Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Physicians working in close-knit communities, whether small towns or urban neighborhoods, have to manage relationships with people who may be simultaneously patients and neighbors, friends, and business associates.
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.
Geoff Hollett, PhD and Jennie B. Jarrett, PharmD, PhD, MMedEd
The Strategic National Stockpile is a national system maintained by the US federal government to deliver medical supplies during emergencies, and it needs administrative changes.
AMA J Ethics. 2024;26(4):E315-320. doi:
10.1001/amajethics.2024.315.