Background on FDA's Sentinel Initiative

Consistent with the Food and Drug Administration's (FDA's) mission to protect and promote the public health, the Agency is embarking on the Sentinel Initiative to create a national, electronic, distributed network, strengthening its ability to monitor medical product safety. As currently envisioned, the Sentinel Initiative will enable FDA to utilize the capabilities of multiple, existing data systems (e.g. electronic health record systems, Medicare data, other medical claims databases) to augment the Agency's current surveillance activities.  The Sentinel Initiative will enable surveillance or queries of distributed data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners and operations will adhere to strict privacy and security safeguards.

At present, as part of its safety surveillance and monitoring efforts, the FDA relies primarily on (1) health professionals or patients who experience serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use and submit a report to the Agency or to the manufacturer (who must then report to the Agency); (2) case reports published in the medical literature; and (3) results of postapproval and other clinical studies when they are performed. However, in recent years, rapid scientific advances, as well as advances in information technology have created new opportunities for monitoring the performance of medical products.  The FDA's Sentinel Initiative will enable the FDA to leverage these new advances to improve upon its methods for monitoring medical product safety.

With the September 2007 passage of the The Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has the mandate to launch the Sentinel Initiative. Section 905 of the FDAAA calls for the Secretary of the Department of Health and Human Services to "...not later than two years after the date of enactment...in collaboration with public, academic, and private entities, develop methods to obtain access to disparate data sources...develop validated methods for the establishment of a postmarket risk identification and analysis system to link and analyze safety data from multiple sources." 

The FDA is serving as advisor on eHI's Connecting for Drug Safety Collaboration, exploring opportunities to use electronic health information to identify and assess safety signals associated with marketed pharmaceuticals.  The FDA has been participating through the National Advisory Board, the Steering Committee and regularly scheduled scientific calls with clinical and research subject matter experts regarding methods and outputs. 

Download the FDA Sentinel Initiative Strategy