The Food and Drug Administration's (FDA) expedited review processes have been instrumental in making treatments available for individuals living with serious illnesses. Manufacturers of new medical products leverage the four expedited programs: (1) priority review; (2) accelerated approval; (3) fast-track, and (4) breakthrough therapy to accelerate drug development and review. While these programs have been undoubtedly successful in fulfilling the goals for which they were introduced, they also attract their fair share of scrutiny, especially the accelerated approval pathway. Over the years, several drugs approved under the accelerated approval pathway have proven controversial and called into question concerns about patient safety for failure of sponsors to complete post-approval confirmatory studies. A recent FDA drug approval decision thrust the approval pathway into the spotlight. This session will review the successes of the accelerated approval pathway for the patient community, reform efforts underway, and how stakeholders are balancing the utility of expedited approval programs with concerns raised about their effectiveness. 

Moderator

Michael McCaughan

Founder, Prevision Policy

Speakers

Jeff Allen

President and CEO, Friends of Cancer Research

Holly Fernandez Lynch

Assistant Professor of Medical Ethics and Law, University of Pennsylvania

Frank Sasinowski

Director, Hyman, Phelps & McNamara

Jamie Sullivan

Senior Director of Policy, EveryLife Foundation for Rare Diseases