To understand how this works, I encourage you to read the article in which I introduced the concept which you can find here. What follows is a brief excerpt.
This index is essentially a spectrum of subjectivity running from the malignant on the left to the benign on the right. I know that some of you will argue that to be human is to encompass all of those qualities on the far right side of the page, but for me, these are more divine attributes. Placing a product within this spectrum is done by assessing how much of an impact it will have on the ruling paradigm. In other words, FDA representatives, since the PDUFA act of 1992 depend on large-cap pharmaceutical companies for their very jobs, and consequently, are likely to subconsciously produce judgments in their favor. It is, therefore, wise to note how many companies could be materially affected by a favorable decision and to what extent they would be materially affected.
So, where on this spectrum is the FDA as a regulatory body? Well, my answer to that question would be, like most of us, all over the expanse of it at any given time based upon the circumstances presented.
Please keep in mind that this is only one aspect of this (drug approval) process. The science under girding each application rightly occupies center stage in our thinking. But to deny the fact that the FDA is now more akin to a bureaucratic oligarchy than a democratic institution is foolish at best. And the consequence of this is, at the very least, an opening of the door to subconscious manipulation of otherwise well-intended agency representatives.
Always be well…