Ep. 118: Holly Fernandez on the Ethics and Practice of Pre-Approval Drug Access through Expanded Access vs. Right-to-Try

Holly Fernandez Lynch is is Associate Professor of Medical Ethics and Law at the University of Pennsylvania, and one of the most influential voices in US bioethics on questions of clinical trial ethics, patient access, and research participant compensation. Holly was an opponent of the 2017 federal right-to-try act, joined Niklas to debate the problems with right-to-try vs. expanded access, and the potential merits and risks of Montana’s approach.

Montana goes beyond federal right-to-try by dropping the life-threatening-disease requirement and lifting the ban on profit. Is a passed phase 1 trial enough protection against snake oil, how is paying a patient to access an unapproved treatment different from paying a research participant to accept risk, and can the data this generates might count as real evidence, or would it be just used as an excuse to skip the FDA process?

More about Holly Fernandez Lynch’s work:

* Holly on LinkedIn

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