July 26, 2017

July 25, 2017

Subscribe to Latest Legal News and Analysis

July 24, 2017

Subscribe to Latest Legal News and Analysis

FDA Reports Uptick in Antibiotic Use in Food Animals

The FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.  Most recently, in September 2016, FDA announced  that it was “entering the next phase” of efforts to avoid increased antimicrobial resistance by requesting comments on the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes.

Against this backdrop, on December 22, 2016, FDA released a report showing that sales and distribution of all antimicrobial drugs approved for use in food-producing animals rose by 1% from 2014 to 2015. The report also showed that the percentage of those antimicrobials that are considered medically important in human medicine increased by 2 percent from 2014 through 2015.

Looking ahead, it is possible that the sales and distribution of antimicrobial drugs approved for use in food-producing animals will decrease.  Of note, FDA’s Guidance for Industry #213 established a target date of December 31, 2016 for drug sponsors of antimicrobials used in the feed or water of food-producing animals to voluntarily make changes to affected products to remove production indications (i.e., growth promotion and feed efficiency) and move the products from over-the-counter availability to veterinary feed directive or prescription status.  Provided industry complies with these changes, the use of antimicrobial drugs products for production indications will be illegal and the remaining therapeutic uses for the treatment, control, or prevention of a specifically identified disease will be limited to use under veterinary oversight.

© 2017 Keller and Heckman LLP

TRENDING LEGAL ANALYSIS


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

202-434-4100