FDA proposes comparative approval standards for new opioids

FDA is moving to establish comparative effectiveness standards for approval of new opioids, according to draft guidance issued Thursday on conducting benefit-risk assessments.

Former FDA Commissioner Scott Gottlieb proposed such a standard shortly before he left the position. In March, Gottlieb told a House committee that the standards would clarify how new opioids would differ from existing ones by being "more abuse deterrent, or maybe the delivery vehicle is differentiated in a way that's going to provide some therapeutic benefit over some existing opioid" (see "Gottlieb Calls for Comparative Standard for Opioids")...