Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), was on the hot seat as he defended protecting patients and encouraging medical device innovation during a Senate Committee on Health, Education, Labor and Pensions, on Tuesday, November 15.
See a video of the hearing here.
Can the CDRH both protect patients while at the same time promote innovation? Shuren says yes. He told the committee that his division needs funding to be predictable, consistent, and transparent and to encourage innovation in the medical device field.
One way to do that, he told the hearing, is to reauthorize the Medical Device User Fee Act. (here)
The Medical Device User Fee Act is scheduled to expire September 30, 2012 but sharp increases are needed to have an adequately trained staff of reviewers who determine if a given device should make it to market. A lack of funding contributes to a high turnover of employees, Shuren said.
Shuren got “pummeled” reported MassDevice (here) by GOP members of the Senate committee. Sen. Richard Burr (R-NC) questioned Shuren on a lag in the negotiations concerning the medical device user fee. Burr pointed out the agency wants more than a 250% increase in user fees.
“Let me ask you – would you agree to pay somebody any money at all, much less a 250% increase over what they’re currently paying, when the terms of what you’re paying for aren’t being met?” asked Burr.
Burr appeared to be hawking for the medical device industry and venture capitalists when he admitted companies tell him about the “horror stories” of going through a difficult approval process.
While Shuren said much of the improvements at the FDA have been to make the process easier to understand, he added that the CDRH does receive submissions from device manufacturers that are of “poor quality".
Instead of sending back the application, the CDRH works with the company to fine-tune the application so it can be approved. Shuren said “When we take in a submission that may not be of sufficient quality and we’re going to work with them, we end up doing some of the work for the company.”
Senators are concerned the review time for applications has grown by up to 100 percent in some cases. (see FDA on user fees here).
It was July 2011 that an Institute of Medicine (IOM) report said the 510(k) is “fatally flawed” putting Shuren and his medical device division in the uncomfortable position of defending what the IOM said should be scrapped. The committee revisited the IOM suggestion that a new regulatory framework replace 510(k). The process only requires a new medical device be substantially equivalent to one already on the market to give it a fast-track and least expensive way to the marketplace.
David Challoner, M.D., chair of the IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, appeared during the second half of the hearing to say the IOM report from this summer was intended to begin a conversation on the approval process of devices.
Gregory Curfman, M.D., Executive Editor of the New England Journal of Medicine reminded the committee that we can no longer regulate medical devices in the same way as 35 years ago when there were simpler and fewer devices. To do so is at the risk of patients, he testified.
The industry and some lawmakers from device manufacturing hubs want the 510(k) to remain in place. A 510(k) application may cost a company less than $20,000, while having a medical device undergo extensive clinical studies can cost a medical device manufacturer $870,000, according to estimates by the GAO in 2005.
The FDA is between a rock and a hard place – does it placate the investment community by making the approval process easier- or does it put patient safety before any other consideration? That is a high wall to climb since the 510(k) does not require clinical data assuring safety.
So while the industry and investors say they will take innovation overseas, patient advocates remind the FDA that its main role is to provide adequate protection for patients.