October 2, 2014
The U.S. Food and Drug Administration has published its fourth annual report summarizing the sales and distribution data of antimicrobial drugs approved for use in food-producing animals. Additional data tables have been added to this latest 2012 report to provide more detailed information and to improve transparency, and the same tables have also been added to the summary reports for the previous years (2009-2011).
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. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public.
Trends from 2009 through 2012 reflected in this year’s summary report include:
- The total quantity of medically important antimicrobials sold or distributed for use in food-producing animals increased by 16 percent over the period 2009-2012. The reason for the increase is unclear, but many factors (such as disease outbreaks and fluctuations in animal populations) could lead to transient increases or decreases of sales of certain drugs in given years.
- The percentage of domestic sales and distribution of medically important antimicrobials that are approved for production use decreased from 72 percent to 68 percent. This number does not represent sales and distribution of drugs solely used for production because most of these products are approved for therapeutic (disease treatment, control or prevention) uses as well.
- The percentage of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals that are sold over-the-counter (OTC) did not change appreciably, decreasing from 98 percent to 97 percent.
In December 2013, the FDA published Guidance #213, which calls for animal drug sponsors of medically important antimicrobials to remove from their product labels indications for use related to growth promotion, and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016. Once these changes are made, it will become illegal to use these products for production purposes or for therapeutic purposes without veterinary oversight. As announced in June 2014, all 26 drug sponsors affected by Guidance #213 have agreed to fully engage in the FDA’s strategy.