The U.S. Food and Drug Administration has released a new Draft Guidance for Industry, titled, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern. The document outlines a risk assessment approach to evaluate the microbial food safety risk of antimicrobial resistance (AMR) posed by new antimicrobial animal drugs.

As part of its pre-approval safety evaluation process, FDA will consider the potential impact on human health of all uses and classes of new antimicrobial animal drugs intended for use in food-producing animals. The draft guidance outlines a risk assessment method that takes into account the effects of the transmission of antimicrobial-resistant foodborne bacteria of concern to human health through the consumption of animal-derived food products. Although FDA’s primary focus will be foodborne pathogens and their resistance determinants, other enteric bacteria may be considered.   

Within the context of risk assessment, many possible mechanisms to address the development of AMR resulting from the use of new antimicrobial animal drugs in food-producing animals are available to the sponsor of a drug. Alternative processes that may be more appropriate to a sponsor’s drug and its intended conditions of use may be used to characterize the microbial food safety of that drug.

The risk assessment approach outlined in the draft guidance is recommended for the evaluation of applications submitted for all new antimicrobial animal drugs in food-producing animals. Sponsors of applications described below are encouraged to consult with FDA to decide if the risk assessment approach is suitable for their application:

• Category I supplemental New Animal Drug Applications (NADAs)
• NADAs for antimicrobial drug combinations
• Abbreviated (generic) NADAs.

The present version of the guidance replaces the version that was made available in October 2003. Revisions include changed criteria, a ranking of medically important antimicrobials, updated data tables, and revised definitions.

The draft guidance also follows recently released data from FDA on U.S. sales of medically important antibiotics for use in food-producing animals in 2020–2021.

Stakeholders are invited to submit comments on the draft guidance by March 20, 2023. Submit electronic comments to www.regulations.gov.  Submit written comments to: Dockets Management Staff (HFA305), U.S. Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  All comments should be identified with docket number FDA-1998-D-0038.