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Sunday, June 23, 2013 11:04:56 AM
The current FDA is set to torpedo Anchor and NCE. The citizen petition is locked and loaded. When the decision to retro Lovaza's OB active ingredient is made the decisions will come down. There's no legitimate reason to have an Ad Com with Vascepa safety and Anchor results. Amarin as a company is refusing to fight out of fear of FDA retailation. C-Path needs Amarin to fail.
Non-Retaliation Policy
At the FDA, our mission is to protect, promote, and enhance the public health. We also have important responsibilities to the industries we regulate, including working to bring new products to the market and minimizing regulatory burdens.
In carrying out this mission, FDA employees are required to make many decisions and take many actions involving complex clinical, scientific, legal, and factual issues. In this context, questions can be, and have been, raised about the fairness of agency proceedings and retaliatory actions-against companies which challenge or criticize the agency.
We take such concerns and allegations very seriously. Without question, companies are free to vigorously challenge agency positions and requirements, and to freely voice their views to the agency, the press, the public, and the Congress. One of our fundamental duties is to be scrupulously fair, even-handed and objective. We can accept no less. Fear of retaliation among those we regulate may chill scientific, legal and policy discourse, depriving the agency of information crucial to sound judgments and decisions. Given our special responsibilities, all FDA employees must make every effort to avoid even the appearance of unfairness or retaliatory action.
Because of the critical importance of these issues, any allegation of retaliation should be reported immediately to the Office of the Ombudsman. In addition, anyone with concerns about retaliation or related issues should contact that office. Such matters will be treated in confidence, and the office will work with other agency offices to address all relevant issues.
http://www.fda.gov/AboutFDA/ContactFDA/ResolveaDispute/HowtoContactanOmbudsman/Non-RetaliationPolicy/default.htm
The CDER Ombudsman has put me touch with a CDER tow the line Pharm D, it was also great to see the Director of Marketing for GSK on her Linkedin page. I will keep the saved picture of this private. I'm sure her job is to just string me along until the Citizen Petition is answered. I now suspect the petition came through C-Path but this should all come out in the Senate Hearing if the FDA want to persist down this road.
I have enough circumstantial evidence to level some serious accusations.
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