The FDA and the Evidence on an Antibiotic

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Sunday, March 11, 2007

The March 4 front-page story "FDA Rules Override Warnings About Drug" suggested that Food and Drug Administration approval of the antibiotic cefquinome for cattle is inevitable. The FDA has not reached any final decision on cefquinome for cattle; we are still collecting information.

The article contains a key factual error regarding the legal and scientific requirements for approving a drug; it assigns excessive importance to an FDA document called "Guidance for Industry 152" (GFI 152) in the approval process of antibiotics for livestock. It then implies, based on that misperception, that approval of cefquinome is a foregone conclusion. Nothing could be further from the truth -- the FDA is reviewing the scientific evidence, and we will reach no conclusions until that review is completed.

GFI 152 provides guidance to developers of animal antibiotics on how to address, in their research, the issue of bacterial resistance to antibiotics in people. Ultimately, the FDA decides whether to approve an animal antibiotic based on the science. This is true for each product application; GFI 152 identifies factors to be assessed but leaves the decision to be made case by case.

If the use of an antibiotic in livestock poses a health threat to people, the FDA will act to protect human health, either by not approving a new antibiotic for livestock or by taking one off the market.

STEPHEN F. SUNDLOF

Director

FDA Center for Veterinary Medicine

Rockville


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