FDA issues 5-year plan to make its Sentinel system more robust

The Food and Drug Administration wants to ensure that its post-market monitoring of drugs and biologics keeps pace with changing drug development and safety ecosystems.

Towards that end, the agency has developed a five-year strategy to grow the capabilities of its Sentinel system by 2023 into a “transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decisionmaking.”

The announcement was made this week in a blog post by FDA Commissioner Scott Gottlieb, MD, and Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology at the agency’s Center for Drug Evaluation and Research.

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Sentinel, a national electronic system for monitoring the safety of FDA-approved drugs and other medical products through active surveillance, has been fully operational since 2016.

However, the FDA plans to pursue five strategic aims to make the Sentinel system more robust.

  • Enhance and expand the Sentinel system’s foundation, including data, infrastructure, operations and technology.
  • Augment Sentinel’s safety analysis capabilities using advances in data science and signal detection.
  • Use the Sentinel system to accelerate access to and broaden the use of real-world data for real world evidence.
  • Broaden the Sentinel system’s ecosystem of stakeholders to pursue the vision of a national resource.
  • Disseminate knowledge and advance regulatory science to encourage innovation and meet the agency’s scientific needs.

“Our plan outlines how the Sentinel system and FDA-Catalyst, as part of the broader agency-wide Sentinel Initiative, can continue to grow and achieve this ambitious vision,” wrote Gottlieb and Dal Pan. “The cumulative impact of all five aims of this new plan will be substantial. It will allow stakeholders to continually discover new approaches to growing the Sentinel system’s capabilities for the next five years and beyond.”

In addition, the FDA is exploring ways to better incorporate information from electronic health records into the agency’s pre- and post-market surveillance. Currently, the FDA’s Sentinel system relies largely on data from health insurance claims. However, the agency wants to leverage data from EHRs to gain additional insights.

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“We’re also developing knowledge management systems and seeking to better leverage artificial intelligence to advance natural language processing in the evaluation of information from claims data and EHRs,” according to Gottlieb and Dal Pan. “The FDA has sought new funding to advance these initiatives in the next year.”

The agency is holding the 11th Annual Sentinel Initiative Public Workshop on April 3 to 5 to discuss the FDA’s five-year plan for the national electronic system for monitoring the safety of FDA-approved drugs and other medical products.

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