On June 30, 2014, the Food and Drug Administration (“FDA”) released its first biannual progress report on its strategy to reduce antimicrobial resistance through the judicious use of antimicrobials, including in food-producing animals.

In December of 2013, FDA had imposed a three-year transition period in which it asked the animal pharmaceutical industry to voluntarily complete the recommended changes to its antimicrobial products, including the re-labeling of certain antimicrobials used in feed in two ways: by removing those indications approved for growth production/feed efficiency, and by requiring veterinary oversight and involvement to obtain these products for treating animals.

FDA reports that in the past six months, all 26 drug manufacturers affected by Guidance for Industry #213agreed to voluntarily engage in FDA’s strategy to phase out the use of medically important antimicrobials in food producing animals for food production purposes; and 31 out of the 283 drug products have been withdrawn from the market, while two other products underwent partial label changes.

FDA intends to update the public on the progress that drug sponsors have made in aligning their products with Guidance for Industry #213 every six months. These progress reports will continue to summarize current and pending actions taken by sponsors to align with the guidance, including the type of action and the type of animal for which the drug is approved for use and the type of application.

Leave a Reply

Your email address will not be published. Required fields are marked *