FDA wants species-level antimicrobial data

A proposal published in May would require drug companies to provide federal authorities estimated volumes of antimicrobials sold for use in each food animal species.

The Food and Drug Administration published the proposal in the Federal Register May 20 and is accepting comments through Aug. 18 at www.regulations.gov under docket number FDA-2012-N-0447.

The FDA has required data on total volumes of antimicrobials sold for use in food production since 2009, and it produced its first annual report on those data in 2010. But agency and food industry experts have said that the absence of details, such as sales categorized by species, has made interpreting trends in the data difficult (see JAVMA, June 15, 2015).

The proposed change would require additional species-specific estimates of product sales.

“Collecting species-specific data is expected to assist FDA in assessing antimicrobial sales trends in the major food-producing animal species and examining how such trends may relate to antimicrobial resistance,” the Federal Register notice states. “Having improved data would also support this Agency’s ongoing efforts to encourage the judicious use of antimicrobials in food-producing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans.”

Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine, said in an announcement that the proposal was a step toward giving the FDA and the public more details on changes in antimicrobial sales and distribution and that further actions are planned. Additional details about practices on farms are needed to understand links between antimicrobial usage and resistance development, the announcement states.

Agricultural use of antimicrobials is expected to change by the end of 2016, the FDA-imposed deadline for pharmaceutical companies to eliminate over-the-counter access to antimicrobials important for use in human medicine, require veterinarian oversight for use of those antimicrobials, and eliminate growth and production uses of those antimicrobials. Agency officials have threatened administrative action against companies that fail to follow these measures, and subsequent announcements have said all affected drug companies have agreed to comply.

Dr. Christine Hoang, assistant director of the AVMA Scientific Activities Division, said the AVMA commends the FDA and supports collection and analysis of more antimicrobial use data to better understand the factors contributing to the development of antimicrobial resistance and the transmission of resistance factors. But she said drug sales data alone would be insufficient for creating accurate estimates of antimicrobial use, “subjecting the data to serious misinterpretations.”

“Therefore, we encourage the FDA to continue exploring other factors and data streams for analyses,” of antimicrobial use, exposure, and risks, she said.

Related JAVMA content:

Antimicrobial sales outpace meat production (June 15, 2015)