Monday, April 12, 2004FDA proposes withdrawal of Baytril
Chris Hill WASHINGTON -- The U.S. Food & Drug Administration issued an initial decision March 16 on a proposal to withdraw the new animal drug application for Bayer Animal Health's Baytril product for poultry. The decision, made by FDA Administrative Law Judge Daniel J. Davidson, applies to enrofloxicin and specifically the Baytril 3.23 percent product. The drug is used in treating a pneumonia-like illness in poultry. FDA's Center for Veterinary Medicine began the efforts to ban the type of drugs in which Baytril is grouped in October 2000. The CVM believes the use of these drugs leads to resistant campylobacter in poultry, which then is transferred to poultry consumers and causes resistant campylobacter infections in people. Industry estimates indicate that the drug, classified as fluoroquinolones, was used sparingly in both broilers and turkeys. Large poultry companies, including Tyson Foods, Perdue Farms and Gold Kist, have subsequently banned the use of the class of drugs in production of their poultry. Abbott Labs, which also produced a fluoroquinolone product, immediately withdrew its two products in October 2000. Bayer has continued to sell its product under an appeal. The company, Bayer, has submitted another appeal to the FDA commissioner on this latest decision. "Having made a strong scientific argument during the hearing process, we are surprised and disappointed in the Administrative Law Judge's decision," said John B. Payne, president and general manager, Bayer HealthCare LLC, Animal Health Division. "This is an extremely complex issue that deserves additional review of the scientific arguments, which we firmly believe support the continued use of Baytril to fight disease in poultry," Payne added. "We will fully examine all of the details in the judge's decision and prepare our appeal accordingly." FDA initially approved Baytril in 1996 for treating air sacculitis, an illness much like pneumonia. Bayer contends with new research that air sacculitis leads to fluctuations in bird weights at the processing plant and contributes "to errors in processing that lead to increased levels of bacterial contamination." Therefore, Bayer says, the use of Baytril contributes to "a healthy food supply." If the FDA commissioner does not act on Bayer's appeal, the ban could go into effect in mid-May, 60 days after the decision. For more information and a link to the judge's decision, visit http://www.fda.gov/cvm/index/updates/baytrilup.htm.
Originally published Monday, April 12, 2004
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