Sorry to repost... but currently sent to NYtimes, Chicago tribune, wall st journal, La times, newsobserver.com, newsday..
FDA-Public Health or Personal Profit
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs as it relates to the FDA's position on Amarin Corp.'s Vascepa. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for the expanded Anchor indication. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science and required outcomes, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation", it seems logical that other drugs with the same efficacy should be treated the same. Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers. AMR101 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and decreased apolipoprotein B (9.3%), total cholesterol (12.0%), very-low-density lipoprotein cholesterol (24.4%), lipoprotein-associated phospholipase A2 (19.0%), and high-sensitivity C-reactive protein (22.0%) versus placebo (p <0.001 for all comparisons).
I'm trying to comprehend the FDA's inconsistencies with regards to these different drugs. Again, the FDA states that "new science" is the reason they rescinded their SPA agreement with Amarin, but it is clear that the science they are using is not new at all.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. 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.
Please try to help me understand why an effective drug like Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies.
