Brandweek: Eli Lilly and Co. agreed to plead guilty to a federal misdemeanor charge that it illegally promoted its Evista osteoporosis medication for the treatment of breast cancer and cardiovascular risk reduction.
The company also agreed to a $36 million fine to settle the charge.
The investigation into the effort began in July 2002. The government alleged that in 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 U.S. Food and Drug Administration for either of these uses; Evista is approved in the U.S. for both the prevention and treatment of osteoporosis in post-menopausal women.
As part of the settlement, a civil consent decree will require Lilly to continue to have a compliance program and to undertake a set of defined corporate integrity obligations related to Evista for five years.
