The Justice Department and Novo Nordisk announced yesterday the conclusion of a series of civil actions against the drugmaker to settle allegations of unethical marketing practices connected with the marketing of Victoza, a Type 2 diabetes drug. Under the agreement, Novo Nordisk agrees to pay the federal and state governments $46.5 million for allegedly violating the False Claims Act and give up $12.15 million in profits made on Victoza sales for allegedly violating the Federal Food Drug and Cosmetic Act.
“Today’s resolution demonstrates the Department of Justice’s continued commitment to ensuring that drug manufacturers comply with the law. 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 Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.
This settlement resolves seven civil actions against Novo Nordisk, and the total figure paid out by Novo Nordisk may still climb as a result. Yesterday, the law firm Phillips & Cohen LLP announced that as part of the settlement Novo Nordisk will agree to pay an additional $1.1 million to the state of California and $350,000 to the state of Illinois for alleged fraud against private commercial health insurers. The lawsuit alleges that Novo Nordisk led an ad campaign promoting off-label use for Victoza as a weight loss treatment for people with Type 1 diabetes, Type 2 diabetes, and prediabetes. These two states have laws which encourage whistleblowers to expose fraud against private insurers. The lawsuit was kept under seal until the Justice Department’s complaint process was finalized.
According to the Justice Department press release, Novo Nordisk may have benefited from downplaying a potential side effect of Victoza. When Victoza was approved in 2010, the FDA required that the company conduct a Risk Evaluation and Mitigation Strategy (REMS) for the drug. Under the REMS order, the FDA ordered Victoza to mitigate the potential risk of a rare form of cancer called Medullary Thyroid Carcinoma. The complaint alleged that some Novo Nordisk sales representatives downplayed the REMS message on Victoza to physicians as “erroneous, irrelevant, or unimportant.”
After a 2011 survey found that doctors were unaware of the potential risk, the FDA then asked Novo Nordisk to modify the REMS. Instead, the complaint alleges, “Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification.”
Victoza has been a consistent moneymaker in recent years for Novo Nordisk. From 2013 to 2015, it generated just under $6 billion in sales, according to data from PMLive, a drug-tracking site.
A Novo Nordisk statement on the settlement stressed that the company takes its responsibility to communicate safety and benefit information of its drugs very seriously. The company also continued to dispute the allegations made by the Justice Department.
“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,” said Douglas Langa, Novo Nordisk’s executive vice president of North America Operations.
Victoza, through a third-party ad server, has been a regular advertiser on Insulin Nation in the summer preceding the publication of this article. No attempt has been made by Novo Nordisk to influence this coverage, and Insulin Nation does not provide special consideration on editorial coverage to advertisers.
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