Amarin Corp Plc (AMRN)

[Biobillionair]

Gilead Sciences joined by Ferring Pharmaceuticals calling the a FDA out on "new" NCE vision.

http://www.fdalawblog.net

The Commissioner’s statutory interpretation of the five-year exclusivity provisions for fixed-combinations with at least one novel drug substance is the only correct interpretation, and must be applied to all relevant applications. No change in the Agency's regulations is required legally or technically.

The Commissioner failed to adequately consider all points raised in the original Citizen Petitions, including wildly inconsistent exclusivity results under its umbrella policy and the support in the legislative history for five-year exclusivity for fixed-combinations with novel ingredients. Due Process and fairness require that five-year exclusivity be recognized for all applicable drug applications with remaining exclusivity, particularly Ferring’s Prepopik.

The Commissioner should adopt Petitioners’ statutory interpretation immediately. The Commissioner’s decision to implement the interpretation prospectively at some indefinite future date (i.e., through final guidance) is arbitrary and capricious action that cannot be considered reasonable when all relevant factors are considered.