your wish is my command
Senator Grassley,
In a letter you had written to Dr. Torti on March 24, 2009 you stated,
“Your memorandum appears to run contrary to many statutes protecting executive branch communications with members of Congress. I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA’s regulatory mission. [This] could be viewed as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower
protection laws. Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn’t working so we can fix it.”
Well to put it bluntly, the Government isn't working! You see Senator Grassley, history seems to repeat itself and again the FDA finds itself in the bulls eye. Just recently the FDA held an ADCOM meeting Oct 16th to determine whether the panel would approve Amarin's drug Vascepa for the expanded ANCHOR indication. The FDA states that "new science" is the reason they rescinded their SPA agreement days later with Amarin (listing the Accord-Lipid, Aim-High and HPS2-Thrive studies ), but it is clear that the science they are using is not new at all. First, their was no mention by the FDA of this new position at any point prior to the ADCOM and it was also missing in the FDA's sNDA acceptance letter. Again, this "new science" existed prior to the ADCOM but was never mentioned. Secondly, when agreeing upon the REDUCE-IT SPA, the results of ACCORD and AIM-HIGH were used by the FDA and Amarin to design REDUCE-IT. Amarin Corp has spent tens of millions of dollars in good faith based on a SPA agreement with the FDA and now has nothing to show for it.
Finally, there are many that believe a far more sinister reason for the FDA acting this way towards a company that has done all in it's power to do what has been asked of it. The reasons for this begins with the well known "Lovaza Citizen Petition, FEB 2013". This petition was drawn up by none other than John Fuson who happens to have ties to the FDA. This petition was nothing more than an administrative loophole to delay the New Chemical Entity decision for Vascepa and in essence was asking to have Vascepa's API listed retroactively in the OB . . In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. Oct 16th, the FDA steered the ADCOM panel to a negative vote by questioning whether their Anchor Indication will reduce CVE's. The SPA agreed upon by the FDA and Amarin never had CVE outcomes as it's endpoint. Amarin and the FDA had a separate SPA agreement for the Reduce-It Study that would provide this information.
All of these actions have resulted in major financial ruin for the company and it's shareholders. It is important for the American people to know that Big Pharma drug companies cannot use improper legal/administrative actions to secure their monopolies in their respective markets. The American people are losing faith in government. Here's hoping you receive this email and provide a timely response.
Respectfully,
AL
P.S. My Grandpa was born in Iowa and I have many family members that live in your great State. They all vote-Grassley
AI
