FDA's Sentinel Initiative Will Improve Adverse-Event Tracking

Rockville, MD (May 22)-In a white paper published today, the US Food and Drug Administration described its Sentinel Initiative to create an electronic safety system that tracks drug performance. The system will help the agency identify possible postmarket adverse events and eventually strengthen FDA’s ability to monitor product performance throughout a drug’s entire life cycle.

The Sentinel System will enable the agency to access established data systems such as electronic health-record systems and medical-claims databases, subject to privacy guidelines. Under the plan, data sources will be maintained and managed by their owners, and minimal data transfer will be required.

FDA called for a public–private collaboration to develop and implement the Sentinel System. The agency will share information with the Centers for Medicare and Medicaid Services (CMS), the Veterans’ Health Administration, and the Department of Defense.

On May 22, 2008, CMS published a final regulation that will help FDA establish the Sentinel System. The regulation allows federal agencies, states, and academic researchers to use claims data from the Medicare prescription-drug program (Part D), subject to privacy protections for beneficiaries and industry, for public health and safety research, quality initiatives, and other research and analysis. Under the CMS rule, FDA can use Part D claims data to investigate drug-safety questions related to particular products.

The Department of Health and Human Services (HHS) will use Medicare Prescription Drug Benefit data and Medicare inpatient and outpatient claims data to create a database that will serve as the prototype for the Sentinel System.

The Sentinel System’s access to established databases of health information will allow the agency to analyze more information than it can today. In an HHS press release, FDA Commissioner Andrew C. von Eschenbach said the system will give the agency “the ability to monitor a product’s performance in millions of patients in real time.” The Sentinel System “will give us an unprecedented ability to detect problems as they first begin to surface,” he added.

Creating an active surveillance system such as the Sentinel System was one of the recommendations that the Institute of Medicine made in a 2006 report about ways to improve the safe use of drugs. The Food and Drug Administration Amendments Act of 2007 includes provisions that call for such a system to be developed. In the white paper, von Eschenbach described the Sentinel Initiative as part of the agency’s Critical Path Initiative.