It is a bit funny given the origins of the FDA. That said, there does need to be some legitimacy. The value of the FDA is that the rules are being applied in a fair and logical manner. This sort of unfairness because of clear bias against mRNA tech is what is gross.

By all means, if there's a good test that's lacking or clear problems that can be demonstrated I absolutely want the FDA to use it's power to stop a drug from coming to market or even pull and existing drug from the market.

The problem I have is that when the FDA acts in an illegitimate manner, it opens the doors to questions like "do we even need this institution" or "should the power of the FDA be reduced." Both of which are things that are both bad and dangerous.

The FDA doesn't need it's powers curbed, it needs competent leadership that will follow the data.

I am absolutely NOT making any economic argument for approval or that an investment beyond $x should somehow guarantee approval! They are all professionals and know the risks and how to manage them.

And NO this is not about "money suddenly cannot buy favors". This is about illegitimate denial of even a hearing because the person occupying the agency's chair promotes idiotic conspiracy theories in order to cultivate a particularly stupid slice of the voting base. The corruption here is political.

The ONLY argument I am making is:

1) The govt agency should AT LEAST give a fair review of all applications, especially when the same agency previously gave guidance, which the applicants followed, on how the studies should be run.

2) The govt agency should NOT be issuing rare "Refusal To File" denials based on an obvious and unsubstantiated bias against a particular technology (in this case mRNA) because the leader of the agency is a conspiracy theorist.

If you aren't going to read the article before commenting, at least read the comment before replying.

Those communications are not public. So we don't know, we only know what each side is saying: FDA says they gave clear guidance, while Moderna claims they were not told a high-dose comparator was required for 65+, which is perhaps another way of saying "you gave guidance that left room for interpretation," which frankly is not an argument that flies with any regulator anywhere, although it can be very frustrating for companies. At any rate there is active dialogue between FDA and Moderna, and if they refile anything could happen