Corporate Compliance

Pharmaceutical manufacturer pays $25 million to resolve off-label marketing charges

Compliance Monitor, June 15, 2011

Novo Nordisk Inc., a Danish pharmaceutical manufacturer, agreed to pay $25 million to resolve charges that it illegally promoted its hemostasis management drug, NovoSeven, according to a Department of Justice press release

The Food and Drug Administration approved NovoSeven to treat certain bleeding disorders in hemophiliacs; however, the U.S. subsidiary promoted NovoSeven to healthcare professionals for off-label uses, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants, and intra-cerebral hemorrhage. 

The off-label promotion of NovoSeven caused Novo to submit false claims to government healthcare programs. Medicare and Medicaid paid for off-label prescriptions as a result of Novo’s focused campaign to influence doctors and hospitals.

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