Federal health officials will mine prescription drug usage by millions of participants in the Medicare drug program to look for problems with medicines and medical devices after they hit the market.
The Food and Drug Administration has been under increasing pressure to develop a drug surveillance system since the painkiller Vioxx was pulled from the market in 2004 after it was linked to increased risk of stroke and heart attack.
New regulations unveiled Thursday by the Health and Human Services Department make it possible for federal agencies, states and academic researchers to use claims data subject to protections for privacy and trade secrets.
The Institute of Medicine recommended creation of such a surveillance system in 2006.
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