Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, has pleaded guilty in a US District Court for promoting unapproved uses of its epilepsy drug Topamax.
The company was found guilty of violating the Food, Drug & Cosmetic Act and has been ordered to pay a criminal fine of $6.14m.
The company used its ‘Doctor for a Day Program’ as a tool to promote Topamax for psychological uses which had never been approved by the US Food and Drug Administration.
Ortho-McNeil paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists.
An Ortho-McNeil affiliate, Ortho-McNeil-Janssen Pharmaceuticals, will also pay $75.37m for illegally promoting Topamax and causing false claims to be submitted to government health care programmes for a variety of uncovered psychiatric uses.
