Off-Label Promotion Settlement Includes Optional Preclearance Process

Amarin may submit up to two proposed communications annually to FDA about unapproved use of its triglyceride-lowering drug Vascepa, and the agency must respond with any concerns within 60 calendar days.

FDA’s settlement of the Vascepa (icosapent ethyl) off-label marketing case is another important development in pharmaceutical and medical device industry First Amendment disputes that experts say may put additional pressure on FDA to revise its approach to off-label promotion.

The settlement with drug manufacturer Amarin Corp. PLC includes an optional preclearance provision for future communications about unapproved uses...

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