The US Food and Drug Administration is proposing revisions to its 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 additional data would improve understanding about how antimicrobials are sold or distributed for use in major food-producing species and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials. The proposed rule also includes a provision to improve the timeliness of the report by requiring the FDA publish its annual summary report of antimicrobial sales and distribution information by December 31 of the following year.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to the FDA on an annual basis the amount of all antimicrobial drugs they sell or distribute for use in food-producing animals, including those antibiotics not used in human medicine. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public.
Current regulatory authority limits the data collection that FDA can mandate to antimicrobial sales and distribution information. While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance. FDA is actively engaged with the US Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need.