Johnson & Johnson subsids to pay $81.5 million over off-label promo of Topamax, and Solvay unit agrees $22 million settlement on Deponit and Hyoscyami

US drugmakers Ortho-McNeil Pharmaceutical and its parent Ortho-McNeil-Janssen Pharmaceuticals, both subsidiaries of Johnson & Johnson, have agreed to pay a total of $81.5 million to resolve criminal and civil liability arising from the illegal promotion of Topamax (topiramate), an antiepileptic and migraine prevention prescription medicine, the US Justice Department announced yesterday.

According to the accord reached with the government, Ortho-McNeil has agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, but not for any psychiatric use, which thus an "unapproved" or "off-label use."

The government alleged that Ortho-McNeil promoted the sale of Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Using this program, the company hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses.