Devices

Changes Sought to FDA’s IT Strategy

Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Association say they appreciate FDA’s timely publication of its information technology (IT) strategy and its efforts to meet its commitments under the most recent PDUFA and BsUFA agreements, as well as requirements under the FDA Omnibus Reform Act of 2022 to develop a comprehensive framework that will shape the future of the agency’s data and technology capabilities. In a joint comment letter, the trade associations express concern that the strategy document “reads more as a guiding principles document than a comprehensive strategic plan envisioned in the PDUFA 7 and BsUFA 3 goals letters.”

The comment says that details on how the strategy will be executed are paramount for its successful implementation. Specifically, the groups write, it would be informative to include the following information for each goal: (1) where the agency is now; (2) where the agency wants to be and when; (3) what the desired outcome is; (4) how the agency will measure success; and (5) what the potential impact is on industry and other external stakeholders.

The associations also voice concern that some of the commitments in the two goals letters may not be adequately addressed in the IT strategy and would benefit from additional discussion in the document.

The letter calls on FDA to use its forthcoming IT Operating Plan to provide additional details, including specific milestones and metrics, about how the agency plans to execute the IT strategy and how it will define and measure success.

The associations also give specific comments in response to FDA questions.

In its letter, the Real-World Evidence Alliance says it strongly supports efforts to scale data sharing across FDA and modernize the data and technical infrastructure to accelerate medical product development and evidence generation.

The alliance praises FDA for naming distinct objectives to accelerate cloud adoption and to improve interoperable and secure data exchange across the agency. It urges FDA to hasten the adoption of cloud-based systems for data submission, which it says would encourage interoperability.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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