Eli Lilly and Co. has agreed to pay approximately $800 million for unapproved marketing and promotional claims regarding its antipsychotic drug Zyprexa.

 

The company pleaded guilty to one misdemeanor violation of the Food and Drug and Cosmetic Act for the off-label promotion of Zyprexa between September 1999 and March 2001. The case began in 2004 and was led by the US Attorney for the Eastern District of Pennsylvania.

 

The company promoted the drug for elderly populations as treatment for dementia, including Alzheimer’s dementia, although the drug is not approved for such uses.

 

Zyprexa was approved by the FDA for the treatment of schizophrenia in 1990, then for depressive episodes associated with bipolar disorder, as part of the Symbyax formulation, in 2003 and acute manic episodes and maintenance treatment in bipolar disorder in 2004.

 

John C. Lechleiter, PhD, chairman, president and chief executive officer of Lilly said, “We deeply regret the past actions covered by the misdemeanor plea. At Lilly we take seriously our responsibilities to abide all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve.”

 

Nearly $438 million will be paid to the federal government, while $362 million will be made available for payment to states participating in the settlement. This settlement was “the largest amount paid by a single defendant in the history of the US department of Justice, US Attorney General Michael Mukasey and Acting US Attorney for the Eastern District of Pennsylvania Laurie Magid said in a statement.

 

Also as part of the settlement, the company has entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services. This agreement is a commitment of the company to continually build on a foundation of compliance, accuracy, and transparency