FDA Moves to Halt Sale of 23andme DNA Test
Just a few weeks ago I wrote about my decision to take the 23andme DNA test and today the FDA moved to halt the sale of 23andme DNA test calling it a medical device. The FDA issued a letter stating the company President, Anne Wojcicki and her company 23andme were marketing “the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). “
There is a fast moving conversation taking place on twitter with varying opinions for and against this decision.
Here is 23andme’s Facebook response:
Hi everyone, Many of you have seen and been asking about this morning’s news.
Here’s the statement we’ve issued to the media: “We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
We’ll continue to keep you updated here as we know more. Thanks for all the messages of support!
One influential writer at Forbes has framed this as a story of a company that did not want to follow the rules and insodoing may be on the road to self-destruction. I am not so sure about that. My gut response is a genie has been released from the can. And it’s now too late to backtrack given there are already 400,000 of these tests already sold with a company goal of 1 million units by end of the year. I am awaiting my results and I am more afraid this may be a FDA move to control what gets sold directly to the public.
I tend to agree with what founder Anne Wojcicki has stated that increased sales and personal knowledge about one’s DNA will cause a “… disruption [that] is a good thing… and by giving people access to their genetic information and insight into their own health, individuals — with the advice of their their doctors — can take more informed measures in keeping themselves healthy.”
How do you feel about the FDA halting sales of your personal DNA information to YOU?