Back when genetic testing company 23AndMe charged into a brick wall (the brick wall won, by the way), I noted the idiocy of believing they could beat the FDA:
On the Twitterz, I wrote that 23andMe’s attorneys should be disbarred for letting things reach this point. Interestingly, it appears that General Counsel left the company several weeks ago (and no replacement has been found). 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.
Piling the libertarian rhetoric on doesn’t help either–that’s a huge red flag for regulators.
But Uber seems to have learned nothing either (boldface mine):
A week after Uber’s fleet of 16 luxury Volvo XC90 SUVs started picking up passengers, the program was brought to a grinding halt. The California Department of Motor Vehicles revoked Uber’s vehicle registrations after Uber refused to obtain a $150 permit authorizing it to test driverless cars in the state. And rather than correct what on the surface seemed like a clerical error, Uber refused to get licensed, instead shipping its autonomous fleet to Arizona where it could test its self-driving cars with less public scrutiny….
According to a lengthy email exchange between Uber and the DMV obtained by The Verge from a public records request, Uber was repeatedly urged to sign up for the state’s autonomous testing permit, with the DMV even offering to expedite the process to make it as quick and seamless as possible. Had it done so, Uber could have saved itself a lot of embarrassment and could be offering trips in self-driving cars in San Francisco right now.
It’s worth noting that when the FDA lowered the boom on 23AndMe, the FDA also was begging to ‘work with’ 23AndMe to develop regulations. Instead, 23AndMe blew them off:
But in multiple emails to the DMV, Anthony Levandowski, vice president at Uber’s Advanced Technologies Group and the company’s top executive in charge of autonomous technology, argued that what it was doing did not meet the legal definition of autonomous vehicle testing, spurring a brain-bending debate over the letter of the law. The debate ended inconclusively, and Uber ultimately launched its doomed public pilot without ever notifying state regulators of its intentions to invite members of the public into the backseat of its self-driving cars.
“In their minds, they really thought they weren’t autonomous,” Jessica Gonzalez, assistant deputy director of public affairs at the DMV, told The Verge. “But we decide what’s autonomous. And under our regulations, it was.”
Their cleverness is matched by their arrogance. Unfortunately, there are some people you can’t intimidate or bullshit. I wonder if Silicon Valley will ever learn this.