December 22, 2016
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 report shows that sales and distribution of all antimicrobials increased 1 percent from 2014 through 2015, tying for the lowest annual increase since 2009. The percentage of those antimicrobials that are considered medically important in human medicine increased by 2 percent from 2014 through 2015.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to FDA on an annual basis the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. This sales and distribution information does not necessarily represent actual use of the products. For example, drug products entering the market may not necessarily be distributed all the way to the farm; veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals, or they may administer them in later years. The FDA is working with federal, academic and industry partners to obtain more information about how, when, and why animal producers and veterinarians use those classes of antimicrobial drugs that are important to human medicine.
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 in order to obtain estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). This breakdown by species will not appear in the FDA’s annual summary reports until the report covering calendar year 2016. The final rule includes a provision requiring the FDA to publish the annual summary report for each calendar year by December 31st of the following year.
The FDA’s Guidance for Industry #213, which pertains to medically important antimicrobials used in the feed or water of food-producing animals, established a target date of December 31, 2016, for drug sponsors to voluntarily make changes to affected products to remove production indications (growth promotion and feed efficiency) and move the products from over-the-counter availability to veterinary feed directive or prescription status. Once these changes are made, use of these products for production indications will be illegal and the remaining therapeutic uses for the treatment, control, or prevention of a specifically identified disease will be limited to use under veterinary oversight. Given that GFI #213 is not expected to be fully implemented until the end of 2016, it is premature to expect to see consequential data shifts in the 2015 annual report.
Please see the 2015 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals for more information.
2015 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals(PDF - 649KB) Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals ADUFA Reports
- ADUFA 105: Final Rule to Collect Antimicrobial Sales and Distribution Information by Animal Species