Six months ago, 23andMe chief legal officer and general counsel Ashley Gould left the company.
This departure may clear up some of the confusion about why 23andMe became the target of a regulatory crackdown. It was a veritable legal mess. Fans had hoped 23andMe intentionally dropped the ball with the feds, perhaps to spark a national debate and a court case. Critics accused the founders of a kind of “Silicon Valley arrogance” to assume they could escape the prying eye of regulators.
A combination of factors led to the Nov. 22 injunction, but the timing of Gould’s departure may have played a role.
Catherine Afarian, a spokesperson for 23andMe, declined to comment on “personnel matters” when asked about whether Gould’s departure in July of 2013 exacerbated matters with the FDA. 23andMe is still searching for Gould’s replacement.
Related: Read our exclusive in-depth interview with 23andMe spokesperson Catherine Afarian: “We are not going anywhere.”
In Gould’s absence, the legal team continues to report to Andy Page, a new hire who was tasked with product and engineering, marketing, finance, business development, laboratory operations, and legal and regulatory issues, according to a press release. Meanwhile, founder and chief executive Anne Wojcicki is focused on the science and research.
Page has extensive experience in growing online businesses. Until recently, he was the president of Gilt Groupe. That explains the drastic uptick in advertising, and the slew of broadcast television ads in the past six months, which appear to have been highly troubling to the feds. For all his e-commerce expertise, Page does not seem to have much experience dealing with the complexities of medical device regulation. His bio on Crunchbase and the press release announcing his appointment indicates that 23andMe is his first health care company.
According to sources familiar with the matter, Gould was responsible for dealing with formal processes and providing statistical evidence to ensure the testing kit is “analytically or clinically validated,” according to the FDA’s standards. Spokespeople from the regulatory agency claim 23andMe has failed to communicate at all since May, just a few months after Gould would accept a new job at biotech firm Hyperion Therapeutics, according to LinkedIn.
In November, the Mountain View, Calif.-based genetic-testing firm was hit with a stern warning letter from the Food and Drug Administration, prompting a media firestorm. The FDA requested that 23andMe stop selling and marketing its $99 genetic testing kit — and two weeks later, 23andMe complied. The firm is still selling and marketing the ancestry features of its service, and customers can download the raw data, but it no longer provides full health reports.
In its letter, the FDA claims that 23andMe “had not even started other studies necessary to support a marketing submission.” The agency was concerned that 23andMe’s results were not clinically accurate — and the firm was delivering false positive results to customers on over 254 diseases and conditions, including Alzheimer’s and Parkinson’s diseases.
Gould appears to have overseen the initial request for FDA approval back in 2012. Her work involved mediating between 23andMe and the various federal agencies. It’s highly complex work, and the debate is still ongoing about whether 23andMe’s saliva collection kit (its “PGS”) should be considered a medical device under the law.
“The result that you get when you review a report, the FDA wants to ensure that’s a valid result,” Gould told Bloomberg in July 2012, when asked about her plans for regulatory approval.
Gould joined the company in 2007 and rose through the ranks to the position of vice president of corporate development and chief legal officer. Gould was also responsible for building a network of outside experts, who could advise 23andMe on processes for managing the feds. Attempts to find contact information for Gould failed.
23andMe is attempting to work with regulators to become the “only FDA approved” direct-to-consumer genetics company.
To learn more about the emerging field of genetic testing, listen in to this KQED Forum debate here.