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Opioid Approvals Must Be Halted, Public Citizen Says

Public Citizen News / July-August 2019

By Mike Stankiewicz

This article appeared in the July/August 2019 edition of Public Citizen News. Download the full edition here.

Not one more new opioid should enter the market until the  U.S. Food and Drug Administration (FDA) creates a currently non-existent regulatory framework for reviewing and approving opioids.

That’s the stance of Public Citizen and a U.S. Food and Drug Administration (FDA) advisory committee chair, who together petitioned the agency for a moratorium on approvals of all new opioids.

This petition was born “of a sense of urgency, after repeatedly attempting to provide insights concerning the opioid crisis to the principals of the FDA. Tragically, they have not listened,” said Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. “The mission of the FDA is to protect the public health. In the eyes of many experts, as it relates to opioids, they have failed.”

The petition was filed by Brown, also a professor of anesthesiology and pediatrics at the University of Kentucky, and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group and previous member of the FDA’s Drug Safety and Risk Management Advisory Committee. Together, they have eight years of experience on FDA advisory committees, most often focusing on prescription opioids.

The FDA approved 27 new or reformulated opioid analgesic medications between 2009 and 2015, even as the number of deaths by opioid abuse escalated. Every day, about 46 people in the U.S. die from prescription opioid overdoses, according to the Centers for Disease Control and Prevention.

In 2011, the agency approved reformulated Opana ER, despite pre-approval evidence cited by Public Citizen at the time that it could easily be manipulated to facilitate intravenous abuse. (The FDA removed it from the market more than five years later because of its dangers.) And last year, the agency approved the controversial and powerful opioid Dsuvia, over the strong objection of Public Citizen and Dr. Brown.

Wolfe and Brown detailed in a telephone press conference the urgent need for the FDA to implement National Academies of Sciences, Engineering, and Medicine (National Academies) mid-2017 recommendations regarding the review and approval of opioids – recommendations the FDA sought but has not implemented.

Those recommendations include creating a regulatory framework to prevent a continuation of dangerous past FDA errors that have contributed to the opioid crisis in the U.S. The National Academies found that the FDA had failed to adequately “incorporate public health considerations into opioid-related regulatory decisions.”

“As an important contributor to the current prescription opioid crisis because of its poor record, the FDA no longer can be trusted to approve new opioids,” Wolfe said. “To continue approving opioids such as Opana ER and Dsuvia before developing this framework for safer opioid regulations is to guarantee further opioid disasters and FDA culpability.”

Brown and Wolfe warned the agency not to approve Dsuvia, which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. Dsuvia is so potent that physican abusers of the intravenous formulation of it, available since 1984 only in hospital settings for general anesthesia – have been known to die when they inject the first dose.

“It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die,” Wolfe said.

Wolfe noted that the FDA changed the review process to suppress opposition to Dsuvia; the agency chose not to ask the full Drug Safety and Risk Management Advisory committee, whose members likely would have recommended against approval, to review the drug.

Similarly, when the agency approved Opana ER in 2011, it claimed that, despite evidence to the contrary, the FDA claimed the drug did not constitute a safety problem and that there was no need for a pre-approval safety advisory committee meeting, which would have highlighted the dangers of the medication.

The FDA removed the drug from the market more than five years later in the wake of rapidly mounting evidence that the predicted intravenous abuse of the drug was leading to a public health emergency.