October 9, 2020

As part of its overall strategy for addressing antimicrobial resistance risks associated with the use of antimicrobial drugs in animals, the U.S. Food and Drug Administration is announcing a potential revised process and criteria for ranking antimicrobial drugs based on their importance in human medicine. FDA is committed to ensuring that this ranking process be based on current and sound science, given the role that the ranking of antimicrobials plays in guiding FDA’s activities related to managing antimicrobial resistance risks associated with antimicrobial use in animals.

To describe these potential revisions in detail, FDA has published a concept paper, and issued a Request for Comments in the Federal Register, to obtain early public feedback on the content of the paper. FDA also plans to hold a virtual public meeting to present the details and receive additional comments.

The concept paper outlines a potential approach for updating the current list of antimicrobial drugs ranked by their importance in human medicine (commonly referred to as “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, including changes in available treatment options, changes in human clinical practices and other scientific advancements. 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.

While the original ranking criteria in GFI #152 emphasized the treatment of foodborne infections in humans, the potential revised criteria in the concept paper more broadly consider the importance of these drugs in human medicine, based on availability of treatment options and seriousness of human illness. These revised criteria are intended to better characterize the overall importance of a drug for treating human infections, whether or not they are foodborne. However, in addition to this importance ranking, other risk factors would be considered as part of an overall assessment of antimicrobial resistance risks associated with the use of an antimicrobial drug in animals. 

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. If the revised ranking list described in the concept paper were to be adopted by FDA, through guidance, it would replace the list currently included as Appendix A to GFI #152. The revised list would be used to inform the recommended risk assessment methodology provided in GFI #152 and also could be utilized as a risk management tool for informing other FDA initiatives related to the judicious use of medically important antimicrobials in veterinary medicine.

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. FDA 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.

The virtual public meeting to discuss this potential revised approach to ranking antimicrobial drugs according to their importance in human medicine will be held on November 16, 2020. For additional information about this meeting, including registration and specific questions on which FDA would like to receive comments, please visit: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs.

How to Comment:

FDA is accepting public comment on “Concept Paper: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs” October 9, 2020 through January 15, 2021. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2020-N-1736 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2020-N-1736 on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Additional Information

• Federal Register Notice: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Public Meeting; Request for Comments 
• Concept Paper: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs 
• Public Meeting Registration
• Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for FY 2019 - FY 2023
• CVM Information about Antimicrobial Resistance