FDA may gather more antimicrobial data

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Federal drug authorities may start collecting data that would indicate the total amounts of antimicrobials sold or distributed for use in particular livestock species.

The Food and Drug Administration published in late July a proposal to supplement its data on overall antimicrobial sales and distribution. Starting in 2010, the agency began releasing annual reports on the total kilogram weights of antimicrobial classes sold for use in all food-producing animals, but those reports do not distinguish how much of each class was used in a particular species.

The notice, which appeared in the July 27 issue of the Federal Register, indicated that a September 2011 Government Accountability Office report, “Antibiotic resistance: Agencies have made limited progress addressing antibiotic use in animals,” had concluded that the antimicrobial sales and distribution information collected by the FDA provided insufficient data for analyzing trends in resistance. Data on drug use in specific food-producing species would help determine whether resistance data were correlated with drug exposure data and help the FDA make decisions on approval and monitoring of antimicrobials.

The notice also indicates collecting such data would be consistent with recommendations published in April 2012 on the judicious use of medically important antimicrobials in food-producing animals. Through that guidance document, the FDA described its plans for reducing the risks posed by antimicrobial resistance by limiting uses in livestock of antimicrobials important for human medicine and increasing veterinarian oversight and consultation for the remaining uses.

The FDA is accepting comments on the proposal through Sept. 25. For more information, search for the docket number, FDA-2012-N-0447, at www.regulations.gov.