Industry Tries Again For Clarity Concerning Off-Label Promotion

more+
less-

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...

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Published In: Communications & Media Updates, Constitutional Law Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dechert LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »