HARRISBURG – Pennsylvania will receive more than $2.6 million as part of a national settlement with the Swiss drug maker Novartis resolving allegations of improper marketing.
The joint federal and state investigation alleged that the company engaged in a pattern of unlawful marketing activity, including “off-label” marketing to promote and sell pharmaceutical drugs.
Off-label marketing involves promoting a drug for uses that have not been approved by the U.S. Food and Drug Administration (FDA). While it is not illegal for a physician to prescribe a drug for an unapproved use, federal law prohibits a manufacturer from promoting a drug for uses not approved by the FDA.
Investigators allege that Novartis Pharmaceuticals Corporation improperly promoted the drug Trileptal, a drug approved to treat partial seizures in patients with epilepsy. The company also allegedly engaged in unlawful kickback schemes to entice physicians to prescribe not only Trileptal, but Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.
Novartis will pay the states and federal government $237.5 million in damages and penalties for losses to the Medicaid and other federal health care programs. Pennsylvania will receive more than $2.6 million.
Novartis will also plead guilty to a misdemeanor charge of misbranding under the Food, Drug and Cosmetic Act and pay a $185 million fine.
As one of the conditions of the settlement, Novartis has entered into a Corporate Integrity Agreement with the United State Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
The investigation for Pennsylvania was handled by the Attorney General’s Medicaid Fraud Control Section.