The Ethical Involvement of Patients in FDA Regulatory Evaluation of New Products: A Health Policy and Bioethics Consortium
There is a growing push to incorporate patient voices more directly at the FDA in decisionmaking about investigational drugs, but what are the optimal parameters of patients' contributions?
How should individual patient voices be weighed against the accumulated data about a drug?
Can we better educate patients to equip them to engage in discussions about trial design, statistics, and evaluation?
How should we consider financial relationships between patient advocacy groups and the pharmaceutical industry sponsor of a drug?
To address these and other questions, we will consider two recent cases: flibanserin (the "female Viagra") for hypoactive sexual desire disorder in women and eteplirsen for Duchenne muscular dystrophy. In both cases, patients had a substantial voice in the data collection and FDA review processes, leading to controversial outcomes.
Diana Zuckerman, PhD, National Center for Health Research
Walid Gellad, MD, MPH, University of Pittsburgh, VA Medical Center
Aaron S. Kesselheim, MD, JD, MPH, Brigham and Women’s Hospital and Harvard Medical School
This event was free and open to the public but registration was required.
Learn more about the Health Policy and Bioethics Consortia.
The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. They are organized by the Center for Bioethics at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.