FDA releases 2019 annual summary report on animal antimicrobials sold or distributed

By David Fairfield, Senior Vice President, Feed

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA/CVM) on Dec. 15 published its 2019 summary report that recaps domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals.

The Animal Drug User Fee Amendments of 2008 (ADUFA) requires that animal drug companies annually report to FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. ADUFA also requires FDA to issue annual summary reports of these sales and distribution data, which the agency has done since 2009.

The 2019 report indicates that domestic sales and distribution of medically important antimicrobials increased by three percent between 2018 and 2019. Further, the report shows that 2019 levels are down 25 percent since 2010 and down 36 percent since 2015, which was the peak year of sales. FDA states this trend demonstrates that on-going efforts to support judicious use of medically important antimicrobials – including transitioning the use of such drugs to require veterinary oversight – are having a positive impact. 

When reviewing the report’s information, FDA states the following should be considered:

• Sales and distribution information does not represent actual use of the products. 
• Before making a direct comparison between the quantity of antimicrobial drugs sold for use in humans and those sold for use in animals, be mindful: 1) there are many more animals in the United States than humans; 2) there are differences in physiology and weight between humans and animals; and 3) different animal species metabolize drugs differently, meaning that some may require more of the drug to be effective, or may need to be treated for a longer time.
• The agency cautions against making direct comparisons of species-specific sales estimates, since there are a variety of factors that confound direct comparison of species-specific sales estimates. 
• The agency cautions against making direct comparisons between the sales volume of different drug classes because not all drug classes are approved for use in all species, not all drug potencies are the same, and not all of the drug classes can be used interchangeably to treat the same conditions.

Related to judicious use of animal drugs, FDA/CVM on Sept. 14 released its five-year action plan that outlines steps the agency intends to take to further foster antimicrobial stewardship in veterinary settings.