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
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