FDA Seeks Public Comment on Potential Approach for Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

The U.S. Food and Drug Administration has published a concept paper to obtain early input from the public on a potential framework for how animal drug sponsors could voluntarily make changes to the approved conditions of use for certain medically important antimicrobial drugs to establish a defined duration of use for those indications that currently lack a defined duration of use. FDA also published a notice in the Federal Register that invites the public to comment on specific questions regarding the concept paper. FDA is accepting public comments on the concept paper until April 12, 2021.

The concept paper focuses on medically important antimicrobial drugs administered through the medicated feed of food-producing animals. These products can only be used with the order of a licensed veterinarian. A limited number of medically important antimicrobials administered through animal feed include approved uses that lack a defined duration of use. This means the labeling for the identified product indication includes no information regarding the duration of administration or otherwise does not provide an appropriately targeted duration of use. The concept paper is limited to feed-use drugs because FDA has determined that all of the approved uses of medically important antimicrobial drugs in dosage forms other than feed already have appropriately defined durations of use.

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