September 5, 2017
Novo Nordisk Inc.
agreed to pay $58.65 million to settle charges it violated the False Claims Act and Food, Drug, and Cosmetic Act by failing to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza. The New Jersey based pharmaceutical manufacturer is a subsidiary of Denmark’s Novo Nordisk A/S. At the time of Victoza’s FDA approval in 2010, the FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug. Under the REMS, Novo Nordisk was required to disclose to physicians the potential risk. If it failed to comply with these disclosure requirements, including requirements to communicate accurate risk information, the drug would be considered misbranded under the law. According to the government, Novo Nordisk failed to comply with the REMS requirements, providing information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The allegations originated in several whistleblower lawsuits filed under the qui tam
provisions of the False Claims Act. The whistleblowers who brought these actions will receive a yet-to-be-determined whistleblower award
from the proceeds of the government’s recovery. Whistleblower Insider