Agency requests information on how to establish appropriate durations of use for therapeutic products
The U.S. Food and Drug Administration (FDA) 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 #213, which will, once fully implemented, limit the use of these drugs to therapeutic-only use under the oversight of a veterinarian, it is now turning its attention to ways to address those antimicrobials that may 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 approved therapeutics that lack defined durations of use on their labels.
In a notice published in the Federal Register, the agency requests information from the public about how to establish appropriately targeted durations of use for the approximately 32 percent 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 help preserve the effectiveness of these antimicrobials in animal and human medicine. Specifically, for certain species and disease indications as listed in the FR notice, the 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 these 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.
The action furthers the FDA’s overall efforts to ensure medically important antimicrobials are used in food animals only for health purposes as outlined in the agency’s GFI #213. In accordance with the FDA’s strategy, drug sponsors have committed in writing to changing the labeling of their medically important antimicrobials used in food animals. These changes are expected to result in these drugs only being used for therapeutic animal health purposes under the oversight of a veterinarian starting January 1, 2017.
The FDA is accepting public comments for 90 days beginning on September 14. To electronically submit comments to the docket, visit http://www.regulations.gov and type FDA-2016-D-2635 in the search box.
To submit comments to the docket by mail, use the following address. Please be sure to include docket number FDA-2016-D-2635 on each page of your written comments.
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