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Comfort from FDA with one question

Here's a small sign that things are turning around at the U.S. Food and Drug Administration.

A few days ago, my blog entry about the presentation by Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiologicial Health, mentioned the concerns of many in the audience from the Medtech industry and how Shuren tried to address them. The opening quote - "We're scared. We don't know what to expect." - came from Connie Hoy, vice president of regulatory affairs and compliance officer, at the firm, Cutera, a maker of laser and light based medical devices, based in Brisbane, Calif.

Hoy was kind enough to email me a couple days after the event, and her response gives a sense of the impression Shuren left. Here's what she said:

Several take aways from the meeting:

I very much liked Dr. Shuren He seemed down to earth and clearly wants to communicate. That in itself is reassuring.

I liked that he took some responsibility for the problems in the FDA
review process. I actually think he was a little hard the reviewers,
for example, when he stated that he thought the agency lacks technical
expertise. That is not the case in the laser side of the business.

I also appreciated that he was able to point out shortcomings on
industry side with out being accusative. He is right, quality of
submissions is critical to a smooth process and it is industries
responsibility to prepare quality submissions.

I also liked the fact that he wants to build a clinical group at FDA.
BUT, that also scares me a bit. One of the things that is important is
that industry can dictate the protocols in their trials. FDA can't be
too prescriptive or it will damage industry by possibly adding too much
cost and/ or time.

Overall, I was comforted and encouraged by what I hear.

The Stanford Biodesign Round Table, at which Shuren talked with panelists and answered questions from the audience, is now available as a video on the Web.

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