FDA to revise annual antimicrobial reporting

FDA to revise annual antimicrobial reporting

IN an effort to improve transparency about the amount of antimicrobials sold or distributed for use in food-producing animals, the U.S. Food & Drug Administration announced Sept. 25 a proposal to provide additional data tables in its annual summary report of this information.

The proposal is available for public comment until Nov. 25.

The Animal Drug User Fee Amendments of 2008 (ADUFA) established a requirement that animal drug companies annually report to FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals, the agency explained.

ADUFA also requires that FDA provide summaries of these sales and distribution data by antimicrobial class and directs the agency to independently report only those antimicrobial drug classes that contain drug products marketed by three or more distinct animal drug companies in a manner that protects both national security and confidential business information, FDA noted.

In July 2012, FDA asked for public comments on possible enhancements to the existing requirements related to the collection of antimicrobial drug sales and distribution data and input on alternative methods for monitoring antimicrobial use in food-producing animals. FDA also requested comments on how the agency can best compile and present its annual "Summary Report of Antimicrobials Sold or Distributed for Use in Food-Producing Animals" to provide additional clarity and level of detail while still protecting confidential business information.

FDA said many of the comments it received suggested that FDA provide breakdowns of the sales and distribution data by route of administration (such as oral or injectable), dispensing status (over the counter, prescription or veterinary feed directive) or indication (whether it is used as a therapeutic, a growth promoter or both).

FDA said the proposed additions to the report expand the current format of sales and distribution data by antimicrobial class to include information on the importance of the drug in human medicine, then providing aggregate data on how the medication is administered to the animal, whether it is available over the counter or requires veterinary oversight and whether it is used as a therapeutic, a growth promoter or both.

FDA said it is also proposing to update the annual reports from previous years to include the new data tables.

Comments on the proposal may be submitted at www.regulations.gov by entering docket number FDA-2012-N-0447.

Volume:85 Issue:40

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