The U.S. Food and Drug Administration proposed a rule that would require animal drug sponsors of all 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). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals 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 to 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) 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 that are 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. Currently, animal drug sponsors are not required to submit sales or distribution data by particular species.
Tuesday May 19, 2015/ FDA/ United States.