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FDA Expands Sentinel Initiative After Successful Pilot Program

In 2009, the U.S. Food and Drug Administration (FDA) launched a Mini-Sentinel pilot program. The program was launched as part of the Sentinel Initiative, which aims to create a new and improved system of tracking the safety of FDA-regulated drugs and medical devices.  Five years later, the Mini-Sentinel program is transitioning into a full-scale operation called the Sentinel System.

The Sentinel System will not replace FDA’s Adverse Event Reporting System.  Rather, the Sentinel System will complement adverse event reporting by adding a layer of “active surveillance” to FDA’s safety monitoring efforts.  The Sentinel System will gather data from patients’ healthcare records and offer FDA valuable information about the safety of drugs and devices.  Throughout the process, the identity of individual patients will remain protected.  The Mini-Sentinel program gained access to the healthcare data of more than 178 million U.S. patients, and the Sentinel System will continue to increase that number.

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