By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) announced on Oct. 9 that the agency will conduct a virtual public meeting to discuss potential approaches and criteria for ranking antimicrobial drugs used in animals based upon their importance in human medicine.
The session is being conducted to help inform FDA’s strategy for addressing antimicrobial resistance risks associated with the use of antimicrobial animal drugs.
To describe the agency’s current thinking on potential approaches for ranking antimicrobial animal drugs, FDA has published a concept paper and issued a request for comments in the Federal Register to obtain public feedback on the paper’s content. The concept paper outlines a potential approach for updating the current list of antimicrobial drugs ranked by their importance in human medicine found in “Appendix A” of FDA’s Guidance for Industry (GFI) #152 to take into account improved understanding of antimicrobial resistance and other changes since the ranked list was established in 2003.
GFI #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concerns,” is used to support the animal drug approval process and provides a recommended risk-assessment methodology for evaluating and mitigating antimicrobial resistance concerns associated with the use of antimicrobial drugs in food-producing animals. FDA said the current list of antimicrobial drug medical importance rankings in Appendix A of GFI #152 will continue to be used to support the animal drug evaluation and risk-assessment process while the potential revised criteria and rankings detailed in the concept paper are under consideration.
FDA stated the concept paper is a means to facilitate public comment on one potential approach to revising antimicrobial drug human medical importance rankings and is not intended to be construed as recommendations or guidance. In addition, FDA said it intends to consider all comments received on the concept paper that are submitted in a timely manner before issuing draft guidance for additional public comment. NGFA’s feed committees and staff will be reviewing and providing comments on the concept paper.
The virtual public meeting to discuss the potential revised approach to ranking antimicrobial animal drugs will be conducted on Nov. 16 from 9:30 a.m. until 4 p.m. Eastern time. Additional information about the meeting, including registration and specific questions on which FDA would like to receive comments, may be accessed on the agency’s meeting webpage. FDA is accepting public comment on its concept paper through Jan. 15, 2021.