BOSTON, Feb. 28 (UPI) -- A U.S. subsidiary of Irish drug maker Elan Corp. will pay $203 million in criminal and civil penalties for the way it promoted its epilepsy medication Zonegran.
Elan Pharmaceuticals Inc. pleaded guilty in federal court in Boston to a misdemeanor violation of the Food, Drug and Cosmetic Act, the U.S. Justice Department said in a release. Elan was sentenced to pay a criminal fine of $97 million and forfeit $3.6 million in assets, and the company agreed to pay $102 million to settle civil allegations under the False Claims Act.
Federal authorities contended Elan illegally promoted Zonegran for a variety of uses that were not medically accepted and not covered by government healthcare programs that received the claims.
Elan promoted the sale of Zonegran for a wide variety of off-label uses, including psychiatric disorders such as mania and bipolar disorder, migraine and chronic daily headaches, and eating disorders.
The whistle-blower in the case will receive $10 million from the civil settlement, the Justice Department said.
"Elan deliberately chose to prioritize profit over its obligation to the FDA and consumers," Carmen Ortiz, the U.S. attorney for Massachusetts, said. "Today's plea and sentencing should serve as a reminder to any company engaging in off-label marketing schemes, that the government is continuing to aggressively investigate and prosecute companies who intentionally put patient safety at risk in order to turn a profit."
