Two subsidiaries of pharmaceutical giant Johnson & Johnson have agreed to pay more than $81 million stemming from allegedly illegal promotion of the epilepsy drug Topamax for psychiatric uses, the Justice Department announced Thursday.
Federal drug regulators approved it as an anti-epileptic drug and for prevention of migraines.
The government says Ortho-McNeil-Janssen Pharmaceuticals Inc. will pay over $75 million for alleged illegal promotion of Topamax for a variety of psychiatric uses.
Ortho-McNeil Pharmaceutical LLC, a subsidiary of OMJPI, has agreed to plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a $6.1 million criminal fine.
In a statement, Ortho-McNeil-Janssen Pharmaceuticals Inc. said it has been cooperating with the government since its investigation began in December 2003.
OMJPI denies it engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical LLC in connection with the misdemeanor plea, the company added.
The government says that Ortho-McNeil Pharmaceutical promoted Topamax sales for unapproved psychiatric uses under a program called "Doctor-for-a-Day." Under it, Ortho-McNeil hired outside physicians who joined sales representatives in visits to health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses.
Associated Press Business Writer Linda A. Johnson contributed to this report from Trenton, N.J.