Final Rule: Antimicrobial Sales

May 17, 2016 05:24 PM

By: John Maday

The FDA last week issued its final rule on annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals.

The program will obtain estimates of antimicrobial sales classified by intended use in major food-producing species including cattle, swine, chickens and turkeys. According to the FDA, species-based data will help further target efforts to ensure judicious use of medically important antimicrobials.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to annually report to FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those antimicrobials used in human medicine.

ADUFA 105 also requires that FDA issue annual summary reports of these sales and distribution data collected from sponsors. The law further requires that these data be reported out by antimicrobial drug class, and includes a provision to improve the timeliness of data by requiring that FDA publish the annual summary report by December 31 of the following year.

 According to a Q&A document from FDA, ADUFA 105 only requires sponsors to list the target animals and production classes specified on the approved labels of the products. It does not require animal drug sponsors to break out the total sales or distribution data by individual food-animal species.

The new reports will include data tables on the importance of each drug class in human medicine, aggregate data on the approved routes of administration for these drug products. The reports also will specify whether drugs are available for over-the-counter purchase or require veterinary oversight, and whether they are approved for use for therapeutic or production purposes.

According to the FDA the enhanced annual summary reports will increase transparency about the extent to which antimicrobials are sold or distributed for use in animal agriculture and provide more detailed information to the public on changes in antimicrobial sales over time as the FDA’s guidance for Industry 213 is implemented. That guidance, which will take full effect in January 2017, asks drug companies to remove performance or production claims from labels for medically important antibiotics used in food animals.

In order to protect confidential business information, no individual sponsors are publicly identified in the summary reports, and ADUFA 105 specifies that data from antimicrobial drug classes with fewer than three distinct sponsors only be included in aggregated form in this report.

The final rule and the Q&A document are available online from the FDA. 

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