Today, the U.S. Food and Drug Administration opened a docket to seek public comment on a report 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 (the Foundation) and summarizes the work completed over a multi-year cooperative agreement funded by the FDA. Under this agreement, the Foundation convened a working group to evaluate the feasibility of developing and maintaining a system to collect and report AMU data in the United States.
The report includes information about AMU standardization and 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.
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 does not currently 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 FDA is accepting public comments on the latest report through October 31, 2023.
Read more at FDA
[Source: FDA 2 August 2023]