An expert tasked with helping the Food and Drug Administration weigh potential new opioid drug approvals is openly calling out the agency for what he alleges are its continued missteps in handling the opioid crisis. In an interview with the Guardian Thursday, Raeford Brown claimed that the FDA has failed to learn from its past mistakes by approving the drug Dsuvia last year, the tablet form of an opioid painkiller up to ten times more potent than fentanyl.
Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, was tapped to chair the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee in 2018. One of the committee’s duties involved recommending whether or not Dsuvia should be approved. (The FDA rarely goes against the recommendations made by its outside committees.) Ultimately, the committee voted 10 to 3 for its approval. But Brown alleged to the Guardian that the approval process had been manipulated, and that the FDA has still largely avoided taking any serious action to curtail the role of legal opioids in the crisis.
“I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything,” he told the Guardian. “The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
In 2017, Dsuvia was actually rejected for approval by the FDA, with the agency calling for additional safety data from its maker, AcelRx. But the vote by the panel convened last October occurred while Brown was unable to attend—a decision Brown contends was intentional. Brown had long criticized the potential approval of Dsuvia, a stance he says the FDA was well aware of.
“There’s no question in my mind right that they did that on purpose,” he said. “The FDA has a lack of transparency. They use the advisory committees as cover.”
Brown isn’t the only one who had trouble with how the FDA ultimately approved Dsuvia. In a letter sent to the FDA last October, senators Joe Manchin (D-WV), Edward Markey (D-MA), Richard Blumenthal (D-Conn), and former senator Claire McCaskill (D-Miss) criticized the agency over Brown’s absence during the panel vote. The senators also criticized the FDA’s decision to not fully include another panel of experts, the Drug Safety and Risk Management Committee, in the approval process of Dsuvia.
Soon after its approval in November, FDA chief Scott Gottlieb went out of his way to tamp down criticism. In a statement, Gottlieb said that there were “very tight restrictions being placed on the distribution and use of this product.”
Dsuvia is a form of the opioid sufentanil, taken as a tablet that dissolves under the tongue. It’s currently approved for people with moderate to severe pain who haven’t responded to other treatments. The drug is supposed to be administered only in medically-supervised health care settings, such as hospitals and emergency rooms, by approved medical staff.
But sufentanil tablets like Dsuvia can still potentially be abused or improperly dosed to patients, according to the National Institute for Health and Care Excellence in the UK. And there’s still the possibility they can end up in the black market. The European Union approved a similar tablet version of sufentanil made by AcelRX, Dzuveo, last summer.
Brown, for his part, doesn’t buy Gottlieb’s assurances. And he thinks until the FDA has gotten its act together, no new opioid drugs should hit the market at all.
“They should stop considering any new opioid evaluation,” Brown told the Guardian. “For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets. What they do has a direct impact on the mortality rate from opioids in this country.”
The FDA as well as AcerRX have not immediately responded to a request for comment from Gizmodo on Brown’s accusations.
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