My take on the FDA's argument.
The FDA's main point, which is repeated ad nauseum,
(1)...is that the FDA determined (from the three "trig studies) that adding further lipid altering drugs to patients on statins lower risk for CVD. Therefore the FDA determined there was insufficient evidence supporting the notion that EPA (and DHA?) would benefit CVD patients. As a consequence Amarin would be required to complete R-IT and prove benefits before the FDA would give them the label expansion to treat CVD.
(2)..By asking for the right to disseminate certain information that is clear and factual (eg. the ANCHOR results) FDA argues Amarin's only possible reason for wishing to publicize this material which deals with CVD is to circumvent the FDA's prohibition on marketing non approved indications. This is where the rubber meets the road. If the FDA's policies prohibit the marketing of an 'off label" indication, but what a company publishes is truthful and not misleading, then what is the law...The FDA argues of course the FDA's policy must prevail.
I ask you after reading the above paragraph..Is such a thing even possible? If the information is factual and not misleading and clearly suggests CVD benefits, then it must be FDA which is wrong in its interpretation of the facts. Or...the issue is so ambiguous that at very least doctors and others should be allowed to read the material and come to their own decision. There is a 14th century papal aspect to the FDA's thinking.
The bulk of the remaining FDA argument revolves around their sworn commitment to protecting the citizens and how they have the right to pistol whip the sponsors...
There is more than enough irony and Homer Simpson reasoning in the draft. The FDA argues it must protect the public against the dreaded dangers of "fish oil" components and frets fish oil may entice people to stray from the benign effects of statins. It argues EPA as a drug could pose much more of a threat than it would as a DS. How so?..The DS market involves many more people. The FDA seems to be unaware only a doctor can prescribe Vascepa, and he knows something about the drug and its side effects. The guy at GNC needs no credentials...and by the way, is the FDA aware of mercury levels in these unregulated "fish oils".
The real issue here (previously outlined), is the FDA doing its job. Does FDA actually know enough about the drugs and the conditions to make any reasonable decision about what is true and not misleading. The FDA has put a lot on the table here including the AdCom and their rejection of JELIS, and the rescinding of the SPA. I would not want to be the one defending these actions..All of which seem arbitrary and inconsistent.
":>) JL
