Q&A with Dr. Jeffrey Shuren

Here is a transcript of an interview conducted Friday between Dr. Jeffrey Shuren, head of the Food and Drug Administration's Center for Devices and Radiological Health and Star Tribune medical technology reporter Janet Moore.

What can we expect at the meeting in Minneapolis next week?

This is one of three town hall meetings we're going to be holding this year. The first is in Minneapolis, then Boston in June, then Los Angeles in October. We wanted to get out to hear what issues, concerns, topics are on the public's mind. I'll give an update on some of our strategic priorities, then we'll open it up to anyone who wants to make comments about anything they want. Then we'll open it up for questions and answers. We're hoping to have a back-and-forth dialogue. It will be informal. It's an opportunity for folks in the Minneapolis area and in that region to weigh in and provide their thoughts.

Certainly rumored changes to the 510k approval process will be discussed. (The 510k process requires companies to prove their device is "substantially equivalent" to one already on the market, and in most cases, clinical evidence is not required. However, that has been changing. The vast majority of medical devices are approved through the 510k process.)

We're taking two steps to review the 510k program. One, we asked the Institute of Medicine to look at it longer term. Their report won't be out until the summer of 2011.

We also felt we needed to do our own assessment. We had an open meeting in February. We received comments on the docket, and our plan is to finish that report in the coming weeks and then put it out for public comment. The intent there is if there are particular [changes] that are no-brainers, and people uniformly say, 'This is worth doing,' we can start working on them now. Then, any of the recommendations that we don't adopt, if we think they require greater vetting, or if there's a lot of difference of opinion, we'd leave them out there for the Institute of Medicine process to consider. Then any of the recommendations that the IOM makes, we'll follow up on, probably not until 2011.

Overall, there's been a very intense and very good dialogue that's going out about the program. We undertook the review in light of questions and concerns that were raised -- by industry, patient groups, the health care community and our own staff. We felt the best way to address concerns is to undertake a more comprehensive assessment of the process and do it in a very public way.

One of the reasons we're undertaking the assessment is because folks in industry and elsewhere raised concerns about the program having a negative effect on innovation. We're looking at the impact it has had on innovation, and if there has been an adverse impact, what we can do to provide greater predictability in the program.

Companies trying to develop new products say it's hard to predict what the FDA is going to do, and therefore it's difficult to raise money.

We're doing the responsible thing. Let's conduct the assessment and figure out what's going on. If there are problems, then what are the causes, and then determine the right steps to fix them.

What other programs/initiatives have you implemented?

We're working on stronger guidance for industry about how they design clinical trials to support their pre-market applications. We've heard there's a lack of clarity.

What else?

We also have a big initiative to foster innovation in medical device design. Our mission has two parts, protecting public health and promoting public health. The FDA is in a very unique position when it comes to medical devices. All moderate- and high-risk devices are reviewed by the agency before they go on the market. So we see all of them.

We're privy to proprietary data and we monitor those devices when they're on the market. So we get a lot of real-world experience. That's the kind of experience and expertise that's not available in industry because each company only knows its own product. It's not available in the venture capital community, the health care community, even some of our regulatory counterparts in other countries.

In the past, when there's a problem we'll tell a manufacturer, "It's your problem, figure it out, go fix it." Now, FDA is willing to make available its experience and its expertise. We won't provide proprietary data, but we'll make our experience available to help industry solve problems.

What's the impact been?

We took a similar action a few weeks ago with infusion pumps. We were seeing systemic problems in infusion pumps, all manufacturers were having some kind of problem. We pooled our experience and identified 85 common problems, and went out publicly to talk about them and then provided guidance on what industry should do to address those potential risks. We developed software that manufacturers can use as a starting point in designing their device, or as a benchmark to compare their own software to help avoid some of these common problems. We're pulling together the parties to discuss ways in which the design could be altered to reduce the likelihood of problems.

What are you doing about post-market surveillance of devices once they're implanted in patients?

Two big steps. One is greater investment in the development of medical device registries.

We're also developing a unique device identifier. Right now, if you take a drug there is national drug code that can tell you the drug's manufacturer, what the drug is, what the dosage is, and you can use that information to link the drug with what the experience of the patient has been with the drug. If a person has an electronic health record you can connect the drug with the patient through that code. There is no similar thing in the device world now. We're creating that unique device identifier that manufacturers would be able to put on a product and then it can be linked to real-world experience. So we'll have a rich data source to understand what's happening with that device when people actually use it. That will tremendously increase the bandwidth of post-market surveillance for devices and might allow us to use data collected in the post-market setting to inform and supplement material that's provided in a pre-market review.

There's a lot of controversy over the advisory panels FDA uses to review medical devices prior to approval. Some say too many panel members are linked to industry. Industry argues that anyone with expertise on a product won't be able to serve on a panel. How do you get the best panels in place?

Your job is no doubt demanding. Why did you accept the position?

I actually like medical devices. I believe very strongly in the benefits that medical devices can have in health care. When the position was open, I was approached and saw it as a wonderful opportunity to have what I hope will be an impact on public health and health care generally.