4 ms·

This really got me: > or a recognition from the FDA that, given turnover at 23andMe (and Wojcicki’s distraction due to her public separation from husband Serge

This really got me: > or a recognition from the FDA that, given turnover at 23andMe (and Wojcicki’s distraction due to her public separation from husband Sergey Brin), the task of initiating outreach fell to them. That's laughably ludicrous.

dnautics 13y ago
You've never had to deal with a three letter agency as a corporation, have you? It's very difficult to ascertain when they want you to take a proactive step to "initiate outreach" and when you're supposed to contact them. And when there's a delay, who knows. In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got a letter back, "we will get back to you in 90 days." It's been 180-ish days. Static. What now? Who contacts whom?
- lingben 13y ago
  Who contacts who? the party that has less power contacts the party that has more power. that is the way of the world, always has been, always will be
- tvladeck 13y ago
  I must confess that your first sentence aggravates me. It comes across as an accusation that I am not qualified to have made the comment that I did. With that in mind, yes, I have. But that's irrelevant. Anyway, you missed my point. My comment did not imply that it was obviously not the FDA's responsibility to make contact. (Nevermind the fact that at the end of the day, it was in fact the FDA that did reach out to 23andMe.) I did imply, however, that turnover at 23andMe and Anne's marital issues were ludicrous reasons for it to have been the responsibility of the FDA.
- EpicEng 13y ago
  That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or, at a minimum, a consultant with similar experience. Ignorance is not a defense, and in practice, it doesn't really matter; they can shut you down, you can't do shit about it.

dnautics 13y ago

You've never had to deal with a three letter agency as a corporation, have you? It's very difficult to ascertain when they want you to take a proactive step to "initiate outreach" and when you're supposed to contact them. And when there's a delay, who knows. In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got a letter back, "we will get back to you in 90 days." It's been 180-ish days. Static. What now? Who contacts whom?

lingben 13y ago
Who contacts who? the party that has less power contacts the party that has more power. that is the way of the world, always has been, always will be
tvladeck 13y ago
I must confess that your first sentence aggravates me. It comes across as an accusation that I am not qualified to have made the comment that I did. With that in mind, yes, I have. But that's irrelevant. Anyway, you missed my point. My comment did not imply that it was obviously not the FDA's responsibility to make contact. (Nevermind the fact that at the end of the day, it was in fact the FDA that did reach out to 23andMe.) I did imply, however, that turnover at 23andMe and Anne's marital issues were ludicrous reasons for it to have been the responsibility of the FDA.
EpicEng 13y ago
That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or, at a minimum, a consultant with similar experience. Ignorance is not a defense, and in practice, it doesn't really matter; they can shut you down, you can't do shit about it.