US v. Caronia: Related Resources
The 2nd U.S. Circuit Court of Appeals' recent decision on United States vs. Caronia raises a big question for the pharmaceutical industry: will the decision have broader applicability to comparative effectiveness research (CER) and other health-related studies?
The 2nd U.S. Circuit Court of Appeals' recent decision on United States vs. Caronia raises a big question for the pharmaceutical industry: will the decision have broader applicability to comparative effectiveness research (CER) and other health-related studies?
At issue in Caronia was whether the First Amendment protects the right of individuals to speak truthfully about off-label uses of Food and Drug Administration-approved products. In its decision, the Court vacated the criminal conviction of a pharmaceutical sales representative who promoted an off-label use of the narcolepsy drug Xyrem. The sales representative, Alfred Caronia, had argued the conviction infringed on his First Amendment rights. Thus, the Court determined that industry and its employees may be able to promote off-label uses of drugs, provided the information shared is factual.
How is this case being interpreted by legal experts and policymakers? To answer that question, we pulled together some recent analyses and articles from a variety of sources.**
- United States vs. Caronia Decision
- Washington Legal Foundation Case Detail
- The US Department of Justice’s Targeting of Medical Speech and its Public Health Impacts, Scott Gottlieb, MD, American Enterprise Institute
- Off-Label Marketing and the First Amendment, Marcia M. Boumil, JD, LLM, New England Journal of Medicine, December 12, 2012
- Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion, Covington & Burling
- Asymmetry in the Ability to Communicate CER Findings, National Pharmaceutical Council conference, February 2012
- Challenges in Comparative Effectiveness Research, Health Affairs issue and briefing
- Temple "Horrified" by Caronia Decision, Jill Wechsler, PharmExec Blog, December 12, 2012
- Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution, Epstein Becker & Green, PC
- In Landmark Ruling, Court Reverses Conviction Involving Off-Label Promotion, FDA Law Blog
- Free speech mandates vacating off-label promotion conviction, says Second Circuit in United States v. Caronia, Hogan Lovells
- U.S. v. Caronia: Second Circuit Holds that the First Amendment Protects Speech Promoting Off-Label Drug Use, Quarles & Brady LLP
- US v. Caronia: A Rift In Prosecution Of Off-Label Promotion?, SNR Denton
- Second Circuit Overturns Off-Label Marketing Conviction on First Amendment Grounds, Kelley Drye
**Please note that this is not a comprehensive list; this information is not intended as legal advice; and the opinions expressed are for informational purposes and do not necessarily reflect NPC’s views.