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In an unusually harshly worded Warning Letter, the Food and Drug Administration (FDA) ordered the genetic testing company, 23andMe Inc., to immediately discontinue marketing its saliva collection kit and personal genome service (PGS) until the company receives FDA marketing authorization for the device because the device is adulterated and misbranded. The device is a direct-to-consumer genetic testing kit that is intended to provide “health reports on 254 diseases and conditions.” As the FDA stated in the publicly available letter to the company’s CEO, Anne Wojcicki (wife of Google co-founder Sergey Brin):

Some of the uses for which PGS is intended are particularly concerning...because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications…if the…risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist…Assessment responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.

The FDA comes out swinging in this letter, obviously anticipating litigation. Unlike most Warning Letters, for example, this one sounds like an advocacy brief, marshalling all of the evidence of the FDA’s hard work, fairness, and concessions to the applicant, followed by its indignation at the company’s disregard of its efforts:

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you 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…However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions…Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, 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.

The Warning Letter is thus significant not only because of the harsh tone of the agency, the company’s high profile CEO, and the prospect that the two will ultimately face off in litigation, but also because it demonstrates the FDA’s vision of a harsher regulatory pathway for the industry than genetic testing companies had expected or hoped for. While the agency says that it has been flexible and spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, it is clear from the letter that the scope of the studies and other requirements imposed by the agency has been so expensive and time-consuming that the company was willing to abandon its 510(k)s (which the FDA has withdrawn).

This advisory was prepared by the Life Sciences and Health Care practice groups at Nutter McClennen & Fish LLP. For more information, please contact your Nutter attorney at 617.439.2000.

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