The Double-Edged Effect of First Amendment Factors on the Government Approach to Off-Label Enforcement: Interpreting Recent Government Statements

The article provides an analysis of recent remarks by Assistant Attorney General Stuart Delery, in which the AAG described the government’s approach to enforcement actions targeting off-label promotion of drugs and devices.  Considering the AAG’s remarks along with recent FDA draft guidance on the distribution of scientific literature, the article focuses on the effect that First Amendment concerns, intensified by recent case law developments, may have had on the way in which the government investigates cases, evaluates evidence, and develops and presents its theories of liability in off-label cases.