FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture

The U.S. Food and Drug Administration announced today it is entering the next phase of its efforts to mitigate antimicrobial resistance by focusing for the first time on medically important antimicrobials (i.e., those important for treating human disease) used in animal feed or water that have at least one therapeutic indication without a defined duration of use.  As the agency completes its work to implement changes under Guidance for Industry #213, which will, once fully implemented, limit the use of these drugs to therapeutic-only use under the oversight of a veterinarian, it is now turning its attention to ways to address those antimicrobials that may currently be legally used in food animals for no defined length of time.  Although GFI #213 outlines the FDA’s expectation that any new approvals of medically important antimicrobial drugs administered to animals via feed and water will have a defined amount of time they can be used, the guidance does not address some currently approved therapeutics that lack defined durations of use on their labels. In a notice published today in the Federal Register, the agency requests information from the public about how to establish appropriately targeted durations of use for the approximately 32% of therapeutic products affected by GFI #213 with no defined duration of use in order to foster stewardship of medically important antimicrobial drugs in food-producing animals and help preserve the effectiveness of these antimicrobials in animal and human medicine