10.12.2015

The U.S. Food and Drug Administration today published its annual report summarizing sales and distribution data for antimicrobial drugs approved for use in food-producing animals. The report shows increases in antimicrobial sales and distribution from calendar year 2013 to 2014: an increase of four percent for all antimicrobials and an increase of three percent for antimicrobial classes considered medically important in human medicine.
This summary report reflects sales and distribution information for 2014, the year after the FDA’s announcement of its judicious use strategy for antibiotics that are important in human medicine and are also used in feed or water of food-producing animals. The FDA’s Guidance for Industry #213 specifies a timeframe of three years, until December 2016, which is the date by which drug sponsors have voluntarily agreed to make label changes to the affected products to remove production indications (growth promotion and feed efficiency) and move the products from over-the-counter availablility to veterinary feed directive or prescription status in order to ensure the remaining therapeutic uses for the treatment, control or prevention of a specifically identified disease will be under veterinary oversight.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to FDA on an annual basis the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. These sales and distribution data do not necessarily represent actual use of the products.