For Comment: FDA Proposes Revisions to Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine

March 16, 2023 — 

FDA/CVM issued a draft update to guidance for industry (GFI) #152, "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern." The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals.

Update March 6, 2023:In response to requests filed by stakeholders, the FDA is extending the comment period for revised draft GFI #152 by an additional 60 days. The comment period will now close on May 19, 2023.

The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003. Updates to the guidance include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and a revised ranking of antimicrobial drug classes as critically important, highly important, or important based on the newly updated ranking criteria (Appendix A).

When proposing revisions to GFI #152, FDA took into account feedback from its 2020 concept paper and public meeting on a potential approach for ranking antimicrobial drugs according to their importance in human medicine. [View AASV's 2021 comments at https://www.regulations.gov/comment/FDA-2020-N-1736-0040]

Once FDA finalizes this revised draft GFI, the agency expects to reassess the rankings in Appendix A periodically to align with current science and clinical practices in human medicine.

For additional information please see:

FR Notice: Notice of Availability: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Draft Guidance for Industry

Guidance: Draft Guidance for Industry #152: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern

CVM Update: FDA Proposes Revisions to Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine

Web QA: Questions & Answers: Draft Revised GFI #152

Submit comments by May 19, 2023, HERE . Please share your comments with AASV by e-mailing AASV Director of Public Health and Communications Dr. Abbey Canon.

[Source: FDA 6 March 2023]