FDA First Amendment Litigation: Will Amarin Case Break The Log Jam?
This article was originally published in The Pink Sheet Daily
Courts have issued mixed rulings in cases challenging FDA restrictions on drug promotion, but with oral arguments set for July 7, Amarin’s suit could provide a definitive answer on what companies can tell physicians.
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Oral arguments didn't go particularly well for the agency in its effort to limit what Amarin can tell doctors about unapproved use of Vascepa.
Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.