Ortho-McNeil, a unit of Johnson and Johnson, entered a guilty plea on Tuesday in the U.S. District Court for the District of Massachusetts to a misdemeanor for alleged illegal promoting of Topamax, a drug designed to treat epilepsy, for uses not approved by the Food and Drug Administration, according to PR Newswire. The government alleged that Ortho-McNeil used a promotional program called the “Doctor for a Day Program” to promote Topamax for psychiatric uses, allegedly paying physicians, including psychiatrists, to accompany sales representatives on sales calls. The government claimed that Ortho-McNeil never applied for approval to use Topamax to treat psychiatric conditions and that there were no reliable clinical trials demonstrating that Topamax is safe and effective to treat psychiatric conditons.
The Court imposed a $6.14 million criminal fine on Ortho-McNeil. An affiliate of Ortho-McNeil, Janssen Pharmaceuticals, has agreed to pay $75 million to settle claims under the False Claims Act that it illegally promoted Topamax for psychiatric purposes and submitted alleged false claims to Medicare. Ortho-McNeil and Jassen also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.
“Promotion” of drugs by manufacturers for off-label uses is prohibited by the Food Drug and Cosmetic Act, 21 U.S.C. 331, 333. Physicians can, and frequently do, prescribe drugs for unapproved uses. In addition to epilepsy, Topamax has been prescribed for uses such as the treatment of headaches and for weight loss.