FDA fires Neuralink reviewers in workforce purge amid Musk ties

FDA dismisses 20 employees, including Neuralink reviewers, as part of broader federal workforce cuts.

The Neuralink logo and a photo of Elon Musk are seen in this illustration taken on December 19, 2022. Photo by Dado Ruvic/Reuters

By Alana Salsabila and Nada Fadiyah

The U.S. Food and Drug Administration (FDA) dismissed 20 employees over the weekend, including staff responsible for reviewing Elon Musk’s brain implant company Neuralink, according to two sources familiar with the matter. The terminations were part of a broader federal workforce reduction, raising concerns about the agency's ability to efficiently and safely process medical device applications.

FDA workforce cuts affect Neuralink oversight

The layoffs affected personnel within the FDA’s Office of Neurological and Physical Medicine Devices, which oversees clinical-trial applications for brain-computer interface (BCI) devices like those developed by Neuralink. The sources, who spoke on condition of anonymity due to fear of professional repercussions, said they did not believe the employees were specifically targeted for their work on Neuralink. However, they noted that the loss of experienced reviewers could slow the approval process for medical device applications, including those from Musk’s company.

Former FDA officials and industry experts have expressed concern over the impact of these cuts on Neuralink’s ongoing human trials. Victor Krauthamer, a former FDA official with three decades of experience, including as acting director of the division responsible for reviewing brain implant trials, warned that the dismissals could have serious consequences.

“It’s intimidating to the FDA professionals who are overseeing Neuralink’s trial,” Krauthamer said. “We should be worried about the whole trial and the protection of the people in the trial.”

Impact on Neuralink and other medical device approvals

Neuralink is currently testing its brain implant in a small group of paralyzed patients, allowing them to control digital devices using only their thoughts. The company is also developing a separate implant aimed at restoring vision. In 2023, the FDA granted Neuralink’s vision-restoring implant a special designation designed to expedite development and regulatory review.

With the dismissal of key FDA reviewers, experts believe the agency will face challenges in maintaining rigorous oversight of Neuralink’s trials and other BCI device applications. Critics argue that the sudden loss of experienced personnel could lead to regulatory delays or reduced scrutiny of safety protocols.

Political and regulatory implications

The workforce reductions come amid broader efforts to cut government spending, a priority championed by Musk. The billionaire entrepreneur, who has invested over $250 million in former President Donald Trump’s re-election campaign, has been leading calls to reduce costs across federal agencies, including those that regulate his businesses, such as Tesla and SpaceX.

The White House, FDA, and Musk did not immediately respond to requests for comment on the firings. Trump has previously stated that Musk would recuse himself from any conflicts of interest related to his various business ventures and federal cost-cutting initiatives.

According to one of the sources, many of the dismissed FDA employees were still in their probationary periods, meaning they had less than one or two years of service and fewer legal protections against termination. The official dismissal notices cited performance-related reasons, despite the fact that several affected employees had received strong performance reviews in recent evaluations. Supervisors of the terminated employees were reportedly not consulted before the layoffs and only learned about them after their staff were informed.

Broader concerns over regulatory oversight

The sudden firings have fueled concerns over the future of medical device regulation in the U.S. With the FDA already facing challenges in reviewing emerging technologies, the loss of skilled reviewers could weaken its ability to assess the safety and efficacy of experimental treatments.

Some industry experts worry that the move signals a shift toward deregulation, particularly in sectors where Musk has significant financial interests. While Neuralink has made bold claims about the potential of its brain implants, the company has faced scrutiny over animal testing practices and safety risks associated with its device trials.

As Neuralink continues to push forward with human trials, the impact of the FDA’s workforce purge on the company’s regulatory pathway remains unclear. However, the firings have already sparked debate over the balance between government cost-cutting measures and the need for strong regulatory oversight in emerging medical technologies.