Razib Khan comments on 23andMe’s pursuit of FDA clearance for their genome service:
I still believe that on a deep level regulatory agencies dont get it. Our own genotype and genome is going to be a cheap commodity in the next few years. Services like Promethease will proliferate to provide people open source information. Is openSNP going to the FDA anytime soon? The main reason that firms like 23andMe will go through regulatory hurdles is that they are, or aim to be, legitimate public entities. In other words this is an artifact of our institutions. Mind you, 23andMe et al. will probably always have slicker user interfaces, and theres some value in that. But that doesnt entail FDA oversight, does it?
I think of the ongoing case of the caveman blogger: “North Carolina Tells Blogger That Providing Dietary Advice Is Illegal, Blogger Tells NC To Read The 1st Amendment”. States and the federal government have no end of ways to make life difficult for people who comment publicly on health. Do we need an offshore data haven for genomes?
The interest of FDA officials in regulating commercial entities offering personal genome interpretation services has been a notable story over the last two years. More details about the story from the 23andMe blog: “23andMe Takes First Step Toward FDA Clearance”.