Opioid-Sparing Claims Should Meet High Bar, US FDA Panel Says
At meeting on Pacira's Exparel, advisory committee members warn against rushing to adopt products purported to reduce opioid consumption absent long-term longitudinal data showing beneficial public health impacts and clinical data linking reduced opioid use to functional outcomes or other clinical benefit.
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In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.
Advisory committee agreed that statistically significant reduction in average opioid use and decrease in absolute amount were insufficient components on their own; a decrease in duration of use and a decrease in the amount of patients who don't need opioids received some support.
In the face of the overwhelming opioid abuse epidemic, it is hard to argue against doing more. But, at least when it comes to some of the FDA-related bills pending, there is a good argument that Congress is in danger of over-legislating.