DeGette, Markey demand documents from FDA on approval of new opioid painkiller Dsuvia
WASHINGTON, D.C. – U.S. Rep. Diana DeGette (D-CO) and Sen. Edward J. Markey (D-Mass.) today called on the Food and Drug Administration (FDA) to provide documents related to its approval of Dsuvia, a new formulation of the opioid painkiller sufentanil.
In their letter, the lawmakers expressed serious concerns about the risk of addiction associated with a supercharged opioid like Dsuvia, as well as with the FDA’s process of approval. There are allegations that the FDA disinvited members of the Drug Safety and Risk Management Advisory Committee to a key meeting in order to make approval more likely.
“While we appreciate the FDA’s intent to ensure Dsuvia is administered appropriately, we remain concerned that Dsuvia’s specific properties also make the product highly divertible,” the lawmakers wrote in their letter to FDA Administrator Dr. Scott Gottlieb. “Sufentanil has been known for decades to be diverted in its current intravenous form, and whether administered intravenously or sublingually, it can deliver a potency that has been known to be lethal in small dosages.”
Specifically, DeGette, chair of the House Energy and Commerce Committee’s oversight panel, and Markey requested documents that relate to the consideration of Dsuvia’s approval at the Anesthetic and Analgesic Drug Products Advisory Committee, any communications from FDA to any members of the Drug Safety and Risk Management Advisory Committee, and any documents used to conclude that Dsuvia “fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield.”
A copy of the lawmakers letter to the FDA can be found HERE.