FDA’s Message To Medical Device Company: Stop

The widely publicized start-up company 23andMe, Inc. markets its "personal genome service product" as providing reports on hundreds of diseases and conditions that enable users to "take steps toward mitigating serious diseases," including diabetes, coronary heart disease, and breast cancer. This all sounds good. As an FDA Warning Letter issued on November 22, 2013, makes clear, however, 23andMe was marketing its product - a medical "device" under the federal Food, Drug & Cosmetic Act - without benefit of FDA approval. FDA thus ordered the company to immediately discontinue marketing.

The FDA's Warning Letter to 23andMe is of interest on several levels. First, there is the interest in the cutting-edge technology of the very personalized medical information which the product offers. The promise to "learn more about [one's] health and ancestry" that the company makes on its website is exciting and enticing.

Similarly, it is impressive that existing technology makes it possible to order a test kit online, collect a sample in the privacy of one's own home, and return the sample to the company's laboratory and then receive a report which promises to "provide specific health recommendations."

The FDA's Warning Letter is also of interest for the record of noncooperation on the part of the company which it recounts. The FDA states that it "do[es] not have any assurance that [23andMe] has analytically or clinically validated [its product] for its intended uses." In the FDA's telling, the company has not completed studies the company agreed to conduct or "even started other studies necessary to support" the product. We must await the company's response to the Warning Letter to hear its side of this story.

And finally, the Warning Letter is of interest as a current example in the ongoing debate regarding personal freedom and regulation in the interest of public health and safety. Movie theatres across the country are showing Dallas Buyers Club, the story of Ron Woodroof's battle with AIDS and the FDA, in which he sought to use and to make available to others with AIDS unapproved drugs. 23andMe is no Ron Woodroof, but there are some similarities.

After watching...