FDA releases update on antimicrobial oversight plan, guidance 213

FDA releases update on antimicrobial oversight plan, guidance 213

FDA is working with USDA and CDC to hold a spring 2015 to discuss ways to collect and use on-farm antimicrobial use data

The U.S. Food and Drug Administration on Thursday announced its second progress report on Guidance 213, its strategy to promote the judicious use of antimicrobials in food-producing animals.

The guidance calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to remove from their product labels indications for use related to growth promotion, and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016.

FDA is working with USDA and CDC to hold a spring 2015 to discuss ways to collect and use on-farm antimicrobial use data

In March 2014, 283 applications were identified as being affected by Guidance 213. Since that time, 11 new generic and combination approvals were added to the list of affected applications; by law, the agency has no basis for refusing to approve these applications as long as they meet regulatory standards for approval.

Related: Time growing short for most antimicrobials in feed and water

Some affected drug sponsors have already started implementing the recommended changes to their affected antimicrobial products, FDA said: Three applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 32 affected applications have been completely withdrawn.

Sponsors of all of the affected applications, including the additions, remain committed to participating in the strategy.

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.

The FDA said it continues to work closely with affected drug sponsors to help ensure that the changes they agreed to make as described in GFI 213 are completed in an orderly manner by the end of December 2016.

Related: FDA Touts Acceptance of Animal Antibiotic Plan, But Groups Uncertain

The FDA also intends to use a variety of metrics to assess the effect of these changes over time, including existing data on drug sales and resistance as well as additional on-farm data, it said.

FDA also is working with the USDA and Centers for Disease Control to hold a joint public meeting in the spring of 2015 to discuss ways to collect and use on-farm use data.

Details of the public meeting will be released closer to the meeting date, FDA said.

TAGS: Regulatory
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