United States: antimicrobials sold or distributed in 2012 for use in food-producing animals

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.

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.