Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases (Aspatore Special Report)

 
9780314290946: Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases (Aspatore Special Report)
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Determining the allowances and limitations of off-label promotion has recently become more challenging with cases such as Caronia. Attorneys and clients alike are keeping tabs on what instances of off-label promotion are being scrutinized in order to remain in compliance and ultimately avoid prosecution. In light of this, key questions have been raised. What is considered "off-label promotion"? What are the repercussions for those who violate government regulations? What role does the First Amendment play in off-label promotion? What impact have recent, noteworthy cases had on food and drug law as a whole? How are the rules governing off-label promotion changing? Has the FDA issued any additional guidance on the subject? What issues remain unclear, despite these recent developments? Navigating Recent Off-Label Promotion Developments provides feedback from some of the nation's leading legal minds on staying up-to-date with current regulations and FDA enforcement practices. These experts discuss how to differentiate between what is classified as allowable, truthful, scientific information versus prohibited off-label promotion. Additionally, the authors give tips on ways to ease client concerns during this time of uncertainty. This report offers readers an on-the-spot look at this issue as it continues to unfold.

Chapters Include:

1. Brian J. Malkin, Partner, Frommer Lawrence & Haug LLP - "Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?"
2. Michael A. Walsh, Partner, Strasburger & Price LLP - "Prosecution of Off-Label Promotion: The Road from Carte Blanche to Strict Scrutiny"
3. Eric D. Hargan, Shareholder, Greenberg Traurig LLP - "Conflicting and Challenging Off-Label Promotion Issues in Recent FDA Litigation"
4. Edgar Asebey-Birkholm, Partner, and James O'Reilly, Of Counsel, Roetzel & Andress - "Counseling Clients on Compliance with Off-Label Promotion Laws"

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Published by Thomson Reuters Westlaw (2013)
ISBN 10: 031429094X ISBN 13: 9780314290946
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