FDA approval of new opioid sparks debate

The FDA's approval of a powerful new opioid painkiller is stirring controversy. Late Friday, the agency approved a new form of sufentanil, a synthetic opioid that's far stronger than fentanyl and has been used in IVs and epidurals for decades. An FDA advisory committee tasked with evaluating the drug, Dsuvia, recommended the agency approve it in a 10-3 vote last month. But critics — including the head of that advisory panel and four senators — urged the FDA not to approve the drug, citing concerns that the drug might be diverted and doesn't offer any unique medical benefits.

In a statement, FDA Commissioner Scott Gottlieb said there will be tight restrictions around Dsuvia’s distribution and use and noted it'll be valuable for treating pain from battlefield injuries when an IV can't be used. "The military application for this new medicine was carefully considered in this case,” he said.