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.
In July 2012, FDA asked for comments from the public on possible enhancements to the existing requirements and on how the agency can best compile and present its annual Summary Report of Antimicrobials Sold or Distributed for Use in Food-producing Animals to provide additional clarity and level of detail.
Many of the comments received suggested that FDA provide breakdowns of the sales and distribution data by route of administration (such as oral or injectable), dispensing status (over the counter, prescription or veterinary feed directive), or indications (whether it is used as a therapeutic, a growth promoter, or both).
The proposed additions to the report expand the current format of sales and distribution data by antimicrobial class to include information on the importance of the drug in human medicine, then providing aggregate data on how the medication is administered to the animal, whether it is available over the counter or requires veterinary oversight, and whether it is used as a therapeutic, a growth promoter, or both.
FDA also proposes to update the annual reports from previous years to include the new data tables.
The closing date for comments to be considered by the agency is November 25, 2013. To comment on the proposal, go to www.regulations.gov and enter docket number FDA-2012-N-0447.
Wednesday, September 25, 2013 / FDA