23andMe Loses The Attitude And Gets Off The FDA Naughty List
In 2013, the US FDA got tired of being stonewalled when it came to seeing proof of Google-backed 23andMe marketing claims regarding BRCA-related genetic risk and drug response, along with marketing blurbs that they can make it possible to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer.
They had asked to see such proof starting in 2009 and the company refused. Maybe 23andMe figured all that money spent on campaign contributions was going to get them a free-pass, it is difficult to know, but by 2013 the FDA was not having it, sending…