Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.
U.S. Attorney Carmen M. Ortiz and Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, announced today that Ortho-McNeil was sentenced by U.S. Magistrate-Judge Robert B. Collings to pay a criminal fine of $6.14 million.
At the plea hearing, the prosecutor told the court that had the case proceeded to trial, the government's evidence would have proven that Ortho-McNeil used a promotional program called the "Doctor for a Day Program" as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the U.S. Food & Drug Administration (FDA). Through the "Doctor for a Day Program," Ortho-McNeil paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists. On these sales calls, through the Doctor for a Day, Ortho-McNeil promoted Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses. However, Ortho-McNeil had never applied to the FDA for any approval for Topamax to treat any psychiatric disorders and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions.
"This case should send a strong reminder that the off-label promotion of pharmaceuticals is illegal, whether it is done directly by company employees, or through programs such as the 'Doctor For A Day Program,'" said U.S. Attorney Carmen M. Ortiz. "We will remain vigilant in our enforcement of these laws regardless of what form the conduct takes," Ortiz concluded.
An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc. will also pay $75.37 million to resolve civil allegations under the False Claims Act that it illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. Also as part of the settlement, Ortho-McNeil-Janssen Pharmaceuticals entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.
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