FDA, 23andMe, and the Democratization of Healthcare

January 15, 2014 | Robert Green and Nita Farahany take on the FDA's treatment of 23andMe in a Nature comment today. Both Green (Brigham & Women's Hospital) and Farahany (Duke University) have spent years considering how individuals process and deal with their consumer genomic results. "We find the FDA’s precautionary approach to 23andMe particularly troubling because it could presage similar actions against other consumer health products," the two said. "We believe that 23andMe should be more transparent about how accurate its genotyping chips are, and even more forthcoming about the limitations of its computer algorithms used for estimations of risk. But regulatory constraints might stifle consumer genomics and other emerging products that could make society healthier and that do not fit neatly into the model of physician-driven health care." Nature