October 26, 2023

Interpretive Summary: FDA guidance regarding antimicrobial drugs in livestock open for public comments

FDA guidance regarding antimicrobial drugs in livestock open for public comments 

By: Sydney Sheffield 

The United States Food and Drug Administration (FDA) has published draft guidance for defining the appropriate duration of use in antibiotics used in the feed of food-producing animals and is seeking public comment. The guidance provides information to sponsors of certain antimicrobial animal drug products who are interested in voluntarily establishing appropriately defined durations of therapeutic administration to food-producing animals where none currently exist. The guidance also proposes timelines for stakeholders wishing to comply voluntarily with this guidance.

In September 2018, the FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings. The draft guidance builds upon the work the Center for Veterinary Medicine (CVM) has already taken to support the prudent use of antimicrobials in animals and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases.

In January 2021, the FDA published and sought public comment on the “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” The FDA considered all information and public feedback received in response to the concept paper during the development of this draft guidance. 

The draft guidance includes an action item intended “to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.” As of September 25, 2023, there are nearly 100 approved animal drug applications for medically important antimicrobials that have one or more indications without a defined duration of use. 

The recommendations in the draft guidance only affect medically important antimicrobials approved for use in or on the feed of food-producing animals.  All approved uses of medically important antimicrobial drugs in other dosage forms, such as injectables, intermammary, or tablets, currently have appropriately defined durations of use.

Revising product use conditions of affected products to better target when and for how long a drug may be used to effectively treat, control, or prevent the disease for which the product is indicated provides for the continued effective use of these products while minimizing the extent of antimicrobial drug exposure. These changes support the FDA’s judicious use efforts and are intended to help alleviate the development of antimicrobial resistance. 

The FDA is accepting public comments on the draft guidance through December 26, 2023. To electronically submit comments to the docket, visit the website and search for the docket number (FDA-2023-D-2925). To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2023-D-2925 on each page of your written comments.  

Read the draft guidance here