Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021;23(9):E745-749. doi:
10.1001/amajethics.2021.745.
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.