Medical Device Safety and The Promise of Robert F. Kennedy Jr.’s “Make American Healthy Again” Directive
President-elect Donald J. Trump’s embrace of Robert F. Kennedy Jr’s Make America Healthy Again (MAHA) directive is one of the most unexpected dimensions of the incoming Trump administration, for one simple reason: it explicitly promises to end the unsafe corporate capture of the administrative state ruling over the agencies of the US Department of Health and Human Services — in particular, the US Food and Drug Administration (FDA).
The FDA wields enormous power in the US healthcare marketplace, because it regulates the entry of medical products into US interstate commerce. Quite literally, seals of FDA approval or clearance of medical products are punched tickets for US healthcare corporations to extract consumer and healthcare revenues from public and private health insurance funds. The American public trust that their government is in the business of defending the public’s health and safety. But, in the year 2024 the health and safety of the American public has been corrupted on the road to corporate fortunes in healthcare, by FDA administrators’ overt favoritism towards industry and elitist academic guilds.
In recent years, in almost every healthcare sector regulated by FDA’s various centers, product safety and safety science have taken a backseat to industry marketing and “efficacy” goals. Under the camouflage of “enhancing entry of innovative lifesaving medical products into the US healthcare marketplace”, the FDA has been complicit in creating a national health security threat that has damaged and killed many unsuspecting and trusting Americans.
Perhaps nowhere is FDA’s overt favor towards industry more visible than in that agency’s Center for Devices and Radiological Health (CDRH) — responsible for approving or clearing the medical devices that come into contact with millions of American lives every day. This deviation away from the FDA’s primary mission of ensuring the reasonable safety and efficacy of medical devices is linked to the way in which CDRH administrators execute the agency’s dominant legal mechanism for clearance of medical devices: that is, the 510(k) process.
Most American patients are unaware that the vast majority of the medical devices used in the course of their care are cleared using the FDA’s 510(k) mechanism — nor that this FDA clearance process is not an “evidence-based” regulatory process, and was NOT designed to ensure a “reasonable degree of safety or efficacy”.
In fact, in 2011 the Institute of Medicine (IOM) published its findings following an analysis of the 510(k) federal statutes, and presented them to the United States Senate’s Health, Education, Labor and Pensions (HELP) committee. The IOM explicitly testified that 510(k) does NOT and can NOT provide a reasonable assurance of medical device safety or efficacy — especially when medical devices are improperly risk stratified by CDRH.
In other words, it’s no exaggeration that FDA puts its stamp of 510(k) clearance on the majority of medical devices used in the care of American patients without having any reasonable assurance of their safety or efficacy.
When it comes to the “efficacy” of medical devices, the engineers and the marketplace are good enough regulators — that is, if a medical device is not effective at what it promises to achieve, the design engineers and the marketplace of users autonomously eliminate ineffective devices. But medical device “safety” is quite another issue and requires far more diligence and care because it almost always affects a minority subset of patients. Afterall, if a device causes visible adverse events in a majority of users, the marketplace eliminates it as well. In other words, the marketplace is a good regulator of both efficacy and safety when large subsets of people benefit or are harmed, respectively. But, when an effective and profitable device is not safe (or is unreasonably or unmitigatedly unsafe) for a minority subset of patients, neither the manufacturer nor the marketplace will necessarily act to regulate safety hazards properly. [It is exactly in this space of “minority harm”, that government or the courts must be vigilant in a democratic republic, where every life matters and is held sacred. For if “minority harm” is ignored by government in the transactions of a free and utilitarian US marketplace, at an inflection point minorities of harmed Americans will become the “harmed majority” — and a society with a harmed or injured majority cannot remain a civil or powerful one.]
And if an executive federal agency’s administrators are dominantly oriented towards synchronizing their regulatory actions with industry, and fail to execute their legal mandate to protect American lives with an appropriate degree of expertise or stringency, then a significant number of effective but unsafe devices and products will be cleared for the US marketplace — this is the reality created by the administrative state at the FDA.
The CDRH, as led by Dr. Jeffery Shuren and his colleagues for over a decade, has been a great champion for industry interests. Shuren’s CDRH used the 510(k) regulatory process to lubricate the medical device industry at cost to many unsuspecting American patients, whose safety was ignored — all the while using the deceptive rubric of “speedy and efficient clearance of lifesaving innovations” to fool Congressional oversight and the public into believing that an effective “life saving device” is necessarily safe too. This farce must end, because medical device efficacy and market lubrication should never be achieved by floridly ignoring evidence-based medical practice or product safety at unmitigated cost to unsuspecting Americans.
Shuren’s CDRH not only abused the 510(k) regulatory process to provide an illusion-of-safety to American consumers and patients in the medical device space, it has also allowed malicious and criminal actors in the medical device space to use the 510(k) clearance process as a portal-for-fraud. Enforcement actions and public warning from CDRH in cases of manufacturer and hospitals failing to report adverse events to FDA have been abysmally deficient. Certainly, prosecutions for fraud in the 510(k) clearance process have had no real place at the CDRH under Shuren. The combination of incompetent administrative review and improper risk stratification of 510(k) applications, pandering to manufacturers who pay fees to the CDRH for its market clearance services, and absent enforcement action in the case of legal violations and criminal activity, easily classify the 2024 CDRH as a “captured” center at FDA, to any reasonable citizen who cares about our nation’s safety and health.
But achieving a reasonable balance between safety and efficacy, allowing the medical device industry to innovate without adverse interference from FDA, and engaging in proper law enforcement to ensure consumer safety, is possible. CDRH could, in fact, utilize the 510(k) mechanism with adequate unbiased expertise, and ethically, to properly risk stratify medical devices and allow industry to innovate without overt restraint. And CDRH could, in fact, allow the marketplace to innovate while maintaining a proper eye on device safety and legal violations. But not until the executive branch moves to reform the engrained administrative state led by the Shuren administration at CDRH.
RFK Jr.’s Make America Healthy Again promise aims to clean up and remove the conflicted and captured administrative state in charge of our nation’s health agencies - in order to protect American lives in a balanced way. In fact, RFK Jr. has always been in the business of properly balancing industry and efficacy with ethics, safety and overall health. Those who have caricaturized RFK Jr.’s position on vaccine safety to imply that he does not understand the delicate balancing act necessary between safety and efficacy, are misinformed or uninformed about his his activism on behalf of the public, are political actors, or are simply industry or elitist shills. RFK Jr’s MAHA is not a simplistic or one dimensional project — it aims to reform and deflate a corrupted administrative state and expert hubris, at a foundational level.
It is my belief and prediction that the US Department of Health and Human Services under RFK Jr’s leadership, will place as much emphasis on defending the safety of American patients and the population, as it will on ensuring that American industry and experts will continue to innovate unrestrained by government administrator’s personal biases and interference.
Safety and efficacy are opposite sides of the same coin. So for FDA to have used its legal authority to promote one side, without a careful and vigilant eye on the other, has been disastrous to public trust and to the lives of many trusting Americans — this must change!
President Donald J. Trump’s embrace of RFK Jr’s promise to Make America Healthy Again may just become one of his most prescient choices — especially when it comes to the administrative state that’s been misusing its legal mandate to downplay medical device safety failures at CDRH for well over a decade — sometimes deliberately.
Time will tell.
Hooman Noorchashm MD, PhD
December 2024.
