Early Experience with an Evolving FDA and HHS was presented at the 2025 Utah Life Sciences Summit on November 12, 2025 in Salt Lake City. Moderated by Seth Olson, Kirton McConkie, attorney, panelists included Peter Marks, MD/PhD, Eli Lilly, Sr. VP of Molecule Discovery & Head of Infectious Disease, Eli Lilly; Former Director, Center for Biological Evaluation and Research, FDA; Christopher Rogers, Becton Dickinson, VP, Regulatory Affairs; and Dana Andersen, Ph.D., Denali Therapeutics, Chief Technical & Manufacturing Officer.
The second Trump administration has already made a significant mark on the policies and priorities of the FDA. This panel addresses a number of regulatory issues that are gaining attention, such the MAHA agenda; AI; manufacturing, supply chain, tariffs; and policies to accelerate drug and device development to name a few. HHS Secretary RFK, Jr. is likely to play a larger role in the direction of the FDA. As HHS Secretary, Mr. Kennedy will likely play a bigger role in directing policy at FDA than has been typical in past administrations. FDA Commissioner, Dr. Martin Makary, is interested in modernizing the agency and is a proponent of technology-driven, innovative approaches to product development to speed approval of new drugs, diagnostics, and devices.
