Approval comes despite questions about approval process, consequences for opioid epidemic


Boston (November 2, 2018) – Senator Edward J. Markey (D-Mass.) released the following statement today after the Food and Drug Administration (FDA) approved Dsuvia, a new formulation of the opioid painkiller sufentanil. Dsuvia is up to ten times more powerful than fentanyl and 1,000 times more powerful than morphine. In the approval announcement, FDA Commissioner Dr. Scott Gottlieb wrote, “We need to address the question that I believe underlies the criticism raised in advance of this approval. To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider...the epidemic of opioid misuse and abuse that’s gripping our nation?”


“Everything in the FDA’s Dsuvia approval announcement militates against approval, and yet this new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen,” said Senator Markey. “Dr. Gottlieb raises critical questions about the flaws in the FDA’s approval process for opioids, but nevertheless gave the go ahead for this dangerous drug before even attempting to answer them. There was no public health need to approve this formulation of supercharged fentanyl in the face of these questions, opposition from one FDA advisory committee chair, and without the full participation of another advisory committee devoted to drug safety.”


This week, Senators Markey, Claire McCaskill (D-Mo.), Richard Blumenthal (D-Conn.), and Joe Manchin (D-W.V.) sent a letter to the FDA expressing serious concerns with the process by which Dsuvia came for approval. The Senators asked the FDA to deny the application unless and until there is an opportunity for full consideration of the application before approval.