The Senate overwhelmingly approved a landmark drug-safety bill Wednesday, doubling the number of government scientists assigned to ferret out risky side effects in medicines already on the market.
The measure also would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs, and significantly expand the Food and Drug Administration's power to require drugmakers to reduce risks.
The computerized surveillance system outlined in the bill would provide a way to keep closer tabs on newly approved drugs.
The FDA's current system relies on anecdotal reports from doctors and picks up only a small fraction of adverse reactions. The legislation would incorporate that system into the broader surveillance network for all new drugs.
The network would scan millions of records in billing files from government healthcare programs and private insurers. Patients' identities would be protected.
The system would raise a red flag if, for example, billing records indicated that arthritis patients given a new painkiller were more likely to get treated for heart trouble than similar patients taking an older drug. Precisely such a research finding from a large HMO's database provided the initial unheeded warnings about Vioxx.
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