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not exactly, he was saying this proves the FDA doesn't really believe this is new significant information, i.e., it's lying
No, I'm agreeing with you that Viscera reduces health care costs by preventive medicine. But one of the panelists at Adcomm mentioned increased costs if approved. It appears the FDA wants absolute proof of efficacy that it will reduce costs and would rather not have expensive new drugs. But the big problem now, Obama under pressure to show cost reductions immediately, reducing pharmacy charges now will do that, me taking Viscera incurs a cost today, probably saves thousands in a few years.
right but we need to convince him of that, he's only thinking of immediate pharmacy charges that will show up, preventive medicine takes longer to show up.
Justice? I doubt it, I still believe this whole thing is to reduce immediate Obamacare costs. Obama, Holder, FDA are all working together. Amarin is correct legally, if it can only fight the unlimited US legal budget.
Yes I think everyone thought Amarin was stupid and would lie down and let the FDA get away with this. I haven't heard a single argument this board has thought up that wasn't brought up today at the CC.
Of course the petition alone won't influence the FDA. But the combined effort of masses of the populace, recruited congressmen, and the real threat of a legitimate legal argument will.
These lawsuits are good, Amarin can either fight the FDA in court now or the stockholders later on
Yes, everyone needs to contact all relevant Congress members! No matter how well-written one letter can be, it can be easily ignored, mass mailings are not ignored. Include name, address, phone number, occupation
yes, US common law comes from English common law, there is specific prformance
the FDA will respond to a citizen's petition in the proper format, but this hasn't been prepared as of yet
all that is true, if you can convince Obama Vascepa will show reduced immediate costs of Obamacare it will be allowed, but all they see are increased pharmacy charges.
I've been faxing your letter to congress, it's not ready?
reasonable doubt is a criminal goal, this would only require preponderance of the evidence
not true, if Amarin can show irreparable damages if contract not enforced and good chance of winning, the contract would be immediately enforced with a temporary injunction until trial completed
I posted on drugs.com and WebMD, i'll try men's health, keep posting more sites you find
Did they have a SPA though?
That's is the problem, but that drug sales rep fought the FDA in court this year and won when they tried to stop him from promoting off label.
I think the real issue is what is the real purpose to allow the FDA an out, probably to protect public health and what were Amarin's expectations in agreeing
But I don't think they need to wait for December, the FDA has already formally noticed it will not honor the agreement, Amarin will be irreparably harmed by waiting until December.
You're right, but I think you can agree both sides have an argument and a compromise at the meeting would be best for all. I don't think stating it's an agreement or a contract really matters.
This needs to be followed up on, first positive thing I've seen so far that's actually happening
SPA is described frequently in the FDA guidelines as an "agreement." It's offer acceptance consideration duties, can't get any more contract than that.
If you look at any of the medical society guidelines, evidence based medicine has been around for awhile. They all rank each guideline on how much evidence there is for each recommendation. Treating triglycerides is based on evidence.
UCSF is currently doing an "Health eHeart Study" because regular studies have gotten "so expensive and burdensome."
I think it is true, the main thing is can Amarin stand up to the FDA with more legal resources. Hopefully at the meeting some deal can be worked out satisfactory to both parties.
Can these posters that have recently called Amarin and spoken with Joe clarify this or call again and ask
The FDA didn't have until December to act, it has to give notice and allow a meeting. This all seems expected after the BD and certainly after Adcomm. We were all saying Joe was lying when he said FDA had not contacted, now we know he was telling the truth and promises to go full ahead on this. If he can fight the unlimited legal resources of the FDA is the real question.
The announcement from Amarin today only says FDA will not approve label that says CV risk reduction, but if you read original Amarin announcement just posted it only says reduce trigs and try to without raising LDL. Maybe the FDA is only trying to beat back the SPA as it expanded, and certainly expanded well after the science changed. This is new science but it's also new legal issues. The Adcomm is hard to beat though, FDA convened and manipulated to cover itself with something that on first glance seems solid evidence.
I don't think Amarin has to wait until December to file a lawsuit, the FDA today rescinded the agreement, that's the actionable part. The lawsuit would be filed now for an injunction to prevent rejection in December or force compliance with the agreement. We'll see at CC in November what route they plan on taking or possible deal.
Or will a successful Reduce-It serve as cover for all the other drugs? Everyone wants Reduce-It completed including the recent Adcomm panelists. Lovaza is still selling well, Niaspan is still recommended in the medical literature. One of this board's fears was all these new meds in the pipeline. Vascepa will be the only choice out there even if its label might not change.
That way of thinking they'd have to pull a lot more than Vascepa, it's the only safe one
Another issue, good news, Medscape reports today hospital removing dietary supplements from formulary to comply with Joint Commission as aren't regulated and not safe.
Your conclusion on what happened is very wrong. The announcement says FDA rescinds SPA, it did not delay it, it dissolved the agreement on grounds it considers part of the agreement, to allow dissolution for new science.
Maybe Amarin can get what some say is the original agreement, to reduce triglycerides with no mention of any other benefit
That's nullification, the agreement was Reduce-It had to be started, not completed. Amarin completed all its duties.
But they can say the broad policy change is due to new scientific evidence.
Geez just got email article from Web MD, saying that triglycerides cause atherosclerosis and need to take fibrates to lower triglycerides as long as they don't raise your cholesterol will prevent heart disease!
Sure all that is true, but any cost savings from Vascepa are not immediate, Obama doesn't wasn't Sean Hannity going over the balance sheets with cost increases next year.
I think what speedrunner said was Amarin thought the FDA was planning on voting no but Amarin was going full speed ahead to change that which would include legal means. Maybe speedrunner can clarify it give an update?
One thing noted, I don't see any mention any notice from the FDA and a Type A meeting scheduled prior to breaking the SPA at PDUFA. Are these formalities necessary with the FDA with Amarin prior to the December PDUFA as most contend?
When did Amarin say that?
But, the good thing for Amarin, is the FDA rules start out saying a SPA does not need to be followed if public health is at risk and then follows with the new scientific evidence. Qsymia had severe risks found by Adcomm and was eventually approved with restrictions. Vascepa has no public health concerns, it's all economic, increasing Obamacare care costs, allegedly.