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.
Speakers
Dan Ollendorf, PhD, MPH
Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, ICER
Stacie Dusetzina, PhD
Professor of Health Policy and Ingram Professor of Cancer Research
Vanderbilt University School of Medicine
Holly Fernandez Lynch, JD, MBE
Associate Professor of Medical Ethics and Health Policy; Associate Professor of Law
University of Pennsylvania
Moderator:
Emily Largent, JD, PhD, RN
Emanuel and Robert Hart Associate Professor of Medical Ethics & Health Policy; Chief, Division of Medical Ethics
University of Pennsylvania Medical Ethics & Health Policy
This program has been approved for a total of 1.5 Substantive CLE credits for Pennsylvania lawyers. CLE credit may be available in other jurisdictions as well. Attendees seeking CLE credit can make a payment via cash or check made payable to ”The Trustees of the University of Pennsylvania” on the day of the event or prior to the event via the online registration link in the amount of $60.00 ($30.00 public interest/non-profit attorneys). In order to receive the appropriate amount of credit, passwords provided throughout the program must be noted in your evaluation form.
Penn Carey Law Alumni receive CLE credits free through The W.P. Carey Foundation’s generous commitment to Lifelong Learning.