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Novo Nordisk announces $58 million settlement following U.S. investigation of Victoza marketing
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Novo Nordisk will pay approximately $58 million to the federal government and to individual states under the terms of a settlement finalized this week regarding marketing of its diabetes drug Victoza, the company announced in a press release.
The settlement announcement follows an investigation, launched in February 2011, of the company’s sales and marketing practices for Victoza (liraglutide), a GLP-1 receptor agonist used to treat type 2 diabetes.
According to a press release from the U.S. Dept. of Justice, the settlement resolves claims alleging that some Novo Nordisk sales representatives gave prescribers a false or misleading impression that an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) was “erroneous, irrelevant or unimportant.” The REMS is intended to mitigate a potential risk for medullary thyroid carcinoma associated with the drug.
Under the terms of the settlement agreement, Novo Nordisk will pay approximately $46.5 million to the federal government and to states that reimbursed for liraglutide under their Medicaid programs. Additionally, Novo Nordisk will pay $12.15 million to resolve a complaint filed by the government on behalf of the FDA in federal court, the company announced.
In connection with this settlement, the company also resolved seven private whistle-blower cases related to the government's investigation.
Under the terms of the settlement, the company admits no wrongdoing and the U.S. Department of Health and Human Services, Office of Inspector General, determined that it would not seek a Corporate Integrity Agreement as part of this settlement, the company said in the release.
"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 health care professionals ask every day," Douglas Langa, executive vice president, North America Operations, said in the release. "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."