23andMe’s Rocky Start

On November 22nd, 2013, the Food and Drug Administration issued a letter of warning to Ann Wojcicki, CEO of 23andMe, about her company’s direct-to-consumer genomic testing service. In what is perhaps the most widely read warning letter in FDA history, Wojcicki is told that it is too risky for people to have access this kind of information without physician supervision. She is then told to stop offering it...