FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Novo Nordisk to Pay $58 Million to Settle DOJ Suits Over REMS Violations

Sept. 11, 2017
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Novo Nordisk will pay more than $58 million for failing to comply with FDA regulations on risk disclosures for its diabetes medication Victoza.

At the time of Victoza’s approval in 2010, the FDA required a Risk Evaluation and Mitigation Strategy due to the drug’s association with potential risks of medullary thyroid carcinoma. The Justice Department claimed the drugmaker violated this regulation by suggesting to physicians that the REMS-required risk information was unimportant or irrelevant.

In creating this impression, Novo Nordisk violated provisions of the FD&C Act and led some doctors to prescribe the drug based on an incomplete picture of the associated risks, according to the Justice Department. A 2011 survey found that half of primary care doctors did not know about the potential risks associated with the drug, leading the FDA to require a clarification of the REMS. However, Novo Nordisk had its sales department obscure the risk information for the modified REMS as well, according to the complaint.

Novo Nordisk has agreed to pay $12.5 million for violations of the FD&C Act, as well as $45.6 million for violations of the False Claims Act for its dissemination of misleading information. The settlement resolves seven whistleblower lawsuits.

Novo Nordisk came under scrutiny for its business practices over the summer, when Sen. Amy Klobuchar (D-Minn.) sent a letter to its CEO and those of two other drugmakers asking the companies to justify recent price hikes for diabetes drugs.

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