Join us for a special breakfast for reporters, where former FDA Commissioner Andrew von Eschenbach will give you the latest on the fast-moving 21st Century Cures legislation. Karen Riley, deputy director of strategy at the FDA’s Office of External Affairs, will also be available to answer questions. The briefing comes just a week after the House Energy and Commerce Committee unveiled bipartisan draft legislation. The committee may begin voting on the measure as early as next week.
Dr. Von Eschenbach will explain the differences between the House and Senate measures, the extent of bipartisan support and challenges to passage, and then he and Ms. Riley will take questions.
*How do laws and regulations need to change to keep pace with innovation?
*What is the best and safest way to streamline clinical trials?
*Do the NIH and FDA need more funding? Would the legislation impose new unfunded mandates on federal agencies?
*Should pharmaceutical companies get increased patent exclusivity? Is this a sweetheart deal for pharma?
*What is the best way to incorporate the patient voice into drug development and the approval process?
*Should telehealth be included?