FDA has issued its final rule that now requires drug companies to report sales data for all antibiotics purchased for use in 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 antibiotics they sell or distribute for use in food-producing animals.
“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,” says William T. Flynn, deputy director for science policy in the FDA’s Center for Veterinary Medicine.
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.