Summary:
5 years ago, 23andMe started marketing a test for among other things a BCRA indicator
July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"
Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing
Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"
Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"
Exactly. I am no fan of the FDA, but what 23andMe did here was extraordinary: they essentially ignored the agency. If Anne Wojcicki was CEO of a similarly-sized medical device company she would have gotten her walking papers today.
Why is ignoring a government agency when they ask you to follow the law praiseworthy? The law says you cant market a diagnostic test without testing to know the accuracy of the test. I don't want to praise the snake oil salesmen who would also want to break this law so why should I praise what 23andMe did?
Because, in this case, the Government agency and the laws they enforce are unconstitutional, and actually harm the people they're supposed to be protecting.
Care to explain how the FDA is harming the people it should protect? It seems to me that they're simply trying to get 23AndMe to accurately market their product. Since 23AndMe is making claims of a medical nature, it falls neatly under the jurisdiction of the FDA as granted by Congress.
Care to explain where in the Constitution the Federal Government is granted the power to regulate medicine? I think you'll find that that power is reserved for the states. With respect to harm, take a look at how many people are killed by delays in drug availability caused by the approval process.
Nothing the FDA does that is legitimate couldn't be better handled through the courts at a state level. And you wouldn't have to ignore the Constitution in the process.
July and Sept 2012 - 23andMe submits a form to the FDA saying "our test isn't really useful for diagnosis and thus shouldn't fall under these rules"
Nov 2012 - FDA says we don't agree with you you need to either prove your effectiveness or change your marketing
Jan 2013 - 23andMe says "it will take us a couple months to do the tests, we'll get back to you"
Nov 2013 - FDA says, "its been 11 months and you never got back to us. Stop selling and let us know within 15 days what you're going to do explicitly because you ignored us for close to a year"