Eli Lilly pays record fine for illegal Zyprexa marketing practices
Eli Lilly has agreed with the US Justice Department to pay more than $1.4bn (Euro 1.1bn) to settle an investigation into alleged improper marketing of the anti-psychotic drug Zyprexa (olanzapine).
Eli Lilly has agreed with the US Justice Department to pay more than $1.4bn (Euro 1.1bn) to settle an investigation into alleged improper marketing of the anti-psychotic drug Zyprexa (olanzapine).
The company engaged in a nationwide campaign to market Zyprexa off-label for untested and unapproved uses and, as part of that campaign, the company minimised and misrepresented its dangers. It has been co-operating with the US government since the investigation started in 2004.
The US Food and Drug Administration (FDA) has approved Zyprexa for very limited conditions - schizophrenia and a specific type of bipolar disorder. It is not approved for patients under 18 years of age. Under FDA rules, prescription drug manufacturers and marketers may only promote their products for approved uses.
The company extolled Zyprexa's efficacy for non-indicated uses including Alzheimer's, depression and dementia.
Eli Lilly will pay $800m in civil penalties and plead guilty to criminal charges, paying an additional $600m fine.
"We deeply regret the past actions," said John Lechleiter, chairman and chief executive of Eli Lilly. "At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realise that we have a tremendous responsibility to the patients and healthcare professionals we serve."
Zyprexa is Lilly's top-selling drug with worldwide sales of nearly $40bn since its approval in 1996. It has been prescribed for an estimated 26 million patients worldwide.