COMPLIANCE

Theranos Adds Compliance Focused Executives and Board Committee

By Kelly A. Briganti, Editorial Director, G2 Intelligence

While still facing serious sanctions from the Centers for Medicare & Medicaid Services, Theranos has been taking steps to rehabilitate its compliance image. The company announced the appointment of a chief compliance officer, a vice president of regulatory and quality and a Compliance and Quality Committee. Daniel Guggenheim, a health care lawyer who formerly served as assistant general counsel at McKesson Corp., will handle “day-to-day implementation and oversight of the company’s compliance program” as chief compliance officer, a Theranos press release stated. Dave Wurtz will oversee regulatory affairs including FDA submissions and approvals and pre- and post-marketing activities. Wurtz formerly undertook a similar role at ThermoFisher Scientific as senior director of regulatory, quality and compliance.

Finally, the company’s board of directors has formed the Compliance and Quality Committee, which will work with both new executives and the board to monitor implementation of the compliance program. “Theranos understands that regulatory compliance is an essential element of any successful and innovative health care company,” said Dr. Fabrizio Bonanni, board member and chair of the Compliance and Quality Committee, in a statement. “This committee will be integral to fulfilling Theranos’ commitment to bringing the highest integrity health information to every person.”

Earlier in the month, an “Op-Ed” written by William H. Foege, MD, MPH, a member of the company’s Scientific and Medical Advisory Board and the Board of Directors, declared there is “another side to the story” and discussed the reason he supports the company in its mission. Foege is a former director of the U.S. Centers for Disease Control and Prevention and former senior medical adviser for the Bill and Melinda Gates Foundation. He indicated he and others were given access to the company’s technology, data and validation reports and he believes that “the very foundation of Theranos’ inventions—and its hundreds of patents—is credible.” To demonstrate this credibility, he notes that the SMAB is assisting the company in preparing for publication of its data in peer-reviewed scientific journals and public presentations.

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