The FDA Doesn't Want You to Unzip Your Genes

Human Karyotype Based On Images Obtained From Digital Light Microscope. (Photo By BSIP/UIG Via Getty Images) BSIP/UIG/Getty Images

The Food and Drug Administration recently ordered 23andMe to stop selling its popular DIY genetic screening service which, with a simple saliva swab, promises to provide, the FDA notes, "health reports on 254 disease and conditions," "carrier status," "health risks" and "drug response" as a "first step in prevention... [that] takes steps toward mitigating serious diseases." In the FDA's warning letter to Google-backed 23andMe, dated November 22 and released on Monday, officials charged that the kit is mostly intended to be used as a "medical device" - which is a big no-no since the Saliva Collection Kit and Personal Genome Service (PGS) are not approved medical devices.

While it might come as a surprise to some that a Silicon Valley darling - 23andMe is headed by biotech entrepreneur Anne Wojcicki, "the soon to be ex-wife of the Google co-founder Sergey Brin" - is under fire from the FDA, it turns out that "spit kits" have drawn the ire of the agency for years. Conflict between 23andMe and the FDA dates back to at least 2009, according to the recent warning letter. In what could fairly be described as an exasperated tone, the FDA states that it has tried working with the company so that the kit would not have to undergo some of the more cumbersome approval processes required of most medical devices, even proposing "modifications to the device's labeling."

Over the past four years, the FDA stated in the letter, the agency has had "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" with 23andMe and claims to have provided the company "with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies." The FDA charges that instead of addressing this criticism, 23andMe ramped up marketing efforts: "We have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS's uses and consumer base without obtaining marketing authorization from FDA." Because of this, "23andMe must immediately discontinue marketing the PGS.... "

Why has it taken four years for the FDA to drop the hammer? And why aren't other direct-to-consumer genetic testing companies getting pounded by the FDA?

Concerns about these types of tests have been raised since at least 2004, when the American College of Medicine Genetics board of directors issued a policy statement warning that "genetic testing should be provided to the public only through the services of an appropriately qualified health-care professional," saying their use is "potentially harmful" because of "inappropriate test utilization, misinterpretation of test results, lack of necessary follow-up, and other adverse consequences."

The FDA maintains that it has been monitoring the field and has issued letters to companies offering these services, saying they "have been on our radar for some time."

"Others have continued discussions with us or decided to get out of the marketplace," an FDA spokeswoman tells Newsweek, whereas 23andMe has "escalated over the years into out-and-out medical claims."

The company has issued a mea culpa of sorts, saying in a statement that it recognizes "we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

When pressed for further comment, 23andMe's publicists said they could not speak beyond what was already in the statement.

The company has 15 days to fix these problems or give the FDA a timetable for when it will fix said problems. If 23andMe doesn't to that, the company might face "seizure, injunction, and civil money penalties."

Michael S. Watson, executive director of the American College of Medical Genetics, tells Newsweek that the FDA's decision is "reasonable." Studies have found that patients armed with personal diagnostics might not pursue proper follow up treatment or might undergo unnecessary, dangerous prophylactics - such as preventive double mastectomies, he says. Genetic testing should be coupled with counseling, he says, so patients get the full picture not included in test results - namely, that having a gene doesn't necessarily mean it will cause a disease.