Each year, every sponsor of an approved or conditionally approved application for a new animal drug containing an antimicrobial active ingredient must report to the Food and Drug Administration (FDA) the amount of each such ingredient in these drug products sold or distributed for use in food-producing animals. FDA summarizes this information and makes it available to the public in annual summary reports. FDA on Thursday released its 2016 report.
This reporting requirement was enacted by Congress in 2008 to assist FDA in its continuing analysis of the interactions (including antimicrobial resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals.
This summary report presents the 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.
FDA observed several trends from 2015 through 2016, including:
- Domestic sales and distribution of antimicrobials approved for use in food-producing animals decreased by 10% from 2015 through 2016.
- 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.
- 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%.
- 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.
- Domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals decreased by 14% from 2015 through 2016, with decreases represented in all individual drug classes.
