FDA Opens Review Into Opioid Prescribing, Warning Regulations (2)

The FDA has opened an extensive review of opioid regulations and is launching a framework aimed at preventing overdose-related deaths nationwide, the agency’s head announced Tuesday.

Food and Drug Administration Commissioner Robert M. Califf said in a blog post that the agency has initiated a review into past opioid decisions, including labeling, “with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics.”

Califf first committed to leading a review on opioid regulations during his December 2021 confirmation hearing, following repeated questions from lawmakers on the FDA’s response to the opioid epidemic. Lawmakers have ...