Ortho-McNeil Admits Guilt in Illegally Marketing Topamax

Ortho-McNeil Pharmaceutical LLC, a unit of Johnson & Johnson, has pleaded guilty in federal court in Boston for promoting its epilepsy drug Topamax for uses which the FDA had not approved. The guilty plea is part of an $81 million settlement agreement reached with the federal government in April.
The FDA had approved Topamax for some epileptic seizures, the pharmaceutical company was guilty of promoting the drug for such off-label uses as bipolar disorder and alcohol dependence.
While doctors may prescribe a certain drug for off-label use, the drug company may not promote their drug for uses that have not been approved by the FDA.
With so many pharmaceutical companies paying multi-million dollar fines for off-label marketing, one has to wonder if the drug companies have decided that their risk/reward analysis makes them favor marketing campaigns that are against the law. It seems that the fines and penalties have not deterred the pharmaceutical companies from aggressively marketing their drugs for uses not approved by the FDA.