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FDA Plans Tougher Review of Devices

Posted: November 10, 2006

The Food and Drug Administration yesterday outlined a plan for tougher monitoring of the safety of medical devices once the products are on the market. It comes just after Democrats , who promise more aggressive oversight of the FDA, wrested control from Republicans in the House of Representatives and Senate.

The FDA said the timing of yesterday's plan was "totally unrelated" to the election outcome. The agency's plan includes an electronic system for reporting serious side effects, to replace the paper reports now filed by medical professionals and patients.

"The entire FDA post-marketing surveillance system is weak both for drugs and devices," said Dr. Steve Nissen , a Cleveland Clinic Foundation cardiologist scheduled to testify at a congressional hearing this month about the FDA. "Unfortunately, adverse event reporting is voluntary and, generally, only 1 to 10 percent of events are reported," Nissen said.

A Democratic-led Congress appears willing to make that and other FDA improvements, starting by shuffling a few key committee chairmen.

Democrats Edward M. Kennedy of Massachusetts , Henry A. Waxman of California , and Bart Stupak and John D. Dingell both of Michigan are poised to head key congressional panels with investigatory powers and FDA oversight.