Tuesday, September 08, 2015 4:13:49 PM
"Politics and the FDA. The FDA was worried at the Adcom that millions of people would be treated with Vascepa and hitherto unknown side effects might show up. I have noted the the FDA is especially sensitive to side effects when large populations are in line to be treated. It is safer for the FDA to disapprove of a drug which might have benefits than to approve of a drug which might do harm. The FDA is especially sensitive to criticism and although it it may get criticized for both approvals and disapprovals, the latter seem to be much worse. The fact that Vascepa has been used on 8000 plus patients without side effects may assuage some of the FDA's fears. "
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