In response to criticism of its existing systems for monitoring the safety of drugs and medical devices, the US Food and Drug Administration (FDA) is launching a new electronic system for identifying safety problems once a drug is on the market.
The Sentinel Initiative was officially launched by the agency in May, though some pilot studies were already under way (Kuehn BM. JAMA. 2006;296:1457). Although the program initially will probe claims from Medicare's Part D prescription drug program cross referenced with medical and hospitalization Medicare claims, the agency said it is developing public-private partnerships that will eventually allow it to search health care databases from insurers, hospitals, and other entities that collect such information.
Kuehn BM. FDA Turns to Electronic “Sentinel” to Flag Prescription Drug Safety Problems. JAMA. 2008;300(2):156–157. doi:10.1001/jama.300.2.156
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