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

1/18/12Follow @bvbigelow

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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 … 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.