Amarin's ($AMRN) lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AstraZeneca, who is awaiting FDA approval for its own product for treating super-high cholesterol.
PACER 5-5-2015 18:25 EST
Nothing new...we wait.
Judge Randy Moss isn't taking this long to have his decision overturned in an appeals. Yep, the FDA was write...takes about 2 seconds.
This decision sets case law and exposes the FDA to significant damages if properly litigated by Amarin stakeholders.
Anyone that followed my rants on Ihub knows the FDA's in deep do do related to Post and Comment rule making. This is likely just the first of all documents that need to be properly posted and commented on. FDA has made unilateral decisions for years under fraudulent pretenses with stakeholders, this included censorship of scientific data. It should make the news tomorrow.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1419]
Withdrawal of Draft Guidance Documents Published Before December 31, 2013 AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is taking this action to improve the efficiency and transparency of the guidance development process.
IMO PDUFA never gets approved again, Woodcock "retires", NIH takes over Scientific FDA roles, FDA is a shell pushing papers for NIH
I was given "fair" warning on cussing, the violation that was used to silence me. Shoot! and darn! are my go to's:)
Disagree, Additionally, as Staff Director of the Subcommittee on Labor, Health & Human Services, Ms. Hallett managed the staff responsible for negotiating the budgets of three cabinet agencies and 14 related agencies, boards, and Commissions. She helped prioritize funding for the NIH in a flat budget, and crafted and successfully negotiated an Ebola supplemental for HHS. In addition, she has worked closely with NIH senior leadership on a number of high impact science policy issues."
She will navigate Francis Collins as "Science" on drug development is turned over to NIH. FDA has proven time after time they base decisions on influence and money (PUDUFA) fees...the new Bill will likely abolish "PDUFA fees"... Fee's will be applied, but they go to NIH science and not further growth of FDA staffing.
In the new proposed legislation, there's no mention of PDUFA....FDA has answered EPADI CP...they have not answered Senate SPA question due months ago. IMO it's doubtful Senate approves any new appropriations for FDA without a major overhaul and that would include new CDER leadership. Dr. Woodcock is not going to be part the the solution...think she get's it?
Appointment of Adrienne A. Hallett as the Associate Director for Legislative Policy and Analysis, NIH
May 1, 2015
It gives me great pleasure to announce the selection of Adrienne A. Hallett as the Associate Director for Legislative Policy and Analysis and the Director of the Office of Legislative Policy and Analysis (OLPA). She will join the NIH on Monday, May 4, 2015.
Ms. Hallett comes to the NIH with 14 years of experience on the staff of the United States Senate Committee on Appropriations where she served most recently as Senior Policy Advisor. During her tenure she worked with Senator Harkin to conceptualize, draft, and promote the Accelerating Biomedical Research Act. She was charged with conducting government-wide oversight of the Ebola and other infectious diseases initiative enacted in 2014, and advised Senator Mikulski on biomedical research and health care across the government. Additionally, as Staff Director of the Subcommittee on Labor, Health & Human Services, Ms. Hallett managed the staff responsible for negotiating the budgets of three cabinet agencies and 14 related agencies, boards, and Commissions. She helped prioritize funding for the NIH in a flat budget, and crafted and successfully negotiated an Ebola supplemental for HHS. In addition, she has worked closely with NIH senior leadership on a number of high impact science policy issues.
Adrienne brings a wealth of resources to the position, including broad contacts across all branches of government and in the private sector, skill in strategic management and negotiation, and complex policy development experience. I am confident that she has the perfect combination of talents needed to successfully lead this critical NIH function.
I want to recognize and thank OLPA Acting Director Lauren Higgins for her outstanding leadership of OLPA since July of 2014. Lauren will continue her important contributions to the NIH as she serves in her role as the OLPA Deputy Director.
Please join me in welcoming Adrienne to the NIH and offering her your full support.
Francis S. Collins, M.D., Ph.D.
FDA is not represented tomorrow, just NIH
I congratulate OREX management for having the brain to keep Nissen in the dark...I'd still be wary of the FDA...they will try to get even.
Panel 1 Witnesses Hamburg and NIH director...
Don't know if this is the start of something big...but it does precede budget discussions.
Amarin has enough evidence to completely evicerate the FDA at this point. The new theory, amongst some HF managers, is the FDA tanked Anchor so Amarin would be FORCED to finish REDUCEIT. The FDA feared that Amarin would drop the trial after an Anchor approval. Ya know what that's called in America? Illegal antitrust. The FDA has fired numerous maggots that perpetrated the crime but this doesn't protect the US Governments liability for these employees actions. The FDA is beyond repair and the plan is to dismantle it and realocate Food to Ag and likely Drug to NIH. Amarin will start to aggressively go off label and I dare the FDA to try and stop them.
Early spring, yes Amarin has Crestor/Vasepa...this would be a NCE, Crestor/Vascepa would not be NCE
This is a NCE under new FDA combo guidance...the hydroxy formulation has superior bioavailabilty over Lipitor and the Lipitor combo has the greatest inflammatory reductions of the tested Statins... Pravastatin ... is "untested" to my knowledge...
Reformulated drug to not infringe, now have to retest....absolutely stupid idea but AZN won't hire me to consult;)
They're also going to take it to a different indication other than CV...and likely try and combo it with a pschy drug...
At some point in the game Amarin won't be for sale...I'd say we're a few Months out from that milestone.
Also happens to be the day OIG meets with House Appropriations Committee to give the report on 2014 Investigations...this is a public document and I will post any and all Amarin related investigation.