On September 5, 2017, Novo Nordisk Inc., a pharmaceutical manufacturer and subsidiary of Novo Nordisk U.S. Holdings Inc., itself a subsidiary of Danish Novo Nordisk A/S, agreed to pay $58.65 to settle claims it did not comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for the Type II diabetes drug Victoza.  The payment includes $12.15 million in disgorgement for Federal Food, Drug, and Cosmetic Act (“FDCA”) violations, as well as a $46.5 million penalty for violations under the False Claims Act (“FCA”).  According to the civil complaint filed in the U.S. District Court in D.C., Novo Nordisk failed to provide information regarding Victoza’s potential risk of Medullary Thyroid Carcinoma, a rare form of cancer, to physicians as required by the FDA-mandated REMS.  Additionally, it was alleged that some of the company’s representatives gave physicians a false or misleading impression that this REMS-required message was inaccurate or unnecessary.  It was further alleged that after the FDA required a modification to the REMS to increase awareness of this risk, Novo Nordisk instructed its salespeople to provide non-compliant statements that obscured these risks.  In addition to these alleged violations, Novo Nordisk’s payment will resolve allegations under the FCA for instructing its sales force to provide messages that created a false or misleading impression among physicians regarding the potential risks of Victoza and encouraging the sale and use of Victoza by adult patients who did not in fact have Type II diabetes.  U.S. v. Novo Nordisk Inc., 1:17-cv-01820 (D.D.C.).

DOJ Press Release