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

September 9, 2016 @ 12:30 pm - 2:00 pm

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.


Please register here.

Registration is required for non-Harvard guests.
Please bring your ID due to building security.
A light lunch will be served.


September 9, 2016
12:30 pm - 2:00 pm
Event Category:


Center for Bioethics
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Waterhouse Room, Gordon Hall 106
25 Shattuck Street
Boston, MA 02115 United States
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