FDA petitioned to halt new opioid approvals

A leading academic that chairs an FDA advisory panel and a consumer advocacy group filed a petition asking the agency to impose a moratorium on approving new or reformulated opioids, according to a STAT news report.

In a Citizen's Petition, Raeford Brown, MD, a professor of anesthesiology and pediatrics at the University of Kentucky in Lexington, and Public Citizen, argued that the FDA was "culpable" in creating the opioid epidemic due to its "dangerously deficient oversight."

The petition claims that the more than two dozen opioids approved between 2009 and 2015 offered more risks than benefits.

A report issued by the National Academies of Science, Engineering, and Medicine found the FDA didn't "incorporate public health considerations into opioid-related regulatory decisions,"  the petition pointed out.

After that report was released, the government adviser recommended that the FDA establish a new regulatory process for approving opioids, but the FDA has not, according to the petition.

"Absent a currently nonexistent effective regulatory framework for opioids that incorporates public health considerations, the FDA cannot be relied upon to approve any more new opioids," the petition read, according to STAT.

Read the full report here.

More articles on opioids:
FDA fast tracks Purdue Pharma's emergency opioid antidote
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Massachusetts hospitals embrace recovery coaches for overdose patients

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