My opinion: the FDA was right to act in November by asking 23andMe to stop marketing its personal genome service. Now, don’t get me wrong, I have been rooting for 23andMe to succeed at what they are doing in the Consumer Genomics (CG) space. I have been hoping that “opening the door to the genome” would produce some interesting new insights about biology that might escape traditional scientific inquiry. I have been hoping, too, that taking genetic information directly to the people might further empower individuals in the health care system and begin to counter balance the medical profession and insurance companies. However, once the FDA communicated to 23andMe that their offerings looked like a medical device to the FDA and would the company please take certain steps, 23andMe’s choice was really to comply or break the law. Based on what’s public, the action by the FDA in November should have been no surprise to the company.
So, the real issue that many are unhappy about is whether CG should be regulated at all. Should the FDA have categorized 23andMe’s personal genome service as a medical device in the first place? There is room for debate on that point, however, I think at that time it was a reasonable position for the FDA to take (remember, in 2010 the CG industry was not without controversy over quality and utility, at least according to the GAO). Furthermore, the industry, including 23andMe was distributing what had for many years been considered medical advice. Why should the CG companies get to ignore regulations that other diagnostic companies are bound by? I, for one, am generally pretty happy to have an agency try to make sure that the medical products that I use are of reasonable quality. That is not the case in other parts of the world.
Since that time things have changed. Some studies have shown that CG info is probably mostly harmless. It may well be time to engage more deeply in the conversation over what, if any, regulations should bear on genetic information. While many are of the opinion that there is no harm to one knowing one’s own genetic code, I’m not so sure. I can certainly envision in a large population some subset of people deciding to take their health in their own hands and making a bad choice based on erroneous genetic information. Maybe we should let them do that. Maybe that is really what we are debating in the guise of the 23andMe/FDA issue.