The termination of approximately 20 employees is anticipated to impede the agency’s capacity to efficiently and securely handle various medical device applications, including those of Neuralink, as per sources and external specialists. “It’s a cause of concern for FDA experts supervising Neuralink’s trial,” stated Victor Krauthamer, an ex-FDA official with a three-decade tenure, including a role as the acting director of the department that reviews requests for human-trials involving brain implants. “The entire trial process and the safety of trial participants should be a priority for us.”
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The FDA, White House, and Musk are yet to respond immediately to requests for comments. Trump has mentioned that Musk will abstain from any conflicts of interest between his multiple business ventures and his endeavors to reduce federal government expenditures. Similar to other governmental bodies, the reductions affected probationary scientists evaluating medical device applications, as per one of the sources. Employees under probation usually have less than a year, or in some cases, less than two years of service and fewer legal protections.
Neuralink is presently conducting trials on its device, enabling paralyzed individuals to operate digital devices solely through thoughts, among a select group of disabled patients. The company is also developing an implant targeted at restoring vision. Last year, the FDA granted the device a special designation to expedite development and federal review, as stated by the company.
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Having invested over $250 billion in President Donald Trump’s reelection campaign, Musk has spearheaded an extensive initiative to curtail government expenses, including at agencies overseeing his enterprises like Tesla and SpaceX. The termination notices issued to the FDA reviewers cited performance-related reasons, despite the fact that these employees had no prior performance issues and had received exemplary ratings just weeks before, according to two informed sources. The supervisors of the terminated employees were not consulted before the mass layoffs and were informed by their subordinates, the sources noted.
This content was initially published on USA TODAY: FDA personnel reviewing Neuralink under Musk’s purview were affected in recent dismissals.
