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FDA PROPOSES NEW INDUSTRY DRAFT GUIDANCE FOR EVALUATING THE SAFETY OF ANTIMICROBIAL NEW ANIMAL DRUGS

The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern." This draft guidance discusses a recommended approach for assessing the safety of antimicrobial new animal drugs, an approach that focuses on the microbiological effects on bacteria of human health concern.

FDA's main safety concern is that use of antimicrobial drugs in food-producing animals may lead to the emergence of bacterial pathogens(disease-causing organisms) that may be harmful to humans and that are resistant to drugs used to treat human illness. The emergence of resistant pathogens makes treating human illnesses more difficult.

This draft guidance document discusses a recommended approach for assessing the antimicrobial resistance concerns as part of the overall preapproval safety evaluation of new animal drugs.

As draft guidance, the document represents the Agency's current thinking on a recommended approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. An alternative approach may be used as long as it satisfies the requirements of applicable statutes and regulations.

In particular, the draft guidance describes a methodology sponsors of antimicrobial new animal drug applications for food-producing animals may use to complete a qualitative antimicrobial resistance risk assessment. The draft guidance document outlines a process for integrating relevant information into an overall estimate of risk and discusses possible risk management strategies.

In 1998, FDA announced its intention to consider concerns about antimicrobial resistance, in addition to other factors such as drug residues, when evaluating the safety of antimicrobial new animal drugs. In January 1999, the FDA published a discussion document (framework document) that outlined possible strategies for managing antimicrobial resistance. The draft document being released today describes an approach for implementing concepts from the framework document.

The public may submit comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The full text of the guidance can be found online at: http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc.

This document will stay in draft form for 75 days, giving FDA time to collect and analyze public comments about the guidance.

September 11, 2002

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