23andMe Brings in New Regulatory Counsel

By Bio-IT World Staff 

April 2, 2014 | This morning, 23andMe announced the appointment of Kathy Hibbs as chief legal and regulatory officer. The hire comes at a time of intense regulatory scrutiny for 23andMe, which continues to seek a way forward after an FDA decision last November prohibited the company from reporting genetic health risks to customers. 23andMe has been operating without a chief legal officer since mid-2013, when Ashley Gould departed from that role. In the months leading up to and following the FDA action, the company's legal team has been reporting to 23andMe President Andy Page.

Hibbs, who has advised medical device companies and clinical laboratories for over 20 years and represented the industry before both the federal and California governments, will now take the lead in managing 23andMe's regulatory strategy. She is leaving her current post as Senior Vice President and General Counsel for Genomic Health, a California-based company that produces genetic tests for the precision treatment of cancer, where she has served for five years. Hibbs has also represented The Personalized Medicine Coalition, an advocacy group for both industry and academic partners with the stated goal of educating policymakers about the benefits of personalized medicine.

In a press statement, Page said that “We are extremely pleased to have Kathy join our leadership team at this important time in our company’s history.”