2024 Antibiotic Awareness Week Updates from FDA-CVM

This week is 2024 World Antibiotic Awareness Week (WAAW), providing the perfect opportunity for the FDA’s Center for Veterinary Medicine to highlight some of its accomplishments over the last year.

Sales & Distribution Publications

In October 2024, the FDA published its 2023 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. The 2023 data indicate that U.S. sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals decreased by two percent compared to the 2022 data that the FDA published in December of 2023. This represents a 37 percent decrease in sales since the sales peaked in 2015.

At the same time, the FDA published 2023 data in the agency’s Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data dashboard. A biomass denominator adjusts annual antimicrobial sales data to account for the size of the population of a given livestock species in the U.S. potentially being treated with those drugs.

National Antimicrobial Resistance Monitoring System (NARMS)

The FDA and USDA-FSIS NARMS teams recently posted data from a 2020-2022 collaborative study on minor species in a new Tableau dashboard: NARMS Minor Species Report. This was the first at-slaughter nationwide AMR study in minor species. The data consist of antimicrobial resistance for Salmonella, Campylobacter, generic E. coli, and Enterococcus isolated from the cecal (gut) contents of minor species (goats, sheep, lamb, veal). The FSIS and FDA also published the findings from this study in the 39th volume of the Sheep and Goat Research Journal.

In May 2024, the FDA published a Interim Data Update about the increase in multidrug resistance (MDR) in strains of Salmonella I 4,[5],12:i:- with azithromycin resistance genes. NARMS agencies are performing additional work to better understand the origin and spread of these strains and the genes resulting from their drug resistance profiles.profiles.

Antimicrobial Use (AMU)

Recently, CVM published a new Data on Antimicrobial Use in Animals web page with helpful information, a recap of activities thus far, and a discussion of what’s still to come. One of the recent highlights in the AMU space is that in September, the FDA awarded cooperative agreement funds for three projects to collect, analyze and report data on AMU in animals.

This grant program supports long term AMU data collection efforts under development within the United States, including proposed public-private partnership frameworks for tracking AMU data.

Enforcement

In December 2023, the FDA announced the issuance of warning letters to nine firms manufacturing and distributing unapproved and misbranded antimicrobial animal drugs for violations of federal law. The agency is concerned because these products contain antimicrobials that are important in human medicine and using them without medical oversight contributes to the development of antimicrobial resistance.

The animal products referenced in the warning letters were marketed and labeled for minor species such as aquarium fish and pet birds. They contain antimicrobials that are important in human medicine, such as amoxicillin, penicillin, tetracycline, and erythromycin, and were being illegally marketed over the counter. 

The FDA continues to monitor the marketplace and intends to act if additional egregious cases come to the agency’s attention.

Policy

In April 2024, the FDA finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers to assist stakeholders involved with veterinary feed directives (VFDs) – veterinarians, VFD feed distributors (medicated feed mills, feed retailers) and clients (owners or other caretakers of the animals) – in complying with the Veterinary Feed Directive (VFD) final rule that published in 2015. This final guidance also serves as a Small Entity Compliance Guide.

Although the core recommendations in final GFI #120 remain the same as the revised draft guidance issued in 2019, the language in the final guidance better aligns with existing industry practices and clarifies flexibilities to reduce the burden on veterinarians, producers, and distributors. One way the FDA offered clarification is by including hypothetical scenarios to illustrate stakeholder responsibilities under the VFD final rule in a more tangible way. These changes were informed by public comment on the revised draft guidance and feedback from stakeholders during VFD inspections.

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