On November 16, 2020, the U.S. Food and Drug Administration is hosting a virtual 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.
The purpose of this meeting is to obtain early public input on a potential revised process and criteria for ranking antimicrobial drugs based on their importance in human medicine. The Agency is seeking public input on a concept paper which includes a potential revised process for ranking antimicrobials according to their relative importance in human medicine, the potential criteria for their ranking, and the resulting ranked list of antimicrobial drugs.
The FDA is specifically interested in receiving public comments on the following questions:
* Are the criteria and the tier-based framework described in the potential revised process for ranking antimicrobial drugs according to their relative human medical importance clear, complete, and consistent?
* What changes do you think are needed to the criteria or tiers, if any?
* Have the proposed criteria been applied correctly to the antimicrobial classes as reflected in their proposed rankings?
* Are there other issues we should consider regarding these criteria and the tier-based framework?
* How often and by what process should FDA update the ranking of medically important antimicrobials?