Off-label litigation: Amarin files 'free speech' suit against US FDA
This article was originally published in SRA
US biopharmaceutical company Amarin has filed a lawsuit against the Food and Drug Administration in the US District Court for the Southern District of New York charging that the agency's regulations restrict the company’s free-speech rights to discuss off-label use of its prescription fish oil pill, Vascepa (icosapent ethyl)1.
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