FDA’s Tactical Exparel Label May Suggest Broader Off-Label Strategy
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?
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US Centers for Medicare and Medicaid Services proposes a change to its reimbursement policies for non-opioid pain therapies which will benefit a single product: Pacira’s Exparel. However, the broader message for that company is mixed.
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.
Inconsistent efficacy data and safety concerns about falls and systemic toxicity lead to advisory committee vote against a labeling expansion for the local anesthetic; Pacira's proposed revisions to the drug's existing infiltration claim also meet some resistance.