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Off-Label Promotion Ruling Increases Pressure For FDA Policy Change

 
• By Sue Sutter

Amarin Corp. PLC's First Amendment legal victory on Vascepa (icosapent ethyl) may intensify pressure on FDA to develop new guidance and regulations governing off-label promotion before its hand is further forced by more adverse court rulings and Congress.

Amarin Corp. PLC's First Amendment legal victory on Vascepa (icosapent ethyl) may intensify pressure on FDA to develop new guidance and regulations governing off-label promotion before its hand is further forced by more adverse court rulings and Congress.

In an Aug. 7 opinion, U.S. District Judge Paul Engelmayer of the Southern District of New York ruled that Amarin...

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