Yesterday, we noted how an FDA advisory committee recommended the drugmaker’s osteoporosis med for reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis, and also endorsed the drug for lowering the chance of getting breast cancer in post-menopausal women at high risk for the disease.

Curiously, Lilly’s press release contained an interesting 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.” Why did we highlight the latter part of the statement? The FDA hasn’t actually approved that indication yet.

As pointed out by Breast Cancer Action, an advocacy group that opposes FDA approval for this indication, Lilly paid a $36 million fine in December 2005, for illegally promoting Evista to docs as a breast cancer “preventative.” The drugmaker also signed a consent decree, which means it’s not supposed to do that sort of thing again.

Specifically, this is what the decree says on page 2: 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.” Something on page 2 should be hard to miss, yes?

The behavior that led to this happened back in 1998, and you can read a summary of the off-label promotion compiled by the Justice Department here. But here we are, a decade later, and what has been learned? Will Ann Nobles, the recently promoted compliance chief, look into this?

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Hat tip to In Vivo