Novo Nordisk will pay $58.65 million to the Justice Department to resolve allegations that it instructed some of its sales representatives to share information with physicians that downplayed safety risks for Victoza, its type-2 diabetes medication.
The FDA approved Victoza in 2010, on the condition that the company implement a Risk Evaluation and Mitigation Strategy (REMS) to warn physicians about the potential risk of patients developing a rare cancer called medullary thyroid carcinoma. The drug now has a black-box warning.
The allegations against Novo include that managers instructed reps to “sandwich” the risk information between promotional messages in order to minimize that information. Reps also reportedly told doctors that the risk of cancer is only associated with mice and rats; that all diabetes drugs have boxed warnings and Victoza was no different; and that this type of cancer is “easy to treat” if a patient was diagnosed.
Because the reps gave doctors a misleading impression about the risks cited in the FDA-mandated REMS program, some physicians who prescribed Victoza were unaware of those risks, the Justice Department alleged. A government survey conducted in 2011 found that half of primary-care doctors were unaware of the cancer risks associated with Victoza.
“We need to trust that pharmaceutical companies truthfully represent their products’ potential risks,” Nick DiGiulio, a special agent in charge of the Department of Health and Human Services’ Office of the Inspector General, said in a statement. “We will continue to work with our partners to ensure federal healthcare dollars are spent only on drugs that are marketed honestly.”
Novo will pay $12.15 million from its Victoza profits to address the allegations that it did not follow the REMS program. It will also pay $46.5 million to address False Claims Act allegations. A corporate integrity agreement is not part of the settlement, Novo said.
In a statement, the drugmaker said it disagreed with the government’s “legal conclusions” and denied wrongdoing. “We’re pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients,” Doug Langa, Novo Nordisk’s president and EVP and head of North America operations, said in the statement.
Novo reported that Victoza – part of a class of drugs called GLP-1s, which includes Eli Lilly’s Trulicity – brought in $3 billion in sales in 2016. In addition, the drugmaker has pursued new indications for the therapy. In 2015, a formulation of Victoza was approved as Saxenda, a treatment for weight loss. Earlier this year, the FDA approved Victoza as a treatment to lower the risk of cardiovascular events like heart attacks and strokes.
Novo spent $128 million on direct-to-consumer advertising for Victoza in 2016, according to Kantar Media.