Weeks after the Food and Drug Administration (FDA) ordered 23andMe to stop providing its genetic testing service, Anne Wojcicki, co-founder and CEO, acknowledged that there was a degree of oversight on their end during a recent interview with Bloomberg.
“I think we fell behind in our communications,” Wojcicki said, adding, “It’s a complicated area. It’s not a clear path about how to regulate all the genetics in this new world of sequencing. We are going to do everything we can to show the FDA that we’re really committed to this process, and we’re going to do it.”
In the letter that the FDA sent last month to Wojcicki, ordering the company to discontinue marketing its Personal Genome Service (PGS), the agency described making several attempts to assist the company with complying with regulatory requirements relating to safety and effectiveness. These steps were necessary for 23andMe to obtain marketing authorization for their PGS device.
The FDA pointedly described spending “significant time evaluating the intended uses of the PGS” and providing “ample detailed feedback” about the kind of data the company needed to submit. The letter also listed “14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” as well as details about the content of the feedback they provided the company to underscore the point that the ball was in 23andMe’s court for a long time with regard to upholding their end of the regulatory responsibilities and ensuring the safety of costumers.
“We’re working aggressively with the FDA," Wojcicki stated to Bloomberg. "I believe that the FDA is committed and we’re committed that there should be a direct-to-consumer path for individuals to get access to this [service] ... so that everyone can get access to their genome and there can be a massive community like 23andMe where we’re solving the world’s problems in health care.”
Currently, the company has suspended the diagnostic aspect of their genetic testing service, while still providing consumers with access to their raw genetic data as well as ancestry-related genetics. But Wojcicki confirmed in the interview that the company is carrying out measures to fulfill regulatory requirements with the aim of being able to offer medical interpretations of a customer’s genome once again. “We are hoping we can work with the FDA to get it back on very soon. I would love to give you a date but I don’t know. We’re going to work hard to make sure that consumers can get access to it.”