Elan Pharmaceuticals Pleads Guilty to Off-Label Marketing

Fined $97 million

Elan Pharmaceuticals Inc. (EPI), a subsidiary of the Irish pharmaceutical manufacturer Elan Corp. PLC, pleaded guilty last week to a misdemeanor violation of the Food, Drug and Cosmetic Act for the illegal promotion of the epilepsy drug Zonegran.

Elan was also sentenced to pay a criminal fine of $97 million and forfeit $3.6 million in substituted assets.

In addition to the criminal plea, Elan has agreed to pay $102 million to resolve civil allegations under the False Claims Act. Those allegations stem from the companys illegal promotion of Zonegran for a variety of uses that were not medically accepted and therefore not covered by the government healthcare programs that received the claims.

According to the government's evidence, in April 2000, the FDA approved Zonegran only as an adjunctive therapy for the treatment of partial seizures in epilepsy for adults over the age of 16, and not for any other uses.

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