U.S. FDA, For Industry,
Animal Drug User Fee Act (ADUFA) 05/19/2015
In May 2015, the FDA issued a proposed rule to obtain more detailed information about antimicrobials sold or distributed for use in food-producing animals by including estimates of sales data by species. The additional data would improve understanding about the extent to which 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. It would also assist the agency in measuring the effectiveness of those efforts.
The U.S. Food and Drug Administration needs to hear from people like you
The proposed rule, if finalized, would require animal drug sponsors to submit species-specific estimates of antimicrobial sales for cattle, swine, chickens, and turkeys. The proposed rule also includes a provision to improve the timeliness of FDA’s annual summary report of these sales data by requiring the FDA to publish its annual summary report of antimicrobial sales and distribution information by December 31 of the following year.
Sources and more information
- FDA proposes rule to collect antimicrobial sales and distribution data by animal species, Additional data to help Agency further target efforts to ensure judicious use of medically important antimicrobials, FDA News, May 19, 2015.
- Support FDA’s Proposal to Collect More Data on Antibiotics in Agriculture!, The Pew Charitable Trusts.
- Support FDA’s Call for Data on Antibiotics in Agriculture!, ecocenter, August 12, 2015.