Reflections on the NCE transcripts...
It's pretty clear that almost no one this board has read these transcript,
There are some real bombshells in these proceedings, none bigger than the timeline of the FDA's actions regarding the NCE decision. This is from pages 50 and 51 of the transcript and is a dialog between Amarin's lawyer Chris Sipes and Judge Moss.
Sipes..On Aug 13 2008 the FDA told Amarin, "We view you as a new chemical entity ---You're going to get five years. We view you as an NCE and because of this you have to do extra studies , additional carcinogenic studies on two different types of rodents." They had to do studies on rats and transgenic mice.
In May 2009 the FDA notified the company that no decision had been made on the NCE and the agency would get back to the company regarding the decision..That didn't happen. On Feb 21, 2014 the FDA notified the company they were not getting the NCE.
Other issues.
Vascepa was the first chemical entity derived from a "natural mixture" that was FDA approved (in this case Lovaza) in which the API of the mixture was the mixture, that did not receive the five year NCE exclusion.
The FDA illegally changed the language of the statute defining "active ingredient, in essence making it subservient to "active moiety" an FDA invention. The illegality stems from the fact the statute does delegate authority to the FDA to make determinations because the the exclusions are set as FDA prohibitions. The court should apply ordinary rules of statutory construction. Only in in a case where there is extreme ambiguity should the FDA be allowed to change the wording..
I believe the court would also disqualify the FDA's actions regarding the SPA on similar grounds that the FDA has exceeded its authority. By changing the intent of the SPA, and interpreting the language to mean "significant scientific issue" was anything they decided fit their purpose.
I know so many of you think this NCE case will not and can not be used as spring board to an investigation of the FDA's nonsensical, capricious, and illegal handling of the SPA..And no one can say this will happen...But I believe the NCE situation is so egregious, that the judge may refer it to justice to investigate improper conduct by the FDA.
I know most of you will disagree. That's fine..I'm used to it..I remember when I posted that the PTO investigator had made a serious error..The message board howled at my arrogance and temerity. And guess what happened...The PTO investigator did make a very serious mistake which later was corrected...So howl on
":>) JL
AI
