Revised:
Virginia,
A consortium of Amarin stakeholders request that Dr. Janet Woodcock reinstate Anchor SPA immediately. (Before Wednesday June 17th) Stakeholders have exhausted ALL administrative means by submitting and commenting to Citizen Petition FDA-2013-P-1612. On March 27th Dr. Woodcock sent denial letters to these stakeholders effectively covering ALL Amarin stakeholders; Dr. Woodcock uses a non-finalized guidance document to excuse the denial. This excuse is not convincing nor will it hold up in court.
In her official duties Dr. Janet Woodcock was directly supervising numerous CDER employees. Specifically the last Official meeting held to discuss Amarin’s SPA appeal. At this level Dr. Woodcock was the ranking member of this meeting and with her vast regulatory experience she did not stop and inform the committee they MUST reinstate Anchor SPA. The excuse of rescindment was outside FDA Regulatory jurisdiction and scheme. FDA does not have the jurisdictional powers to practice medicine, a fact the courts have ruled on numerous times. The “ regulatory judgement" used by FDA to rescind SPA was not a safety or efficacy judgement, it was a medical judgement. Furthermore, this medical judgement does not meet the current standard of care.
These actions and damages are cognizant under Federal Tort Claims Act (FTCA) and are ripe to be submitted.
Numerous stakeholders intend to file and follow through to Class Action if needed.
Amarin stakeholders respectfully request , in the full scope of her administrative powers, Dr. Woodcock reinstate Anchor SPA.
Please send a receipt this message was received by your office.
Thank You,
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