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 in the government’s complaint, after a survey in 2011 showed that half of primary care doctors polled were unaware of the potential risk of MTC associated with the drug, the FDA required a modification to the REMS to increase awareness of the potential risk. Rather than appropriately implementing the modification, the complaint alleges that Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification. Novo Nordisk has agreed to disgorge $12.15 million in profits derived from its unlawful conduct in violation of the FDCA.
Novo Nordisk will pay an additional $46.5 million to the federal government and the states to resolve claims under the FCA and state false claims acts. This portion of the settlement resolves allegations that Novo Nordisk caused the submission of false claims from 2010 to 2014 to federal health care programs for Victoza by arming its sales force with messages that could create a false or misleading impression with physicians that the Victoza REMS-required message about the potential risk of MTC associated with Victoza was erroneous, irrelevant, or unimportant and by encouraging the sale to and use of Victoza by adult patients who did not have Type II diabetes. The FDA has not approved Victoza as safe and effective for use by adult patients who do not have Type II diabetes.
“At Novo Nordisk, we take our responsibility to communicate the safety and clinical benefits of our medicines seriously, and remain committed to properly addressing safety questions healthcare professionals ask every day,” said Doug Langa, Executive Vice President, Head of North America Operations and President of Novo Nordisk Inc. “Our focus will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision. While we do not agree with the U.S. government’s legal conclusions and deny any wrongdoing, we’re pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients.”
Analysis
The bottom line for companies is to take their FDA issued REMS very seriously and take opportunities to ensure that clinicians understand those REMS. This can be done through multiple venues and sales representatives need to see that these are not to be discounted.