One Week Before Appeal Deadline, 143 Groups Send Letter to Bayer Urging Company to Accept Ruling Upholding FDA's Proposed Ban on Cipro-Like Drugs for Poultry 5/10/2004
From: Sean Crowley, 202-478-6128 or 202-550-6524 (cell) or scrowley@mrss.com, for Keep Antibiotics Working WASHINGTON, May 10 -- One week before the Bayer Corporation's May 17 deadline to appeal a ruling upholding the Food and Drug Administration's proposed ban on Bayer's Cipro- like antibiotics for use in poultry, 143 health and other groups sent Bayer's CEO a letter urging Bayer to accept the March 16 ruling by an FDA Administrative Law Judge ( http://www.fda.gov/ohrms/dockets/dailys/04/mar04/031604/00n-1571-idf0001-vol389.pdf ). FDA's initial proposal to ban Bayer's animal drug, Baytril, was issued in October 2000. The proposal was based on data showing that use of Baytril in poultry cut the effectiveness of the related antibiotic Cipro in treating Campylobacter, the most common cause of severe bacterial food poisoning. (Both Baytril and Cipro are members of the fluoroquinolone class of antibiotics.) "The Judge's opinion makes clear that the decision to ban Baytril is not even remotely a close call," said the faxed letter (www.KeepAntibioticsWorking.com) to Bayer CEO/President Dr. Attila Molnar from the American College of Preventative Medicine, Physicians for Social Responsibility, Union of Concerned Scientists and 140 other groups. "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." 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 3-1/2 years since FDA's October 2000 proposal," the letter said. "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." Several major U.S. poultry corporations have stated they no longer use fluoroquinolones to produce chicken for human consumption. Many leading food-service companies -- including McDonald's, Dairy Queen, Burger King, Domino's, Hardee's, Wendy's, Popeye's, Subway, and Bon Appetit -- also 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. ------ Keep Antibiotics Working ( http://www.KeepAntibioticsWorking.com ) is a coalition of health, consumer, agricultural, environmental, humane and other advocacy groups with over nine million members dedicated to eliminating a major cause of antibiotic resistance -- the inappropriate use of antibiotics in farm animals. ------ May 10, 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 with 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 Holistic Nurses Association, American Medical Student Association, American Society for Clinical Laboratory Science, American Society of Plastic Surgical Nurses, Inc., Amigos Bravos, Animal Welfare Institute, Arkansas Nurses Association, Audubon International/Audubon Society of New York State, Blue Heron Environmental Network, Inc., Border Ecology Project, 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), Citizens for Sludge-Free Land, Citizens of Putnam County for Clean Air and Water, Clean Water Action Alliance of Minnesota, Clean Water for North Carolina, Coalition for a Clean Minnesota River, Coast Action Group, Community Alliance with Family Farmers, Concerned Citizens of Hidden Meadows, Consumer Federation of America, Department of the Planet Earth, 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 Medical Association, Florida Nurses Association, Food Animal Concerns Trust, Friends of Alum Creek and Tributaries, Friends of Arizona Rivers, Friends of the Nanticoke River, Generation Green, Glenview Prairie Preservation Project, Global Resource Action Center for the Environment Public Fund, Grass-roots, Halifax River Audubon, Hardy Groves, Inc., Health and Medicine Policy Research Group, Hoosier Environmental Council, Humane Education Network, Humane Farming Association, Humane Society of the United States, Huntington Breast Cancer Action Coalition, Illinois Stewardship Alliance, IHM Justice and Peace Office: Working for a Sustainable World, 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, Lake Superior Greens, Land Stewardship Project, Leukemia and Lymphoma Society, LIVING Upstream, Lymphoma Foundation of America, 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, Mercy Investment Program, Michigan Environmental Council, Michigan Nature Association, Minnesota Catholic Conference, Minnesota Project, My Mother's Garden, Inc., National Catholic Rural Life Conference, National Environmental Trust, Natural Resources Defense Council, Neponset River Watershed Association, Nevada State Medical 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, Northland Health and Wellness, Northwest Environmental Defense Center, 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, Preserve Wild Santee, Prevention Is The Cure, Inc., Protect Our Earth's Treasures, Protecting Animals USA, Rahway River Association, Regional Farm & Food Project, Rivers Foundation of the Americas, San Francisco Medical Society, Science and Environmental Health Network, Sierra Club, Society for Animal Protective Legislation, South Carolina Coastal Conservation League, Southern Streams, Stonyfield Farm, Inc. (& O'Naturals), Stream Team 714, Sustain, Sustainable Earth, Tear of the Clouds LLC/Keeper Springs, Tri-County Conservation League, Union of Concerned Scientists, United Anglers of California, Ursulines of Tildonk for Justice and Peace, U.S. PIRG, Vermont Public Interest Research Group, Virginia Forest Watch, Waterkeeper Alliance, Western Nebraska Resources Council, West Virginia Rivers Coalition, Women, Food and Agriculture Network, Wyoming Outdoor Council | |