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Off-Label Preclearance Process Eyed As Potential Fix For FDA's Policy Dilemma

 
• By Sue Sutter

However, FDA lacks funding to promptly respond to off-label promotion submissions on broad scale; model outlined in settlement of Amarin's Vascepa case could bolster support for third-party vetting system.

Structural and funding changes within FDA likely would be needed before the preclearance process accorded to Amarin Corp. PLC in the Vascepa (icosapent ethyl) off-label promotion litigation settlement could serve as a broader regulatory framework for such communications.

Alternatively, the settlement's model could bolster calls for an independent third-party body, sanctioned by FDA, to vet such communications in a timely fashion.

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