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U.S. vs. Caronia: Forever Changing Commercial Free Speech in the United States?

WASHINGTON — Jan 22, 2013

DIA hosted a webinar bringing together legal, pharmaceutical industry and regulatory experts to discuss the implications of the recent U.S. v. Caronia decision, which may alter the rights of pharmaceutical manufacturers to promote U.S. Food and Drug Administration-approved products for unapproved uses, commonly known as “off-label promotion.”

A recent U.S. Second Circuit Court of Appeals ruling overturned the criminal conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce on the grounds that the conviction violated the First Amendment. The court determined that the First Amendment protected the defendant’s speech promoting off-label uses of the drug Xyrem, and that the government sought to prosecute the defendant solely on the basis of his speech. The government, however, likely will continue to pursue enforcement actions concerning other forms of promotion of off-label uses, and companies should tread cautiously, as challenges to the law’s provisions concerning these actions have not been settled.

The court ruling may be the most significant commercial free speech decision by a federal appeals court in many years and could be appealed to the U.S. Supreme Court.

The DIA webinar, on Wednesday at 11 a.m., will present the facts of the case and possible ramifications for the pharmaceutical industry. Panelists will discuss how the decision could impact settlements on “false claims” prosecutions, as well as possible rules by FDA concerning professional and consumer advertising, including social media. Off-label marketing using comparative effectiveness and economic studies also will be explored.

The webinar was moderated by:

  • John Kamp, JD, Ph.D., of counsel, Wiley Rein and Executive Director of the Coalition for Healthcare
  • Alan R. Bennett, J.D., Managing Partner, Washington, D.C., Office, Ropes & Gray, United States
  • Bert W. Rein, Partner, Wiley Rein LLP, United States
  • James M. “Mit” Spears, J.D., Executive Vice President and General Counsel, PhRMA, United States







ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.