Denmark’s Novo Nordisk will compensate around USD 58.7 million to settle claims that the drug manufacturer’s sales team understated the significance of the warnings prescribed by the United States Food and Drug Administration regarding the cancer risks of its diabetes drug Victoza.
The United States Justice Department said that Tuesday’s settlement would dissolve the claims; Novo Nordisk provided its sales spokespeople with data to present in front of physicians that formed the fake or deceptive notion that warnings were incorrect or insignificant.
Deputy Assistant Attorney General Chad Readler said that when a drug maker fails to render precise risk data with patients and doctors, it divests doctors of information crucial to medical decision-making.
A unit of Denmark’s Novo Nordisk A/S, Novo Nordisk Inc did not admit unlawful activity as an element of the civil settlement, which the company supposed to resolve an inquiry established in 2011 regarding the marketing and sales practices for Victoza drug.
The head of Novo Nordisk’s North American operations, Doug Langa said that although the drug manufacturer was continuously denied the misconduct and did not concur with the United States government’s decisions, it was delighted to have negotiated settlement.
He further said that at Novo Nordisk, they take accountability to convey the clinical and safety benefits of the drugs sincerely, and stay loyal to appropriately dealing the safety doubts asked by medical professionals daily.
According to the settlement, Novo Nordisk will pay off USD 12.15 million to the government that the United States Justice Department asked it made by breaking the Federal Food, Drug, and Cosmetic Act during the period of 2010 to 2012.
The Justice Department has mentioned in a lawsuit lodged in federal court in Washington that it desecrated that law arising from a disappointment to obey the FDA- prescribed risk program.
The lawsuit claimed that program expected Novo Nordisk to present information regarding the possible risk of an uncommon form of cancer linked to the Victoza drug to doctors. Victoza drug gained FDA authorization in 2010. It further said that Victoza’s FDA-permitted tagging also enclosed a boxed warning concerned to that kind of thyroid cancer.
The lawsuit also said that Novo Nordisk’s sales team used communication and strategy that produced a fake or deceptive impression among physicians concerning the cancer risks, directing some doctors to be unacquainted about them.
The Justice Department said that the Novo Nordisk will pay an extra USD 46.5 million to settle allegations under the False Claims Act that Novo Nordisk’s behavior caused the compliance of fake claims during the period of 2010 to 2014 to federal health care programs.