Added studies could impair devicemakers Posted on July 21st
Additional safety studies of medical devices like stents may help patients and consumer confidence, but such reviews could level a financial hit to makers of those products, such as North Chicago-based Abbott Laboratories.
The stepped-up scrutiny comes as the U.S. Food and Drug Administration has been under pressure from Congress and consumer groups over its perceived lax oversight of devices and drugs.
The drug industry has been shaken by some high-profile cases involving safety. The painkiller Vioxx, for example, was withdrawn in September 2004 after a study linked the drug to increased risk of heart attacks. In the last two years studies have linked drug-coated stents, tiny scaffoldlike metal devices used to keep arteries open, to potentially dangerous blood clots and have hurt their sales.
In May the FDA announced its “Sentinel Initiative,” which provides a national electronic monitoring system for medical product safety, allowing the agency to “query multiple existing data sources, such as electronic health record systems and medical claims databases, for information about medical products,” agency officials said at the time.
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