The Coming Sea Change at Trump’s FDA: Towards an Era of Safety and Public Transparency for Medical Devices.
It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as the Power Morcellator. The sheer force of Dr. Reed’s voice, as a Harvard Medical School faculty member and a physician-scientist — and the injustice it uncovered to countless other women like her — became a bellwether case that demonstrates an ongoing and severe safety failure operational in the medical device regulatory space at FDA.
Of course, this safety failure in the FDA’s medical device regulatory arm, the Center for Devices and Radiological Health (CDRH), is hardly unique to that center. Industry and conflicted academic “experts”, not patients, play an outsized role in governing and corrupting almost all of FDA’s centers. But, certainly, the source of the safety failure at CDRH is crystallized in the dangerous regulatory regime that agency center utilizes to clear the vast majority of medical devices for the US healthcare marketplace: The 510(k).
At a legislative level, CDRH’s 510(k) regulatory regime was not designed to ensure the safety or efficacy of the medical devices it regulates — a fact that is well known to most public health experts and FDA regulators themselves. CDRH’s 510(k) does not use anything even remotely resembling an “evidence-based” framework to provide clearance to thousands of new medical devices annually, used in the care of patients across the US and abroad.
Even more problematic is that the medical device industry pays FDA for the 510(k) clearances obtains. In other words, almost the entire 510(k) clearance apparatus at CDRH is literally funded by the medical device industry — the very industry that stands to gain the most from the 510(k) clearances it funds. This is a serious conflict of interest in the healthcare space, and should not pass ethical muster — even when the argument is that such payments from industry to government are saving taxpayer dollars. Because the moment industry starts paying to keep the FDA’s centers’ lights on, is the moment industry, not the people, will have an outsized voice in govering the very agency that is charged with regulating it.
Worse yet, the CDRH personnel whose 510(k) related activities are funded by medical device makers, exert virtually no real scrutiny over the manufacturer’s claims in their 510(k) applications for market clearance — either because their “reviews” are deliberately superficial and nominal, or because they are grossly incompetent from an expert perspective. It is literally true that the overwhelming majority of medical devices that seek 510(k) clearance for use in the US marketplace, are granted them, without difficulty and at mach speed, by an reasonable standard — and despite the fact that these devices are literally directly engaging the most vulnerable of America’s citizens: patients who trust American healthcare at their most vulnerable!
In effect, the 510(k) regulatory process is a sham federal regulatory process, where the fox is using nominal “government employees” with highly variable expertise, whose salaries are paid for by the industry they regulate, to guard the lucrative medical device hen-house. But the truth that many American do not know, is that 510(k) is an unsafe federal regulatory mechanism that is designed only to provide an illusion-of-safety. In truth, 510(k) has been executed by prior administrations to, at best, speed the entry of new “life-saving” medical devices into the US marketplace — and, at worst, as a portal-for-fraud by hyper-aggressive or blatantly criminal medical device entrepreneurs hellbent on profiting from American patients.
And though it is true that a large majority of medical devices in current use across the United States, are highly effective at their intended uses, it is NOT true that this efficacy is complemented by a “reasonable or robust assurance of safety”. The reason for this dangerous discordance between safety and efficacy in the US medical device space, is the way in which the CDRH’s current administrative state is executing the 510(k) regime. To date CDRH’s dominant goal has been to increase the efficiency and speed of clearance of 510(k) medical devices into the US marketplace. But the deceptive claim implicit to this approach is that medical device safety is also reasonably assured: that when FDA acts to release more “life-saving” devices into the US marketplace fast, reasonable safety is assured. But this is a terrible, and deliberate, deception promoted by prior CDRh administrations under Dr. Jefferey Shuren’s leadership across several executive administrations, Democrat and Republican.
CDRH’s deceptive execution of 510(k) is fully on display when real and catastrophic safety failures and illegal activity have emerged in the recent past: In fact, CDRH exerts almost as much resistance to correcting these safety failures and eliminating unsafe or misbranded devices from the US marketplace, as does the medical device industry itself. So, the CDRH not only fails to deliver a reasonable assurance of medical device safety to the American public using the 510(k) regulatory regime — but when real failures are identified, it is resistant or unable to eliminate the safety hazards and illegal conduct its own broken 510(k) regulatory regime helps create.
The above safety failures have been the order of business at the FDA’s CDRH for well over 2 decades, where our public health agency has relinquished its commitment to medical device safety in favor of fast clearances of presumably effective medical device — though, truth be told, even the contention of proven efficacy is compromised at the CDRH because of the way that agency’s leadership has executed 510(k).
But there is a sea-change coming to the FDA. The Trump administration’s Department of Health and Human Services, under the direction of Robert F. Kennedy Jr., is promising to overhaul the entire broken system at FDA.
The new FDA promises to eliminate conflicts of interest in the form of payment, by medical product manufacturers to its centers, for product approvals/clearances.
The new FDA promises to eliminate unqualified personnel, who are only serving as nominal government employee, but in reality are supported by industry dollars to just-say-yes to industry actors.
The new FDA promises to put product safety, at least, on par with speedy market clearance and efficacy.
The new FDA promises to stop using FDA’s seals of approval and clearance as sham marketing labels.
The new FDA promises to eliminate and prosecute false claims and advertising.
The new FDA promises to allow the marketplace of experts and patients decide if a product is truly safe and effective.
The new FDA promises to warn or prosecute manufacturers, who fail to properly report safety problems to the public or whose behavior is illegal.
It’s almost certain that a sea change is coming to the FDA in the direction of safety — and away from colluding with academia and compromised institutional “experts”, in doing industry’s bidding at the expense of unsuspecting American patients, who should be able to trust their government to not cause harm.
After the rancor and filibustering of the political season ends on January 20, the season of policy-making and real change begins. With Robert F. Kennedy Jr. and his track-record of effective activism at the helm of the revitalized Department of Health and Human Services, there’s almost no doubt that promises made, will be promises kept.
