FDA request input on antimicrobial use in animals

By: Sydney Sheffield 

The United States Food and Drug Administration (FDA) is seeking public comments on a new report, which discusses 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 created for the FDA by the Reagan-Udall Foundation (the Foundation) and summarizes the work completed over a multi-year cooperative agreement funded by the FDA.

“Antimicrobial use data can help foster antimicrobial stewardship and slow the development of antimicrobial resistance because it provides insight into what drugs are being used, how much of the drugs are being used, and how they’re being used,” the FDA said in a press release. 

Currently, the FDA does not have the authority to require end users to report AMU data. However, because these data would be vital in helping to guide stewardship efforts, the FDA has been exploring, with the Foundation’s assistance, whether a PPP could balance the need for public health information with practical concerns of the veterinary professionals and producers who would voluntarily contribute to the data repository. 

The report includes information about AMU standardization and the protection of data confidentiality. It also summarizes stakeholder input and public comments about potential PPP objectives, membership, organizational structure, and financing. The report describes a potential PPP structure, supported in part by public and private resources, that includes a Data Repository Coordinator, External Data Partners, and a Steering Committee. 

Specifically, the FDA is seeking additional information on:

Cost estimates for External Data Partners to develop and sustain the collection of AMU data in animals, recognizing the diversity of data sources across animal sectors

Cost estimates for the setup and maintenance of the AMU data repository under the PPP framework 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

The FDA is accepting public comments on the latest report through October 31, 2023. Visit www.regulations.gov to learn more about submitting comments to the FDA. 

Read The Foundation’s summary report here.