The US Food and Drug Administration have finalised a rule that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption or food-producing animals.
Companies are now required to provide estimates of 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 sales 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, D.V.M., M.S., deputy director for science policy in the FDA’s Center for Veterinary Medicine.
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 Dec. 31 of the following year.
The rule was proposed in May 2015, and 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.
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