FDA panel chair and consumer advocate petition FDA to halt opioid approvals
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Arguing that the Food and Drug Administration is “culpable” in creating the opioid crisis, a consumer advocacy group and a leading academic — who also chairs an FDA advisory panel — are
calling for the agency to impose a moratorium on approving any new or reformulated opioids.
In a Citizen’s Petition filed with the FDA, Public Citizen and Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, maintained the agency has
displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provided benefits that outweighed the risks. Two drugs — Opana ER and
Dsuvia — were singled out as examples.
In arguing their case, they further pointed to a report issued two years ago by the National Academies of Science, Engineering, and Medicine that found the FDA failed to adequately
“incorporate public health considerations into opioid-related regulatory decisions.” The private, nonprofit government adviser also recommended the agency adopt a new regulatory framework,
which has not yet happened.