Stuart Pape

Opinion author

Stuart Pape is chair of Polsinelli Law Firm’s FDA practice and previously served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food. He also served as executive assistant to FDA Commissioner Donald Kennedy. He helps clients understand and face challenges presented by regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide.

The FDA underwent significant changes during the first year of the second Trump administration, directly affecting business risk and opportunity. Understanding key 2025 trends will be critical to developing regulatory strategies and maximizing opportunities for success.