Dec. 22, 2005 – Ending a three-year investigation into allegations of illegally marketing an osteoporosis drug, Eli Lilly and Company yesterday agreed to plead guilty to a misdemeanor and pay a $36 million fine to settle charges brought by the Department of Justice.
After sales of its post-menopause osteoporosis drug Evistra failed to garner the revenue expected, Eli Lilly began advertising the medicationâ€™s purported powers to prevent and reduce the risk of breast cancer, though the FDA had specifically rejected the claim, the Justice Department said in a statement announcing the deal. The company also developed plans to promote Evistra as able to reduce cardiovascular disease risk, again without FDA approval.
As part of the settlement, Eli Lilly agreed to a permanent injunction on marketing Evistra for such "off-label" purposes. Additionally, the company pledged to hire an outside consultant to assess and monitor its compliance with the deal.
The government settled both criminal and civil charges against Eli Lilly yesterday. The company will pay $12 million in criminal fines and an additional $24 million to rectify the civil suit.
In a statement, Eli Lilly disputed the civil sanction but said it agreed to pay it "in order to reach a final resolution." In offering an apology, the company noted that the charges did not allege unlawful intent.
"We deeply regret the 1998 conduct, which has resulted in a federal misdemeanor charge," Lilly CEO Sidney Taurel said. "We take seriously our responsibilities to abide by all the laws governing our business practices and are committed to ensuring our employeesâ€™ actions reflect the highest legal and ethical standards of conduct."
Off-label drug marketing is a common industry practice. Some 40 to 60 percent of all prescriptions written for unapproved uses, the San Francisco Chronicle reported earlier this year. The American Medical Association, which advocates for physiciansâ€™ authority, backs continued off-label prescribing. But in Senate testimony this past March, the AMA said it supports "post-marketing surveillance" and an increased collaboration between drug companies, the FDA and physicians to better communicate the risks and benefits of such uses.
While the FDA requires companies to seek approval prior to advertising new drug uses, direct marketing to physicians is not as regulated. Congress diluted protections against off-label prescriptions with the 1997 Food and Drug Administration Modernization Act, which permits companies to give information on off-label uses directly to doctors.