I just sent this to FDA Ombudsman office, will let you know if I hear back:
Hello, I understand your office acts as an internal watchdog over the FDA to some degree, so I was wondering if you have been monitoring the recent events with the drug Vascepa between the FDA and a company called Amarin.
If you are already investigating this SPA rescission please let me know, as it is extremely suspect, and goes entirely against the SPA program.
If you are not yet investigating this series of events you should be, as millions of patients with high TG’s are being denied access to a safe drug for no good reason anyone can determine.
From the 10/16 Adcom that was run like a kangaroo court, to the sudden and likely illegal SPA rescission, to the appeal where the division did not even bother replying to the company’s questions, this whole situation has been designed to keep this indication from reaching the doctors who want it. Why?
At best this looks like complete incompetence from that division, and at worst something far more sinister like corruption. Visit this sit for much more detail and a copy of the recent Citizen Petition. www.epadruginitiative.com
If the FDA is denying a safe drug (which is ALREADY approved for another indication), to doctors/patients who need it, then they are killing US citizens for no discernible reason. I hope your office can shine some light on this situation and hold those responsible accountable for their actions.
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