The U.S. Food and Drug Administration published its annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals.
Several trends observed include:
1. Domestic sales and distribution of antimicrobials approved for use in food -producing animals increased by 24% from 2009 through 2015, and increased by 1% from 2014 through 2015.
2. In 2015, domestic sales and distribution of medically important antimicrobials accounted for 62% of the domestic sales of all antimicrobials approved for use in food -producing animals. Tetracyclines accounted for 71% o f these sales, penicillins for 10%, macrolides for 6%, sulfas for 4%, aminoglycosides for 4%, lincosamides for 2%, and amphenicols, cephalosporins, and fluoroquinolones each for less than 1%.
3. Domestic sales and distribution of medically important antimicrobials approved for use in food- producing animals increased by 26% from 2009 through 2015, and increased by 2% from 2014 through 2015.
- Tetracycline sales represent the largest volume of these domestic sales (6,880,465 kg in 2015), increasing by 31% from 2009 through 2015, and increasing 4% from 2014 through 2015.
- Lincosamide sales volume showed the greatest percentage increase in domestic sales (96%) from 2009 through 2015, although domestic sales decreased by 22% from 2014 through 2015, to a level similar to 2011. Aminoglycoside sales volume showed the greatest percentag e increase in domestic sales (13%) from 2014 through 2015.
4. 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 72% to 68% from 2009 through 2012, remained unchanged at 72% from 2013 through 2014, and then decreased to 71% in 2015. 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.
5. 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 98% to 97% from 2009 through 2015.
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. This sales and distribution information does not necessarily represent actual use of the products. For example, drug products entering the market may not necessarily be distributed all the way to the farm; veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals, or they may administer them in later years. The FDA is working with federal, academic and industry partners to obtain more information about how, when, and why animal producers and veterinarians use those classes of antimicrobial drugs that are important to human medicine.
ADUFA 105 also requires the FDA to issue annual summary reports of sales and distribution data collected from sponsors each year, by antimicrobial class for classes represented by three or more distinct sponsors, and to provide those summaries to the public. In May 2016, the agency issued a final rule revising its annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). This breakdown by species will not appear in the FDA’s annual summary reports until the report covering calendar year 2016. The final rule includes a provision requiring the FDA to publish the annual summary report for each calendar year by December 31st of the following year.
Thursday December 22, 2016/ FDA/ United States.