December 7, 2017
The U.S. Food and Drug Administration today published its annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals. The 2016 report shows that antimicrobial sales decreased from 2015 to 2016, with domestic sales and distribution of all antimicrobials decreasing by 10 percent and domestic sales and distribution of medically important antimicrobials decreasing by 14 percent. In previous years (between 2009 and 2015), overall sales volumes increased annually.
The 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 the 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. The FDA 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.
2016 Summary Report Key Points
- The 2016 Summary Report does not reflect changes made under Guidance for Industry (GFI) #213. The 2016 Summary Report captures data for the 2016 calendar year (January 2016 to December 2016). It does not account for changes in sales or distribution resulting from the implementation of the FDA’s GFI #213. On Jan. 1, 2017, in response to GFI #213, drug sponsors, working together with the Agency, voluntarily transitioned their medically important antimicrobials used in the feed or water of food-producing animals from over-the-counter to either prescription or Veterinary Feed Directive marketing status, and withdrew approval of all production indications (growth promotion and feed efficiency) for the affected products.
- Sales and distribution information does not represent actual use of the products. It is important to acknowledge that these data are sponsor estimates of product sales and are not intended to be a substitute for actual usage data. For example, veterinarians and animal producers may purchase drugs, but never actually administer them to animals, or they may administer the drugs in later years.
- Species-specific sales estimates should not be directly compared. There are a variety of factors that confound direct comparison of species-specific sales estimates, including differences in population size, weight, lifespan, and drug metabolism.
- 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- ADUFA Reports
- Final Rule to Collect Antimicrobial Sales and Distribution Information by Animal Species