FDA Employees Laid Off Amid Major Restructuring Raising Concerns for Public Health

On the evening of February 15, the U.S. government announced layoffs affecting several employees at the FDA. The exact number of affected staff and the specific departments involved remain unclear. This decision was revealed by three sources to STAT.

Reports indicate that many of the laid-off employees worked within the Center for Devices and Radiological Health (CDRH), with a significant number involved in regulating AI imaging devices. The surge in companies submitting AI-integrated medical devices has prompted the FDA to hire additional AI experts to effectively evaluate these rapidly evolving technologies.

These layoffs impacted both research and regulatory roles, including those tasked with conducting AI research to keep the FDA updated on industry advancements, as well as personnel ensuring the safety and efficacy of AI devices. Such reductions could hinder the FDA's ability to protect patients and delay product review timelines.

Sources disclosed that FDA management did not inform employees prior to the email sent on February 15 detailing the layoffs. An FDA leader noted that some employees who had been with the agency for over two years were terminated due to performance issues. One termination email stated, “Unfortunately, the FDA believes you are no longer suited for continued employment due to your abilities, knowledge, and skills not aligning with the agency's current needs.”

These layoffs are part of a broader initiative that began on February 14, involving agencies such as NIH and CDC, which aim to cut 5,200 temporary workers across various health departments. Approximately 750 CDC employees are also affected, with contractors at CDC and HHS losing their jobs in recent weeks.

Since the Trump administration took office, there has been a significant workforce reduction effort, facilitated by the Department of Government Efficiency (DOGE). Federal employees have been encouraged to leave through buyouts, return-to-work orders, and limited legal protections.

As for the future of the FDA, concerns loom large. The nominee for FDA Commissioner, Martin Makary, has yet to receive Senate confirmation, with Sara Brenner currently serving as acting commissioner. Prior to January 20, when Trump took office, several FDA officials had already departed, including CDER Director Patrizia Cavazzoni and FDA Chief Deputy Commissioner Namandjé Bumpus.

The FDA's spokesperson has not publicly commented on the latest layoffs. Reports suggest that the FDA employs nearly 20,000 individuals overseeing products that account for 20 cents of every dollar consumers spend in the U.S. Biotech and multinational investors are particularly concerned about layoffs among staff funded by user fees, established under the Prescription Drug User Fee Act (PDUFA) in 1992. They worry that these cuts could slow down the review processes for drugs and medical products, potentially impacting stock prices.

Former FDA Commissioner Robert Califf expressed concerns about balancing power within the FDA and other government departments. He highlighted that the FDA operates under the oversight of multiple entities, including HHS, the executive branch, and Congress, which complicates unilateral decision-making.

Califf’s worries extend to the future leadership of the FDA, especially after the nomination of anti-vaccine activist Robert F. Kennedy Jr. as HHS Secretary, who has stated intentions to overhaul the FDA. On February 4, the Senate Finance Committee approved Kennedy’s nomination.

“I am concerned about every department within the FDA. I don’t believe you will find FDA personnel working on issues that go unnoticed,” Califf remarked.