The First Amendment and Pharmaceutical Promotion

The growing movement to treat pharmaceutical promotional claims as constitutionally protected commercial free speech threatens FDA’s ability to regulate drug marketing, despite the fact that neither patients nor physicians can independently evaluate the voluminous proprietary data underlying drug approvals. History demonstrates the dangers of loosened regulation: from over $15 billion in industry settlements for illegal off-label promotion to the current flood of unsubstantiated claims for dietary supplements exempted from FDA oversight.