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labner

10/31/13 2:59 PM

#19955 RE: raistthemage #19954

Another example of FDA corruption involving Hamburg (and Senator Grassley):


Maybe, she could care less about the Spa being rescinded. Fda is untouchable. This story points to corruption, insider trading all at the hands of Hamburg, after receiving warnings that her actions were conflict of interest and the discovery that she did not sell shares in dental company as she claimed. She disobeyed an executive order to band the use of mercury in dental fillings. This story came out months after her appointed yet she is still there. Not trying to be a conspiratist, just pointing out the obstacles we are up against.

http://www.toxicteeth.org/Grassley--F.aspx
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ziploc_1

10/31/13 3:06 PM

#19957 RE: raistthemage #19954

The SPA IS a contract, which the FDA can abrogate only in the face of new scientific evidence which comes to light between the signing of the SPA and the PDUFA date. Its clear the "scientific evidence" in this case did not have anything to do with Amarin's SPA for Vascepa. The FDA was intent on making new policy and decided to use Amarin as a tool.
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wmjenkins3938

10/31/13 4:02 PM

#19971 RE: raistthemage #19954

SPA is described frequently in the FDA guidelines as an "agreement." It's offer acceptance consideration duties, can't get any more contract than that.