Targeted dosing to treat pediatric inflammatory bowel disease is challenging because dosing guidelines are based on data gathered from adult subjects of clinical trials. Patients’ families and health care organizations also incur high costs and must try to balance potential benefits against risks of ongoing monitoring.
AMA J Ethics. 2018;20(9):E841-848. doi:
10.1001/amajethics.2018.841.
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.
Whether or not to inform patients of off-label drug prescribing has been the subject of heated debate for a long time, with convincing arguments made on both sides of the issue and no consensus reached.