Hauser's FDA Rx: The FDA needs an NTSB

March 10, 2013 by Arezu Sarvestani

Post-approval medical device and pharmaceutical surveillance duties should be taken away from the FDA, says long-time patient safety advocate and FDA critic Dr. Robert Hauser, who's advocating for an independent bureau akin to the National Transportation Safety Board.

Dr. Robert Hauser

Dr. Robert Hauser hopes to push a major change at the FDA, looking to shift the monitoring of medical devices and drugs that are already on the market from the FDA to an independent entity.

Hauser, a long-time patient safety advocate and vocal FDA critic, is aiming to sell Capitol Hill on a new structure for the U.S. healthcare regulation system akin to how the nation deals with transportation safety, he told in an exclusive interview.

"We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings," Hauser told us today during the American College of Cardiology conference in San Francisco. "I'm interested in making a safer device or drug for a patient. I'm going to recruit a couple people and go to Congress."

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The concept is still in its infancy – the 1st time Hauser mentioned it to anyone was during a panel at the ACC conference yesterday, he said.

Hauser, a veteran of the Minneapolis Heart Institute who's well-known among cardiologists, likens his healthcare proposal to the U.S. regulatory structure for airlines, in which the FAA handles most of the work while the entirely independent National Transportation Safety Board monitors and investigates accidents and is solely responsible to Congress.