Novartis Pharmaceuticals Corporation agreed to plead guilty for off-label marketing of the anti-epileptic drug Trileptal between July 2000 and December 2001. Novartis will pay a criminal fine of $185 million. The company is also paying $237.5 million to settle civil liabilities for off-label marketing of Trileptal and paying kickbacks to healthcare providers to induce them to prescribe Trileptal, as well as Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin.

Novartis marketed Trileptal, approved by the FDA for the treatment of epilepsy patients, for off-label uses including neuropathic pain and bipolar disease, targeting psychiatrists and pain specialists. They allegedly also funded continuing medical education programs given by medical professions to promote the drug’s off-label usage.  According to the government’s criminal information, Novartis earned hundreds of millions of dollars from this promotional campaign.

The settlement resolved four quitam actions filed by former Novartis employees. These whistleblowers will share in $25,675,053 of the federal recovery.

Novartis also signed a Corporate Integrity Agreement, a five-year oversight compliance program. Novartis will be subject to exclusion from Federal healthcare programs, including Medicare and Medicaid if they violate this agreement in any material way, as well as fines for less significant infractions.

Read the entire U.S. Department of Justice press release, “Novartis Pharmaceuticals Corporation to Pay $422.5 Million for Off-Label Drug Marketing.”