FDA Releases Final Antimicrobial Sales Rule

Lizzy SchultzAg Group, Animal Health, Antibiotics, FDA, Policy, Veterinary

FDA The U.S. Food and Drug Administration (FDA) has issued the final rule and revision regarding the annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales by major food-producing species (cattle, swine, chickens, and turkeys). The revisions will improve industry understanding of how antimicrobials are sold or distributed for use in major food-producing species, and intends to help further target efforts to ensure judicious use of medically important antimicrobials.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to annually report the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals to the FDA, including those antimicrobials used in human medicine. The revision adds the requirement for sponsors to report species-specific sales estimates will complement the data collection plan we are developing to obtain additional on-farm use and resistance data.

The collection of data from multiple sources, including enhanced sales data from antimicrobial animal drug sponsors, is needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture.

ADUFA 105 also requires that FDA begins to issue annual summary reports for these sales, as well as distribution data collected from sponsors. The law requires that these data be reported out by antimicrobial drug class. To report summary data in a manner protective of both national security and confidential business information, only those antimicrobial drug classes and other categories with three or more distinct sponsors of approved and actively marketed animal drug products are independently reported. The final rule will include a provision that improves the timeliness of this annual summary report by requiring that FDA publish the report by December 31 of the following year.