Novartis Pharmaceuticals Corp. will plead guilty and pay criminal and civil fines totaling $422.5 million to resolve whistleblower claims that it used off-label marketing and paid kickbacks to doctors to illegally promote the antiepileptic Trileptal and five other drugs, federal prosecutors said Thursday.
The Food and Drug Administration approved Trileptal for the treatment of epilepsy, but federal prosecutors said Novartis created marketing materials promoting the drug for off-label uses, including neuropathic pain and bipolar disease, which were not FDA-approved. Novartis allegedly targeted psychiatrists and pain specialists, who used anti-epileptic drugs like Trileptal off-label. The other drugs that were allegedly illegally promoted were Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin.
Prosecutors allege that Novartis marketed and promoted Trileptal as a treatment for bipolar disease and neuropathic pain and told its sales representatives to visit doctors who would not normally prescribe Trileptal due to the nature of their practices. Novartis also allegedly funded continuing medical education programs that used medical professionals to promote off-label uses of Trileptal.
Prosecutors said Novartis made hundreds of millions of dollars in profits from the misbranding and off-label promotions. The criminal fines and forfeitures total about $185 million.