FDA and 23andMe: Innovation Will Never Prevail If the Innovator Fails to Properly Manage Their Relationship with the Regulator


[The FDA order against 23andMe to stop genetic testing shows that in the balance between regulation and innovation, innovation will never prevail if the innovator fails to properly manage its relationship with the regulator:]

On November 22, 2013, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to 23andMe, Inc. regarding its 23andMe Saliva Collection Kit (an at-home genetic testing kit) and Personal Genome Service. The letter indicates that FDA had requested information from and sent communications to the company numerous times since September 2012 - including calls, meetings, “hundreds of email exchanges, and dozens of written communications” - in efforts to help the company comply with FDA requirements, which are designed to ensure that 23andMe’s products do not provide a false positive result for genetic markers which could cause consumers to undergo unnecessary procedures or therapies, and lead consumers to “change their dosage or discontinue a drug without professional advice."

However, it seems that 23andMe failed to provide FDA with promised study and test results and other requested information. Consequently, FDA ordered 23andMe to “immediately discontinue marketing” the product and deemed 23andMe’s applications for FDA clearance (filed in 2012) to be withdrawn. FDA’s November 22 letter to 23andMe was extremely harsh, both in terms of substance and form. In terms of substance, FDA Warning Letters typically allow the recipient an opportunity to correct violations prior to taking enforcement action. That is not the case here. In terms of form, the letter goes into excruciating detail to describe what FDA clearly perceives to be a disregard of authority on the part of 23andMe, most notably:

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.

(emphasis added).
FDA is routinely criticized in cases where FDA regulation is perceived to stymy innovation. One ongoing example involves FDA’s regulation of autologous stem cell procedures as the manufacturing of biologic drugs. This over-regulation has resulted in widespread criticism. For instance, Andrew von Eschenbach, a former Commissioner of FDA, described the circumstances as follows:

Lawyers—many lawyers—are now trying to resolve this dispute. But at a time when science and technology are creating marvelous medical breakthroughs, the FDA should be leading and guiding the development of state-of-the-art therapies like regenerative medicine. Instead, the agency's process for regulating complex new technologies often starts too late, after companies and researchers have sunk millions of dollars and thousands of hours into painstaking research.

However, in the case of 23andMe, FDA’s regulatory ambitions are not the issue. 23andMe’s product is not the issue either. Instead, the issue appears to be the company’s failure to respond on a timely basis to FDA’s unobjectionable requests for information. In communicating with FDA, members of industry have many options. They can schedule in-person meetings, teleconferences, and email FDA personnel directly. They can even go up the chain of command or contact a Center Ombudsman if they believe they are not being dealt with fairly or in a timely fashion. However, once the FDA has chosen to exercise its authority, no company, no matter how innovative, can ignore FDA or refuse to respond to information requests without facing enforcement action.


[JD Supra's new Law Matters series asks experts for their quick take on legal developments of the day, and specifically how such matters affect people in their personal and professionals lives. Stay tuned for other posts in the series.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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