US drug company guilty of promoting drug inappropriately

American pharmaceutical giant Eli Lilly and Company has agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the US Department of Justice has announced.

This resolution includes a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind.

Eli Lilly will also pay up to $800 million in a civil settlement with the federal government and the states.

Eli Lilly agreed to enter a global resolution with the United States to resolve criminal and civil allegations that it promoted its antipsychotic drug Zyprexa for uses not approved by the FDA, including treatment for dementia, as well as Alzheimer’s dementia, in elderly people the Department said. Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label.

The FDA originally approved Zyprexa, also known by the chemical name olanzapine, for the treatment of manifestations of psychotic disorders, short-term treatment of acute manic episodes associated with Bipolar I Disorder, short term treatment of schizophrenia in place of the management of the manifestations of psychotic disorders.  Zyprexa has never been approved for the treatment of dementia or Alzheimer’s dementia.

The criminal information, filed in the Eastern District of Pennsylvania, alleges that from September 1999 through to at least November 2003, Eli Lilly promoted Zyprexa for the treatment of agitation, aggression, hostility, dementia, Alzheimer’s dementia, depression and generalised sleep disorder.

The information alleges that Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses.

The information alleges that beginning in 1999, Eli Lilly expended significant resources to promote Zyprexa in nursing homes and assisted-living facilities, primarily through its long-term care sales force. Eli Lilly sought to convince doctors to prescribe Zyprexa to treat patients with disorders such as dementia, Alzheimer’s dementia, depression, anxiety, and sleep problems.

“This case should serve as still another warning to all those who break the law in order to improve their profits,” said Patrick Doyle, Special Agent-in-Charge of the Office of Inspector General (OIG) for the Department of Health and Human Services in Philadelphia.  “OIG, working with our law enforcement partners, will pursue and bring to justice those who would steal from vulnerable beneficiaries and the taxpayers.”