Novo Nordisk has said it has reached a resolution with the US federal government and the states about an investigation launched in February 2011 concerning sales and marketing practices for Victoza, its type 2 diabetes drug. The investigation was disclosed by Novo Nordisk for the first time in a company announcement on 16 February 2011.
Novo Nordisk's settlement resolves eight lawsuits accusing the company of downplaying warnings for Victoza and misleading doctors by disguising salespeople as medical educators and paying kickbacks to persuade doctors to prescribe its medicines. The US government claims that Novo failed to comply with the FDA's Risk Evaluation and Mitigation Strategy (REMS), which requires that the company give doctors information about the drug's potential cancer risk.
“When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making,” said Chad Readler, the acting head of the justice department’s civil division.
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 Victoza under their Medicaid programmes.
Additionally, Novo Nordisk will pay $12.15 million to resolve a complaint filed by the government on behalf of the FDA in federal court. In connection with this settlement, the company has also resolved several private whistle-blower cases related to the government’s investigation. The US Department of Health & Human Services, Office of Inspector General, determined that it would not seek a Corporate Integrity Agreement as part of this settlement.
“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 Douglas Langa, president, Novo Nordisk and senior vice president, North America Operations. “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 US 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.”