Topamax Manufacturer Fined $6M By FDA For Illegal Promotion of Topriamate

Topamax is an antiseizure medication manufactured by Ortho-MacNeil Pharmaceutical, a Johnson & Johnson subsidiary. Recently, Ortho-MacNeil pleaded guilty to misdemeanor violation of the Food, Drug & Cosmetic Act, and was fined more than $6,000,000.00 for its misconduct. An Ortho-MacNeil affiliate, Ortho-MacNeil-Janssen Pharmaceuticals, Inc., will also pay more than $75,000,000.00 to resolve civil allegations under the False Claims Act for improper Topamax promotion.

According to an FDA press release entitled “Ortho-MacNeil Pharmaceutical LLC Pleads Guilty To Illegal Promotion of Topamax and Is Sentenced To Criminal Fine of $6.14 Million,” Ortho-MacNeil marketed Topamax for psychiatric uses for which it was not FDA-approved.