WASHINGTON (Legal Newsline) — The U.S. Department of Justice announced Sept. 5 that Novo Nordisk Inc., a pharmaceutical manufacturing company, will pay $58.65 million after allegations of failing to comply with the FDA-mandated risk evaluation and mitigation strategy (REMS) for its Type II diabetes medication Victoza.
“[This] resolution demonstrates the Department of Justice’s continued commitment to ensuring that drug manufacturers comply with the law,” said acting assistant attorney general Chad A. Readler of the Justice Department’s Civil Division. “When a drug manufacturer fails to share accurate risk information with doctors and patients, it deprives physicians of information vital to medical decision-making.”
According to allegations, the FDA approved Victoza in 2010 with stipulations of a REMS to mitigate any potential risk in humans a rare form of cancer called medullary thyroid carcinoma (MTC) associated with the drug. The department said Novo Nordisk failed to properly comply with the REMS rule.
“Novo Nordisk’s actions unnecessarily put vulnerable patients at risk,” said U.S. attorney Channing D. Phillips for the District of Columbia. “We are committed to holding companies accountable for violating the integrity of the FDA’s efforts to ensure that doctors and patients have accurate information that allows them to make appropriate decisions about which drugs to use in their care. Working with the FDA and other law enforcement partners, we have sent a strong signal to the drug industry.”