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This is why exclusivity will start at date of Orange Book update:
From Judge Mosses court 9-29:
s that the approval letters signify completion of the FDA’s process for reviewing and approving a manufacturer’s NDA. . . . Some requirements that may remain after the FDA sends such a letter are ministerial and do not affect the finality of that approval. In those circumstances—including when the manufacturer will have to finalize a label to reflect DEA scheduling—the FDA does not need to consider further any aspect of the NDA and so it treats its “approval” as final. In other cases, however, the requirements that remain are substantial and will require further substantive review and approval. In those cases, the agency expressly requires further action in its approval letter as a signal that the FDA has concluded that its process is not yet completed. Although not the only method that the FDA might use to differentiate applications that require no further substantive review from those that still demand some significant approval, the approach the FDA has adopted is a reasonable one. The operative statute makes it necessary for th e FDA uniformly to define the “date of approval,” and the agency drew that line in a reasonable place. The Court, accordingly, concludes that the FDA’s interpretation of 21 C.F.R. § 314.108(a) is not “plainly erroneous or inconsistent with the regulation,” and it thus defers to that interpretation
Plausible IMO
Amarin patents just approved 9-22 that create further barrier to AZN entry...so I really don't see the point in studying the unknown compound. It's unclear if they're using old or new Epanova formula. Study started when Amarin was still litigating their patents.
It really odd.
BB
Starting in October FDA will be transparent... Not until then though:
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-23389.pdf
Fine...one parting post...FDA is screwed
Executives at health care companies are increasingly pushing back against the Food and Drug Administration’s ability to regulate them, and two Minnesota men are on the front lines of the high-stakes legal fight.
A pair of unrelated criminal indictments were handed down during a recent five-month span, charging two Minnesota medical-device company executives with conspiring to illegally market their wares despite clear rejections from the FDA. The cases fit with a trend of federal prosecutors targeting executives for charges, rather than just the deep-pocketed companies they run.
But the two executives — former Acclarent sales executive Patrick Fabian and current Vascular Solutions CEO Howard Root — have joined a burgeoning movement challenging what they see as the FDA’s unconstitutional restrictions on commercial speech.
Both Minnesota men are trying to expose secret grand jury hearings and undermine the indictments because they believe prosecutors inaccurately portrayed what devicemakers can and cannot tell doctors and hospitals.
A judge heard oral arguments on Fabian’s grand jury concerns last week. The judge in Root’s case is in the process of deciding whether to dismiss the case based on what has already been revealed
http://www.startribune.com/med-tech-executives-look-to-turn-tables-on-federal-prosecutors/328270541/
Any idea where this could lead?
See ya Ihub,
BB
HD
I can't lay this out any clearer without a Hungarian translator...the FDA must grant exclusivity only after Generic suit is finished...this is the Congressional intent of law. FDA Regulation doesn't supersede the law I have provided dealing with 5 years of being free of generic litigation. NCE will only be updated when generic suit is done and the date will start at this date. Any date prior to Generic law suit conflicts with the Congressional intent of law.
If Amarin is awarded starting from approval, as you propose, this goes against intent of law...no generic law suits.
The delay and incorrect ruling of exclusivity factually costed Amarin $150 million plus attorney fees. No exclusivity prevent upfront partner payment for launch and also any hope of BO.
The FDA should be writing Amarin $200 million check just based on NCE alone. (speculation)
Fact....Congressional intent was for generics to not litigate innovators of new drugs for at least 5 years...this obviously was not Amarin's case.
NCE will be through 2020.
Amarin has had trouble getting Generic suit stopped because the FDA has failed to update the OB...FDA has failed to update OB because Watson appealed....
The FDA's intent is to delay Vascepa for as long as possible...whatever their motives are (piss us off more or help PCSK9's) doesn't even matter...
Now Janet is holding on to power by a biosimular string and promises of saving health care $40 Billion with the approval of a biosimular...definition that goes against FDA mission statement...it's laughable!
Biosimular legislation must go, but that for another day;)
BB
HD
FDA regulation is based on US law, it MUST conform with the law passed by Congress. A Federal Judge can rule the FDA Regulation doesn't match with the intent of US law. If in fact this happens, the FDA has two choices, change Regulation or Appeal to a higher court.
This is how it works...period. These are the Laws the FDA has based their interpretation of when FDA attorney's wrote FDA Regulations. Specific to NCE is the 5 years of protection awarded to a new drug product. The ONLY intent of Congress was to keep the generic filers off the backs of the innovating company. This is clearly spelled out in the law (ii).
The law contains no makeup for the innovating company if the FDA get's beat in Federal Court and accused of arbitrary and capriciously failing to meet the intent of the law.
There's no justifiable means for the FDA to rule Amarin is granted 5 years of exclusivity at approval when they have been battling generics in court. ZERO! ZERO chance the FDA can rule Vascepa 5 year NCE started on July 26th with approval when they have been in court still in court with generics.
I can't spell this out any clearer....FDA MUST grant exclusivity for Vascepa when the OB is updated and Generic law suit is done...period...FACT!!!
BB
21 U.S. Code Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S. Code Chapter 9, Subchapter V - DRUGS AND DEVICES
21 U.S. Code Part A - Drugs and Devices
(ii) If an application submitted under subsection (b) of this section for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b) of this section, is approved after September 24, 1984, no application which refers to the drug for which the subsection (b) application was submitted and for which the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted may be submitted under subsection (b) of this section before the expiration of five years from the date of the approval of the application under subsection (b) of this section, except that such an application may be submitted under subsection (b) of this section after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A) of this section. The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.
I can guarantee the Pacira Document is tantamount to the joint letter.
Don't forget NIH and Brigham's joint resolvin patents... a conflict of interest shared by 3 October 16th 2013 Ad Com members. I have proof the FDA CDER Ombuds was notified of this conflict prior to Ad Com.
BB
You forgot Pacira...FDA must respond to Pacira's First complaint Oct 26th.
BB
HD
This is NOT, "In line with the Congress intent and the Court (Moss) ruling, FDA will grant NCE for 2012-2017." DOJ states "FDA’s interpretation would fail at step two of Chevron" page 3 of the most recent appeal filing on 9-15-2015. This is the motion to dismiss Watson appeal.
When step two of Chevron is breached there is no fix in the statute, if so Judge Moss would be obligated to order FDA grant NCE starting from statute date; date of approval.
"If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute . . . Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute."
"the statute" is silent on when to start NCE after decision is delayed for 18 months then wrongly assigned.
"Based on permissible construction of the statute"....Amarin has NOT benefitted from NCE yet, Otherwise they wouldn't have me and you bickering about when it starts!
When to start exclusivity is being discussed by Amarin and FDA. I'd guess FDA shared intent to start at the day of update not approval with Watson...this is likely the redacted portion of this filing.
BB
++++++++++++++++++++++++++
Info on step two Chevron:
The Court, in an opinion by Justice John Paul Stevens, upheld the EPA's interpretation. A two-part analysis was born from the Chevron decision (called the "Chevron two-step test"), where a reviewing court determines:
First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute . . . Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.
+++++++++++++++++++++++++++
Full DOJ (Not FDA) Motion to dismiss Watson appeal:
This action under the Administrative Procedure Act was instituted by Amarin Pharmaceuticals, challenging a determination by the Food and Drug Administration. Appellant Watson Laboratories was not a party to the district-court proceedings. The district court vacated the FDA decision and remanded the matter to FDA for further proceedings.
Page 2 of 9
has not appealed. But after the district court’s decision, Watson moved to intervene and filed a notice of appeal. Watson’s appeal should be dismissed for lack of jurisdiction. Watson is not a party to this case. And even if Watson were a party, it could not appeal the district court’s order, which did not finally resolve the matter but instead remanded the case to FDA for further proceedings.
STATEMENT
Amarin Pharmaceuticals manufactures Vascepa, a drug that has been approved by FDA as an adjunct to diet to reduce triglyceride levels. Amarin sought a five-year period of marketing exclusivity, known as “new chemical entity” or “NCE” exclusivity, that is available for certain approved new drugs. See 21 U.S.C. §§ 355(c)(3)(E)(ii), 355(j)(5)(F)(ii). FDA concluded that Vascepa was not eligible for five-year NCE exclusivity and denied Amarin’s request. Amarin instituted this lawsuit under the Administrative Procedure Act. On May 28, 2015, the district court granted summary judgment to Amarin. The district court agreed with Amarin that the statute unambiguously foreclosed FDA’s interpretive approach. Summ. J. Op. 18- 36; see Chevron U.S.A. v. Natural Res. Def. Council, 467 U.S. 837, 842 (1984).
Page 3 of 9
The court also concluded, in the alternative, that FDA’s interpretation would fail at step two of Chevron, and was arbitrary and capricious. Summ. J. Op. 36-39. The district court thus “vacated” FDA’s “decision denying Amarin’s claim for exclusivity” and “remanded to the FDA for proceedings consistent with this Opinion.” Id. at 40. FDA is currently engaged in the remand proceeding required by the district court’s order.
On July 22, 2015, Watson Laboratories, which was not a party to the case, moved to intervene for purposes of filing a notice of appeal. Watson contended that its own applications for drug approval were affected by whether Amarin was entitled to a five-year period of exclusivity, and that it sought to appeal the district court’s order. Watson contemporaneously filed a notice of appeal, which caused this Court to docket this appeal. Amarin and the government both opposed Watson’s intervention motion, and the district court has not yet acted on it.
ARGUMENT
1. Because the district court has not yet acted on Watson’s motion to intervene, Watson is not a party to this case. As a nonparty, Watson has no right to appeal. See Marino v. Ortiz, 484 U.S. 301, 304 (1988) (“The rule that only parties to a lawsuit, or those that properly become parties, may appeal
Page 4 of 9
an adverse judgment, is well settled.”). Until the district court acts on Watson’s motion, Watson has no right to pursue an appeal in this Court.
If the district court denies Watson’s motion to intervene, Watson can appeal that order. See Alt. Research & Dev. Found. v. Veneman, 262 F.3d 406, 409 (D.C. Cir. 2001). But unless Watson obtained reversal of the denial of the motion to intervene, it could not otherwise appeal the district court’s decision. See id. at 411 (“Because the district court correctly denied intervention, NABR is not a party to the action and does not have standing to appeal [other orders of the district court]; the court dismisses the appeal from those rulings.”).
2. Even if the district court grants Watson’s motion to intervene, Watson’s appeal must still be dismissed because this Court lacks jurisdic- tion over a private party’s appeal of an order remanding a matter to an agency for additional proceedings.
“It is well settled that, as a general rule, a district court order remanding a case to an agency for significant further proceedings is not final” and thus is not appealable under 28 U.S.C. § 1291. Pueblo of Sandia v. Babbitt, 231 F.3d 878, 880 (D.C. Cir. 2000) (internal quotation marks omitted). This jurisdictional rule “promotes judicial economy and
Page 5 of 9
efficiency by avoiding the inconvenience and cost of two appeals: one from the remand order and one from a later district court decision reviewing the proceedings on remand.” Sierra Club v. U.S. Dep’t of Agric., 716 F.3d 653, 656 (D.C. Cir. 2013).
There are two exceptions to this general rule, but neither applies here. First, a remand order will be considered final if the remand is for solely “ministerial” action. Pueblo of Sandia, 231 F.3d at 881. For example, this Court concluded that a remand order was purely ministerial when it was limited to “modifying the retroactive effect of the [arbitration] award . . . to 150 days before the date of the arbitrator’s award.” Verizon Wash., D.C. Inc. v. Commc’ns Workers of Am., 571 F.3d 1296, 1301 (D.C. Cir. 2009). Such ministerial actions require no substantive work or exercise of discretion after the matter is remanded.
The order at issue here does not merely contemplate a ministerial act by FDA, but rather contemplates significant further proceedings. The order vacated FDA’s decision denying Amarin’s claim for five-year exclusivity and “remanded to the FDA for proceedings consistent with this Opinion.” Summ. J. Op. 40. This remand order requires FDA to reconsider Amarin’s claim for a five-year period of exclusivity in light of the Court’s
Page 6 of 9
opinion, and to issue a new written decision on that claim.
In a letter to FDA, counsel
for Watson stated, XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX CENSORED XXXXXXXXXXXXXXXX
???????.” Letter from James N. Czaban to FDA, June 17, 2015, at 2 (Dkt. 40, Ex. A).
Second, an order that remands a matter to an agency may be appealed by the agency itself, even if the order contemplates significant additional administrative proceedings, because “a government agency cannot later challenge its own actions complying with a remand order.” Sierra Club, 716 F.3d at 656-657. But that exception does not apply to a private party, which “may still challenge the remanded proceedings—as well as the remand order requiring them—after the proceedings are complete.” See id. at 657. In Sierra Club, an intervenor that agreed with the underlying agency decision sought to appeal a district-court order that had remanded the matter to the agency for further proceedings, although the
?
Page 7 of 9
government agency abandoned its appeal. Id. at 656. This Court dismissed the intervenor’s appeal for lack of jurisdiction, holding that the remand order at issue was not a final order and that a private party therefore had no right to appeal. Id. at 656-658.
This case is controlled by Sierra Club. Here, as there, a private party that agrees with the original agency decision seeks to appeal a district- court order remanding the matter to the agency for significant further proceedings, even though the government has declined to appeal. This appeal should be dismissed for lack of jurisdiction.
Page 8 of 9
CONCLUSION
For the foregoing reasons, this appeal should be dismissed. Respectfully submitted,
SCOTT R. MCINTOSH
s/ Daniel Tenny
DANIEL TENNY
(202) 514-1838
Attorneys, Appellate Staff Civil Division
U.S. Department of Justice 950 Pennsylvania Ave., NW Room 7215
Washington, DC 20530
?SEPTEMBER 2015
This is against the wording of Statute, but it's the intent of Congress FDA CORRECTLY assign exclusivity at approval date. The two court case wins and DOJ wording arbitary & capricious in appeal docket support this decision.
This with label change could start to repair damages. Label should be full Anchor with JELIS study and information about REDUCEIT to confirm results with lower LDL in U.S. population.
Nothing less should be accepted by Amarin.
BB
JL
What the FDA doesn't have the power to do is be arbitrary and capricious. Moss has explained the decision doesn't match the regulatory intent of congress, which is 5 years of protection. DOJ has stated in last appeal docket filed to court of appeals, FDA was arbitrary and capricious. There is no other way for the FDA to unwind the mistake, congressional intent was 5 years at date of approval...this clearly didn't happen. The only way to achieve original intent is to award 5 years at the date of the OB/decision date.
Anything else would be arbitrary and capricious...which is a label the FDA can not afford to have attached to either NCE or First law suit win.
BB
Interesting proposal but it could open FDA to litigation from combos with NCE + old drug...which IMO should happen anyway. FDA came out with that policy in 2014 and refused to retroactively apply it.
The two Amarin court victories have no doubt altered FDA business practices.
BB
FDA Cardiovascular bar changes depending on what?
Total studied 7020
8.3% of the 2,333 patients who received a placebo in the study died,
5.7% of the 4,687 patients who got either of two doses of Jardiance
Rate of deaths per 1,000 patients per year, it drops 35% to 19.4 deaths per 1,000.
=================
Clinical Trials review:
REDUCE-IT 12-2011
4-2015
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjectshttps://clinicaltrials.gov/ct2/show/NCT02422446?term=vascepa&rank=5
empagliflozin
BI 10773
https://clinicaltrials.gov/ct2/show/NCT01131676?term=empagliflozin+%2B+cardiovascular&rank=1
Last updated May 10, 2015
First received: June 5, 2015
Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function
Great question...from a physiological standpoint theoretical they could. Mechanism of Lily drug is to excrete glucose via kidney in urine. One on label warning is the potential for an increase in LDL. A combo drug would have to be studied....obviously.
BB
From a legal stand point both FDA and Amarin need Watson Appeal to go away...the major issue I have is the appeal should have never occurred...FDA doesn't comment on open legal cases.
OB is updated for day but not for August...90% chance it doesn't update with exclusivity...small chance it's changed to not exclusivity determined yet for this product. Might happen next week.
BB
Orange Book Data Updated Through July 2015
Patent and Generic Drug Product Data Last Updated September 18, 2015
FDA has until Oct 26th to end the dispute with Pacira. Due to the proximity and nature of both Pacira and Amarin cases FDA needs to close out issues with both parties.
IMO if FDA decides to argue merits of Pacira case this information will impeach any hope the have against defending against Amarin. They have really no hope in defending against Amarin...
FDA really screwed up the Science and Regulation with Amarin stakeholders...then when justice was requested Pacira case pops onto radar.
This will be (already has) a landmark case against FDA either in court or settlement.
BB
Amarin - Pacira - Stack
Today Judge grants Government until Oct 26th to reply to Pacira complaint.
Full docket text for document 28:
ORDER granting [27] Letter Motion for Extension of Time. The Government's time to oppose the motion for preliminary injunction is extended until October 26, 2015. (Responses due by 10/26/2015). (HEREBY ORDERED by Judge Edgardo Ramos)(Text Only Order) (Ramos, Edgardo)
Amarin & Pacira may not be directly connected but CEO of Pacira is on Amarin Board of Directors
Amarin v. FDA is stayed until Oct 30th.
With the timing of these two dockets I'm concerned these two cases stem from FDA's harsh feelings towards Amarin.
BB
YouTube Amarin off-label
Outstanding legal review of the situation.
"[I]t has now been over four years
since April 2011 when Amarin
demonstrated the effect of Vascepa®
on patients with persistently high
triglycerides and Amarin still cannot
freely communicate the results of
the ANCHOR trial in a truthful and
non-misleading manner without
fear of criminal prosecution and
civil liability due to FDA’s regulatory
regime.34"
However, there are
important limitations to the court’s
decision in Amarin that must frame
its applicability. While the court went
deeply into the merits of the case,
the opinion reflects a ruling only on
Amarin’s motion for preliminary
injunction. The opinion provides,
however, a great deal of insight into
the court’s thinking on the matter and
its eventual ruling, should the case
proceed. The government has a number
of options at this point, one of which
is to file an interlocutory appeal. The
government’s next move may have a
significant impact on this ruling.
While this ruling in Amarin, coupled
with the Second Circuit’s decision
in Caronia, appear to foreclose FDA
from prosecuting a pharmaceutical
manufacturer for truthful and nonmisleading
off-label promotion, it is
important to note that this precedent
has only been established in the
Second Circuit to date and there is
considerable uncertainty as to how
sister circuits would rule if faced with
the same set of facts. The venue for
future litigation concerning off-label
promotion, whether initiated by a
pharmaceutical manufacturer or FDA,
will be a matter of strategic importance
for future litigants, whether on the side
of industry or the government.
Could see close to a 20% bump compared to holiday.
BB
James-
I have emailed this abstract to Woodcock, I will post any reply she gives me. After Amarin's 60 days are up I'm considering reviving my CP requesting Warning letters be sent for the LDL bumps seen in the Diabetic Metabolic Syndrome population with mixed Omega's and Fibrates.
BB
Lost Anchor revenue % of Fibrates, Lovaza, and generic L, toxic financing $150 M, damages due to pharmacological liable (fish oil : snake oil) propaganda campaign waged through Forbes.
Add this in. Guessing more like $7 Billion plus
BB
Lol on the sweet spot pun.-BB
This is a study I intend to forward to FDA leadership.
BB
Study was from Kaiser population, Vascepa is not on Kaiser's formulary. Sad. This is the Anchor rescinment population...wonder if this study could estimate cost of increased CVE compared to a Vascepa treated population.
BB
Risk of future coronary heart disease (CHD) among individuals with diabetes and 'metabolic dyslipidemia' (high triglycerides [TG] and low high-density cholesterol [HDL-C] levels) remains a matter of concern. Little is known regarding risk of CHD for this phenotype with low-density lipoprotein cholesterol [LDL-C] levels <100 mg/dL. We analyzed a diabetes cohort of 28,318 members (ages 30 – 90 years) of Kaiser Permanente Northern California during 2002-2011
"Third, the Government
intends to use the additional time requested to explore whether the parties can amicably
resolve or narrow the issues raised by plaintiffs’ motion."
The power of the Amarin ruling...consider settlement before Woodcock opens her mouth.
Pacira could push this and show the efforts to communicate with the FDA prior to suit...this could get painful for FDA.
BB
FDA (Government) requested an extention of time to respond to Pacira suit, filed today:
BY ECF:
The Honorable Edgardo Ramos
United States District Court
40 Foley Square
New York, NY 10007
Re: Pacira Pharm., Inc. et al. v. U.S. Food & Drug Admin. et al., 15 Civ. 7055 (ER)
Dear Judge Ramos:
I write respectfully on behalf of all defendants (the “Government”) in the abovereferenced
case to request a thirty-day extension of the Government’s time to oppose the
motion for a preliminary injunction that plaintiffs filed on September 9, 2015. Plaintiffs
consent to this request. Under Local Rule 6.1(b), the Government’s opposition papers may be
due as early as September 23, 2015, with three additional days possibly added pursuant to
Federal Rule of Civil Procedure 6(d) because service was effected by certified mail. This is
the first request for an extension or adjournment by any party.
The Government makes this extension request for three reasons. First, plaintiffs’
motion raises a number of complex issues that require extensive coordination between
Government counsel and subject-matter experts at the U.S. Food and Drug Administration.
Second, under Federal Rule of Civil Procedure 12(a)(2), the Government ordinarily has sixty
days to respond to a complaint against its agencies and officers. Third, the Government intends to use the additional time requested to explore whether the parties can amicably
resolve or narrow the issues raised by plaintiffs’ motion. We thank the Court for considering
this request.
Yes, Woodcock is set to waste Senate HELP committee time tomorrow updating Biosimulars ... that tone will give us a clue to gauge congressional pressure.
BB
The wording used is settlement...not negotiation. Amarin should settle for nothing less than REDUCEIT label.
EOM
BB
Wow...missed this...First Judge assigned to Pacira case was Ronnie Abrams she's the daughter of First Amendment lawyer Floyd Abrams.
Good reason to reassign a new Judge...bet the FDA was crapping their pants in the mean time...
BB
White House announces intent to nominate Robert Califf – Commissioner of FDA, Department of Health & Human Services
I assume his mission will be to bring science to the FDA.
Bennet, Burr, Warren, Hatch Introduce Bill to Help Patients by Facilitating Faster Development of Drugs for Rare Diseases
Bipartisan bill would help pave the way for advancing new drugs for rare diseases
IMO 21st Century Cures Act is dead on arrival at Senate HELP committee. Likely back door negotiations moving Califf into FDA head and killing the bill. FDA will not have to defend it's First Amendment losses if Cures bill is not debated. Again, the 21st Century Cures bill sitting in committee at Senate HELP, bill contains a mandate for FDA to update off-label speech 18 months after passage of bill, this was written prior to FDA NCE and First court losses.
The new Bipartisan bill saves important rare disease language...hopefully will contain monetary settlement for Amarin.
BB
Zum
This could be used as a base for a new indication for Vascepa, preventing patients for kidney failure and hemodialysis (HD) would save billions in healthcare dollars. Cardiovascular patients on HD have a 50% chance of having a CVE per year, so it would obviously be linked to reducing CVE if these patients could be kept off HD.
BB
Raf
ANCHOR label will prevent change ups at the pharmacy level. This is a real problem that I know is happening.
General Medicine and Family Medicine docs will be more likely to prescribe on label.
Label change will treating increase the insurance coverage Vascepa has today. It will be the only on label drug that treats high trigs without increasing LDL in metabolic syndrome patients.
The FDA has damaged the launch and reputation of Vascepa, not sure a label change can cure this.
BB
Hiatt had conflicts, I'm not concerned about the ad com. The ongoing litigation and information shared with Watson by FDA Defense attorney will have severe repercussions for the FDA. Dr. Hiatt is not a dangerous criminal, he's a Cardiologist basically volunteering his time away from his clinical practice to participate in Advisory Committees....something you couldn't pay me to do.
My only focus now is how the DOJ intends to make Amarin and stakeholders whole.
BB
Page was updated 9-15-2015 and does not have Pacira letter.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm?Page=11
Today Pacira case reassigned Judges
NOTICE OF CASE REASSIGNMENT to Judge Edgardo Ramos. Judge Ronnie Abrams is no longer assigned to the case.
BB
PATIENT ADVOCATE LANA KEETON SUES J&J AND FDA FOR CRIMINAL OBSTRUCTION OF JUSTICE UNDER FEDERAL RICO STATUTES
DEAD WOMEN MATTER
Yikes FDA...
http://meshmedicaldevicenewsdesk.com/patient-advocate-lana-keeton-sues-jj-fda-for-criminal-obstruction-of-justice-dead-women-matter
Agree, but when your arbitrary and capricious with NCE ruling...then leak confidential legal information prior to completion of case to a party that was admittedly not involve in the proceedings you've push past arbitrary nature of the original sloppy job. Per DOJ filing Watson should have never been in a position to appeal. Only after Watson was informed, where they privy to a decision they chose to not be actively involved in.
Did the FDA have the right to disclose confidential information to Watson prior to closure of the case? No!
DOJ notified FDA it was not going to appeal NCE case, so why did the FDA notify Watson prior to case closure? Certainly not because they where in a hurry to resolve this 3+ year process.
FDA's actions have surpassed an arbitrary nature.
This seems to be an Obstruction of Justice.
"Obstructing the Due Administration of Justice consists of (1) the defendant obstructing or impeding or attempting to obstruct or impede the due administration of justice in a pending court proceeding or investigation and (2) the defendant doing so by threats of force or with intent to undermine the integrity of the pending proceeding or investigation. For the D.C. Court of Appeal’s most recent decision interpreting this statute, please click here."
BB