"Off-label marketing can undermine the doctor-patient relationship and adversely
influence the clear judgment that a doctor's patients have come to rely on and trust," said David Memeger, U.S. Attorney for the Eastern District of Pennsylvania, which led the federal probe.
"Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the FDA has deemed are safe and effective. That legal obligation takes priority over a company's bottom line."
In the civil agreement, Novartis will pay the federal government and participating states $237.5 million, plus interest, to settle invalid claims for payment for Trileptal and the other drugs that were submitted to Medicare, Medicaid, and other government-sponsored healthcare programs. State Medicaid programs will share $88.2 million of the settlement.
Novartis President for North America Andy Wyss said the U.S. subsidiary of Switzerland's Novartis International AG was "pleased" with the resolution. "(Novartis) will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products," Wyss said. "Our goal is to ensure that patients receive the medicines they need and we will continue to work with the government and other organizations to improve healthcare for all Americans."
The civil cases were filed by former Novartis employees who will split $25.6 million from the settlement, under federal whistleblower statutes. Novartis also entered into a five-year corporate integrity agreement with Health and Human Services' Office of Inspector General.