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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.
On Monday, in U.S. District Court in Boston, the drug maker admitted that it used its “Doctor for a Day” program, paying 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. In addition to the fine, the company agreed to sign a corporate responsibility agreement which is supposed to restrict them from future wrongdoing.
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 brought to the federal government’s attention after 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. Side effects of Topamax have been linked to an increased risk of suicide and suicidal thoughts, which has been added to a black box warning for the medication and other epilepsy drugs. Research has also linked the use of the drug during pregnancy to a risk of Topamax birth defects, such as cleft lips, cleft palates, genital defects and other birth malformations.