not true, the Court in Caronia included pharmaceutical companies and their representatives in its ruling, the rep did fight because it was a criminal conviction and companies just pay the fine rather than risk losing, Amarin will ask a judge to rule for it before trying off label but has same rights as reps.

that's not true at all, SPA includes labeling agreement, the sNDA has not been decided, the SPA was rescinded, there is no new PDUFA date. PDUFA is an act of Congress

you're last paragraph can't be true. the FDA said all endpoints for SPA were met, it was rescinding the SPA

yes Congress did, section 505(b)(5)(C)(ii) of the Act. The harm public health is from the PDUFA letter from the Clinton administration, but adopted by Congress. they are both in FDA Guidelines. See the comment from the House Appropriations Committee

This is part of the PDUFA Goals Letter, referred from the new House document, section VI.A.5 states that a SPA can't be altered unless public health concerns unrecognized at the time:

VI. SPECIAL PROTOCOL QUESTION ASSESSMENT AND AGREEMENT
A. Procedure: Upon specific request by a sponsor (including specific questions that the sponsor desires to be answered), the agency will evaluate certain protocols and issues to assess whether the design is adequate to meet scientific and regulatory requirements identified by the sponsor.
1. The sponsor should submit a limited number of specific questions about the protocol design and scientific and regulatory requirements for which the sponsor seeks agreement (e.g., is the dose range in the carcinogenicity study adequate, considering the intended clinical dosage; are the clinical endpoints adequate to support a specific efficacy claim).


2. Within 45 days of Agency receipt of the protocol and specific questions, the Agency will provide a written response to the sponsor that includes a succinct assessment of the protocol and answers to the questions posed by the sponsor. If the agency does not agree that the protocol design, execution plans, and data analyses are adequate to achieve the goals of the sponsor, the reasons for the disagreement will be explained in the response.


3. Protocols that qualify for this program include: carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim. (For such Phase 3 protocols to qualify for this comprehensive protocol assessment, the sponsor must have had an end of Phase 2/pre-Phase 3 meeting with the review division so that the division is aware of the developmental context in which the protocol is being reviewed and the questions being answered.)


4. N.B. For products that will be using Subpart E or Subpart H development schemes, the Phase 3 protocols mentioned in this paragraph should be construed to mean those protocols for trials that will form the primary basis of an efficacy claim no matter what phase of drug development in which they happen to be conducted.


5. If a protocol is reviewed under the process outlined above and agreement with the Agency is reached on design, execution, and analyses and if the results of the trial conducted under the protocol substantiate the hypothesis of the protocol, the Agency agrees that the data from the protocol can be used as part of the primary basis for approval of the product. The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

yeah, but also thought referring to changing NCE rules, so good chance to vent other FDA changes that are hurting AMRN

it was from a post from Biobill around May 18 from same site as current SPA thing:http://www.fdalawblog.net I can post entire blog if you want but not at computer now

yes Adcomm, Dr. Hiatt the real villain in all this, gave cover to FDA

I wonder if the SPA investigation started with the HELP Committee:

Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances
By Jeffrey N. Wasserstein –

We have previously noted that FDA has increasingly regulated through issuance of guidance documents – rather than through notice-and-comment rulemaking as required by the Administrative Procedure Act. The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) has also taken note of it, albeit without the flair and occasional snark our readers have come to expect from the FDA Law Blog!

Earlier this week, Senator Lamar Alexander (R-TN), the ranking member of the Senate HELP Committee, along with Senators Richard Burr (R-NC), Johnny Isakson (R-GA), and Orrin Hatch (R-UT), sent a letter to FDA Commissioner Margaret Hamburg “to express significant concern about [FDA’s] use of draft guidances to make substantive policy changes.” The letter notes that draft guidances are becoming default FDA policy, notwithstanding that they are issued for comment purposes only. Moreover, draft guidances are not revised, finalized, or withdrawn in a timely manner. Although the letter doesn’t mention it specifically, we note that some guidances (see, e.g., here) have been kicking around in draft form since the last century. The letter also notes that these guidances often do not take into account – or even worse, conflict with – the views of the scientific community. As we’ve noted in the past, this would be solved with notice-and-comment rulemaking.

A lot of us wrote letters to the HELP Committee, if you notice all Republicans, good way to separate and conquer, keep up the letters!

there probably are politicians in bed with FDA corruption but it's all politics, we need to support the politicians that could gain an advantage sorting this out

this may have started out as an Amarin issue but breaching SPAs breaks down the entire program that Congress set up to allow drug development. Plus throw in some probable FDA and Adcomm corruption and it's much bigger than Amarin.

wow! Federal Court can use this for Congress' intent to interpret law and get sympathy from judge. keep up letters to Congress, also need to endanger public health rescind SPA

I've always considered wild salmon a perfect food, the life-cycle is so short they don't have time to accumulate mercury like tuna

I pay $9 per month, 4g daily, savings card from Amarin

I pay $9 per month, 4g daily, savings card from Amarin

how did Lovaza get 14.2 on it label and how does Vascepa get it on its label? 14.2 shows treatment of high triglycerides significantly reducing triglycerides non-HDL-C and raising HDL-C

even if that's true that all politicians are corrupt, politicians of one party like to get an advantage over the other. if you notice post 27254 all mentioned are Republicans. They would love to find corruption in the FDA administered by a Democratic President.

i'm no fan of the FDA but it can't delay a drug without that statement, the delayed company would immediately get an injunction from a federal judge. they had to make that rule to keep frivulous requests and wrong delays, you need a good reason to delay drug and you might have it

Bio, you might want to just sign the statement, it's truth to the best of your knowledge. By asking for that statement it might be a sign the FDA is taking your petition seriously. They just kind of ignored the EPADI petition request for a delay.

Bio, as I remember whenever you request a delay you have to certify additionally under penalty of perjury. I questioned how the EPADI petition did not include this also

Bio, I didn't see where NLA said to treat trigs >150, it says optimal <150 and metabolic syndrome includes >150, and to treat trigs >500?

yeah what does with or without omega 3 mean in relation to Reduce-it?

Bio, why doesn't your article mention Amarin's suing the FDA for NCE also?

Dr. Hiatt Adcom, NEJM, financial conflict of interest, causes hemorrhage and hyperglycemia LOL

wrong, BioChica is correct, the price is n US dollars not, 1,86 is an error.

not as good news as Kowa but today Medscape down again on statins:

http://www.medscape.com/viewarticle/822462?src=sttwit

Amarin needs to bribe politicians as big pharmaceuticals do:

AB881
Regulate the cost of prescription drugs.
In January 2004, Yee voted against the bill in committee.
The bill died in committee on 6-10 vote.
Yee reported nearly
$46,000 in campaign donations from opponents of the bill from April 2004 through 2010.

if he could sell Niaspan for that much money must be a genious, Abbott is smarter than GSK, looks good

no the Medscape CME isn't just O3, it clearly shows why Vascepa is superior to dietary supplements and Lovaza, mentions Anchor, Reduce-it, and JELIS favorably, and says bleeding and hyperglycemia not problems

nice Medscape CME, like advertisement for Vascepa:
http://www.medscape.org/viewarticle/822066?src=wnl_edit_tpal

the FDA"gag rule" is only relevant if the "agency is not a party." When the FDA is a defendant the court and discovery rules determine what is relevant and subpoenable, FDA gets no special treatment.

FDA records can be used in court, employees will testify if records inadequate and testimony important. You can only take the Fifth if the testimony woul incriminate you criminally, no execption for FDA. Judge can force all documents and testimony in NCE trial to become public knowledge.

that's rediculous the judge would laugh at you for selling at wrong time

haha, lawyers suing Lipitor!

http://evidencespeaks.com/lipitor/index.php?cid=200&afid=3&usid=6063&sid=FB1018

it's a well known fact that lawyers at the bottom of their class make the most money

not true Dew, black box warnings are used for stuff like that, see FDA Guidance for Industry section IV.A: "e.g., reduced effectiveness in certain patient populations"

Another government agency changing policy to reduce Obamacare costs and being sued in court:

FTC Releases Policy Paper on APRNs as U.S. Supreme Court Agrees to Hear Major FTC Case
Friday, March 07, 2014
On March 7, the Federal Trade Commission (FTC) released a new policy paper titled “Policy Perspectives: Competition and the Regulation of Advanced Practice Nurses” (APRN). This primary care focused paper frequently references the 2011 IOM Future of Nursing Report. Encouraging lawmakers to exercise caution when considering scope of practice matters, the paper reviews the background of APRNs and scope of practice matters; as well as competition advocacy comments by FTC staff.
FTC involvement in state level legislative and regulatory activity is a growing concern for the ASA. In correspondence and a face-to-face meeting, ASA had previously expressed concern to the FTC about the Commission’s letters to state medical boards and legislatures inducing boards and legislatures to take action contrary to patient safety.
On March 3, the U.S. Supreme Court announced it would hear arguments in North Carolina State Board of Dental Examiners v. FTC. Under review is a federal appellate court’s decision to support a Federal Trade Commission (FTC) order that the North Carolina State Board of Dental Examiners violated federal antitrust laws when it issued cease-and-desist letters to non-dentist teeth-whitening providers in the state.
Previously, the ASA joined the American Medical Association, the American Dental Association, and other healthcare groups in a friend of the court brief in support of the North Carolina State Board of Dental Examiners’ request for review of the appellate court’s decision. That brief was filed November 27, 2013.

I don't get it, generics can't use the name Vascepa and if they are not equivalent to Vascepa they aren't Vascepa, they're something else, which will be known to all. Am I missing something?

more investigation might reveal the mechanism for neurocognitive adverse events associated with statins

the only thing I know is that Amarin said there was a delay in the normal predicted schedule because Amarin set a second set of more detailed questions to the FDA