FDA proposes rule to collect antimicrobial sales and distribution data by animal species

The FDA has proposed a rule requiring animal drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). This data would be used in an effort to better understand how antimicrobials are sold or distributed for use in major food-producing animals, and to help the FDA target its efforts to ensure the appropriate use of medically important antimicrobials.PharmaDrugs

The AVMA has long supported the responsible therapeutic use of antimicrobials under veterinary oversight for treatment, control, and prevention of disease; for the protection of animal health and welfare; and for the protection of public health. We commend the FDA’s ongoing efforts to encourage judicious use in food animals to help ensure continued availability of safe and effective antimicrobials for animals and humans. The AVMA supports the collection and analysis of additional antimicrobial use data to better understand the many factors that contribute to antimicrobial resistance development and transmission. Understanding that species specific data is expected to assist FDA in assessing and evaluating sales trends and the potential relationship to resistance, the AVMA has recommended that sales and distribution information for individual animal species be provided.

We think it’s important to note, however, that sales data alone—even if segregated by species—does not provide enough information for an accurate estimation of use, subjecting the data to serious misinterpretations. Thus, the AVMA strongly discourages analyses of antimicrobial usage, exposure, or risk of development and transmission of resistance based upon such data alone, and we encourage the FDA to continue exploring other factors and data streams related to antimicrobial resistance in food-producing animals.

The AVMA will be reviewing the proposed rule and associated information and will provide our feedback to the FDA. To provide your feedback to the AVMA, email regulatorycomments@avma.org. To respond directly to the FDA, you can do so electronically at www.regulations.gov or via the mail to: Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

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