News & Events

FDA In Brief: 2016 annual summary report of sales and distribution data for antimicrobial drugs intended for use in food-producing animals

For Immediate Release: Dec. 7, 2017

Media Inquiries

  Juli Putnam

"Dr. William T. Flynn, D.V.M., deputy director for science policy, FDA’s Center for Veterinary Medicine. “While the decline in antimicrobial sales in 2016 when compared to 2015 is noteworthy, additional sources of information are necessary to give a fuller picture of progress being made to foster antimicrobial stewardship in veterinary settings. The agency is fully committed to ensuring the judicious use of these lifesaving drugs in both animals and people so that we can preserve their effectiveness for years to come."

The U.S. Food and Drug Administration today published its annual report summarizing sales and distribution estimates for all antimicrobial drugs approved for use in food-producing animals. The report issued today shows that antimicrobial sales decreased from 2015 to 2016 with domestic sales and distribution of all antimicrobials decreasing by 10 percent during this time period, and domestic sales and distribution of medically important antimicrobials decreasing by 14 percent. Overall sales volumes increased annually between 2009 and 2015.

This 2016 report reflects the first time that animal drug sponsors were required to report estimates of species-specific sales and distribution data for antimicrobials. This additional information will improve the FDA’s understanding of sales and distribution data, but it is important to recognize that these estimates of product sales do not substitute for actual species-specific usage data. While sales data provide insight on antimicrobial drugs entering the marketplace, more data should be considered in order to accurately assess the progress of efforts to foster judicious antimicrobial use, such as data on actual use, animal population demographics, and animal health, plus data on resistance trends. The FDA continues to work with federal, academic, and industry partners to learn more about how, when, and why animal producers and veterinarians use medically important antimicrobial drugs.

The 2016 annual report summarizing antimicrobial sales and distribution data covers a time period prior to full implementation of FDA’s Guidance for Industry (GFI) #213, which led to the transition of 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, as well as the removal of all production indications (growth promotion and feed efficiency) from these products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Page Last Updated: 12/07/2017
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