Novo Nordisk $58 Million Settlement and REMS - Off Label Prosecution Still Alive and Well

Novo Nordisk will pay roughly $58.7 million to resolve claims that the company’s sales force downplayed the importance of mandated United States Food and Drug Administration (FDA) warnings about the cancer risks of its diabetes prescription, Victoza. In a civil complaint filed on September 5, 2017, in the U.S. District Court for the District of Columbia, the government asserted claims under the FDCA, alleging that at the time of Victoza’s approval in 2010, the FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate the potential risk in humans of a rare form of cancer associated with the drug - Medullary Thyroid Carcinoma (MTC). The FDA-mandated REMS required Novo Nordisk to provide information regarding Victoza’s potential risk of MTC to physicians. Manufacturers that fail to comply with the requirements of the REMS, including requirements to communicate accurate risk information, leads the drug to be misbranded under the law. The complaint alleges that some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint further alleges that Novo Nordisk did not comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza. As alleged...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs