What's new ? - 2018

What's new ? - 2018

The FDA report on antibiotics in food animals

19 December, 2018

This report presents the sales and distribution data 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 for the 2017 calendar year. This 2017 summary report also includes multiple years of domestic sales and distribution data of actively marketed antimicrobial drugs by drug class, medical importance, and route of administration, as well as observations on the changes in the sales and distribution of these drugs from 2016 through 2017. This 2017 summary report reflects changes in the marketplace since the complete implementation of Guidance for Industry (GFI) #2132 in January 2017, when all affected products that are medically important in human medicine (specifically, antimicrobials used in feed and water) transitioned from over the-counter (OTC) marketing status to either prescription (Rx) or Veterinary Feed Directive (VFD) marketing status and all production claims were removed.
Key observations from the report include:
• Domestic sales and distribution of medically important antimicrobials approved for use in food producing animals:
- decreased by 33% from 2016 through 2017.
- decreased by 43% from 2015 (the year of peak sales) through 2017.
- decreased by 28% from 2009 (the first year of reported sales) through 2017.
- Tetracyclines, which represent the largest volume of these domestic sales (3,535,701 kg in 2017), decreased by 40% from 2016 through 2017.
• The 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 5,770,655 kg to 0 kg from 2016 through 2017 as a result of the implementation of GFI #213.
• The domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals that are sold OTC decreased from 8,000,326 kg to 271,280 kg from 2016 through 2017 as a result of the implementation of GFI #213.
• Of the 2017 domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals:
- Tetracyclines accounted for 64%, penicillins for 12%, macrolides for 8%, sulfas for 5%, aminoglycosides for 5%, lincosamides for 3%, and cephalosporins and fluoroquinolones each for less than 1%.
- An estimated 42% was intended for use in cattle, an estimated 36% intended for use in swine, an estimated 12% intended for use in turkeys, an estimated 5% intended for use in chickens, and an estimated 5% intended for use in other species/unknown.
- An estimated 80% of cephalosporins, 72% of sulfas, 48% of aminoglycocides, and 44% of tetracyclines were intended for use in cattle. An estimated 84% of lincosamides and 40% of macrolides were intended for use in swine. An estimated 61% of penicillins were intended for use in turkeys.

Related Links
Link The Full Report