Hauser’s FDA Rx: The FDA needs an NTSB

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 MassDevice.com 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."

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.

Establishing a separate agency with the authority to handle healthcare problems such as medical device recalls would help relieve a fundamental conflict of interest with in the FDA, according to Hauser.

"The FDA is being asked to approve devices and then to be responsible for monitoring performance for devices and drugs," he said. "Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug.

"They’re all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it’s discussing, potentially, the performance of another group inside the agency?"

The proposed bureau, which Hauser said could be called the "National Drug & Device Safety Board," would have engineers, scientists, statisticians and administrators, and a board to report its findings to Congress.

The group would monitor healthcare products after they’re given the green light by the FDA, participating in post-market studies and watching registries from around the world. Hauser’s vision is that the data gathered would be completely transparent, fully open to the public. That could confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, he noted.

There are obstacles to be overcome. For example, information on issues with particular materials in medical devices, isn’t shared with other device makers due to its proprietary nature, he told us. And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was "not bound to adopt IOM recommendations."

Hauser is acutely aware of the hurdles he’ll face in proposing a massive change to the regulatory system, but he’s pressing onward anyway.

"Idealistic? Well, yeah, but it’s kind of practical, too – why would we want people to repeat mistakes that have already been made?" he told us. "There’s 1 chance in 100, but it’s worth taking the chance. It’s worth the effort, because maybe in the conversation something will happen that’ll change things."

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