January 11, 2021


US FDA seeks public comment on durations of use for antimicrobials 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.

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. For some of these products, labelling for the identified product indication includes no information regarding the duration of administration or otherwise does not provide a targeted duration of use. FDA has determined that all of the approved uses of medically-important antimicrobial drugs in dosage forms other than feed already have defined durations of use.

Today, there are 89 approved animal drug applications for medically-important antimicrobials that have one or more indications without a defined duration of use. These make up approximately 28% of all medically-important antimicrobials approved for administration through animal feed.

In the potential approach described in the concept paper, the process for voluntarily revising the conditions of use (e.g., dosage regimen, instructions for use, etc.) would involve sponsors working with FDA to make changes to the approved labelling.

FDA is accepting public comments on the concept paper until April 12, 2021. More information is available at: https://www.fda.gov/animal-veterinary/cvm-updates/fda-seeks-public-comment-potential-approach-defining-durations-use-certain-medically-important