FDA Accepting Comments on GFI #213

Lizzy SchultzAg Group, Animal Health, Antibiotics, FDA, legislation, Veterinary

FDA The U.S. Food and Drug Administration (FDA) has announced that the agency is entering the next phase of efforts to mitigate antimicrobial resistance through Guidance for Industry #213 (GFI #213), which will, once fully implemented, limit the use of medically important antibiotics to therapeutic-only use under the oversight of a veterinarian.

The FDA has announced that it is shifting its attention to ways to address those antimicrobials that may currently be legally used in food animals for no defined length of time.

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, but the language of the guidance does not address some of the currently approved therapeutics that lack defined durations of use on their labels.

TheFederal Register published a notice this week that requests information from the public on the best ways to establish appropriately targeted durations of use for the approximately 32% of therapeutic products affected by GFI #213 with no defined duration of use.

The FDA specifically 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

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

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