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U.S. Department of Health and Human Services


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FDA's Sentinel Initiative - Background

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At a time when patients and caregivers are demanding more information about the associated benefits and potential risks of the products they use, 21st century technology has opened up innovative methods of monitoring FDA-regulated products that will enhance public health safety in ways previously unachievable.

FDA is leveraging this technology, together with emerging automated healthcare data sources to better understand its regulated products.

In the fall of 2007, Congress passed the FDA Amendments Act (FDAAA), mandating FDA to establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders.  The Sentinel Initiative is FDA’s response to that mandate. Its goal is to build and implement a new active surveillance system that will eventually be used to monitor all FDA-regulated products.

FDA has used administrative and insurance claims databases to investigate safety questions about Agency-regulated products, but generally it has only worked with one particular healthcare system at a time to evaluate a given safety issue. Its goal now is to create a linked, sustainable system--which FDA calls the Sentinel System--that will draw on existing automated healthcare data from multiple sources to actively monitor the safety of medical products continuously and in real-time.

Establishing a long-term, sustainable system raises many questions of great public interest, including issues about governance, privacy, data standards and public availability of results. For this reason, Sentinel’s development will require considerable stakeholder participation.

Since announcing the Initiative, FDA has fostered a broad public forum to explore the complexities of creating such a system.  Numerous meetings have been held with a variety of stakeholders.  Contracts have been granted to examine a range of subjects that will affect Sentinel. And pilot projects are under way that will contribute toward answering some of the many technical and policy issues that must be addressed.