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

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to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released a new draft guidance document addressing truthful and non-misleading communications regarding product uses not approved or cleared by the FDA.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 They discuss the implications of the FDA's draft guidance document, including the "scientifically sound and clinically relevant" criteria for reprints, the scope of the "firm-generated presentation" definition, and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.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200