FDA Tells 23andMe to Stop Marketing DNA Kits; 23andMe Says It’s Sorry for Being Slow
23andMe’s $99 DNA kits can’t be advertised for their abilities to detect diseases and conditions without permission from the FDA, the FDA formally told the company on Nov. 22, as reported today by Bloomberg.
The FDA told the Silicon Valley startup to stop marketing its personal genome service until it receives authorization, threatening regulatory action including seizure, injunction and civil financial penalties if 23andMe does not comply within 15 days.
23andMe and the FDA have been in compliance discussions since July 2009, with 14 in-person and phone meetings, hundreds of emails and dozens of letters, the agency noted.
To be sure, many tech startups pursue the strategy of innovating first, regulating later. 23andMe is a genetics startup, but it has not run at the plodding pace of a medical-device company. It was founded in 2006, and released its first DNA-testing services in 2007. CEO Anne Wojcicki is currently on the cover of Fast Company magazine with the headline “The Most Daring CEO in America.” The company is backed by investors including New Enterprise Associates, Google Ventures, MPM Capital, Yuri Milner and Sergey Brin.
A representative for 23andMe sent the following statement: “We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
Asked whether the company would have to halt sales entirely, as others have suggested, the representative declined to comment. For now, kits remain available for sale on 23andMe.com.
The FDA’s main problem with 23andMe seems to be around the idea that it empowers users to make their own medical decisions, which could lead them to manage their own drug dosages, or to pursue prophylactic surgery to prevent breast cancer, a la Angelina Jolie. Or, “a false negative could result in a failure to recognize an actual risk that may exist,” the agency noted.
But the FDA doesn’t actually have classifications for many things that 23andMe promises to do. The agency says it also would need to create medical-device classifications or give premarket approval for many of 23andMe’s various uses.