Lilly settles Evista marketing caseEli Lilly agreed to plead guilty to a misdemeanor and pay a $36 million fine in connection with off-label promotion of osteoporosis drug Evista (raloxifene).
The plea is for one misdemeanor violation of the Food, Drug, and Cosmetic Act occurring in 1998, when it promoted Evista for use in preventing breast cancer and reducing cardiovascular risk. The drug is not approved for either indication.
"We deeply regret the 1998 conduct," Lilly Chief Executive Sidney Taurel said in a statement. "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."
A civil complaint the firm also settled alleges similar conduct continued into 2000. Lilly disagrees with the allegation.
The $36 million settlement includes a $6 million criminal fine, a forfeiture to the government of $6 million and payment of $24 million to settle the civil action.
Lilly said it took a charge in the fourth quarter sufficient to cover the settlement payment.
Information in the case, details of which were released today by the Justice Department, alleges that Lilly engaged in a number of tactics to "broaden the market for Evista," including training sales reps to "prompt or bait" questions by doctors to promote the drug for off-label uses during sales pitches, sending "unsolicited medical letters" for such uses to doctors and creating and distributing a videotape to reps during which a Lilly sales person stated that Evista is "the best drug for prevention" of diseases such as osteoporosis, breast cancer and cardiovascular disease.
A group of people associated with sales and promotion for Evista in 1998 "perhaps were a bit aggressive in their tactics," Lilly spokesman Phil Belt told MM&M.
The case, brought in the Southern District of Indiana, involved close coordination between the FDA Office of Criminal Investigations and the Justice Department.
The settlement must be approved by an Indianapolis federal court, and Lilly said it expects a hearing "within the next few weeks."