The Food and Drug Administration has announced the availability of a discussion paper entitled “A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals”.

This discussion paper is the second step in the agency’s consideration of issues related to the use of antimicrobial new animal drugs in food-producing animals, the first step being the release of a draft guidance entitled “Guidance for Industry: Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals”. This guidance provides that the agency now believes that sponsors of all antimicrobial new animals drugs intended for use in food-producing animals need to provide information that will allow the agency to evaluate the human health impact of the microbial effects of the intended uses.

In asssessing the human impact of such uses, the draft guidance states that two separate but related issues should be evaluated:

1. The quantity of antimicrobial drug- resistant enteric bacteria formed in the animal’s intestinal tract following exposure to the antimicrobial new animal drug (resistance); and

2. Changes in the number of enteric bacteria in the animal’s intestinal tract that cause human illness (pathogen load).

Reference: Federal Register 64(3): 887-8 (1999).

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