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The Boston Globe - Senator John Kerry Cosponsors Medical Device Bill

News Article

Location: Washington, DC

By Tracy Jan

Senator John Kerry, along with a bi-partisan group of his colleagues, sponsored a bill today to acclerate the FDA approval process for medical devices by making it easier for the agency to consult with experts, along with other provisions.

The bill, The Patient Access to Medical Innovation Act, would require the U.S. Food and Drug Administration to comply with the same conflict of interest requirements as the National Institutes of Health and all other federal agencies.

The FDA requires up to 18 advisory panels be summoned to evaluate new medical technologies when the agencies lacks their own experts to do so. But stringent restrictions on panel members now often prevent the best experts from reviewing specific devices or technologies, according to Kerry's staff, and thus significantly slow the approval process.

The bill would also lift the current profit cap on devices used to treat rare conditions and diseases that go through a special approval process.

"This legislation strengthens the approval process while cutting the red tape that keeps these critical devices from the hospitals, doctors and nurses who can use them to save lives," Kerry said in a statement. "Massachusetts has long been at the heart of these technological innovations."

Kerry, along with FDA Commissioner Margaret Hamburg, had met with Massachusetts medical device and biotechnology leaders in Boston in July to discuss key issues facing the industries.

Other sponsors of the bill are: Senators Al Franken, a Minnesota Democrat, Lamar Alexander, a Tennessee Republican, and Kay Hagan, a North Carolina Democrat.

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