Reflections on the NCE hearing...
About 130 pages of transcript...
Judge Moss is deferential to both sides..surprisingly polite and generally helpful.
Chris Sipes (Covington) for AMRN
Entwhistle (From DOJ) and Shoshona Hutchinson (FDA)
Sipes is very sharp and extremely well prepared he is 1-800-FDA Law..and serves as a reference source on citations (cites) for the judge and the FDA.
FDA council, not so well prepared. Frequently just parroting the judge.
Arguments are almost solely about the distinction between the terms "active ingredient" (AI) and "active moiety" (AM). Statutes (the law set down by congress) rely heavily on AI...Sipes argues the FDA changed its mind after 2009, in the 2014 Vascepa case. Historically the FDA has considered the AI of a naturally occurring mixture (Lovaza, surfactants et al), to be the mixture itself. In the Vascepa case the FDA argued that EPA was an active moiety contained in the Lovaza mixture and therefore V did not meet the requirements for the NCE exclusivity.
Sipes argues that definition for generics is they must have the same AI as the initial drug and Vascepa does not contain DHA, so it does not have the same AI as Lovaza and deserves exclusivity.
Lot of arguing over the intentions of H-W to promote innovation in drugs, and the FDA must maintain some consistency in its dealings, otherwise capital will not take risks in drug innovation, if the FDA is constantly changing the rules.
The impression here (mine) is that the FDA may have felt that Amarin was "gaming" the system, because they were taking a product in plain sight (EPA) and not something that had been engineered by chemists and computers.
The FDA's arguments are not strong and many boil down to, "thats the way FDA does things"..but the judge is deferential. Telling point is when the judge said, "So active ingredient was just a slip by congress." Clear the FDA utilizes AI and AM interchangeably in a manner that suits the FDA best.
FDA asserts Amarin's interpretation of the exclusivity AI requirement would disrupt the entire regulatory process..Sipes completely shoots this down, citing several instances where the FDA changed policy and the "world didn't end"...and corrected FDA earlier contention that a mixture (Lovaza) could have an active ingredient, but two active moieties..with 1997 FDA position that "the active moiety in a natural mixture is the mixture itself..and recent single AIs derived from previously FDA approved mixtures have been given the NCE..
Judge at end of session offered both parties a period to reconsider their arguments, and meet again..Judge also promised a speedy decision on the matter..
":>) JL
