020920 FDA Offers Guidance on Livestock Antibiotic

Washington (Reuters Health) - The US Food and Drug Administration (FDA) has issued guidelines on how to determine whether new antibiotic drugs used in animals are likely to lead to drug-resistant disease in the humans who eat them.

The FDA's draft guidance document lays out an approach for investigating the potential for causing drug resistance as part of the pre-approval evaluation of these drugs.

According to the FDA, national and international health organizations have seen evidence that use of antimicrobial drugs in food-producing animals could lead to the emergence of drug-resistant bacteria that can harm humans.

For instance, the FDA noted, Salmonella and Campylobacter can exist in the digestive tract of food-producing animals without causing illness, but people can suffer severe illness after consuming these bacteria in meat, milk or eggs.

"FDA's main concern is that use of antimicrobial drugs in food-producing animals may lead to the emergence of bacterial pathogens that are resistant to drugs used to treat human illness, potentially making human illnesses more difficult to treat," the agency said.

In January 1999, the FDA also issued a proposed framework for managing the potential risk.

According to the FDA, this risk assessment process will produce an estimate of the potential risk posed to human health by the proposed new antimicrobial animal drug.

"FDA believes that the potential human health consequences of exposure to the defined hazardous agent may be estimated qualitatively by considering the human medical importance of the antimicrobial drug in question," the agency states in the guidance document.

FDA guidance documents are not legally binding, but they reflect the agency's preferred approach for dealing with specific issues.

Specific comments on the proposed methodology will be accepted for 75 days following publication of the draft guidance document in the September 13 issue of the Federal Register, the agency said. The agency added that it would also accept general comments at any time.

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