FDA ban on fluoroquinolone antibiotics in poultry

April 1, 2004

Dr. Attila Molnar, President and CEO
Bayer Corporation
100 Bayer Road
Pittsburgh, PA 15205-9741

Dear Dr. Molnar:

The undersigned organizations strongly urge you to comply immediately the Food and Drug Administration's proposal to ban Baytril, a fluoroquinolone antibiotic used in poultry. Such a decision would accord with the recent determination by an Administrative Law Judge that FDA's proposed ban of Baytril is supported by a "substantial body of evidence" Decision of March 16, 2004, p. 64).

The Judge's opinion makes clear that the decision to ban Baytril is not even remotely a close call. In addition to concluding that substantial evidence links use of Baytril in poultry to increased fluoroquinolone resistance in Campylobacter, the Judge determined that the credibility of one of Bayer's key witnesses was so "severely compromised" that "his testimony cannot be relied upon" in light of his repeated mis-quotation of the scientific literature in his sworn testimony (p. 15). The Judge also characterized this same witness as using "faulty" and "unsubstantiated" methods (p. 62) and found that some of Bayer's arguments were "not relevant" (p. 32), while others were "inconsistent" (p. 63). Bayer has already dragged this proceeding out for three and a half years following FDA's October 2000 proposal.

The Judge's 68-page decision is based on a formal evidentiary record that included 388 bound volumes containing more than 1,100 documents, and on cross-examination of experts lasting for more than a week. Enough is enough.

Though not a focus of the Judge's decision, it is also worth noting that several major poultry corporations in the US have stated they are no longer using fluoroquinolones to produce chicken for human consumption. Similarly, many leading food-service companies - including McDonald's, Dairy Queen, Burger King, Domino's, Hardee's, Wendy's, Popeye's, Subway, and BonAppetit - have stated that they do not purchase chicken raised with these drugs. In addition, pending legislation would ban the national school lunch program from serving chicken that was produced with the use of fluoroquinolones.

While FDA regulations provide Bayer with a 60-day period in which to appeal the ruling to the FDA Commissioner, we strongly encourage Bayer not to do so, and instead to comply immediately with the Judge's decision that Baytril should be withdrawn from the market. Bayer is now the only manufacturer of fluoroquinolones for poultry, as the only other manufacturer of fluoroquinolones for poultry (Abbott Laboratories) voluntarily stopped marketing its version of the product when FDA first moved to ban it.

Baytril is virtually identical to Cipro, which is a key drug in treating severe food-borne illness in humans such as that caused by Campylobacter - particularly in people with weakened immune systems, such as cancer patients, transplant recipients, and persons with HIV/AIDS. In light of Bayer's motto, "Expertise with Responsibility," the responsible action now is to discontinue the manufacture of Cipro-like drugs for poultry without further procedural delays.

Sincerely,

ACCORD Ag, Inc.
Action for a Clean Environment
Adrian Dominican Sisters
Alliance for Sustainable Communities
American Academy of Neurology
American College of Preventive Medicine
American Medical Student Association
American Society for Clinical Laboratory Science
Animal Welfare Institute
Audubon International/The Audubon Society of New York State
Breast Cancer Fund
Center for Food Safety
Center for Science in the Public Interest
Children's Health Environmental Coalition
Citizens for Humane and Wholesome Food
Citizens for Pennsylvania's Future (PennFuture)
Clean Water for North Carolina
Clean Water Action Alliance of Minnesota
Coalition for a Clean Minnesota River
Coast Action Group
Community Alliance with Family Farmers
Concerned Citizens of Hidden Meadows
Consumer Federation of America
Des Moines Water Works
Earth Day Coalition
Ecology Center
Edison Wetlands Association
Endangered Habitats League
Environment Colorado
Environmental Defense
Episcopal Diocese of Rhode Island, Environment Committee
Family Farms for the Future
Farm Sanctuary
F.H. King: Students of Sustainable Agriculture
Florida Nurses Association
Food Animal Concerns Trust
Friends of Arizona Rivers
Friends of the Nanticoke River
Generation Green
Global Resource Action Center for the Environment
Halifax River Audubon
Hardy Groves, Inc.
Human Education Network
Humane Farming Association
Humane Society of the United States
Huntington Breast Cancer Action Coalition
Institute for a Sustainable Future
Institute for Agriculture and Trade Policy
Iowa Association of Water Agencies
Iowa Children's Water Festival
Iowa Citizens for Community Improvement
Iowa Environmental Council
Kettle Range Conservation Group
Land Stewardship Project
LIVING Upstream
Maine Chapter of the American Academy of Pediatrics
Maine Medical Association
Maine People's Alliance
McCook Lake Chapter of the Izaak Walton League of America
Medical Society of New Jersey
Michigan Environmental Council
Minnesota Project
My Mother's Garden, Inc.
National Anti-Vivisection Society
National Catholic Rural Life Conference
Natural Resources Defense Council
Neponset River Watershed Association
New Jersey Environmental Lobby
New Mexico Medical Society
North Carolina Association of Black Lawyers' Land Loss Prevention Project
Northeast Center for Social Issue Studies
Northeast Organic Farming Association of Massachusetts
Northeast Organic Farming Association of New Jersey
Northeast Organic Farming Association of New York
Northeast Organic Farming Association of Vermont
NY/NJ Environmental Watch
Ohio Division, Izaak Walton League of America
Ohio Public Health Association
Ohio Valley Environmental Coalition
Oregon State Public Interest Research Group
Organic Consumers Association
Organic Independents
Organic Trade Association
Park County Environmental Council
PCC Farmland Fund
PCC Natural Markets
Physicians for Social Responsibility
Rahway River Association
Regional Farm & Food Project
Rivers Foundation of the Americas
San Francisco Medical Society
Sierra Club
Society for Animal Protective Legislation
South Carolina Coastal Conservation League
Southern Streams
Stonyfield Farm, Inc. (& O'Naturals)
Stream Team 714
Tri-County Conservation League
Union of Concerned Scientists
United Anglers of California
U.S. PIRG
Vermont Public Interest Research Group
Virginia Forest Watch
Waterkeeper Alliance
Western Nebraska Resources Council
West Virginia Rivers Coalition

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