That tells a lot about who pays for healthcare in the US.
HN is indeed sliding.
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.
Very interesting when people complain about "corruption" when money suddenly cannot buy favors.
It's not entitled for approval. It's entitled to have an unbiased approval process.
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.
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.
More information was shared from HHS spokespeople after Moderna posted the letter, which companies usually keep secret because they are embarrassing.
The FDA's main objection is that Moderna refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy. Specifically, FDA said it was "pretty clear" that it recommended using a high-dose comparator in seniors. By comparison, Moderna used a standard-dose comparator in seniors. The implication is that this choice juiced Moderna's efficacy stats.
This has nothing directly to do with safety.
Source: I work in pharma
