Replies to post #17818 on Amarin Corp Plc (AMRN)

[exwannabe]

Re: Legal action

No, I am not saying the FDA is immune.

I am saying that they will be treated as the "primary court" (sorry, I do not know lawyer speak) that determines the facts.

The courts can rule against the FDA, but they will grant the FDA the ability to do the fact finding. And they will also grant them the ability to make that key decision that the science has changed. This puts a high burden on someone trying to win a case here. They can not simply try to prove the FDA wrong, they will have to prove the FDA was somehow capricious or otherwise not following the law in making their determination.

If there is any hope at all in getting an approval pre R-IT, it will be with cooperation from the FDA. A private "we can not afford to run R-IT to completion" discussion has a better chance than the lawsuit would (though I think it is hunker down time regardless).

[yellow_bluff]

The FDA can indeed be sued.

[jessellivermore]

linh..

THe FDA is not immune to the rule of law and can, and is sued and has lost suits

http://www.naturalnews.com/032190_health_claims_FDA.html#

The FDA has the power to determine whether foods or drugs are safe or effective, but it still has to base its decisions on factual information, and not conjecture or speculation...The FDA in its parental role also has a responsibility to know significant facts about the drugs it is evaluating, including scientific information, and can not "cherry pick" facts which support its basis and exclude facts which inconveniently do not.

The above citation is in regards to a situation analogous to AMRN's labeling for expanded indication. There is a wealth of information based on hard science that EPA can and does benefit people with diabetes and atherosclerosis. AMRN has a right to include that information on its label..and will win in court if that happens..

":>) JL