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.

 

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