Industry Tries Again For Clarity Concerning Off-Label Promotion


With the ink barely dry on the Supreme Court’s recent decision that pharmaceutical detailing is First Amendment protected commercial speech, see Sorrell v. IMS Health Inc., ___ U.S. ___, 2011 WL 2472796, at *8 (U.S. June 23, 2011), the industry is trying again for clarity in the morass that is the FDA’s current regulation (if it can be called that) of off-label promotion.

Earlier this week, seven large drug/device manufacturers (Allergan, Eli Lilly, J&J, Novartis, Novo Nordisk, and Sanofi-Aventis) filed a Citizen Petition with the FDA demanding that the Agency replace its current mish-mash of non-binding guidance documents, letters, press releases, criminal plea agreements, and just plain tea leaves with real, live regulations concerning several aspects of off-label promotion. These aspects are...

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