Eli Lilly To Pay $36M To Settle Allegations of Improper Marketing of Osteoporosis Drug Evista
Eli Lilly officials on Wednesday announced an agreement to plead guilty to a federal misdemeanor and pay $36 million to settle allegations that the company illegally marketed the osteoporosis medication Evista for two uses not approved by FDA, the AP/Washington Post reports. Under federal law, physicians can write prescriptions for medications for uses not approved by FDA, but pharmaceutical companies cannot market treatments for unapproved uses (Callahan, AP/Washington Post, 12/21). FDA has approved Evista for the treatment of osteoporosis in women after menopause (Adams, Knight Ridder/Miami Herald, 12/21). According to the Department of Justice, a three-year investigation found that Lilly marketed Evista for the prevention of and reduction of risk for breast cancer and for the reduction of risk for heart disease. DOJ said that Lilly sales representatives sent unsolicited letters to physicians to promote unapproved uses of Evista. In addition, Lilly produced a videotape for sales representatives in which the company claimed Evista was "the best drug" for the prevention of osteoporosis, breast cancer and heart disease, according to DOJ. Lilly sales representatives also distributed to physicians copies of a medical study in which Evista was used to treat breast cancer, but the company told the representatives "to hide the disclosure page of the reprint which noted ... 'the effectiveness of (Evista) in reducing the risk of breast cancer has not yet been established.'" A Lilly ad in Prevention Magazine also said that Evista "lowers cholesterol (and) addresses concerns about breast cancer," DOJ said (Swiatek, Indianapolis Star, 12/22).
Settlement Details
The settlement includes a permanent injunction and a consent decree under which Lilly agreed not to engage in illegal marketing and promotional practices. In addition, Lilly must pay a $6 million criminal fine, a $6 million forfeiture to the federal government and $24 million to settle a DOJ civil action lawsuit (AP/Washington Post, 12/21). The settlement will not lower future earnings for Lilly because the company anticipated the settlement and included the $36 million cost in earnings results for the fourth quarter of 2004 (Indianapolis Star, 12/22). The settlement requires approval by a federal judge in Indianapolis.
Comments
Lilly Chair and CEO Sidney Taurel said in a statement that the company will "continue to take steps designed to assure that Lilly's promotional activities remain fully compliant." Acting FDA Commissioner Andrew von Eschenbach said, "These fines and the permanent injunction demonstrate that there is as strong system in place for ensuring that pharmaceutical companies fully comply with all aspects of the drug approval process." Don Woodley, a principal with Woodley Farra Manion Portfolio Management, said, "This settlement is very reasonable and affordable. It's chump change for a company of Lilly's size" (AP/Washington Post, 12/21).
