Any suggestions for my letter to Senators? Thanks
Honorable Senate HELP Committee members,
As an Amarin stakeholder I am extremely disappointed FDA/CDER/specifically Division of Metabolism and Endocrinology Products (DMEP) does not share the values America was based on. Since the fall of 2012, I've studied FDA Statutes, Regulation, MAPPs, Guidance for Industry documents, past FDA approvals, Case law; followed blogs; contact CDER Ombudsman, FDA Ombudsman, numerous Congressional Reps and Senators; to find no solid base for the four primary significant Regulatory changes made unlawfully by unilateral CDER decision making. It's been an exhaustive process; I'm utterly horrified FDA has continued a process of unilateral interpretation and application of law. Stakeholders’ have been silenced over the years with unusual posting practices for both Rule Making Dockets and Citizen Petitions. On many occasions, outright censorship of both science and stakeholder opinion has occurred. The Federal Court system is littered with legal cases against the FDA or directly due to FDA activity involving Amarin. Amarin has been a plaintiff in 7 Federal cases (6 Generic ANDA Patent Law suits, 1 Law suit initiated by Amarin seeking NCE) and defendants in 4 (Investors litigating Amarin based on FDA rescindment of SPA). All litigation and damages, to Amarin stakeholders, is due to four primary significant changes made to Regulatory Schemes by unilateral FDA decision making. Here's a list of the litigation:
1:14-cv-00324-RDM AMARIN PHARMACEUTICALS IRELAND LIMITED v. FDA
3:13-cv-06663-FLW-TJB SKLAR v. AMARIN CORPORATION
3:13-cv-07210-FLW-TJB SIEGEL et al v. AMARIN CORPORATION PLC et al
3:13-cv-07793-FLW-TJB Bove et al v. Amarin Corporation, PLC. et al
3:13-cv-07794-FLW-TJB Bentley v. Amarin Corporation Plc et al
3:14-cv-02550-MLC-TJB AMARIN PHARMA, INC. et al v. APOTEX, INC. et al
3:14-cv-02551-MLC-TJB AMARIN PHARMA, INC. et al v. ROXANE LABORATORIES, INC.
3:14-cv-02760-MLC-TJB AMARIN PHARMA, INC. et al v. DR. REDDY'S LABORATORIES, INC. et al
3:14-cv-03259-MLC-TJB AMARIN PHARMA, INC. et al v. WATSON LABORATORIES, INC. et al
3:14-cv-03558-MLC-TJB AMARIN PHARMA, INC. et al v. TEVA PHARMACEUTICALS USA, INC.
3:14-cv-03924-MLC-TJB AMARIN PHARMA, INC. et al v. ANDRX LABS, LLC et al
The FDA will argue Amarin and stakeholders are simply unhappy because the FDA disagrees with Vascepa NCE, Anchor SPA; and the agency is simply understaffed to respond to stakeholder complaints. Neither is a convincing arguement; FDA has unilaterally changed four Regulatory Schemes historically followed without the proper rule making procedures. First Amarin was not assigned exclusivity with 7-26-2012 Marine NDA approval; historically the Regulatory Scheme has been to assign market exclusivity with approval. Then in 2014 CDER DMEP notified Amarin via public meeting they plan to change the long regulatory scheme of approving drugs using “untested” surrogate markers; even with a current SPA Amarin will be the first this policy is applied to. At this same meeting, DMEP notified Amarin they intended to rescind Anchor SPA based on their new Regulatory Scheme. After this meeting, Amarin stock, traded on NASDQ, crashed losing $1 Billion in market cap. Finally, Amarin was awarded NME 2-21-2014 and denied 5 year NCE. Any of the above significant changes in regulatory schemes would provide a significant hurtle for small Biopharm; all four is beyond comprehension and warrants your intervention.
FDA has failed to answer a Citizen Petition requesting reversals of two of the four significant changes in regulator schemes. FDA has also failed to answer SPA related requested by YOUR committee in 2015 Omnibus. Amarin is currently being litigted for fraud related to the FDA's rescindment. (see above cases)
21. Special Protocol Assessment
The Committee is aware that questions have arisen in connection with the rescission of a Special
Protocol Assessment [SPA] Agreement. While FDA can rescind a SPA agreement reached under
section 505(b)(5)(C) of the Food, Drug, and Cosmetic Act if certain requirements are met, the
Committee expects that FDA should be accountable for continued diligence in in identifying
issues that bear on a SPA agreement and in notifying the sponsor of such issues within a
reasonable period of time after FDA becomes aware. To ensure clarity over the standard to
rescind a SPA agreement, the Committee encourages FDA to revise and re-issue, after public
comment, its existing guidance regarding SPA agreements, including the statutory standards
associated with the rescission of such agreements.
FDA Response
The statute permits an SPA agreement to be rescinded if “a substantial scientific issue essential to
determining the safety or effectiveness of the drug has been identified after the [clinical trial] has
begun.”64 FDA takes SPA agreements seriously and has rarely rescinded an SPA agreement.
Since FDAMA was enacted in 1997, CDER has issued over 1000 SPA agreements. Fewer than 1
percent have been rescinded. SPA rescission decisions are made on a case-by-case basis after
careful review of the circumstances to determine whether the statutory standards have been met.
FDA is working to revise the Guidance for Industry: Special Protocol Assessment to clarify which
protocols qualify for review under SPA, clarify the SPA process, provide sponsor options after
receipt of a Non Agreement Letter, and add a new section that describes rescission of an SPA,
including the opportunity for the sponsor to meet with FDA prior to rescission. We anticipate
publication of the revised draft guidance by the end of calendar year 2015.
In conclustion, FDA has shown no sign of changing practice of significant rule changes; the most recent example is 2015 Otsuka Pharama v. FDA. The FDA changed regulatory scheme offering generic to compete despite Otsuka's Pediatric Orphan status designation through 2021. The case is active and provides further evidence the FDA’s agenda does not match signed Statues and current regulations. These ongoing practices of unlilateral law making and aplication make stakeholder wary of any FDA future descinsions related to Amarin's ongoing cardiovascular trial, REDUCE-IT. It is vital Amarin stakeholders get answers to the Citizen Petition submitted to Dr. Woodcock on December 5th, 2013. These unilateral changes in regulatory schemes have shaken every stakeholders trust throughout the industry. For these reasons please request Dr. Woodcock answer Amarin stakeholders petition before approving any budget for an agency’s that does not abide by the laws you pass.
I implore you ask Dr. Woodcock specifically about the comments to this docket:
ID: FDA-2013-P-1612-0005. Comments 0410 through 0425+ have been generated after the FDA Dockets Management have changed their posting policy’s.
Thank You,
