FDA Makes Broad Concessions In Settling Pacira Promotion Suit
This article was originally published in The Pink Sheet Daily
Agency will formally rescind Exparel warning letter and expand labeling to clarify that pain drug is not limited to any specific surgery.
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Inclusion of failed studies in US label for Pacira’s Exparel label is unusual but appropriate given regulatory history with that application. Could FDA take that approach with other products to address unapproved uses in the context of uncertainty about prohibitions against 'off-label' promotion?
In unusual move, labeling lists data supporting use as nerve block as well as other trials that 'do not support' a broader nerve block indication beyond brachial plexus; labeling includes data on reduced opioid use but notes clinical benefit has not been established.
Many an unfortunate NDA sponsor has faced a long day when heading into US FDA advisory committee review. But Pacira faced a really long day for the review of a supplemental indication of Exparel. In fact, it was a day and a half.