Lilly Resolves Investigation of Marketing and Promotional Practices

January 22, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Eli Lilly and Company has reached resolution regarding its previously reported government investigation into the company's US marketing and promotional practices for "Zyrexa" (olanzapine), an antipsychotic drug, thereby ending a government investigation started in 2004.

Indianapolis, IN (Jan. 15)-Eli Lilly and Company resolved the previously reported government investigation into the company’s US marketing and promotional practices for “Zyprexa” (olanzapine), an antipsychotic drug. The resolution ends a government investigation that began in 2004. As part of the resolution, the company pleaded guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act. Resolution was reached with the US Attorney for the Eastern District of Pennsylvania (EDPA) and the Department of Justice's Office of Consumer Litigation.

The misdemeanor plea is for the off-label promotion of Zyprexa between September 1999 and March 2001. Under the terms of the resolution, Lilly agreed to make payments totaling nearly $800 million. Approximately $438 million will be paid to the federal government and approximately $362 million will be made available for payment to settling states.

As part of the settlement, Lilly entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services. This agreement will require the company to maintain its compliance program and to undertake a set of defined corporate integrity obligations for five years.