| Novo Nordisk pays $25 million due to improper off-label drug promotion
The US Department of Justice (DOJ), in a June 10, 2011 press release, said Danish pharmaceutical company, Novo Nordisk, will pay $25 million to resolve its civil liability and allegations of off-label promotion of NovoSeven.
The Food and Drug Administration (FDA) only approved NovoSeven to treat some hemophiliac’s bleeding disorders. Although doctors may prescribe the drugs for other uses, manufacturers are prohibited from promoting or marketing a drug for any other use than the one it received from the FDA.
It was Novo Nordisk’s US affiliate, Novo Nordisk Inc, out of Princeton, New Jersey, that illegally promoted the drug. The company urged health care professionals to use the drug for such off-label uses as using it for a coagulatory agent for trauma patients, cardiac and liver surgery and liver transplants and intra-cerebral hemorrhage.
It was the company’s unlawful promotion that caused false claims to be filed with government health program. The filings were not reimbursable by the programs. Both Medicare and Medicaid ended up paying for off-label prescriptions throughout the country.
“Pharmaceuticals should be marketed only for uses that the FDA has approved as safe and effective,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “The off-label promotion alleged here not only wasted taxpayer dollars, but also undermined the FDA’s important role in ensuring that drugs are properly marketed to government agencies and members of the public.”
The actions today originated with a whistleblower suit filed in Maryland. That case is resolved as part of today’s settlement.
Whistleblowers play a vital role in the government’s fight against health care fraud. Those whistleblowers will receive more than $3.5 million of the federal government’s $21.4 million settlement in the case. State Medicaid units will receive $3.5 million as their part of the civil settlement.
Further actions taken against Novo Disk include setting up an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. The agreement will set up procedures and reviews to avoid and promptly detect conduct similar to this case.
Report Medicare fraud here.
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