The best course for 23andme at this point is to tone down on their marketing claims, work with the FDA and seek approval. Otherwise they will be reduced to those fat reducing pills that sell with a warning.
Hate me all you want, there are plenty of medical device veterans in the Valley and it is inconceivable that the well funded company was unable to anticipate this situation, hire a few and plan ahead. This is a failure of execution, not a swooping in of some evil government agency.
If they work over the next few weeks and months with the FDA they can get appropriate approvals and move on.
Labeling claims are not a joke. They do actually mean life, death or consequences of poor decisions.
Sincerely,
Srihari
On Wed, Nov 27, 2013 at 6:15 AM, todd <todd.kuiken@wilsoncenter.org> wrote:
Some of you may have heard about the FDA decision this week which in essence stops 23&me from selling their DNA kits. There is a white house petition to reverse this decision. If the petition gets 97,000 signatures the White House has to respond (based on their rules).--
https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB
Todd
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