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The FDA Didn’t Inspect Neuralink Before Granting Human Trial Approval

As Neuralink touts its first human brain-computer interface (BCI) implant patient, a member of Congress is taking the Food and Drug Administration to task for letting it happen without kicking the tires first.

As Reuters reports, Congressman Earl Blumenauer, an Oregon Democrat, has charged the FDA with failing to inspect Neuralink's facilities before granting it approval to implant its BCI chip in a human, which the company proceeded to do earlier this year and splashily unveil in recent weeks.

That approval, as Reuters previously reported, was announced in late May 2023 — months before Wired revealed in an in-depth investigation that Neuralink's earliest experiments on rhesus macaque monkeys had some incredibly gruesome results, including brain swelling and self-harming behaviors.

In an email to Futurism, the FDA says that it did "conduct a thorough inspection" of the Neuralink facilities — in June 2023, which was after it granted the company human trial approval. According to the agency, it's not uncommon for it to do inspections following the approval of human trials, which fall under its investigational device exemption (IDE) protocols and require an application process.

"For all IDE submissions, the FDA reviews all data and information contained in the company’s application," the agency told Futurism. "The agency’s focus for determining approval of an IDE is based on assessing the safety profile for potential subjects, ensuring risks are appropriately mitigated and communicated to subjects, and ensuring that the potential benefits, including potential benefits to subjects in the study and the value of the knowledge to be gained, outweigh the risk. "

In his letter to the FDA, however, the Oregon congressman who sits on the health subcommittee of the House of Representatives' Ways and Means Committee said he's concerned the agency may nevertheless have ignored "troubling evidence" about Neuralink's safety practices. Those would include the government's own findings, especially the Department of Agriculture's report which found that in 2019, a surgeon used an unapproved sealant to close the holes the company's team drilled into a monkey's skull during implantation experiments.

Blumenauer pointed to another Reuters report, published at the end of February, about the FDA issuing Neuralink a citation over problems with its record-keeping practices — a warning issued just a month after it granted the company human trial permission.

"These alleged failures to follow standard operating procedures potentially endangered animal welfare," Blumenauer wrote, "and compromised data collection for human trials."

Just a few months before the FDA granted Neuralink's approval last spring, Reuters reported that the agency had on multiple occasions denied the company permission to start human trials under the IDE exemption since it began applying in 2022.

Along with contacting the FDA about the congressman's charges, Futurism has also reached out to Neuralink and Blumenauer's office to get to the bottom of whatever protocols may or may not have been broken.

More on Neuralink: Neuralink Told Its First Human Patient Not to Worry About Those Gruesome Monkey Deaths