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Comment by toss1 | Hacker News Reader

So, the 'administration' specifically demands pharmaceutical companies move production to the US.

Then, when they do, and invest "hundreds of millions of dollars running Phase 3 trials enrolling over 43,000 participants based on FDA guidance..." to ge a new product approved, they get zero consideration.

Why would the executives not look at this and say "why should we remain based in the US at all?", and just move headquarters to a more business-friendly country?

Sure, the US is a big market, but if one cannot get anything close to a fair treatment of your products, you have no ability to work in that market anyway.

We have a true kakistocracy, a government by the worst, most corrupt, and least qualified.

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I have no stake in this FDA thing, but it's very amusing to read economic arguments of why FDA should approve something because a US company spent $x and should be entitled to get such thing approved...

Very interesting when people complain about "corruption" when money suddenly cannot buy favors.

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.

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

The article was basically economists saying the way FDA is doing things is bad for business.

Which is also what you said as well.

> US company spent $x and should be entitled to get such thing approved...

It's not entitled for approval. It's entitled to have an unbiased approval process.

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