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

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 go out and hear the complaints—I’m sure he’s heard the same complaints over and over—and meet with different people,” Shuren says. “I often joke that the changes he’s trying to make are like trying to turn a battleship with a paddle.”

Panetta, who has headed Biocom since 1999, traces the industry’s difficulties with the FDA to about 2002. “We saw an FDA that began to become responsible for a number of new initiatives that had an impact on their resources, [with] greater complexity and a rapid increase in the sophistication of devices and diagnostics that were being developed in areas where there wasn’t any history,” he said

Beginning at this time last year, the FDA’s medical device division issued a white paper on its plans for an “innovation initiative,” and outlined its plan to create an “innovation pathway” that Shuren describes as “a number of common sense business process improvements” intended to make the center’s premarket review of medical devices proceed faster and more smoothly.

With its clusters of companies focused on biomedical diagnostics and wireless health, San Diego represents something of a new frontier—or perhaps the Wild West—for FDA regulators. Shuren’s tour here also included stops at the diagnostics specialist Gen-Probe (NASDAQ: GPRO), DexCom (NASDAQ: DXCM), which makes blood-sugar monitoring devices, and ResMed (NYSE: RMD), which has been working with Qualcomm (NASDAQ: QCOM) on new business models for managing sleep-disordered breathing.

In terms of regulating wireless medical devices, Shuren voiced concerns about radio interference and interoperability, especially in hospital settings. For diagnostic devices, he says the importance of verifying that a test is accurate has been immensely complicated by the proliferation of personalized genetic diagnostics. Beyond that, he’s asking what it means if a genetic diagnostic test result indicates, for example, a 10 percent risk of diabetes. In other words, what does a given diagnostic result mean? And at what point does the data become relevant and useful?

In an FDA blog last month, Shuren outlined some of the agency’s accomplishments so far. But now comes the hard part. In discussing his quest to bring clarity, efficiency, and consistency to the process of ensuring that medical products are safe and effective, Shuren says agency officials need better scientific tools to carry out their regulatory duties. “If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science,” he says.

The improved regulatory tools Shuren has in mind include improved computer modeling, which could be used to more accurately predict the safety and effectiveness of devices under different conditions. He also wants the industry to help pool its resources by creating what he calls a “Switzerland” for medical devices—a public-private biomedical research partnership like the pharmaceutical industry’s Biomarkers Consortium,that could be used to safely share proprietary information without fear of having trade secrets leaked to competitors. Establishing a similar entity for medical devices is more of a challenge, Shuren says, because the universe of device makers includes consumer electronics, wireless, and other non-traditional biomedical companies and product life cycles are short and fiercely competitive.

Shuren and Biocom’s Panetta also talked about the necessity of engaging FDA regulators much earlier in the development process for medical devices. “The more than we can do to engage the agency early on, the better off we’re going to be down the road,” Panetta says. With genetic diagnostics, for example, he says, “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.”

Or as Shuren put it, “It’s a little bit of Dorothy and the red slippers. You can get back to Kansas, but you have to be willing to use the tools you’ve been given.”

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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