FDA Favoring Opioid Manufacturers: Advisory Committee Chair
The chairman of the FDA Anesthetic and Analgesic Drugs Advisory Committee, anesthesiologist Raeford Brown, says the agency is putting the interests of narcotic drug manufacturers ahead of public health. In an explosive interview with The Guardian, Brown took particular aim at the recent FDA approval of AcelRx’ Dsuvia (sufentanil sublingual tablet), calling it a “terrible drug,” and saying the approval process was manipulated.
“They should stop considering any new opioid evaluation,” Brown declared. “For every day and every week and every month that FDA doesn’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 committee chairman said he no longer has confidence in repeated FDA executive assurances that the agency is taking the opioid epidemic seriously and is prepared to put public health above drug makers’ commercial interests. He charged there is “a war” within the agency as officials in charge of opioid policy have “failed to learn the lessons” of the epidemic.
“I think FDA has learned nothing,” he said. “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. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
The Guardian points out that Brown’s concerns echo those voiced by several U.S. senators who have condemned FDA for “complicity” in the opioid epidemic by first approving the powerful painkillers that drove the crisis and then failing to use its powers to protect the public health as the death toll escalated.
It says four senators wrote to FDA commissioner Scott Gottlieb in 2018, asking that the agency not approve Dsuvia, which was developed within the Defense Department. An advisory committee rejected the drug in 2017, the news account says, over safety concerns. The senators said they were “deeply troubled” that when Dsuvia was resubmitted for consideration in 2018 FDA excluded members of its drug safety advisory committee from the meeting. They also said they were concerned that the advisory committee decision was made when Brown was not at the meeting due to a professional conference.
“There’s no question in my mind that they did that on purpose,” Brown said. “FDA has a lack of transparency. They use the advisory committees as cover.”
Brown described for The Guardian a breakdown in confidence and trust between his advisory committee and FDA officials responsible for opioid approvals. He characterized the agency officials as out of touch with the consequences of the epidemic, the newspaper says, and locked into a view promoted by drugmakers that those who become hooked are to blame for their addiction and not the pills or prescribing practices. He blamed the situation in part on a “cozy, cozy relationship between the pharmaceutical industry and various parts of FDA.”
FDA declined to respond to Brown’s specific allegations, The Guardian says.
Gottlieb reportedly has defended Dsuvia by saying it is required for use in circumstances where other drugs cannot be administered, such as a battlefield. He said there would be “very tight restrictions” on its distribution to stop it from appearing on the illegal market. And he said FDA has “learned much from the harmful impact” of the prescription opioid crisis.
But Brown counters that “nothing is fundamentally being done to effect change in the regulation of opioids. If FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is not better than it was in 1995, then we’ll be cleaning this up for a long time.”