Episode 62 – Has FDA Meaningfully Changed Its Restrictions on Off-Label Communications?

Connected With Latham · Dec 13, 2023 · 26m

Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA. Notably, the document updates the standard for using scientific or medical journal reprints and creates a new category for firm-generated presentations. These changes suggest a potential expansion of the safe harbor for manufacturers' communication of scientific information. In this episode of Connected With Latham…