FDA’s Shuren Makes West Coast Swing, Talks About Regulatory Reform

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Since he set out last year to revamp the way the FDA reviews medical devices, Jeff Shuren of the FDA’s Center for Devices and Radiological Health (CDRH) has often met with industry leaders to hear their feedback and ideas for how to improve medical device regulation. Last week, he met with industry leaders in San Francisco, and this week he’s in Southern California.

Shuren’s schedule in San Diego yesterday included a stop at Nuvasive (NASDAQ: NUVA), a pioneer in innovative spinal surgery products, which must have been an interesting meeting. Last week, Nuvasive CEO Alex Lukianov told an audience in San Francisco that FDA regulatory delays in reviewing Nuvasive products are costing the company an estimated $70 million a year.

Shuren, who has overseen the FDA center for just over two years, also met with local reporters, and provided an overview of the steps he’s taken to make the regulatory review of new medical devices more predictable, transparent, and efficient. The way the industry has been talking, though, it sounds like Shuren has taken only the first steps on what must be a 1,000-mile journey.

Eight out of 10 biomedical CEOs say they “agree or strongly agree” that the FDA regulatory approval process has slowed the growth of their organizations, according to a new survey from PwC [PricewaterhouseCoopers], BayBio, and the San Diego-based California Healthcare Institute (CHI). BayBio and CHI released some early results of the annual survey at an event timed to coincide with the JP Morgan Healthcare Conference, the biggest annual gathering of life science investors and executives.

Frustration throughout the life sciences industry has been mounting, but Joe Panetta, who heads San Diego’s Biocom industry group, sounded a more conciliatory theme as he sat next to Shuren during the media briefing. “Both industry and the FDA agree that we need to provide safe and effective products for patients and physicians,” Panetta said. “We’re definitely partners in that initiative, and it doesn’t do anyone any good to keep beating up on each other.”

The FDA’s Shuren is “trying to take specific actions to improve the decision-making process at the FDA, and also the decision-making culture,” says Ross Jaffe of Versant Ventures, who was among the Bay Area VCs who met with Shuren last week at a dinner organized by CHI. “To his credit, he’s willing to … Next Page »

Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at bbigelow@xconomy.com or call (619) 669-8788 Follow @bvbigelow

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  • Jesse_EngAmer

    This is what its all about:

    “We don’t want to be caught off guard in the future because we haven’t engaged at the level that Jeff is talking about with some of this personal genomics technology. We want to avoid those types of situations in the future. We hope by developing this public-private partnership, we can be getting answers to those types of questions at a much earlier stage and we hope to create a much more expeditious and smoother review process.”

    We see it in the recalls. We see it in pharmaceuticals. We see it in devices. The FDA needs to be preventative. The FDA seems to only react, react, react. And in some sense, they can only react. However, often the FDA admits to having information before say, a shortage, arises. Studies show many a shortage have been prevented or at least diminished when the FDA has prior knowledge. This is the type of progress the American public needs to get behind.