Gary Marchant covers the FDA’s crackdown on genetics company 23andMe:
[T]he FDA was not required to take this heavy-handed and drastic action. We know this because many of the exact same genetic tests are already being provided to consumers through their physicians, without any FDA approval. There are approximately 3,000 genetic tests now commercially available through your doctor, of which only a handful have received FDA approval. So it is apparently now unlawful for 23andMe to sell you a genetic test but OK for your physician to order the exact same test, at a much higher cost to the consumer. This is an unjustified and unwarranted double standard.
There are important reasons why at-home genetic testing may be preferable to consumers.
To many, their genetic information is very private, and they prefer to get the results privately at home rather than through their physician, who will likely put the information in the patient’s medical record. It is much cheaper to get tested through 23andMe, which is currently offering its entire battery of genetic tests for only $99. It would cost many hundreds if not thousands of dollars to get the same tests through one’s physician, and health insurance does not cover the cost of most genetic tests presently. As a practical matter, most physicians are unlikely to order the complete set of genetic tests offered by 23andMe, so those who are interested and curious to get as much genetic information as possible will be blocked from doing so if they must go through their doctor.
Drum admits that he’s “sort of agnostic about the issue of whether personal genome services should fall into the category of highly regulated diagnostic tests”:
[W]hile your genome may be medical information, interpreting your genome and explaining whether it puts you at risk for different diseases is very close to medical advice. And not just general medical advice, of the kind that Dr. Oz purveys on television. It’s specific, personal medical advice, of the kind that only licensed physicians are allowed to provide.
That’s the argument, anyway. If 23andMe is going to perform a lab test and then send you a personal letter suggesting that you, personally, are or aren’t at high risk for some disease, it’s acting an awful lot like a doctor.
Reihan joins the conversation:
One gets the impression that the FDA is now seeking to protect us from hypochondria, in which case it will have to do more than regulate harmless saliva testing kits. Perhaps the FDA should redefine internet-enabled devices as medical devices, as these devices are used to access WebMD and Yahoo Answers, where all kinds of information is shared about medical conditions, not all of which is relevant or reliable.
Nick Gillespie thinks the FDA’s rules are outdated:
Peter Huber of the Manhattan Institute, a conservative think tank, has an important new book out called The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine.. Huber writes that whatever sense current drug-approval procedures once might have had, their day is done. Not only does the incredible amount of time and money – 12 years and $350 million at a minimum – slow down innovation, it’s based on the clearly wrong idea that all humans are the same and will respond the same way to the same drugs.
Given what we already know about small but hugely important variations in individual body chemistry, the FDA’s whole mental map needs to be redrawn. “The search for one-dimensional, very simple correlations – one drug, one clinical effect in all patients – is horrendously obsolete,” Huber told me in a recent interview.
The Dish 