Facing sanctions and a criminal probe, the blood-testing startup Theranos hired an in-house lawyer from McKesson to hold the newly created position of chief compliance officer.
Dan Guggenheim joins from McKesson, where he spent nearly 12 years including the last five as an assistant general counsel, regulatory law.
Theranos is facing a series of escalating problems : On July 7, the agency that oversees clinical labs, the Centers for Medicare and Medicaid Services, revoked a key lab certificate, issued monetary penalties and cancelled its payments from federal health insurance programs for lab services after an inspection of the company’s Newark, New Jersey labs turned up a number of violations. It also banned the company’s CEO Elizabeth Holmes from owning and operating labs, although it hasn’t yet taken effect and is subject to appeal.
In April, the Wall Street Journal reported that federal prosecutors are investigating whether the company misled investors about the state of its technology and operations.
Facing these problems, on Thursday, the company announced it has hired two executives and formed a regulatory and compliance committee to advise the board about the company’s obligations.
In addition to Guggenheim, the company hired Dave Wurtz as its vice president, regulatory and quality who will oversee the process of obtaining “FDA clearances and approvals and marketing of new products and managing the regulatory affairs, medical device quality systems and clinical affairs teams,” according to the company’s press release.
Meanwhile, Guggenheim, the lawyer, “will lead day-to-day implementation and oversight of the company’s compliance program, with an emphasis on maintaining and enhancing policies, procedures, training and monitoring mechanisms to promote compliance with all applicable state and federal regulations.”
At McKesson, he led “a team of lawyers and legal professionals providing advice on laws and regulations related to the marketing and sale of drugs, medical devices and healthcare business services,” according to his LinkedIn profile.
Guggenheim was not immediately available for comment but we’ll update this post if we hear back from him.
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