Ortho-McNeil Pharmaceutical LLC, a division of Johnson & Johnson, has plead guilty to charges that it illegally promoted off-label uses for the epilepsy drug, Topamax, and agreed to pay a $6.1 million fine. The company admitted it paid doctors thousands of dollars to travel with salespersons to psychiatrist offices, to promote Topamax for uses that were not approved by the FDA as safe and effective. The criminal fine was part of a Topamax settlement agreement reached by the drug maker and an affiliate, Ortho-McNeil-Janssen Pharmaceuticals, Inc., with the Department of Justice earlier this month. Janssen has reached a civil settlement that will require it to pay $75.37 million to resolve whistleblower lawsuits that brought the “Doctor for a Day” program to light.The allegations were revealed by two individuals filed qui tam lawsuits under the False Claims Act. As a result of the settlement, whistleblower compensation of more than $9 million will be paid to the individuals who brought the suits.Although Topamax was only approved for treatment of epilepsy and preventing headaches, the medication was promoted for unapproved psychiatric uses. The drug makers had outside physicians join sales representatives when they visited health care providers and spoke at meetings and dinners about prescribing Topamax for psychiatric uses that were not approved by the FDA.
Topamax (topiramate) generated more than $2 billion in annual sales for Johnson & Johnson before a generic version became available last year.