A Newly Candid FDA on the Future Of Medical Device Regulation

We all know the Food and Drug Administration is one of the most important entities for those who develop drugs and medical devices, but for the public, and even many of the people in industry, it remains a notoriously mysterious organization. So I was very excited about the opportunity to have an in-depth phone conversation with Jeffrey Shuren, who heads the agency’s Center for Devices and Radiological Health. Shuren has played various policy roles at the FDA since 1998 and has been at the helm of the center since September, first as acting director, and then as official director since January this year.

When we spoke, Shuren had just returned from a Town Hall meeting that the FDA had sponsored in Boston, and where medical device manufacturers were not shy about voicing their concerns about the agency. Chief among them was how difficult it is to predict how the agency will react to submissions for device approval. Shuren was very conscious of this being a major problem, especially for small companies.

I sense the agency is really trying to reach out to the public, to industry, and to members of the press. This is just my personal experience, but when I used to be a reporter for a major national newspaper, covering very high-profile medical devices, I was very rarely able to get on the phone with top FDA officials, in spite of numerous interview requests. At the time, the agency spoke to the press mostly through spokespeople, and often solely via e-mail. It is very refreshing to see Shuren, as well as Joshua Sharfstein, the agency’s deputy commissioner, giving interviews these days. This is the kind of transparency the agency has needed for a while.

Anyway, here’s an excerpt of my interview with Shuren. Among other things, we talked about how the agency is taking a more proactive role in not only ensuring device safety, but also balancing safety with efficacy. We talked and about the future of the controversial 510k program, through which many manufacturers get their devices approved following few or no clinical trials by showing that the new devices are “substantially equivalent” to ones already on the market. These are issues I bet many of you in the industry will be interested in.

Sylvia Westphal: How did things go at the town hall meeting?

Jeffrey Shuren: I found the session very valuable. Having a two-way dialogue for people to talk about whatever is on their mind and to have us engage in a back-and-forth is the best way to understand what’s most important to the people who we regulate and also the people we serve, because ultimately we are serving the public.

SW: I know manufacturers spoke up fervently.

JS: I think there were some very important comments that we heard and number one on the list is predictability. Providing predictable and consistent regulatory pathways to market and being predictable in other actions that the center takes is paramount for industry to plan for what they need to do to develop a device and get it to market, and also for venture capitalists to … Next Page »

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