The head of medical device industry group Advamed has raised serious concerns about recent staff reductions at the Food and Drug
Administration, warning they could harm patient care and diminish America’s global leadership in medical technology innovation.
In a letter addressed to the Department of Health and Human Services (HHS), Advamed CEO Scott Whitaker emphasized that the significant personnel cuts implemented at the FDA over the weekend could severely impact the agency’s operations. Whitaker noted in a LinkedIn post that these staffing reductions were planned prior to Robert F. Kennedy Jr. taking office as HHS Secretary, and appeared to contradict Kennedy’s stated mission of improving American health outcomes.
The workforce reduction comes as part of President Donald Trump’s broader initiative to streamline federal agencies through the Department of Government Efficiency service, which is overseen by presidential adviser and businessman Elon Musk. Among those affected by the cuts was Ross Segan, who had served as the FDA’s medical device safety chief. The changes also prompted the resignation of the agency’s food division leader, according to initial reporting by Food Fix.
While Advamed supports efforts to enhance government efficiency and responsible use of taxpayer funds, Whitaker expressed that the FDA personnel cuts could be counterproductive. He indicated his
organization’s desire to collaborate with Secretary Kennedy, HHS leadership, and FDA officials to reverse these reductions while developing alternative approaches that would meet the administration’s objectives without compromising patient safety or America’s medtech sector leadership.
The timing of these cuts is particularly concerning given the FDA’s existing challenges in processing the tens of thousands of device applications it receives annually. Though recent improvements in review times had been achieved through a new user fee agreement that incentivized greater efficiency, Whitaker explained that the staff reductions would eliminate numerous new employees hired under this arrangement.
Of particular concern is the impact on the FDA’s artificial
intelligence capabilities. Whitaker highlighted that the elimination of specialized AI positions would force the agency to reassign non-experts to evaluate artificial intelligence technologies. This restructuring could significantly slow down the review process and potentially lead to questionable decision-making in this critical and rapidly evolving field.
The cuts have already begun affecting key leadership positions within the agency. Following the initial wave of layoffs, the head of the FDA’s food division submitted their resignation, as first reported by Food Fix. The departure of Ross Segan, who oversaw medical device safety, represents another significant loss of institutional knowledge and expertise.
Despite the challenges posed by these staffing reductions, Whitaker expressed hope for constructive dialogue with federal leadership. He emphasized the importance of finding solutions that would maintain both government efficiency and the FDA’s crucial role in ensuring public health and safety while preserving American leadership in medical technology innovation.
These developments occur against the backdrop of President Trump’s larger initiative to reduce the federal workforce, though industry leaders argue that maintaining adequate staffing at critical agencies like the FDA is essential for both public safety and continued technological advancement in the healthcare sector. The situation highlights the complex balance between administrative efficiency and maintaining effective regulatory oversight in the medical device industry.