I Regret to Inform You That the FDA Is FDAing Again

[bestouff]

> "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.

[tim333]

As a non US person I'm grateful to Americans for paying so much towards drug development.

[josefritzishere]

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/

[baggachipz]

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

[toss1]

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.

[ChrisArchitect]

Previously: https://news.ycombinator.com/item?id=46968424

[toss1]

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]

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.

[CGMthrowaway]

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]

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

[bmandale]

This could just as easily be someone at the top saying "find a legitimate sounding reason to refuse this because we want to refuse it anyways". They will always give such a reason, that doesn't mean it's the real reason.