23andme gene testing kit ()
PALO ALTO — On paper, the top legal job at 23andMe might look like one of the hottest tickets in town. The high-profile Mountain View–based company, backed by Google and run by Anne Wojcicki, has pioneered the potentially paradigm-shifting personal genomics model. The job arguably just got more interesting when the Food and Drug Administration strong-armed the company into ceasing its interpretation of genetic test results. 23andMe now faces several class actions related to its regulatory missteps.
But the general counsel’s office has been empty since July, when longtime VP of corporate development and chief legal officer Ashley Gould left to take a similar post at Hyperion Therapeutics. The company’s seeming lack of urgency to fill the post has puzzled some in the Valley, given that other disruptive start-ups in highly regulated sectors—think Uber or Airbnb—have made the GC job a priority. So too did 23andMe, at least in the early days.
Since Gould’s departure, however, 23and­Me seems to have recalibrated. The company has declined to disclose any information regarding a possible replacement. Several Bay Area recruiters contacted by The Recorder said there seems to be little buzz about any active search to fill the post, an indicator that the company may still be assessing its next steps or canvassing candidates quietly.
At a private company of 23andMe’s size, with an estimated 100 employees, it would not be uncommon to forgo a chief legal officer. “Many privately held companies are perfectly fine partnering with outside counsel,” noted Julie Brush, founding partner of Solutus Legal Search. But the fact that the company appointed a GC right out of the gate signals just how highly it may have valued its regulatory relationships.
According to State Bar records, 23andMe now has just one in-house attorney, Andrea Henry, who was promoted to associate general counsel in October, according to her LinkedIn profile. Henry came to the company in March 2011 after three-and-a-half years at Latham & Watkins. The company declined to comment, and Henry did not respond to a request for an interview.
In addition to the company’s lawyers, two other executives are likely involved in the FDA issue: Andy Page, a former Gilt Groupe executive named to the newly created post of president in June, handles everything from legal and regulatory issues to finance, business development and laboratory operations, according to a press release announcing his hire; and Judith Blunt, the company’s senior director of regulatory affairs and quality assurance, who came aboard in late 2011. In a 2012 post on a Personal Genome Project Forum, she said was “responsible for accomplishing FDA clearance” at 23andMe. The company did not make Blunt available for an interview.
Scott Dubin, founder of attorney search consultant firm The Dubin Group, said he did not have knowledge of 23andMe’s process but noted that top-notch FDA lawyers tend to be concentrated in the Beltway and can be hard to come by in the Bay Area. The company may at some point decide that it simply needs a leader who can manage its highly sophisticated outside counsel, like Orrick, Herrington & Sutcliffe.
Orrick securities litigation partners James Kramer and Robert Varian are representing 23andMe in class actions against the company, but were not authorized to comment for this story. They have not yet entered appearances on behalf of the company, according to court records.
But those suits perhaps are just one pressing concern.
In November the FDA revealed by way of a public letter that after years of cooperation and dozens of meetings to hash out how direct-to-consumer genetic testing should be regulated (the FDA likened the test to a medical device; the company saw things a little differently), 23andMe had essentially ignored the agency for more than six months. As a consequence, the FDA told 23andMe to stop marketing its tests, adding that noncompliance might lead to an injunction or other penalties.
23andMe seems to have been humbled by the lashing, recasting its work as supplying “ancestry-related genetic reports and raw genetic data.” Previously, it had played up the health implications that drew hundreds of thousands of consumers and had gotten the FDA so very nervous.
23andMe had been working with the FDA practically since its inception. At a 2010 congressional hearing, Gould stated that the company first met with the FDA in 2007, before its saliva kits had been made available to consumers. “Thereafter, in 2008, we met with FDA Commissioner [Andrew] von Eschenbach and his staff and they encouraged us to proceed. We have had ongoing discussions with FDA since that time,” she testified.
23andMe announced developments over the years with some fanfare—noting in July 2012, for instance, that it had submitted several tests for FDA approval. Given the stakes, the failure of 23andMe to communicate with the FDA has mystified those watching the company. Some speculate that it was no mere oversight, but perhaps a deliberate provocation.
But it may be simpler than that, just another young company so ready to rocket toward growth that duller-seeming duties slipped through the cracks as the top legal officer made preparations and left for another job. Cofounder Linda Avey, who left the company in 2009 but remains an investor, told The New Yorker that news of the situation had surprised her. “The whole time I was there, we were in an outreach mode with the FDA. I can’t imagine there was that much of a cultural shift since then. It might be they weren’t paying close attention.”
With the FDA’s public letter in full view, potential candidates for an in-house role now have insight into the daunting work that lies ahead.
Major, Lindsey & Africa’s Nicole Lipman, in-house practice partner, and Judith Allen, managing partner, said such situations are frequently “exhilarating.” Bet-the-company legal issues tend to generate a lot of interest in GC positions, they said, noting their firm has placed GCs at companies including Uber, BlackBerry and Abercrombie at critical junctures.
23andMe’s regulatory path could set precedent for navigating what can sometimes be a messy FDA approval process. It has seen competitors, such as Navigenics and deCODE, arrive and fade from relevance, and the fate of the “quantified self” movement, at least as it relates to genomics, rests largely with 23andMe.
That kind of situation can be attractive. “For a corporate governance lawyer,” one recruiter said, “I can’t imagine a more exciting place to be.”
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