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New FDA rule that revises its annual reporting requirements

The Food and Drug Administration revised its rule on 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.

FDA said 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.  The 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 Animal Health Institute, which represents companies such as Bayer, Elanco and Phibro, said they're disappointed in the final rule. AHI said in a statement that the rule will result in an inaccurate representation of the data and estimating sales data will lead to imprecise numbers that will be used as definitive measures of antibiotic use.

The industry group is encouraging the FDA to reconsider this ruling and instead, develop a comprehensive plan for antibiotic data collection that is clear in its goals and provides information that will aid all users in making decisions about the use of antibiotics.


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