FDA releases long-awaited antibiotic guidelines

Washington-At presstime, the Food and Drug Administration (FDA) issued guidelines for animal drug evaluations to combat antibiotic resistance in people, Reuters reports.

The FDA's draft guidance document lays out an approach for investigatingthe potential for causing drug resistance as part of the pre-approval evaluationof these drugs.

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

For instance, FDA says, Salmonella and Campylobacter can exist in thedigestive tract of food-producing animals without causing illness, but peoplecan suffer severe illness after consuming these bacteria in meat, milk oreggs.

"FDA's main concern is that use of antimicrobial drugs in food-producinganimals may lead to the emergence of bacterial pathogens that are resistantto drugs used to treat human illness, potentially making human illnessesmore difficult to treat," the agency says.

In January 1999, the FDA also issued a proposed framework for managingthe potential risk. According to the FDA, this risk assessment process willproduce an estimate of the potential risk posed to human health by the proposednew antimicrobial animal drug.

The agency states, "FDA believes that the potential human healthconsequences of exposure to the defined hazardous agent may be estimatedqualitatively by considering the human medical importance of the antimicrobialdrug in question."

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

Specific comments on the proposed methodology will be accepted for 75days following publication of the draft guidance document in the Sept. 13issue of the Federal Register, the agency says.