On August 2, 2023, the United States Food and Drug Administration (FDA) announced that it had opened a docket to seek public comment on a report (Summary Report: Establishing a Draft Framework for a Public-Private Partnership to Support the Tracking of Antimicrobial Use in Food-Producing Animals) by the Reagan-Udall Foundation 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 describes the potential PPP structure, including objectives, membership, financing, and information about AMU data standardization and protection. FDA is accepting public comments on the report through October 31, 2023.
Background
The report states that antimicrobial resistance (AMR) is a growing global threat requiring new product research and development and greater AMU stewardship in human and animal health. It also says that limited AMU data makes it difficult to improve stewardship and better understand the relationship between AMR and AMU.
FDA does not have the authority to require end users to report AMU data. As part of its efforts to better understand the relationship between AMR and AMU, FDA therefore engaged the Reagan-Udall Foundation to communicate with relevant stakeholders on the feasibility of creating a PPP to develop an AMU data repository. FDA hopes that such a partnership could balance the need for public health information with concerns of veterinary professionals and producers who would voluntarily contribute to the data repository.
Summary of Potential Framework
The report addresses key aspects of the potential framework, including objectives, potential organizational structure, financial support, data collection infrastructure, and reporting structure.
Key PPP objectives include:
- Collecting high-quality, representative, and de-identified AMU data to monitor trends across diverse veterinary sectors, including major food-producing animals, companion animal (e.g., dogs, cats, and horses), and minor species;
- Publishing national AMU data to help inform stewardship program development and responsible antimicrobial use;
- Providing additional context relevant to regulatory and policy decisions; and
- Controlling access to appropriately de-identified and aggregated AMU summary data.
Under the proposed organizational structure to support AMU data infrastructure development, FDA would develop the PPP and long-term strategy for functional and efficient infrastructure implementation; a Third Party Data Repository Coordinator (DRC) would develop and establish a database repository; External Data Partners (EDPs) would contribute data; and a Steering Committee would establish and update the priorities of the PPP over time. Members of the Steering Committee would be limited to representatives that contribute data and resources to the PPP, including leaders from the EDPs, DRC, and FDA.
In terms of financial support, FDA would be the primary funding source for initiating DRC and EDPs, but both the DRC and EDPs would be funded through a competitive grants process, and the EDPs data collection would likely be supported by a combination of FDA and private sector funding sources.
The Data Collection Infrastructure would make the DRC, in collaboration with the EDPs, responsible for building the AMU data collection tools, pipelines, and databases required to source, standardize, and store aggregated, de-identified data. The framework lays out several goals for the data collection infrastructure, including data security, advanced analytics, and ensuring data contributors retain data ownership. With respect to data access, different levels of AMU data access would be outlined in data use and sharing agreements whereby access to EDP raw data would be restricted to owners of the data and their subcontractors. General public level access would include internet postings by the DRC of AMU metric summary data (e.g., summary reports and peer-reviewed scientific publications) and any other information the Steering Committee authorizes the DRC to post.
What Can You Do?
FDA encourages stakeholders to comment on the potential framework and provide concrete information and suggestions for how to put the framework into practice. Although interested in receiving comments on all aspects of the report, the agency specifically requests additional information on:
- Cost estimates for EDPs to develop and sustain the collection of AMU data in animals;
- Cost estimates for the setup and maintenance of the AMU data repository;
- Comments on the type of organizations most appropriate to coordinate a national AMU data repository; and
- Comments on how the Steering Committee should be structured, and membership roles and responsibilities long-term.
FDA is accepting comments on the report until October 31, 2023 through FDA’s docket (No. FDA-2022-N-0824).
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If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
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