Regulatory Focus™ > News Articles > Novo Nordisk Pays $58M to Settle REMS Allegations

Novo Nordisk Pays $58M to Settle REMS Allegations

Posted 06 September 2017 | By Michael Mezher 

Novo Nordisk Pays $58M to Settle REMS Allegations

Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide).

Victoza, Novo's top-selling drug, brought in more than $1.8 billion in sales in the first half of 2017, accounting for 20% of the company's overall sales.

The allegations stem from a federal investigation into Novo's marketing practices that began in 2011 following whistleblower claims made against the company.

Under the settlement, Novo will pay $12.15 million to settle claims that it violated the Federal Food, Drug and Cosmetic Act (FDCA) and $46.5 million to settle allegations under the False Claims Act (FCA) and various state false claims acts.

The company also resolved seven related whistleblower suits for an undisclosed amount.

But in settling the complaints, Novo maintains that it didn't do anything wrong.

"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 Doug Langa, Novo's head of North America operations.

REMS Compliance

At the center of the allegations are claims that Novo attempted to mislead physicians by downplaying the potential risk for Victoza to cause certain types of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).

During premarket studies some rodents exposed to Victoza developed thyroid C-cell tumors. While a link between Victoza and such tumors in humans has not been established, the US Food and Drug  Administration (FDA) approved the drug with a boxed warning stating that the risk for MTC was unknown and required Novo to notify physicians of the potential risk under its REMS program.

According to the complaint, members of Novo's marketing team performed a skit for its sales force, during which a marketing manager "joked" about the unknown risk of MTC by saying "do you think we're treating mice and rats? I mean really!"

The complaint also claims that Novo sales representatives were "coached by managers to minimize the importance of the MTC message by 'sandwiching' information about it between promotional messages regarding the efficacy of the drug."

This, the complaint says, led to sales representatives making statements to downplay the potential risks of Victoza, including that the risk for MTC was "only applicable to rats and mice," and that Victoza is "no different and no less safe than those other [diabetes] drugs."

In 2011, in response to surveys conducted by Novo to assess doctors' awareness of the potential risk for MTC, the company found that only half of primary care physicians were aware of the boxed warning and FDA modified the REMS to require the company to send additional letters to doctors to increase awareness of Victoza's risks.

While Novo did deliver the letters, the complaint alleges that Novo's vice president of marketing for Victoza sent a recorded message to sales representatives instructing them to assure physicians that there were no new safety concerns for the drug, despite FDA's assertion that the survey results constituted a new safety concern.

"The information provided by [Novo's] sales force to primary care physicians contradicted FDA's instructions in that the Agency deemed this to be new safety information that required a modification to the REMS and not 'part two' of the REMS requirement. This message could give primary care providers the impression that the REMS modification and MTC risk message were erroneous, irrelevant, or unimportant," the complaint states.

Department of Justice, Complaint, Settlement Agreement

Categories: Regulatory News

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