Replies to post #420328 on Amarin Corp Plc (AMRN)

[Tatsumaki]

IMHO it is time for the FDA to consider adjusting downwards the criteria for prescribing Vascepa.

The FDA doesn't go around and propose adjustments to existing labels for drug companies unless they're addressing a specific safety concern with the product. Improvement of public health is not their mandate. Regulating the general safety and efficacy of drugs is it (and also gatekeeping the process for the big guys but hey). So they simply react and act upon applications by drug makers requesting such changes. Amarin would need to file an sNDA with an updated label and patient population with supporting evidence and pursue that change if it was a valid one.