FDA’s annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals shows that antimicrobial sales decreased from 2015 to 2016. Domestic sales and distribution of all antimicrobials decreased by 10 percent and domestic sales and distribution of medically important antimicrobials decreased by 14 percent. In previous years (between 2009 and 2015), overall sales volumes increased annually.
FDA has published annual summary reports since 2009 in compliance with requirements established by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). ADUFA 105 requires antimicrobial drug sponsors to report to the FDA on an annual basis the amount of antimicrobial drugs sold or distributed for use in food-producing species during the prior year. ADUFA 105 also requires FDA to issue annual summary reports of sales and distribution data collected from sponsors each year, by antimicrobial class for classes represented by three or more distinct sponsors, and to provide those summaries to the public.
In May 2016, the agency issued a final rule revising its annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). The 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is the first annual summary report to include these species estimates. FDA anticipates that having these additional species-specific data will improve the agency’s understanding of sales and distribution data.
Sales data provide insight regarding antimicrobial drugs entering the marketplace, but additional sources of information should be considered when assessing progress of efforts to foster judicious antimicrobial use, including actual use data, animal demographics and animal health data, and data on resistance. DA continues to work with federal, academic, and industry partners to obtain more information about how, when, and why animal producers and veterinarians use medically important antimicrobial drugs in food-producing animals.