On August 18, 1995, the Food and Drug Administration approved a new fluoroquinolone antibacterial drug, sarafloxacin hydrochloride, for use in chickens and turkeys. Sarafloxacin was the first fluoroquinolone approved for use in food-producing animals. It is a prescription drug distributed under the trade name Saraflox® WSP by Abbott Laboratories, North Chicago, Illinois. Saraflox® WSP is administered in drinking water to control mortality in broiler chickens and growing turkeys infected with Escherichia coli organisms susceptible to sarafloxacin. On October 12, 1995, FDA approved Saraflox® Injection, also manufactured by Abbott Laboratories, for control of early chick mortality associated with bacterial infection by E.Coli.

These approvals of fluoroquinolone products for food animal use followed lengthy consideration by FDA's Center for Veterinary Medicine (CVM) about possible microbial resistance to these drugs. Fluoroquinolones are the newest class of antimicrobial drugs developed for treating infections in people and animals. CVM approved enrofloxacin (another fluoroquinolone product) for use in companion animals in January 1989. Since then, some members of the human health community expressed concerns about the possible approval of fluoroquinolones in food animals. FDA held a joint meeting of the Agency's Veterinary Medicine and Anti-Infective Drugs advisory committees on May 11-12, 1994, to discuss this issue. Members of both committees concluded that FDA could approve fluoroquinolones found to be safe and effective for animal use.

CVM is interested in preserving the usefulness of these valuable new drugs and other fluoroquinolones by minimizing the potential for development of resistant pathogens. Part of the strategy to achieve this objective is to control unnecessary treatment of animals with fluoroquinolones. To facilitate accomplishment of this important objective, CVM is initiating an educational program to inform veterinarians and producers about the appropriate use of fluoroquinolones and is revising the Compliance Policy Guide 7125.06, Extra-label Use of Animal Drugs in Food-Producing Animals, to include regulatory guidance for these drugs.

To control the extra-label use of this class of drugs, FDA will assign a regulatory priority based on their actual use. The highest priority for regulatory action will be for extra-label use of fluoroquinolone products in major food-producing animal species (cattle, swine, chickens, and turkeys) that are not included in the approved labeling. For example, the highest priority for regulatory action would be assigned when a fluoroquinolone product only approved for use in chickens were used in a different major food-producing species such as cattle.

FDA is collaborating with the U. S. Department of Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC) to develop a surveillance system to monitor antimicrobial susceptibility in enteric pathogens. Under the program, USDA will test Salmonella samples from animals for susceptibility to antimicrobial drug products. The CDC will conduct similar testing on Salmonella and E. coli. isolated from humans. The manufacturer, Abbott Laboratories, will test E. coli obtained from chickens and turkeys to monitor their susceptibility to sarafloxacin. The manufacturer will also provide geographically-based drug distribution information to CVM as part of their annual Drug Experience Reports. The information from the monitoring programs will be used to assess the development of fluoroquinolone-resistant organisms and make any adjustments in the extra-label drug use regulatory program.

Additional information on the approval of Saraflox WSP® is contained in the Federal Register of September 28, 1995. Questions regarding CVM's position on the extra-label drug use of fluoroquinolones may be directed to CVM's Office of Surveillance and Compliance at 7500 Standish Place, HFV-200, Rockville, MD 20855, or by calling (301) 594-1761.