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

A Health Policy and Bioethics Consortium

Friday Sept. 9
12:30-2:00pm

Waterhouse Room, Gordon Hall 106
Harvard Medical School
25 Shattuck Street
Boston, MA 02115

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A light lunch will be served.

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Description:
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.

Experts: 

Diana Zuckerman, PhD
President, National Center for Health Research

Walid Gellad, MD, MPH
Assoc. Prof. of Medicine, University of Pittsburgh & Pittsburgh VA Medical Center 

Moderator:

Aaron S. Kesselheim, MD, JD, MPH
Assoc. Prof. of Medicine, Brigham and Women's Hospital & Harvard Medical School

The Health Policy and Bioethics Consortia are hosted by the Harvard Medical School Center for Bioethics and organized by the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Harvard Law School Petrie-Flom Center and the Harvard Program in Therapeutic Science. 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. Support provided by the Oswald DeN. Cammann Fund at Harvard University.