US drug giant Eli Lilly has settled the previously-reported government investigation into its marketing and promotional practices for the osteoporosis drug Evista (raloxifene), under which it has pleaded guilty to a misdemeanour violation of the Food, Drug, and Cosmetic Act for the agent’s off-label promotion during 1998.
The investigation kicked off in July 2002, and lead to charges that Evista was actively promoted by Lilly employees in 1998 to cut the risk of breast cancer and developing certain heart conditions, thereby going against the rule which forbids active promotion of drugs for uses other than those for which they are approved.
Lilly has agreed to pay $36 million under the settlement, but noted that, as it took a charge in the fourth quarter of last year to cover any settlement, which was enough to cover the final agreement, it will take no further charges related this incident.
Sidney Taurel, Chairman and Chief Executive Officer of the firm, commented: “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.”