What was the Victoza settlement about?
Novo paid $58.65 million after allegedly instructing its sales force to downplay a required medullary thyroid cancer warning — even after an FDA survey found half of primary care doctors were unaware of the risk.
In September 2017 Novo Nordisk agreed to pay $58.65 million to resolve allegations concerning its diabetes drug Victoza. The FDA had required Novo to communicate a potential risk of medullary thyroid carcinoma, a rare cancer, under a Risk Evaluation and Mitigation Strategy. After a 2011 survey found half of primary care doctors were unaware of the risk, the FDA required stronger messaging.
The government alleged Novo instead instructed its sales force to give doctors statements that created the misleading impression the required warning was erroneous, irrelevant or unimportant. The settlement also resolved allegations of off-label promotion for adults without type 2 diabetes. Of the total, $12.15 million was disgorgement under the Food, Drug, and Cosmetic Act and $46.5 million resolved False Claims Act allegations covering 2010 to 2014.