FDA Policy/General

Animal Antimicrobial Reporting Rules Changed

FDA has finalized a rule that revises the annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in animals intended for human consumption. Under the revised rule, companies are now required to provide estimates of sales broken down by major food-producing species 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.

An agency statement says that the new sales data will improve its 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.

Adding the requirement for sponsors to report species-specific sales estimates will also complement the data collection plan FDA is developing as part of the National Strategy for Combating Antibiotic-Resistant Bacteria with the Department of Agriculture and the Centers for Disease Control and Prevention, the statement says. 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, it adds.

The final rule also includes a provision to improve the timeliness of annual reports by requiring FDA to publish its summary report of the antimicrobial sales and distribution information it collects for each calendar year by 12/31 of the following year.

The rule was proposed 5/2015 and the finalized version 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, FDA says. Drug sponsors are required to comply with the reporting requirements in the final rule when submitting their reports covering calendar year 2016.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome