FDA’s Data Strategy Modernization Starts With Public Outreach

As federal agencies work through the 20-item to-do list that is part of the Federal Data Strategy, the Food and Drug Administration is going a step further and reworking its internal data strategy for the new decade.

On Wednesday, the agency will post a notice in the Federal Register announcing plans to develop the new strategy, as well as an upcoming public hearing to get feedback from FDA employees and outside experts.

“Data is at the heart of FDA's work as a science-based agency, and we anticipate ongoing, rapid increases in the amount and complexity of the data that informs FDA's regulatory decision-making process and how we advance our public health mission,” according to the notice.

Revising the data strategy follows up on the agency’s Technology Modernization Action Plan, or TMAP, released in September. While the main pillars of the plan center on developing FDA’s IT infrastructure, the end goal is to make better use of data.

“The TMAP provides a sturdy technological foundation for development of FDA’s ongoing strategy around data itself—a strategy for the stewardship, security, quality control, analysis and real-time use of data—that will accelerate the path to better therapeutic and diagnostic options for patients and clinical care providers, and better tools to enhance and promote public health,” according to a description of the plan on FDA’s website.

To kick off the effort, the agency will hold a public hearing March 27 at FDA’s White Oak Campus in Silver Spring, Maryland, “to provide an opportunity to hear from FDA staff and outside experts on topics directly related to modernizing FDA's data strategy, including data quality, data stewardship, data exchange and data analytics,” according to the notice.

FDA officials plan to frame the public meeting around three core areas of data management: standards and policy; data security, privacy and management; and strategies and data sharing. The federal register notice provides some sample questions to get the discussion going, including:

• What are the consequences/issues as we move from "static point-in-time data sets" to updating digital data streams for analyses?
• What should FDA do to promote the management and organization of data assets across the agency as the amount and complexity of data—e.g., in regulatory submissions to FDA—is rapidly increasing?
• How can FDA design its data strategy and policy development to facilitate appropriate data access, data sharing within the agency and via data sharing agreements, as well as the appropriate reuse and repurposing of data to advance agency regulatory science priorities?

People interested in attending must be registered by noon on March 24.

The agency is also looking for additional panelists and presenters for the event. Those interested in presenting should send an abstract of their presentation and a one-pager outlining their credentials in this space no later than Jan. 28.