A settlement has been reached to resolve False Claims Act allegations against Novo Nordisk Inc.
The allegations arose from a lawsuit that claimed Novo Nordisk Inc failed to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza.
According to the government, the Food and Drug Administration approved Victoza for sale in 2010; it required Novo Nordisk to provide information to physicians about the potential risk of a rare form of cancer called medullary thyroid carcinoma (MTC). Allegedly, company sales representatives gave information that created a false or misleading impression about the required risk message that led some doctors to be unaware of the potential risks.
Reportedly, a 2011 survey showed that half of primary care doctors were unaware of the potential risk of MTC, the FDA required Novo Nordisk to company to change its procedures to increase awareness of the risk. Allegedly, Novo Nordisk told sales representatives to provide statements to doctors that obscured information about the risk.
“Novo Nordisk Inc. sales representatives misled physicians by failing to accurately disclose a potential life threatening side effect of a prescription drug, and needlessly increased risks to patients being treated with this drug,” said Assistant Director in Charge Andrew W. Vale of the FBI’s Washington Field Office. “The FBI is committed to ensuring that the private industry provides honest and accurate risk information to the public and will continue to work closely with our law enforcement partners to investigate companies who do not comply with FDA-mandated policies.”
The settlements include a payment of $46.5 million for violations of the False Claims Act between 2010 and 2014 and $12.5 million for violations of the federal Food, Drug and Cosmetic Act from 2010 to 2012. Out of those settlements, $3.32 million will go to state Medicaid programs.
