US lawmaker seeks answers on FDA inspection of Musk’s Neuralink By Reuters

By Marisa Taylor

WASHINGTON (Reuters) – A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.

Reuters reported last month that FDA inspectors found problems with record keeping and quality controls for animal experiments at Neuralink last June, less than a month after the startup said it was cleared to test its brain implants in humans.

Neuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip which enables paralyzed patients to control a computer using only their thoughts.

In a letter to the FDA on Monday, Democratic U.S. Representative Earl Blumenauer said he was concerned the agency ignored “troubling evidence” of animal testing violations that had been raised dating back to at least 2019.

Blumenauer also cited reports by Reuters since late 2022 that described employees’ complaints of “hack jobs” of animal experiments due to a rushed schedule, causing needless suffering and deaths. Employees also worried that data quality would be compromised, the media organization reported at the time. He asked the FDA to explain how it reconciled reports of such lapses with its decision to authorize Neuralink’s human trial.

“These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials,” wrote Blumenauer, who serves on the House Ways and Means subcommittee on health.

In response to queries from Reuters about the letter, the FDA said it would respond to the lawmaker directly. The agency also said it routinely carries out inspections after a human trial is approved. When it inspected Neuralink, the FDA said it did not find violations that would undermine the safety of the trial.

Neuralink did not immediately respond to questions.

In recent years, a handful of device companies have begun testing such brain implants in humans, including Synchron and Blackrock (NYSE:) Neurotech, who have both demonstrated the ability of patients to control certain actions with their thoughts.

Last week, Neuralink presented a livestream on Musk’s social media platform X, showing how the first patient implanted with its brain device was able to play online chess using his mind. Noland Arbaugh, a 29-year-old who was paralyzed below the shoulders after a diving accident, also posted a comment on X by relaying his thoughts.