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.
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what are the documented instances of diversion of Dsuvia? Lack of retail distribution almost certainly makes this very rare because it is so much more difficult to obtain.
As you note, Opana ER was approved in 2006, which is outside of the 2009-2015 timeframe discussed here. And it wasn’t designated “abuse deterrent” because that approval predates FDA guidance on what that would be and how it would be determined. It’s like saying a person didn’t travel by auto before autos were invented.
Not that facts matter anymore in the Rx opioid conversation (unless they fit the current narrative).