February 01, 2024

Interpretive Summary: FDA releases antimicrobial report

FDA releases antimicrobial report 

By: Sydney Sheffield 

The United States Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) published the 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This year, the FDA published the results in an interactive dashboard that allows users to interact with the data and create data visualizations using criteria such as antimicrobial drug class, species, and year. 

With the passage of the Animal Drug User Fee Amendments (ADUFA) of 2008, Congress established specific reporting requirements for sponsors or manufacturers of antimicrobial animal drugs. In May 2016, the FDA issued a final rule for drug sponsors of antimicrobials sold or distributed for use in food-producing animals, which confirmed the reporting requirements and established a new requirement for sponsors to provide estimates of sales broken out by major food-producing species 

The results of the study show that domestic sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals increased by 4% between 2021 and 2022. Compared to the peak year of sales in 2015, 2022 sales were down 36%. Sales volume may fluctuate over time in response to various factors, including changing animal health needs or changes in animal populations.

“While sales data on antimicrobial drug products intended for food-producing animals do not necessarily reflect the actual use of antimicrobial drugs, sales volume observed over time can be a valuable indicator of market trends related to these products. However, when evaluating the progress of ongoing antimicrobial stewardship in veterinary settings, it is important to consider additional information sources including actual use data, animal demographics, animal health data, and data on antimicrobial resistance,” the FDA said in the press release.

In 2014, the FDA increased the amount of data included in the annual summary reports. The current FDA annual summary reports include additional data tables on the importance of each drug class in human medicine, the approved routes of administration for these antimicrobials, whether these antimicrobials are available over the counter or require veterinary oversight, and whether the antimicrobial drug products are approved for therapeutic purposes, or for production purposes or both therapeutic and production purposes.

According to the FDA, the sales and distribution data only reflect the total quantity of antimicrobial drug product that enters the market and does not represent how much or in what way these drugs are ultimately used. Veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals, or they may use them in later years. 

The FDA has also updated its Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data to include the 2022 biomass-adjusted sales data. A biomass denominator adjusts annual antimicrobial sales data to account for the size of the population of a given livestock species in the United States potentially being treated with those drugs.