Novartis will pay a $185 million fine for promoting off-label uses of the antiepilepsy drug oxcarbazepine (Trileptal) and another $237.5 million in civil penalties to settle a suit involving Trileptal and five other drugs, the Department of Justice announced.
The criminal case, brought by the U.S. Attorney's Office for the Eastern District of Pennsylvania, charged the company with promoting use of Trileptal for neuropathic pain and bipolar disease and for targeting marketing efforts -- including funding CME activities -- at physicians who do not typically prescribe antiepileptics.
The civil case, brought by the federal government and several states, alleged not only promotion of off-label uses of Trileptal, but also that Novartis paid illegal kickbacks to induce physicians to prescribe that drug as well as valsartan (Diovan), the amlodipine/valsartan combination (Exforge), octreotide (Sandostatin), aliskiren (Tekturna), and tegaserod (Zelnorm).
The company admitted guilt to only the single charge pertaining to Trileptal, a statement from Novartis said.
The action against Novartis is another in a line of recent Justice Department cases against drug companies over off-label promotion.
The civil suit also alleged that Novartis "caused invalid claims for payment" for the six drugs to be submitted to government program such as Medicare and Medicaid, a Justice Department statement said.
As part of the plea agreement, Novartis signed a corporate integrity agreement with the Department of Health and Human Services that promises the company will undergo annual third-party compliance review, will issue a letter to healthcare professionals notifying them of the settlement, and will provide information on its website about future payments -- such as honoraria or travel expenses -- made to physicians.
Serious breach of that agreement could result in exclusion of the company from Federal healthcare programs, the Justice Department statement said.
The charges were first filed in 2005.