The Food and Drug Administration approved Novo Nordisk's hemostasis management drug NovoSeven to treat certain bleeding disorders in hemophiliacs. After FDA approval, a manufacturer may not market or promote a drug for uses not specified in its new drug application or for uses not approved by the FDA. Unapproved uses are known as "off-label" uses.
Novo Nordisk's U.S. subsidiary, which is located in Princeton, N.J., allegedly 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.
False claims were submitted to government healthcare programs that were not reimbursable because of Novo Nordisk's unlawful promotion, it was alleged. The federal share of the civil settlement is $21,425,790.59. The state Medicaid share of the civil settlement is $3,574,209.41.
"Health care patients should be able to trust that their prescription drugs are safe, effective and prescribed only for FDA approved uses," Maine Attorney General William Schneider said. "These off-label promotions waste Maine taxpayer dollars and we will seek recovery from pharmaceutical companies for this kind of healthcare fraud."
The settlement resolves a a whistleblower lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act that is pending in the District of Maryland. Under terms of the resolution, the whistleblowers are set to receive more than $3.5 million from the federal share of the civil recovery.
Novo Nordisk also agreed to enter into an expansive corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services as part of the settlement. That agreement creates procedures and reviews meant to avoid and promptly detect similar conduct in the future.
