Has FDA Lost Its Grip? The Amarin Deal

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.

Indeed, to the FDA, the deal with Amarin likely was the choice of the lesser of two evils – settle the legal dispute and let the company have its way, although with input from the agency, or wind up in an appeal, which had the chance of going badly for

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