The National Chicken Council filed comments on Monday with the Food and Drug Administration (FDA) in response to the agency’s Antimicrobial Drug Sales and Distribution Reporting Advanced Notice of Proposed Rulemaking (ANPR), which was published in the Federal Register on July 27, 2012. In response to industry requests for additional time, FDA officially extended the comment period setting the final submission date to November 26, 2012.
In the ANPR, FDA solicited comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008. 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. FDA contends that collecting data on antimicrobial drugs used in food-producing animals will assist in tracking antimicrobial use trends and in examining how such trends may relate to antimicrobial resistance in livestock and consequently in humans.
The comments submitted by NCC object to additional resources being spent on antimicrobial use data without first understanding the specific goals and objectives related to the collection of additional antimicrobial information. “Without clearly stated goals and without an assurance that additional information will not exacerbate the existing misinterpretation of antimicrobial use in the livestock industry, NCC does not believe that species-specific sales and distribution information will provide a public benefit. If the goal of antimicrobial use data is to assess the risk of antimicrobial use in food animals on public health, NCC urges FDA to work with the U.S. Department of Agriculture’s Agricultural Research Service scientists and laboratories on developing the appropriate rigorous research project.”
NCC continued to challenge FDA’s methodology and design for additional data, expressing serious concern that measuring antimicrobial sales or use is not an effective way to gauge the “success” of voluntary actions taken regarding antibiotic products. NCC’s final comments are available here.
