Caronia and the ‘New’ 1st Amendment Safe Harbor

By Jose P. Sierra

The Second Circuit decision vacating Alfred Caronia’s criminal misbranding conviction on free speech grounds has been hailed as a landmark First Amendment case and a victory for the pharmaceutical company. Although lawyers and commentators have been arguing since the 1990s that off-label promotion (at least when accurate and non misleading) deserves some constitutional protection under the First Amendment, prior to Caronia efforts to get the issue before the federal courts have come up short. Amendment protection, will the U.S. Food and Drug Administration someday have to consider drafting guidance on a First Amendment safe harbor?

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This article first appeared in the Law 360, December 2012.