After receiving this information we should...
I currently am requesting a $53 million settlement...perhapse other can work on this:
WARNING!!! Do not ignore the truth, it's provided to you in the FDA's own words. The FDA didn't grant NCE due to large indication and 8 generic ANDA itching to file. This decison was ponitifacate for 18 Months directly damaging Amarin's ability to conduct business. Anchor was rescinded for the very same reason.
REDUCE-IT changes nothing under these circumstances, the FDA wants to give REDUCEIT to the 8 Generic filers and you must act now to stop them. WE MUST GET THIS INFO TO CONGRESS, PRIOR TO THIS TUESDAY HOUSE MEETING.
The following are direct quotes from the 2014 exclusivity meeting prior to Janet Woodcock granting NME on 2-21-2014:
"Amarin Pharmaceuticals Ireland Limited and its U.S. affiliate, Amarin Pharma Inc. (collectively, Amarin) have requested that the Food and Drug Administration (FDA or the Agency) recognize 5-year NCE exclusivity for Amarin’s drug product Vascepa (icosapent ethyl) Capsules (new drug application (NDA) 202057).1 Amarin claims that eicosapentaenoic acid (EPA), the single active moiety in Vascepa, was not previously approved as an active moiety of any other drug, and Vascepa is entitled to 5-year NCE exclusivity because EPA is not a previously approved active moiety.
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Currently, eight abbreviated new drug applications (ANDAs) have been submitted and are awaiting a filing decision. If FDA concludes that Vascepa has 3-year exclusivity, the Agency can receive any pending ANDAs that are otherwise sufficiently complete to permit a substantive review. If FDA concludes that Vascepa has 5-year NCE exclusivity, the Agency must refuse to receive the ANDAs until at least 4 years from the date of the initial Vascepa approval. The Exclusivity Board concludes that Vascepa is not eligible for 5- year NCE exclusivity, because EPA, the single active moiety in Vascepa, was also an active moiety contained in another, previously approved drug, Lovaza (omega-3-acid ethyl esters) Capsules (Lovaza). Accordingly, the pending ANDAs are eligible to be received (if they otherwise meet the criteria for receipt of an ANDA)."
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Following this comment is:
"Prior Agency Actions
Although FDA generally considers the active ingredient of a naturally derived mixture to be the mixture itself, Amarin oversimplifies the analysis by asserting that this is also always true for the active moiety or moieties of every such mixture. Amarin asserts that the Agency’s prior practices establish that the “prior approval of a mixture a single-ingredient drug product will not preclude NCE exclusivity for later drug product containing a constituent of the mixture.”90 Similarly, the company alleges that “the active ingredient of a drug product comprised of a mixture is the mixture as a whole and not the individual constituents.”91
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Though we agree that the active ingredient of Lovaza is the Lovaza mixture as a whole, we disagree that this leads to the conclusion that the Lovaza mixture is also Lovaza’s only active moiety.
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(If this was the case the FDA would have granted Fuson Lovaza CP and OB both EPA & DHA on the record...preventing EPA from being first approved by Amarin as the first approval of Icosapent Ethyl Ester Active Moiety)
As discussed above, a drug product with a single active ingredient may contain multiple active moieties. The identification of the active moieties of a naturally derived mixture depends on how well the mixture can be characterized, whether the component in question is consistently present in the mixture, and whether there is evidence that the component is clinically active.
The prior actions that Amarin cites do not counsel a different outcome.
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Though the Agency’s past actions indicate that FDA has not had a fully consistent practice in this regard, and that it has even arrived at conflicting conclusions, this is not by itself sufficient reason to conclude that Amarin’s selective reading of these actions should be accorded conclusive weight."
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