According to NGFA, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine on Dec. 12 published the 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals.
Key observations from the report include that domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals:
1) decreased by less than 1 percent from 2020 through 2021;
2) decreased by 38 percent from 2015 (the year of peak sales) through 2021; and
3) decreased by 33 percent from 2012 through 2021.
The report also notes that an estimated 41 percent of such drugs was intended for use in cattle, an estimated 42 percent was intended for use in swine, an estimated 11 percent intended for use in turkeys, an estimated 3 percent intended for use in chickens, and an estimated 3 percent intended for use in other species/unknown.
FDA’s objective is to slow the development of antimicrobial resistance and preserve the effectiveness of antimicrobials for fighting disease in animals and humans. The agency’s goal is not solely measured by reduced sales volume of antimicrobials, but also includes placing these products under veterinary oversight, fostering good antimicrobial stewardship practices by optimizing the use of these products, and limiting their use to only when necessary to treat, control, or prevent disease.
Background: Sponsors of an approved or conditionally approved animal drug application containing an antimicrobial active ingredient are required each year to report to FDA the amount of such ingredients in 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. 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. In 2016, FDA issued a final rule codifying annual reporting requirements and added a new reporting provision to obtain estimates of sales by major food-producing species.
FDA’s summary reports include sales and distribution data of all antimicrobial drugs that are specifically approved for antibacterial uses or are known to have antibacterial properties, consistent with the requirements enacted by Congress. However, FDA has identified certain antimicrobial active ingredients as “medically important” based on their utility for treating disease in humans. Certain other antimicrobial drugs are not considered medically important. Ionophores, for example, lack utility in human medicine and their use in animals, primarily as coccidiostats, does not pose cross-resistance concerns; thus, they do not have the same human health risks as medically important antimicrobials and consequently they are found under the Not Medically Important section in the reports.
More information about the report may be obtained by reviewing FDA’s Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals.