are not antimicrobial. We invest a lot of time and money into 
doing that, and we are starting to see the results of that. And 
it is really important to the profession.
    Ms. Schrier. Thank you. I have had discussions with some of 
the dairymen, for example, in my district about just that.
    I also just wanted to touch on the other issue that Mr. 
Griffith had brought up about telemedicine and its importance, 
because the issue of being able to purchase antibiotics without 
a prescription, without the involvement of a veterinarian 
contributes to antimicrobial resistance. So being able to use 
telemedicine especially as we are trying to expand broadband is 
a real win for resistance, for the animals, for veterinarians, 
and for the farmers.
    Thank you, and I yield back.
    Mr. Guthrie. Thank you. The gentlelady yields back.
    The Chair recognizes himself 5 minutes to ask questions. 
And I want to follow up what Dr. Schrier was talking about with 
one of my questions. I was looking at, Dr. Teller, how has the 
FDA worked with drug sponsors to develop new 
antimicrobiologicals in food-producing animals that are safe 
for human consumption and gets to, they have guidance judicious 
use of antimicrobial drugs. And the question is, how has that 
guidance impacted the ability to get food from food-producing 
animals into grocery stores?
    Ms. Teller. I am going to have to----
    Mr. Guthrie. How well have they been good to work to 
together and how that impacted----
    Ms. Teller. Yes. So the FDA, the AVMA, the manufacturers, 
we all work together on that. A lot of it does come down to 
education. Veterinarians are in the trenches working with our 
food animal producers, our allied associations such as the 
American Association of Bovine Practitioners, our swine 
veterinarians, our poultry veterinarians, to make sure that we 
can advocate for them here with Congress, as well as with the 
regulatory agencies to help streamline that process so that we 
do have rapid but safe turnaround to approve these medications.
    Mr. Guthrie. OK. All right. And then the guidance, the 
judicious use of medically important antimicrobial drugs, that 
guidance?
    Ms. Teller. Yes. So that guidance is very important to us. 
We work to educate our veterinarians on how to apply that 
guidance to what they are doing in the real world. There is 
obviously--whenever there is change, there is angst 
particularly on the producer side. And we are working very hard 
with them and our food animal veterinarians to educate them on 
how they can best implement that guidance.
    Mr. Guthrie. OK. Thank you.
    So for Dr. Cumberbatch and Ms. Batliner, though the 
questions is about the same except for one different word: How 
will the agreement accelerate, Dr. Cumberbatch, the development 
of pioneer drugs, and Ms. Batliner, how will agreements, the 
bills before us today, help accelerate for generic animal 
drugs?
    Dr. Cumberbatch, if you would like to go first?
    Dr. Cumberbatch. Yes. Thank you. The agreement before you 
would maintain the stability of this program. It is going to 
help us get products to the market faster and make sure that 
they are backed by data. Now we need to measure the progress we 
are making, not just the wheels that are spinning. The activity 
that is being done, that is very important. And I know that you 
guys have a focus on the supply chain and manufacturing. 
There's goals within this agreement to make sure that we are 
specifically improving the manufacturing section within the 
drug approval process. That is a big priority for us.
    Mr. Guthrie. Thank you. Ms. Batliner.
    Ms. Batliner. The proposed ADUFA IV program would continue 
to build upon the performance that we have seen across the 
previous programs in terms of the predictability and the time 
by which FDA gives us their response, whether that be positive 
or negative. With that said, we do have a good relationship 
with CVM, and we are committed to continuing that collaboration 
where they are being more clear, developing more guidance, and 
so forth, which then helps us to put forth a better package for 
them to approve, that subject generic animal drug.
    It think it is important to note just how few pioneer 
animal drugs have a generic counterpart. So we would really 
like to see better penetration of generic animal drugs into the 
marketplace in general. So we look forward to continuing the 
progress that we have made with AGDUFA and really focus, 
though, on efficiency. For me to get a rejection letter faster 
doesn't really help anyone. So what we look to do as an 
industry is to work with CVM to make sure we understand the 
requirements, but then also have them, you know, keep those 
requirements kind of in check and based on sound science.
    Mr. Guthrie. Thank you.
    Ms. Batliner. Requirements for the sake of more paper work, 
I think maybe, you know, doesn't accomplish the goal, so a 
focus on the science and what is really required to keep these 
products safe and effective.
    Mr. Guthrie. Thank you. I appreciate that. That concludes 
my questions. So I will yield back, and I will recognize the 
lady from Tennessee, the gentlelady from Tennessee, Mrs. 
Harshbarger.
    Mrs. Harshbarger. Thank you, Mr. Chairman. Thank you to the 
witnesses for being here today. I want to start with you, Ms. 
Batliner, and it was something you said in your statement. You 
said, ``CVM should have the resources necessary to meet the 
stated goals of AGDUFA and to protect the generic animal ... 
industry from unfair competition from illegal pharmacy 
compounding.''
    Can you tell me what ``illegal pharmacy compounding'' 
means?
    Ms. Batliner. Sure. Thank you for the question. And I do 
want to draw a clear, bright line between legal and completely 
acceptable and necessary pharmacy compounding in veterinary 
health. It does serve a purpose. There are guardrails around 
how that compounding happens, and we have no challenge on that.
    Mrs. Harshbarger. I am very aware of how that compounding 
happens. Are you talking about 503Bs versus 795-compliant 
503As?
    Ms. Batliner. So where our concerns lie is when compounding 
pharmacies are importing bulk drugs and formulating finished 
dosage forms for masses, not for one individual, you know, 
client/patient relationship but rather formulating to bulk 
stock, office stock.
    Mrs. Harshbarger. Well, that is what the GFI addresses.
    Ms. Batliner. Right. So once that becomes enforced, then we 
are hopeful that that definitely improves the situation.
    Mrs. Harshbarger. Because we know we have to have a 
patient-specific prescription for those animals, and there's 
several guidelines on that. You know, there is 503A, you know, 
the traditional compounders, and they have to be 795 compliant, 
or 797 if they do sterile, and, of course, 503Bs, it is a 
different setup, but they can certainly do that.
    Dr. Teller, in your statement, you said ``more approvals of 
generic animal drugs help ensure consistent access to the drugs 
veterinarians [use] to treat our patients. In such instances, 
access to another FDA-approved generic animal drug with 
demonstrated bioequivalence that is manufactured under FDA's 
good manufacturing practices is preferred to alternatives such 
as compounded drugs.''
    I guess my question is, what do you do when you can't get 
any alternative? You have to turn to a compounder or the animal 
goes without. I have seen this in many instances, even with 
human drug compounding.
    Ms. Teller. We absolutely compound. We work with 
compounding pharmacies, and we have to do it every day. There 
is not ever going to be enough drugs approved to cover all the 
species, the sizes, and the doses that we need. So certainly 
being able compound from approved drugs is our first choice. We 
also know that there are times that we need to be able to do 
that from bulk drug substances. And we worked with the FDA when 
they came out with guidance 256.
    I have to say we are not super in favor of the list. So we 
are cautious and working with them on that, and they have 
publicly committed to being efficient in reviewing those drugs 
and moving them to approved list.
    Mrs. Harshbarger. I know, it is like, you know what needs 
to be on the list. We are here to help them. I have offered my 
assistance many times.
    Dr. Teller, I have another question. In your testimony, you 
mentioned the need for new and innovative medicines to fill 
those unmet needs for veterinarians. Can you walk us through 
some of the unmet needs your members have in their practices?
    Ms. Teller. Sure. So a couple of examples on the food 
animal side: ocular squamous cell carcinoma, so cancer around 
the eye. That is tremendous. It impacts cattle.
    Mrs. Harshbarger. Absolutely,
    Ms. Teller. And on the small animal side, hemangiosarcoma, 
which is a blood-based tumor. There is no great treatment for 
that at this moment. Life expectancy in general is around 3 
months--maybe, if you do chemo, 5, 6 months. And if we had a 
medication that could take care of that, it would be amazing.
    Mrs. Harshbarger. Yes. Can you explain how the animal drug 
user fee agreements have improved animal health, both for pets 
and for food-producing animals?
    Ms. Teller. We appreciate the fees being reasonable and 
going towards making the process safer and more efficient 
because it does get those medications to us faster so that we 
can treat our patients, whether it is on a farm or in 
somebody's house.
    Mrs. Harshbarger. OK. I just wanted to make sure you 
understood the importance of compounding, not just for animals 
in the veterinarian industry but also on the human side too. 
That is just something I have done for 37 years. And you know, 
there is such value in that.
    I guess with that, my time is up, and I yield back, Mr. 
Chairman.
    Mr. Guthrie. I thank the gentlelady for yielding back.
    I believe that is all Members who have been presented to 
ask questions. We have concluded that part of this hearing. I 
ask unanimous consent to insert in the record the documents 
included on the staff hearing document list.
    There is one. No objection?
    Ms. Eshoo. No objection, Mr. Chairman.
    Mr. Guthrie. Without objection, so ordered.
    I remind the Members that they have 10 business days to 
submit questions for the record and ask witnesses to respond to 
questions promptly. Members should submit their questions by 
the close of business on April the 13th. Thank you all for 
being here. I know it has been a long morning because we broke 
for votes for a while, but really appreciate your attention to 
this, the hard work that you do before you come to the hearing 
just to get the bills ready, and to prepare for the hearing. 
And it is much appreciated, and we thank you for being here.
    And without objection, the subcommittee----
    Ms. Eshoo. Mr. Chairman, it is not that I have an 
objection, but I just want to raise, I think, a very serious 
issue. This morning, a Federal judge in Texas struck down major 
portions of the ACA's requirement that health insurers cover 
preventative services with no cost sharing for patients. This 
ruling applies nationwide, affecting everyone with private 
insurance. And that is--I want to raise it.
    It is not only ACA. And what this affects, at least some of 
the preventative services, we know that we are way behind in 
cancer screenings in our country due to the pandemic. It 
effects drugs to prevent HIV infections, pregnancy care, 
colonoscopies, and there is no stay while it is appealed.
    So I am asking you to take under consideration as chairman 
of our subcommittee that we have a hearing on this. It is not 
only ACA enrollees, but all privately insured people in our 
country.
    Mr. Guthrie. Thanks. We just saw that this morning and 
haven't had time to review----
    Ms. Eshoo. I understand.
    Mr. Guthrie. We are concerned. We want people to get cancer 
screenings and screenings they need. We will commit to a 
hearing. I am not sure what our schedule will be. We are 
mindful of it, and we want to make sure that people have the 
proper screenings. We think prevention saves money in the long 
run, but not only does it save money, but saves life. That is 
the most important.
    Ms. Eshoo. Thank you for taking it under consideration.
    Mr. Guthrie. Thank you. Well, the subcommittee, without 
objection, is adjourned.
    [Whereupon, at 12:26 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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    [Ms. Forfa did not answer submitted questions for the 
record by the time of publication. Replies received after 
publication will be retained in committee files and made 
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=115630.]
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