Less than a month after announcing that Elon Musk’s Neuralink Inc. had been cleared to test human brain implants, Food and Drug Administration inspectors said the company had been cleared to test human brain implants, according to a regulatory report seen by Reuters. It was discovered that there were problems with the record management and quality control of animal experiments.
Inspectors identified quality control deficiencies at the company’s California animal research facility. A similar inspection at Neuralink’s Texas facility found no problems, according to agency records.
These visits took place from June 12 to June 22 of last year and are the only FDA inspections of the Neuralink facility on record.
The inspector’s report was shared with Reuters By Redica Systemsis a data analytics company that obtains FDA compliance reports through open records requests.
“These problems demonstrate a lack of attention to detail,” says Jerry L. Chapman, senior quality specialist at Redica Systems.
Laboratory problems identified by FDA inspectors included missing calibration records for equipment used in one of the studies, such as a pH meter.
In another investigation, seven devices, including a “vital signs monitor,” had no calibrated records.
Neuralink conducted experiments on hundreds of animals, including monkeys.
Other issues include quality assurance personnel not giving approval to the final study report or documenting deviations from approved protocols or standard operating procedures.
“This certainly indicates that the company needs to be vigilant about certain practices,” Chapman said, adding that the company will be required to follow similar practices in human trials.
This brain implant is being tested to allow patients paralyzed by spinal cord injury or amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, to communicate using thoughts that power computer devices. There is.
Reuters reported in December 2022 that U.S. Department of Agriculture investigators investigated Neuralink’s animal testing after complaints from internal staff that the company’s animal testing was rushed and caused unnecessary suffering and death. The agency said it was investigating possible animal welfare violations.
The Physicians Committee for Responsible Medicine, an animal welfare advocacy group, has filed formal complaints with both the Department of Agriculture and the Food and Drug Administration about the alleged violations.
The Department of Agriculture announced in July that it found no violations of animal research rules beyond the 2019 incident Neuralink had already reported.
“Violation of fundamental requirements”
Three regulatory experts told Reuters that the FDA has adopted Good Laboratory Practice standards for animal research to ensure that scientific data collected in the development of drugs and medical devices is reliable. It has its own requirements called.
Neuralink cited its animal research data in the FDA’s request to test the implant in humans.
Musk, the company’s billionaire founder, announced in May that his device had been cleared for human trials, and last month said the first patient received the implant and was recovering well. .
Neuralink did not respond to questions about the FDA visit.
According to the FDA’s database, the agency does not issue designations indicating the severity of problems found in inspections.
Experts said the problems identified, while serious, do not appear to be significant enough to warrant a worst-case test designation by the FDA, which should prompt action.
FDA spokeswoman Carly Pflaum said Neuralink “provided sufficient information to support approval” of the human trial application.
Pflaum said the agency routinely conducts such tests after approval for human trials and before commercial approval to “ensure the integrity and reliability of the data” and to comply with other FDA regulations. It is said that they are doing so.
“FDA will continue to monitor the safety of people enrolled in Neuralink’s implant device studies through required periodic reports,” Pflaum said.
Ryan Merkley, director of research advocacy for animal rights group PCRM, said the FDA should have tested Neuralink before approving human trials, given the group’s concerns months ago.
Victor Krauthammer, a former longtime FDA official, said the agency has the authority to conduct tests before allowing the company to proceed with clinical trials and has done so in other cases.
“It would have made sense for the FDA to conduct a test before approving human trials,” said Krautmer, who previously reviewed human trial applications for brain implants at the FDA. “These are violations of fundamental requirements, and we don’t want to worry about them happening again in human clinical trials.”
