A letter addressed to the U.S FDA (Food and Drug Administration) Monday contains Democratic Representative, Earl Blumenauer saying he was concerned the agency ignored “troubling evidence” of animal testing violations that had been raised dating back to at least 2019.
Blumenauer, who is involved in health policy questions why the FDA did not inspect and approve Neuralink before allowing the brain implant company to test its device in humans.
Although, FDA inspectors were reported to have 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 makes a brain chip which enables paralyzed patients to control a computer using only their thoughts. The company had first tested its device in monkeys and other animals and now testing the device in humans seems successful.
Blumenauer said, “These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials.”
In response to queries 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 at the time of report never responded to queries on the letter.
