Medical device makers give FDA official an earful

May 20, 2010 by Minnesota Publi...

The director of the Food & Drug Administration's Center for Devices and Radiological Health, Dr. Jeffrey Shuren, receives a critical reception at a government-sponsored "town hall" meeting.

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By Martin Moylan

Bloomington, Minn. — The federal official who oversees the review and approval of medical devices came to the Twin Cities May 18, to hear what industry leaders and medical experts have to say about how the agency is doing its job. They aired a host of complaints.

The medical device industry employs some 50,000 people in Minnesota. Medtronic Inc. (NYSE:MDT), St. Jude Medical Inc. (NYSE:STJ) and other medical device companies headquartered here do 10s of billions of dollars in sales each year.

So it's not surprising that some 550 people showed up for the town hall-style meeting with Jeffrey Shuren of the Food & Drug Administration. Shuren is director of the FDA's Center for Devices and Radiological Health, the agency that decides if devices such as pacemakers and stents can be sold for use in patients.

Shuren heard lots of complaints about the FDA's review process.

Dr. John Sherman said he was medical director of a company developing treatments for spinal injuries. But he said the FDA approval process drove away investors. They were worried about putting money into a product that the FDA might not approve for a long time, if ever.

Sherman said that uncertainty was fatal for the company.

"It was shut down primarily because of some of the lack of predictability surrounding the FDA," said Sherman. "This is tremendously innovative technology. I would argue it was probably some of the most innovative technology I have ever seen as a spine surgeon."

The FDA also heard from unhappy venture capitalists — the folks who fund most medical device start-up companies, which may have great ideas but may be years away from sales or profits.

Peter McNerney, a prominent Twin Cities medical technology venture capitalist, said investors are shying away from upstart med tech companies because the FDA approval process is too hard to gauge and too likely to shoot down new products.

"The regulatory process has become long and uncertain and, in many instances, unnecessarily burdensome," McNerney said. "As a result, we have lost our ability to evaluate regulatory risk."

Nationwide, venture capital investment in medical device companies declined by more than one-third over the past two years, he added.