Press Release

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Sue Ducat
Director of Communications
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The FDA's Sentinel Initiative


A new policy brief from Health Affairs and the Robert Wood Johnson Foundation addresses the Sentinel Initiative, launched in 2014 by the Food and Drug Administration (FDA), to proactively and systematically detect and respond to emerging risks in prescription medicines. Previously, the FDA relied on mostly voluntary collection of adverse effect reports through its Adverse Event Reporting System (FAERS), a database with severe limitations in how it identifies and tracks drug risks. A confluence of developments--the increased use of electronic health records (EHRs), big-data analytics, and improving overall alignment among health care systems--made it possible to track patient outcomes and treatment results on a larger scale. At the cutting edge of the big-data revolution, the Sentinel Initiative offers great promise, but for now the FDA is still learning how to tap its full potential.


Topics covered in this brief include:


      • What's the background and the law? The brief describes the limitations of the pharmaceutical industry's drug testing process. Testing is often performed on only a part of the population, so safety problems or side effects can emerge once a drug is widely distributed. FAERS, designed to collect reports of such problems, has weaknesses, spelled out in the brief. In the wake of several high-profile drug safety problems in the early 2000s, Congress ordered the FDA to develop a more robust process. In 2008 the Department of Health and Human Services announced the beginnings of the Sentinel Initiative, piloted before becoming a full-scale system.

      • What's the policy and the debate? Sentinel today not only probes links between drugs and adverse effects: Its data can be used to detect disease trends and patterns. However, as the brief explains, program critics have raised concerns that some of its data still come from medical claims that fail to describe actual patient outcomes. Critics of Sentinel also say that the FDA should take more regulatory action from findings seen by the program's extensive data networks.

      • What's next? As Sentinel transitions from a series of pilot projects to a national full-scale program, the FDA and its project partner, Harvard Pilgrim in Boston, plan to increase the number and types of data partners over the next few years. Increasing its bandwidth should help enable the FDA to begin using this new tool to its full potential.
About Health Affairs

Health Affairs is the leading journal at the intersection of health, health care, and policy. Published by Project HOPE, the peer-reviewed journal appears each month in print, with additional Web First papers published periodically and health policy briefs published twice monthly at Read daily perspectives on Health Affairs Blog. Download weekly Narrative Matters podcasts on iTunes.