Should Xenotransplantation Surgeries Be Authorized Under the Food and Drug Administration's Expanded Access Pathway?

Abstract

This article examines use of the US Food and Drug Administration's (FDA's) expanded access pathway to permit cardiac xenotransplants. This article first argues that, although data are collected from cardiac xenotransplant surgeries authorized through the FDA's expanded access pathway, uses of preclinical trial data do not align with the FDA's stated aims of expanded access. This article also argues that potential risks of xenotransplantation merit greater caution than risks posed by devices and that it is unclear how caution about such risks is regarded and operationalized during the FDA's expanded access authorization processes.