The US Food and Drug Administration (FDA) proposed a rule that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.

The proposed rule also includes a provision to improve the timeliness of the report by requiring the FDA to publish its annual summary report of antimicrobial sales and distribution information by December 31 of the following year.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) 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 that are not used in human medicine. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public. Currently, animal drug sponsors are not required to submit sales or distribution data by particular species.

“Consistent with data collection objectives outlined in the Administration’s National Strategy for Combating Antibiotic-Resistant Bacteria, this proposed rule is a step toward providing more detailed information to the FDA and the public on changes in antimicrobial sales and distribution over time,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “We plan further actions to complete the task.”

Current regulatory authority limits the data collection that FDA can mandate to antimicrobial sales and distribution information. While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance. The FDA is actively engaged with the US Department of Agriculture, Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need. (type FDA-2012-N-0447 in the search box). Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDA is accepting public comments on the proposed regulation for 90 days from the date of publication of the notice of availability in the Federal Register. Electronic comments should be submitted to www.regulations.gov

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.