What makes the whole issue especially puzzling is that the FDA claims 23andMe has failed to provide adequate information that their service is "substantially equivalent" to any other legal devices with similar functions -- since May of 2013.
You might think that if the FDA blocks 23andMe's DNA test sales the company will freeze up and shutter it's doors, but I don't.
Nevertheless, there's been an explosion of responses to the FDA's decision. Here's a quick run down of a few of the best.
Matthew Herper, at Forbes, put up the most entertaining position, by far:
Really? In six months, a company choosing to work in a business in which it knows the FDA believes it has jurisdiction decided not to respond to the agency for six months? At a time when 23andMe was going to be launching an advertising campaign to try to sign up a million people to its service? At a moment when Anne Wojcicki, the company’s chief executive, was going to be on the cover of FastCompany talking about how 23andMe is revolutionizing health care? And 23andMe thought the FDA was just going to, I don’t know, not notice?
Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.I don't know about "single dumbest regulatory strategy", but more on this in a minute.
David Dobbs, at The New Yorker, is more guarded and suggests that internal shuffling at 23andMe may be partly to blame:
Another possibility is that the company simply dropped the ball. Linda Avey, who founded 23andMe with Anne Wojcicki, in 2006, and left in 2009, still owns shares and keeps in touch with some employees, says she doesn’t know what created the rift between the company and the F.D.A. “It surprised me,” she said. But she pointed out that 23andMe’s general counsel, whom she understands was leading the negotiations with F.D.A., left the company this summer; perhaps it fell through the cracks.I doubt that's the case. You don't drop the ball on work that's essentially make-or-break for your company, unless of course that it isn't anymore.
Michael Eisen, a member of the Scientific Advisory Board for 23andMe, takes the middle ground on the evolving state of personal genetics:
The data are, at this point in time, very very messy. I don’t think anyone disagrees with that. The question is what to do about that. One the one side you have people who argue that the data are so messy, of so little practical value, and so prone to misinterpretation by a population poorly trained in modern genetics that we should not allow the information to be disseminated. I am not in this camp. But I do think we have to figure out a way for companies that provide this kind of information to be effectively regulated. The challenge is to come up with a regulatory framework that recognizes the fact that this information is – at least for now – intrinsically fuzzy.Which kind of falls in line with this next opinion. Gholson Lyon, an Assitant Prof at Cold Spring Harbor, comes at FDA's stonewalling of 23andMe from the viewpoint of a scientist at The Conversation:
We need to collect billions of data points for analysis by computers. The only company in major contention to do this soon is 23andMe. With FDA’s latest attempt to stop 23andMe, all it is really doing is delaying, or worse stopping, the revolution that today’s medicine desperately needs.And this, I have always thought, was the point of 23andMe.
While I believe that personal genetics will elicit a huge change in medicine, actually doing that requires knowledge of how a person's genetics impacts their health. For many genes, like BRCA1/2 which are the oft cited breast cancer risk markers in the media, the links between genetics and disease are established.
But for many others, a lot of work still needs to be done: clinical trials based on experiments need to be designed; experiments based on hypotheses need to be run; hypotheses flowing from data analyses need to be identified; and analyses need data sets to start from. Fuzzy data is better than no data at all.
I expect that's where 23andMe is going to graciously come into play. If the FDA actually winds up killing the company's main data collection channel, the company already has about 400,000 people genotyped and has built up enough traction to run for a while without having to sell another $99 test for a long time.