The Unfinished Business of Reforming the FDA’s Accelerated Approval Pathway
A Conversation with Stacie B. Dusetzina, PhD, Holly Fernandez Lynch, JD, MBE, and Dan Ollendorf, PhD, MPH
The FDA’s accelerated approval pathway allows the agency to approve drugs for serious diseases with unmet treatment need based on predicted clinical benefit, which must be confirmed through postmarket studies. Accelerated approval’s tradeoffs between speed and certainty have received substantial attention, especially challenges associated with the rigor and completion of confirmatory studies. In the wake of the FDA’s controversial accelerated approval of a drug for Alzheimer’s disease, in 2021, Congress enacted several reforms, while the FDA offered additional guidance on the pathway and several reforms of its own. Where does accelerated approval stand today and what reforms are still needed? In this panel discussion, experts in medicine, economics, law, and ethics will discuss access, quality, cost, and other issues facing accelerated approval.
Co-sponsored by the Department of Medical Ethics and Health Policy and the Center for Technology, Innovation & Competition.
Speakers
Stacie B. Dusetzina, PhD
Professor, Health Policy and Ingram Professor of Cancer Research, Vanderbilt University School of Medicine
Holly Fernandez Lynch, JD, MBE
Associate Professor, Medical Ethics and Health Policy, Perelman School of Medicine; Associate Professor, Law, Penn Carey Law School
