23andMe provides personalized DNA results that are interpreted to provide information about ancestry and health risks for various diseases. Because the results provided by 23andMe border on medical information, the FDA has been working closely with the company since 2009 to ensure that their marketing and analysis were accurate and in accordance with federal regulations. However, in May of 2013 23andMe ceased communications with the FDA and simultaneously ramped up marketing of their Personal Genome Service (PGS) for providing “health reports on 254 diseases and conditions.” In retaliation, the FDA sent a letter to 23andMe on Nov 22 warning them to stop marketing their PGS without approval or face harsh regulatory actions. This letter sparked a public debate about how much regulation should be imposed on this new technology, which was the focus of our discussion on Wednesday.
The question at the heart of the debate is: do individuals have the right to access their own genetic information (and interpretations of it) without medical (and hence FDA) oversight?