Reforming the FDA to Meet Today’s Innovation Challenges

Drug development costs continue to escalate as innovators struggle with lengthy approval timelines that can run a decade or more. With FDA user fee negotiations approaching and the Trump Administration increasing pressure to reduce prices, policy reforms leveraging artificial intelligence and real-world evidence could bring down costs and get valuable new treatments and cures safely and quickly to patients.

Former FDA Commissioner Scott Gottlieb, Former FDA Acting Commissioner Janet Woodcock, ArsenalBio CEO Ken Drazan and other experts on Friday, September 19, discussed pathways for sustainable FDA reform and pharmaceutical innovation. Lowell Schiller, Nonresident Senior Scholar and former FDA Acting Chief Counsel, also presented on a new Schaeffer Center white paper outlining policy recommendations to advance medical product innovation and patient access.

Read more about the event here, and full video is below.

Agenda

9:00 am ET Welcome Remarks	Dana Goldman, PhD Founding Director, USC Schaeffer Institute
9:05 am ET Schaeffer White Paper: Blueprint for FDA Reform	Lowell Schiller, JD Nonresident Senior Scholar, USC Schaeffer Institute; Former Acting Chief Counsel, FDA
9:20 am ET The Future of the FDA	Scott Gottlieb, MD Former Commissioner, FDA
9:50 am ET Panel Discussion and Q&A	Ken Drazan, MD Chairman, CEO and Co-founder, ArsenalBio Annie Kennedy Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases Janet Woodcock, MD Former Acting Commissioner, FDA Moderated by: Barry Liden, JD Director of Public Policy, USC Schaeffer Institute
10:50 am ET Closing Remarks	Barry Liden, JD Director of Public Policy, USC Schaeffer Institute