Late on a Friday in November 2013 I was at a strategy offsite when my executive assistant texted that we had received a package by courier from the U.S. Food and Drug Administration. At the time, 23andMe had been in a years-long back-and-forth with the FDA over how we should be regulated, so this news made me anxious. Hoping to gain as much time as possible, I texted back, “Don’t sign for it!” She replied, “It’s too late, I already did.” As it turned out, that package contained a warning letter that would forever change the course of 23andMe.
23andMe’s CEO on the Struggle to Get Over Regulatory Hurdles
In 2013 the genetic testing firm 23andMe received a cease-and-desist letter from the U.S. Food and Drug Administration forbidding it from selling its spit-in-a-tube DNA test to consumers. Since its founding, six years earlier, 23andMe had operated in a murky space: Previously, genetic tests were ordered only by doctors, and it was unclear whether the device the company sold to consumers to facilitate testing constituted a “medical device.” Over the next two years, while it continued to sell tests giving consumers information about their ancestry and ethnic origins, 23andMe had to work with the FDA to gain regulatory approval for its consumer health product. This required the company to prove not only that the test was valid but also that test results could be understood by untrained consumers. CEO Anne Wojcicki writes that the process helped her recognize an element of Silicon Valley arrogance in how the company had previously dealt with regulators, and helped 23andMe improve its product and become more resilient.