FDA Drives Medical Innovation Overseas As 23andme Looks Elsewhere To Help People

from the fda-failures dept

Last fall, we noted that the FDA had come down hard on 23andme for offering its inexpensive and easy to use genetic testing without first getting detailed FDA approval. As we noted at the time, this seemed to be a typical FDA overreaction. People aren't using 23andme as the final word on something, but rather as a useful indicator to explore more deeply with medical professionals if they needed to be aware of something, change lifestyles, etc. Furthermore, we noted how stopping 23andme and similar offerings would only delay important innovations that the medical world really needs today.

And, now it appears that all the FDA has really succeeded in doing is driving that innovation overseas, as 23andme focuses on expanding in various countries abroad, rather than the US.

While it awaits the agency's approval, a process that could take years, 23andMe aims to offer partial or full genetic-testing services in one or more countries outside of the United States by the end of the year, with likely contenders including Canada, Australia and the United Kingdom, the source said.

A big part of the problem is that the FDA is simply not designed to actually deal with innovative healthcare products. It was built to handle one thing and one thing only: approving pharmaceuticals. And it has a very hammer-and-nail approach to everything it does. Nearly a decade ago, we wrote about Andy Kessler's book The End of Medicine. While that book is now a little outdated, one thing that was quite clear in that book is how ill-prepared (and ill-interested in ever becoming prepared) the FDA is for technological innovations in the healthcare space. The FDA understands clinical testing for drugs, and has trouble understanding anything that doesn't fit into that paradigm.

Providing more useful information to people about their own genes and makeup is a very useful tool. Yes, there can be false positives, but is it better to keep people totally ignorant, or to better inform them across the board? Sure, perhaps it makes sense to do thorough testing of drugs to make sure they're safe (though, even with that there are plenty of compelling arguments for why the FDA does that wrong too), but when it comes to a service that is about providing more information to people, allowing them to be better informed and do more research to be healthier, you'd hope that the FDA would learn how to enable more innovation, rather than shutting it down... and sending the innovation overseas.

Filed Under: fda, genetics, information, overseas, personal genetics, regulations
Companies: 23andme