Amarin Corp Plc (AMRN)

[sts66]

(More likely) the DS EE- isn't an exception. FDA has already made determinations that synthetic substances are drugs ... however: Is it a scientific determination or not?

I'm tempted to answer with "is that a trick question?" because to my mind, classifying synthetic substances are drugs can only be a scientific determination, and it unilaterally applies to all substances. You have to examine the substance in question using chemistry or microscopic imaging devices (science) to see whether the substance is one that occurs in nature, or if it's been synthesized in a lab or factory to create a new and different substance - IOW, it's not an FDA opinion or other type of ruling, it's black and white fact. EE-EPA does not occur in nature, nor can the human body create it, so IMO it's a synthetic drug, period, end of story.

After the first determination was made for the very first case where this question was asked, that should have been the end - the FDA decision covers all future questions, establishes precedence - I just cannot see any other way of interpreting this based on my scientific background, which of course doesn't take FDA politics or other contradictory rulings into account. I also can't imagine FDA making a determination that would set themselves up for the massive workload of having to make individual decisions for every DS on the market - but OTOH, I believe that's exactly what they claimed in their ITC letter - that if AMRN gets what they want, it sets FDA up for a slew of other drug makers filing similar complaints, so perhaps that supports the view that they are claiming they did NOT make a scientific determination in prior cases, which begs the question "on what basis was the determination made if science was not used?" - and I don't know how to do that w/o science, as explained above. Unless they're simply leaning on "has an IND been submitted for the substance prior to the DS appearing on the market" stuff, which to me still doesn't jibe with synthetic vs. naturally occurring regulations of FDCA. FDA has just made a huge mess for themselves IMHO.