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Drug Maker Sues FDA for Right to Market Meds for unapproved Uses

Monday, May 11, 2015 | 0

A drug manufacturer has filed suit against the U.S. Food and Drug Administration for the right to market a medication to doctors for “off-label” uses – an act that has led to hundreds of millions of dollars in fines for some of the makers of the top pharmaceuticals used in workers’ compensation. Amarin Pharma’s complaint, filed Thursday in the U.S. District Court for the Southern District of New York, spells out the argument for why the FDA’s regulations against off-label marketing conflict with the First and Fifth Amendments of the U.S. Constitution. T...

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