FDA Overreach and 23andMe

According to the FDA, a soiled plastic cup is a medical device subject to its jurisdiction. In its seemingly infinite expanse, the FDA has issued a cease and desist letter to 23andMe stating:

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.”

What’s the “PGS” process? Sign up on 23andMe’s website, pay the fee, and soon thereafter receive your “test kit” in the mail.  The “kit” is a small  plastic tube that you spit into, seal, and then send back to 23andMe. Using a panel of probes, 23andMe detects single nucleotide polymorphisms (SNPs) in your DNA, and issues an online report to you about how your SNPs correlate with various traits. When your results are ready, you sign back into the website where you’ll receive a personalized report that looks like something like this: Health and Traits – Health Risks – 23andMe.

The 23andMe report gives you some probabilistic genetic predisposition information (with caveats about its applicability beyond those of European ancestry). It does not offer, nor does it purport to provide, a medical diagnosis of any condition. True, your genetic predisposition information, along with your family history, ancestry, symptoms, diagnostic tests ordered by your physician, and even sleep data you collect using your fitness tracker can assist in the diagnosis of an illness or disease. But just because information can help in the diagnosis of a medical condition does not mean it should be considered a “medical device” subject to FDA jurisdiction.

In fact, just like people show up in their doctor’s offices with 23andMe reports, they show up with their Fitbit tracker data, too. Is the FDA going to issue Fitbit a cease and desist letter, too?

Maybe I’m being too harsh. Maybe the FDA is right. Maybe we just can’t handle the truth.

Want to learn more? Tune in tomorrow morning as I discuss the issues on The Takeaway, or on NPR in San Francisco (KQED). Follow me on twitter for updates @NitaFarahany, or go ahead and sign the petition in opposition. Do read 23andMe’s pithy response.




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