DENVER — Colorado Attorney General John Suthers announced today that Colorado has received $776,510 as part of two settlements with Novartis Pharmaceutical Corporation to settle allegations of off-label marketing.
Under the first settlement, Colorado will receive $580,800 as its share of a $422.5 million settlement between Novartis, the federal government and the states. This settlement resolves allegations that the company engaged in an off-label marketing campaign that improperly promoted the anti-convulsant drug Trileptal and engaged in a kickback scheme to promote Trileptal and five other drugs.
The $422.5 million global settlement resolves four federal whistleblower lawsuits and claims from the states and the federal government. The settlement accounts for fines, damages and penalties to compensate Medicaid and other federal programs that suffered as a result of the company’s conduct. Novartis will also enter a guilty plea to a misdemeanor federal charge of misbranding under the federal Food, Drug and Cosmetic Act, 21 USC 331(a) and 333(a).
Trileptal (oxcarbazepine) is an anti-epileptic drug that has U.S. Food and Drug Administration approval for certain uses including the treatment of partial seizures in patients with epilepsy. According to the government’s allegations, Novartis promoted the sale and use of Trileptal for unapproved conditions including bipolar disorder and neuropathic pain. It generally is not illegal for doctors to prescribe drugs for off-label uses, but it is illegal for drug manufacturers to market drugs for non-FDA-approved uses. State Medicaid programs generally do not pay for drugs prescribed for off-label purposes.
The settlement also resolves allegations that Novartis paid illegal kickbacks to health professionals by supporting various activities to induce them to promote Trileptal as well as the drugs Diovan, Zelnorm, Sandostatin, Tekturna and Exforge. The activities included speaker programs, advisory boards and gifts such as travel, entertainment and meals.
The state of Colorado also has received $195,710 as part of a second settlement with Novartis concerning the off-label marketing of the drug tobraymycin (brand name TOBI). The drug, an inhaled antibiotic approved to treat some conditions suffered by cystic fibrosis patients, was marketed for off-label uses such as uses for non-cystic fibrosis patients. Colorado’s $195,710 share is part of a $72 million settlement Novartis has agreed to pay the federal government and other state governments.
The Colorado Attorney General’s Medicaid Fraud Control Unit facilitated Colorado’s share of the settlements. In addition to the monetary recoveries, Novartis will enter into a Corporate Integrity Agreement with the federal government, under which the U.S. Department of Health and Human Services will closely monitor the company’s future marketing and sales practices.