Yesterday the “personal genomics” company 23andMe got a letter from the FDA ordering them to immediately discontinue marketing their genetic screening service until they get authorization from the agency.
Some libertarians were furious, but I don’t think they’re quite grappling with the problem the FDA is angry about. The critical language comes from this line in the letter: “You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May.”
Translated from agency-speak, this is saying that the FDA wanted studies to support 23andMe’s medical claims in its advertisements, but the company didn’t provide them, and then broke off communication. I’m guessing they thought they could stall the FDA until they got enough data from their test kits to perform the studies the agency wanted.
The lesson here in general is that most of the time it pays to engage with regulatory agencies. Silicon Valley techno-utopians are often impatient with the government getting in the way of their latest “disruption” or whatever, but blatantly ignoring a government agency is a quick way to spark a cycle of mutual suspicion and recrimination.
Of course, all law enforcement agencies should be as impartial as possible, and few things are more loathsome than swaggering policemen demanding everyone respect their authoritah. But a critical part of a functional bureaucracy is an espirit de corps and pride in the agency mission. And the FDA is not the Border Patrol; their mission is to keep Americans from being poisoned. 23andMe should respect that fundamental legitimacy—and if they were being mistreated, there are others paths to recourse. Simply ignoring the agency is arrogant and self-defeating.
Overall, Derek Lowe has the most measured take, noting that the key issue is that 23andMe made many health claims. If they had simply stuck to providing DNA sequencing while scrupulously avoiding medical commentary or potential diagnoses, they wouldn’t have sold nearly so many tests, but the FDA probably would have left them alone.
On the other hand:
I’ll add a bitter, cynical note: if only 23 and Me had been able to come up with some way to market their DNA test as a nutritional supplement, they’d be in the clear. Maybe some sort of sugar pill that you took before you spit in the little sample container? Then they could say “Not intended to treat, cure, or modify any disease” at the bottom of the page, in six-point microtype, and everything would have been fine, as if by magic. No one would have paid any attention to it, of course, because no one ever pays any attention to that language when they go out and buy all kinds of “supplements”, and the FDA would have staggered backwards at the sight of Orrin Hatch’s law, like Christopher Lee in a Hammer vampire film being hosed down with a face full of holy water.
UPDATE: A correspondent reminds me that this is old Monthly territory: this piece by Steve Teles details the organizational lessons of the FDA, and this piece by Stephanie Mencimer tells the story of Orrin Hatch’s corrupt bargain with the supplement industry.