Why the FDA approved a powerful new opioid

The Food and Drug Administration (FDA) took some heat on Friday for approving Dsuvia, a new opioid painkiller that’s up to 10 times more powerful than therapeutic fentanyl.

What they’re saying: FDA Commissioner Scott Gottlieb acknowledged the criticism in a statement about the approval, and said it may be time for the agency to think differently about the standards for approving opioids.

• “We generally consider each new drug approval — and each new opioid drug approval — largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug.”
• “Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers.”