From: annfonfa@aol.com Sent: Tuesday, March 23, 2004 11:46 AM To: fdadockets@oc.fda.gov Subject: Don't appeal the Baytril Decision (Docket # 00N -1571) Mr. Attila Molnar, President and CEO Bayer Corporation 100 Bayer Rd. Pittsburgh, PA 15205 Dear Mr. Molnar, President and CEO Bayer Corporation, As the president of The Annie Appleseed Project, I urge you to stop fighting the proposed ban by the Food and Drug Administration (FDA) on the use of Baytril in treating chickens and turkeys, and immediately withdraw it from the market with no further delaying tactics. As you know, Baytril is a fluoroquinolone antibiotic, a class of drugs that also includes Cipro. Fluoroquinolones are considered one of the most valuable classes of antibiotic drugs available to physicians because of their effectiveness against a broad range of disease-causing bacteria and relative lack of side effects. Cipro is the antibiotic most often used to treat severe cases of food poisoning caused by bacteria. FDA showed that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, the most common cause of severe bacterial food poisoning. Data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans has recently risen to 19 percent; when Cipro-like drugs were first approved for use in poultry in 1995, such resistance was negligible. Although you claim that Baytril is critical for poultry production, that argument is undercut by the fact that six top poultry producers have announced that they no longer use these drugs in chickens produced for human consumption. Moreover, major chicken purchasers, including McDonald's, have instructed their suppliers to stop using fluoroquinolones. Today, nearly four years after the FDA first proposed to ban use of Cipro-like drugs in poultry, rates of Cipro resistance in bacteria that cause severe food poisoning are disturbingly high, and the science linking use of Baytril in poultry to such disease is stronger than ever. Please show your concern for public health by immediately withdrawing Baytril from the market for use in poultry. Sincerely, Ann Fonfa The Annie Appleseed Project 245 Canterbury Circl Palm Beach Gardens, Florida 33418-8220 cc: FDA Baytril Decision (Docket # 00N -1571)