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FDA releases antimicrobial progress report

Agency to hold public meeting on use of antimicrobials in food-producing animals.

The U.S. Food & Drug Administration announced Aug. 21 its third progress report highlighting recent actions to promote the judicious use of antimicrobials in food-producing animals.

Additionally, the agency announced open registration for a public meeting to obtain stakeholder input on approaches for collecting on-farm antimicrobial drug use and resistance data.

There were 293 applications initially affected by Guidance For Industry #213, which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to voluntarily 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 reported that all of the affected drug sponsors have committed in writing to making the changes described in the guidance and some of sponsors have already started implementing the recommended changes to their affected antimicrobial products: 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have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application, and 32 affected applications have been completely withdrawn.

Public meeting

Gathering information on the way medically important antibiotics are used is essential to measuring the impact of FDA's judicious use strategy as outlined in Guidance for Industry #213. FDA currently collects sales data on antimicrobial drugs sold for use in food-producing animals (reported under section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105)) and data on antimicrobial resistance (collected under the National Antimicrobial Resistance Monitoring System (NARMS)). However, the agency recognizes that additional information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance.

FDA, U.S. Department of Agriculture and the Centers for Disease Control & Prevention are working together to develop and implement a plan to collect additional data on antibiotic use in food-producing animals and will conduct a jointly sponsored public meeting to obtain input on approaches for collecting on-farm antimicrobial drug use and resistance data.

The public meeting will be held on Sept. 30, 2015, from 8:00 a.m. to 4:30 p.m. at the Jefferson Auditorium, 14th and Independence Avenue SW, Washington, DC 20201.

On-farm use data collection is consistent with objectives outlined in the National Action Plan for Combating Antibiotic-resistant Bacteria to enhance monitoring of antimicrobial-resistance patterns, as well as antimicrobial sales, usage and management practices, at multiple points in the production chain for food-producing animals and retail meat.

Early registration for the public meeting is recommended because seating is limited. Due to limited resources, the meeting will not be webcast. A recording of the meeting will be available approximately 60 days after the meeting takes place.

Attendees may register, ask general questions about the meeting, request an opportunity to make an oral presentation or request special accommodations due to a disability by contacting Kelly Covington, Food & Drug Administration, Center for Veterinary Medicine (HFV-6), 7519 Standish Pl., Rockville, MD 20855, 240-402-5661, email: Kelly.Covington@fda.hhs.gov.

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