Draft Guidance for Industry 152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern

Sharon R. Thompson, DVM, University of Tennessee, College of Veterinary Medicine

This draft guidance discusses an approach for assessing the safety of antimicrobial drugs for use in food animals with regard to their microbiological effects on bacteria of human health concern. Prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective. For antimicrobial drugs for use in food animals, the safety evaluation includes consideration of the potential impact of this use on human health. The draft guidance addresses the concern that the use of antimicrobial drugs in food animals may lead to human exposure to resistance determinants or resistant bacteria through ingestion of animal-derived foods. This exposure may result in human illness when the exposed person is treated with the human antimicrobial drug of interest and antimicrobial effectiveness has been compromised.

A qualitative risk analysis approach is described for evaluating antimicrobial resistance concerns as part of a pre-approval evaluation. The process is intended to organize and integrate an array of relevant information and provide direction as to how this information may be used to manage risk. The process is composed of the following steps: Hazard identification, Release assessment, Exposure assessment, Consequence assessment, Risk estimation, and Risk management considerations. The steps highlighted in bold make up the qualitative antimicrobial resistance risk assessment described in the figure below (copied from Draft Guidance 152, p. 7).

The risk estimation results in a ranking of low, medium or high risk for human health to be adversely impacted by emergence of antimicrobial resistance associated with the use of the drug in animals. These risk-based rankings are then associated with certain risk management categories that will restrict the use of the drug in food animals.

Dr. Sharon R. Thompson, Director, Partnership Programs, College of Veterinary Medicine, University of Tennessee, 2407 River Dr., Knoxville, TN 37996-4550, Tel: 865-974-7445, Fax: 865-974-4773, email: srthompson@utk.edu.