Amarin Corp Plc (AMRN)

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Don’t Label Me!

What is the FDA’s definition of a generic?

“A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used.”

So, if this is true, then the label for Generic VASCEPA must be “for the same clinical benefit” as VASCEPA.
The problem is that the MARINE benefit, (TG’s>500 mg/dl) supposedly for pancreatitis doesn’t exist by itself. (Oh wait, yes it does. LOVAZA). Oh My! What a mess.

So, If Hikma etal. proposes the MARINE Skinny Label will the FDA require them to change the label like they did for TEVA’s Coreg®? If so, then Amarin will immediately file suit for infringement just like GSK did against TEVA.

Because in America doctors can Rx Off Label, writing prescriptions for a drug instead of for an indication is dangerous and disingenuous. Skinny Labeling is just another loophole for unscrupulous generics to steal IP at the immense cost to consumers. WHAT A SCAM.

In this regard we should be more like the EMA which are sticklers for writing prescriptions ON-LABEL for specific indications.