• Reuters, Friday, October 1, 2010 8:05 AM

Novartis is settling criminal and civil charges that it improperly marketed its epilepsy drug Trileptal for unapproved uses -- including for pain and conditions such as bi-polar disorder -- by pleading guilty and paying a total of $422.5 million, Jon Hurdle and Bill Berkrot report. Novartis must also post information about any payments made to doctors on its website.

Doctors can prescribe medicines for any purpose they deem fit but pharmaceutical companies can only promote them for uses approved by the U.S. Food and Drug administration. "That legal duty takes priority over generating profits," says Zane Memeger, the U.S. attorney for the Eastern District of Pennsylvania. "This prosecution demonstrates our continuing commitment to ensure that pharmaceutical companies comply with the law."

The off-label marketing, which took place between July 2000 and December 2001, generated "hundreds of millions of dollars," for the Swiss company, according to Memeger. The civil settlement also resolves claims that Novartis paid illegal kickbacks to healthcare professionals to induce them to prescribe Trileptal and five other drugs: Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

Read the whole story at Reuters »