23andme are either there today or they aren’t. They dealt the play last summer when they started this process, and advertised it. They’ve upped it by framing themselves as a daring company. But they’re going after the FDA with this strategy. And if you come at the king, you best not miss.
That is from a blog post by John Wilbanks (HT: chemjobber on twitter). Defending the FDA by analogy to Omar Litte, a rip-and-runner (he robs drug dealers) from the old HBO show The Wire, is pretty interesting. (See Youtube here for an example.) It got me thinking…What else does our old friend Omar have to say about our present situation?
Well, most critics of 23andMe say that the company’s problem is its own making. True, its boneheaded regulatory affairs strategy of late consists of simply ignoring communications from the FDA. Of course, the FDA understandably became irritated, and it has responded. But is its response good policy? We all will be unable to use an affordable, at-home testing service to easily learn about the most important parts of our own genomes. That seems bad. But maybe it’s good: 23andMe’s quality control might be inadequate, and the FDA’s policy may offer us a strong protection against inaccurate information. Who knows? 23andMe’s critics may not be keen to address that particular issue, but most of them can agree with Omar on the simple fact that the game is out there, and it’s either play or get played.