The Unfinished Business of Reforming the FDA’s Accelerated Approval Pathway
4:30pm - 6:00pm • Silverman 240B, Penn Carey Law School, 3501 Sansom Street, Philadelphia, PA
2026-10-22 16:30:00 2026-10-22 18:00:00 America/New_York The Unfinished Business of Reforming the FDA’s Accelerated Approval Pathway A Conversation with Stacie Dusetzina, PhD, Holly Fernandez Lynch, JD, MBE, and Dan Ollendorf, PhD, MPH. Co-sponsored by the Center for Technology, Innovation & Competition and the Leonard Davis Institute of Health Economics Register here. 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. Silverman 240B, Penn Carey Law School, 3501 Sansom Street, Philadelphia, PA Penn Medical EthicsA Conversation with Stacie Dusetzina, PhD, Holly Fernandez Lynch, JD, MBE, and Dan Ollendorf, PhD, MPH.
Co-sponsored by the Center for Technology, Innovation & Competition and the Leonard Davis Institute of Health Economics
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.