Lilly And The Evista Consent Decree: Vote Here

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evista1.jpgYesterday, we pointed out a Lilly press release about an FDA panel endorsing its Evista osteoporosis med for two extra uses - reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis, and also for lowering the chance of getting breast cancer in post-menopausal women at high risk for the disease.

But Lilly’s press release contained this sub-hed: “Evista is currently indicated for the prevention and treatment of osteoporosis and may provide (emphasis added) an important option for postmenopausal women at increased risk for breast cancer.” The FDA, however, hasn’t approved that indication yet.

In fact, Lilly paid a $36 million fine in 2005 for illegally promoting Evista to docs as a breast cancer “preventative,” and signed a consent decree, which means it’s not supposed to do that again. Specifically, the decree says: Lilly is “permanently enjoined from directly or indirectly promoting Evista for use in preventing or reducing the risk of breast cancer…unless and until it is authorized to do so by the FDA by the approval of a supplement to the New Drug Application for Evista.”

The bad behavior occurred in 1998, and you can read a summary of the off-label promotion compiled by the Justice Department here. A Justice Department spokesman wouldn’t comment when asked if the press release is an issue. Ann Nobles, Lilly’s chief compliance officer, was unequivocal: “We believe that our actions were consistent with the laws and the consent decree.”

What do you think? The polls remain open, so please go here to vote.

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