[Senate Hearing 115-777]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-777

                        IMPROVING ANIMAL HEALTH:
                         REAUTHORIZATION OF FDA
                         ANIMAL DRUG USER FEES

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                                   ON

EXAMINING IMPROVING ANIMAL HEALTH, FOCUSING ON REAUTHORIZATION OF FOOD 
             AND DRUG ADMINISTRATION ANIMAL DRUG USER FEES

                               __________

                           FEBRUARY 13, 2018

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]


        Available via the World Wide Web: http://www.govinfo.gov
        
                                __________
                               

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
28-827 PDF                  WASHINGTON : 2020                     
          
--------------------------------------------------------------------------------------
        
        
          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington, Ranking Member
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia			ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky			AL FRANKEN, Minnesota
SUSAN M. COLLINS, Maine			MICHAEL F. BENNET, Colorado
BILL CASSIDY, M.D., Louisiana		SHELDON WHITEHOUSE, Rhode Island
TODD YOUNG, Indiana			TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah			CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas			ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska			TIM KAINE, Virginia
TIM SCOTT, South Carolina		MARGARET WOOD HASSAN, 
                                         New Hampshire  
                                     
                                     
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                 Evan Schatz, Democratic Staff Director
             John Righter, Democratic Deputy Staff Director
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                       TUESDAY, FEBRUARY 13, 2018

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     3

                                Witness

Solomon, Steven, DVM, MPH, Director, Center for Veterinary 
  Medicine, U.S. Food and Drug Administration, Rockville, MD.....     5
    Prepared statement...........................................     6

 
                        IMPROVING ANIMAL HEALTH:
                         REAUTHORIZATION OF FDA
                         ANIMAL DRUG USER FEES

                              ----------                              


                       Tuesday, February 13, 2018

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:05 a.m. in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, presiding.
    Present: Senators Alexander [presiding], Isakson, Paul, 
Young, Roberts, Murkowski, Murray, Casey, Bennet, Murphy, 
Warren, Hassan, Smith, and Jones.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will please come to order.
    Today, we are holding a hearing on updating the Animal Drug 
and Generic Animal Drug User Fee Agreements. Senator Murray and 
I will each have an opening statement, then we will introduce 
the witness. After the testimony, Senators will each have 5 
minutes of questions.
    Farmers and families in Tennessee want to have access to 
the drugs that keep their animals and their pets healthy.
    For example, I know an East Tennessee farmer who raises 
calves. He checks on them several times a day, and when he 
notices one is not feeling well, he pulls him aside and gives 
him a drug. This farmer wants to ensure the drug he gives the 
sick calf is safe for the calf and for our food supply.
    We know that the human medical products we use are safe 
because the Food and Drug Administration has approved them.
    The way any farmer knows the drug he has given to his calf 
is safe is the same: the FDA has approved it.
    Similar to the User Fee Agreements this Committee 
reauthorized last year for human medical products, this year we 
need to reauthorize the Animal Drug and Generic Drug User Fee 
Agreements.
    These are agreements between the FDA and the animal drug 
industry to pay user fees to help speed the approval of new 
drugs for farmers and ranchers, families, and veterinarians to 
keep their animals and pets safe and healthy.
    These agreements are much smaller than the human drug user 
fee agreements. The revenue FDA receives from the Animal Drug 
User Fees is only about 3 percent of the revenue FDA receives 
from the human drug program. However, they are still critical 
to keeping our animals healthy and preventing outbreaks of 
disease.
    There are two agreements, one for new brand animal drugs, 
which the FDA calls pioneer drugs, and one for generic new 
animal drugs.
    Last year, the FDA received 780 applications for new 
pioneer animal drugs and 240 applications for generic new 
animal drugs for review. While animal drugs are used to treat 
almost every animal species, much of the drug development 
focuses on the seven major species: horses, cattle, pigs, dogs, 
cats, chickens, and turkeys.
    I was telling Senator Murray while coming in about the 
book, ``Guns, Germs, and Steel: The Fates of Human Society,'' 
that I read a few years ago by Jared Diamond, Ph.D. One of the 
main things I took away from it was how few domesticated 
species there are; maybe 14, 15, 16, something like that.
    But these seven major species include both animals that are 
common family pets, as well as the livestock that is our food 
supply.
    On average, the animal drug industry spends over $30 
million a year to develop new products for farm animals, and 
over $22 million a year for new treatments for our pets. And 
according to the animal drug industry, it can take up to 8 
years for a drug intended for use in farm animals to be 
available for veterinarians and farmers, and over 6 years for 
new pet medicines.
    These agreements help bring these new medicines to the 
veterinarians who write prescriptions for families to care for 
their pets and treat diseases, such as cancer or heartworm 
disease.
    While these agreements are important to our family pets, we 
also want to ensure the farmers and ranchers raising our food 
supply are able to treat their animals with the safe drugs they 
need. Farmers often use animal drugs to prevent outbreaks of 
infectious diseases, to treat pain, or prevent swelling of 
joints in animals.
    Having safe and effective animal drugs is important to both 
the consumer--that food-producing animals are safe to eat--and 
the farmer or rancher that he has a product to treat his 
animals and prevent outbreaks.
    According to the Tennessee Department of Agriculture, the 
cattle and calves industry and the poultry industry are two of 
our State's largest agriculture sectors. Since the last 
reauthorization of these agreements, the number of cattlemen in 
Tennessee who have been Beef Quality Assurance Certified--
meaning they have proper training to administer animal drug 
products--has increased from about 17,000 cattlemen to 23,000.
    It is important that farmers and ranchers continue to have 
access to new medicines to keep their animals healthy and 
prevent infectious disease outbreaks.
    These updated agreements have been carefully worked out 
between the Food and Drug Administration and animal drug 
industry with input from farmers and ranchers, food and feed 
producers, veterinarians, and other stakeholders.
    The FDA and the manufacturers of animal drugs held eight 
meetings to discuss the pioneer drug agreement and six meetings 
on the generic drug agreement.
    Our Committee has held eight bipartisan staff briefings 
over the last few months in preparation for reauthorizing these 
agreements.
    Today, we are going to hear from Dr. Steven Solomon, a 
veterinarian and the Director for the Center for Veterinary 
Medicine at the FDA about the agreements. One of the important 
goals in the updated Animal Drug User Fee Agreements is for the 
FDA to reduce approval times in certain areas.
    These user fees are a critical funding source for the FDA 
to do its job to expedite the review of safe and effective 
treatments for animals.
    If Congress does not do its job to reauthorize these 
critical programs, more than 115 people, who work on reviewing 
these drugs, will lose their jobs. This will lead to delays in 
approving new animal drugs and bringing new treatments to 
farmers, ranchers, veterinarians, and families. We have to do 
this by August 1, 2018.
    We hope to mark up these two important agreements by the 
end of this month so we can move them to the floor, and this 
Committee can continue our work on other important issues.
    These agreements are essential to ensure the animal drugs 
on the market are safe and effective, and keep farm animals and 
pets healthy, and help keep our food supply safe.
    I look forward to quickly reauthorizing them.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman.
    Thank you, Dr. Solomon, for joining us today.
    As we begin to work to reauthorize the Food and Drug 
Administration's Animal Drug and Animal Generic Drug User Fees, 
I am optimistic that we can do this with the same bipartisan 
spirit we brought to this important issue the last time the 
Animal Drug User Fee, or ADUFA, were up for reauthorization.
    The same bipartisan spirit we brought to this issue last 
year when we passed the FDA Reauthorization Act and 
reauthorized the user fees for prescription drugs, medical 
devices, generic drugs, and biosimilars.
    The FDA has a critical role in protecting public health and 
ensuring the safety of food, drugs, and devices that families 
in my home State of Washington and across the country depend 
on.
    Part of that role is to ensure that our Nation's animal 
population is healthy. But the development of drugs for animals 
presents a unique set of challenges and considerations.
    One challenge is the sheer set of different health needs we 
might use drugs for, from treating illnesses that might harm 
people or the animal to preventing them.
    Another is the sheer number of different animals we care 
for from those that are commonly pets, like dogs, cats, and 
horses, to animals we commonly rely on for our food supply like 
chickens, and cows, and turkeys, and pigs.
    To minor species that are not common, but are so important 
to their owners, or may be critically important to protecting 
public health.
    Finally, we have to make sure the drugs approved are not 
only safe for the animals, but also safe for the people who may 
consume their meat and the environment around them.
    The Animal Drug User Fee Agreements help the FDA maintain 
needed resources and manages this important task which affects 
our lives and our families in many ways.
    Some of the ways are obvious and personal. When we go to 
the vet with a furry family member who has an injured paw or a 
runny nose, we want to know they are getting treatment that is 
safe and effective.
    Some are less obvious, but no less important. We want our 
farmers and livestock producers to know that the products they 
use are humane for their animals and safe for consumers. We 
want to know how the drugs we give animals impact the larger 
environment, so that we are not creating dangerous and 
unintended negative consequences.
    An important example of this is the work the FDA does to 
ensure antibiotics are being used judiciously in animals to 
avoid creating new resistant strains of bacteria that can harm 
our families.
    I am pleased the FDA continues to collect antibiotic sales 
data and has taken valuable steps to drive down use of 
antibiotics in our food and animals.
    I hope to hear more from you, Dr. Solomon, about how we can 
continue to better understand how antibiotics are being used in 
our food supply chain through collaboration with the Department 
of Agriculture.
    As we work to reauthorize this important legislation, I am 
optimistic the new agreements can bring more collaboration and 
communication to the drug development process by bringing 
regulators and sponsors together earlier to clarify 
expectations.
    Congress has historically reauthorized ADUFA with 
bipartisan support, and I believe this Committee can build on 
that track record if we keep our focus on ensuring the health 
and safety of our families and animals.
    I am confident the insight from our witness today, and the 
stakeholders offering comments to our bipartisan discussion 
draft released last week, will help us do that.
    Thank you, Dr. Solomon. Again, I am looking forward to your 
testimony.
    The Chairman. Thank you, Senator Murray.
    I want to thank Senator Murray and her staff, as well as 
the majority staff, for working so well together over the last 
couple of years on our user fee agreements.
    They are complicated, and we were able to come to a 
consensus about them last August, and I look forward to the 
same kind of process here.
    I am pleased to welcome Dr. Steven Solomon. He will have to 
up to 5 minutes to give his testimony. He was appointed 
Director of the Food and Drug Administration's Center for 
Veterinary Medicine in January 2017.
    Before he was appointed as Director of that Center, Dr. 
Solomon served in various policy and leadership roles at the 
FDA for almost 30 years.
    He was Deputy Associate Commissioner for Regulatory 
Affairs, the Assistant Commissioner for Compliance Policy, and 
is a veterinary medical officer in the Center for Veterinary 
Medicine.
    Welcome, Dr. Solomon. Thank you for being here. We look 
forward to your testimony. If you can summarize in 5 minutes, 
we will then go to questions.

  STATEMENT OF STEVEN SOLOMON, DVM, MPH, DIRECTOR, CENTER FOR 
    VETERINARY MEDICINE, U.S. FOOD AND DRUG ADMINISTRATION, 
                      ROCKVILLE, MARYLAND

    Dr. Solomon. Good morning, Chairman Alexander, Ranking 
Member Murray, and Members of the Committee.
    I am Dr. Steven Solomon, Director of the Center for 
Veterinary Medicine at the Food and Drug Administration.
    Thank you for the opportunity to discuss the FDA's 
proposals for reauthorization of the Animal Drug User Fee Act 
and the Animal Generic Drug User Fee Act.
    As you mentioned, I recently returned to CVM as the 
Director after working extensively in other roles in the FDA. 
This is a very good time to be at CVM for a number of reasons, 
including the fact that we are seeking the development of 
significant and innovative new animal products. New animal 
drugs offer the promise of longer and healthier life for our 
pets and other companion animals.
    For example, FDA has approved new oncology treatments for 
dogs targeting canine-specific tumors. These drugs represent a 
significant advance for veterinary medicine, which 
traditionally relies on human oncology treatments.
    In recent years, the FDA has improved innovative therapy 
options that target bone changes in horses to treat a common 
cause of performance-ending lameness.
    New stem cell therapies offer great promise for future 
veterinary treatments and cures. Meanwhile, approval of the 
first generic version of a vital heartworm treatment has 
alleviated a shortage of a critically important treatment for 
dogs and provided an alternative for pet owners.
    The FDA plays a vital role in animal agriculture by 
reviewing safety and efficiency of new drugs for food-producing 
animals such as cattle, pigs, and chickens.
    For Food-producing animals, we also evaluate whether 
products derived from treated animals are safe for human 
consumption.
    Awareness of the public health challenge created by 
antimicrobial resistance has led to important changes in animal 
agriculture.
    For example, as an alternative to antimicrobials, the FDA 
approved a new treatment to prevent mastitis in dairy cows. At 
the same time, animal welfare awareness has grown and we have 
approved the first drug to reduce pain in food producing 
animals.
    The FDA considers timely review of new animal drug safety 
and effectiveness to be central to the agency's missions to 
protect and promote human and animal health.
    ADUFA and AGDUFA are highly successful programs that 
enhance the availability of approved drugs for food producing 
and companion animals. Before their enactment, the FDA CVM had 
a large backlog of overdue submissions and sponsors had to 
wait, on average, 500 to 700 days for drug review. However, 
thanks to ADUFA and AGDUFA user fees, CVM eliminated the 
backlog in applications and dramatically reduced review times.
    Both programs enable the FDA to maintain an outstanding 
scientific and technical workforce, improve timely 
communication with drug sponsors, and achieve other 
efficiencies in the drug approval process while maintaining 
scientific standards for drug safety and efficiency.
    However, without reauthorization, both programs will sunset 
on October 1, 2018. Timely reauthorization is needed to assure 
the FDA's ability to deliver continued high levels of 
performance and ensure there are no disruptions to these 
important programs.
    The ADUFA IV proposal is built on the success of prior 
ADUFA achievements and proposes changes to current performance 
goals to further enhance review. In it, the FDA agrees to 
maintain current performance goals for most applications and 
submissions, and to add four new performance goals to enhance 
the exchange of scientific information.
    The FDA would slash the timeframe for reviewing categorical 
exclusion and animal drug availability and combination 
medicated feed requests by two-thirds. We also established new 
goals for pre-submission conferences and tissue residue method 
demonstrations.
    ADUFA IV also includes an FDA commitment to work on 
implementing the U.S.-European Union Good Manufacturing 
Practice Inspection Mutual Recognition Agreement for animal 
drug facilities.
    The AGDUFA III agreement includes a significant additional 
financial commitment from the animal generic drug industry that 
reflects its growth. These resources would help significantly 
decrease review times for multiple generic submissions and 
provide greater review predictability.
    Both the ADUFA and the AGDUFA recommendations require 100 
percent electronic submission starting next year to facilitate 
efficient review. Additionally, both programs include financial 
recommendations to bolster the program's stability.
    The ADUFA IV and AGDUFA III agreements produced with 
considerable input from the FDA, industry, and other important 
stakeholders build on the achievements of these highly 
successful programs. They will ensure the FDA has the resources 
needed to conduct timely reviews and assist drug sponsors in 
fostering innovation, enhancing access to safe and effective 
therapies for food-producing and companion animals.
    The FDA looks forward to working with the Committee to 
achieve a timely reauthorization of these important human and 
animal health programs.
    Thank you for the opportunity to discuss the ADUFA and 
AGDUFA program.
    I would be happy to answer any questions.
    [The prepared statement of Dr. Solomon follows:]
                  prepared statement of steven solomon
    Good afternoon, Chairman Alexander, Ranking Member Murray, and 
Members of the Committee. I am Dr. Steven Solomon, Director of the 
Center for Veterinary Medicine (CVM) at the Food and Drug 
Administration (FDA or the Agency), which is part of the Department of 
Health and Human Services (HHS). Thank you for the opportunity to 
discuss FDA's proposals for the reauthorization of the Animal Drug User 
Fee Act and the Animal Generic Drug User Fee Act for an additional 5 
years (ADUFA IV and AGDUFA III).
    I recently returned to CVM as the Director after more than 20 years 
serving in other roles in FDA. This is a very exciting time for 
veterinary therapeutics necessary to protect both animal and human 
health. Advances in biotechnology are leading to the development of 
innovative, new animal drug products and approaches that offer the 
promise of a safer and healthier future for the people and animals we 
serve.
    According to the American Veterinary Medical Association, more than 
half of American households include pets, most of whom are viewed as 
part of their families. Overall, this includes approximately 70 million 
dogs, 74 million cats--and a diverse assortment of birds, fish, and 
other animals. Our companion animals are living longer as promising new 
products are being developed to treat chronic and insidious diseases. 
In recent years, FDA has approved innovative treatment options, 
including two treatments for navicular disease in horses, one of the 
most common causes of lameness. The drugs, for the first time, target 
bone changes commonly caused by the disease. FDA has also approved new 
oncology treatments for dogs targeting canine-specific tumors. The 
drugs represent a significant advance for veterinary medicine which 
traditionally relies on oncology treatments approved for humans to 
treat cancer in animals. These approved animal drugs contain canine-
specific dosing instructions and safety information. Stem cell 
therapies offer great promise for future veterinary treatments and 
cures. Meanwhile, approval of the first generic version of a vital 
heartworm treatment has alleviated a shortage of this critically 
important treatment for dogs--and provided a safe, effective, and more 
affordable alternative for pet owners.
    FDA plays a vital role in animal agriculture by reviewing the 
safety and efficacy of new drugs for food producing animals, such as 
cattle, pigs, and chickens. When reviewing new animal drugs indicated 
for food producing animals, FDA also evaluates whether edible products 
derived from treated animals (e.g., meat, milk and eggs) are safe for 
human consumption. Awareness of the public health crisis created by 
antimicrobial resistance has led to important changes in animal 
agriculture--and innovative new products. For example, as an 
alternative to antimicrobials, FDA approved a new treatment to prevent 
mastitis in dairy cows. Another innovative new approval was the first 
drug to reduce pain in food producing animals.
    FDA considers timely review of the safety and effectiveness of new 
animal drug applications (NADAs) to be central to the Agency's mission 
to protect and promote human and animal health. ADUFA and AGDUFA are 
highly successful programs that facilitate the availability of approved 
products for food-producing and other animals and foster a flexible, 
risk-based review framework to accommodate innovative approaches to 
drug development. Prior to initiating these user fee programs, FDA's 
CVM had a large backlog of overdue submissions, and sponsors had to 
wait on average 500 days for pioneer drug review responses and 700 days 
for generic drug review responses. As a result of ADUFA and AGDUFA user 
fees, CVM eliminated the backlog in applications and has dramatically 
reduced the time needed to review animal drug applications and other 
submissions. Both programs help FDA to maintain a stable scientific and 
technical workforce, improve timely communications with drug sponsors, 
and achieve other efficiencies in the drug approval process while 
maintaining science-based regulatory standards for drug safety and 
efficacy.
    In my testimony today, I will provide the status of FDA's 
reauthorization activities. I will also provide some information about 
each program, our achievements to date, and our proposed changes.
               Status of FDA's Reauthorization Activities
    The ADUFA III and AGDUFA II provisions of the Federal Food, Drug, 
and Cosmetic (FD&C) Act will sunset on October 1, 2018. Timely 
reauthorization is needed to ensure FDA's ability to deliver continued 
high levels of performance and help ensure there are no disruptions to 
these important programs. FDA began the reauthorization process on May 
16, 2016, with public meetings for both programs. These meetings 
included presentations by FDA and presentations and public comment by 
representatives of different stakeholder groups, including regulated 
industry, veterinary professionals, scientific and academic experts, 
and representatives of consumer advocacy groups. Transcripts and 
webcast recordings are available on FDA's website at https://
www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/
ucm042891.htm for ADUFA and https://www.fda.gov/ForIndustry/UserFees/
AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm for AGDUFA.
    Based on comments to a public docket and the Agency's own analysis 
of program challenges, FDA developed a set of potential proposed 
enhancements for ADUFA IV and AGDUFA III and began negotiations with 
industry. AGDUFA III negotiations took place between August 2016 and 
January 2017; ADUFA IV negotiations took place between October 2016 and 
April 2017. Discussions with a broader group of stakeholders also 
occurred throughout this process.
    Negotiated recommendations were published in the Federal Register 
in October for public comment. \1\ Final public meetings were held on 
November 2, 2017, to discuss the ADUFA IV and AGDUFA III 
recommendations and solicit input from stakeholders. The final 
recommendations were transmitted to Congress in early January, and 
include, for each program, the goals letter outlining performance 
metrics, proposed legislative language, and a summary of public 
comments.
---------------------------------------------------------------------------
    \1\  FDA, ``Animal Drug User Fee Act; Recommendations; Request for 
Comments; Extension of Comment Period,'' Docket No. FDA--2011--N--0656, 
October 25, 2017, 82 FR 49380-82, available at https://www.gpo.gov/
fdsys/pkg/FR-2017-10-25/pdf/2017-23172.pdf; FDA, ``Animal Generic Drug 
User Fee Act; Recommendations; Request for Comments; Extension of 
Comment Period,'' Docket No. FDA-2011-N-0655, October 25, 2017, 82 FR 
49377-79, available at https://www.gpo.gov/fdsys/pkg/FR-2017-10-25/pdf/
2017-23173.pdf.
---------------------------------------------------------------------------
                            ADUFA Background
    The 5-year reauthorization cycles for ADUFA--and AGDUFA--have 
supported continuous program innovation, evaluation, and improvement. 
Through successive reauthorizations, program enhancements have evolved 
and expanded to include extensive communication and consultation 
between drug sponsors and FDA throughout drug development. ADUFA I 
enabled FDA to increase the number of staff dedicated to animal drug 
review by approximately 30 percent. ADUFA II included important 
measures to enhance communications with industry, develop and implement 
electronic submission capability for applications and submissions, and 
added pre-approval foreign inspection goals. It also supported 10 
public workshops on mutually agreed upon topics.
    ADUFA III added review flexibility to shorten second-cycle review 
and included extensive information technology enhancements. The early 
information process has fostered drug product innovation and increased 
the availability of safe and effective products. Early information 
leverages existing data and informs the scope of animal studies 
required to demonstrate the new animal drug's safety and effectiveness, 
which helps move the project more quickly into clinical trials.
    Under ADUFA III, FDA has made multiple enhancements to the 
chemistry, manufacturing, and controls (CMC) technical section of the 
NADA--one of the most complex components of the new animal drug 
submission--which have reduced overall review time. The Agency now 
permits the submission and review of early completed CMC information, 
permits comparability protocols to be submitted as protocols without 
substantial data in an investigational new animal drug (an INAD) file, 
and permits certain prior approval manufacturing supplements to be 
resubmitted as Supplements--Changes Being Effected in 30 Days (CBE-
30's).
    FDA continues to improve communications, timeliness, and 
predictability of foreign pre-approval inspections. As a result of 
ADUFA III, sponsors may voluntarily submit a list of foreign 
manufacturing facilities they anticipate including in their 
applications subject to pre-approval inspections for the following 
fiscal year. Six sponsors voluntarily submitted such lists in FY 2016, 
allowing better planning for all parties involved and timely execution 
of good manufacturing practice (GMP) inspections by FDA.
    Also as part of ADUFA III, FDA agreed to two long-term goals. 
First, we agreed to explore the possibility of pursuing statutory 
changes to expand the use of conditional approval. FDA is continuing 
work on the goal of exploring the feasibility of statutory revisions to 
expand the use of conditional approvals to other appropriate categories 
of new animal drug applications beyond the current FD&C Act authority 
provided under the Minor Use and Minor Species Animal Health Act of 
2004 (MUMS Act). CVM formed a Conditional Approval Working Group that 
has conducted preliminary activities to evaluate the feasibility, 
practicality, criteria, and potential requirements for expanding the 
use of conditional approval to certain major uses in major species. FDA 
is committed to continuing to explore through a public and transparent 
process the expanded use of conditional approval consistent with the 
Agency's mission to protect and promote public health. In our second 
long-term goal, FDA agreed under ADUFA III to explore the feasibility 
of statutory revisions that may modify the current requirement that the 
use of multiple new animal drugs in the same medicated feed each be 
subject to a separate approved application. The Agency held a public 
meeting on March 16, 2015, to discuss this issue with stakeholders. In 
FY 2016, CVM fulfilled its commitment as outlined in the ADUFA III 
goals letter and provided written recommendations concerning the use of 
multiple new animal drugs in the same medicated feed for consideration 
through the Federal Register on May 2, 2016. \2\ This proposal formed 
the basis for process changes being recommended in ADUFA IV.
---------------------------------------------------------------------------
    \2\  FDA, ``Recommendations on the Regulation of Combination Drug 
Medicated Feeds; Availability; Reopening of Comment Period; Request for 
Comments,'' Docket No. FDA-2014-N-1050, April 29, 2016, 81 FR 25677-78, 
available at https://www.regulations.gov/document'D=FDA-2014-N-1050-
0002; and FDA, ``Recommendations on the Regulation of Combination Drug 
Medicated Feeds,'' May 2, 2016, available at https://
www.regulations.gov/docket?D=FDA-2014-N-1050.
---------------------------------------------------------------------------
                           ADUFA Performance
    FDA continues to deliver predictable high levels of performance 
against ADUFA goal commitments for timely review, as shown in Table 1. 
Final FY 2016 performance data show FDA exceeded the 90 percent review 
performance level for all seven submission types. In preliminary FY 
2017 performance, FDA is currently exceeding the review-time goal for 
all seven submission types.

          Table 1: FDA Review Performance--ADUFA FY 2016: Percent of Submissions Acted on by Goal Date
----------------------------------------------------------------------------------------------------------------
   Application/                        Goal: Act on 90
 Submission Type         Filed          Percent Within        On Time            Overdue        Percent on Time
----------------------------------------------------------------------------------------------------------------
 Original NADAs                 15           180 days                 14                  1                 93
             and
   Reactivations
----------------------------------------------------------------------------------------------------------------
 Administrative                 18            60 days                 18                  0                100
           NADAs
----------------------------------------------------------------------------------------------------------------
Non-manufacturing                0           180 days                  0                  0               ----
    Supplemental
       NADAs and
   Reactivations
----------------------------------------------------------------------------------------------------------------
  Manufacturing                324           120 days                322                  2                 99
    Supplemental
       NADAs and
   Reactivations
----------------------------------------------------------------------------------------------------------------
     Qualifying                  6            60 days                  6                  0                100
        Labeling
     Supplements
----------------------------------------------------------------------------------------------------------------
   INAD Studies                181           180 days                181                  0                100
----------------------------------------------------------------------------------------------------------------
     INAD Study                277            50 days                275                  2                 99
       Protocols
----------------------------------------------------------------------------------------------------------------

    NADA = New Animal Drug Application; INAD = Investigational New 
Animal Drug
                         Proposal for ADUFA IV
    ADUFA IV builds on the success of prior ADUFA achievements. The 
negotiated recommendations propose changes to current performance goals 
to further enhance review.
    FDA agrees to maintain the ADUFA III performance goals regarding 
review of most original and administrative NADAs, investigational new 
animal drug studies, non-manufacturing supplemental NADAs, and 
reactivations. To enhance the exchange of scientific information, the 
Agency and industry have agreed on four new performance goals in ADUFA 
IV: reducing the timeframe for reviewing Categorical Exclusion requests 
from 180 to 60 days for certain qualifying submissions; shortening the 
review timeframe for combination medicated feed applications requiring 
no data; scheduling pre-submission conferences within 60 days upon 
FDA's receiving a complete agenda request; and for a product requiring 
a tissue residue method trial, scheduling the method demonstration 
within 120 days of receiving a complete request. The ADUFA IV 
recommendations also include a provision requiring 100 percent 
electronic submission starting in FY 2019 and a commitment by FDA to 
work on implementing the U.S.-European Union GMP Inspection Mutual 
Recognition Agreement for animal drug facilities.
    Additionally, ADUFA IV offers the following recommendations:

          Eliminating the Offset Provision, which will allow 
        any excess collections to be more readily available for use by 
        FDA for the process for the review of animal drug applications.

          In conjunction with eliminating the Offset Provision, 
        for any fiscal year the Workload Adjuster is invoked in which 
        FDA had excess collections in the second preceding fiscal year, 
        provide for FDA to reduce the workload-based fee increase by 
        the amount of excess collections. If FDA did not have excess 
        collections in the second preceding fiscal year, FDA will 
        collect the full amount of the workload-adjusted fee revenue.

          Continuing to authorize recovery of collection 
        shortfalls; however, provide for any fee increase to recover 
        shortfalls to be reduced by the amount of remaining prior year 
        excess collections not already applied for purposes of reducing 
        workload-based fee increases.

          Modifying the Workload Adjuster base years from ADUFA 
        II (FY 2009 through FY 2013) to ADUFA III (FY 2014 through FY 
        2018) to ensure the adjuster adequately captures changes in 
        FDA's workload during ADUFA IV.

    The ADUFA IV recommendations submitted to Congress include total 
fee revenue estimates for FY 2019 of $30,300,000, which includes one-
time information technology funding in the amount of $400,000. The 
proposed statutory language specifies base annual fee revenue of 
$29,900,000 for each of FY 2020 through FY 2023; however, this amount 
is subject to possible adjustments, including for inflation, workload, 
and collections shortfall.
                           AGDUFA Background
    AGDUFA I authorized FDA's first-ever generic animal drug user fee 
program, launched in FY 2009, to provide livestock and poultry 
producers and pet owners with greater access to safe, effective, and 
more affordable generic animal drugs. Under AGDUFA I, FDA increased the 
number of staff dedicated to generic new animal drug application review 
by approximately 45 percent enabling the Agency to accelerate review, 
eliminate a backlog of 680 applications, and create a more predictable, 
streamlined process, including electronic submission capability. 
Electronic submissions have grown from approximately 3 percent of 
submissions in FY 2011 to 58 percent in FY 2017.
    AGDUFA II included further enhancements. FDA added flexibility with 
a second-cycle shortened review process for key submission types, such 
as protocols, data submissions, and applications that significantly 
impact the generic new animal drug approval timeline.
    Qualifying submissions receive a significantly reduced second-cycle 
review to shorten approval timelines. FDA also made multiple 
enhancements to the CMC technical section, similar to the ADUFA changes 
noted above.
    AGDUFA II added a pre-approval foreign inspection goal to improve 
communications, timeliness, and predictability of these inspections. 
FDA also developed question-based review (QbR) for bioequivalence 
submissions, and deployed a QbR for blood-level bioequivalence protocol 
submissions. Additional templates to further enhance the review of 
bioequivalence submissions are currently under development.
                           AGDUFA Performance
    FDA continues to review sponsor submissions and deliver predictably 
high levels of performance against AGDUFA goal commitments for timely 
review, as shown in Table 2. Final FY 2016 performance data show FDA 
exceeded the 90 percent on-time goal for all five submission types. 
Based on preliminary analysis of FY 2017 performance, FDA is again on 
track to exceed the review-time goals for all five submission types.

             Table 2: FDA Review Performance--FY 2016: Percent of Submissions Acted on by Goal Date
----------------------------------------------------------------------------------------------------------------
                                      Performance Goal:
 Submission Type         Filed        Act on 90 Percent       On Time            Overdue        Percent on Time
                                            within
----------------------------------------------------------------------------------------------------------------
Original ANADAs                 16           270 days                 16                  0                100
             and
   Reactivations
----------------------------------------------------------------------------------------------------------------
 Administrative                  1           100 days                  1                  0                100
          ANADAs
----------------------------------------------------------------------------------------------------------------
  Manufacturing                156           270 days                153                  3                 98
    Supplemental
      ANADAs and
   Reactivations
----------------------------------------------------------------------------------------------------------------
  JINAD Studies                 63           270 days                 61                  2                 97
----------------------------------------------------------------------------------------------------------------
JINAD Protocols                 22           100 days                 22                  0                100
----------------------------------------------------------------------------------------------------------------

    ANADA = Abbreviated New Animal Drug Application; JINAD = Generic 
Investigational New Animal Drug
                        Proposal for AGDUFA III
    The AGDUFA III negotiated agreement includes a significant, 
additional financial commitment from the animal generic drug industry 
that reflects the program's growth. The agreement is designed to slash 
review times for generic submissions and increase the predictability of 
FDA's review process by providing CVM resources sufficient to keep pace 
with actual costs. Review times for the following submission types will 
be cut as indicated in Table 3 below: ANADAs (originals, reactivations, 
and administrative); prior approval supplements; and JINAD data 
submissions and protocols. Like the ADUFA IV recommendation, AGDUFA III 
also would require 100 percent electronic submission starting in FY 
2019.

   Table 3: AGDUFA III Performance Goal Review Times (Complete 90 percent within the following number of days)
----------------------------------------------------------------------------------------------------------------
                Application Type                        Current Goal                 AGDUFA III Proposal
----------------------------------------------------------------------------------------------------------------
Administrative Abbreviated New Animal Drug                        100                                   60
                      Application (ANADA)
----------------------------------------------------------------------------------------------------------------
           ANADA originals/reactivations                          270        240 (180 day review + 60 day admin)
----------------------------------------------------------------------------------------------------------------
  ANADA reactivations (shortened review)                          190        120 (60 day review + 60 day admin)
----------------------------------------------------------------------------------------------------------------
            Prior Approval supplements (Chemistry,                270                                  180
                      Manufacturing, and Controls)
----------------------------------------------------------------------------------------------------------------
Generic Investigational New Animal Drug (JINAD)                   270                                  180
                         data submissions
----------------------------------------------------------------------------------------------------------------
JINAD data submissions (shortened review)                          90                                   60
----------------------------------------------------------------------------------------------------------------
                         JINAD protocols                          100                                   75
----------------------------------------------------------------------------------------------------------------

    Additionally, AGDUFA III offers the following recommendations:

          Eliminating the Offset Provision, which will allow 
        any excess collections to be more readily available for use by 
        FDA for the process for the review of generic new animal drug 
        applications.

          In conjunction with eliminating the offset provision, 
        for any fiscal year the Workload Adjuster is invoked in which 
        FDA had excess collections in the second preceding fiscal year, 
        provide for FDA to reduce the workload-based fee increase by 
        the amount of excess collections. If FDA did not have excess 
        collections in the second preceding fiscal year, FDA will 
        collect the full amount of the workload-adjusted fee revenue.

          Modifying the Inflation Adjuster from a fixed 4 
        percent in AGDUFA II to a variable inflation adjuster in AGDUFA 
        III, matching the inflation adjuster used for the ADUFA 
        program.

          Modifying the Workload Adjuster base years from 
        AGDUFA I (FY 2009 through FY 2013) to AGDUFA II (FY 2014 
        through FY 2018) to ensure the adjuster adequately captures 
        changes in FDA's workload during AGDUFA III.

    The AGDUFA III recommendations submitted to Congress include total 
fee revenue estimates for FY 2019 of $18,300,000; in FY 2020 through FY 
2023, this amount is subject to possible adjustments, including for 
inflation and workload.
                               Conclusion
    The ADUFA IV and AGDUFA III agreements, produced with considerable 
input from FDA, industry, and other important stakeholders, build on 
the achievements of these highly successful programs. They will help 
ensure FDA has the resources needed to conduct timely reviews and 
assist drug sponsors in bringing more animal drugs to the market. They 
also will foster innovation and provide enhanced access to safe and 
effective animal therapies. FDA looks forward to working with the 
Committee to achieve a timely reauthorization of these important human 
and animal health programs.
    Thank you for the opportunity to discuss the ADUFA and AGDUFA 
programs. I would be happy to answer any questions.
                                 ______
                                 
    The Chairman. Thank you, Dr. Solomon, and thank you for 
being here.
    We will now go a 5 minute round of questions and we will 
start with Senator Isakson.
    Senator Isakson. Thank you, Mr. Chairman.
    Thank you for being here today. I have a couple of 
questions, one on the Center for Veterinary Medicine's Draft 
Guidance for Industry on No. 187.
    It is my understanding that you have issued a policy that 
will consider gene-edited animals as animal drugs regardless of 
how minor or complex the edit is.
    Is that correct?
    Dr. Solomon. The regulatory framework under 187 is that 
they are new animal drugs. However, many of these products, we 
would be able to use enforcement discretion to and therefore, 
not have to go through a review process.
    For example, things like genetically altered fish that are 
these little glow fish that you see, we did an evaluation of 
those and found that they pose no human safety, no target 
animal safety problems, and no environmental concerns. 
Therefore, we used enforcement discretion and did not apply 
those standards.
    Similar, we apply other standards for animal models of 
disease and other laboratory animals under that framework.
    Senator Isakson. Again, I am not a scientific or a medical 
person, so I want to make sure I understand.
    If you approve a gene edit treatment for one type of 
animal, it is approved for all animals.
    Is that what you are saying?
    Dr. Solomon. We base on the risk associated with the type 
of animal and the gene editing it is. If it is associated with 
a food-producing animal, then there is more review and we use 
the regulatory framework of getting the data for a new animal 
drug.
    If we find no concerns on safety, then we are able to use 
enforcement discretion and allow those to go to market without 
a review process.
    Senator Isakson. Has it ever come up as a trade issue with 
the Europeans, or the Koreans, or others because it is like a 
GMO, like a genetic modification?
    Dr. Solomon. There are very few of these animals on the 
market, so it has not been a trade issue, although, we 
certainly understand there is great sensitivity on these 
issues.
    Senator Isakson. Are you issuing any conditional 
modifications or conditional approvals at the Center?
    Dr. Solomon. Conditional approvals were authorized by 
Congress under the Minor Use and Minor Species Act of 2004 and 
therefore, other than the species that Senator Alexander 
mentioned before as the major species.
    We have had four products get conditional approval. One has 
gone through full approval process. It is on the market. It is 
a product for fish. There is another one that is still under 
review and two of the products could not make it through the 
conditional approval process, which requires full efficacy 
review at the end of 5 years.
    Senator Isakson. I know rabies is controlled, to a certain 
extent, by the disbursement of rabies medicine in the wild, 
hoping it will be consumed by raccoons and other types of 
animals that could carry rabies.
    Do you have the same approval authority on those types of 
drugs as you would any that is given to an animal?
    Dr. Solomon. For veterinary biologics, like a rabies 
vaccine, they are actually approved by Center for Veterinary 
Biologics. That is part of the USDA, not the FDA for biologics.
    That differs from where we are on human biologics, which 
are approved by our Center for Biologics within the FDA.
    Senator Isakson. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Isakson.
    Senator Murray.
    Senator Murray. Thank you.
    Dr. Solomon, animal drugs face additional development 
challenges compared to human drugs. They can only be used for 
their approved indications. They have to be assessed for their 
impact on the environment, and they may need to be evaluated 
for how they impact meat or other food products.
    In addition, since animal drugs are approved for a given 
species, there are often fewer subjects available for clinical 
trials.
    During the recent reauthorization of the human Drug User 
Fees, Congress, FDA, and the industry worked to ensure the 
agency is considering all scientific tools to demonstrate a 
drug meets the gold standard of safety and efficacy like using 
real world evidence and embracing alternative clinical trial 
designs to overcome challenges in the human drug development.
    I wanted to ask you, what has the agency learned from 
previous animal and human drug user fee cycles that can help 
address innovation and development challenges for animal drugs 
under the FDA's current legal authorities?
    Dr. Solomon. Thank you for that question.
    We do work closely with our human counterparts on different 
models of disease, and we have used many of those processes to 
develop innovative drugs.
    For example, the drug that we first produced for pain 
relief in animals, you cannot ask an animal, ``What is your 
pain score?'' as we typically do in humans.
    We actually worked with the sponsors that the pain was 
associated with a disease called infectious pododermatitis, it 
is a disease called foot rot, where animals do not want to put 
weight on it.
    We developed weight mats to evaluate how much weight the 
animal puts on this mat because if they are more pain free, 
they are going to be able to be less lame and put weight on it.
    Similarly, for diseases like Addison's disease, which is a 
decreased level of cortisol, rather than trying to do 
measurements of cortisol, which are very challenging, we use 
surrogate points to look at the ratios of sodium and potassium.
    We have many examples of how we use alternatives, including 
using a lot of information from other countries. We recently 
approved a drug for noise aversion in dogs. Once again, dogs 
that go through thunderstorms, they can get high anxiety. They 
can get very concerned. There are field trials in Europe of 
animals getting the drug where there are fireworks, and we used 
that data so we did not have to do those studies in the United 
States.
    Senator Murray. Very good.
    The CDC estimates that over 400,000 people are sickened 
each year by food that is contaminated with antibiotic 
resistant bacteria. Bacteria exposed to suboptimal doses or 
long durations of antibiotics are prone to develop resistance, 
whether they are in a person or an animal. Everyone wants to 
keep our animals healthy. But inappropriate, overuse of 
antibiotics in food-producing animals can fuel resistance, 
which can then hurt our families.
    Now, the FDA has begun to bring down the inappropriate use 
of antibiotics in food animals by eliminating nonmedical uses 
on drug labels and bringing the use of antibiotics and feed 
under veterinary supervision.
    In November, the FDA reported that animal antibiotic sales 
from 2015 to 2016 went down 14 percent. That is good progress, 
but the threat of antibiotic resistance demands ongoing 
vigilance.
    I wanted to ask you, how is the FDA using its current 
authorities to continue to reduce non-judicious use?
    Dr. Solomon. It is a major public health challenge on 
antibiotic, antimicrobial resistance. It needs judicious use 
both on the veterinary side and on the human side.
    As you mentioned, we did reduce all the products that had 
growth promotion claims. They now have therapeutic claims. They 
are also under use by veterinary oversight, which was critical.
    The American Veterinary Medical Association just recently 
issued some new definitions of antibiotic, antimicrobial 
stewardship and good principles. We were very pleased to see 
that come out there.
    The American Association of Veterinary Medical Colleges has 
created a curriculum that veterinary students can better 
understand judicious use principles. We continue to look at 
engaging the data that we need to better measure how we slow 
the resistance of antimicrobial resistance by working with the 
USDA and CDC. It is a very challenging issue to try and 
measure. We need to look at trends over time; a critical public 
health issue.
    Senator Murray. Thank you very much. Appreciate it.
    The Chairman. Before we go to Senator Paul, I wonder if 
Senator Isakson wants to reclaim his remaining time to ask 
about his dog Gracie's separation anxiety.
    [Laughter.]
    Senator Isakson. I wondered if he had any free samples of 
that medicine, because I have a dog that needs it bad.
    [Laughter.]
    Dr. Solomon. I understand completely.
    Senator Isakson. It would help my marriage a lot.
    [Laughter.]
    The Chairman. Senator Paul.
    Senator Paul. We have become more interested in some of the 
food additives, and how they become approved, and how long it 
takes, because we have some companies that are interested in it 
in Kentucky that sell algae that is high in omega-3 to feed to 
cows to try to have more omega-3 in the milk, and the same with 
chickens, and things like that.
    This process and this algae are for sale in Canada and 
Europe. They tell this company here, ``You need to do some 
preapproval study that will cost half a million before you can 
even get started.'' It is like, I do not know, it just seems to 
take a long time.
    I think some are estimating three to 5 years, but two and 3 
years in the European Union. It is like, if it has already been 
approved in the European Union, we are talking about feeding 
salad to a cow. I mean, we are talking about feeding algae to a 
cow, something that is naturally occurring.
    Should it really take 5 years to figure this out and a 
couple of extra years to have pre-study done? Is there 
something we can do better? Can we look at foreign data more? 
Are we looking at foreign data?
    Dr. Solomon. Thank you for the question.
    The approval process has several mechanisms for food 
additives. Once again, it is important to recognize that for 
our animals, that often the food that we give them is the sole 
food that they consume, versus the varied diet that we humans 
eat. And therefore, it is important to assure the safety for 
the animals and also the human food safety associated with it.
    We do have processes for food additive petitions, generally 
recognized as safe notifications for food ingredients.
    We do use foreign data when it is appropriate to the type 
of growing conditions and for the type of feed stuffs we use in 
the United States.
    Senator Paul. Yes, but it seems to me if it is approved in 
Canada and Europe, you could just look at their studies. A 
committee could meet and over half the time, you could just 
approve it. I mean, that is never happening. It still takes you 
years and years and years.
    They are being asked for even a protocol study before they 
even do their study, and they are not even assured of even 
getting to the study, because you are requiring that, and it is 
already approved and being used all over the world.
    I do not really think you are using the foreign studies the 
way they ought to be used. I think you really ought to review 
them and there is a good chance, I would say, a very good 
chance you ought to be able to just look at them and approve 
them.
    Are you ever looking at foreign studies of things we are 
doing in Europe or Canada, and just approving them without 
making them do all the studies again?
    Dr. Solomon. We do use data from other countries, as I 
mentioned before, on the drug side of the house.
    Senator Paul. Have you ever approved any food additive 
without making them repeat all of the studies that are repeat 
studies in our country?
    Dr. Solomon. We need to assess the validity of the data 
collected in another country and see how applicable it is to 
the United States.
    Senator Paul. We do not ever approve them just from the 
foreign studies. We make them repeat the studies again. So, I 
mean, that is a question.
    For example, we are growing hemp now and hemp is, I think, 
naturally high in omega-3.
    If I want to feed the roots of a hemp plant to a cow, do I 
have to go to the FDA to ask for permission to do that?
    Dr. Solomon. Once again, if it is a new feed ingredient 
that has not been evaluated for safety.
    Senator Paul. It seems kind of crazy if it is not drug, if 
it is just something that grows in the ground and we are going 
to feed it to our cows, and somehow, I have to go through a 5-
year process to ask your permission to do it. I do not know.
    I would think we ought to be able to do this better, Mr. 
Chairman. We talk about ways to fix this. There has to be a way 
to get them to look at foreign studies. They say they are going 
to do it, but then they do not. Or they do it, and they still 
make our companies repeat all of these studies.
    There has to be a way we can speed this up. It puts us at a 
competitive disadvantage. Really, we are talking about feeding 
algae. We are talking about feeding something naturally growing 
to animals as a supplement. And I think we have to figure out a 
way to make the process better.
    Do you have any suggestions or do you think we are doing a 
good job doing this? I mean, three to 5 years seems like a long 
time. It is longer than the rest of the world and you are 
making a company, that has already gone through this process in 
another part of the world, go through it again.
    Really, if they have done 2 years in Canada or 3 years in 
Europe, now we are doing three to 5 years on top of what they 
have already done in other countries, and they are having to 
repeat all of the same studies again.
    I just think for something that is being ingested by 
animals, it might be excessive.
    Dr. Solomon. We continue to look at efficiencies in the 
program. There has been a 150 percent increase in food added 
petitions over the past several years. There has been a 
threefold increase in generally recognized as safe petitions.
    We want to use the foreign animal data, data used in other 
countries when it is applicable to conditions in the United 
States.
    Senator Paul. Is the current process too long or is the 
current process just fine?
    Dr. Solomon. I think there are always opportunities for 
improvement and we will continue to look at those.
    Senator Paul. Thanks.
    The Chairman. Thank you, Senator Paul.
    Dr. Solomon, Senator Paul has raised this issue before, and 
I have talked to him about working with our staff and with you 
to see if we can appropriately address it in this legislation.
    Would you be willing to work with Senator Paul and our 
staff to see if there are improvements that we can make in the 
area?
    Dr. Solomon. We would be delighted to work with them.
    The Chairman. Thank you very much.
    Senator Paul, we will look forward to continuing the 
discussion.
    Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman, and Ranking 
Member Murray, for this hearing.
    Dr. Solomon, good morning, and thank you for being here.
    Dr. Solomon. Good morning.
    Senator Hassan. Thank you for your work.
    We often hear that the animal drug market and the human 
drug market have many differences. For example, the animal drug 
market is much smaller than the human drug market. And unlike 
the human drug market, there are not really third party payers 
in the animal drug market with probably a couple of small 
exceptions here and there.
    But as we consider reauthorizing the user fees, I think we 
should also remain mindful of the unique considerations related 
to animal drugs.
    It would be helpful to me for context if you could walk us 
through the main differences between these two markets, the 
animal drug market and the human drug market, and explain why 
it is important to understand these differences.
    Dr. Solomon. Thank you.
    As you put out, there is a significant difference in both 
the payers for the market and the economics of the veterinary 
pharmaceutical industry in developing these products.
    We are very conscious of that need, so we work closely with 
the sponsors very early in the developmental process to try and 
get drugs that have unmet needs, and can help the food animal 
populations and companion animals get to the market.
    You also gave us incentives under the Minor Use and Minor 
Species Act to try and bring many of those drugs where the 
economics are even more challenging and bring you those.
    We actually do work in the minor species area with the USDA 
and other ones to actually have the studies done by academics 
or other research centers, so that the sponsor does not bear 
all the cost of trying to bring those products to market. So, 
that helps a little bit in the minor use and minor species.
    We also give a number of incentives such as the conditional 
approval that we talked about, that allows up to 5 years to 
demonstrate the efficacy of the product.
    Senator Hassan. Right.
    Dr. Solomon. We have a process to work closely with the 
sponsors early in the process, make sure that they have a clear 
understanding of the types of studies, trying and use different 
approaches recognizing the difference in species and the 
difference in production conditions, to try and develop the 
work and get these products to market, which we share with the 
industry.
    Senator Hassan. Well, thank you very much. That is very 
helpful.
    I also wanted to touch on something you raised in your 
testimony. You point out how electronic animal drug review 
submissions have grown in recent years. I know that both the 
Animal Drug User Fee Agreement and the Animal Generic Drug User 
Fee Agreement that have been agreed on by the FDA and industry 
require now 100 percent electronic submissions starting in 
Fiscal Year 2019.
    Can you walk us through why electronic submissions are 
important and how the FDA will facilitate this requirement?
    Dr. Solomon. I step back to, as I said, I have recently 
returned to CVM. When I was originally there, there used to be 
large trucks backing up with volumes and stacks of paper to try 
and deliver the new animal drug applications.
    We would have to take those applications apart, give them 
to the target animal safety, the people looking at efficiency, 
looking at the human food safety.
    By getting the electronic submissions, the data is all 
available to all the technical submission sections. It becomes 
a far more efficient process for reviewing the data.
    Senator Hassan. That is really helpful to know. Thank you 
and congratulations to you and everybody at CVM for making that 
process move forward.
    I want to finally just to touch on and follow-up on Senator 
Murray's question about the interplay of antibiotic use with 
animals and the impact on humans as well.
    I am pleased with the work CVM has done to help 
policymakers and other stakeholders better understand the sale 
and use of antibiotics in animal agriculture, and particularly 
CVM's collection and reporting of antibiotic sales and 
distribution data for food producing animals by species.
    A provision in the second reauthorization of ADUFA has been 
instrumental in helping us better understand the role of 
antibiotics in production agriculture. And your continuing 
efforts to inform policymakers by ensuring that drug sponsors 
also report estimates according to food producing species is a 
natural and appropriate extension of the charge Congress gave 
you when it enacted this provision.
    Can you tell us more about what role this data, this 
specific to food-producing species plays in helping the FDA 
assess progress in instituting judicious antibiotic use 
practices in veterinary settings?
    Dr. Solomon. Trying to determine the progression and trying 
to decrease the development of resistance is a challenging 
scientific area. This is one data point is the sales data. That 
does not equate to the actual usage data. We are working with 
the USDA and others to try and get the actual data for what 
people are actually using.
    It also combines with information from our national 
antibiotic resistance monitoring system where we measure 
resistance that is happening both in people, through the CDC, 
through the USDA with retail meat samples, and through animals. 
We try and look at resistance patterns and changes.
    These data points all need to come together to sort of 
measure continued progress doing it. I think we are looking at 
not single data points. We are looking at trends over time to 
measure the impact of the actions we are taking.
    Senator Hassan. Well, thank you very much.
    Thank you, Mr. Chair.
    The Chairman. Thank you, Senator Hassan.
    Senator Smith.
    Senator Smith. Thank you very much, Chairman Alexander and 
Ranking Member Murray.
    Thank you, Dr. Solomon, for being here today.
    I wanted to talk with you a little bit about the One Health 
approach, which I understand is something that your daughter in 
veterinary school is interested in, which is very, very cool.
    Dr. Solomon. Very much.
    Senator Smith. In 2015, when I was Lieutenant Governor, 
Minnesota poultry growers were hit really hard by the avian flu 
epidemic, and 9 million birds were affected, around 100 farms 
across the State. It was really devastating.
    Now thankfully, this particular disease did not move from 
animals to humans, but it did really raise the specter of that 
and the concern for that.
    I have, as I mentioned before we started, I have had an 
opportunity to work with Senator Young on legislation that 
would promote this One Health approach.
    Could you talk a little bit about how you see that strategy 
and how you are working on that as you think about this 
reauthorization?
    Dr. Solomon. I cannot speak to specific legislation, but 
the concepts of One Health are really being ingrained.
    If you just look at how we review animal drugs, we are 
looking at target animal safety. We are looking at animal 
health. We are looking at human food safety or human user 
safety, so we are looking at the human aspects. And we have to 
do environmental impacts; so all three of them are sort of 
incorporated in One Health.
    We have also designated a person within CVM to be the 
monitor working on One Health because there are lots of 
initiatives going throughout the country that are better 
integrating human health, animal health, and environmental 
impacts.
    Senator Smith. I think sometimes it is difficult for us to 
figure out how to do this kind of holistic approach.
    What are some of the barriers you have to overcome to make 
that happen?
    Dr. Solomon. I think there has been a real change in 
people's thinking about how they approach and tackle problems 
like you described.
    There is not simply an answer of, ``I am just going to give 
a vaccine.'' Or, ``I am going to try and give an antimicrobial 
to deal with it.'' There is recognition that there are a lot of 
conditions that need to really tackle these complex issues.
    By bringing the different scientific disciplines together, 
bringing people together, I think it really creates an 
integration and a holistic approach to better tackle these 
problems.
    Senator Smith. Thank you.
    I would like to ask you a little bit about generic animal 
drugs. You mentioned this briefly in your testimony.
    As you noted in your testimony, more than half of American 
households include pets, including both of my children's. And 
spending on pets has doubled over the last 12 years, I 
understand, with Americans paying nearly $10 billion for pet 
medications and health-related pet products.
    However, compared to the human drug arena, there have been 
relatively few animal drugs that have generic substitutes. And 
so, that means that American families and Minnesota families 
are paying so much more for care for their pets.
    Could you tell us a little bit about how you see this, and 
what the FDA could do to help incentivize more generics?
    Dr. Solomon. The generic animal drug industry is a 
relatively new industry. It is really growing.
    Over the past authorization, there was an increase in work 
that was really positive. So, one of our measures is a workload 
adjustment and it was tremendous. It was the highest of any of 
the user fee agreements. We had over 50 percent increase in 
workload, very positive signs that more generics are coming to 
the market.
    The current reauthorization significantly reduces 
timeframes for getting these products to the market. So that 
was something the generic drug industry and the FDA sat down, 
negotiated, reduces timeframes so we can get more generic 
animal drugs to the market.
    Senator Smith. Great. Thank you.
    Thank you very much, Mr. Chair.
    The Chairman. Thank you, Senator Smith.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman.
    Mr. Chairman, I feel a little bit like a fish out of water 
here in the HELP Committee talking about animal health and the 
Center for Veterinary Medicine. We do not have a vet school in 
Alaska. We wish we had one.
    But I do have an issue that I would like to raise. I think 
many on this Committee have actually heard me raise the issue 
of genetically engineered salmon, whether in the HELP Committee 
or certainly on the Appropriations Committee.
    But as I look to what the CVM does--protect human and 
animal health by ensuring the safety and effectiveness of 
animal drugs, and then review new animal drugs--it really does 
cause me to, once again, raise an issue that I feel very, very 
strongly about, and I think it is fair to say most Alaskans 
share the concern that we have.
    Our FDA, that has approved, what I have called 
``frankenfish,'' this genetically engineered salmon, but they 
have approved it through the new animal drug pathway. Now, 
there were millions--millions--of Americans who wrote-in to 
oppose this approval, wrote into the FDA.
    But effectively what we are talking about is the first 
ever--the first ever--genetically engineered species of animal 
that is approved for human consumption, and it was approved 
through the animal drug route, which just does not make sense 
to me.
    I actually left my office, and I had to move my way through 
about a dozen Alaskans who were back to visit me. They are the 
Alaska longliners. They fish for a living. They are part of a 
very important industry.
    The seafood industry, in Alaska creates about $14.6 billion 
in economic output and nearly 112,000 jobs nationally. In 
Alaska, more than 63,000 direct jobs, over $4.6 billion comes 
from the seafood industry. The Ranking Member here knows full 
well the value of strong fisheries.
    But when I came to say that I was going to be speaking on 
the fact that you have the first-ever genetically engineered 
species of animal approved for human consumption, approved 
through an animal drug route, the fishermen said to me, ``Do 
they not understand that you have animals, and you have 
humans?''
    I said, ``Well, apparently there is a distinction within 
the FDA that somehow or other thinks that you can use the 
animal drug pathway to signoff on, again, a genetically 
engineered species that is designed for human consumption.'' 
You can tell I have a real issue, a real problem with this.
    I have insisted--and I have spoken recently with the head 
of the FDA, that if, in fact, the FDA is going to continue 
down, what I believe is, a wrong-headed approach--at a bare, 
bare minimum these species should be labeled as genetically 
engineered salmon. And they should further require a third 
party scientific review for the approval process for this fish, 
and for any other future fish that might go through this type 
of an approval process.
    I think most are saying that, at a bare minimum, that is 
what they would understand to be appropriate.
    I have had conversations with colleagues who say, ``Well, 
wait a minute. How is this issue of a G.E. salmon any different 
than a genetically engineered crop?'' bringing in the broader 
GMO debate.
    What I would remind people is that genetically engineered 
animals are not crops. A fish is not a piece of corn. And 
recognizing that what we are doing here, or proposing to do, is 
to introduce a new species into our markets, into our homes, 
and quite possibly, contrary to what any environmental 
assessment claims, into our ecosystems.
    This is a significant issue. I believe a significant 
problem and it is one, Mr. Chairman, that I will continue to 
raise. I appreciate the opportunity to raise it in the context 
with Mr. Solomon here today, as we are talking about 
reauthorization of the FDA Animal Drug User Fees.
    Thank you very much.
    The Chairman. Thank you, Senator Murkowski.
    Senator Jones.
    Senator Jones. Thank you, Mr. Chairman, Ranking Member 
Murray.
    Dr. Solomon, thank you for being here.
    Let me just kind of piggyback on what Senator Isakson said. 
As somebody here who is new, I have two British Labs who are 
having serious problems about daddy not being home for the last 
6 weeks. But my wife will tell you I am having more problems 
than they are, probably, with that.
    I also want to thank you for your work on behalf, on a 
personal note, for a son whose life's work has been working 
with zoo animals. He is about to get a degree in zoo and 
aquarium management, and he has done it ever since he was 5 
years old. So, thank you for your work on that.
    Most of my questions about user fees have all have been 
answered. What I would like to just get from you a little bit 
is as regard the budget and the funding for your department.
    We just went through a budget process here in which we 
finally came together in a bipartisan way to come up with a 
budget, and hopefully may end the kind of high stakes budgeting 
process that we have seen.
    Could you just kind of give me a rundown on the priorities 
for your department for the Center for Veterinary Medicine in 
the coming year through the FDA funding?
    Dr. Solomon. In the recently released President's budget is 
some additional funding, $9.7 million proposed, to be able to 
support the process of the ADUFA and AGDUFA. Part of that comes 
from user fees. Some of it comes from budget authority.
    It is critical, with the increased workload, that we keep 
up with it. So, we were delighted to see that in there. That is 
a critical component of it.
    Senator Jones. Right.
    Dr. Solomon. We also recognized that the evaluation of 
drugs goes through the whole lifecycle.
    We do a certain amount of studies that are based on limited 
clinical data and the number of animals. We do a fairly 
thorough review, but we also find--and it is not unusual in 
human medicine--when you put the products on the market, there 
may be increased opportunities to evaluate the safety of it.
    We are continuing to look for opportunities to look at the 
whole lifecycle, post marketing area in addition to the 
preapproval area. We are also looking for opportunities in the 
areas previously mentioned to improve our review of animal feed 
ingredients because of the same concerns about the safety of 
those products and getting them on the market.
    Senator Jones. All right. Well, that is great.
    That is really all I have, Mr. Chairman. Thank you.
    Thank you, Dr. Solomon.
    Dr. Solomon. Thank you.
    The Chairman. Thank you, Senator Jones.
    Senator Murray, do you have any other questions or 
comments?
    Senator Murray. I do not have any additional comments, 
except that I would say that I am really pleased with this 
hearing and our work on moving this forward.
    I also want to thank you on the progress we are making on 
the cosmetics reform proposal too as well, which is critical to 
moving forward.
    The Chairman. Yes, Senator Feinstein, Senator Collins, and 
you have all been working on that. Thank you for saying that.
    Dr. Solomon, Senator Murray and I are operating under the 
assumption that we need to get our work down and to the 
President by August 1.
    What happens if we do not?
    Dr. Solomon. Failure to reauthorize would be very 
disruptive. The industry is counting on this. There are 
constant reviews. We get over 6,000 submissions a year to 
review it.
    Failure to reauthorize would have an impact on the 115 
people that you talked about previously. We would have to give 
notices 60 days prior to those folks if they were no longer 
going to be able to have the funds to be able to support their 
activities.
    Failure to reauthorize has a tremendous effect on folks, 
both the industry and how disruptive it would be. But trying to 
recruit talented staff that we have there, they want to know 
that there is a process and a stable work environment within 
the Center for Veterinary Medicine.
    The Chairman. Thank you.
    You mentioned there are seven major species. Just out of 
curiosity, how many domesticated species are there?
    Dr. Solomon. I will have to get back to you on that one.
    The Chairman. There are not many, right?
    Dr. Solomon. There are a few. I have the same book you do. 
I will have to go back and review it.
    The Chairman. I would be interested.
    Senator Warren, we are about to wrap up. Let me say the 
closing words and then, if it is all right with you, I am going 
to leave the final question and 5 minutes to you. Would you be 
good enough to close the hearing?
    Senator Warren. I plan to, thank you, if the witness feels 
safe under those circumstances.
    The Chairman. The hearing record--subject to Senator 
Warren's 5 minutes of questions, and I appreciate her 
willingness to do that--the hearing record will remain open for 
10 days. Members may submit additional information for the 
record within the time, if they would like.
    Thank you for being here today.
    The Committee will stand adjourned following Senator 
Warren's questions. Thank you for doing that, Senator Warren.
    Senator Warren. Thank you.
    The Chairman. Senator Murray, thank you.
    Dr. Solomon, thank you for coming today.
    Dr. Solomon. Thank you.
    Senator Warren. Thank you, Mr. Chairman, I appreciate it, 
and I appreciate this opportunity to ask a question.
    I wanted to go back to the question about antibiotic drugs.
    The FDA's job is to protect public health, and a big part 
of that is making sure that drugs are safe, that they work. We 
have been talking today about how the FDA does this work for 
drugs that are used in animals. I want to focus on how the 
drugs used in animals can also affect human health, and this is 
about antibiotics.
    Antibiotics are obviously extremely important for treating 
bacterial infections, but as we know, they are becoming less 
and less effective. Today, resistance has been seen in almost 
antibiotics that have been developed.
    The CDC estimates that 2 million people in the U.S. develop 
antibiotic resistant infections every year that results in 
about 23,000 deaths and adds about $20 billion in healthcare 
costs to our already overburdened system.
    Antibiotic resistance, we know, comes from the overuse of 
antibiotics, and not just overuse in humans, but overuse in 
animals.
    Dr. Solomon, can you just get me started here by saying a 
word about how the use of antibiotics in food animals can lead 
to antibiotic resistance in humans?
    Dr. Solomon. Thank you for the question.
    The process is giving antibiotics to animals may cause 
certain resistance in those animals in the gut of those 
animals.
    If, on the process of those animals being slaughtered, that 
resistant bacteria gets on the meat, and then people consume 
that, and it is undercooked, they may be able to get that 
resistant microbe. Or, simply people that are handling the 
animals----
    Senator Warren. Wait, on someone's hands?
    Dr. Solomon. Hands.
    Senator Warren. Yes.
    Dr. Solomon. I mean, we see problems. We have a current 
problem with people feeding raw pet food to their animals, and 
unfortunately, two children got very sick because that raw pet 
food, as many raw products, had salmonella in it, and they got 
very ill. So, handling raw products like that can get them 
exposed.
    Senator Warren. Okay. So, it matters if animals become 
antibiotic resistant or have antibiotic resistant bacteria, and 
that that then moves over into humans and threatens humans.
    Now, I know that the FDA has taken a lot of steps to 
address this issue, including requiring veterinarians to 
supervise all antibiotic use in animals. This was meant to make 
sure that food animal producers use antibiotics only when it is 
medically necessary, like when the animal is sick or there is a 
risk of disease, and not use antibiotics just to grow the 
animals faster.
    The 2008 ADUFA reauthorization also required the FDA to 
collect data from drug manufacturers on the amount of 
antibiotics they sold for use in animals.
    Dr. Solomon, these data tell us how many antibiotics go out 
the door from the drug company to the farm. But do these data 
tell us how and when those drugs are actually used on animals?
    Dr. Solomon. They do not. Right now, this is sales data and 
how that equates to actual usage data, is data that we are 
still trying to collect.
    We are working with the USDA and doing some of our own 
contract work to try and better understand the actual usage 
data, and making sure that everyone is following judicious use 
principles.
    Senator Warren. Good. So, I am glad to hear that you are 
trying to get better data.
    In March 2017, the Governmental Accountability Office made 
several specific recommendations for ways to improve this kind 
of data collection by the FDA.
    The GAO also recommended that the FDA work on establishing 
duration limits on drug labels for certain antibiotics used in 
animals. In other words, limits on how much of an antibiotic 
can be used in an animal and for what specified time.
    Along with Senator Feinstein and Gillibrand, and colleagues 
in the House, I followed up with a letter to then Secretary 
Price about the department's work to implement those 
recommendations. I never received a response to that.
    Dr. Solomon, I would like to follow-up directly with you 
and submit some written questions for the record after this 
hearing about your progress on the GAO's recommendations.
    Will you commit to answering those questions?
    Dr. Solomon. Yes, we would be delighted to work with you 
and get answers to those questions.
    Senator Warren. Good. I do appreciate it.
    I look forward to hearing more from you about how you are 
responding to the GAO's recommendations and in trying to track 
your progress on this issue.
    With 2 million people in the United States developing 
antibiotic resistant infections every year, it is clear that 
more work needs to be done and I look forward to continuing to 
work with the FDA to build on its earlier policies to collect 
better data and to make sure that we have more careful use of 
antibiotics.
    Thank you.
    Dr. Solomon. Thank you.
    Senator Warren. Thank you, Madam Chair.
    Senator Murray. [presiding]. Thank you.
    I believe Senator Roberts is on his way. Is that correct or 
not? How far out is he? A couple of minutes.
    What I will do on behalf of the Chairman is to recess for 2 
minutes until Senator Roberts comes. If you would not mind 
waiting, Dr. Solomon, we will let him reconvene and ask his 
questions and close out the Committee hearing.
    I apologize. Thank you.
    [Hearing recessed at 11:01 a.m.]
    [Hearing resumed at 11:04 a.m.]
    Senator Roberts. [presiding]. The HELP Committee now 
resumes its session.
    Dr. Solomon, thank you for coming. I appreciate it very 
much. It is not often that we have a coup like this, but every 
once in a while, something like this takes place.
    In the last user fee agreement, sir, the FDA agreed to 
explore the expansion of conditional approvals and develop some 
recommendations by September 2015.
    The FDA missed that deadline and in the new user fee 
agreement, there is no commitment or extension of this timeline 
to continue working on this issue.
    However, it is my understanding there was supposed to be a 
meeting last week to lay out a process to move forward on this 
issue.
    Can you share some insight on what happened at this 
meeting? Was there a new timeline agreed to? And if not, what 
would be a reasonable timeline for the agency to publish 
recommendations and issue guidance?
    Dr. Solomon. Thank you for the question.
    Senator Roberts. I am suggesting 1 year or 2 years at 
least.
    Dr. Solomon. Just to step back. The conditional approval 
was authorized under the Minor Use and Minor Species Act, which 
allows products to demonstrate efficacy, not at the time that 
the original safety evaluation takes place, but up to 5 years 
later, and then the product has to come in.
    There was a proposal from industry to expand that from 
conditional approval for minor species to conditional approval 
for major species.
    We worked with industry on that proposal. We had a series 
of meetings associated with it. We reached a lot of common 
understanding, but there were still some areas of disagreement.
    Unfortunately, we got caught up in the new authorization 
process. When I came in, which was January of last year, and 
found out that we had not finalized that work, I met with the 
animal health industry, gave my commitment to work on that 
issue because I think it had some opportunity for us to be able 
to treat some significant health conditions and some areas of 
drugs that had difficult efficaciousness.
    We held a meeting last week to outline proposals. I 
reconfirmed my commitment with them. They asked for us to work 
on this expeditiously. We agreed to work on it, so we are 
appointing a committee, both within CVM and the animal health 
industry to work on it.
    We need to revisit where we were before and make sure we 
still have a common understanding of that process, and then we 
need to work on areas that we still have some challenges, which 
include the issues of can a product, an animal drug product 
have both an approved indication and a conditional indication 
on the same label.
    We are committed to expeditiously work with this issue and 
bring back recommendations to the Committee, and work with the 
Committee on that area.
    Senator Roberts. Dr. Solomon, every once in a while, I am 
asked, ``When are we going to get a farm bill?'' since I have 
the privilege of being the Chairman of the Senate Agriculture 
Committee.
    My answer, rather than a specific date, I do not go beyond 
that in terms of years, but I say, ``Sooner than later.''
    Can I at least elicit that kind of a response from you?
    Dr. Solomon. We are committed to work on it and it will be 
sooner rather than later.
    Senator Roberts. All right. Thank you, sir.
    Recently, Commissioner Gottlieb told this Committee, we 
should consider how to create incentives for the development of 
animal drugs including a breakthrough therapy designation. This 
is something that has been successful on the human side and was 
recently expanded to devices under the 21st Century Cures Act.
    Given the numerous expedited pathways for human drugs, do 
you agree with Commissioner Gottlieb that this is something we 
should explore also on the animal side?
    Dr. Solomon. There are a large number of unmet animal 
health needs that need to be worked at. There are significant 
conditions on there, and I think it is important that we 
explore any opportunities to try and address the significant 
animal and public health issues, and drugs that can help fill 
those needs appropriately.
    Senator Roberts. Let me just say that I can speak for 
virtually every member of the Senate Agriculture Committee in 
our eagerness to working with you and my colleagues on this 
Committee, of course, to see if this is something we could move 
forward with these agreements.
    The growing use of guidance documents for government wide 
has been a concern to me for quite a while. Now, I recognize 
that the FDA has long used guidance documents and that they are 
integral to providing, certainly, to the industries that the 
FDA regulates, especially when good guidance practices are 
followed.
    Currently, CVM has a couple of very old draft guidances on 
adverse event reporting from 2001 and 2006. The regulations 
referenced in these documents were written prior to the 
electronic reporting of adverse events. And as a result, the 
companies are being told to continue managing disharmonized 
systems for adverse event collection and reporting. The 
technology and systems have evolved over the past decades. The 
regulations and guidance need to follow.
    Will you work to withdraw or update and reissue these 
items?
    Dr. Solomon. There are a number of outdated items. Under 
the regulatory reform, we collected a number of ideas from 
industry and also going internally to look at older guidances 
and regulations that may no longer be needed. So, we hope to be 
able to update those.
    Senator Roberts. I want to talk for just a moment about 
applicant burden reduction. The FDA's drug center on the human 
side, CDER, does not routinely require the submission of all 
raw data of new drug applications.
    However, the Center for Veterinary Medicine has expanded 
their data collection requirements over the years to include 
nearly all raw data associated with the study.
    This requirement seems overly burdensome, not only for 
innovators, but also for the agency to review. It also appears 
contrary to the agency's effort to expand electronic 
submission.
    What, if any, efforts have you considered to streamline and 
standardize the process of submitting study reports as a risk-
based approach to audit specific studies been considered?
    Dr. Solomon. Thank you.
    We did understand that under our regulatory reform, we got 
some input from the industry about the use of raw data. We have 
a workgroup that is evaluating this and try and make the 
appropriate decisions on what data is valuable and critical to 
determine the safety, human food safety and the environmental 
impact of products, and where we do not need all the data.
    Senator Roberts. I want to talk just a moment about 
electronic submissions.
    The new agreement requires 100 percent of applications to 
be submitted electronically by October. You mentioned in your 
testimony that last year, the electronic submissions for 
generic applications were at 58 percent.
    My question is: is this a realistic goal? How is the agency 
going to assist applications with this process?
    Dr. Solomon. We negotiated this agreement with the generic 
animal drug industry recognizing that they had a far longer way 
to go than the pioneer industry.
    We have committed to also assist them with this process to 
help facilitate and give them any assistance. We also got some 
funding to help facilitate the electronic entry of these.
    We will continue to work with the industry on this area, 
but it makes a far more efficient review process.
    Senator Roberts. Dr. Solomon, I want to thank you for the 
work that you do. As I look over the rest of these questions, I 
do not see any reason why we cannot submit then for the record 
and simply adjourn the Committee, and let you go about your 
business.
    Dr. Solomon. Thank you.
    Senator Roberts. Thank you, sir.
    The hearing record will remain open for 10 days. Members 
may submit additional information for the record within the 
time, if they would like.
    Senator Roberts. The Committee stands adjourned.
    [Whereupon, at 11:13 a.m., the hearing was adjourned.]

                                  [all]