FDA gains industry engagement on antimicrobial resistance plan

Six-month progress reports will be issued on drug label changes

The U.S. Food and Drug Administration (FDA) has announced the first of its progress reports on its strategy to promote the judicious use of antimicrobials in food-producing animals. All 26 drug manufacturers affected by Guidance for Industry(GFI) #213 have now agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs.

While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.

FDA will update the public on the progress drug sponsors have made in aligning their products with GFI #213 and intends to do so on a six-month basis. FDA’s progress reports will summarize current and pending actions taken by sponsors to align with the guidance, including the type of action (e.g., withdrawal, change in marketing status) and, when possible without revealing confidential business information, the type of animal for which the drug is approved for use and the type of application (pioneer, generic, combination).

The FDA’s reports on progress in the animal health industry’s engagement in GFI #213 are available here.