There's an interesting discussion thread about this issue on HackerNews:
https://news.ycombinator.com/item?id=6794122
One part of the discussion particularly stood out for me:https://news.ycombinator.com/item?id=6794122
"If you look at the FDA's website, it's littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA can evaluate the medical claims they're making.
See, e.g., this one from June 10, 2010:
http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf
All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:
(...)
The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
(...)
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
(...)
There's even a helpful mailing address and fax number:
(...)
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway."
I know that in US of A there's this vision of entrepreneurship as "distrupting" the rules that are perceived to be obsolete (see AirBnB or Uber), but sometimes people just push too far. There's a reason why FDA exists, and it's not only about making money to big pharma.
I hope that 23&Me folks get this issue cleaned up fast; they seem like a good people and company.
(also hi, first post here :))
Jacek Złydach,
http://temporal.pr0.pl/devblog | http://esejepg.pl | http://hackerspace-krk.pl
http://temporal.pr0.pl/devblog | http://esejepg.pl | http://hackerspace-krk.pl
TRC - Bringing you tomorrow's solutions yesterday.
On 2 December 2013 22:10, Katie Kearns <katie.kearns@gmail.com> wrote:
On Fri, Nov 29, 2013 at 12:46 AM, Srihari Yamanoor <yamanoor@gmail.com> wrote:This is the delicate issue - the balance of patient rights vs. commercial profit making, both of which are needed. This is not the first time the FDA has had to deal with this emotionally titillating issue. Cancer patients and their loved ones have never been able to reconcile with the stance of experimental drug administration on patients with no other available treatments (and the ethical/business issues there can be the subject of tons of PhDs).I never used 23andme as I believe genes before data is sort of a cart before horse thing, but can you expand on the "patent me" point. I am interested, even if it needs an offshoot thread.I find the FDA is far too conservative, especially when it comes to people with no other options. But 23andme was clearly way overstepping what the data actually supported in order to make it "easy" for people.
-Katie--To view this discussion on the web visit https://groups.google.com/d/msgid/diybio/CALY99PWXL6ZuUrDPdHzwmvOviORtmENGGyCrHizCGadHKoekoA%40mail.gmail.com.
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