UCS Urges Public Health Provisions in the Animal Drug User Fee Act (ADUFA)
Letter from UCS and other members of the Keep Antibiotics Working coalitions to the Committee on Health, Education, Labor and Pensions
May 15, 2008
The Honorable Edward M. Kennedy
Chairman
Committee on Health, Education, Labor and Pensions
U.S. Senate
Washington, DC
The Honorable Michael B. Enzi
Ranking Member
Committee on Health, Education, Labor and Pensions
U.S. Senate
Washington, DC
Members
Committee on Health, Education, Labor and Pensions
U.S. Senate
Washington, DC
Re: The Animal Drug User Fee Act
Dear Chairman Kennedy, Ranking Member Enzi, and Members of the Senate Health, Education, Labor and Pensions Committee:
We the undersigned members of Keep Antibiotics Working (KAW), Consumers Union, and the Consumer Federation of America, 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 have focused our efforts on 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 1–5, 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 from Title 1 and Title 2 of the Preservation of Antibiotics for Medical Treatment (PAMTA, S. 549), a bill that addresses the ongoing resistance issues associated with approved antibiotics. The PAMTA provisions would:
1) Initiate the immediate review of safety with regards 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,
The Keep Antibiotics Working Coalition
Center for Science in the Public Interest
Environmental Defense
Food Animal Concerns Trust
Global Resource Action Center for the Environment
Humane Society of the United States
Institute for Agriculture and Trade Policy
National Catholic Rural Life Conference
Natural Resources Defense Council
Physicians for Social Responsibility
Safe Tables Our Priority (S.T.O.P.)
Sierra Club
Union of Concerned Scientists
Waterkeeper Alliance
Consumer Federation of America
Consumers Union
* KAW is a coalition of health, environmental, agricultural, environmental, animal welfare and science organizations, with over 9 million members, dedicated to the preservation of antibiotics for use in human and animal medicine.
Consumers Union is an expert, independent, nonprofit organization, whose mission is to work for a fair, just, and safe marketplace for all consumers.
The Consumer Federation of America is a nonprofit association of 300 consumer groups, representing more than 50 million Americans, that was established in 1968 to advance the consumer interest through research, education and advocacy.
