Formal Title: [Docket No: FDA-2012-N-0447] Antimicrobial Drug Sales and Distribution Reporting
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.
Excerpts from AVMA Response:
The AVMA has thoroughly reviewed the docket and is providing recommendations for consideration.
The AVMA is writing in response to the FDA’s request for comment on a proposal regarding the content and format of data tables for the FDA’s annual summary report of sales and distribution data. We applaud the FDA’s efforts to enhance and refine the data tables to include new tables segregating medically important and non–medically important antimicrobials (e.g. ionophores) by active ingredients within antimicrobial classes, route of administration, and dispensing status as previously recommended by the AVMA.
A. Sales and Distribution by Species
The AVMA has previously recommended that sponsors of antimicrobial products provide sales and distribution information for individual animal species whenever possible and that, at a minimum, sponsors should delineate between companion animal and livestock sales and distribution. However, we recognize that many products are labeled for use in multiple species and thus for these, sales data cannot be segregated by individual animal species. We also recognize that a small number of antimicrobial drug products are approved and labeled for use in food animal and companion animal species such as dogs and cats; sales data for these are also included in the summary report, although the contribution of sales for companion animal usage to the total sales is likely inconsequential. The AVMA would appreciate the inclusion and clarification of such information in a supporting narrative for the summary report.
B. FDA’s Annual Summary Report
The AVMA also strongly encourages that the accompanying narrative to the summary data tables clearly state that sales data do not provide sufficient information for an accurate estimation of use, subjecting the data to the potential for serious misinterpretation.1 Therefore, 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.
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 antimicrobial use data (rather than sales data) to better understand the many factors that contribute to antimicrobial resistance development and transmission. Yet, 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. We believe that the focus should remain on strategies such as judicious use education for producers, veterinary students and veterinary personnel, and implementation of greater veterinary oversight.
1. Bondt N, Jensen VF, Puister-Jansen LF, et al. Comparing antimicrobial exposure based on sales data. Prev Vet Med 2013;108:10–20.
Relevant AVMA Policy: