I Regret to Inform You That the FDA Is FDAing Again

https://marginalrevolution.com/marginalrevolution/2026/02/i-regret-to-inform-you-that-the-fda-is-still-fdaing.html

36•asplake•1h ago

Comments

josefritzishere•1h ago

RFKs quackery has the potential to kill more people than Idi Amin. Vaccines save about 4 Million lives per year according to the CDC. https://www.cdc.gov/global-immunization/fast-facts/

toss1•1h ago

You call out idiocy, using actual data, and get downvoted. On HN, without so much as a comment describing why you might be in error.

HN is indeed sliding.

baggachipz•58m ago

I'm sure it won't be long until that page is scrubbed and replaced with Newspeak.

toss1•1h ago

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.

hnfong•50m ago

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.

cogman10•33m ago

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.

CGMthrowaway•1h ago

If you would like to read the Refusal to File letter: https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fb...

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

thombat•24m ago

Derek Lowe's take on this, probably written before those HHS comments, was that "the agency appears to have signed off on the trial design as proposed, and I can’t see Moderna going ahead with it if the agency had done otherwise". Does it appear that the design was actually approved?

https://www.science.org/content/blog-post/mrna-refusal-file

CGMthrowaway•58s ago

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 but never said it was required"). At any rate there is active dialogue between FDA and Moderna, and if they refile anything could happen

bestouff•19m ago

> "You cannot make a return on investment if you don’t have access to the U.S. market."

That tells a lot about who pays for healthcare in the US.