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Janet got both cajones kicked by the judges...luck of the Irish? So happy to see that arrogant jerk get taken down!
Zip, on cc yesterday JT said upon a favorable decision. Amarin had a plan to get the word out to the medical community but would not elaborate until the decision. I would hope he now imparts his plan to us in the next week....
Thank god it's only your opinion....reduce it will be the defining moment!
Ironic that those who would have us believe that Vasecpa is no better than supplements, yet here is BP fighting to take it generic....
I keep forgetting we live in a banana republic....
"The Government lacks knowledge or information sufficient to form a belief as to their truth or falsity and thus denies them". This language seems to be coomonplace in our government these days, and thus avoids accountability for its actions. how many times is this sentence communicated in the latest filing? It is a sham!
How can our beloved FDA be left in charge of American lives if they lack knowledge or information so often?
This is unbelievable.....
Not sure how your comment makes sense as the marine indication is what's current and being prescribed and is not being mistaken for ds fish oil. Wouldn't the education you suggest be more about positive effects on anchor population in addition to marine? Why would docs confuse this with ds fish oil?
I'm continually amazed at the ineptness of the FDA, as well as their arrogance!
Healthcare news...JULY 13, 2015
21st Century Cures, Amarin Court Case Advance
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John Kamp, executive director at the Coalition for Healthcare Communication
John Kamp, executive director at the Coalition for Healthcare Communication
Although communication policy about medicines often moves slowly in Washington, two events last week portend advances not seen in decades.
You've no doubt heard about the overwhelming vote in favor of the 21st Century Cures bill, but you may have missed the drama in a New York federal courthouse early in the week. In Washington, the House of Representatives passed a historic medicines bill. In New York, the FDA weakly defended its off-label marketing policies and set up the judge to issue a likely order limiting the FDA's off-label enforcement.
Taking the Cures bill first, the House voted 344-77 in favor of measures that promise faster cures to American patients by spurring research at the National Institutes of Health, speedier drug and device approvals at the FDA and more robust communication with industry and providers. The next step is the Senate, where the companion bill has thus far languished but will likely be taken up this fall in time for enactment later this year or early next.
The House bill is formidable—over 300 pages—and would enact multiple provisions related to research, approvals and communication. The bill would require the FDA to streamline the drug-approval process, consider more flexible forms of clinical trials and incorporate patient experience into its decision making. Further, it would require the FDA to consider doctors' clinical experience of a drug as well as clinical trials, and it encourages the agency to use new approval standards incorporating biomarkers, new clinical trial designs and surrogate endpoints.
Although largely ignored by the popular press, the bill's three communication provisions could well open the door to much more robust communication and marketing by our industries.
First, the Physician Payment Sunshine Act provision sheds new light on shady interpretations by the Center for Medicare and Medicaid Services on education issues. The amendment, backed primarily by a coalition of medical societies, publishers and others coordinated by the Coalition for Healthcare Communication, was co-sponsored by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR). Clarifying the original intent of the Sunshine Act, the provision would exempt from Sunshine-reporting certified CME events and the acceptance by doctors of medical reference texts and journal reprints.
Second, the payer-communication provision would significantly expand long-standing provisions that enable drug sponsors to talk openly with payers about some off-label issues, especially economic and comparative-effectiveness studies. This provision expands both the audience and the scope of the discussion, enabling discussion with “payers and similar entities” and increasing the range of studies that can be discussed.
The third communication provision sets a deadline for the FDA's repeatedly delayed further guidance on off-label communication. Related to that, in the New York courtroom last Tuesday, off-label enforcement was the point of discussion. The argument did not go well for the FDA as the agency staunchly defended existing off-label marketing restrictions and refused to set a timetable for issuing guidance.
There, eminent First Amendment litigant Floyd Abrams argued for the plaintiff, drugmaker Amarin, that the court should file a preliminary injunction restraining the FDA from enforcing certain off-label restrictions on Amarin's marketing communications. The Amarin court challenge was set up by two major federal court decisions casting doubt on the constitutionality of off-label restrictions: the 2010 US Supreme Court decision, Sorrell v. IMS Health, striking limits on drug marketing in Vermont; and the 2013 federal appeals decision, US v. Caronia, invalidating the conviction of a drug detailer for sharing truthful and non-misleading information that was off-label.
Early in the argument, Abrams stipulated that Amarin intended to engage in proactive, promotional, off-label speech. Much of the subsequent discussion turned on what disclaimers needed to accompany that speech, not whether Amarin has a right to speak.
Later, the FDA's lawyer argued for a very narrow interpretation of Caronia, emphasizing that the decision turned on a faulty jury instruction. Paul Engelmayer, a federal judge for the US District Court for the Southern District of New York, disagreed, noting that the decision in his view stood for the proposition that truthful, non-misleading speech was constitutionally protected—even when it was proactive and promotional. A judicial order is expected within two to four weeks.
Bottom line, it was a good week for those seeking to expand treatment options to patients and to increase the communication about those options to clinicians.
John Kamp is the executive director at the Coalition for Healthcare Communication.
Perhaps in Espana, under generalissimo Franco the FDA might have prevailed, but here in the good ol USA we hold dear to our freedom of speech amendment....Amarin will get a positive decision.
I've been long 4 years now and have never seen any positive outcome for Amarin to be very painful for shorts...therefore if history is any lesson, this trial although seemingly going Amarins way, will once again not be painful for shorts. Probably because it's been my longest held investment...:(
JL, my comment was in reference to your comment about lawyers having so much influence over physicians behavior...I would think insurance companies do too. I've been lucky tho, I'm covered for off label. And been in the stock since 2011. But I certainly am not fond of insurance companies and their shenanigans!
You forgot to mention insurance companies as another gatekeeper....
$9m is a rounding error when it comes to Medicare payments, yet V hits the radar? Something don't smell right!
Per my previous post, just draw up a new contract Janet, requiring Amarin to complete reduce-it while allowing for an expanded label based on anchor data....(which brings us 360degrees from ad com and appeals).
Problem solved !
It's definitely a long read, perhaps Janet is hoping the judge will fall asleep reading this primarily boilerplate paper describing the duties of the FDA and it's challenging role in protecting the public from the bad guys...( meanwhile I'm thinking about all the bad drugs the FDA allowed the public to consume).
I have to laugh when they emphasize substantial scientific evidence needed in the approval process, yet the studies they cited as a reason to reject anchor are highly questionable substantial science. Furthermore, it's lame on their her part to emphasize the safety aspect in all drug approvals, when in fact this drugs safety profile is one of the best I've ever encountered. But it does appear that she is focusing on reduce it not being completed by Amarin if Amarin was given anchor approval or win the lawsuit.
So I say to Janet, then you wouldn't object to a contract between Amarin and the FDA much like anchor spa that would require reduce it to complete while an expanded label for the anchor target population is allowed?
Of course the idea of some body reneging on a contract much like the.FDA did might leave her squeamish....
I don't agree, Americans do care, it's just that the politicians we elect aren't getting the job done and the election process is the best legal way to press for change...that and the legal system. Do you live in the U.S.?
Zu is this patent the first you've heard of it? It is for me and I find it quite interesting as my PSA levels are 12-13' but in two previous biopsy's, they were negative. I haven't tested since getting starting vascepa 7-8 months ago...maybe it's time to see if it's making a difference.
Protecting the statin boys? Page 10 describes the FDA worry that a physician may misapprehend the health claim amarin seeks and thus prescribe vascepa instead of a dietary change or prescribed statin therapy! Seems lame to me. And page 7 what does FDA mean by "recommendation"...when it comes to dissemination of anchor trial data...as to educational or scientific settings, and what constitutes "appropriate background or training to distribute such materials"? Is Amarin allowed not to follow FDA recommendations should they choose so? And can a sales rep have the appropriate background or training?
When will you be filing your lawsuit against FDA and HHS for damages? Or are you just venting?
I thought his presentation was fine and his choice of words to express his confidence in the outcomes study to be sincere.
Well I'm certainly not going to defend her, but I am hopeful that she is astute enough to delve into the reasons Amarin has filed this lawsuit...and see the error of her ways. The FDA brought this upon themselves opening the door for a precedent as Erika points out, but I don't see her or the FDA coming out ahead on this one, as a matter of fact, unless she reverses her opinion, she may find egg on her face. And if I'm not mistaken, I think Amarin is only asking to be able to speak freely to the medical community about anchor results.
Forbes is now posting reader comments and it looks like Erika is getting an education. I like seeing these comments, especially JL's comment inviting her to discuss the entire matter offline. It would be awesome if Erika stepped up and turned the tables on the FDA as she claims she seeks out fraud....
Well based on my own clinical trial, my chronic knee/joint pain has diminished quite significantly and for an old soccer player, this is a godsend. Wished they could get labeling for that symptom!
The authors inability to understand the truth is obvious, unless of course it's a hit piece designed to create FUD, which I believe is the case. You shouldn't be surprised about the comments!
JL, I tend to think that after two hit pieces from Forbes, especially today timed with NCE decision, Forbes is the mouthpiece for BP.
Wall st Journal weighs in. May 21st online copy. Check it out.
Equates to a corrupt federal agency....is my guess!
JL, one thing I'm wondering about is whether the ability to disseminate anchor results to the medical and patient population would result in a substantial script increase as the insurance companies might not cover as it would still be off label? Thoughts?
Kiwi, have to agree with you about deflection, I thinks this earning s miss caught everyone off guard and the timing off the latest lawsuit doesn't seem like a mere coincidence.
Consensus estimates were for loss of .11 a share and they came in at .18 loss..very disappointing and mgmt explanation was seasonal issues as well as how revs are determined (wholesale distr vrs script count). Seems a bit lame to me, but if the same holds true for competitors then it's valid.
But I would expect to have a great Q2!
15.6M
Forbes article makes no sense...on what basis is he saying Amarins notion of free speech for commercial/ corporate is different than that of the individual? And of course if they were to win, that marketing materials would be sent out...after all, that's the point isn't it?....to be able to convey the truth about anchor to the public?
More than publicity stunt kiwi...obviously it's garnering attention, but I believe there's merit behind this lawsuit and will be interesting to see how the FDA defends itself, as truth is all that the American public asks for.
I agree...long overdue especially since appeals travesty was dropped. Maybe Mgmt is thinking favorable NCE decision is imminent!
Thank god for V, otherwise I may have suffered a heart attack with all this behind closed doors wheeling n dealing drama!
JL is hear your logic, but it's my understanding that anchor approval was the vehicle to not only fund reduce it, but keep the company afloat. At the time the decision to not continue the appeals, funds were definitely in jeopardy, so if mgmt had an idea that reduce it results were great at the time or even hypothesize that they would be, how would that help them get thru the reduce it trial...without addt'l funding?
It's plausible that they did not have the manpower and/or funds to fight two fronts....I.e. the NCE lawsuit and the spa appeal, so maybe mgmt had to make a decision which one was more winnable in the short term...and when one thinks of it that way, with NCE you are in court hopefully with an impartial judge, and with appeals you have only the crooks at the FDA.
BB, we know that the FDA is crooked as a dogs hind leg. I agree the appeals should not have been dropped...at least without a viable explanation from Thero....he owes that to the shareholders. I certainly hope that mgmt has their ducks in a row legally speaking with the reduce it spa. I hate to think the FDA can get away with another spa sham. It's obvious that our congress has no teeth and is quite disheartening. You've put in a lot of effort to champion our cause, don't give up now because truth will prevail in the end.