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The FDA Approves a Controversial New Opioid Painkiller

The Food and Drug Administration is approving a powerful new opioid painkiller, the agency announced Friday. The drug, called Dsuvia, has been controversial: Some advocates (and even the chair of the FDA's advisory committee on painkillers) have publicly opposed its approval. "[I]f approved, Dsuvia will be abused and start killing people as soon as it hits the market," the advocacy group Public Citizen wrote to the Washington Post before the decision was announced.

The drug is needed for certain surgeries, and its risks will be minimized by making it only available in hospitals and other health-care settings, and not at retail pharmacies, the FDA argues. In particular, the Pentagon was interested in Dsuvia as a painkiller that could be used on the battlefield, FDA Commissioner Scott Gottlieb wrote in the public announcement of Dsuvia's approval. An advisory panel recommended Dsuvia's approval 10 to three.

At the same time, the FDA is now considering a new framework for how it decides to approve new opioids, taking into account the new drugs' risks for diversion and overdose, Gottlieb wrote. Previously, the FDA generally considered new medicines on their own merits, without considering how they might play into a misuse or addiction epidemic.

"But opioids are a unique class of medicines," Gottlieb wrote. "I believe that there are population-based considerations when it comes to drugs that are subject to such widespread abuse and misuse that warrant us considering each approval within a broad public health context."

The idea falls in line with recommendations that an independent panel of scientists made to the FDA in 2017. At that time, scientists argued for "opioid exceptionalism" and suggested opioid-specific regulations like tighter rules on advertising opioids and funding education for doctors on best practices for managing pain.