The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters had a report a month ago detailing FDA inspections that found potential issues with record keeping and quality control. Those investigations took place in June, a month after the FDA authorized human trials for Neuralink.
Neuralink develops a brain-computer interface (BCI) technology designed to enable users to control a computer or mobile device. The company won a regulatory nod in May for its first-in-human implant, and in September it opened up recruitment for its clinical trial. Last week, Neuralink shared a video of the first recipient of the implant using the chip to play online chess.
On top of the FDA issues, some neuroscientists have frustrations about the lack of detailed information besides Musk’s social media posts.
According to Reuters, Blumenauer asked the FDA to explain its decision to grant in-human trials while being aware of complaints of “hack jobs” of animal experiments. Blumenauer, a longtime skeptic of Neuralink, asked the U.S. Department of Agriculture to exert proper oversight of USDA-inspected facilities in 2022 after reports of the BCI company’s animal practices.
Reuters said Blumenauer claims the “alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials.” The outlet reports that the FDA plans to respond to the lawmaker directly. The agency also reportedly said it routinely inspects after approving human trials. Additionally, the FDA said its inspections of Neuralink saw no violations that would undermine the human trial’s safety.
