On Tuesday, the U.S. Food and Drug Administration’s Center for Veterinary Medicine released its third annual report summarizing 2011 sales and distribution data of antimicrobial drugs approved for use in food-producing animals.
The Animal Drug User Fee Act (ADUFA), as amended in 2008, requires antimicrobial drug sponsors to annually report the amount of antimicrobial active ingredient in the drugs they sold or distributed for use in food-producing animals. ADUFA also requires that FDA provide public summaries of these sales and distribution data. The collected data helps FDA evaluate antimicrobial resistance trends and other issues relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals.
FDA cautions that several variables make it difficult to compare antimicrobial sales and distribution data in food-producing animals with such data collected for antimicrobials intended for human use. These variables include the number of humans vs. that of food-producing animals during the data period, differences in physical characteristics (such as weight) between humans and the various species of animals, molecular weights and dosages of the different antimicrobials, as well as other differences in the conditions of use of the antimicrobials.
In July 2012, FDA solicited comments from the public on a number of issues regarding the collection of antimicrobial drug sales and distribution data, including how FDA can most effectively compile and present its annual summary report. FDA believes it would be helpful to have more information on how medically important antimicrobial drugs are currently used in food-producing animals in order to enhance ongoing efforts to monitor antimicrobial resistance. These efforts are important to support the agency’s current strategy to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.
FDA extended the comment period to Nov. 26, 2012, and the agency is now reviewing the comments. In particular, FDA is considering these comments as part of an ongoing effort to enhance the content and format of its annual summary report. FDA intends to implement the updated format when it summarizes the data reported for 2012, and also plans to re-analyze and update prior year reports to conform to the new format.
For more information, access the following reports: