DRW Monthly
May 2009
Issue No. 30

FDA's Sentinel Initiative to Track Safety of National Drugs, Biologics and Medical Devices

The Food and Drug Administration's (FDA) Sentinel Initiative was launched May 2008 in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA). The FDAAA provisions mandated that the FDA take the lead in developing an electronic surveillance system to increase the agency's capacity to monitor regulated medical products on the market. Although the FDA has a number of systems already in place to track adverse events and product problems, these monitoring tools all represent a passive approach to obtaining data. Each of the existing measures obliges the agency to depend completely upon consumer, medical professional and healthcare product company feedback to respond to potential public safety concerns.

The Sentinel System, by comparison, will enable the FDA to make queries across a broad collection of interoperating electronic health care data systems including electronic health record databases, administrative claims databases and registries, to identify possible post-market adverse events. The Centers for Medicare and Medicaid Services' Medicare Prescription Drug Benefit database which links to Medicare inpatient and outpatient claims data, is serving as the prototype for the Sentinel System.(1) Based on the proposed system, data would continue to be managed by the operating system owners in order to ensure the protection of personal and proprietary information and would then be sent to the participating data holders. The data holders, in turn, would evaluate their information and send summary results to the FDA for agency review within pre-established privacy and security safeguards. It is anticipated that this gradually developed and implemented system will facilitate the growth of active surveillance methodologies related to signal detection, signal strengthening and signal validation.(2) Moreover, the Sentinel System may also be used to support future research on use and outcomes, epidemiology studies, existing risk identification and analysis processes and may even support the development of new pathways to disseminate up-to-date medical product and health-related information.(3)

The most recent activity surrounding the Sentinel Initiative involves the opening of the FDA public docket to receive and make available information relating to this system. The docket information consists primarily of documentation prepared by contractors involved in the development of the Sentinel System. The contracts examine a wide range of technical and policy issues that will affect the Sentinel System. Written or electronic comments pertaining to the docket information may be submitted at any time to the FDA's Division of Dockets Management.

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