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FDA Tightens Reporting Rules for Antimicrobials Used in Animals
As part of its drive to slow the development of antimicrobial resistance, the FDA has revised annual reporting requirements for all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals.
Companies must now estimate sales broken down by major food-producing species (cattle, swine, chickens, and turkeys) in addition to the overall estimates they already submit on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. The new data will improve the agency’s understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.
“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” said Dr. William T. Flynn, DVM, deputy director for science policy in the FDA’s Center for Veterinary Medicine.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and 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. Prior to finalizing this rule, animal drug sponsors were not required to submit sales or distribution data by species.
Adding the requirement for sponsors to report species-specific sales estimates will also complement the data collection plan the FDA is developing, as part of the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, 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 important for providing a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture.
The final rule also includes a provision to improve the timeliness of annual reports by requiring the FDA to publish its summary report of the antimicrobial sales and distribution information it collects for each calendar year by December 31 of the following year.
The rule, proposed in May 2015, takes into consideration hundreds of public comments from the veterinary community, animal feed manufacturing and livestock production associations, drug manufacturers, consumer groups, and other stakeholders. Drug sponsors are required to comply with the reporting requirements in the final rule when submitting their reports covering the period of calendar year 2016.
Source: FDA; May 10, 2016.