Two days ago, we pointed out a Lilly press release about an FDA panel endorsing its Evista osteoporosis med for two extra uses - reducing the chance of breast cancer in post-menopausal women with osteoporosis, or for those 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.â€
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 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.â€
Ann Nobles, Lilly’s chief compliance officer, was unequivocal: “We believe that our actions were consistent with the laws and the consent decree.†A Justice Department spokesman wouldn’t comment when asked if the press release is an issue. Of course, the department is now aware of the issue and, if usual procedures are followed, could investigate whether a violation occurred, confer with the FDA and, if its decided a violation was intentional, file criminal contempt charges agiainst Lilly.
Meanwhile, we asked your opinion: Did Lilly violate the decree? A large majority says "Yes." Mind you, this isn't scientific. But it does suggest the issue is worth examining further. Whether the Justice Department does so remains to be seen.
Yes - 64 votes, or 80 percent; No - 16 votes, or 20 percent.