Two Johnson and Johnson subsidiaries agreed to pay more than $81 million to resolve allegations of illegal promotion of the epilepsy drug Topamax, the U.S. Justice Department said on Thursday.
It said one unit, Ortho-McNeil Pharmaceutical LLC, agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for misbranding Topamax in violation of the Food, Drug and Cosmetic Act.
The other unit, Ortho-McNeil-Janssen Pharmaceuticals, will pay more than $75 million to resolve civil allegations under the False Claims Act it illegally promoted Topamax and caused false claims to be submitted to government health care programs, the department said.
The Food and Drug Administration had approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, the department said. The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for unapproved psychiatric uses.
The company said the promotional program at issue occurred between 2001 and 2003.
Ortho-McNeil-Janssen Pharmaceuticals said it has been cooperating with the federal government since its investigation began in December 2003.
Ortho-McNeil Pharmaceutical said it voluntarily discontinued the program before receiving the government's first subpoena in the investigation.
(Reporting by James Vicini; editing by Andre Grenon and Robert MacMillan)