Today, January 15, 2009, the U.S. Department of Justice announced that it had reached settlement with Eli Lilly for charges of off-label promotion of its drug Zyprexa. According to the DOJ, “The monetary settlement, totaling $1.415 billion, is the largest amount paid by a single defendant in the history of the United States Department of Justice (“DOJ”).”
As a regulatory and compliance professional, this is big, sobering, and eye-popping news. This settlement comes two days after FDA finalized its Good Reprint Practices guidance that provides rules for the dissemination of off label medical publications by drug and device manufacturers. I expect to see critics of industry and FDA link these two events. But before you do, please read FDA’s guidance and the settlement documents carefully.
FDA’s Guidance document will not allow the behavior alleged in the Lilly case. In fact, FDA’s revisions to the draft guidance document appear to squarely ensure that the alleged behavior is not enabled by the final guidance document. I wanted to get this point of view out as soon as I could, before people (maybe people who write for papers like the NYT) write headlines that blur these important technical distinctions. Lets have sound dialogue and sound journalism.
Yours truly,
John
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