Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market
Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.
One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.
Announced in a May 2016 statement, the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).
Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner?
Findings Shed Light on FDA Process Problems
“Our results revealed significant weaknesses in pre-approval and post-approval regulation of high-risk obstetrics and gynecology devices”, wrote the study’s authors.
The researchers identified 18 high-risk women’s health devices that the FDA approved based on questionable data between 2000 to 2015, some of which were for:
• Contraception; and
Steve Xu, MD, the study’s Senior Author and a resident in Northwestern Medicine Dermatology, stated, “We looked at the classes of devices with the highest potential risk to patients—the devices that had to go through the most rigorous pre-market approval process. Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to obstetrics and gynecology devices, the evidence leading to approval has a lot of weaknesses.”
The researchers found that:
• Median FDA approval time was 290 days;
• Four of the devices were approved even though they failed to show efficacy in clinical trials;
• Six devices were not required to face post-market studies to assess ongoing safety;
• Three devices were withdrawn from the market after receiving FDA approval (two of the withdrawn devices were not reviewed by physicians, and the other withdrawn device was reviewed but not recommended for approval by the Obstetrics and Gynecology Advisory Committee.)
The Northwestern University statement suggested that FDA approvals should be based on clinical studies that are more rigorous than current requirements, and that studies should take place “before and after” devices go to market.
The researchers also noted that the 21st Century Cures Act, currently before the Senate, contains provisions that would reduce medical device regulation. An earlier version (H.R.6) passed in the House of Representatives in May of 2015.
“We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use,” stated Jessica Walter, MD, First Author of the study and a resident in the Department of Obstetrics and Gynecology at the Feinberg School of Medicine. “There are provisions [in the 21st Century Cures Act] that would broaden the definition of the ‘valid scientific evidence’ manufacturers need in order to prove medical benefit. Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”
The researchers suggested that the FDA seek more input from expert advisory committees and use higher quality studies before approving products.
The researchers also urged clinicians outside of obstetrics and gynecology specialists to be cautious. All specialists using medical devices have a responsibility to understand how FDA regulation works, stated the researchers, and to take a more active role in collecting and reporting data.
FDA Regulation of LDTs Will Impact Pathology and Clinical Lab Industries
If researchers can find obvious flaws in how the FDA approved a relatively limited number of medical devices, how could the regulatory agency offer timely, accurate, cost effective reviews of thousands of laboratory developed tests (LDTs)?
Dark Daily previously reported on the impact increased FDA regulation of LDTs would have on medical practices in an e-briefing that explored the November 2015 FDA report, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests,” as well as a Wall Street Journal (WSJ) article, which reported that about half of Mayo Clinic’s 3,500 annual medical tests are LDTs. In the WSJ article, Mayo stated that closer regulation by the FDA would impact its bottom line and ability to provide quality care. (See Dark Daily, “FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?,” May 4, 2016.)
Study Data Could Educate FDA and Fend Off LDT Regulation
Might the findings from the Northwestern Medicine study be useful for clinical lab industry leaders seeking to head-off FDA regulation of LDTs? Or could these research findings be used to educate the agency about the challenges it would face should it succeed in regulating LDTs? That remains to be seen.
In the meantime, regulators who need a 290-day median approval time to approve medical devices are unlikely to perform better when deluged by thousands of applications to review LDTs. Regardless, these studies can be early warnings of what’s to come and provide helpful guidance. Perhaps they also can make a difference for medical laboratories and for patients who need LDTs.
—Donna Marie Pocius
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