Episode 88 – Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?

FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil or criminal actions. While we can expect the agency's core activities to continue, its priorities may shift under the incoming Trump Administration. One point of emphasis might be increasing inspections at ex-US manufacturing sites, both to help ensure the quality of products sold into the United States from abroad, and to encourage US-based manufacturing. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Jennifer Bragg, and Bill McConagha discuss important FDA enforcement trends, including the impact of First Amendment jurisprudence on the regulation of promotional statements, increasing reliance on tools like import alerts and warning letters to address alleged misconduct, and oversight of manufacturing facilities outside of the US — all in the context of how the incoming presidential administration may shape the FDA enforcement landscape. They also examine how the recent overturning of the Chevron doctrine may impact FDA's regulatory and guidance activities.    Latham's related webcast — "FDA Life Sciences Enforcement Updates: Recent Trends and a Look Ahead" — is available on-demand here.   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