US Lawmaker Questions FDA’s Oversight of Neuralink

A US lawmaker with a focus on health policy has raised inquiries regarding the Food and Drug Administration’s (FDA) failure to conduct a pre-testing inspection of Elon Musk’s Neuralink, a brain implant company.
The company was permitted to test its device on humans without undergoing an FDA inspection.
According to a report by Reuters last month, FDA inspectors discovered issues related to record keeping and quality controls for animal experiments at Neuralink in June of the previous year.
This revelation came less than a month after Neuralink claimed to have received clearance for testing its brain implants in humans.
Neuralink, which initially conducted tests on monkeys and other animals, is currently conducting trials on humans.
The company’s brain-chip holds the promise of enabling paralyzed patients to control computers solely using their thoughts.
In a letter addressed to the FDA on Monday, Democratic U.S. Representative Earl Blumenauer expressed concerns regarding the agency’s apparent disregard for “worrisome evidence” of animal testing violations that had been raised as early as 2019.
Blumenauer also referred to Reuters reports dating back to late 2022, which documented employee complaints about rushed schedules resulting in substandard animal experiments, causing undue suffering and fatalities.

Employees’ concerns

The reports also highlighted concerns among employees about compromised data quality.
Blumenauer requested clarification from the FDA on how it justified authorizing Neuralink’s human trial in light of these reported lapses.
“These alleged failures to adhere to standard operating procedures potentially jeopardized animal welfare and compromised data collection for human trials,” Blumenauer, who serves on the House Ways and Means subcommittee on health, stated in his letter.
The FDA, in response to Reuters’ inquiries regarding the letter, indicated that it would directly address the lawmaker’s concerns.
The agency further noted that it routinely conducts inspections after approving human trials.
During its inspection of Neuralink, the FDA stated that it did not uncover any violations that would compromise the trial’s safety.