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As the Trump administration pushes to “Make America Healthy Again†and lays the groundwork for various reforms to American health care, it should set its sights on reforming the Food and Drug Administration’s evaluation processes.
While the administration has recognized that novel technologies like artificial intelligence can fuel new medical breakthroughs, the FDA has shown that it is unprepared to evaluate these innovations in a timely manner. As the administration considers how to reform the agency, creating a more apparent on- and off-ramp for FDA approval for medicines and treatments should be a priority.
Emergent technologies, like AI or extended reality (XR) devices, are making strides in health care. However, technological and scientific breakthroughs are continuously bogged down by the FDA’s lack of knowledge of these novel technologies and its lack of alternatives to address those shortcomings.
This was the experience of MediView, an XR surgical solution company, as it tried to gain FDA approval and bring its product to market. MediView’s product, through the use of augmented reality glasses, is providing surgeons with real-time, 3D digital images of their patients that allow doctors to more accurately monitor patients or review any potential complications before any cut is made. However, as the company aimed to obtain the FDA’s approval, it was met with multiple hurdles.
Initially, regulators had little to no knowledge of the underlying technology behind the product. That meant before the product was under review, the company had to bear the burden of helping regulators understand XR technology.
As a novel technology, it was met with unclear guidelines from regulators regarding the proper avenues for approval. Regulators flip-flopped over what paperwork or form had to be submitted, causing delays and ballooning compliance costs.
MediView’s example should be a warning call for other emergent technologies, such as AI-powered treatments and medicines. As AI-powered innovations attempt to come to market, they will likely experience similar woes as they go through the approval process, preventing life-saving medications and treatments from being available to patients who desperately need them.
The solution partly rests in ensuring that the agency employs staff that has the knowledge necessary to navigate the technical and technological aspects of this approval process.
The agency had been making progress toward tackling that issue, but the blanket-firing of probational government workers pushed by the Department of Government Efficiency will undo some of these advances, as some of these probational employees were recent hires more likely to be in tune with novel technologies. While some of these fired employees have been brought back into the agency, it is expected that some of these review teams remain understaffed after the initial wave of firings reduced the FDA’s workforce by 10%.
However, the other part of the equation goes beyond staffing and talent. The FDA has structural issues that have held them back with “traditional†medicines and only worsened with digital innovations. The agency has shown to be too slow to review products and has been unfairly dismissive of promising medications over superfluous issues.
With more novel and unconventional tech-based innovations like personalized AI-based treatments, these issues are likely to compound. Fortunately, the FDA has taken positive steps, showing some openness to approaching tech-driven products differently. For example, the FDA has created a category for software-based products and treatments instead of considering them medical devices. Under this new regime, software-based products would not need to reapply for approval every time they make minor updates to software as long as they go under a precertification process.
As President Donald Trump and DOGE evaluate ways of reigning in public health care spending, they should leverage the potential cost-savings of AI-enabled products in their favor. To do so, they need these products to hit the market. Curtailing regulatory stopgaps that could leave these products stuck in lengthy review processes is a step in that process.
Juan Londoño is the chief regulatory analyst at the Taxpayers Protection Alliance. He wrote this for .
