FDA Center for Devices & Radiological Health chief Dr. Jeffrey Shuren got pummeled by Republican members of the Senate Health, Education, Labor & Pensions committee this week.
Shuren took tough questions from North Carolina’s Sen. Richard Burr (R), who called the agency out on its failure to meet goals associated with medical device user fee negotiations during a congressional hearing on medical devices, protecting patients and promoting innovation.
"Negotiations suggest that the agency is seeking a more than 250 percent increase in user fees from current levels," Burr said. "Let me ask you – would you agree to pay somebody any money at all, much less a 250 percent increase over what they’re currently paying, when the terms of what you’re paying for aren’t being met?"
Burr also accused the agency of "bashing" the industry for the increase in application review times, which Shuren insisted wasn’t the CDRH’s position on the root of the problem.
"We have not been out there saying that the problems are all due to industry," Shuren told the committee. "I’ve been saying for a long time now that, actually, the problems are multi-factorial and that a good part of it is due to the FDA."
"It troubles me, and I would hope that it would trouble you, that most companies across this country tell horrific stories about going through the approval process at the FDA," Burr retorted, adding that the concerns companies and venture capitalists voice about unpredictability at the agency need to be weighed into decisions on how to improve the process.
Shuren added that many of the agency’s goals involve improving procedures at the FDA to make the device review process more efficient and easier to understand, but he did put some of the responsibility on the industry’s shoulders.
"We do get, from a number of companies, submissions that are of poor quality," Shuren said. Unlike the pharmaceutical review process, in which bad submissions are sent back to the manufacturer, the CDRH works with companies to improve the application, he explained. "When we take in a submission that may not be of sufficient quality and we’re going to work with them, we end of doing some of the work for the company."
Sen. Orrin Hatch (R-Utah) closed the session by inquiring about the time and effort the FDA has spent on the 510(k) process, "a program that really seemed to be working pretty dog-gone well," and asking what the agency planned to do about application review times that had grown by 50 percent to 100 percent in some cases.
"When U.S. industry is losing its competitive edge and patients are waiting longer and longer for treatments and cures, that’s a matter of great concern for me," Hatch said. "I think we’re falling behind the rest of the world in approvals, yet we have some of the most imaginative people working in this country."
Burr has been an active participant in discussions concerning medical devices review times. He lent his signature to a letter led by fellow Minnesota Sen. Amy Klobuchar to FDA head Dr. Margaret Hamburg, raising concerns over "increased review times, inconsistent expectations, and poor communication from the FDA."
The hearing followed the introduction of the Patient Access to Medical Innovation Act, a bill led by another Minnesota legislator, Sen. Al Franken (D), aimed at increasing incentives for devices for treating rare diseases and relaxing conflict-of-interest standards for medical experts serving on med-tech review panels.