On May 19, 2015, FDA published in the Federal Register proposed a rule to collect antimicrobial sales and distribution data by major food animal species (cattle, swine, chickens, and turkeys). The purpose of the rule is to improve FDA’s understanding how antimicrobials are sold or distributed for use in food-producing animals, so FDA can further target its efforts to ensure judicious use of medically-important antimicrobials.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) requires antimicrobial drug sponsors to report to FDA annually the amount of all antimicrobial drugs that they sell or distribute for use in food-producing animals. From this information, FDA must prepare summary reports of sales and distribution information by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public. Currently the rule does not require animal drug sponsors to submit sales or distribution data by particular species.

The proposed rule includes parameters for the content of annual summary reports as well as provisions to protect confidential information and national security, consistent with Section 105 of ADUFA. Specifically, the sponsor’s annual report would need to include:

• A listing of each antimicrobial active ingredient contained in the product;
• A description of each unique marketed product by unit (i.e., container size, strength, and dosage form);Show citation box
• For each such product, a listing of the target animal species, indications, and production classes that are specified on the approved label;
• For each such product, the number of units sold or distributed in the United States (i.e., domestic sales) for each month of the reporting year; and
• For each such product, the number of units sold or distributed outside the United States (i.e., quantities exported) for each month of the reporting year.

FDA already revised the 2012 summary report (retroactively from 2009-currnet) format to include additional data tables on the importance of each drug class in human medicine, the approved routes of administration for these antimicrobials, whether these antimicrobials are available over-the-counter or require veterinary oversight, and whether the antimicrobial drug products are approved for therapeutic purposes, or for production purposes of both. Before comparing human and animal sales and distribution data, however, there are important differences to take into account, including: (1) the sizes of human and animal populations, (2) the physical characteristics (e.g., weight and physiology), (3) intended indications/uses, and (4) duration of treatment and dosage.

Additional information about the rule may be obtained from FDA’s press release, which includes links to a Questions and Answers Document, as well as a link to the ADUFA Reports page.