For Comment: FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

October 4, 2023 — 

Open for Public Comment: FDA Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

On September 25, 2023, the U.S. Food and Drug Administration released a draft guidance for industry (GFI) to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use.

When a drug lacks a defined duration of use, it means the labeling does not include information about how long a product can be administered for an approved indication.

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The recommendations in the draft guidance only affect medically important antimicrobials approved for use in or on the feed of food-producing animals.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 (e.g., injectable, intermammary, tablet, etc.) already 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(s) 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 FDA's judicious use efforts and are intended to help mitigate the development of antimicrobial resistance.

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FDA considered all information and public feedback received in response to the concept paper during development of this draft guidance.

Read AASV's comments to the concept paper at https://www.regulations.gov/comment/FDA-2016-D-2635-30670.

Review the draft and submit comments by December 26 HERE. Please share your comments with AASV by e-mailing AASV Director of Public Health and Communications Dr. Abbey Canon