Concern over Antimicrobials in Food Animals Leads FDA to Consider Adding Data to Report
In an effort to improve transparency about the amount of antimicrobials sold or distributed for use in food-producing animals, the U.S. Food and Drug Administration (FDA) today announced a proposal to provide additional data tables in its annual summary report of this information. The proposal is available for public comment until November 25, 2013.
The Animal Drug User Fee Amendments of 2008 established a requirement 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 that FDA provide summaries of these sales and distribution data by antimicrobial class. The law directs the agency to independently report out only those antimicrobial drug classes that contain drug products marketed by three or more distinct animal drug companies, and to report data in a manner that protects both national security and confidential business information.