pharmafileSeptember 07, 2017
Tag: Novo Nordisk , litigation
Novo Nordisk has resolved a probe by the US Justice Department which accused the Danish drugmaker of illegal marketing activities in the sale of its top selling product Victoza and other drugs from its diabetes portfolio. The company has agreed to pay the sum of $58.7 million to close the case.
Novo Nordisk was accused of intentionally minimising the cancer risk posed by Victoza, failing to comply with FDA requirements to provide physicians with sufficient information. A 2011 survey revealed that around half of primary care professionals were unaware of the risk, prompting the FDA to call for the firm to take steps to increase awareness – a call the company ultimately ignored.
The manufacturer was also alleged to have disguised sales representatives as diabetes educators who visited doctors’ offices in order to illegally promote its products, as well as engaging in kickback payments to physicians in order to encourage them to prescribe its drugs.
Chad Readler, Acting Head of the Justice Department’s civil division said: "When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making."
The $58.7 million sum breaks down to a $12.5 million charge for violations of the Federal Food, Drug, and Cosmetic Act from 2010 to 2012, and $46.5 million to settle whistle-blower lawsuits.
"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," commented Douglas Langa, President of Novo Nordisk and Senior Vice President of 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"
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