Shot of shelves stocked with various medicinal products in a pharmacy

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

December 13, 2023
New draft guidance document signals an expanded safe harbor for communicating scientific information on unapproved uses of approved medical products.

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to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA.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, Ben Haas, Global Vice Chair of Latham’s Healthcare & Life Sciences Practice Group, speaks with counsel Monica Groat and associate Nate Beaton. They discuss the implications of the FDA’s draft guidance document, including the “scientifically sound and clinically relevant” criteria for reprints, the scope of the “firm-generated presentation” definition, and the parts of the document that may be challenged by industry.

Listen here or subscribe via Apple Podcasts, Google Podcasts, Spotify, or anywhere else you listen to podcasts.