Regulation of Pharma Speaker’s Truthful Message Violates the First Amendment

Dec. 3, 2012 – The U.S. Court of Appeals for the Second Circuit released a long-awaited decision today reversing the conviction of Alfred Caronia, a detailer for Orphan Medical Inc., who admitted that he intentionally promoted Xyrem for uses not approved by the FDA. The decision relies heavily on the reasoning of the recent Supreme Court decision in IMS v. Sorrell, to find that FDA-related regulation of truthful speech by drug companies must meet the exacting standards of the First Amendment.

“Although the FDA can continue to regulate false and misleading marketing by regulated companies, this decision likely will force serious reassessment of label-based restriction,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “While medical marketers must continue to comply with existing law, policymakers and lawyers throughout our community will be busy reviewing this decision and an inevitable appeal to the Supreme Court,” Kamp stated.