Amarin invokes First and Fifth Amendments in law suit challenging FDA off-label promotion

8 May 2015

Cardiovascular biopharma specialist Amarin (Nasdaq: AMRN) and four independent physicians have filed a law suit to permit off-label promotion.

The law suit, filed in the District Court for the Southern District of New York, seeks a judicial declaration that Food and Drug Administration regulations limiting off-label promotion are unconstitutional under the First and Fifth Amendments. It relates specifically to Amarin’s proposed promotion of its triglyceride-reducing drug Vascepa (icosapent ethyl).

The physicians in the suit say they have First Amendment rights to receive truthful and non-misleading information from Amarin.

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