Being a gigantic political donor to Democrats can only take you so far when it comes to the FDA, even if Democrats control it at the moment. And being a darling of science media and having a Silicon Valley pedigree has its limits as well.
An FDA director recently hammered $100-million-in-venture-capital home DNA company 23andMe just a few weeks after co-founder Anne Wojcicki and "other billionaire Silicon Valley wives" - that is the verbage of Ariana Eunjung Cha at the Washington Post, not me - went on a charm offensive in Washington, D.C.
Her only friends were in D.C. turned out to be, ironically, Republicans. The FDA sent them a cease and desist letter last autumn because their claims were a little close to being...medical.
Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health and isn't afraid to speak plainly. In a post about 23andMe, he wrote
Consumers are not empowered by tests that tell them they need higher or lower doses of widely-used drugs, when the opposite is true. Moreover, some genetic tests have questionable value
and
Concerns about the need to demonstrate accuracy were at the heart of our five-year effort to work with the firm 23andMe that resulted last year in the company ceasing marketing its disease risk and drug dosing tests until it could demonstrate their accuracy.
Translation: 23andMe assumed its political clout meant they could just ignore the FDA. Which is exactly what they did. So after investigators from the U.S. Government Accountability Office bought genetic tests from 23andMe and got poor quality results - some gave risk predictions the oposite of the investigator’s actual medical condition.
They're not out of it, the FDA is just telling them they can't do anything that they used to be to in order to make a buck.
FDA is not standing in the way of 23andMe selling tests intended to help consumers trace their ancestry, identify relatives and tell them why they like or don’t like the taste of cilantro.
