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Has FDA Lost Its Grip? The Amarin Deal

 
• By Donna Young

While the FDA was insistent its settlement with Amarin Corp. plc, which a federal district judge has signed off on, only applies to that company, in which the agency has agreed to not stand in the way of the firm sharing "truthful and non-misleading" information about certain unapproved uses of its fish-oil pill Vascepa (icosapent ethyl), the deal, nonetheless, shows US regulators can be flexible, or at least, when they're backed into a corner.

While the FDA was insistent its settlement with Amarin Corp. plc, which a federal district judge has signed off on, only applies to that company, in which the agency has agreed to not stand in the way of the firm sharing "truthful and non-misleading" information about certain unapproved uses of its fish-oil pill Vascepa (icosapent ethyl), the deal, nonetheless, shows US regulators can be flexible, or at least, when they're backed into a corner.

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