FDA Moves To Crush 23andMe

23andMe is a service that combines a home-based saliva testing DNA-sample kit combined with a web-based service to explain what the results mean and put you in touch with other users. At $99, it’s a breakthrough hit in affordable personal technology – and now the Food and Drug Administration is determined to snuff it out. I discuss this appalling development in a new post at Overlawyered: 

…Some of us want to seek out distant relatives and clues about national origins, or satisfy curiosity about patterns of disease in our family lines. For adoptive families, home genome testing can be hugely valuable in cases where one knows little about the medical history of an adoptee’s birthfamily. It’s our body, and our right to inform ourselves about it — or so we thought.

The FDA very likely has decent legal grounds to forbear from a crackdown should it choose to. But the key takeaway sentence from Matthew Herper’s piece in Forbes criticizing the company is: “This is not the way to deal with a powerful government regulator.” Disrespectful, anti-authority attitudes from someone an agency intends to regulate? Ask former Buckyballs CEO Craig Zucker where that gets you. …

Science blogger Razib Khan has suggested that information services like 23andme, rather than submit to expensive and cumbersome regulation as “medical devices,” may simply pack up and move offshore. But even if they do, that won’t be the end of our government’s jealous wish to regulate them – or so I predict in my post.

P.S. Is it relevant that governments themselves, through their law enforcement agencies, run elaborate saliva-, blood- and DNA-collection operations that are hedged with few of the protections of voluntariness, privacy and openness that one finds with 23andMe?