[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




                   COMMITTEE PRINTS ON ADMINISTRATION
  LEGISLATIVE PROPOSALS ON THE ANIMAL DRUG USER FEE ACT AMENDMENTS OF 
         2008 AND THE ANIMAL GENERIC DRUG USER FEE ACT OF 2008

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                              JUNE 5, 2008

                               __________

                           Serial No. 110-123


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov

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                    COMMITTEE ON ENERGY AND COMMERCE

                  JOHN D. DINGELL, Michigan, Chairman

                    COMMITTEE ON ENERGY AND COMMERCE

                   JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California          JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts         Ranking Member
RICK BOUCHER, Virginia               RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York             FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
BART STUPAK, Michigan                JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York             HEATHER WILSON, New Mexico
ALBERT R. WYNN, Maryland             JOHN B. SHADEGG, Arizona
GENE GREEN, Texas                    CHARLES W. ``CHIP'' PICKERING, 
DIANA DeGETTE, Colorado                Mississippi
    Vice Chairman                    VITO FOSSELLA, New York
LOIS CAPPS, California               STEVE BUYER, Indiana
MIKE DOYLE, Pennsylvania             GEORGE RADANOVICH, California
JANE HARMAN, California              JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine                     MARY BONO MACK, California
JAN SCHAKOWSKY, Illinois             GREG WALDEN, Oregon
HILDA L. SOLIS, California           LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas           MIKE FERGUSON, New Jersey
JAY INSLEE, Washington               MIKE ROGERS, Michigan
TAMMY BALDWIN, Wisconsin             SUE WILKINS MYRICK, North Carolina
MIKE ROSS, Arkansas                  JOHN SULLIVAN, Oklahoma
DARLENE HOOLEY, Oregon               TIM MURPHY, Pennsylvania
ANTHONY D. WEINER, New York          MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah                   MARSHA BLACKBURN, Tennessee
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana               

_________________________________________________________________

                           Professional Staff

              Dennis B. Fitzgibbons, Chief of Staff
               Gregg A. Rothschild, Chief Counsel
                   Sharon E. Davis, Chief Clerk
              David Cavicke, Minority Staff Director

                                  (ii)

                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California          NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York                 Ranking Member
BART GORDON, Tennessee               RALPH M. HALL, Texas
ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
    Vice Chairman                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine                     MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York             SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois             JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California           TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas                  MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon               MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex officio)






  
                             C O N T E N T S

                              ----------                              
                                                                   Page
 Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
 Hon. Henry A. Waxman, a Representative in Congress from the 
  State of California, opening statement.........................     3
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, prepared statement................................     4
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
Hon. Steve Buyer, a Representative in Congress from the State of 
  Indiana, opening statement.....................................     5
 Hon. Jim Matheson, a Representative in Congress from the State 
  of Utah, prepared statement....................................   100

                               Witnesses

Bernadette Dunham, Ph.D., D.V.M., Director, Center for Veterinary 
  Medicine, Food and Drug Administration; accompanied by Steven 
  Vaughn, D.V.M., Director, Office of New Animal Drug Evaluation, 
  CVM, FDA.......................................................     6
    Prepared statement...........................................     9
    FDA response to submitted questions for the record...........   101
Richard Carnevale, V.M.D., Vice President of Regulatory, 
  Scientific and International Affairs, Animal Health Institute..    33
    Prepared statement...........................................    35
Stephanie Batliner, Chairperson, Generic Animal Drug Alliance; 
  Director, Pre-Market Regulatory Affairs, IVX Animal Health Inc.    38
    Prepared statement...........................................    40
Robert Martin, Executive Director, Pew Commission on Industrial 
  Farm Animal Production.........................................    46
    Prepared statement...........................................    48

                           Submitted Material

Committee print on the ``Animal Drug User Fee Act Amendments of 
  2008''.........................................................    68
Committee print on the ``Animal Generic Drug User Fee Act of 
  2008''.........................................................    76
.................................................................

 
COMMITTEE PRINTS ON ADMINISTRATION LEGISLATIVE PROPOSALS ON THE ANIMAL 
 DRUG USER FEE ACT AMENDMENTS OF 2008 AND THE ANIMAL GENERIC DRUG USER 
                            FEE ACT OF 2008

                              ----------                              


                         THURSDAY, JUNE 5, 2008

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:13 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. (chairman) presiding.
    Members present: Representatives Pallone, Waxman, Towns, 
Green, Schakowsky, Matheson, Deal, Buyer, and Murphy.
    Staff present: William Garner, Jessica McNiece, Melissa 
Sidman, Ryan Long, Lance Kotschner, Chad Grant, Jodi Seth, 
Lauren Bloomberg, and Bobby Clark.

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

    Mr. Pallone. The meeting of the subcommittee is called to 
order.
    Today we are going to have a hearing on two committee 
prints of the Administration's legislative proposals on first, 
the Animal Drug User Fee Act amendments of 2008, and second, 
the Animal Generic User Fee Act of 2008, and I am going to 
recognize myself initially for an opening statement.
    Prior to 2003, the FDA's review of animal drug submissions 
was taking over a year and a half to be completed. This 
obviously led to serious concerns that new and innovative 
pharmaceutical products were not making their way into the 
marketplace in order to treat our Nation's pets as well as food 
animals that help sustain the Nation's food supply. 
Accordingly, in 2003, Congress enacted the Animal Drug User Fee 
Act, ADUFA, which was modeled after the successful user fee 
programs for the review of human drug and medical device 
submissions. Like the user fee programs that preceded it, ADUFA 
authorized the FDA to collect fees to help ensure that the 
agency had the resources it needed to provide a timely review 
of animal drug applications. ADUFA also set new performance 
goals for FDA to review and act upon submissions within a 
stated timeframe. By the fifth year of the authorization 
period, FDA was supposed to review 90 percent of submissions 
within the statutorily required time frame of 180 days. 
According to the required annual performance reports for the 
most recent fiscal years, FDA says that the agency has been 
meeting or exceeding the timeliness goals established under the 
program, and I am looking forward to hearing more from FDA 
about how this program has been working over the past 5 years 
and how it can be improved upon.
    Now, under the Administration's legislative proposal to 
reauthorize ADUFA, the review times would remain the same as 
the existing performance goals for fiscal year 2008. The 
proposal would increase the amount of fees collected from $15 
million to $24 million over 5 years for a total of $98 million. 
Revenues would be derived from a mix of application product, 
establishment, and sponsor fees. Other important provisions of 
the Administration's proposal include a new end-review 
amendment process and improved communications between FDA and 
the regulated industries. Absent from the Administration's 
proposal, however, is any provision relating to the issue of 
antimicrobial resistance. I recognize that there is a growing 
concern among stakeholders and members of this subcommittee 
about the use of antibiotics in food animals for prophylactic 
and/or growth purposes. As these practices become more 
commonplace, bacteria that are resistant to antibiotics begin 
to proliferate and this poses a significant threat to humans 
who may come into contact with antibiotic-resistant bacteria 
through eating contaminated or undercooked meat, by caring for 
livestock, or through polluted waterways.
    So clearly we face significant challenges when it comes to 
maintaining the effective use of antibiotics with fewer and 
fewer innovative antibiotic products coming down from the 
pharmaceutical pipeline. It is even more important that we keep 
the antibiotics that are currently on the market working, and I 
am anxious to hear testimony both from the FDA and the 
witnesses on our second panel about the problem of antibiotic 
resistance and what, if any, consideration should be made 
regarding this issue as we move forward with reauthorizing 
ADUFA.
    In addition to the reauthorization of ADUFA, the 
Administration has offered a proposal to establish a new animal 
generic drug user fee. According to FDA, the average review 
time of an animal generic drug submission was 570 days in 
fiscal year 2007 in spite of a 180-day statutory requirement. 
At the end of last year, there was a recorded backlog of 446 
submissions waiting for review and agency action. As more and 
more brand pharmaceuticals come off patent over the next 5 
years, we need to make sure that FDA has the resources it needs 
to effectively review generic animal drug submissions in a 
timely manner. Accordingly, the agreement between the FDA and 
the industry would provide for the collection of user fees 
increasing annually from $4.8 million to $6 million over 5 
years for a total of $27 million, including the yearly cost of 
inflation. These additional revenues are designed to help speed 
up the review process, and by year 5 of the authorization 
period, most reviews of generic animal drug submissions would 
occur in 270 days or less, a substantial improvement over the 
time it now takes FDA to conduct such reviews. I am pleased 
that the industry and the FDA have been able to work out this 
agreement. I am looking forward to hearing more about it today. 
If implemented, AGDUFA, we are calling it, will speed lower 
cost animal drugs to the marketplace and bring significant 
savings to ranchers, farmers, and pet owners. While this is an 
important and noteworthy goal, I also think it is equally, if 
not more important, to ensure the timely review of generic 
human drug applications.
    Over the past few years, I have tried to work to improve 
the speed in which the agency works to review generic 
applications for human drugs. We have lobbied appropriators for 
additional monies for the Office of Generic Drugs. 
Additionally, last year we included a provision in the FDA 
Amendments Act of 2007 to reform the citizen petition process, 
which has been abused in an effort to delay agency approval of 
generic applications. While steps have been taken to improve 
the efficiency in which the agency is reviewing generic human 
drug applications, more can and should be done to help ensure 
patients have access to cheaper and safer medications, and I 
see that Mr. Waxman is here and I know that he has always been 
a champion of trying to improve generics, get them on the 
market and try to bring costs down. I just mention the human 
because I do think we have to keep that in mind even as we are 
talking about the animal drugs today.
    Mr. Pallone. Mr. Waxman is recognized for an opening 
statement.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman. I appreciate 
your holding this hearing.
    As we consider FDA's animal user fee program, we have to 
recognize it has been successful in speeding new medicines for 
animals to the market and that is important and that is why we 
have this user fee program for animals and that is why, quite 
frankly, we have the user fee program for FDA to approve human 
drugs as well. This reauthorization of the Animal Drug User Fee 
Act, or ADUFA, also gives us an opportunity to look at 
providing FDA with new tools to address what has become a 
glaring public health crisis. We now have an overwhelming body 
of evidence showing that the overuse of antibiotics in 
industrial farm production is threatening to destroy the 
effectiveness of many of our most important antibiotics for 
human use. Most recently, the Pew Commission on Industrial Farm 
Animal Production issued a report concluding that our current 
system of producing food animals and its reliance on the 
indiscriminate use of antibiotics poses an unacceptable level 
of risk to public health. I am glad that the executive 
director, Robert Martin, will be here today to walk us through 
some of the Commission's findings.
    We also have reports from the Institute of Medicine, GAO, 
and the World Health Organization, all of which describe the 
very serious and growing threat to global public health 
generated by antibiotic resistance. Americans have experienced 
firsthand the importance of ensuring that we preserve our 
arsenal to fight the new and emerging superbugs like MRSA. We 
know that the overuse of antibiotics hampers our ability to do 
that. So we clearly need to look at ways to reduce the overuse 
in animals of these antibiotics that are so vitally important 
for preventing and curing diseases in humans.
    This legislation deals with one critical issue related to 
animal drugs but clearly there are others. It is our 
responsibility as a subcommittee concerned with the health of 
the American public to examine those issues, and I hope in the 
course of this hearing we might consider evaluating the 
possibility of adding additional legislation to the 
reauthorization bill to deal with animal drug antibiotic use 
that is leading to human resistance to the antibiotics itself.
    I yield back the balance of my time, Mr. Chairman. Thank 
you.
    Mr. Pallone. Thank you, Mr. Waxman, and I would ask 
unanimous consent to include in the record the statement of 
Chairman Dingell. Without objection, so ordered.
    [The prepared statement of Mr. Dingell follows:]

                   Statement of Hon. John D. Dingell

    Mr. Chairman, thank you for beginning the consideration of 
two legislative proposals recently sent up by the 
Administration, and for your leadership on these important 
public health matters. Today's hearing is the first step in 
crafting legislation that will provide the necessary resources 
for the Food and Drug Administration (FDA) to safely and 
efficiently review animal drug applications.
    The Animal Drug User Fee Act (ADUFA) expires on October 1, 
2008, less than 4 months from now. It is the responsibility of 
this Committee and the Congress to ensure that this program is 
reauthorized in a timely manner to avoid any personnel 
disruptions at the FDA. Hardworking, skilled employees at FDA 
are depending on us to do our job, so they can continue to do 
their job.
    An important component of the Administration's proposals 
focuses on the need for greater resources at FDA. We have heard 
from a wide range of stakeholders on this point and I agree. 
This legislation must provide FDA with the necessary user fee 
structure to provide resources for the timely and thorough 
review of new animal drug applications. Equally important, we 
must ensure that Congress appropriates the requisite funds that 
have been authorized for FDA.
    As we begin this process of reauthorizing ADUFA and 
considering the proposed legislation to establish an animal 
generic drug user fee, we must diligently work towards 
strengthening the safety and effectiveness of the Nation's 
supply of animal drugs. I thank the Chairman for holding this 
hearing on the proposals before us today and I look forward to 
the testimony of the witnesses.
                              ----------                              

    Mr. Pallone. Next is our vice chair, Mr. Green of Texas.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Mr. Chairman, thank you for holding the hearing 
on today's Animal Drug User Fee Act and the Animal Generic Drug 
User Fee Act. The Animal Drug User Fee Act was first signed 
into law in 2003 and allowed the FDA to collect user fees from 
brand-name drug companies to reduce the backlog of the FDA's 
review system for brand-name drugs. The Animal Drug User Fee 
Act and the Animal Generic Drug User Fee Act will provide the 
FDA with additional funds to supplement their appropriations 
funding from Congress and for expediting animal drug 
applications from Congress. These additional resources support 
FDA's responsibility under the Food, Drug, and Cosmetic Act to 
ensure that new animal drug products are safe and effective for 
animals as well as for the public with respect to animals 
intended for food consumption. The legislation allows the FDA 
to expedite and improve its review of the application for new 
drugs so that safe and effective new drugs will be available 
more quickly.
    The current ADUFA law will expire October 1 and generic 
drug companies would like a swift review process as well, which 
is why we are having the hearing today on these bills. I 
support both the bills and I thank the committee for having the 
hearing and look forward to the testimony of our witnesses, and 
I yield back my time.
    Mr. Pallone. Thank you, Mr. Green.
    Mr. Towns.
    Mr. Towns. Thank you very much, Mr. Chairman, for holding 
this hearing.
    The reauthorization of the ADUFA is essential in providing 
safety measures directed towards animal health and disease 
prevention. Requiring animal health companies to provide 
additional funding to the FDA's Center for Veterinary Medicine 
will enable the Center to meet its performance goals and 
expectations.
    The proposed AGDUFA bill is also a step toward meeting 
future standards of growth and performance. The AGDUFA bill has 
potential to provide essential resources to reduce the amount 
of time to review generic animal drug applications, which is 
very, very important. This initiative also helps support 
important health priorities. It supports a priority to 
transform health through an improved process that makes new 
drugs available in less time.
    In general, it has been proven that companies that research 
and develop animal drugs have been successful at reducing the 
review backlog while also increasing the FDA's accountability 
of the standards it utilizes for its applicants. The 
reauthorization will also support FDA staff and reviews in 
place to continue uninterrupted.
    Again, let me thank you, Chairman Pallone, of course for 
having this hearing and I look forward to working with the 
committee to move these two ideas forward.
    On that note, I yield back.
    Mr. Pallone. Thank you, Mr. Towns.
    I recognize the gentleman from Indiana, Mr. Buyer, for an 
opening.

  OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF INDIANA

    Mr. Buyer. Thank you, Mr. Chairman.
    I am glad we are holding the hearing today and I am hopeful 
that the process of reauthorizing the Animal Drug User Fee Act 
will be quick and smooth. It is vital to the business and 
agriculture in my home State of Indiana that this program is 
reauthorized quickly. This program is critical to providing for 
innovative medications for companion and food animals. I 
strongly support the proposal before us today and commend the 
animal drug community for the work they did to develop it. I 
urge the subcommittee to preserve this well-vetted proposal and 
to restrain from attaching measures that compromise a quick 
passage.
    The Animal Drug User Fee Act has been very successful in 
speeding the process of getting innovative drugs to our 
Nation's market. Since its initial authorization in 2003, FDA's 
review process for new animal drugs has decreased significantly 
from an average of 295 days to 180 days. I look forward to 
authorizing a process to speed the development of generic 
animal drugs as well. Currently, FDA's review process for 
generic animal drugs lasts on average 4 to 5 years. This year 
we have a new proposal for a generic drug user fee program 
which will decrease this review time to an average of 270 days.
    Again, I strongly support the two proposals before us 
today. They have been well vetted by the business and 
regulatory communities and it is critical to our companion and 
food animal communities that these measures move forward 
quickly without delay, and I thank the chairman for his good 
work along with the ranking member.
    Mr. Pallone. Thank you.
    The gentleman from Pennsylvania, Mr. Murphy, is recognized 
for an opening.
    Mr. Murphy. I waive opening, Mr. Chairman.
    Mr. Pallone. The gentleman waives. OK. So I think we are 
done with the opening statements. We have two panels today. 
Welcome. The first panel consists of Dr. Bernadette Dunham, who 
is director of the Center for Veterinary Medicine at the FDA. 
She is the speaker, and she is accompanied by Dr. Steven 
Vaughn, who is director of the Office of New Animal Drug 
Evaluation, and David Wardrop, Jr., who is director of the 
Office of Management, but I understand you are going to speak 
and they are going to accompany you for questions. You know the 
drill, 5-minute opening. We may subsequently send you some 
written questions at the discretion of the committee.
    I now recognize Dr. Dunham. Thank you for being here.

STATEMENT OF BERNADETTE DUNHAM, PH.D., D.V.M., DIRECTOR, CENTER 
    FOR VETERINARY MEDICINE, FOOD AND DRUG ADMINISTRATION; 
 ACCOMPANIED BY STEVEN VAUGHN, D.V.M., DIRECTOR, OFFICE OF NEW 
                ANIMAL DRUG EVALUATION, CVM, FDA

    Dr. Dunham. Thank you very much. Good morning, Chairman 
Pallone and members of the subcommittee. I am Dr. Bernadette 
Dunham, director of the Center for Veterinary Medicine, 
referred to as CVM, at the U.S. Food and Drug Administration, 
which is part of the Department of Health and Human Services. I 
am accompanied today by Dr. Steven Vaughn, to my right, 
director of the Center for Veterinary Medicine's Office of New 
Animal Drug Evaluation, and to my left, Mr. David Wardrop, Jr., 
executive officer and director of CVM's Office of Management.
    FDA appreciates the opportunity to testify on the 
reauthorization of the Animal Drug User Fee Act and the 
proposed Animal Generic Drug User Fee Act. This morning I will 
be presenting an abbreviated oral testimony, if acceptable to 
the Committee. FDA has submitted a detailed written statement 
for the record. Thank you.
    FDA is the federal agency that regulates almost everything 
we eat except for meat, poultry and processed egg products, 
which are regulated by our partners at USDA. FDA's 
responsibility extends to live food animals and animal feed. 
The Animal Drug User Fee Act, referred to as ADUFA, enacted in 
2003, authorizes FDA to collect user fees from the animal drug 
industry to enhance the process for the review of animal drug 
applications. Fees collected under ADUFA are in addition to the 
base appropriations and they enable FDA to pursue a 
comprehensive set of review performance goals and commitments 
designed to improve the timeliness and predictability of the 
review of new animal drug applications, supplemental NADAs and 
investigational new animal drug submissions
    I am here today to share some very good news with you. 
Since ADUFA's enactment, FDA has exceeded all the program's 
review performance goals. Review times for original NADAs have 
decreased from 295 days to 180 days. Resources provided by 
ADUFA have allowed CVM's scientists to keep pace with the rapid 
advances in science and medicine that drive the quality of 
healthcare and as a part of their work in review the animal 
drug applications. User fee funding has enabled the agency to 
hire and retain highly qualified scientific staff to address 
critical public health issues such as antimicrobial resistance 
that play a role in the review of new animal drug applications. 
This legislation has been extremely valuable to FDA to help us 
fulfill our commitment to promote and protect public and animal 
health.
    The user fee provisions of ADUFA will sunset on October 1, 
2008, if not reauthorized. Recognizing that timely 
reauthorization is needed to ensure there is no disruption to 
the program, FDA held public meetings, negotiated with the 
Animal Health Institute, which represents the majority of 
animal drug industry for pioneer drugs, published negotiated 
recommendations in the Federal Register, and accepted comments 
on those recommendations. FDA's proposal to Congress includes 
input from stakeholders. Our goals for the legislative proposal 
to reauthorize ADUFA are to sustain and enhance the core 
program's operation and performance while providing predictable 
review times and resources sufficient to keep pace with actual 
costs. Performance improvement enhancements are aimed at 
reducing costs for some submissions, providing for improved 
handling of inspections, improving communication between 
sponsors and the agency, and increasing the flexibility of the 
application process. FDA's proposal also includes technical 
changes to increase the administrative efficiency of the user 
fee program.
    Because user fees have not kept up with the increasing 
costs of the program, FDA is proposing to change the financial 
provision of ADUFA to place the program on sound financial 
ground. At the proposed funding level of $98 million over 5 
years, FDA has confidence that it will have a stable review 
workforce over the 5 years covered by ADUFA II. This will 
enable FDA to commit to a continuation of the fiscal year 2008 
performance goals throughout the period covered by ADUFA II as 
well as to additional performance enhancements.
    Now I would like to address the Animal Generic Drug User 
Fee Act, AGDUFA. Currently, FDA's review of generic animal 
drugs is funded entirely through appropriations. Under FDA's 
generic animal drug user fee proposal, the generic animal drug 
industry would pay user fees that would be available to FDA in 
addition to the appropriated funds to spend on the process for 
the review of generic animal drug submissions. The proposed 
legislation will generate an estimated $27 million in user fees 
over 5 years. Fees dedicated to the review process of 
applications will provide essential resources to improve 
generic animal drug review times. Review times for generic 
animal drug submissions have increased significantly in recent 
years, and at the end of fiscal year 2007, there was a backlog 
of 446 submissions for generic animal drugs, an increase of 93 
percent over fiscal year 2000. The statutory review time is 180 
days, but in fiscal year 2007, the actual review time was 570 
days. With 49 pioneer animal drugs to come off of patent 
between 2009 and 2011, review times will increase unless 
improvements are made. This legislation is critical to FDA to 
improve its approval process for generic animal drugs. By 
passing AGDUFA, Congress will provide significant savings to 
ranchers, farmers, rural communities, and pet owners who 
struggle to pay the high price of pioneer drugs for their 
animals. In preparing its AGDUFA proposal for Congress, FDA 
negotiated with the Generic Animal Drug Alliance, which 
represents the majority of the animal generic drug industry. 
FDA'S AGDUFA recommendations ensure that generic animal drug 
user fee program will have a sound financial footing and strong 
performance goals. Resources generated through user fees will 
be sufficient to cover the actual cost of meeting specified 
performance goals.
    AGDUFA's performance goals mirror those of ADUFA. The first 
goal is to reduce specific review times for sentinel 
submissions. It is estimated the review of an original generic 
animal drug application takes approximately 700 days in fiscal 
year 2009. It will take 270 days by 2013. For generic 
investigational new animal drug protocols, the 400 days needed 
to review in 2009 will be reduced to 100 days by 2013. These 
significant process improvements will help bolster a struggling 
generic animal drug industry. The AGDUFA proposal includes an 
amendment process to reduce the time and review cycles 
associated with similar submissions from a single sponsor and 
it incorporates several changes aimed at improved communication 
between sponsors and the agency. Resources generated by AGDUFA 
will be used to increase review staff, refine FDA's business 
process for review of generic animal drug submissions, provide 
training and development for program staff and develop policies 
targeted at more efficient review. This proposal benefits from 
FDA's ADUFA experience and will allow FDA to continue to 
maintain the high standards of safety and effectiveness for 
animals.
    In conclusion, FDA's ADUFA and AGDUFA legislative proposals 
represent considerable input from and agreement of stakeholders 
and the agency. FDA urges passage of these proposals and we 
will work with Congress in any way we can to assist with that 
effort.
    Thank you for the opportunity to present testimony before 
the subcommittee, and we welcome any questions.
    [The prepared statement of Dr. Dunham follows:]

   [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Mr. Pallone. Thank you, Doctor. We are going to have some 
questions now from members of the subcommittee.
    You know there is great concern about antimicrobial 
resistance. While the overuse of antibiotics is certainly a 
factor, many researchers believe that the use of antibiotics in 
food animals also poses a great risk. In 2004, the GAO issued a 
report assessing Federal agencies' efforts to address the risk 
to humans from the use of antibiotics in animals and the GAO 
found that while FDA had begun conducting risk assessments, 
most of these assessments were for drugs other than those that 
were critically important for human health. Can you tell how 
much progress the FDA has made in conducting risk assessments 
on existing approvals that are critically important to human 
health versus risk assessments at the time of initial review? I 
am making that distinction between existing approvals and risk 
assessments at the time of initial review for the drug.
    Dr. Dunham. The concerns for antimicrobial resistance have 
been and continue to be a top priority for the agency. Concerns 
arising from antimicrobials in animal feed was identified more 
than 30 years ago, and in regard to those responses, FDA has 
taken into account antimicrobial resistance as part of the 
animal drug review process, and we do look at all the data on 
the potential resistance to be selected to the animal and also 
to be transferred to bacteria that could contaminate food 
products.
    Mr. Pallone. But do you have any--can you make a 
distinction in terms of your progress on the existing 
approvals, you know, the currently approved drugs as opposed to 
those assessments that are done when you are initially 
reviewing the drug that haven't been approved yet?
    Dr. Dunham. Assessment on drugs that have not been 
approved?
    Mr. Pallone. I think we are trying to make a distinction 
between those drugs that have been on the market and have been 
approved for some time as opposed to those that are going 
through the process now.
    Dr. Dunham. I understand. We have a review process that is 
going right now to take a look at some classes of 
antimicrobials that have been approved for a very long time. 
Those are classes, not individual drugs, and we are going 
through and pulling and looking at each one of those. So there 
is a tremendous amount of work that is being done right now to 
take a look at those as well as the literature review available 
for all of those classes of antimicrobials that very, very 
early on were approved compared to--
    Mr. Pallone. Do you have--and you don't have to give it to 
me today, you can get back to me but--
    Dr. Dunham. Oh, I would be happy to get back to you.
    Mr. Pallone. But is there a schedule for conducting these 
risk assessments for those drugs that have been approved for 
some time that you can get back to us, you know, more 
information about how you are going about that and how long it 
is going to take? I will say a schedule.
    Dr. Dunham. All right. We would be happy to get that 
information.
    Mr. Pallone. OK. And my impression is, the FDA has not been 
able to conduct a lot of risk assessments on those currently 
approved drugs. I mean, would you want to comment on that? I 
mean, do you think there is enough? Do you think there should 
be more?
    Dr. Dunham. At the moment we are currently going back, as 
you mentioned, and reviewing that, and we will be glad to give 
you a further update on that information.
    Mr. Pallone. In getting back to me, if you could indicate 
the average length of time to conduct a risk assessment on 
those products that are currently approved and whether you 
think that length of time is acceptable. I guess that is all I 
wanted. Just get back to us on that.
    Let me get to a second set of questions here. Again, it 
goes back to antibiotics. We have heard from various 
stakeholders about FDA's authority to act when they think that 
the use of an antibiotic in a food-producing animal is harmful 
to human health. Take, for example, the case of Baytril, 
manufactured by Bayer. It is my understanding that FDA found 
that the use of the product in poultry posed a threat to human 
health and sought to withdraw its approval. After 5 years of 
appeals and administrative proceedings, the approval was 
finally withdrawn. So the question is, does the FDA have any 
concerns about the process which you have to undergo to 
withdraw a product's approval if you think it poses a threat? 
Do you think that 5 years that I mentioned in the case of 
Baytril is an excessive amount before the approval can be 
withdrawn? Do you think this process deters the agency from 
conducting risk assessments on products with existing 
approvals? So essentially this would be the opportunity to 
change that process and to change the law if you thought that 
we should, so I just wanted you to comment on it.
    Dr. Dunham. Thank you very much. As you know right now, our 
authority does allow us to go through that review process to 
determine if there is a serious health threat and, if so, we 
would be addressing that, and as you mentioned with the Baytril 
procedure, we have to make sure there is reasonable certainty 
of no harm, and if so, we do investigate and an opportunity to 
have a notice of hearing at which time we take a look at the 
information that is there and the safety of that drug, and 
during that procedure, if we have decided that, then the 
sponsor has the burden to come back and show us information. In 
the case of Baytril, as you pointed out, this was withdrawn.
    Mr. Pallone. But it took 5 years. So my question is, do you 
think that we should do--well, first, do you think that is 
excessive? And obviously if you think it is a problem, what 
would you want us to do in reauthorizing the law to correct it?
    Dr. Dunham. Well, at the moment, that authorization has 
been working but we would be very happy to work with you if you 
have anything alternative that we would like to consider. At 
the moment we follow that procedure and, as you well know, the 
product would remain on the market during the time that we go--
    Mr. Pallone. So you do feel it is too long and that we 
should try to address it? I am not trying to catch you in being 
evil or anything. I am just trying to find honestly if you 
think that that is something we should try to correct because 
you think it is too long a process.
    Dr. Dunham. Well, as I said, at the moment right now, with 
our process and what we have a chance to do and how we do it, 
it has been working and that is the caveat that we undergo the 
approval process and then the withdrawal process.
    Mr. Pallone. So you are open to a change. OK.
    Mr. Deal.
    Mr. Deal. Thank you, Mr. Chairman.
    I suppose we ought to ask, in light of the reauthorization 
issue before us, what would happen if Congress fails to enact 
the ADUFA reauthorization by September 30, and would there be 
layoff notices sent to employees, and how many employees would 
be affected and when would these notices have to go out?
    Dr. Dunham. Yes, sir. This would be critical if we do not 
get this reauthorization to the program and all that we have 
accomplished. We do have to apply notice 60 days in advance of 
the reenactment time to our employees and we would possibly be 
impacting 58 employees that we currently have under the ADUFA 
procedure. So we would lose the talent that we have right now 
and the impact would really step us back with the whole program 
that has been incredibly well performing. It has been a 
successful program and we really would be hurt if we couldn't 
get this reinstituted.
    Mr. Deal. So time is of the essence, in other words?
    Dr. Dunham. Yes, sir, it is. Thank you.
    Mr. Deal. Let me ask this question. Does the CVM believe it 
has enough authority to protect the effectiveness of 
antibiotics used to treat human illness, especially those that 
are considered by FDA as critically important to human health, 
and if not, then what further authorities would you feel like 
you need from Congress?
    Dr. Dunham. As you know, we do have the authorities to go 
through and review, because that is our goal, to approve safe 
and effective products, and we do look at public health, and if 
there were indications that any drug on the market was 
impacting human health, then we can conduct a thorough review 
and take action, as we mentioned a minute ago, on that.
    Mr. Deal. So you feel like you do have adequate authority 
in that regard?
    Dr. Dunham. Yes, sir.
    Mr. Deal. This agreement calls for an end-review amendment 
of deficiencies in a sponsor's application, and also the 
creation of electronic submission too. How do you anticipate 
that these will affect approval times?
    Dr. Dunham. Oh, it is going to be well welcomed. If we can 
move into the electronic age, for example, the ease with which 
the sponsors can provide us that and the ease with which our 
reviewers can access and modify as well as storage of all the 
data that comes from the electronic submission will be a great 
improvement as we move forward in the 21st century. So that 
would be great. Thank you.
    Mr. Deal. I think that answers my questions. Thank you very 
much.
    I yield back, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Deal.
    The gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I wanted to get 
back to that issue that you had raised, Mr. Chairman, about the 
potential overuse of antibiotics and the effect that it can 
have on humans, and maybe you answered this question but I am 
wondering if you could explain the 2003 FDA guidance for 
industry that laid out the agency's requirements for evaluating 
antimicrobial drugs that may pose a risk to public health. Is 
that what you were referring to in the answer to the chairman's 
question?
    Dr. Dunham. Yes, it was part of our procedure. Whenever we 
do a review, if there was a concern to public health of a 
specific product, then we can take a very detailed approach and 
look through that, take a look at the science, and if there is 
indication of harm, then we will follow through and take that 
information, review it, and if we have determined that is the 
case, as was the example with Baytril, then we can put out a 
notice of opportunity for hearing at which time then the 
sponsor would have an opportunity to push back and give us 
information to say whether or not that project is safe or not. 
The review goes through and a decision would be made at the end 
of that notice of opportunity for hearing.
    Ms. Schakowsky. And what was the conclusion of that 
investigation?
    Dr. Dunham. In the case of Baytril, it was removed and we 
no longer use that for treatment in poultry.
    Ms. Schakowsky. Is it a matter of a particular drug or is a 
matter of the quantity of antibiotic present in the animal 
products that we eat?
    Dr. Dunham. In the case of the drug, you are looking at the 
drug itself, and when you take a look at, for example, a 
residue, as we would follow through in an animal of that drug 
product, there are limits that we establish courtesy of the 
review process. In the case of the drug, if, as you mentioned a 
minute ago, there was an impact to public health, then we take 
a look at that drug and its impact specifically and how it is 
being used.
    Ms. Schakowsky. And do we have good scientific data on just 
what the impact is, the cumulative effect of eating animal 
products that are treated with antibiotics? Is this an area 
where we are still doing research and studying this?
    Dr. Dunham. This area is in fact very complicated. It is 
not black and white. There are so many venues that impact this 
and we, yes, are along with many other scientists heavily 
involved with current studies and review to assess all of this 
and understand this very complicated procedure.
    Ms. Schakowsky. Because it is very threatening, the fact 
that we have all these drug-resistant incidents where this 
could be a major threat to public health over time, and we want 
to be sure that the FDA is looking ahead.
    Dr. Dunham. Yes we are, and I think again, with the talent 
that we have, cutting-edge science to know what is happening, 
the traceability, surveillance programs, information 
internationally as well as domestically comes into play. 
Environmental issues, medicine in general, everything is very 
much in tune to understand all of this, and I think it is a 
very exciting area that we have for our scientists to be 
involved.
    Ms. Schakowsky. And does the FDA have all the authority it 
needs to enforce its guidance and perhaps enforce new standards 
that could be set up?
    Dr. Dunham. Yes, we do.
    Ms. Schakowsky. Do you think there is enough evidence at 
this point to at least consider phasing out the use of 
antimicrobials for non-therapeutic use in food animals?
    Dr. Dunham. That is another area that we are looking at the 
information right now. It is under review.
    Ms. Schakowsky. And what is the timeline for that?
    Dr. Dunham. I am going to respond back to Mr. Pallone and 
you with the information that we will return to you in written 
documentation.
    Ms. Schakowsky. Yes, but you do have a protocol and a 
timeline and all that for completing this review or this study?
    Dr. Dunham. We have information that I will be able to 
provide to you that will give you an outline of everything we 
have, yes.
    Ms. Schakowsky. The Union of Concerned Scientists estimates 
that 70 percent of all antibiotics in the United States are 
used in healthy pigs, poultry, beef, and cattle. Is that the 
case?
    Dr. Dunham. I would have to get back to you to confirm any 
documentation of that number.
    Ms. Schakowsky. The doubling of the user fee that is being 
proposed, and so this will mainly be used to shorten the review 
period? I know you went over it in your testimony, but if you 
could just summarize, though, how that money would be used?
    Dr. Dunham. Right now for ADUFA, we will continue with our 
review times that we have now reached at the end of ADUFA I.
    Ms. Schakowsky. Which is how many days?
    Dr. Dunham. One-hundred and eighty days without statutory 
time, which now under ADUFA II will allow us to further enhance 
working through communication with our sponsors. We will have 
10 public workshops over the 5-year period. We will be able to 
work with our sponsors now to have an understanding of any of 
the pre-approval potentially foreign facility inspections, to 
work with them in advance to again keep the times down and to 
complete that information that is collected. We hope very much 
to move forward into the 21st century with electronic 
submissions and reviews which will help not only storage but 
access and free moving of the information that we receive for 
our reviewers, and we will have an opportunity to further 
enhance overall communication with sponsors. For example, 
sometimes they come in at the very, very end and there may be 
non-substantial information but something that needs to still 
be reviewed, and we can add that on with very little additional 
time instead of going back, as we used to under ADUFA I, and 
have to do another notice of a letter to come back and go 
through another review cycle. Keeping it down to one review 
cycle time is very, very critical. This will help get that 
product that is going through approval on the market without 
having further delay.
    Mr. Pallone. The gentlewoman is a minute over.
    Ms. Schakowsky. Oh, I am sorry. If I could just ask one 
more thing about the pet food that we get? Can we be sure that 
it is safe now?
    Dr. Dunham. We have our food protection plan and I think we 
have come a long way since the melamine incident, which has 
really been fantastic to open up the awareness to people not 
only for pet food but human food and feed in general. So yes, 
we have come a long way.
    Ms. Schakowsky. Thank you.
    Mr. Pallone. The gentleman from Indiana, Mr. Buyer.
    Mr. Buyer. Thank you, Mr. Chairman.
    The FDA had given previous testimony and the Commissioner 
has also supported for us to give authority to the FDA to 
destroy counterfeit, adulterated, or misbranded drugs that may 
be found in any of our ports of entry, and that is with regard 
to human consumption. Do you not believe that it would make 
sense that we also extend that authority, that if you find a 
misbranded, adulterated or counterfeit drug that would be used 
for animals that you also be given the authority to destroy?
    Dr. Dunham. I don't believe I have had an opportunity to 
really address this within our group for CVM. I know it is 
happening on the human side. We haven't seen as much 
counterfeit opportunities for animal drugs the way I know you 
do see it on the human side, but we definitely would appreciate 
any opportunity to keep only our approved products on the 
market and be able to intervene whenever we do see adulterated 
products coming across.
    Mr. Buyer. So therefore, following the syllogism of logic, 
would it not make sense that FDA be given the authority to 
destroy if in fact you found a misbranded, adulterated, or 
counterfeit animal drug? If you want to do it for humans, you 
would think you would want to do it for an animal drug too, 
would you not?
    Dr. Dunham. And I would just need to confirm that we have 
gone through with our counsel on that to let you know that we 
have had a green light to look at animal drugs as well.
    Mr. Buyer. Let me ask about your personal opinion. Do you 
not in your personal opinion think that it is common sense, if 
we are going to protect humans, we ought to protect animals 
equally?
    Dr. Dunham. We do with our drugs to make sure they are safe 
and effective and approved. I do agree, yes.
    Mr. Buyer. All right. I don't want to do the dance with 
you, OK? It is easy for me to pick up the phone and ask the 
Commissioner because the Commissioner is going to say 
absolutely.
    Dr. Dunham. Yes, we do. I do.
    Mr. Buyer. All right. Now let me ask you in your 
professional opinion, since we also know, now, would FDA 
support--if we were to put in language giving you the authority 
to destroy a counterfeit, adulterated, or misbranded drug, 
would you not welcome that authority?
    Dr. Dunham. Yes, I would.
    Mr. Buyer. All right. Thank you.
    Mr. Chairman, here is my question to you. I think we have 
an opportunity here. As Mr. Matheson and I are working with you 
and Chairman Dingell on the food and drug safety side of the 
bill, not only creating electronic pedigree, but one of the 
provisions for which you have also agreed is about giving the 
authority to FDA to destroy these misbranded, adulterated, or 
counterfeit drugs. It is easier for us to put that provision in 
this bill with regard to animals rather than in the other drug 
and safety bill expanding that and say well, we want to include 
animals. See what I am saying? We have two different 
provisions, one dealing with human consumption on food and 
human use on drugs. Let us leave those provisions to apply to 
humans. This is our opportunity to take that provision and 
leave it in the animal bill.
    Mr. Pallone. I think I followed you, and I think we will 
look into it. I don't want to prejudge it in any way but we 
will certainly look into it.
    Mr. Buyer. I just think we have an opportunity. We have got 
something that is moving. Earlier when I had proposed this when 
we were doing the reauthorization of PDUFA, Chairman Dingell 
said whoa, Steve, hold off, we are going to do a food and drug 
safety bill, and that is when Mr. Matheson and I began to work 
together on building an electronic pedigree bill that 
incorporates what the Commissioner was asking for, and so as we 
are working cooperatively on that side of the bill to deal with 
human consumption and medications, I just once again think it 
makes a lot of sense that we work with you and I will work with 
Mr. Matheson, that this could be included perhaps in your own 
manager's amendment that we take care of this issue.
    Now, as the lady from the FDA just testified, well, we are 
not seeing that as much, my sensing would be that if people are 
beginning to drive toward generics because of costs, it is only 
a matter of time before the criminal syndicates then move into 
this economic space because it is highly lucrative, and that is 
where they are moving. So let us give them the tools to be able 
to combat this before the syndicates can move into the space 
would be my argument, and I would like to work with the ranking 
member and the chairman to do just that. And Mr. Matheson, you 
and I have not had an opportunity to discuss this. This just 
came up, but I think this is one that only makes sense. 
Building a consensus on how to dance. I yield back.
    Mr. Pallone. Let me just explain to you. I think you all 
understand what we have before us are two drafts based on what 
the Administration and the industry agreed to. Obviously the 
purpose of the hearing today is to entertain any other ideas 
either for or against that, so this is certainly something that 
we will look into without prejudging whether we would 
definitely do it. But the whole idea of today's hearing is to 
get these kinds of ideas. So thank you.
    The gentleman from Utah.
    Mr. Matheson. Thank you, Mr. Chairman, and thank you, Mr. 
Buyer, for raising that issue, by the way.
    Dr. Dunham, I wanted to ask you a couple of questions about 
antibiotics, if I could. The World Health Organization has 
established a measurement for antibiotic usage data collection 
called Defined Daily Doses, and Europe has mandatory reporting 
of the consumption data collection using this measure and it is 
my understanding that it has enabled comparisons that we are 
unable to perform right now in the United States. Does the FDA 
require manufacturers to submit data in this format or some 
other comparable format using a uniform measurement?
    Dr. Dunham. At the moment, we do receive the quantity that 
they produce on anniversary of the approval. We receive that 
information from them.
    Mr. Matheson. Does the information you receive help you in 
terms of having a way to better understand patient safety, in 
this case, animal safety? I mean, is the data you are getting 
comparable to what the Europeans ask for as mandatory reporting 
data? I didn't think it was. That is why I am asking.
    Dr. Dunham. Well, we have adverse drug reporting that we 
will look at on any individual drug that has been approved. We 
have that system that is all part of our Federal Food, Drug, 
and Cosmetic Act.
    Mr. Matheson. Can you tell me the percentage of antibiotic 
drugs sales that are for humans versus animals?
    Dr. Dunham. I cannot but I could certainly look into that 
and get you some information, sir.
    Mr. Matheson. Do you know whether the antibiotics that are 
used to treat sick animals or animals exposed to disease or--
let me rephrase this. Are antibiotics used to treat sick 
animals or animals exposed to disease or for other purposes 
such as growth promotion and/or disease prevention?
    Dr. Dunham. There are products on the market that are 
approved for growth promotion and feed efficiency and then they 
are also there to treat disease.
    Mr. Matheson. Does FDA maintain a database of animal 
antibiotic use data?
    Dr. Dunham. We again would receive the information as far 
as quantities and any adverse reaction to those drugs.
    Mr. Matheson. OK. Mr. Chairman, that is all I have to ask. 
I will yield back.
    Mr. Pallone. The gentleman from Pennsylvania, Mr. Murphy.
    Mr. Murphy. Thank you, Mr. Chairman.
    Just a couple quick questions on some issues. I am 
concerned about the timing of this bill. Before, you were asked 
about some impacts it would have in terms of layoff notices, 
you commented on that. I am concerned about the clinical impact 
of any delays here. Does current status of this or in any 
additions that would be coming up in this changed legislation 
impact you? So for example, would the delays hold up any 
ability to handle any improvements or modernizations in what 
you do now?
    Dr. Dunham. Yes, it would, because of the advances we have 
been looking for, and a specific example would be if we wanted 
to move forward with the electronic era, it would be impacted 
by this as well. But more importantly, the biggest impact by 
far is going to be the lack of the scientific technical 
expertise and talent that we need to continue to do the reviews 
and that is going to stall and we are going to have a delay 
again on having the review to enable safe products to be 
approved and be used to help both protect companion animals and 
food animals.
    Mr. Murphy. Would it then negatively impact on your ability 
to enforce new regulations or, more specifically and more 
concerning, to respond to any emergencies?
    Dr. Dunham. Overall, whenever we do receive anything like 
an emergency reaction, we would have the staff to respond to 
that. The biggest impact is going to be again the review of any 
new products coming through that we would like very much to 
have come through for approval and be on the market. That would 
be delayed.
    Mr. Murphy. I see. And just another question I thought of 
while Mr. Buyer was raising his questions too. With regard to 
drugs that are used both for animals and for humans, so similar 
ones or identical ones, and what Mr. Buyer was raising about 
counterfeit or other drugs coming over on black markets, and it 
is an issue we have discussed a number of times in this 
committee, is there jurisdiction now if it is the same drug for 
both animals and human use that if it came through labeled as 
an animal drug but was identical to human, would you have the 
power at this point to take action that he is referring to?
    Dr. Dunham. If we haven't gone through the approval process 
of that drug and it is coming from outside the United States, 
then it is not approved. It has to come through our review 
process. So many times you will have a drug approved in another 
country but you wouldn't be able to import it and use it if it 
hasn't gone through our review process.
    Mr. Murphy. What action would you take if you found it at a 
port?
    Dr. Dunham. Then you would be able to prevent entry coming 
into the port.
    Mr. Murphy. If that drug was approved for human use but not 
animal drug, I mean, does it go--
    Dr. Dunham. Well, once again, if it is not approved, the 
only way that you would be able to possibly have a veterinarian 
use that is if it is an approved drug through FDA. So a human 
approved drug through the FDA procedure, not outside of the 
United States, and only then would a veterinarian be able to 
use that. So even if it is approved in another country, a human 
drug, still coming over here it hasn't gone through our review 
process even on the human side.
    Mr. Murphy. I raise the issue because we hear some people 
trying to use animal drugs because they are less expensive than 
human drugs, but that is a discussion for another hearing 
another day. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Murphy.
    I am going to have a second round because I for one have 
some questions I wanted to ask Dr. Dunham, and this is an area 
that, as I said, we basically took the Administration's 
proposal so we do have some questions.
    Another issue that has been brought to my attention 
regarding antimicrobial resistance is the lack of data that 
exists on how antibiotics are sold and used by ranchers, meat 
producers, farmers, et cetera. As I understand it, currently 
there are no data sources that FDA can draw upon that show the 
total quantity of antibiotics used in animals, the species they 
are used in, the purpose of the use, therapeutic versus 
prophylactic or growth promotion purposes, or the method used 
to deliver the antibiotic. Is that correct, in your opinion?
    Dr. Dunham. We do not have the individual use. We have the 
drug and what it is approved for and only information on 
quantity marketed at the end of the anniversary do we have 
information coming back unless there were some adverse events, 
and then we would have data from that.
    Mr. Pallone. OK. Do you think that it is important for FDA 
in its mission to have access to that additional data, and how 
would that data enable FDA to better track antimicrobial 
resistance or determine any threats to the public health?
    Dr. Dunham. As I said, for that opportunity at the moment, 
what we have, it comes in strictly as quantity marketed, and we 
have been complying with that and using that information but we 
don't have access to anything further.
    Mr. Pallone. Well, do you think it would be burdensome to 
collect this additional data from manufacturers and those 
delivering the antibiotics, what I am suggesting?
    Dr. Dunham. I probably would have to make some inquiries 
and get back to you.
    Mr. Pallone. You can get back to us. Sure. Get back to me 
in writing. I would be very happy with that.
    Dr. Dunham. Thank you.
    Mr. Pallone. I understand that at some point, if Congress 
does not act to reauthorize ADUFA, you would have to issue the 
RIF notices. We dealt with this possibility before, when we 
were dealing with PDUFA and MDUFA. Can you tell me how many 
employees at FDA might be subject to those RIFs, and what is 
the agency's deadline for issuing those notices and whether you 
have any flexibility in determining when the notices will be 
sent out? Because when the agency was able to hold off sending 
out RIF notices when we dealt with PDUFA and MDUFA last year, I 
think what they did is, because they knew the Congress was 
moving to reauthorize in a timely fashion, they had the 
flexibility not to send out the notices. Is that true?
    Dr. Dunham. I would need myself to personally confirm that. 
Otherwise I do know we are required 60 days before that date to 
let the employees know they could undergo a RIF, and that is 
why is so critical that we move this piece of legislation 
forward.
    Mr. Pallone. Do you know how many employees would be 
subject to those notices?
    Dr. Dunham. Approximately 58.
    Mr. Pallone. Fifty-eight. All right. Well, again, get back 
to us on that issue of flexibility, because I know that there 
was some flexibility used with regard to PDUFA and MDUFA 
because they knew that we were moving, and I commit to you that 
obviously the reason we are having this hearing today is 
because we do want to move forward with passing a bill and 
getting it signed into law in a timely fashion.
    And then lastly, in your testimony you note that FDA worked 
and negotiated with industry, both the Animal Health Institute 
and the Generic Animal Drug Alliance, in putting forward the 
ADUFA II and the AGDUFA proposals. Did you also meet with 
consumer groups and incorporate concerns raised by those 
groups? And if so, what changes did you make to incorporate 
consumer concerns?
    Dr. Dunham. With the submitted comments to our documents, 
the majority of the views were supported of the ADUFA and 
AGDUFA proposal, and there were a few that would like us to do 
a little more, like you mentioned, which is to look at aspects 
of do we do enough on antimicrobial resistance, and as we have 
explained to you today, our procedures of the review do 
incorporate looking at issues of antimicrobial resistance 
during the review process. So if anything, it would be a chance 
of where do we do more, and I think we have the capability of 
doing that and incorporating that into our review right now.
    Mr. Pallone. OK. Thank you.
    Any other member want to ask additional questions? Mr. 
Deal.
    Mr. Deal. Thank you. Can you tell us what is the FDA 
approval process if we compare the approval process of 
antibiotics for animals versus the approval process of 
antibiotics for humans? Is it more or less stringent in the 
animal environment?
    Dr. Dunham. If I may, I am going to have Dr. Vaughn go 
through that review process difference between human and 
animal.
    Mr. Deal. My understanding is that there may be a benefit 
analysis in one area versus benefit analysis in the other, but 
I will let you answer.
    Dr. Vaughn. Thank you, Mr. Deal. On the animal drug side, 
our evaluations are for primarily human food safety for the 
products that are derived from those animals and the potential 
transference of any adverse effects either through chemical 
residues or antimicrobial resistance or impact of the drugs on 
human gastrointestinal flora. And so to that end, we are 
looking strictly from a safety standpoint and it is not offset 
by the potential benefit that may be derived from that drug in 
animals.
    Mr. Deal. OK. A related question deals with the definition 
I guess of a term that we often hear used and that is the term 
`therapeutic use' of a drug. Some of these areas I am going to 
list maybe seem simplistic to ask you the question, but do you 
feel that it is appropriate to use antibiotics in animals for 
the following purposes, first of all, disease treatment?
    Dr. Vaughn. For disease treatment, yes, sir.
    Mr. Deal. All right. What about for disease prevention?
    Dr. Vaughn. Disease prevention, if I can explain a little 
bit, the way we go about establishing indications on our labels 
for those products that do get approved, we do look at them as 
therapeutic and non-therapeutic, and for the non-therapeutic, 
we would include things for growth promotion, average daily 
gain, feed efficiency, those types of claims, and in those 
cases, for antimicrobials, we have not approved a single 
product for quite a few years. Those applications just are not 
coming to us. And on the therapeutic side, we consider claims 
such as prevention, control, and treatment, and as a 
veterinarian, I can tell you that it is important, depending on 
the disease process, to intervene at the appropriate time to 
have the best effect for that drug, and in some cases, if we 
wait until we actually have clinical signs of disease, that we 
will not be able to get the clinical effect that we need to be 
able to get from these therapeutic products.
    Mr. Deal. So treatment, prevention, and control would all 
be considered appropriate therapeutic usage for antibiotics in 
animals?
    Dr. Vaughn. Yes, sir.
    Mr. Deal. OK. I think that is all. Thank you very much.
    Mr. Pallone. Does any other--yes, Ms. Schakowsky.
    Ms. Schakowsky. I just want to clarify something. You said 
that the FDA, that you have adequate authority to take action 
if you conclude there is a problem with antibiotic resistance, 
but yet in response to the chairman's questions about Baytril, 
you said that it took 5 years to remove that drug and that is 
just one drug. So to me, that doesn't seem--either it doesn't 
seem like adequate authority or that the process is awfully 
slow. So if the FDA knows that a drug is generating antibiotic 
resistance, don't you think 5 years is too long to deal with 
that and that the American people could be at risk for too 
long?
    Dr. Dunham. As I mentioned, the procedure that we use in 
having to go through in this case the review and the court 
hearing, took that long, and we would be happy to work with you 
if you have any additional suggestions or ideas you would like 
to modify to that procedure that currently our jurisdiction 
allows us to go that way. We had that review, and you are 
right, it took 5 years before completion. During that entire 
time, the product would stay on the market. That is currently 
the system that we operate under. So we would be happy to work 
with you.
    Ms. Schakowsky. Well, I would appreciate that because in 
your mind, isn't 5 years an awfully long time if this is 
something that should be off the market?
    Dr. Dunham. And it takes a scientific review and the back-
and-forth before a decision was made.
    Ms. Schakowsky. But don't you think that is an awfully long 
time to--obviously the conclusion was that there is some kind 
of risk. Isn't 5 years too long? Don't we need to work on that, 
in your view, to figure out how to shorten the process?
    Dr. Dunham. We would be very happy to work with you on 
anything that you have that you are willing to provide.
    Ms. Schakowsky. Thank you.
    Mr. Pallone. Mr. Matheson, did you want to ask additional 
questions? OK.
    Thank you, Dr. Dunham and the two that accompany you. I 
think this was very helpful. And as I said, we basically put 
these proposals together based on the Administration's 
agreement and we are just going to follow up after the hearing 
and try to see if we have any additions or suggestions to 
change it, but we do intend to move this in a timely fashion, I 
want to assure you.
    Dr. Dunham. I appreciate that very much. Thank you for the 
opportunity.
    Mr. Pallone. And I will ask the second panel to come 
forward now. Welcome. Let me introduce our second panel. To my 
left is Dr. Richard Carnevale--I don't know if I am pronouncing 
that correctly--who is Vice President of Regulatory, 
Scientific, and International affairs for the Animal Health 
Institute, and next is Ms. Stephanie Batliner, who is 
Chairperson of the Generic Animal Drug Alliance and also 
Director of Pre-market Regulatory Affairs for IVX Animal Health 
Inc. from St. Joseph, Missouri, and then is Robert Martin, who 
is Executive Director of the Pew Commission on Industrial Farm 
Animal Production. We have 5-minute opening statements become 
part of the record, and the Committee may submit additional 
questions in writing for you to answer very quickly after the 
hearing. And so we will start with Dr. Carnevale.

   STATEMENT OF RICHARD CARNEVALE, V.M.D., VICE PRESIDENT OF 
REGULATORY, SCIENTIFIC AND INTERNATIONAL AFFAIRS, ANIMAL HEALTH 
                           INSTITUTE

    Dr. Carnevale. Good morning, Mr. Chairman and members of 
the subcommittee. Thank you very much for holding this hearing 
on this important piece of legislation and for the opportunity 
to speak to you today about the benefits to human and animal 
health from FDA-approved animal medicines.
    I am Dr. Richard Carnevale. I am a veterinarian and a vice 
president with the Animal Health Institute, a trade association 
in Washington that represents companies that make medicines for 
animals. Our companies share a common mission: we contribute to 
public health by protecting animal health. As companion animals 
have become a more important part of our everyday lives, they 
have moved from the backyard into our living rooms and 
bedrooms, increasing their importance to humans and requiring 
attention to their health needs. As medical breakthroughs from 
human medicine are adapted to animal medicine, our pets are 
living longer and healthier lives.
    Animal health products also give veterinarians and 
livestock and poultry producers the necessary tools to protect 
the health and well-being of food-producing animals. A vital 
first step in producing safe meat, milk, and eggs is keeping 
animals healthy. Veterinarians work hard to prevent disease in 
animals. However, it is important for them to have medicines 
available when they are needed to treat a disease they cannot 
prevent.
    The statutory standard for FDA approval of animal drugs 
under the Federal Food, Drug, and Cosmetic Act is the same as 
that for human drugs: they must be proven safe and effective. 
As a result, the animal drug review process looks much like the 
human drug review process. Animal drug companies submit data 
from scientific studies to demonstrate safety, efficacy, and 
the ability to meet the same stringent manufacturing standards. 
It is a costly process, requiring as much as $100 million and 7 
to 10 years to bring an animal drug to market. In the case of 
food animals, the standard to ensure that meat, milk, and eggs 
are safe for human consumption adds an additional set of 
requirements that increases the costs and time to market.
    Animal health companies rely on a rigorous, efficient, 
predictable, and science-based review process at the Food and 
Drug Administration's Center for Veterinary Medicine to provide 
these products to society. That is why our companies supported 
the first authorization of the Animal Drug User Fee Act more 
than 5 years ago. ADUFA I made it possible for our companies to 
bolster funding at CVM so that they could meet performance 
standards to improve the efficiency and predictability of the 
animal drug review process.
    We believe ADUFA I has been successful. The backlog of 
overdue pioneer animal drug submissions that existed at the 
beginning of the program is gone. FDA CVM has successfully met 
the performance timelines established by the legislation. As a 
testament to this progress, 2007 was a banner year for approval 
of new and innovative products with CVM approving nine new 
chemical entities, giving veterinarians new medicines to fight 
diseases and other conditions in animals.
    The legislation before you to reauthorize this successful 
program builds upon this record of achievement. Whereas the 
total cost of ADUFA I came to around $43 million over 5 years, 
sponsors will contribute $98 million to this process over the 
life of the next legislation.
    Many will benefit should Congress approve this bill. FDA 
CVM of course benefits by having additional resources to meet 
its mission of protecting public health. Animal health company 
sponsors benefit from a stable and predictable review process, 
allowing them to make informed decisions about the investment 
risks of research and development dollars. Veterinarians and 
animal owners benefit from having new and innovative medical 
advances to treat, control, and prevent diseases in their 
patients. And finally, consumers benefit from a safer food 
supply as a result of the availability of additional tools to 
keep food animals healthy because healthy animals means 
healthful and safe food. These widespread benefits are why a 
broad coalition of companion animal interests and animal 
agriculture interests support this legislation. Attached to my 
testimony, Mr. Chairman, is a copy of the coalition letter sent 
to you earlier this year from a broad mix of groups asking for 
congressional action on this bill.
    The regulatory process this bill will support is one of the 
most protective of human health in the world. The bill does not 
in any way alter or change the rigorous pre- and post-approval 
animal safety and food safety standards. FDA CVM has a rigorous 
and robust process that takes into account animal and human 
safety throughout the life cycle of the product. We strongly 
believe this bill intensifies CVM's public health focus by 
increasing the resources used to meet that mission. The timely 
availability of animal medicines approved by FDA protects 
public health. A process that is cumbersome and inefficient 
delays those products that are safe and effective and 
encourages the use of untested and illegally compounded 
products in an attempt to address unmet animal health needs. 
The rigorous review process and monitoring systems in place are 
at the heart of a broad system of protections that ensure that 
all medicines including antibiotics are safe for animals and 
humans.
    Mr. Chairman, I have attached more information in my 
written statement on the review process related to 
antimicrobials.
    In summary, Mr. Chairman, CVM has a rigorous science-based 
review process that provides to society the products necessary 
to protect public health by protecting animal health. The 
reauthorization of ADUFA will continue to provide the Agency 
the resources necessary to maintain and improve this process, 
provide new and innovative products to allow our pets to live 
longer and healthier lives, and contribute to food safety and 
food security by keeping food animals healthy. I urge you to 
move a clean ADUFA II bill in a timely manner so this program 
can continue without interruption. Thank you.
    [The prepared statement of Dr. Carnevale follows:]

                     Statement of Richard Carnevale

    Mr. Chairman and members of the Subcommittee:
    Thank you for holding this hearing on this important piece 
of legislation, and for the opportunity to speak to you today 
about the important human and animal health benefits that 
result from using medicines to keep animals healthy.
    I am Dr. Richard Carnevale. I am a veterinarian by training 
with a degree from the University of Pennsylvania and I am here 
today on behalf of the Animal Health Institute, a trade 
association that represents companies that make medicines for 
animals. Our companies share a common mission: we contribute to 
public health by protecting animal health. With food animals in 
more demand from our growing global population, the importance 
of the nexus between animal health and human health has never 
been greater, and is one of the driving forces behind the 
Center for Disease Control's ``One Health'' initiative. Recent 
highly-publicized threats like avian influenza highlight this 
nexus. As companion animals have become a more important part 
of our everyday lives they have moved from the backyard into 
our living rooms and bedrooms, increasing their importance to 
humans and requiring greater attention to their health needs. 
As medical breakthroughs from human medicine are adapted to 
animal medicine, our pets are living longer and healthier 
lives.
    Animal health products also give veterinarians, and 
livestock and poultry producers, the necessary tools to protect 
the health and well-being of food producing animals. More and 
more evidence demonstrates that a vital first step in producing 
safe meat, milk, and eggs is keeping animals healthy. 
Veterinarians work hard to prevent disease in animals, but it 
is important for them to have medicines available when needed 
to treat a disease.
    The statutory standard for FDA approval of animal drugs 
under the Federal Food, Drug, and Cosmetic Act is the same as 
that for human drugs: they must be proven to be safe and 
effective. As a result, the animal drug approval process looks 
much like the human drug approval process: animal drug 
companies submit data packages to demonstrate safety, efficacy, 
and the ability to meet the same stringent FDA manufacturing 
standards. It is a costly process, requiring as much as $100 
million and 7-10 years to bring an animal drug to market. In 
the case of food animals, the standard to ensure that meat, 
milk, and eggs are safe for human consumption adds an 
additional set of requirements that increases the cost and time 
to market.
    The market for animal drugs, however, is nothing like the 
market for human drugs. Our products are used to treat seven 
different major species of animals and many more minor species. 
A blockbuster animal drug will have sales of $100 million, and 
the vast majority of animal health products have a market size 
of around $1 million. There is no Medicare or Medicaid and, 
except in rare cases, no employer supported health insurance--
the cost of animal drugs is borne in full by the animal owner.
    Animal health companies rely on a rigorous, efficient, 
predictable, and science-based review process at the Food and 
Drug Administration's Center for Veterinary Medicine (CVM) to 
provide these products. That's why our companies supported the 
first authorization of the Animal Drug User Fee Act more than 5 
years ago. The Animal Drug User Fee Act of 2003 (ADUFA I) made 
it possible for our companies to bolster funding at CVM so that 
they could meet performance standards to improve the efficiency 
and predictability of the animal drug approval process.
    As a result of an efficient and predictable regulatory 
process, animal health companies can be more confident 
investing research dollars in the United States. According to 
data AHI collects, in 2006 pioneer animal health companies 
invested $663 million in research and development of new and 
innovative products, a seven percent (7%) increase over the 
preceding year.
    We believe ADUFA I has been successful. The backlog of 
overdue pioneer animal drug submissions that existed at the 
beginning of the program is gone. FDA/CVM has successfully met 
the performance goals established by the legislation. 
Timeframes have been uniformly met, restoring predictability to 
the review process. As a testament to this progress, 2007 was a 
banner year for approval of new and innovative products with 
CVM approving nine new chemical entities, giving veterinarians 
new medicines to fight diseases and other conditions in 
animals. Examples include medicine to treat heart failure in 
dogs, control pain and inflammation from osteoarthritis, and to 
treat and prevent motion sickness.
    The legislation before you to reauthorize this successful 
program builds upon this record of achievement. Animal health 
companies approached ADUFA II with the goal of reducing overall 
review times. CVM came to the table with a need for additional 
resources to compensate for the gap between the increased 
employee cost and Congressional appropriations. The end-review 
amendment process established in this agreement will help 
reduce the overall review time by reducing the number of 
submission cycles. The ten agreed upon workshops will help CVM 
and sponsors deal with the complex scientific questions that 
often surround the review of these products.
    Whereas the total cost of ADUFA I came to around $43 
million over 5 years, sponsors will contribute $98 million to 
this process over the life of this legislation. The only change 
in the financial structure is the inflation factor calculated 
annually during the life of ADUFA I has been agreed to and 
built into the annual costs of ADUFA II, giving both sponsors 
and CVM more predictability regarding the program's revenue. 
Many will benefit should Congress approve this legislation:
    1. FDA/CVM benefits by having additional resources to meet 
its mission of protecting public health.
    2. Animal health sponsors benefit from a stable and 
predictable review process, allowing them to make informed 
decisions about the investment risks of research and 
development dollars.
    3. Veterinarians benefit from having new and innovative 
medical advances available to treat, control, and prevent 
diseases in their patients.
    4. Livestock and poultry producers, and the veterinarians 
on whose advice they rely, also have the tools needed to keep 
food animals healthy.
    5. Pet owners benefit by having their animals live longer 
and healthier lives, increasing their enjoyment of these 
companions.
    6. Consumers reap the food safety benefits that come as a 
result of the availability of additional tools to keep food 
animals healthy.These widespread benefits are why a broad 
coalition of companion animal interests and animal agriculture 
interests support this legislation. Attached to my testimony is 
a copy of a coalition letter sent to you earlier this year from 
this broad mix of groups asking for congressional action on 
this bill.

             Protections in Place to Protect Public Health

    We would like to emphasize that the regulatory process this 
bill will support is one of the most protective of human health 
in the world. This bill does not in any way alter or change the 
rigorous pre- and post-approval animal safety and food safety 
standards. FDA/CVM's has a rigorous and robust approval process 
that takes into account safety throughout the lifecycle of the 
product, including safety to the animal, safety to humans, a 
thorough process for measuring the potential transfer of 
antimicrobial resistant bacteria between animals and humans, 
environmental safety, animal handler safety and drug experience 
reporting and adverse reaction evaluation to assess post-market 
safety.
    We strongly believe this bill intensifies CVM's public 
health focus by increasing the resources used to meet that 
mission. The timely availability of animal medicines approved 
by FDA protects public health. A process that is cumbersome and 
inefficient delays those products that are safe and effective 
and encourages the use of untested and illegally compounded 
products in an attempt to address unmet animal health needs. 
These types of treatments can create a health hazard for the 
animals and jeopardize food safety. Increasing agency resources 
and setting achievable timeframes will only help improve the 
agency's ability to meet its high safety standards.
    The rigorous review process and monitoring systems in place 
are at the heart of a broad system of protections that ensure 
that all medicines, including antibiotics, are safe for animals 
and humans. Antibiotics for use in animals must meet all the 
same requirements as antibiotics used in humans, with two 
additional requirements: first, sponsors must show the meat 
from animals in which the product is used is safe for human 
consumption. Second, beginning in 2003, CVM instituted Guidance 
for Industry (GFI) # 152, which outlines a qualitative risk 
assessment process that is applied to all antibiotics approved 
for use in animals. This guidance process is designed to 
measure the risk of antibiotic resistant bacteria being 
transferred from animals to humans if the product is approved. 
Based on this risk, FDA makes decisions to either deny or 
approve the produce with certain restrictions to significantly 
reduce risk. Restrictions can include requiring a veterinary 
prescription, prohibiting extra-label use and prohibiting use 
in certain species. The methodology is very conservative--
meaning it is very difficult to get an antibiotic approved. 
Further, the guidance is sufficiently broad so that if new, 
previously unidentified or undescribed, resistant organisms or 
genes were to become of concern, the Agency can act swiftly to 
take this information into account. The existing guidance 
allows the Agency sufficient flexibility to allocate resources 
appropriately to changing issues of safety related to 
resistance emergence.
    The GFI # 152 process applies not only to new submissions, 
but to all existing products as well. FDA has established a 
priority list for the re-evaluation of all antibiotics 
currently approved and marketed. Most of the drugs on the list 
are antibiotics administered in animal feed for the prevention 
and control of animal diseases or to increased the weight gains 
and improve feed efficiency. The re-review under Guidance 152 
was stimulated by new funding that FDA received and continues 
to receive via annual appropriated money specifically earmarked 
for these reviews. Bear in mind, though, the evaluation of 
these products did not begin with Guidance 152. In response to 
concerns raised some 30 years ago, the Bureau of Veterinary 
Medicine in FDA, in the 1970s, required sponsors of these 
products to conduct tests to determine the potential for 
resistance to be selected in the animals and to be transferred 
to bacteria that could cause human disease. While the standards 
and science may have changed over the years, the safety of 
these products has been an ongoing exercise at FDA. Moreover, 
published quantitative risk assessments performed by both the 
agency and individual product sponsors have generally affirmed 
that the risks to human health from these antibiotics in animal 
feed under approved conditions of use are quite low.
    We fully support efforts by the agency to continue to 
evaluate the safety of these products using all available 
scientific data under a sound risk assessment approach in order 
the determine the true risk to public health and guide 
appropriate risk management interventions to protect public 
health.
    In addition to the rigorous review process and the 
additional public and private risk assessments that have been 
conducted, there are other post-approval layers of protection 
to ensure the safe use of antibiotics.

                          Monitoring programs

    USDA's Food Safety and Inspection Service monitor meat 
samples for the presence of antibiotic residues as a check on 
the observance of the withdrawal times set by FDA. It is very 
uncommon for FSIS to find a violative residue, an indication 
that products are being used according to label directions.
    The National Antimicrobial Resistance Monitoring System 
(NARMS) is a multi-agency program coordinated by FDA to monitor 
the possible emergence of antibiotic resistant bacteria and 
allow for implementation of management and control measures if 
needed. The three agencies involved are:
     The USDA Agricultural Research Service (ARS), 
which collects samples from slaughter and processing facilities 
to monitor for antibiotic resistance trends in farm animals;
     The FDA, which monitors for resistant bacteria in 
retail meats;
     The Centers for Disease Control and Prevention 
(CDC), which collects isolates, or samples, from public health 
laboratories to monitor for the emergence of antibiotic 
resistant food-borne pathogens in humans.
    To date, the program has produced 7 years of data 
representing over 50,000 animals and 11,000 human Salmonella 
isolates. Most bacterial species isolated from humans and 
tested for resistance against drug classes potentially related 
to animal usage have shown stable or declining resistance 
patterns. Most of the multiple-drug resistance types, such as 
Salmonella typhimurium DT104 show stable or declining 
prevalence in both food animals and humans since 1996, 
according to an expert report issued in 2006 by the Institute 
of Food Technologists entitled ``Antimicrobial Resistance: 
Implications for the Food System.''

                        Judicious use principles

    Responsible, or judicious, use programs that are specific 
to different livestock species give veterinarians and producers 
specific guidelines to help them safely and properly use of 
antibiotics in their health management systems. Generally, 
these guidelines have been prepared collaboratively by FDA, 
CDC, and veterinary groups.
    There remains a great deal of confusion about how 
antibiotics are used in animal agriculture. CVM approves these 
products for four specific purposes:
    1. Disease treatment
    2. Disease prevention
    3. Disease control
    4. Growth promotion, as measured by the amount of feed 
needed to produce a pound of animal weight or increased rate of 
weight gain.
    Many assume in-feed uses equate to growth promotion, but 
this confuses the use with the route of administration. In 
fact, any of the four uses can be administered via feed, as 
that is the only practical way to administer medication to 
large flocks or herds. In most cases, a veterinarian is 
involved in this process, recommending feed that is 
specifically formulated for the health management system used 
for the flock or herd.
    Perhaps the most discussed, and most misunderstood use, is 
the growth promotion use. The Animal Health Institute collects 
annual data from its members on the amount of antibiotics sold 
for use in animals. As part of that survey, we ask members to 
estimate the amount sold that is used for growth promotion. In 
2006, that amount was 4.6 percent of the total. Each year we 
publically release the results of this survey, and a copy of 
the 2006 results is attached to my testimony.
    There is one other note about growth promotion: when the 
European Union phased out the use of antibiotics for growth 
promotion, according to data from the Danish government, animal 
death and disease rose, requiring a greater amount of 
antibiotics to be used to treat disease. Clearly, as has been 
discussed in many peer-reviewed articles, this use also had the 
effect of suppressing disease that did not necessarily produce 
symptoms.
    Mr. Chairman, CVM has a rigorous, science-based approval 
process that provides to the American public the products 
necessary to protect public health by protecting animal health. 
Every year scientists uncover new diseases in animals, some of 
which potentially pose a threat to human health. As more 
animals are raised to feed the planet and as animals are reared 
closer to people, we will continue to need new medicines to 
protect animal and human health.
    The reauthorization of ADUFA will continue to provide the 
agency the resources necessary to maintain and improve this 
approval process, provide new and innovative products to allow 
our pets to live longer and healthier lives and contribute to 
food safety by keeping food animals healthy. I urge you to move 
a clean ADUFA bill in a timely manner so this program can 
continue without interruption.
                              ----------                              

    Mr. Pallone. Thank you, Doctor.
    Ms. Batliner.

 STATEMENT OF STEPHANIE BATLINER, CHAIRPERSON, GENERIC ANIMAL 
  DRUG ALLIANCE; DIRECTOR, PRE-MARKET REGULATORY AFFAIRS, IVX 
                      ANIMAL HEALTH, INC.

    Ms. Batliner. Good morning. I appreciate the opportunity to 
be here this morning. My name is Stephanie Batliner and I am 
here in my capacity as the chairperson of the Generic Animal 
Alliance. The Generic Animal Drug Alliance is an independent 
professional trade organization that represents the interests 
of sponsors, manufacturers and distributors of generic animal 
drugs before regulatory agencies and Congress.
    FDA approved and regulated generic animal drugs are 
essential to both pet owners and food producers to reduce costs 
and increase accessibility to important pharmaceuticals. 
Through access to and affordability of therapeutic 
pharmaceuticals, the generic animal health industry aids in the 
protection of our Nation's food supply and the safety of our 
Nation's pet owners. It is critical to the success of the 
animal health generic drug industry to have a predictable and 
efficient CVM review process for the approval of abbreviated 
new animal drug applications, or ANADAs. The current review 
cycle time frames, as we have discussed earlier this morning, 
are an untenable situation both for industry and for CVM. The 
statutory review time frame for an ANADA is 180 days. 
Currently, review times for ANADAs are over 600 days and 
climbing, and this is far beyond anything that is reasonable 
and practical. It is important to point out that often an 
animal drug application will go through multiple cycles of 
review so right now it is pretty well accepted that it will 
take 4 or 5 years from first submission to time of approval for 
a generic animal drug.
    Our support for a user fee program stems from our 
experience in witnessing the successes accomplished under 
ADUFA. The performance goals were consistently met by the 
Center for Veterinary Medicine resulting in shortened 
regulatory review cycle time frames. During our discussions 
with CVM on how to approach the problem of generic review 
times, we were able to define boundaries necessitated by the 
economics of the generic animal drug industry and still arrive 
at an outcome that ensures a stable, reliable revenue source to 
support the review process at CVM in a manner not currently met 
by appropriated funds.
    The legislative language and associated performance goals 
contained within the proposal for AGDUFA are very similar to 
that enacted with ADUFA 2003. There are, however, several 
important differences between the two programs. In AGDUFA, 
participants will not pay an establishment fee. The sponsor fee 
prescribed within AGDUFA is tiered to provide relief to 
sponsors who hold fewer ANADA approvals and the performance 
goals for AGDUFA do not return generic application review times 
to statutory requirements. Rather, 270 days is the highest 
level of performance that the generic animal drug industry 
could afford. While we are pleased with the overall content of 
the legislative proposal, additional funding requirements for 
CVM became apparent during our negotiations. The purpose of 
AGDUFA is to supplement the resources used specifically for 
review of applications and administration of the regulatory 
process, not to alter the existing stringent requirements for 
approval of a generic animal drug.
    Generic Animal Drug Alliance believes that it is important 
also to express our support for the reauthorization of ADUFA. 
Many of our member companies do participate in user fee 
activities on the pioneer side and as such have been 
contributing user fees over this past 5 years of the first 
round of ADUFA.
    In summary, GADA supports the legislation to authorize the 
Animal Generic Drug User Fee Act. The current review process is 
untenable for sponsors of legal, safe and effective products 
and is favorable to entities who would promote untested and 
illegally compounded products to fulfill unmet animal health 
needs. Access to generic animal drugs that have been approved 
and are regulated by CVM increases the public health through 
improved quality of life for companion animals and increased 
safety of the food supply. Thank you.
    [The prepared statement of Ms. Batliner follows:]

   [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Mr. Pallone. Thank you.
    Mr. Martin.

STATEMENT OF ROBERT MARTIN, EXECUTIVE DIRECTOR, PEW COMMISSION 
              ON INDUSTRIAL FARM ANIMAL PRODUCTION

    Mr. Martin. Good morning, Mr. Chairman and members of the 
Healthcare Subcommittee. My name is Robert Martin and I am the 
executive director of the Pew Commission on Industrial Farm 
Animal Production and I very much appreciate the opportunity to 
appear here today at this important hearing.
    The Pew Commission on Industrial Farm Animal Production is 
an independent commission funded by a grant from the Pew 
Charitable Trust to Johns Hopkins Bloomberg School of Public 
Health to investigate the problems associated with industrial 
farm animal production operations and to make consensus 
recommendations to solve them. Fifteen commissioners with 
diverse backgrounds began meeting in early 2006 to start their 
evidence-based review of the problems caused by industrial farm 
animal production.
    Over the last 2 years the Commission conducted 11 meetings 
and received thousands of pages of material submitted by a wide 
range of stakeholders and interested parties. Two public 
hearings were held to hear concerns from the generic public 
with IFAP issues. Eight technical reports were commissioned 
from leading academics to provide information on the 
Commission's areas of interest, and the commissioners 
themselves brought expertise in animal agriculture, public 
health, animal health, medicine, ethics and rural sociology to 
our discussion. In addition, the Commission visited several 
IFAP production facilities. We visited broiler production, 
swine production, dairy production, egg production as well as a 
large cattle feedlot.
    The Commission's findings make clear that the present 
system of producing food animals in the United States is not 
sustainable and presents an unacceptable level of risk to 
public health, damage to the environment as well as unnecessary 
harm to the animals we raise for food. In addition, the current 
system of industrial food animal production is detrimental to 
rural communities.
    The Commission released its full report on April 29, 2008, 
that included 24 primary recommendations. The Commission was so 
concerned about the indiscriminate use of antibiotics in food 
animal production and the potential threat that causes to 
public health that five of those main recommendations deal with 
antibiotic use, and those five general recommendations are, 
number one, restrict the use of antimicrobials in food animal 
production to reduce the risk of antimicrobial resistance to 
medically important antibiotics; number two, clarify 
antimicrobial definitions to provide clear estimates of use and 
facilitate clear policies on antimicrobial use, improve 
monitoring and reporting of antimicrobial use in food animal 
production in order to accurately assess the quantity and 
methods of antimicrobial use in animal agriculture, improve 
monitoring and surveillance of antimicrobial resistance in the 
food supply, the environment, animal health and the human 
population in order to refine our knowledge of antimicrobial 
resistance and its impact on human health, and five, to 
increase veterinary oversight of all antimicrobial use in food 
animal production to prevent this overuse.
    One of the things that I think shocked the Commission more 
than anything was when we started looking at these issues and 
in particular antimicrobial use that we couldn't get a 
definitive amount that is used in food animal production. The 
range is 30 percent on the low side to 70 percent on the high 
side but they were quite concerned that no entity is compiling 
the amount used and how it is used and the types used, and even 
at the low end, 30 percent, that is a significant amount of 
antibiotics being fed to animals indiscriminately and on the 
high end, it would be quite alarming. I think that they were 
also very concerned about the lack of post-market activities in 
food animal use and hence the development of several of our 
recommendations on monitoring and assessing the impact.
    With that, again, thank you for the opportunity to appear 
and I will be happy to answer any questions.
    [The prepared statement of Mr. Martin follows:]

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    Mr. Pallone. Thank you, Mr. Martin. Thank all of you. We 
will take some questions now and I will start with myself.
    I did want to start with Mr. Martin. In your testimony, you 
discussed the need to pass legislation such as the Preservation 
of Antibiotics for Medical Treatment Act of 2007 as introduced 
by Representative Slaughter. My understanding of this bill is 
that it shifts the burden of proving that the use of an 
antibiotic drug in food animals is no longer safe for human 
health from the FDA to the manufacturer of that product. Is 
that correct?
    Mr. Martin. Yes.
    Mr. Pallone. Can you tell us why you think it is important 
for the manufacturer to bear that burden as opposed to the FDA?
    Mr. Martin. Well, I think the manufacturer bears some 
responsibility in the sales of the product and I think we 
looked at frankly a lack of resources at the FDA.
    Mr. Pallone. Now, can you talk about the differences 
between the provisions in that bill, PAMTA, I guess it is, and 
the Guidance for Industry Number 152 that was issued by the 
FDA?
    Mr. Martin. I am not an expert on PAMTA or Guidance 152.
    Mr. Pallone. So you don't want to comment. All right. Do 
you want to get back to us?
    Mr. Martin. I will.
    Mr. Pallone. All right. Get back to us in writing. That 
would be fine. Now, another question. One thing that the ADUFA 
and AGDUFA proposals have been criticized for is their lack of 
any post-market safety provisions. Specifically, there is no 
authorization for the use of ADUFA funds for post-market safety 
activities. We spent a lot of time talking about antimicrobial 
resistance today and I think that fits in this category of 
post-market safety as well as pre-market safety but I am 
wondering if there are any other types of post-market activity 
that you think the committee should consider authorizing for 
use of ADUFA funds. I will give you an example. Under PADUFA 
from last year, we allowed monies to go for collecting, 
developing, and reviewing safety information on the drugs 
including adverse event reporting, and we expanded the list of 
authorities that FDA could use PADUFA feeds for and expanded 
the amount of user fees collected to fund those authorities. 
What is your opinion?
    Mr. Martin. I think that would be appropriate. The Pew 
Commission did not actually review that specifically but given 
our position, I think that would be appropriate. I think that a 
portion of the fees could go to activities like reviewing 
animal antibiotics already on the market under FDA's new 
standards for pre-market approval and collecting data on how it 
is used in animals and expanding the national antimicrobial 
resistance surveillance system.
    Mr. Pallone. OK. Do you want get back to us with a list of 
authorities you think that the FDA should have to improve post-
market safety?
    Mr. Martin. Sure.
    Mr. Pallone. And I guess also how much funding you think we 
would need to expand those authorities. I will ask you another 
question, Mr. Martin, and then I will move to Ms. Batliner. One 
complaint I have heard about ADUFA is that there been a shift 
in resources away from other missions so that CVM could meet 
the requirements of ADUFA. Are you aware of that criticism and 
could you comment on what functions might not be adequately 
funded at FDA due to ADUFA funding?
    Mr. Martin. We didn't really get into that in any detail, 
and our recommendations and positions are consensus, so I 
really can't stray too far from what has been presented.
    Mr. Pallone. All right. Ms. Batliner, do you care to 
comment on that? Do you think that ADUFA funding has had any 
impact on shifting resources away from the review of generic 
animal drug submissions to meet timeliness goals of ADUFA?
    Ms. Batliner. Well, certainly the generic application 
review times have grown during the time that ADUFA was in 
effect. My understanding from discussions with the Center for 
Veterinary Medicine is that in 2003, the appropriated monies 
devoted to generic application review were locked in place, so 
to speak. Since we as an industry were not supplying user fees, 
we continued to receive the amount of appropriated funds for 
generic review that we had received in 2003. In that time, the 
workload has increased dramatically, so I do not believe that 
they have shifted resources but rather limited the resources 
that were engaged in generic application review.
    Mr. Pallone. Now, is that the only thing that has led to 
the increase in the review times or are there other things you 
want to mention?
    Ms. Batliner. I really believe that is a resource issue at 
CVM and the number of reviewers that they are allocating for 
generic application review.
    Mr. Pallone. OK. Now, I understand that the 
Administration's proposal would bring enough fees to improve 
the review time for the generic animal submissions but as you 
mentioned, FDA still would not be able to complete reviews by 
the statutory deadline, 180 days. Do you want to give us a 
sense of how much more money it would have taken in terms of 
collecting additional fees to reach that goal?
    Ms. Batliner. I believe $47 million was the figure that we 
were provided when we began discussions with CVM about 
returning to statutory review times.
    Mr. Pallone. Forty-seven million dollars?
    Ms. Batliner. I believe so.
    Mr. Pallone. All right. Thank you very much.
    Mr. Deal.
    Mr. Deal. Thank you. Mr. Martin, you heard my questioning 
of the prior panel about this question of what is an 
appropriate use of antibiotics, antimicrobials with regard to 
therapeutic versus non-therapeutic usage, and I think the first 
panel agreed that appropriate therapeutic usage of these drugs 
would be for disease prevention, disease control and disease 
treatment. Do you agree with that?
    Mr. Martin. Well, the Commission defines therapeutic use as 
appropriate in food animals with diagnosed microbial disease. 
So ours is narrower than--
    Mr. Deal. So you would be only at the point that they have 
been diagnosed with something, not for prevention of something?
    Mr. Martin. Right.
    Mr. Deal. Why would you think that it would be humane or 
even in the public health if an animal is going to be subject 
to a disease to use an antibiotic to prevent that from 
occurring?
    Mr. Martin. Well, we do have a definition of prophylactic 
use that states that they can be used in healthy animals in 
advance of an expected exposure to an infectious agent or after 
such exposure but before a laboratory confirmed clinical 
disease is determined by a licensed professional. So we do have 
a provision for prophylactic.
    Mr. Deal. It is still a little bit narrower than the 
general prevention, right?
    Mr. Martin. Right.
    Mr. Deal. Let me ask you this. As we know, we think we are 
the food basket of the world but we still import a lot of food 
products into this country. Did your commission undertake to 
determine what foreign counties that are importing food into 
this country, meat products in particular, for example, how 
their use of antibiotics compared or contrasted with the usage 
here in the United States?
    Mr. Martin. No, we did not. I mean, we looked at some 
developments in Europe for the impact on the pool of resistant 
bacteria but we did not have the time to do an in-depth 
analysis.
    Mr. Deal. Probably at some point that is something somebody 
needs to take a look at, wouldn't you think?
    Mr. Martin. Yes.
    Mr. Deal. Because we are in a competitive world market and 
what other countries do, especially if they import in our 
country, we need to be at least on hopefully a proverbial level 
playing field in a competitive environment. Now, back to the 
definition of therapeutic versus non-therapeutic. The non-
therapeutic usage would be what?
    Mr. Martin. We define that as use for additive or for 
growth promotion, feed efficiency, weight gain, routine disease 
prevention in the absence of documented exposure or other 
routine purposes in animal production. So I think our linchpin 
is documented exposure.
    Mr. Deal. So where does the Pew Commission come down with 
regard to use of antimicrobials for those purposes, the non-
therapeutic purposes?
    Mr. Martin. Well, we would like to phase out and ban the 
use of antimicrobials for non-therapeutic uses.
    Mr. Deal. OK. Just in general knowledge without having done 
an in-depth survey, I think you know that the usage for those 
non-therapeutic usages is pretty universal around the world, 
that they are being used for those non-therapeutic purposes, 
are you not?
    Mr. Martin. Well, I think there have been some restrictions 
recently in Europe since 1996--well, I think 1989 in Sweden, 
1986 in Denmark and now I think the E.U. is moving--
    Mr. Deal. That is the growth hormones, et cetera?
    Mr. Martin. Yes. Well, and non-therapeutic use of 
antimicrobials.
    Mr. Deal. All right. Thank you all.
    Mr. Pallone. The gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. To follow up on that, I was looking at the 
other countries that have banned. It was Sweden in 1986, 
Denmark it says in 1998, and the European Union in 2006, but I 
was interested to see that the report also determined that the 
overall health of the animals, mainly swine, was not affected 
and the cost to producers was not significant, and I imagine 
that one of the arguments that would be used in favor of 
continuing the use as we do for these antibiotics would be the 
cost. So your report found otherwise. Can you expand on that at 
all?
    Mr. Martin. Yes. We looked at, I think, the data in Denmark 
and it showed that therapeutic use went up for a short time but 
once the instituted better animal husbandry practices, 
spreading the animals out and cleaning their stalls more 
frequently, that the therapeutic use went down. We have done an 
economic analysis, one of our technical reports, that compares 
that industrial farm model that is common today with gestation 
crates and liquid waste management systems compared to a, it is 
another intensive-type operation called a hoop barn for swine, 
that requires a little more interaction by the managers. They 
have to be a little more involved with the animals instead of 
them being housed in rows in gestation crates, and we have 
actually found that the cost when you account for the 
environmental and health impacts of the current system, 
internalize those costs instead of externalizing that and 
compare them to the hoop barn system, that the hoop barn 
systems are actually cheaper.
    Ms. Schakowsky. I wonder if--pronounce your name again for 
me, Doctor.
    Dr. Carnevale. Carnevale.
    Ms. Schakowsky. I wonder if you wanted to comment on that. 
It seems as if, if in fact the animals are as healthy and the 
costs may even be somewhat less and therefore the impact on 
public health would be improved, that this is kind of a no-
brainer. Why wouldn't we ban the use for, we are saying for 
non-therapeutic use? Why wouldn't we?
    Dr. Carnevale. Well, let me comment on that. First of all, 
the AVMA, American Veterinary Medical Association, defines 
therapeutic use as prevention, treatment, and control, and in 
fact, so do other international organizations like Codex and 
the World Health Organization. They also define those uses as 
therapeutic, to get back to Mr. Deal's question. With regard to 
the information we have from Europe, there was a study in 
Denmark by the World Health Organization called the Fullam 
Report and in fact it is not true that there was no impact to 
animal health. There was. There was a tremendous loss of baby 
pigs when they withdrew those antimicrobials.
    Ms. Schakowsky. Well, Mr. Martin acknowledged that at first 
there was some effect but that with a change in various 
procedures, that that is no longer true.
    Dr. Carnevale. Well, what happened is, they had to increase 
their use of therapeutic antibiotics, and in fact, that use 
continues to go up. Now, the overall use of antimicrobials is 
down but the other important thing in that report that I want 
to emphasize is the experts in that report concluded that any 
human health impact before or after the ban was negligible. So 
in fact, there is not really good enough that the ban in 
Denmark or the European Union has had any impact on human 
health at all.
    Ms. Schakowsky. Well, do you think the use of antibiotics 
in general does have an effect? I mean, what is your conclusion 
on human health?
    Dr. Carnevale. Yes, certainly the use of antimicrobials in 
humans and animals can lead to resistance, absolutely. There is 
no question about that. That is why we need to use them 
prudently and that is why the AVMA has adopted a set of prudent 
use guidelines--
    Ms. Schakowsky. But why would you conclude that if the 
decrease in use has had a negligible effect?
    Dr. Carnevale. Why I would conclude that?
    Ms. Schakowsky. Why would you conclude that it actually 
does have an impact, significant impact on human health if the 
reduction in its use doesn't--you are arguing two things, that 
the reduction didn't really matter but that in fact reducing 
the use does matter.
    Dr. Carnevale. Well, I am saying that uncontrolled use 
could have adverse consequences. We do not have uncontrolled 
use in the United States.
    Ms. Schakowsky. Do we have a good percentage of how many of 
our food animals are treated with antibiotics?
    Dr. Carnevale. I do not know the percentage. I do know--
    Ms. Schakowsky. Does anybody? No, I don't mean just on this 
panel. Is it known? Is it documented? Do we know that? Because 
didn't you say, Mr. Martin, that it was hard to figure out if 
it was 30 percent or 70 percent?
    Mr. Martin. Yes, we couldn't find anybody that was 
documenting it.
    Dr. Carnevale. There are data, I recall, from USDA called 
the National Animal Health Monitoring System, and they have 
recorded periodically in doing studies on various classes of 
livestock and poultry, they have concluded how much use. I 
don't have those numbers available to me but I think they are 
in those reports.
    Ms. Schakowsky. I see I have gone over time. Thank you, Mr. 
Chairman.
    Mr. Pallone. I don't have any additional questions so if 
any member wants to continue. Go ahead, Mr. Matheson.
    Mr. Matheson. Thank you. It sort of plays again on what my 
colleague was just asking, and on the first panel I was asking 
about use data and the fact we don't have enough use data, so I 
think you are on the right track.
    Mr. Martin, I wanted to just ask you a couple of quick 
questions. By way of introduction, I and a number of my 
colleagues on this committee have introduced the Strategies to 
Address the Antimicrobial Resistance Act. We call it the STAAR 
Act. It is a bill that provides a multi-pronged approach to 
address the threat of antibiotic resistance including enhanced 
research, surveillance, and data collection, and specifically, 
my bill requires animal and human antibiotic drug manufacturers 
to provide the FDA with human and animal antibiotic use data. 
In the case of animals, the information would be submitted on a 
calendar-year basis by volume separately for use by species. In 
summaries the data would be publicly available but the bill 
would protect confidential business information. A few years 
ago, the Government Accountability Office looked at the 
possible impact on humans of animal antibiotic use. 
Specifically the GAO stated that Federal agencies do not 
collect the critical data on antibiotic use in animals that 
they need to support research on the human health risk. So that 
kind of led into my question, which is, do you believe we need 
this type of data to better determine any relationship between 
use in animals and antibiotic resistance in humans?
    Mr. Martin. Yes, and the Commission was aware of your 
legislation and the companion bill in the Senate by I believe 
Senators Brown and Hatch.
    Mr. Matheson. Yes.
    Mr. Martin. There is a similar bill there.
    Mr. Matheson. It seems to me it is another piece of the 
puzzle to help determine whatever public policy strategies we 
need to address antibiotic resistance.
    Mr. Martin. Yes.
    Mr. Matheson. It is my understanding that European 
countries have purchased data from IMS Health Global Services 
to support their epidemiological research. Are you familiar 
with this data?
    Mr. Martin. No, I am not.
    Mr. Matheson. I am glad you mentioned there is a companion 
bill in the Senate as well, and I think it helps address some 
of the issues we raised today.
    Mr. Chairman, that concludes my line of questioning. I will 
yield back.
    Mr. Pallone. I am going to go around again if anybody has 
additional questions. I don't, but Mr. Deal and then Ms. 
Schakowsky if you do.
    Mr. Deal. I just have a couple of quick ones, and Dr. 
Carnevale, I would address them to you. What safeguards does 
the Animal Health Institute have in place to prevent antibiotic 
resistance? Do you have any safeguards that your organization 
has put in place?
    Dr. Carnevale. Well, the Animal Health Institute is a trade 
association. We don't have any specific safeguards. Our 
companies certainly do. They have good stewardship programs on 
their individual products. They have field personnel out there 
to make sure that producers and veterinarians know how these 
drugs should be used, know how they should be used according to 
label and to reduce the presence of antibiotic resistance. I 
also mentioned before that the American Veterinary Medical 
Association has gotten together their specialty groups that 
deal with each class of animals, whether it be poultry, 
livestock and even companion animals, as a matter of fact, and 
they put together guidelines for veterinarians to follow on how 
to appropriately use antibiotics to reduce the chance of 
resistance development.
    Mr. Deal. And within the agriculture community itself, are 
you aware of policies that they put in place to try to reduce 
the use of these antibiotics and especially as they relate to 
antibiotic resistance in humans?
    Dr. Carnevale. Yes. As a matter of fact, I can cite one, 
and that is the Pork Quality Assurance Program, which in fact 
they have worked very hard, the Pork Board has worked very hard 
to get their producers to know how to use antibiotics 
appropriately, know how to control diseases, and that is an 
integrated program that they have in operation which at the 
heart of it involves the use of antimicrobials in an 
appropriate fashion. So I think that is a model program.
    Mr. Deal. Thank you. That is all.
    Mr. Pallone. Anyone else? Ms. Schakowsky?
    Ms. Schakowsky. Let me just ask Mr. Martin, if you could 
just elaborate a little bit exactly how antibiotic resistance 
is generated as a result of using antibiotics in animals 
because some have argued that we actually can't know whether 
antibiotic resistance is a result of the use of antibiotics in 
animals as opposed to humans, and I wondered if you could 
respond to that, and Ms. Batliner, if you wanted to say 
something, go ahead.
    Mr. Martin. Dr. Carnevale even said that all antibiotic use 
leads to resistance, some resistance, and I think it gets a 
little bit back to the data collection issue. If 30 percent of 
the antibiotics used in the country are fed to animals for 
growth promotion and non-therapeutic ways, that by logic has to 
add to the antimicrobial resistance pool in the environment. If 
it is 70 percent, it is quite a problem. We had two physicians 
on the Commission and one veterinarian, and their beliefs are 
that once it is in the environment, that--and it is not their 
beliefs, their training and learning. You know, once it is 
excreted out of the animal and goes, in the case of a swine 
facility, flushed into an open cesspool where it is collected 
for a few weeks and then sprayed on the ground without 
treatment, that is the method of disposal of swine waste, that 
gets into the groundwater. Johns Hopkins is doing a study now, 
the School of Public Health is doing a study now. They are 
looking into antibiotic-resistant bacteria that were found in 
dolphins off Woods Hole in Massachusetts that has been linked 
back to effluents in North Carolina, coastal effluents in North 
Carolina. So the transmission--I mean, bacteria are like any 
living thing. When they are put under stress, they adapt and 
change to survive, and bacteria uniquely can transfer their 
resistance and antimicrobial-resistant bacteria can transfer 
that resistance to a bacteria that has never been exposed.
    Ms. Schakowsky. Is it not a matter of eating the treated 
meat?
    Mr. Martin. No, that is not the real exposure risk.
    Ms. Schakowsky. That is not the exposure risk. OK.
    Mr. Martin. That is the Commission's viewpoint. It is in 
the environment, and workers that are in industrial farm animal 
production facilities for prolonged periods can carry that 
resistant bacteria out into the community. In traditional 
farming systems, the farmer may be interacting with the animals 
for several short periods of time over a day. In an industrial 
production facility, the workers are in the barns with the 
animals for extended periods of time being exposed. So it is 
more that kind of transmission out into the community--
    Ms. Schakowsky. What about milk from cows that are treated?
    Mr. Martin. The FDA has very strict rules about anything 
showing up in milk. I mean, they are very strict about hormones 
and antibiotics. We found it is more of an environmental 
concern and particularly with swine production, getting into 
groundwater, whether some of the lagoons will overflow into 
rivers in a flood or a heavy rain. The University of Iowa has 
done studies about higher rates of asthma and exposure to 
pathogens up to 5 miles in a downwind plume from hog CAFOs, and 
the EPA now is undergoing a fairly intensive monitoring program 
to see exactly what is in the air coming out of industrial 
operations. But it is really not, from the Commission's 
viewpoint, it is not--you don't ingest it in the meat because 
it is being fed to the animal. It is more in the environmental 
impact.
    Ms. Schakowsky. Thank you. Go ahead.
    Dr. Carnevale. Can I comment on that? Yes, certainly you 
can find resistance. A lot of the resistance that might be in 
the environment frankly could be due to human use as well as 
animal use. You can find resistance. The issue is not finding 
resistance. The issue is, what is the risk of the presence of 
that resistance to human health, and that is why it is 
important that we stress risk assessment. That is why the FDA 
and international organizations have taken on the task of 
trying to determine what the risk of this potential resistance 
that might occur is to human health. In many cases, when they 
look at the data, they look at the farm-to-table continuum, if 
you will. They find that for many of these antibiotics, there 
is a very low risk of this resistance leading to a human health 
concern. That doesn't mean we don't use the antibiotics 
properly to try to make sure that we don't create--we create as 
little resistance as we can. Resistance also is not permanent. 
In many cases you can use a drug, you can get resistance to it. 
As soon as you remove the drug, the resistance goes away. So it 
is not an all-or-none situation. It is a very complex area, and 
this is why we think risk assessment is the way to get at the 
concerns. We fully support the FDA conducting risk assessments 
on a pre- and post-approval basis. In fact, Mr. Chairman, I 
would note that the House Agriculture Appropriations Committee 
in fact gave FDA about $1 million 5 years ago and it appears in 
their budget every year to conduct post-approval reviews of 
these antibiotics, so that process is going on with funding 
from Congress. Thank you.
    Mr. Pallone. Thank you. You know, it was kind of 
interesting because I listened to all the comments about the 
dangers from diseases that can be borne by animals yet you also 
read these articles or statements about how--I remember reading 
something the other day about how it is good for kids to have 
pets because if they don't have pets, they don't go out on the 
street and get exposed to diseases and things and they don't 
develop resistance to it. So who knows. I guess it is very 
complicated.
    I think we are done. Thank you. This was very helpful. And 
as I mentioned, we do intend to move this bill in a timely 
fashion because we know the deadline is looming for the 
authorization. I guess it expires at the end of the fiscal 
year, so we are well aware of that and we appreciate your 
comments today. And I will say again that if members want to 
submit written questions, they will be submitted to the clerk 
within the next 10 days and then you will be notified soon 
after that.
    So thank you again, and without objection, this meeting of 
the subcommittee is adjourned.
    [Whereupon, at 11:56 a.m., the subcommittee was adjourned.]
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                     Statement of Hon. Jim Matheson

    Thank you for holding this hearing today, Mr. Chairman and 
Ranking Member Deal.
    I understand that we are here today to consider a timely 
reauthorization of the Animal Drug User Fee Act as well as the 
creation of a new program, the Animal Generic Drug User Fee 
Act. While I look forward to working with my colleagues on the 
committee on both of these proposals, I would like to use my 
time today highlighting the issue of antibiotic resistance.
    I, along with several of my colleagues on this committee, 
introduced legislation H.R. 3697, Strategies to Address 
Antimicrobial Resistance Act. Senators Brown/Hatch/Durbin have 
introduced the Senate companion bill. The STAAR Act provides a 
comprehensive approach to the antimicrobial resistance crisis. 
It provides strategies and authorizes critically needed funding 
to strengthen federal antimicrobial resistance surveillance, 
prevention and control, and research efforts. This legislation 
has the support of several infectious disease leaders 
including: The Infectious Disease Society, The Pediatric 
Infectious Disease Society, The American Medical Association, 
The American Public Health Association, and Premier Hospitals, 
an alliance of 1700 nonprofit hospitals across America.
    Antibiotic use presents unique challenges to drug safety. 
They are researched and developed to respond to infectious 
organisms that continue to mutate and build resistance to the 
product even after approval. Even if we all demonstrate good 
judgment and use antibiotics wisely, eventually, the bad bugs 
become resistant.
    In 2004, the GAO issued a report entitled: ``Antibiotic 
Resistance Federal Agencies Need to Better Focus Efforts to 
Address Risk to Humans from Antibiotic Use in Animals''. In 
this report, the GAO states: ``Although they have made some 
progress in monitoring antibiotic resistance, federal agencies 
do not collect the critical data on antibiotic use in animals 
that they need to support research on the human health risk. 
The data that could help this research include the types and 
quantities of antibiotics sold for use in animals, the purpose 
of their use (such as disease treatment or growth promotion), 
the species in which they are used, and the method used to 
administer them. These types of data are needed to study the 
linkages between antibiotic use in animals and the human risk 
from antibiotic resistance and to develop and evaluate 
strategies for mitigating resistance.'' While I do not oppose 
antibiotic use in sick animals--I want to be sure we have the 
best information to determine the full extent, if any, that 
antibiotic use in animals contributes to antibiotic resistance 
in humans.
    It will take a coordinated effort and a partnership between 
manufacturers, federal agencies, providers, and patients to 
truly make a difference in slowing the trend of antimicrobial 
resistance. It is my hope that Congress and this committee will 
address provisions to protect antibiotic safety and 
effectiveness, as well as improve access to new antibiotics.
    I look forward to hearing from our witnesses and will yield 
back the balance of my time.
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