Eli Lilly to pay more than $800 million for off-label promotion of Zyprexa

Eli Lilly and Co. has agreed to plead guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act and will pay more approximately $800 million for unproven marketing and promotional claims involving the antipsychotic medication Zyprexa.

Lilly, which has been cooperating with the government in its investigation since it began in 2004, recently announced that it reached resolution with the U.S. Attorney for the Eastern District of Pennsylvania and the Office of Consumer Litigation of the Department of Justice. In addition to pleading guilty, the company will enter into a settlement agreement, resolving the federal government's civil investigation.

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

The misdemeanor plea is for the off-label promotion of Zyprexa between September 1999 and March 2001. Specifically, the plea states Lilly promoted Zyprexa for elderly populations as treatment for dementia, including Alzheimer's dementia, although the drug is not approved for such uses. Under the settlement terms, Lilly agreed to pay nearly $800 million.

Approximately $438 million will be paid to the federal government and approximately $362 million will be made available for payment to states participating in the settlement. Also, as part of the settlement, Lilly has entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

This agreement will require Lilly to maintain its compliance program and to undertake a set of defined corporate integrity obligations for five years. They also provide for an independent third-party review organization to assess and report on the company's systems, processes, policies, procedures, and practices.

This agreement reflects Lilly's commitment to continually build on a foundation of compliance, accuracy, and transparency, the company said.

The settlement is subject to approval by the federal court in Philadelphia; the company expects a hearing on the settlement to occur within the next few weeks.