In this issue of JAMA Internal Medicine is an analysis by Heyward et al1 about the oversight the US Food and Drug Administration (FDA) has attempted to impose on prescription opioids. The authors note that there is insufficient evidence to conclude that the FDA’s efforts to mitigate risk from opioids has been successful. The article does point toward the conclusion that the FDA has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution.