In the progress report, FDA said the agency continues to work with affected drug manufacturers to ensure changes are completed by the end of December 2016. The agency noted plans to use a variety of metrics to assess the effects of Guidance #213 over time, such as existing drug sales, resistance and additional on-farm data.
Regarding other findings in the report, FDA said 283 applications were identified as being affected by Guidance #213 in March 2014. Since then, 10 new generic and combinations approvals were added to the list of affected antimicrobial applications in food-producing animals.
Some drug makers have already started implementing FDA's recommendations. For example, three applications were converted from over-the-counter availability to prescription-dispensing status.
Guidance #213 reflects FDA's current thinking on the use of medically important antimicrobial drugs for production purposes. The agency now believes that use of antimicrobials in food-producing animals does not represent judicious use.
“FDA believes that production use indications such as “increased rate of weight gain” or “improved feed efficiency” are no longer appropriate for the approved conditions of use for medically important antimicrobial drugs,” the report said.
Production indications have been withdrawn from one application, the report noted, while 32 affected applications were completely withdrawn. But drug manufacturers remain committed to participating in the Guidance #213 strategy, FDA said.
“One drug sponsor who was not previously affected by GFI #213, Pharmgate LLC, acquired all of the affected applications of Pennfield Oil Co. and ADM Alliance Nutrition Inc. Pharmgate has notified the agency in writing of its intent to engage in the judicious use strategy as outlined in GFI #213,” FDA said in the report said.
