Novartis Defends Itself Against Kickback Allegations From Former Employee

Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise. Former Novartis executive Min Amy Guo has alleged that in 2012, the company initiated a study of breast cancer drug Afinitor with McKesson Corporation. The study of Afinitor, which received approval from the U.S. Food and Drug Administration (FDA) in 2012 as a breast cancer treatment, would have been performed by McKesson and overseen by a client-focused group at Novartis, as opposed to Guo’s group, the Health Economics and Outcomes Research Group, which she helmed. The move, Guo’s attorneys have argued in court, was a violation of federal kickback statutes. According to Guo’s legal filings, as reported by NJ.com, when Guo raised objections to the nature of the study, Novartis began to raise its own concerns about Guo and ultimately terminated her – an investigation that her attorneys called “a cover to fire her.”
In her lawsuit against the company, Guo said the study as it was designed as a “clear violation” of processes that oversee those types of third-party studies. Because of the conflict, the study appeared to be a kickback under the guise of research. Guo, according to the arguments, believed that the design of the study was in danger of being in violation of a Corporate Integrity Agreement the company signed with the U.S. Department of Justice in 2010 as part of an earlier settlement. That particular agreement, law360 reported, required Novartis to comply with all federal healthcare program requirements, including kickback rules. According to the lawsuit, Guo raised concerns about the study and the appearance that structure of the agreement could appear to be an inducement for McKesson, which had acquired its own oncology business in 2010.