Eli Lilly and Company, the Department of Justice's Office of Consumer Litigation and the US Attorney's Office for the Southern District of Indiana have reached a settlement of the previously reported government investigation into Lilly's Evista marketing and promotional practices. As part of the settlement, Lilly has agreed to plead guilty to one misdemeanour violation of the Food, Drug, and Cosmetic Act and agreed to pay a total of $36 million in connection with the overall settlement.
The plea is for the off-label promotion of Evista during 1998. The government has not, however, charged the company with any unlawful intent, nor does Lilly acknowledge any such intent. The settlement is subject to approval by the federal court in Indianapolis; the company anticipates a hearing on the settlement will occur within the next few weeks.
This investigation commenced in July 2002 and has resulted in the government alleging that, during 1998, certain Lilly employees promoted Evista for the prevention and reduction in the risk of breast cancer and cardiovascular risk reduction. The product is not approved by the US Food and Drug Administration for either of these uses, although both uses are the subject of large, multi-year registration clinical trials that began in the late 1990s. Evista is approved in the US for both the prevention and treatment of osteoporosis in post-menopausal women, claims company release.
"We deeply regret the 1998 conduct, which has resulted in a federal misdemeanour charge. We take seriously our responsibilities to abide by all the laws governing our business practices and are committed to ensuring our employees' actions reflect the highest legal and ethical standards of conduct. Although the government has not charged Lilly with any unlawful intent, we will continue to take steps designed to assure that Lilly's promotional activities remain fully compliant," said Sidney Taurel, chairman and chief executive officer for Lilly.
In addition to the misdemeanour charge, the government has filed a civil complaint alleging similar Evista-related conduct continued into 2000. The company disagrees and has not admitted to these allegations. However, the company has agreed to settle the dispute over these allegations in order to reach a final resolution of this investigation.
As previously reported, Lilly took a charge in the fourth quarter of 2004 in connection with this investigation. The 2004 charge was sufficient to cover this settlement payment; consequently, no further charge will be taken by the company.
In addition, as part of the settlement, a civil consent decree will require Lilly to continue to have a compliance programme and to undertake a set of defined corporate integrity obligations related to Evista for five years. Lilly has implemented and continues to review and enhance a broadly based compliance programme that includes comprehensive compliance-related activities designed to ensure that its marketing and promotional practices comply with promotional laws and regulations.
In a separate investigation previously disclosed by the company, the US Attorney's Office for the Eastern District of Pennsylvania informed Lilly that a whistleblower action under the civil False Claims Act has been filed in that District, alleging that the company engaged in certain unlawful marketing practices related to Evista.