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Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million
Date:5/21/2010

BOSTON, May 21 /PRNewswire-USNewswire/ -- 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 epilepsy drug 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
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SOURCE U.S. Department of Justice
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