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GAO: FDA shirks device-approval mandate

January 15, 2009

A U.S. health agency does only minimal testing before approving high-tech medical devices, despite an order to do full reviews, a federal report said Thursday.

Most of these complex devices such as pace makers and replacement heart valves receive quick approvals with minimal testing because manufacturers tell the U.S. Food and Drug Administration the products operate just like older devices already approved, the Government Accountability Office report said.

So on the one hand, the manufacturer wheels in their new Ferrari to the FDA and says, ‘Look, it’s a car just like the Model T,’ Memorial Sloan-Kettering Cancer Center Dr. Peter Bach told The New York Times.

Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes, Bach said.

The GAO — Congress’ audit, evaluation and investigative arm — recommended the FDA fulfill promises it made 14 years ago to fix its system for approving complex medical devices.

In 1995, the FDA promised Congress it would come up with rules for testing such devices, but never followed through, the GAO said.

The FDA had no immediate comment.


Source: upi



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