The head of medical device industry group Advamed has raised serious concerns about recent staffing cuts at the Food and Drug
Administration, warning they could compromise patient safety and America’s competitive edge in medical technology innovation.
In a letter addressed to the Department of Health and Human Services (HHS), Advamed CEO Scott Whitaker expressed alarm over the substantial reduction in FDA personnel that occurred over the weekend. The cuts were planned prior to Robert F. Kennedy Jr.’s installation as HHS Secretary, and Whitaker argued they contradict Kennedy’s stated mission to “make America healthy again.”
The staff reductions are part of a broader initiative by President Donald Trump to streamline the federal workforce through the Department of Government Efficiency service, which is overseen by Tesla CEO and Trump advisor Elon Musk. Among those affected by the layoffs was Ross Segan, who had served as the FDA’s head of medical device safety. The changes also prompted the resignation of the FDA’s food division leader.
While Advamed supports efforts to optimize taxpayer spending, Whitaker emphasized that these particular cuts could be counterproductive. He called for collaboration with Secretary Kennedy and FDA leadership to reverse the staffing reductions while finding alternative ways to meet the administration’s efficiency goals without compromising healthcare innovation or patient safety.
The timing is particularly concerning as the FDA was making progress in reducing device application review times, thanks to recent user fee agreements that created new efficiency incentives. “Unfortunately, as a result of these reductions, FDA will lose hundreds of new employees, the best and most innovative hires under our most recent agreement,” Whitaker noted in his LinkedIn statement.
Of particular concern is the impact on the FDA’s artificial
intelligence capabilities. The elimination of specialized AI positions means non-experts will now be tasked with evaluating sophisticated AI technologies, potentially leading to significant delays and
questionable decision-making in the review process.
The FDA has been managing an enormous workload of device applications annually, and these cuts threaten to create additional bottlenecks. Whitaker emphasized that the reductions could undermine the agency’s ability to effectively evaluate new medical technologies and maintain the United States’ global leadership position in medical device innovation.
The situation reflects a delicate balance between administrative efficiency and maintaining robust regulatory oversight of medical products. While the Trump administration pursues its broader goal of reducing federal employment, industry leaders like Whitaker argue that certain agencies, particularly those responsible for public health and safety, require adequate staffing to fulfill their essential functions.
The impact of these cuts extends beyond just administrative
efficiency. With the FDA losing key personnel in critical areas like device safety and AI evaluation, there are growing concerns about the agency’s capacity to maintain its high standards for medical device review and approval. This could potentially slow the introduction of innovative medical technologies to the market and affect patient access to new therapeutic options.
The medical device industry, while supportive of government efficiency measures in principle, views these specific FDA staff reductions as potentially damaging to both public health and American technological leadership. As the situation develops, industry stakeholders are watching closely to see how HHS and FDA leadership will address these challenges while maintaining the agency’s crucial regulatory functions.