FDA to take new tack on postmarketing surveillance

June 16, 2008

FDA will review claims data from Medicare and other sources to identify unsafe drugs and devices.

Until now, the Food & Drug Administration had to wait for post-market reports of adverse events to reach the agency before it could remove unsafe drugs or devices from the market. Now under a new Sentinel Initiative it is launching, the agency will be able to promptly evaluate claims data from Medicare, other federal programs, and participating private insurers to identify safety problems. In addition, final regulations published by the Centers for Medicare & Medicaid Services state that researchers can access claims data from Medicare Part D, with patient identity shielded, for research purposes.