The Department of Justice says Zyprexa marketers violated federal rules.
The Department of Justice says Eli Lilly will pay the largest criminal fine ever imposed on an individual corporation in the history of US prosecution.
The $1.4 billion settlement ends a massive investigation into the promotional practices for Lilly’s antipsychotic drug Zyprexa.
US Attorney Laurie Magid says Lilly urged primary care and nursing home doctors to prescribe Zyprexa for common conditions including sleep disorders and dementia, not approved by the Food and Drug Administration.
Magid: And not just directed at the relatively small number of people in the community that suffer from schizophrenia or bipolar disorder.
Magid says company executives were worried about money and looking for the next big seller to treat a wide group of patients.
She says the pharmaceutical giant violated federal law and continued its marketing practices in the face of warnings that the drug should not be prescribed to elderly patients for dementia.
Magid: Off-label promotion is a serious matter, it can lull physicians into thinking that a drug has been approved by the FDA as safe and effective.
Magid says off-label marketing undermines the Food and Drug Administration approval process designed to protect the public.
Six whistleblowers will share in a portion of the Lilly fine, and hundreds of millions of dollars will be returned to the Medicaid program.