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Defending FDA’s Off-Label Policy: What Are The Alternatives?

This article was originally published in RPM Report

Executive Summary

As part of FDA’s defense in a First Amendment case filed by Amarin, the agency’s Janet Woodcock submitted a declaration outlining the government interests at stake – and explicitly responding to alternative approaches that a federal appeals court suggested in the landmark Caronia ruling that opened the door for Amarin’s suit. Here is an excerpt from the declaration responding to those alternatives.

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