The FDA, however, hasnâ€™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 â€œpreventative,â€ and signed a consent decree, which says: Lilly is â€œpermanently enjoined from directly or indirectly promoting Evista for use in preventing or reducing the risk of breast cancerâ€¦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, Lillyâ€™s chief compliance officer, was unequivocal: â€œWe believe that our actions were consistent with the laws and the consent decree.â€ A Justice Department spokesman wouldnâ€™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.