Video: The Ethical Involvement of Patients in FDA Regulatory Evaluation of New Products

There is a growing push to incorporate patient voices more directly at the FDA in decision making 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.

Watch a video of the event below or via the Center for Bioethics YouTube channel.

Center for Bioethics YouTube channel
There is a growing push to incorporate patient voices more directly at the FDA in decision making about investigational drugs, but what are the optimal parameters of patients'