Novo Nordisk agrees to $58 million settlement with US DoJ

The US unit of Danish diabetes care giant Novo Nordisk (NOV: N) will pay $58.65 million to resolve allegations that the company failed to comply with the Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) for its top-selling type 2 diabetes medication Victoza (liraglutide), the Justice Department announced yesterday.

The resolution includes disgorgement of $12.15 million for alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) from 2010 to 2012 and a payment of $46.5 million for alleged violations of the False Claims Act (FCA) from 2010 to 2014.

In a civil complaint filed today in the US District Court for the District of Columbia asserting claims under the FDCA, the government alleged that, at the time of Victoza’s 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. The REMS required Novo Nordisk to provide information regarding Victoza’s potential risk of MTC to physicians. A manufacturer that fails to comply with the requirements of the REMS, including requirements to communicate accurate risk information, renders the drug misbranded under the law.