Eli Lilly Fined $1.42 billion for Off-label Promotion of Zyprexa (Olanzapine)

Eli Lilly, a top US drugmaker, is fined $1.42 billion for off-label promotion of Zyprexa (olanzapine), ending a five-year federal investigation. Here’s a breakdown of where the money is going:

  • Criminal fine: $515 million (largest criminal fine in the US!)
  • Civil settlement (no admission of wrongdoing): $800 million (roughly half to the federal government and the rest to the states) + $100 million in assets

This is in addition to the $1.2 billion Eli Lilly paid to settle ~20,000 lawsuits claiming it down-played the side-effect of weight gain and that Zyprexa led to development of diabetes and other diseases. 

Zyprexa, first approved (by the FDA) in 1996, is FDA-approved for the treatment of schizophrenia and bipolar disorder, but was marketed for the treatment of dementia, Alzheimer’s disease, and depression.  Zyprexa is Lilly’s most profitable drug, accounting for worldwide sales of nearly $40 billion (since 1996) and $4.8 billion in 2007.

Off-label uses are legal and provide much-needed relief or treatment of rare or overlooked (by the drugmakers) diseases, but this fine illustrates that this is a drugmaker gone too far!  Thoughts?  Leave comments.  Thanks.