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.
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.
Nisha Quasba joins Ethics Talk to discuss her article, coauthored with Elliot Vice: “What Should Prescribers and Policy Makers Know About US Drug Importation?”
Dr Amy B. Cadwallader joins Ethics Talk to discuss her article, coauthored with Kavitha Nallathambi: “How Should Regulators and Manufacturers Prevent Avoidable Deaths of Children From Contaminated Cough Syrup?”
Dr Geoff Hollett joins Ethics Talk to discuss his article, coauthored with Dr Jennie B. Jarrett: “How Should Resources From National Stockpiles Be Managed?”