[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

[BillK]

On Tue, Nov 26, 2013 at 9:30 PM, Brian Manning Delaney  wrote:
> Makes sense of course, but it would have been clearer if they had just
> written "stop selling".
>
> It is curious, however, that selling is precisely what 23andMe has not
> stopped doing. I know someone who purchased a kit (well, ordered and paid
> for a kit) a few hours ago.
>


It looks as though 23andMe are assuming that the mention of 15 days to
respond means they can carry on as normal for at least 15 days. The
speculation is that 23andMe will then start discussions with the FDA
to try to drag things out much longer.

However the FDA are getting annoyed after four years of discussion, so
may take other actions like an injunction to stop the business and
civil monetary penalties. Google are probably not worried about
monetary penalties, but going by history it is not wise to pick a
fight with the FDA.


BillK