Concern that extralabel use of cephalosporin antimicrobial drugs in food animals may pose a public health risk has led the Food and Drug Administration to prohibit this extra-label use.
The FDA issued the order of prohibition as a final rule in the July 3 Federal Register. As stipulated by rules implementing the Animal Medicinal Drug Use Clarification Act, there is a comment period, ending Sept. 2. The rule will take effect Oct. 1 unless the FDA revokes or modifies the order or extends the comment period.
The AVMA will review the FDA proposal in detail and furnish science-based comments to the agency. Current AVMA policy advocates that the FDA Center for Veterinary Medicine consider limited prohibition on the extralabel use of any drug considered for prohibition in food animals, consistent with protection of the food supply, public health, and animal welfare.
The FDA decided against limiting the prohibition to certain individual cephalosporin drugs or to generations of cephalosporins, citing the potential for confusion and evidence of cross-resistance among drugs in the cephalosporin class.
Cephalosporins are some of the most widely used antimicrobial agents in human medicine, and certain ones are approved for use in various animal species. They are members of the β-lactam class of antimicrobials. Acquired resistance to β-lactams in animal isolates has been observed by the U.S. National Antimicrobial Resistance Monitoring System and by Canadian and Danish surveillance programs. A report from the European Antimicrobial Resistance Surveillance System states that third-generation cephalosporin resistance appears to be increasing rapidly in Europe.
Comments identified by Docket No. FDA—2008—N—0326 may be submitted electronically through the Federal eRulemaking Portal, www.regulations.gov, or by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
For further information, contact Dr. Neal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9200; or neal [dot] batallerfda [dot] hhs [dot] gov.