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FDA Seeks Input on Potential Changes to Antimicrobial Drug Reporting

The U.S. Food and Drug Administration is seeking comments on a proposal to make changes to the reporting requirements for antimicrobial sales and distribution.

The agency said in a Federal Register notice that it is considering revisions to the regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported.

“Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance,” read the notice.

As the policy stands now, companies that make approved antimicrobial drugs for multiple animal species — including both food-producing and nonfood-producing animals — do not report sales and distribution information for each individual animal species. Drug sponsors currently only report total product sales. The information must be reported for the preceding calendar year, and include separate information for each month of the calendar year, and be submitted to FDA each year by no later than March 31. ADUFA 105 also requires the agency to publish a summary report of the antimicrobial sales data.

The notice points out that a recent Government Accountability Office report concluded that the information collected by FDA “does not provide sufficient data needed to analyze trends in antimicrobial resistance, such as information on actual drug use in specific food-producing animal species.”

Having better data would help FDA analyze resistance trends and would better support the work of the National Antimicrobial Monitoring System (NARMS): “Improved data would enable the Agency to better correlate resistance trends data in NARMS with drug exposure, thereby providing improved information for science-based decisionmaking int he approval and monitoring of safe and effective antimicrobial drugs.”

FDA is seeking comments specifically on whether it should amend the regulation to require the submission of additional data, including (for antimicrobial drug products that are approved and labeled for more than one food-producing species) an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each species: “Specifically, comments should address how sponsors can both practically and accurately provide separate sales and distribution information for each species.”

The agency is accepting electronic or written comments until Sept. 25. To submit comments electronically, see the Federal eRulemaking Portal and follow the instructions for submitting comments.

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