Purdue Pharma and other pioneers of powerful opioid painkillers probably felt a twinge of regret on Friday when the FDA approved a powerful new opioid painkiller that's 10 times stronger than fentanyl - the deadly synthetic opioid that's been blamed for the record number of drug overdose deaths recorded in 2017 - and 1,000 times more powerful than morphine, ignoring the objections of lawmakers and its own advisory committee in the process.
After all that trouble that purveyors of opioids like Purdue and the Sackler family went to in order to win approval -doctoring internal research and suborning doctors to convince the FDA to approve powerful painkillers like OxyContin despite wildly underestimating the drug's abuse potential - the agency might very well have approved those drugs any way? And opioid makers might have been able to avoid some of the legal consequences stemming from this dishonesty, like the avalanche of lawsuits brought by state AGs.
What's perhaps even more galling is that the FDA approved the drug after official data showed 2017 was the deadliest year for overdose deaths in US history, with more than 70,000 recorded drug-related fatalities, many of which were caused by powerful synthetic opioids like the main ingredient in Dsuvia, the brand name under which the new painkiller will be sold.
Dsuvia is a 3-millimeter tablet of sufentanil made by AcelRx. It's a sublingual tablet intended to provide effective pain relief in patients for whom most oral painkillers aren't effective. The FDA's advisory committee voted 10-3 to recommend approval of the drug, a decision that was accepted by the FDA on Friday. The agency justified its decision by insisting that Dsuvia would be subject to "very tight" restrictions.
"There are very tight restrictions being placed on the distribution and use of this product," said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency's approval of Dsuvia. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia."
Still, some of the agency's actions looked to critics like attempts to stifle internal criticism. For example, the agency scheduled the advisory committee vote on a day where the chairman of the committee, who was opposed to approval, could not attend - while circumventing its normal vetting process,
despite the fact that the member in question had notified the agency of his unavailability months beforehand.
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Originally Posted by Zippyjuan
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