The U.S. Food and Drug Administration on Tuesday finalized a rule available here 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 to FDA on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. Prior to finalizing this rule, animal drug sponsors were not required to submit sales or distribution data by particular species.
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. FDA also said that adding the requirement for species-specific sales estimates will compliment the data collection plan FDA is developing, as part of the National Strategy for Combating Antibiotic-Resistant Bacteria with USDA and the Centers for Disease Control and Prevention.
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 December 31 of the following year.
“The National Chicken Council supports the efforts of the USDA and FDA to monitor antimicrobial resistance and their work with the agricultural community to discuss methods of judicious use and stewardship. Research initiatives such as the NARMS and NAHMS reports provide valuable information to the public, as well as to broiler chicken producers. The continued reliance on antimicrobial sales and distribution data unfortunately dilutes and distorts the information provided by NARMS and NAHMS, and NCC believes that the collection of species-specific data would contribute to consumer confusion and negative perception regarding agricultural animal production without providing a public health benefit,” said Ashley Peterson, Ph.D, NCC senior vice president of scientific and regulatory affairs.
We are deeply disappointed that many comments were not considered by the FDA as the agency finalized this rule,” Peterson said.
The rule was first proposed in May 2015.
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