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

By Marisa Taylor

WASHINGTON (Reuters) – A U.S. lawmaker involved in health policy 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 on 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 had been cleared to test his brain implants on humans.

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

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

Blumenauer also cited Reuters reports from late 2022 that described employee complaints of animal experiments “hacking jobs” due to a rushed schedule, causing unnecessary suffering and deaths. Employees also feared that the quality of the data could be compromised, the media organization reported at the time. She asked the FDA to explain how it reconciled reports of such errors with its decision to authorize human testing of Neuralink.

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

In response to Reuters’ questions about the letter, the FDA said it would respond directly to lawmakers. The agency also said it regularly conducts inspections after a human trial is approved. When it inspected Neuralink, the FDA said it found no violations that would undermine the study’s safety.

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, which have both demonstrated patients’ ability to control certain actions with their thoughts.

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