The passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) mandated that FDA develop a system for postmarket risk identification and analysis. In response, The U.S. Food and Drug Administration (FDA) launched the Sentinel Initiative. FDA’s Sentinel system has made significant strides toward developing a national system for generating post-market safety evidence.
On February 21, the Engelberg Center for Health Care Reform at Brookings convened an expert workshop, “Payer Involvement in the Sentinel Initiative,” to discuss the opportunities and challenges in establishing the Sentinel Initiative as a national resource which could provide better evidence to support decision-making in the post-market setting by a range of health care stakeholders. Representatives from the FDA and Sentinel data-partners discussed key issues with an expansion of the Sentinel system to support a wide-range of stakeholders.