Novo Nordisk will pay nearly $58.7 million to resolve claims the drugmaker’s sales staff downplayed the importance of U.S. Food and Drug Administration-mandated warnings about the cancer risks of its diabetes medication Victoza.
The U.S. Justice Department said Tuesday’s settlement would resolve claims Novo Nordisk supplied its sales representatives with information to give to doctors that created the false or misleading impression that warnings were wrong or unimportant.
“When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making,” Acting Assistant Attorney General Chad Readler said in a statement.
Novo Nordisk Inc, a unit of Denmark’s Novo Nordisk A/S, did not admit wrongdoing as part of the civil settlement, which the company said would resolve an investigation launched in 2011 concerning the sales and marketing practices for Victoza.
Doug Langa, the head of Novo Nordisk’s North American operations, in a statement, said while the drugmaker continued to deny wrongdoing and did not agree with the U.S. government’s conclusions, it was pleased to have negotiated a 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,” he said.
Under the settlement, Novo Nordisk will pay the government $12.15 million that the Justice Department said it earned by violating the Federal Food, Drug, and Cosmetic Act from 2010 to 2012.
It violated that law stemming from a failure to comply to a FDA-mandated risk program, the Justice Department said in a lawsuit filed in federal court in Washington.
The lawsuit said that program required Novo Nordisk to provide doctors information about the potential risk of a rare form of cancer associated with the drug, which gained FDA approval in 2010.
Victoza’s FDA-approved labeling also contained a boxed warning related to that form of thyroid cancer, the lawsuit said.
Novo Nordisk’s sales force employed messages and tactics that created a false or misleading impression with doctors regarding the cancer risks, leading some physicians to be unaware of them, the lawsuit said.
The company will pay an additional $46.5 million to resolve claims under the False Claims Act that Novo Nordisk’s conduct caused the submission of false claims from 2010 to 2014 to federal health care programs, the Justice Department said.
Those claims arose out of seven whistleblower lawsuits.
(Reporting by Nate Raymond in Boston; Editing by Peter Cooney and Andrew Hay)