FDA requests public input on analyzing antimicrobial use in animals

Emil / stock.adobe.com

Officials with the FDA are seeking feedback from the public on a report¹ outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals. The report was prepared for the FDA by the Reagan-Udall Foundation and summarizes the work completed over a multi-year cooperative agreement funded by the FDA.²

Antimicrobials are pharmaceuticals that kill or curb the growth of microorganisms. This makes them critical tools for preventing and fighting diseases in both people and animals. However, antimicrobial resistance can occur which threatens public or animal health by making it difficult or impossible to treat the diseases caused by these microorganisms.³

According to the report, AMU is recognized as a growing global threat. The FDA does not currently have the authority to require end users to report AMU data.² The FDA considers this a threat in need of immediate action in new product research and development and greater stewardship of antimicrobial use in human and animal health. The report states, “For the purpose of this effort, the definition of ‘antimicrobial use’ is the amount of antimicrobial prescribing, authorizing, administering, and delivering for administration in a defined animal species or population."¹

The FDA is accepting public comments on the latest report through October 31, 2023. Although the FDA is interested in receiving comment on all aspects of the report, the agency is requesting additional information on the following:²

• Cost estimates for external data partners to develop and sustain the collection of AMU data in animals, recognizing diversity of data sources across animal sectors.
• Cost estimates for the setup and maintenance of the AMU data repository under the PPP framework that is described in the report.
• Descriptions or suggestions on the type of organizations most appropriate to coordinate a national AMU data repository.
• Descriptions or suggestions on how the Steering Committee should be structured and membership roles and responsibilities long-term.

To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2022-N-0824 in the search box. The FDA expects to make more future announcements on this framework’s progress within the next calendar year and any future iterations of the framework will be shared for public comment before being finalized.

References

1. Establishing a Draft Framework for a Public-Private Partnership to Support the Tracking of Antimicrobial Use in Food-Producing Animals. FDA report. August 2023. Accessed August 2, 2023. https://reaganudall.org/sites/default/files/2023-08/072823_Summary%20Report_Final.pdf
2. FDA seeks public comment on possible framework for collecting and analyzing data on antimicrobial use in food-producing animals. News release. August 2, 2023. Accessed August 2, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-seeks-public-comment-possible-framework-collecting-and-analyzing-data-antimicrobial-use-food?utm_medium=email&utm_source=govdelivery
3. Antimicrobial use and antimicrobial resistance. American Veterinary Medical Association. Accessed August 2, 2023. https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance#:~:text=Antimicrobials%20are%20used%20to%20prevent,including%20via%20feed%20or%20water.