A U.S. House subcommittee hearing yesterday on the FDA’s oversight of medical devices devolved along sadly predictable party lines, with Republicans charging that the federal watchdog agency is strangling med-tech innovation and Democrats looking to undermine the reports behind the GOP’s arguments.
Which is too bad, because all the political noise obscured the real and pressing cause behind any problems at the Center for Devices & Radiological Health.
Led by Rep. Cliff Stearns (R-Fla.), chairman of the House Energy & Commerce Committee’s oversight subcommittee, Republicans in the vanguard accused the FDA of putting the U.S. med-tech industry at a disadvantage.
"Numerous reports, case studies and firsthand accounts indicate that a lack of consistency, predictability and transparency in the Food & Drug Administration review process is undermining patient care and our leadership position in medical devices," Stearns told the Sunshine News blog.
"The United States’ leadership position in the global medical-device industry is in jeopardy,"added Rep. Fred Upton (R-Mich.). "The overly burdensome regulations that are stifling American innovation and job creation must end."
"FDA is unpredictable and discourages innovation, and that hurts patients," echoed Rep. Joe Barton (R-Texas).
To shore up their case, Republicans called on Michael Mandel of the Progressive Policy Institute think tank and his case study of a Mela Sciences Inc.’s pre-market approval application, which has been under review for 25 months and counting. Mandel’s study, “Is the FDA Strangling Innovation?,” found that the FDA "is clearly blocking innovation" in not granting a PMA for the company’s MelaFind skin-cancer detection device.
"By not approving MelaFind, the FDA is clearly blocking innovation. The device is far from perfect, but it’s a real-time system that by some measures does as well as an experienced dermatologist in identifying lesions to be biopsied," Mandel wrote. "But beyond the approval or rejection of one particular device, the larger issue is whether the U.S. has unintentionally set up a system of approvals that are biased against cost-saving ‘disruptive innovation.’"
For their part, Democrats sought to undermine the studies behind the Republicans’ assertions, commissioning a trio of editors from leading medical journals to evaluate the reports. After reviewing the Stanford University study “FDA Impact on U.S. Medical Technology Innovation,” by researchers led by Josh Makower, and another by the California Healthcare Institute and the Boston Consulting Group, all three found problems with both studies’ methodologies and conclusions.
"While I am sympathetic to some of the industry concerns we will hear today, I do fear that all too often the device industry and its allies try to blur those trade-offs between safety and speed," said Rep. Diana DeGette (D-Colo.).
"We need to ask how unsafe devices have gotten on to the market," added Rep. Henry Waxman (D-Calif.).
But when you set aside all the political positioning and spin, and outliers like Mela Sciences, and the issue becomes clear: the Center for Devices & Radiological Health just doesn’t have the horses it needs to fulfill its mandate.
As CDRH chief Dr. Jeffrey Shuren told the subcommittee, his bureau contends with twice the reviewer turnover rate of its sister drug and biologics arms. That turnover means a dearth of experienced reviewers conversant with ever-more complex medical technologies, which in turn means longer review times
"We need to find the means to handle the ever-increasing workload and reduce staff and manager turnover," Shuren told the panel, echoing remarks he made last week at the MassDevice Big 100 Regional Roundtable.
"Our folks deal with a high workload," Shuren told us at the event, citing the 8.6 percent turnover rate among CDRH reviewers. "We have inexperienced staff. The majority of my reviewers have less than four years of experience. My front-line managers generally have three years experience or less because of the turnover rate.
"We have an insufficient number of managers," he added, noting ratios ranging from one manager for 14 reviewers to 1 for 27. "Anyone who runs a business would probably say those ratios are intolerable."
Then there’s the backlog of guidance documents the agency issues to help device makers navigate the system.
"My people are pulled between doing a review of your applications and working on a guidance document. They’re going to go with the applications first, but that means the guidance lags," Shuren told the audience of more than 250 medical device executives.
Not to mention a budget process that doesn’t tell CDRH how much it’ll have to spend until the fiscal year has already begun and a House FDA budget that would cut its funding.
"For the device program, if you take into account the amount that would get cut, plus the increase in costs we have no control over … we’re talking about about a 12-and-a-half percent cut, which for our program is huge," Shuren said at the event. "We’re very much on the margins."
That means moves to improve the agency, such as reviewer training programs that would send them into the field for real-world experience or reducing requests for unnecessary information, could fall by the wayside.
"I have issues with the times we’re asking you for things we shouldn’t have asked you for," Shuren said. "About 8 percent of the time, we actually ask for things we shouldn’t have. That has to stop."
But without a substantial increase in the resources it can bring to bear, it’s unlikely that those unnecessary requests — and all the other pressing needs — the FDA will not be able to keep up with med-tech industry. If the FDA really is holding back innovation, it’s the ridiculous, obstructive partisanship in Washington and its concommitant inability to get anything done that’s to blame.