Ethics and Effects of Individual Patient Testimonies in Public Health Decision Making

When evidence for new drug approval is uncertain, the FDA may convene Advisory Committee meetings at which expert members review evidence, hear from patients, and vote on whether to recommend approval. There is no regulatory or ethical guidance on what role patient testimony should play in these votes or FDA decisions. By reviewing testimony and conducting interviews with patients and decisionmakers, this project will seek to analyze the experience and normative role of testimony. Dr. Kesselheim and his team plan to develop actionable recommendations for integrating patient voices in regulatory decision-making.