A pair of Democratic lawmakers is asking the Food and Drug Administration to provide documents that would explain its decision last fall to approve Dsuvia, a tablet version of a decades-old intravenous painkiller that is up to 10 times more potent than the highly addictive fentanyl.
The agency greenlighted its use amid controversy that alternatives exist and that such a powerful opioid could easily be abused by being diverted, despite a prohibition on retail pharmacy sales. But as noted previously, the endorsement was championed by the military, which maintained that such a medicine is needed in combat zones.
But in a letter to the FDA, Sen. Edward Markey (D-Mass.) and Rep. Diana DeGette (D-Colo.) expressed “serious concerns” about addiction risks and the potential for diversion. They questioned the approval process itself, given that the chair of an FDA committee very publicly raised questions about the need for the drug and some members of another FDA panel were disinvited from a review meeting last fall.
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