Eli Lilly pleaded guilty to violating U.S. law in its marketing of anti-psychotic drug Zyprexa and will pay $1.42 billion to settle criminal and civil allegations, officials said on Jan. 15.
Eli Lilly said it had entered a misdemeanor plea for violation of federal law in its off-label promotion of Zyprexa between September 1999 and March 2001 and agreed to pay $615 million.
The Justice Department said the criminal fine of $515 million was the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a U.S. criminal prosecution of any kind. Lilly also agreed to forfeit $100 million in the settlement.
Officials said so-called "off label" use of drugs was a serious legal issue. "Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA's role in protecting the American public by determining that a drug is safe and effective for a particular use before it is marketed," said Gregory Katsas, assistant attorney general.
The company said it had admitted in its plea that it had promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer's dementia, "although Zyprexa is not approved for such uses."
The company did not admit the alleged wrongdoing in the civil allegations.
Copyright Agence France-Presse, 2009