In scathing remarks directed at the FDA’s handling of opioid approvals, the head of the agency’s advisory panel has lambasted its “cozy, cozy relationships” with the pharmaceutical industry and called for a halt in considering any new opioids for approval.
Raeford Brown, chair of the FDA’s anesthetic and analgesic drug products advisory committee, did not pull any punches in his interview with the Guardian:
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. 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 FDA’s tendency to put the interest of drugmakers ahead of public health was most recently manifested in the controversial approval of AcelRx’s Dsuvia, according to Brown, an anesthesiologist, who called it a “terrible drug.”
Dsuvia was approved following a 10-3 vote by the panel of outside experts in favor of a green light, one year after it was first rejected by the FDA. Brown was absent from the advisory panel meeting as he was away at a professional conference.
“There’s no question in my mind right that they did that on purpose,” he told the Guardian. “The FDA has a lack of transparency. They use the advisory committees as cover.”
The OK drew flak despite the lopsided panel review vote as critics pounced on the introduction of another powerful pain med that could be ripe for abuse. In a statement, FDA chief Scott Gottlieb countered his critics by noting the need for a non-IV opioid as well as the defense department’s demand for a therapy that would be beneficial on the battlefield.
That did little to convince Brown, who accused FDA officials of being out of touch with the consequences of the opioid epidemic, which has claimed hundreds of thousands of lives the in the US and continues to be responsible for about 130 deaths every day.
“Nothing is fundamentally being done to effect change in the regulation of opioids,” he said. “If the FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is no better than it was in 1995, then we’ll be cleaning this up for a long time.”
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