Amarin Corp Plc (AMRN)

[sts66]

What the FDA wants is the whole "off label promotion" legal issue to disappear.

Even if they somehow settle with AMRN and the PI disappears FDA still has to address the 21st Century Cures Act and it's off-label drug promotion section - FDA cannot escape addressing this issue forever:

http://www.lifescienceslegalupdate.com/2015/05/articles/legislative-developments/proposed-21st-century-cures-act-addresses-off-label-promotion-issues-for-drugs-and-devices/

The present version of the 21st Century Cures Act specifies that, within 18 months of its enactment, the Secretary of Health and Human Services “shall issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.”