Eli Lilly writes biotech fine history
The American biotech company Eli Lilly will pay US 1.415 billion to resolve allegations of off-label promotion of a dementia drug.
This resolution includes a criminal fine of USD 515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a US criminal prosecution of any kind. Eli Lilly will also pay up to USD 800 million in a civil settlement with the federal government and the states.
Eli Lilly agreed to enter a global resolution with the US to resolve criminal and civil allegations that it promoted its antipsychotic drug Zyprexa for uses not approved by the FDA, the Department states. Such unapproved uses are also known as off-label uses because they are not included in the drug’s FDA approved product label.Eli Lilly, headquartered in Indianapolis, is charged in the information with promoting Zyprexa for such off-label or unapproved uses as treatment for dementia, including Alzheimer’s dementia, in elderly people.
The company has signed a plea agreement admitting its guilt to a misdemeanor criminal charge. Eli Lilly also signed a civil settlement to resolve civil claims that by marketing Zyprexa for unapproved uses, it caused false claims for payment to be submitted to federal insurance programs such as Medicaid, TRICARE and the Federal Employee Health Benefits Program, none of which provided coverage for such off-label uses.
The plea agreement provides that Eli Lilly will pay a criminal fine of USD 515 million and forfeit assets of USD 100 million. The civil settlement agreement provides that Eli Lilly will pay up to an additional USD 800 million to the federal government and the states to resolve civil allegations originally brought in four separate lawsuits under the qui tam provisions of the federal False Claims Act.
