The Ethical Involvement of Patients in FDA Regulatory Evaluation of New Products image

September 9, 2016 12:30 - 2:00 PM
Lectures and Panels
Waterhouse Room, Gordon Hall 106
Harvard Medical School, 25 Shattuck St., Boston, MA

Register for this event

This event is free and open to the public but space is limted and registration is required. Register online now!


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.



The Health Policy and Bioethics Consortia are organized by the Program On Regulation, Therapeutics, And Law (PORTAL) at the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and hosted by the Harvard Medical School Center for Bioethics, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Harvard Program in Therapeutic Science, with support from the Oswald DeN. Cammann Fund at Harvard University. This new monthly series 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.


bioethics   clinical research   fda   health law policy   human subjects research   pharmaceuticals   regulation