WASHINGTON — Six months after the Institute of Medicine (IoM) issued a report recommending the dissolution of FDA’s 510(k) medical device approval process, the agency has yet to release their official response — a delay that has legislators concerned.
Unofficially, agency officials have said that, while they respect the IoM’s work, they have no intention of doing away with 510(k) — the FDA’s program for providing expedited approval to moderate-risk Class II medical devices by proving “substantial equivalence” with devices already on the market.
IoM contended that the process cannot assure that devices are safe or effective and that many of the old devices used for comparison have been on the market since before laws began requiring medical device evaluation. FDA officials have argued it is better to improve the existing program than do away with it when there is no alternative to take its place.
Regardless of which is the better path to take, legislators are looking for action in one direction or the other.
Making Poor Comparisons
“There’s no virtue in getting devices to patients quickly if they don’t work or if they cause injury or death. I think most Americans would be alarmed if they understood the process we use now to approve devices,” said Sen. Tom Harkin (D-IA) at a recent Senate Health, Labor and Pensions Committee hearing. “They would think that for any high-risk device — anything that’s implantable in the human body — that experts at FDA would examine clinical data and conclude that the device is demonstrated to be safe and effective. But that’s not what happens. Most devices are cleared through a process by which devices are shown to be ‘substantially equivalent’ to another device that’s already on the market, even if that device was substantially equivalent to a previous device, and that previous device was substantially equivalent to a previous device, and on and on and on.”
Harkin used the circumstances surrounding the approval of “metal on metal” artificial hip implants — implants that use metal ball and socket joints. In recent years, physicians have found that, as the devices wear down, they can release metal shavings into the surrounding tissue, causing inflammation and permanent damage. The metal implants also have been associated with a high accumulation of metal ions in patients’ tissues and bloodstreams.
A study released last month by researchers at the Patient-Centered Comparative Effectiveness Program at Weill Cornell Medical College in New York found that the metal implants fare no better than the older metal-on-polyethylene or ceramic-on-polyethylene implants. However, there is evidence of higher rates of replacement surgery associated with the metal-on-metal implants.IOM Says Get Rid of 510k approval FDA Responds Not So Fast Cont.
“All metal-on-metal implants were approved under FDA’s 510(k) process, in many cases without clinical data,” Harkin said. “Today there are half a million Americans walking around with a dangerous hip implant and few options.”
Jeffrey Shuren, MD
Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), defended 510(k), even for complex implantable devices. “In some cases, it does make sense for an implantable device to be considered through 510(k) if it truly is moderate risk,” Shuren said. “And sometimes we know that up-front. Sometimes we learn over time about that risk and, what was previously a high-risk device, we make it a low-risk device. Our law is based upon taking risk into consideration in terms of applying what our requirements are, and we take it very seriously.”
Shuren admitted this process is based on the judgment of FDA reviewers, rather than hard, clinical data, and that the process failed in the case of metal-on-metal hip implants. “We, under the least burdensome principle, decided that we weren’t going to ask for clinical data in this case. And these were always trade-offs and judgment calls as we try to figure out what the least justified burden is to impose on the company. That’s a scientific decision, and sometimes we slide to a place and it’s not the right call,” Shuren said. “There were failures [in the hip implants] that we might have detected if we had asked for other kinds of information.”
High Turnover in CDRH
Many of the problems with 510(k) are not with the program itself but with a lack of resources, Shuren said.
The No. 1 problem identified by FDA was insufficient predictability in the review process, which has several root causes. The first is a very high reviewer and manager turnover at CDRH — almost double than that of FDA’s centers for drugs and biologics. That high turnover rate results in insufficient reviewer training and insufficient oversight by managers, Shuren told legislators.
“Almost half of my reviewers have four years of experience or less,” Shuren said. Experience is even less for front-line managers — a turnover rate that disrupts the review process.
“There is also not enough management oversight,” Shuren said. “Sometimes the ratio of reviewer to manager is as high as 27 to 1.”
Some of these personnel issues could be addressed through higher user fees, Shuren testified. Currently FDA is working with Congress and industry to reauthorize the Medical Device User Fee Act (MDUFA). Fees for medical device applications are significantly lower than fees for new drug applications.
The savings to industry generated by the quicker, safer and more efficient review process resulting from more resources would outweigh any reasonable increase in fees, Shuren said.
However, Shuren would not respond in depth to the IoM report. FDA was still getting administration approval of its official response, and so he was “hamstringed,” Shuren said.
Asked why the agency rejected the report’s core conclusions, Shuren said, “We think the 510(k) program, in most cases, has worked well. If we’re going to be [replacing it], I’d ask what are we putting in its place. It’s a question the Institute of Medicine felt they were not in a place to actually say. To get rid of the program would be highly disruptive. And what are we gaining in return? Do we have an alternative program that can assure safety and effectiveness and can do a better job then what we’re doing right now?”
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