The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
The FDA says it is concerned that consumers would misunderstand genetic marker information and self treat. For example, the agency cites the company for testing for versions of the BRCA gene that confers higher risk of breast cancer worrying that women might get a false positive test leading "a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions...."
What the test results would actually lead patients to do is to get another test and to talk with their physicians. The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.
It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test. Nevertheless the agency orders that...
...23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.
The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.
Update: The folks at TechFreedom have just launched a petition at Change.org to FDA Adminstrator Margaret Hamburg urging her to reverse this ridiculous ban. From the petition:
The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But banning personal genomics isn’t the answer.
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.
H/T Mike Riggs and Andrew Mayne.