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First Amendment Suit: FDA Draws Line At Amarin's Heart Disease Claim

This article was originally published in The Tan Sheet

Executive Summary

Amarin Pharmaceuticals’ marketing plan for its Rx fish oil drug Vascepa, including noting the qualified heart health claim allowed for omega-3 supplements, could “establish precedent that would return the country to ... when companies were not required to prove that their drugs were safe and effective for each of their intended uses,” FDA argues.

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