The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.
Although patients’ medical gender transition can be facilitated by counseling, as a matter of medical ethics, informed consent must be obtained for treatment.
AMA J Ethics. 2016;18(11):1079-1085. doi:
10.1001/journalofethics.2016.18.11.ecas2-1611.