Central Hudson-Plus: Why Off-Label Pharmaceutical Speech Will Find Its Voice


From establishing First Amendment protection for commercial speech in Virginia Citizens to applying heightened scrutiny in IMS Health, the Supreme Court’s commercial speech jurisprudence has greatly expanded over the past thirty-five years. Because off-label pharmaceutical advertising contains some speech that could be considered core scientific expression under the First Amendment and because the FDA discriminates between speakers, off-label speech prohibitions are ripe for challenge. Moreover, the Court’s reliance on noncommercial speech cases in IMS Health and its extension of the First Amendment to corporate, political speech hints that the Court is poised to grant heightened protection to commercial speech.

This Comment asserts that some of the FDA’s regulatory policies are unlikely to withstand the Court’s new iteration of the Central Hudson standard—what this Comment has termed “Central Hudson-plus.” Even if the Court continues to apply the Central Hudson commercial speech doctrine, the FDA will need to articulate less restrictive means to advance its interests. Because protecting the nation’s health depends on safe, effective drugs and access to pertinent information, this Comment urges the FDA to align its regulatory regime with the Supreme Court’s current First Amendment thought. Providing for wider dissemination of truthful, accurate information about off-label uses could aid physicians in the provision of appropriate medical care but also hold manufacturers accountable for distributing misleading information.