A couple of years ago, when the DNA personal testing company 23andMe inexplicably ignored numerous requests, I was completely flabbergasted by 23andMe’s behavior:
I’m not always a big fan of the FDA (they still haven’t really figured out how to approve new antibiotics), but the reality is that the FDA is like those humongous tractors used to move space rockets: they’re slow, but crush everything in their path. You can’t bullshit these guys–they just keep coming.
Have no doubt–the tone of this letter indicates ‘the nuclear option’ (to use a recent phrase). It’s about as devastating as it gets. How the hell did 23andMe’s leadership (such as it is) let this happen? The mind boggles…
Translated into English, 23andMe had an opportunity to tell regulators how they should be regulated–and, if they had been really clever, even twist the regulations to harm their competitors. That’s a lobbyist’s wet dream. Instead, they didn’t even bother to respond. Just how stupid and arrogant does one have to be to do that?
Answer: pretty fucking stupid. Anyway, that brings us to blood testing company Theranos which has decided to fuck around with the FDA.
Is it something in the water out west? Do they not know that regulatory agencies exist? Or is this a belief that if you can brazenly bullshit VC guys, you can pull the same move on regulators? (guess what? You can’t).
It’s all the more inexplicable because the company’s board is full of ex-federal pros.
The mind boggles.