FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lawmakers Press FDA for Documents Relating to Controversial Opioid Approval

Feb. 21, 2019

Congressional Democrats are calling on the FDA to answer “substantive questions” surrounding the agency’s approval of Dsuvia, AcelRx’s sublingual formulation of the powerful opioid sufentanil.

In a letter to FDA Commissioner Scott Gottlieb, Sen. Ed Markey (D-Mass.) and Rep. Dianne DeGette (D-Colo.), who chairs the House Energy and Commerce oversight subcommittee, asked for specific documents relating to the November 2018 approval.

The agency’s approval followed an Oct. 12 meeting of the Anesthetic and Analgesic Product Advisory Committee, which voted 10 to 3 that the drug’s benefits outweighed its risks.

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