The FDA recently banned marketing of 23andMe’s genetics home testing kits, effectively stopping sales of the product that has brought the genomics revolution to over 500,000 people. Today, TF President Berin Szoka shed some light on the issue in USA Today, writing:
Mass-marketing 23andMe could change the cultural paradigm of medicine: The more people get tested, the more will ask their doctor about their results, and the more doctors will have to start incorporating personalized genomics into their practices.
But the FDA doesn’t care about these benefits — only that someone might, theoretically, get hurt. It wants 23andMe to spend years jumping through bureaucratic hoops, which means delaying the inevitable shift in how medicine is practiced.