Dem chair asks FDA for documents on powerful new opioid

Democratic lawmakers are requesting documents from the Food and Drug Administration as they probe the agency’s controversial decision to approve a powerful new opioid.

Rep. Diana DeGette (D-Colo.), the chairwoman of the Energy and Commerce oversight subcommittee, and Sen. Ed Markey (D-Mass.) on Tuesday wrote to the FDA asking for documents that the agency relied on in approving the new opioid.

{mosads}The approval of the drug, called Dsuvia, in November, was controversial because advocates and some lawmakers had warned against approving a powerful new opioid amid the epidemic of opioid overdoses.

Dsuvia is 10 times more powerful than fentanyl and 1,000 times more powerful than morphine.

DeGette and Markey expressed concern the drug could be abused, saying it can “deliver a potency that has been known to be lethal in small dosages.”

In November when announcing the approval of the drug, FDA Commissioner Scott Gottlieb acknowledged its potential dangers but said it could be beneficial to the military.

He noted that the drug can be administered under the tongue, which could be helpful on the battlefield in situations where injecting a drug is difficult.  

“It fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said.