Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products, the Justice Department announced.

According to the agreement reached with the government, the East Hanover, N.J.-based company will plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for the off-label promotion of Trileptal in violation of the Food, Drug and Cosmetic Act.

The Food and Drug Administration (FDA) approved Trileptal as an anti-epileptic drug, for the treatment of partial seizures, but not for any psychiatric, pain or other uses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as "unapproved" or "off-label" uses.

In addition to the criminal fine and forfeiture, Novartis has agreed to pay $237.5 million to resolve civil allegations under the False Claims Act that the company unlawfully marketed Trileptal and five other drugs, and thereby caused false claims to be submitted to government health care programs. Specifically, the civil settlement resolves allegations that Novartis illegally promoted Trileptal for a variety of uses, including psychiatric and pain uses, which were not medically accepted indications and therefore not covered by those programs.

In addition, the agreement resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Trileptal and five other drugs, Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The federal share of the civil settlement is $149,241,306, and the state Medicaid share of the civil settlement is $88,258,694.

"This resolution demonstrates the Department of Justice's ongoing dedication to taking action against pharmaceutical fraud in all its forms," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Unlawful off-label promotion and providing illegal inducements to health care professionals undermine the integrity of our health care system and we will continue to pursue these types of violations."

"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 Zane D. Memeger, U.S. Attorney for the Eastern District of Pennsylvania. "Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the Food and Drug Administration has deemed are safe and effective. That legal obligation takes priority over a company's bottom line.

The civil settlement resolves four lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. The four cases are: U.S. ex rel. Austin v. Novartis Pharmaceuticals Corporation; U.S. ex rel. McKee v. Novartis Pharmaceuticals Corporation; U.S. ex rel. Copeland v. Novartis Pharmaceuticals Corporation; and U.S. ex rel. Garrity v. Novartis Pharmaceuticals Corporation. As part of today's resolution, the whistleblowers, all former employees of Novartis, will receive payments totaling more than $25 million from the federal share of the civil recovery.

"This settlement represents a landmark victory in our district's continuing battle against health care fraud. We intend to bring to justice any pharmaceutical company that attempts to cloud physicians' medical judgment through kickback practices and illegal promotional activities," said A. Brian Albritton, U.S. Attorney for the Middle District of Florida.