Regulatory Brief

 Antimicrobial Animal Drug Sales and Distribution Reporting

Formal Title: Docket Number (FDA-2012-N-0447); Antimicrobial Animal Drug Sales and Distribution Reporting

Brief Description:

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to the FDA on an annual basis the amount of all antimicrobial drugs they sell or distribute for use in food-producing animals, including those antibiotics not used in human medicine.

The U.S. Food and Drug Administration is proposing revisions to its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales by major food-producing species (cattle, swine, chickens, and turkeys). The additional data is intended to improve understanding about how antimicrobials are sold or distributed for use in major food-producing species and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.   


AVMA Response:

The AVMA has thoughtfully reviewed the docket and is providing recommendations for consideration. We continue to support the collection and analyses of additional antimicrobial use data to better understand the many factors contributing to the development and transmission of resistance. The AVMA firmly believes that efforts to combat resistance must also consider animal health and welfare needs which in turn affect human health and food safety.
With respect to the additional species specific reporting, the AVMA agrees that species specific data is needed to assess antimicrobial sales trends and the potential relationship to resistance development (as noted in our prior comments).  However, the AVMA strongly believes that sales data alone should not be used in analyses of antimicrobial usage, exposure, or risk of development and transmission of resistance.  Sales data has been shown to be an extremely inaccurate estimation of use, subjecting the data to the potential for serious misinterpretation.   Therefore, while we support the additional reporting criteria, we remain uncertain if species specific estimates of product sales as a percentage of total sales will be meaningful in informing microbial food safety risk assessments and potential comparisons with NARMS data.  The AVMA recommends that the FDA continue to explore other data streams as a part of its on-going activities related to minimizing the development of resistance. 

Background Documents:

Relevant AVMA Policy

1.             Bondt N, Jensen VF, Puister-Jansen LF, et al. Comparing antimicrobial exposure based on sales data [published online ahead of print Aug 13, 2012]. Prev Vet Med doi:10.1016/j.prevetmed.2012.07.009.
2.             US FDA Center for Veterinary Medicine. Evaluating the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. Guidance for industry No. 152. Available at: Accessed Sep 19, 2012.