CU comments to FDA on their Advanced Notice of Proposed Rulemaking (ANPR) on Antimicrobial Animal Drug Sales and Distribution reporting

Comments of Consumers Union on
Food and Drug Administration (FDA) Advanced Notice of Proposed Rulemaking: Antimicrobial Animal Drug Sales and Distribution Reporting
Docket No. FDA-2012-N-0447
Prepared by Michael Hansen, Ph.D.
Senior Scientist
November 26, 2012

Consumers Union1 (CU) welcomes the opportunity to comment on the U.S. Food and Drug Administration’s (FDA) Advanced Notice of Proposed Rulemaking (ANPR) on antimicrobial animal drug sales and distribution reporting. We commend FDA for addressing the problem of overuse of antibiotics in food animals, which has created a serious global public health problem for both human and animals, and for the agency’s attempts to reduce the injudicious use of antimicrobials in food-producing animals in order to help minimize antimicrobial resistance development. We also commend FDA for soliciting public comments on how to improve both data collection and public reporting of antimicrobial drug sales in order to better monitor the growing threat of antimicrobial resistance.

Last year, the U.S. Government Accountability Office (GAO) recommended that FDA collect “more detailed data on antibiotic use in food animals, including the species in which antibiotics are used and the purpose of their use” so as “To track the effectiveness of policies to curb antibiotic resistance, including FDA’s voluntary strategy to reduce antibiotic use in food animals.”2 We strongly agree with GAO’s recommendations and believe that FDA needs both to collect more data on antibiotic sales and use in livestock, poultry and aquaculture and report those data to the public so as to determine if the FDA’s voluntary guidance approach, e.g. Guidelines for Industry (GFI) 2093 and 2134, is achieving its goals of reducing injudicious antimicrobial use and
having the desired public health outcome of minimizing antimicrobial resistance development.

In general, CU believes that FDA should require companies to report sales and distribution data for each food-producing animal species for each antimicrobial active ingredient sold, and that FDA should release far more of the data collected as a result of Section 105 of the Animal Drug User Fee Amendments (ADUFA) of 2008. In addition, FDA should require annual reporting of data regarding antimicrobial drugs added to animal feed, as part of the Veterinary Feed Directive regulations, by veterinarians and feed mills in a standardized format and should aggregate those data into a publicly available registry that reports data for each separate food-producing animal species, by state and by month.

For the full comments, click here (PDF).