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:

The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

AVMA Response:

The AVMA has thoughtfully reviewed the docket and is providing recommendations for consideration.
 
The AVMA recognizes that as part of that process, the FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. The AVMA also understands that the FDA believes the collection of data on antimicrobial drugs used in food-producing animals will assist in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

A.    Sales and Distribution Data by Species

The AVMA recommends that sponsors of antimicrobial products provide sales and distribution information for individual animal species. Products approved and labeled for multiple species should be segregated whenever possible to provide sales and distribution information for individual animal species. At a minimum, sponsors should delineate between companion animal and livestock sales and distribution. However, even if segregated by species, sales data does not provide enough information for an accurate estimation of use, subjecting the data to serious misinterpretations.1 Thus, the AVMA strongly discourages the application of antimicrobial sales and distribution data in analyses of antimicrobial usage, exposure, or risk of development and transmission of resistance.

B.     FDA’s Annual Summary Report 

Whenever possible (so as to maintain confidential business information), classes of antimicrobials should be further segregated by individual antimicrobial drug compounds prioritized in order of importance to human health. An example of the prioritization scheme can be found in FDA guidance for industry No. 152.2

Over-the-counter and prescription status should be reported with individual drug compounds if possible, while maintaining proprietary interests.

C.    Alternative Methods for Obtaining Antimicrobial Use Data

The AVMA continues to support the judicious therapeutic use of antimicrobials under veterinary oversight for treatment, control, and prevention of disease, for the protection of animal health and welfare, and for the protection of public health. We support the collection and analyses of additional antimicrobial use data to better understand the many factors that contribute to antimicrobial resistance development and transmission. However, the benefits of that information may be minimal without an integral component—a control or comparison group. The assumption is that more surveillance data will provide a better understanding of resistance trends and the overall ecology and evolution in the animal or human population, but it has yet to be determined what the control group is or to what the data will be compared. Furthermore, there may be unrealized costs associated with the data collection, including the burden of data collection, loss of confidentiality, misunderstanding and misuse of the data, and other potential costs.

In addition to usage data, the AVMA encourages the FDA to explore other factors related to antimicrobial resistance in food-producing animals, recognizing that usage trend data may not correlate with antimicrobial resistance trends in humans, food, or food animals. Variations in therapeutic uses can be affected by many factors such as disease processes that can further confound our understanding of the development and transmission of antimicrobial resistance that may be related to the use of medically important antimicrobials in food-producing animals.

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: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052519.pdf. Accessed Sep 19, 2012.