The text...Page 95 of the trial transcript..
"THE COURT: Let me ask you this. As I've
articulated here, is that in fact what the FDA -- go
ahead.
MS. HUTCHINSON: The opposite. We would, in
fact, think that there is not a way to create a
separate rule for this situation. It's all or
nothing."
The context for this runs back to at least page 69 and is too complicated to do much other than a brief synopsis. The issue is the FDA's handling of natural mixtures which do not conform to the easy decisions in cases where there is one identifiable drug. The FDA usually defines the the entire mixture as the active ingredient (the AI). The mixtures sometime do not contain identifiable AIs, others like Lovaza are clearly mixtures of two well known components, EPA and DHA. Calling the mixture itself the API can benefit the drug company when it comes to fighting off generics.
What the FDA has done in a very inconsistent manner is to introduce its own term..active moiety, a term not named in the H-W congressional statutes. By introducing its own creature into the mix, the FDA can then change the definition of AI to mean one thing in the FDA approval process, and anther in the determining of exclusivity. They do this e.g. by calling the mixture the AI in the approval, but for other drugs seeking exclusivity, they identify "active moieties" within the mixture and use them to deny the exclusivity. This process trashes the statute term AI. Also the FDA has been very inconsistent in its policies on this issue, with many situations just like Amarin where they gave the NCE.
The judge prior to the above passages had been fairly dismantling FDA's
disregard for congress and their inconsistency. He acknowledged that mixtures created a good deal of ambiguity and did not want to throw the baby out with the bathwater (sounds like me, but he said that). And suggested that maybe the FDA could come up with a halfway position, When Shoshana Hutchinson (FDA) chimed in.
Reviewing this again...Still think the judge was seeing things the way Amarin does.
":>) JL
