A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Isabelle Freiling, PhD, Nicole M. Krause, MA, and Dietram A. Scheufele, PhD
Misinformation is an urgent new problem, so health professions communities need solutions as much as they need to be wary of ethical pitfalls of rushed interventions.
AMA J Ethics. 2023;25(3):E228-237. doi:
10.1001/amajethics.2023.228.
The FDA’s approval for over-the-counter sales of emergency contraception marked a departure from its standard approval process and obstructed access to a safe and effective drug. That departure could set a dangerous precedent for future decisions.