FDA layoffs spark industry, lawmaker backlash over risks to patient safety

U.S. Food and Drug Administration (FDA) © Tada Images - stock.adobe.com

The recent wave of job cuts at the U.S. Food and Drug Administration (FDA) has drawn sharp criticism from both the medical technology industry and Senate Democrats, who warn of dire consequences for patient care, public health and the nation’s leadership in medical innovation.

The layoffs — part of the Trump administration’s broader government-wide staff reductions under the “Department of Government Efficiency” (DOGE) — affected personnel responsible for reviewing medical devices, monitoring food safety and evaluating artificial intelligence (AI) applications in health care.

AdvaMed, the largest trade association representing the medical technology industry, expressed concern over the cuts, which could have significant implications for the approval process for new medical devices.

Scott Whitaker, president and CEO of AdvaMed, called the layoffs a threat to both patient safety and the U.S. medical technology sector.

“Over the weekend, significant job cuts were made to FDA that could have a very negative impact on patient care in this country,” Whitaker wrote in a statement on LinkedIn. “… Device review times were already too long, though they were improving as the result of our latest user-fee agreement.”

User fees are industry-paid fees, authorized by Congress, that fund FDA positions by channeling fees from the drug, medical technology and tobacco industries to the agency. These fees, not taxpayer dollars, covered the salaries of many of the employees who were laid off.

Senate Democrats, led by key committee ranking members, Sens. Ron Wyden (D-Oregon), Bernie Sanders (I-Vermont), Kirsten Gillibrand (D-New York) and Senate Minority Leader Chuck Schumer (D-New York), issued a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., demanding an explanation for the cuts.

The letter described the moves as an “abdication” of the administration’s responsibility to safeguard public health and outlined the broad impacts of the firings, including disruptions to Medicaid and Medicare services, setbacks in drug and medical device approvals, and diminished preparedness for public health emergencies.

“These firings represent the abdication of your sworn duty to ensure the health and well-being of America’s families,” they wrote. “You have an obligation to the American people, who rely on you as the nation’s top public health official, to stop these ill-conceived and dangerous attacks on agencies and programs that Americans rely on every day.”

The layoffs heavily impacted divisions overseeing AI-driven medical technologies, including surgical robots, diabetes management systems and diagnostic imaging tools. The New York Times reported that at least 25 AI experts were cut, raising concerns that review times could slow down, jeopardizing both patient safety and medical innovation.

The cuts also affected staff overseeing product safety in diabetes devices — an area that has seen rapid advancements in continuous glucose monitoring and automated insulin delivery.

“AI in health care is a clear, illustrative example,” Whitaker said. “… Eliminating FDA’s recent critical new hires in the AI space will dramatically slow review times and require reassigning non-experts already at FDA to review these technologies who will inevitably make slower and potentially inappropriately conservative decisions.”

Layoffs also impacted food safety, infectious disease prevention and tobacco regulation, raising broader public health concerns. The FDA’s tobacco division, which is funded entirely by an excise tax rather than taxpayer dollars, lost about 85 staff members responsible for overseeing e-cigarettes and underage tobacco sales enforcement.

The fallout from the layoffs has also triggered legal challenges, with unions representing FDA employees attempting — albeit unsuccessfully — to block the firings. Meanwhile, former FDA and HHS officials have warned that the cuts could diminish the agency’s ability to respond to emerging health threats, including infectious disease outbreaks and foodborne illnesses.

AdvaMed and Senate Democrats continue to push for a reversal of the cuts, warning that reduced FDA capacity threatens the nation’s leadership in medical innovation. With mounting pressure, it remains uncertain whether the administration will reconsider.