Senator Markey and Rep. DeGette Demand Documents from FDA on Approval of New Opioid Painkiller Dsuvia

Opioid painkiller is up to ten times more powerful than fentanyl and 1,000 times more powerful than morphine

 

Washington (February 12, 2019) – Senator Edward J. Markey (D-Mass.) and Representative Diana DeGette (CO-01) 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 express serious concerns about the risk of addiction and diversion associated with a supercharged opioid like Dsuvia, as well as with the FDA 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,” writes the lawmakers 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.”

 

A copy of the letter to the FDA can be found HERE.

 

In their letter, Senator Markey and Rep. DeGette, Chair of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee, request documents that relate to the consideration of Dsuvia’s approval at the Anesthetic and Analgesic Drug Products Advisory Committee, any communication from FDA to any members of the Drug Safety and Risk Management Advisory Committee, and 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.”

 

In October 2018, Senators Markey, Richard Blumenthal (D-Conn.), Joe Manchin (D-W.V.), and Claire McCaskill sent a letter to the FDA expressing concerns with Dsuvia’s pending application for approval.

 

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