Thoughts On 23andMe & The FDA

This week the world of consumer health technology got a rude shock, when the FDA warned personal genomics company 23andMe that its marketing was in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). The FDA seemed most concerned about the potential for 23andMe customers to misread their DNA results and take unnecessary or harmful medical action.

The FDA has a point. 23andMe simply has to do a better job of making the results of its tests useful and usable. 23andMe has done about as good a job of helping its users interpret their genetic results as it has of communicating with the FDA. In other words, not good enough. I wrote a blog post touching on some of these themes back in April.

It’s not all 23andMe’s fault. In my book research, I’ve read a lot about personal genomics. And the more I read up on genetics, epigenetics, etc., the more I see that the scientific community still has very little clue about what actually causes disease. Like the rest of us in 2003, when the human genome was fully sequenced, 23andMe’s founders were no doubt hoping the scientific community would make swift progress interpreting it. That hasn’t been the case.

For all that, I still believe that genetics is the key to medical advancement. But we’re not there yet and that’s where 23andMe has gotten into trouble with the FDA. It has indeed been making claims it can’t prove. And it seems to have tried to blow off the FDA by stalling them.

Is the FDA and the rest of the medical establishment too conservative about innovation and health data that consumers can get directly? Well… is the Pope Catholic? The real question is, when will 23andMe get its act together? If 23andMe had done a better job of helping users interpret their data – and emphasizing the risks – then the FDA would probably not have sent them a warning letter.

23andMe CEO Anne Wojcicki stated today, “It is absolutely critical that our consumers get high quality genetic data that they can trust.” It’s just as important, in my view, that 23andMe help its customers make sense of that data.

I hope for all our sakes that 23andMe can get its show back on the road, because they’re the only direct-to-consumer genomics service left. And I want my genetic information. More importantly, I want to know how to make better use of it.