Drug pricing and opioids have remained front and center as the 116th Congress got sworn in and started hosting hearings and embarking upon investigations. On February 12, 2019, Representative Diana DeGette, chairwoman of the Energy and Commerce oversight subcommittee, and Senator Ed Markey, wrote a joint letter to the United States Food and Drug Administration (FDA) requesting documents that the FDA relied on in approving a new opioid.
In November 2018, the FDA approved Dsuvia for use only in certified medically-supervised health care settings for administration by a health care professional, despite some advocates and lawmakers warning that it is ten times more powerful than fentanyl and 1,000 times more powerful than morphine. In his announcement approving the drug, FDA Commissioner Scott Gottlieb acknowledged the possible dangers, but that it had the potential to be beneficial to the military, as it can be administered on the tongue, which can be helpful on the battlefield where injecting a drug can sometimes be difficult. “It fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb said.
The letter notes that Dsuvia was approved following the October 12, 2018 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Dr. Raeford Brown, the Chair of the Committee, was absent from the meeting, but had previously “expressed serious concerns about the safety and efficacy of the product and opposed its approval.”
Following the meeting and the subsequent approval, Dr. Brown has raised questions about the FDA approval process, including the allegation that the FDA actually disinvited certain members of the Drug Safety and Risk Management Advisory Committee to that October 12, 2018 meeting.
Dr. Brown co-authored an editorial in the Washington Post, where he pushed back against the FDA’s reasoning that the drug is useful on the battlefield, noting that the “clinical trials for the drug did not reflect the kind of medical conditions – such as massive trauma or shock – for which it would be used in a real-world military setting.” He continued, “instead, Dsuvia was tested on patients following minor surgical procedures” and that following those procedures and administration of Dsuvia, it “required nearly an hour, on average, to meet the standard of clinically meaningful pain relief, suggesting it would not meet the needs of injured soldiers.”
In the letter, DeGette and Markey expressed their concern that the drug has the potential for abuse, as it can “deliver a potency that hash been known to be lethal in small dosages.”
At the close, DeGette and Markey comment the Agency’s “plan to consider the broader public health context of future opioid approvals rather than merits of the individual drug application in question,” before asking for the following documentation:
- All documents the FDA relied on in concluding that Dsuvia “fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield;”
- All documents that relate to … communication between FDA and the U.S. Army Medical Research and Material Command concerning the FDA’s consideration of the Dsuvia application, between October 12, 2017 through November 2, 2018;
- All documents that relate to … communications between the FDA and any members of the Drug Safety and Risk Management Advisory Committee, disinviting them from the October 12, 20218 Anesthetic and Analgesic Drug Products Advisory Committee meeting concerning Dsuvia;
- All documents concerning the FDA’s decision to disinvite members of the Drug Safety and Risk Management Advisory Committee from the October 12, 2018 Anesthetic and Analgesic Drug Products Advisory Committee meeting;
- All documents relating to the FDA’s decision not to empanel the full Drug Safety and Risk Management Advisory Committee for consideration of the Dsuvia application.
The letter requested that all documents be produced no later than March 5, 2019.