Antimicrobial Animal Drug Sales and Distribution Reporting

August 18, 2015 The Honorable Stephen Ostroff, M.D. Acting Commissioner U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 RE: Docket No. FDA-2012-N-0447, Proposed Rule on Antimicrobial Animal Drug Sales and Distribution Reporting Dear Acting Commissioner Ostroff: The Natural Resources Defense Council, an environmental organization that seeks to protect public health, welcomes the opportunity to comment on the enhanced data collection strategy proposed by the Food and Drug Administration on antibiotic sales in food animals. Antibiotic resistance is a public health crisis. Common procedures like transplant surgeries, dialysis, chemotherapy, caesarian sections - modern medicine as we know it - are at risk because antibiotics are losing their efficacy. Both the Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic use in animal agriculture as a contributor to antibiotic resistance. Accurate data on where and how antibiotics are used is necessary to identify trends in usage trends that lead to antimicrobial resistance, for educational stewardship programs, and to assess any progress in reducing antibiotic overuse, such as under the FDA's Guidance for Industry #213 (Guidance 213). Because the FDA clearly has the authority and public health mandate to collect such data, and because of the urgent need for comprehensive data on antibiotic use in farms, we again urge the FDA to use its authority to collect data from manufacturers of medicated feed to obtain the clearest picture of current antibiotic use. Records are kept for two years at these feed mills, which should allow FDA to put measures into place that would facilitate the collection of usage records. Furthermore, FDA could ensure confidentiality by aggregating the data released in its yearly report. While we appreciate the FDA's efforts to date to gather information on antibiotic sales at the animal species level, these efforts are not sufficient. The most accurate data cannot be obtained from drug labels where multiple species are listed and where a significant fraction therefore may be categorized as having been administered to an unknown species. In addition, apart from what we are urging above, there are no other efforts in coordination with CDC or USDA that would provide more accurate information regarding on farm antibiotics use. The USDA publicly states that without additional funding, it will undertake no additional actions on data collection, including longitudinal studies on farm antibiotic use data, in their proposed Antimicrobial Resistance Action Plan.* Clearly, the FDA can and must do more to collect the best possible data on antibiotic use at the farm level, and feed mill data is a good place to start. We urge the FDA to put forth the best data available so that scientists, policy makers, veterinarians, farmers, public health advocates and all other concerned stakeholders can use the best information to find solutions and stem the tide of antibiotic resistance. The public's health demands no less. Thank you for your consideration. Sincerely, Carmen Cordova, Ph.D. Staff Scientist David Wallinga, M.D., MPA Senior Health Officer * http://www.usda.gov/documents/usda-antimicrobial-resistance-action-plan.pdf, p. 2

Attached please find a copy of NRDC's comments on FDA's Advanced Notice of Proposed Rulemaking for Antimicrobial Animal Drug Sales and Distribution Reporting.