FDA Releases Fifth Progress Report on GFI #213

Lizzy SchultzAg Group, Animal Health, Antibiotics, FDA, Feed, Health, Pharmaceutical, Policy, Veterinary

FDA The U.S. Food and Drug Administration (FDA) has released its fifth progress report highlighting its recent actions to promote the judicious use of antimicrobials in food-producing animals with the publication of Guidance for Industry (GFI) #213.

All of the affected drug sponsors have committed in writing to making the changes described in the guidance by the end of 2016, and the FDA fully expects this process to be completed by the year-end deadline.

293 applications were initially affected by the Guidance, and many of these sponsors have already started implementing the recommended changes to their affected antimicrobial products. Four applications have been converted from over-the-counter to prescription dispensing status, production indications have been withdrawn from one application, and 41 affected applications have been completely withdrawn.

In May, the FDA sent a letter to affected drug sponsors, reminding them about the year-end deadline for aligning their product with GFI #213.

The FDA issued another letter last month that reminded retail establishments currently selling medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.

In order to provide resources for continued education and outreach during the implementation of GFI #213, the FDA has made presentations to dozens of stakeholders groups and responded to hundreds of individual questions over the past six months. Those interested in requesting a presentation on the judicious use of antimicrobials in food-producing animals, or those searching for more information, should contact the FDA Center for Veterinary Medicine at AskCVM@fda.hhs.gov.

To agency also issued a final rule on May 10, 2016 that revises the annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals, and will provide additional data intended to improve the understanding of how antimicrobials are sold or distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.