June 13, 2008 The Honorable John D. Dingell Chairman Committee on…

June 13, 2008

The Honorable John D. Dingell
Chairman
Committee on Energy and Commerce
U.S. House
Washington, DC

The Honorable Joe Barton
Ranking Member
Committee on Energy and Commerce
U.S. House
Washington, DC

Members
Committee on Energy and Commerce
U.S. House
Washington, DC

Re: The Animal Drug User Fee Act

Dear Chairman Dingell, Ranking Member Barton, and Members of the House Committee on Energy and
Commerce:

We write to urge that the reauthorization of the Animal Drug User Fee Act (ADUFA) include provisions that will
ensure public health and drug safety after the animal drug is on the market, along with the substantial incentives for
approving new animal drugs.

Antibiotics, the miracle drugs of the last century, are in danger of being lost as a result of overuse in both human
and animal medicine. While both settings deserve urgent attention, we are particularly concerned about the
relatively neglected area of food animal production, where enormous, often inappropriate, use of antibiotics is
commonplace.

Antimicrobial resistance is the greatest public health risk related to the use of veterinary drugs in animals under
current regulatory regimes (World Health Organization. Joint FAO/OIE/WHO Expert Workshop on Non-Human
Antimicrobial Usage and Antimicrobial Resistance: Scientific Assessment Geneva, December 1­5, 2003).
Therefore the long-term management of antibiotic resistance is the most critical issue facing the Food and
Drug Administration (FDA) in assuring the post-market safety of veterinary antimicrobials.

Antimicrobials (including antibiotics) are different from most other drugs in that resistance to them results from
exposure and worsens over time. This means that in order to avoid the consequences of resistance--more virulent
diseases, higher medical costs, and increased human suffering--the agency must be in a position to manage
resistance after drugs are approved.

We urge that ADUFA, when it is passed, include provisions like those in the Preservation of Antibiotics for
Medical Treatment Act (H.R. 962) that address the ongoing resistance issues associated with approved antibiotics,
including:

    1) Initiate the immediate review of safety with regard to antibiotic resistance of existing antimicrobial
       compounds in drug classes that are used both in human and animal medicine. Unless the drug sponsors are
       able to provide data showing that the nontherapeutic use of an antibiotic in food-producing animals does
       not generate a health risk in humans, such uses of the antibiotic would be phased out in animal agriculture,
       and
    2) Require the collection of veterinary drug use data essential to the assessment and management of
       antimicrobial risks represented by approved antimicrobial drugs.

For both of these areas of post-market drug safety, ADUFA should set reasonable performance goals.

When the Prescription Drug User Fee Act (PDUFA) was reauthorized as part of the FDA Amendments Act of
2007, increased fees to provide for post-market human drug safety were included. Similarly, any reauthorization of
ADUFA should address post-market animal drug safety.

Over the past five years, FDA has consistently neglected the tasks necessary for the long-term management of
resistance, in part because the infusion of fees coming from drug companies through ADUFA failed to identify and
fund post-market safety goals. Congress should not make the same mistake in this reauthorization.

According to its mission statement, FDA is a consumer protection agency with a mandate to provide safe drugs.
The most important aspect of safety when dealing with antimicrobials is the evolution of resistant organisms.
Congress should assist FDA in fulfilling its mission by assuring through the steps outlined above that antimicrobial
drugs approved by the agency both in the past and in the future are safe with regard to antimicrobial resistance.

If you have any questions or would like to discuss this matter in detail, please contact Margaret Mellon at 202-223-
6133 or email mmellon@ucsusa.org. Thank you for considering our views.

Sincerely,


Academy of Medicine of Toledo and Lucas County               Mankato Area Environmentalists
Adrian Dominican Sisters                                     Minnesota COACT (Citizens Organized ACting
American Academy of Ambulatory Care Nursing                     Together)
American Academy of Neurology Professional                   Minnesota Medical Association
     Association                                             Missouri Coalition for the Environment
American Nurses Association                                  Naturesource Communications
Western Nebraska Resources Council                           New Mexico Environmental Law Center
Catholic Charities, Diocese of Sioux City                    Northeast Organic Farming Association -
Catholic Health Association of the United States                Massachusetts
Catholic Healthcare West                                     Northeast Organic Farming Association -
Center for Food Safety                                          Vermont
Citizens for Pennsylvania's Future (PennFuture)              Northwest Environmental Advocates
Department of the Planet Earth                               Ohio AIDS Coalition
Buckeye Environmental Network                                Ohio Environmental Council
Endangered Habitats League                                   Ohio Nurses Association
Park County Environmental Council                            Ohio Osteopathic Association
Georgia AIDS Coalition                                       Oklahoma Nurses Association
Grassroots Environmental Education                           Organic Consumers Association
Healthy Schools Network                                      Organic Trade Association
Henry A. Wallace Center for Agriculture and                  PCC Farmland Trust
     Environmental Policy, Winrock International             PCC Natural Markets
Huntington Breast Cancer Action Coalition                    Simply Living
Illinois Stewardship Alliance                                South Carolina Nurses Association
Izaak Walton League of America                               Stonyfield Farm, Inc.
Leukemia and Lymphoma Society
Maine Organic Farmers and Gardeners Association




Signer list updated June 19, 2008