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A national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, medical devices--and ultimately all FDA-regulated products once they reach the market--is now on the horizon. Launched in May 2008 by FDA, the Sentinel Initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products.
Monitoring the safety of its regulated products is a major part of FDA’s mission to protect public health. But, currently, the Agency’s efforts are limited to its largely passive safety monitoring systems, which depend on healthcare professionals, patients, consumers and pharmaceutical companies to report any adverse effects of FDA-regulated products. The Sentinel System would enable FDA to actively query diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely.
Sentinel will be developed and implemented in stages. As the system is envisioned, data would continue to be managed by its owners and questions would be sent to the participating data holders. Within pre-established privacy and security safeguards, these data holders would evaluate their information and send summary results to FDA. It is also anticipated that Sentinel will facilitate the development of active surveillance methodologies related to signal detection, strengthening, and validation.
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