The Food and Drug Administration (FDA) released its 5th biannual progress report on the judicious use of antimicrobial drugs in food-producing animals, and the agency’s actions to promote judicious antimicrobial use. The agency has released reports since December 2013 outlining the measures that have been taken to meet the December 2016 deadline of Guidance for Industry (GFI) #213 asking animal drug sponsors to remove production uses from medically important antimicrobial drugs.
To date, all drug sponsors that are affected by GFI #213 have made written commitments to remove production uses from drug applications, and 41 affected applications have already been withdrawn from the market. Other affected products have been converted to prescription dispensing status, or have had production indications removed from the label.
The FDA also reported outreach activities to remind those affected by GFI #213 of what will be required, and how to prepare for the changes. On June 20, the agency issued a reminder letter to retail establishments that sell medically important antimicrobial drugs for use in food and water that those products will require either a prescription or veterinary feed directive (VFD) by January 1, 2017. The letter also advised retail establishments on handling current and future inventory of medically important antimicrobial drugs for use in feed or water. A copy of the letter may be found here.
The agency has additionally announced research grants for on-farm antimicrobial data collection projects, with funds for two awards of up to $300,000 per individual awardee. These grants aim to fund data collection efforts on baseline information about antimicrobial use in cattle, swine, chickens, and turkeys. These data collection efforts are in addition to the final rule issued by the FDA on May 10, 2016, requiring drug sponsors to report estimates of antimicrobial sales to each major food-producing species. The final rule for Antimicrobial Animal Drug Sales and Distribution by individual species may be found here.
A link to the full progress report by the FDA may be found here.
