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Drug giant Eli Lilly and Co., manufacturer of such blockbuster drugs as Prozac and Zyprexa have pled guilty to a misdemeanor charge as a part of a legal settlement with the US government. The US charged that Eli Lilly had been marketing its drug Evista for off-label purposes.
Off-label use of a drug means that the FDA has not approved a drug for that use. While the practice of using drugs in an off-label manner is legal, marketing by a drug company for that specific off-label use is illegal.
Evista is currently FDA-approved to treat symptoms related to osteoporosis in post-menopausal women. The violations occurred when Eli Lilly began marketing Evista to prevent or reduce the chance of breast cancer and heart problems. Because the drug has not been extensively tested or approved for those uses, the company is in a serious violation of drug laws.
Eli Lilly will pay $36 million in fines to the government as a result of the inquiry. In addition, Eli Lilly will also remain in a compliance program that sets up certain integrity policies that deal with Evista and its marketing for five years.
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