Another European pharma company settles off-label allegations

by Ben Vernia | June 10th, 2011

On June 10, the Department of Justice announced that the Danish company, Novo Nordisk, will pay $25 million to settle allegations that it promoted a drug off-label. This follows an announcement earlier this week of a settlement with UCB, of Belgium. According to DOJ’s press release:

Novo Nordisk Inc., a Danish pharmaceutical manufacturer, has agreed to pay $25 million to resolve its civil liability arising from the illegal promotion of its hemostasis management drug, NovoSeven, the Justice Department announced today. The Food and Drug Administration (FDA) approved NovoSeven to treat certain bleeding disorders in hemophiliacs. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in its new drug application and approved by the FDA. Such unapproved uses are also known as “off-label” uses.

The U.S. subsidiary, Novo Nordisk Inc., which is located in Princeton, N.J., promoted NovoSeven to health care 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. As a result of this unlawful promotion, Novo Nordisk caused false claims to be submitted to government health care programs that were not reimbursable by those programs. Medicare and Medicaid paid for off-label prescriptions throughout the United States as a result of Novo’s focused campaign to influence doctors and hospitals. The federal share of the civil settlement is $21,425,790.59, and the state Medicaid share of the civil settlement is $3,574,209.41.

The case was originally brought as a qui tam suit in Maryland by two whistleblowers, who will receive $3.5 million of the federal portion of the settlement (a 16.3% share).

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