09.12.2017

The U.S. Food & Drug Administration has published its annual report summarizing sales and distribution data for the 2016 calendar year for actively marketed antimicrobial drugs approved for use in food-producing animals by drug class, medical importance, route of administration, indication, and dispensing status, as well as species-specific estimates of these sales and distribution. The species-specific estimates are new to this year’s report and are the result of rulemaking implemented in 2016.
Several trends observed from 2015 through 2016 include:
1. Domestic sales and distribution of antimicrobials approved for use in food-producing animals decreased by 10% from 2015 through 2016.
2. In 2016, it is estimated that 43% of the domestic sales and distribution of medically important antimicrobials was intended for use in cattle, 37% intended for use in swine, 9% intended for use in turkeys, 6% intended for use in chickens, and 4% intended for use in other species/unknown.
3. In 2016, domestic sales and distribution of medically important antimicrobials accounted for 60% of the domestic sales of all antimicrobials approved for use in food-producing animals. Tetracyclines accounted for 70% of these sales, penicillins for 10%, macrolides for 7%, sulfas for 4%, aminoglycosides for 4%, lincosamides for 2%, and cephalosporins and fluoroquinolones each for less than 1%.
4. In 2016, it is estimated that 80% of domestic sales and distribution of cephalosporins, 64% of sulfas, 51% of aminoglycocides, and 49% of tetracyclines was intended for use in cattle. It is estimated that 83% of domestic sales and distribution of lincosamides and 61% of macrolides was intended for use in swine. It is estimated that 63% of domestic sales and distribution of penicillins was intended for use in turkeys.
5. Domestic sales and distribution of medically important antimicrobials approved for use in foodproducing animals decreased by 14% from 2015 through 2016, with decreases represented in all individual drug classes.
• Tetracycline sales represent the largest volume of these domestic sales (5,866,588 kg in 2016), decreasing 15% from 2015 through 2016. • Cephalosporin sales volume decreased by 4% from 2015 through 2016.
• Lincosamide sales volume showed the greatest percentage decrease in domestic sales (22%) from 2015 through 2016.
6. The percentage of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals that have an approved indication for production use decreased from 71% to 69% from 2015 through 2016.2 This number does not represent sales attributable to products used solely for production indications because most of these products are also approved for therapeutic indications and FDA does not have indication-specific sales and distribution data.
7. The percentage of domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals that are sold over-the-counter (OTC) decreased from 97% to 96% from 2015 through 2016.