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FDA Aims To Enhance Antimicrobial Drug Use Data

The FDA is seeking comment on how to best access detailed information on antimicrobial drugs.

The FDA is seeking input on methods for assessing antimicrobial drug use in food-producing animals.

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The U.S. Food and Drug Administration is seeking public comment on how the agency can collect more detailed information on antimicrobial drug use and how best to disseminate that information without stepping on manufacturers’ toes, the FDA reported today.

Under current law, manufacturers are required to report how much of each antimicrobial product they sell and distribute and for which species the product is indicated. However, some classes of antimicrobials are indicated for more than one species, making it difficult for the FDA to determine how much of each product is being used in each species.

The Government Accountability Office concluded that the information collected by the FDA does not provide sufficient data to analyze trends in antimicrobial resistance, so the agency is requesting that manufacturers provide an estimate on how much of each drug is being used on each species.

The enhanced information would allow the agency to better correlate antimicrobial drug use to antimicrobial resistance, as measured by the National Antimicrobial Resistance Monitoring System.

The FDA also publishes antimicrobial sales and distribution reports for public consumption, but under current law the agency is allowed only to report those antimicrobial drug classes with three or more distinct sponsors, so as to protect confidential sales information. The agency is seeking comment on how best to compile and present summary information on antimicrobial use without disclosing the confidential sales data.

Finally, the FDA is seeking input on any other methods for assessing antimicrobial use in food-producing animals that would aid in comparing antimicrobial use to antimicrobial resistance.

Comments can be submitted electronically at www.regulations.gov. They also can be submitted via fax to 301-827-6879, or sent on paper or CD-ROM to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

All submissions must be received by Sept. 25, 2012 and should include Docket No. FDA-2012-N-0447.

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All comments will be posted at www.regulations.gov.

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