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

spike spike66 at att.net
Wed Nov 27 15:04:56 UTC 2013


>... On Behalf Of BillK

>...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
_______________________________________________


On the contrary, in the current situation, picking a big public fight with
the FDA is a very logical next step.  The FDA wants to force 23andMe to meet
standards that most people would consider inapplicable to those kinds of
devices.  Meeting FDA standards is a process which is way too expensive and
too slow.  The spit kits are a perfect example of a device which should not
be considered a medical device, but rather a home diagnostic tool which
would point the consumer to FDA approved medical devices, if the consumer
really thinks it necessary.

The 23 kits are a good example of a device which has been brought down to
the consumer level by pricing them at the 100 dollar level.  If 23 buckles
and agrees to work with the bureaucracy, then those kits would be priced out
of that range, which would discourage the masses from using them.  For
myself, I was waiting for the price to go below about 300 bucks.  It went
from 500 to 100 practically overnight.  If 23 gets tangled in bureaucracy,
it will be back at 500 overnight.

In this particular case, Anne Wojcicki can afford to play chicken with the
Feds.  She and Mr. Google will not go hungry, even if the FDA shuts down 23.
But the reputation of the FDA and government bureaucratic intervention in
consumer affairs in general is at a historic low point with the spectacular
crash on takeoff of the "Affordable" "Care" Act.  Now is the very best time
for 23 to pick this fight, and 23andMe is the very best test case I can
imagine: popular with the proletariat, affordable, not a medical diagnosis
device exactly, not even on the same level as a home pregnancy test, clearly
something that is not doing anyone any harm, as opposed to the FDA, which
plenty could argue are doing a great deal of harm.

BillK, this is a perfect test case.  We have a tech startup which used all
private funding, which works right, created a useful tool which has done
plenty of good for the public and no real or convincing harm, an
organization which has done a great job of protecting privacy, being bullied
by an organization which spent hundreds of millions of dollars on a website
that doesn't work and places private information into the public domain.
The US federal government spent HUNDREDS of MILLIONS of dollars, and
couldn't even launch a goddam website correctly, then they assure us,
PROMISE us that the website will be all fixed and running by this Saturday,
and oh by the way, they still aren't encrypting anything, not even working
on that yet, but by this Saturday, it will all be fixed they promise, and if
you liked your insurance plan you can keep your insurance plan, period end
of story, and if you liked your doctor you can keep your doctor period end
of story.

BillK, if the FDA goes after 23andMe, which of those two will you be rooting
for?

spike








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