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FDA to target some therapeutic, in-feed antimicrobials

The U.S. Food & Drug Administration announced Sept. 12 that 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 (GFI) #213, which will, once fully implemented, limit these drugs to therapeutic use only under a veterinarian's oversight, FDA 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 in the Sept. 12 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 to help preserve the effectiveness of these antimicrobials in animal and human medicine.

Specifically, for certain species and disease indications listed in the Federal Register notice, FDA wants to obtain additional information on:

* The underlying diseases requiring these drugs for therapeutic purposes and periods when livestock or poultry are at risk of developing these diseases;

* More targeted antimicrobial use regimens for these diseases and husbandry practices that may help avoid the need for the antimicrobials or that may help make more targeted antimicrobial use regimens more effective, and

* Strategies for updating affected labeling of drug products that do not currently include a defined duration of use.

This action furthers FDA's overall efforts to ensure that medically important antimicrobials are used only for health purposes in food animals, as outlined in GFI #213. In accordance with FDA's strategy, drug sponsors have committed in writing to changing the labeling of their medically important antimicrobials used in food animals. These changes, starting Jan. 1, 2017, are expected to result in these drugs being used for therapeutic animal health purposes only and under the oversight of a veterinarian.

FDA is accepting public comments for 90 days beginning Sept. 14. To electronically submit comments to the docket, visit, and type FDA-2016-D-2635 in the search box.

To submit comments to the docket by mail, use the following address: Division of Dockets Management, HFA-305, Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Be sure to include docket number FDA-2016-D-2635 on each page of written comments.

Additional Information

Judicious Use of Antimicrobials

Notice of Request for Comments; Durations of Therapeutic Administration; Judicious Use of Antimicrobials in Food-Producing Animals

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