Novo Nordisk just won a nod from the FDA for the cardiovascular risk reduction of Victoza, which should further propel sales of the blockbuster. But in its own nod to a darker side of its sales history, the company has settled, for nearly $60 million, another batch of lawsuits over past marketing of the Type 2 diabetes drug.
The complaints from the Justice Department and sales reps-turned-whistleblowers alleged that Novo had flouted its Risk Evaluation and Mitigation Strategy (REMS) requirements. It was supposed to warn prescribers that Victoza had been associated with a risk of the rare cancer Medullary Thyroid Carcinoma, but the DOJ complaint says Novo had its sales team give doctors the impression that the REMS requirements “were erroneous, irrelevant, or unimportant.”
Under the $58.65 million settlement, Novo is giving up $12.15 million in profits and paying $46.5 million for alleged violations of the False Claims Act.
“Novo Nordisk’s actions unnecessarily put vulnerable patients at risk,” Channing D. Phillips, U.S. Attorney for the District of Columbia, said in a statement.
The company denied it did anything wrong but said it was glad to get the suits behind it.
“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," Doug Langa, who heads Novo’s North America operations, said in a statement.
The suits are similar to one brought by some states unsealed earlier this year against Novo and clinical education companies that said they set up a “white-coat marketing scheme” to pump up sales of NovoLog, Victoza and Levemir. That suit, brought by about 30 states, was unsealed as part of a settlement process. It said the company disguised sales reps as medical educators and paid kickbacks to persuade doctors to prescribe its medicines. Novo denied any wrongdoing in that case as well.
Victoza continues to be a big seller for the company, although it has faced increasing competition. The GLP-1 diabetes drug brought in $843 million, in the last quarter up 25%.
The FDA in August officials declared that Victoza reduces the risk of heart attack, stroke and cardiovascular death, joining Eli Lilly and Boehringer Ingelheim’s Jardiance, which already has the designation. Novo can now tout the declaration in conversations with doctors, but more importantly with payers, which have been putting unprecedented pressure on diabetes meds.