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US Rep. Earl Blumenauer wants to know why the US Food and Drug Administration (FDA) didn't investigate Neuralink further before the Elon Musk-owned company implanted its chip into its first human patient.
In a letter sent to the agency on Monday, the Oregon Democrat says the FDA seemingly did not take "troubling evidence" into account surrounding animal testing violations. He wants the agency to explain why it allowed Neuralink to begin its human trials in May 2023, Reuters reports.
"These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials," Blumenauer argues in the letter.
The FDA plans to respond to the Congressman directly, but claims it did not find evidence that would make Neuralink's human trials unsafe. The FDA also told Reuters that it inspects human trials regularly after approval.
Last year, the FDA found issues with Neuralink's animal experiments in California, citing quality control concerns, a lack of adequate records, and medical instruments that had not been calibrated. A Reuters investigation published earlier this month found that seven Neuralink instruments, including a "vitals signs monitor," had not been calibrated during previous animal tests.
Blumenauer, along with seven other members of Congress, sent a previous letter to the department in 2023 demanding it address perceived conflicts of interest the department's oversight panel had over Neuralink's animal trials.
In 2022, the US Department of Agriculture began investigating Neuralink months after numerous Neuralink employees complained that its animal testing was rushed, leading to "needless suffering and deaths." Neuralink conducted "botched" experiments on animals and has killed over 1,500 animals including monkeys, sheep, and pigs as of December 2022, Reuters found.
In January, Musk shared that Neuralink had implanted its first chip into a human patient, and that the individual was "recovering well." That patient, 29-year-old Nolan Arbaugh, is a quadriplegic who says the Neuralink chip allows him to play video games like Civilization VI using only his mind.