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May 18, 1999
CVM VIEW OF DATA ON ANTIMICROBIALS USED IN ANIMALS
Information published recently in the New England Journal of Medicine (NEJM) suggests a direct link between the use of antimicrobials in animals and the development of bacteria resistant to the drug finding their way into people.
The NEJM report was developed from data collected by Health Department officials of the State of Minnesota that showed campylobacter bacteria, a bacteria commonly found in poultry, became increasingly resistant to a fluoroquinolone drug after that drug had been approved for use in poultry. FDA has approved certain fluoroquinolone products for use in poultry to prevent outbreaks of disease caused by bacteria. Further, the report indicates that the resistant campylobacter were found in samples taken from humans suffering from foodborne illness. The poultry products tested in this study originated in 15 poultry processing plants in nine States.
Officials of the Food and Drug Administration’s Center for Veterinary Medicine (CVM) will closely study the data to see what implications the information may have for the use of fluoroquinolones in poultry. FDA shares the concerns about emerging resistance to fluoroquinolones in poultry. FDA has asked the drug manufacturers to collect additional information regarding resistance as part of their existing post-approval monitoring programs. Also, FDA is exploring with the drug sponsors ways to mitigate resistance of public health concern.
In addition, CVM officials have already taken steps to alter the animal drug approval system to be able to make adjustments when antimicrobial resistance becomes a concern, either for human or animal treatment.
The adjustments are incorporated in a philosophy laid out in what is called the "Framework Document,". The Framework calls for drugs with the highest risk of creating problems for human therapy to be the least likely to be approved for animal uses. Further, the philosophy calls for monitoring of increases in resistance so that FDA can take actions before a threat to human health develops. The monitoring system, which is already in place, tests human and animal isolates collected at several sites across the U.S. for resistance to 17 antimicrobial drugs.
Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm