I really hope Moderna takes this to court for the good of all, but apparently companies are hesitant to do so because it might damage their relationship with the FDA? Here's Claude Sonnet 4.5:
"If Moderna has documented evidence (particularly official FDA meeting minutes) that contradicts the agency's current position, an APA challenge based on the change-in-position doctrine has meaningful prospects, especially [now Chevron deference is overturned.] However, this would be a high-stakes, precedent-setting case with significant implications for the company's FDA relationship.
The strength of any case depends entirely on what documentation exists regarding FDA's prior guidance. If it's truly as clear as the CEO claims, the case could be strong. If it's more ambiguous or based on informal discussions, it becomes much weaker."
And more:
"The most viable legal route appears to be a lawsuit under the Administrative Procedure Act (APA), 5 U.S.C. § 706, arguing the FDA acted "arbitrarily and capriciously" by:
Change-in-position doctrine violation: The recent Supreme Court case FDA v. Wages and White Lion Investments (2025) established that when the FDA changes its position from pre-decisional guidance without adequate explanation, this can violate the APA"
I work on housing in California. One of the worst things about it is discretion. When the rules are vague or so restrictive that everyone needs an exception, applicants have to schmooze the decision making bodies. People wind up bribing their neighbors to not oppose the project. It's awful.
You should be able to build what the General Plan lets you build, whether or not the mayor likes you.
And you should be able to get approval for your drug if it meets clear standards, whether or not some FDA bureaucrat hates you.
It is absolutely bonkers to me that Moderna ran a huge trial without knowing if the FDA would accept it. And the FDA didn't tell them! They had to go on vibes! This system is insane!
I think this whole article pre-supposes a good faith disagreement about vaccine development. Given everything else we know, it seems much more likely that this is driven by generalized anti-vax sentiment. Why this particular vaccine from this particular company ended up getting hit, who can say, but something like this happening is overall unsurprising given what the political reality is.
And yes, obviously that is in reality even worse then your worse case scenario.
"One might argue that the current decision was motivated by a long-standing skepticism of the current administration towards mRNA vaccines. This wouldn’t make the decision any better, but at least it could give us hope that it’s an isolated incident.
Unfortunately, the problem seems to extend beyond mRNA vaccines. This is not the first late-stage reversal under the current FDA. In November 2025, biotech company uniQure announced that the FDA had reversed its prior position on the company’s gene therapy AMT-130 for Huntington’s disease. Although the agency had previously indicated that Phase 1/2 data—compared against an external natural history control—could support a Biologics License Application (BLA) under the accelerated approval pathway, it now determined that the existing data are insufficient for submission.
The shift came despite promising results showing statistically significant slowing of disease progression and supportive biomarker improvements. CEO Matt Kapusta expressed surprise, noting that the feedback represented a “drastic change” from guidance provided in late 2024."
I guess I don't understand why this would give us hope it's an isolated incident. Being anti-vax is not disconnected from being anti-pharmaceuticals, in fact there's a huge overlap. So on the contrary, we should expect more capricious actions like this, for reasons that don't have anything to do with sincere scientific disputes.
The FDA has been beyond corrupt for a long time in many ways. Full of revolving-door bureaucrats and lobbyists who make a fortune approving drugs that kill and along with big-food have made the US the sickest nation on the planet. It's about time this is being brought to an end after millions have died from this criminal enterprise.
I really hope Moderna takes this to court for the good of all, but apparently companies are hesitant to do so because it might damage their relationship with the FDA? Here's Claude Sonnet 4.5:
"If Moderna has documented evidence (particularly official FDA meeting minutes) that contradicts the agency's current position, an APA challenge based on the change-in-position doctrine has meaningful prospects, especially [now Chevron deference is overturned.] However, this would be a high-stakes, precedent-setting case with significant implications for the company's FDA relationship.
The strength of any case depends entirely on what documentation exists regarding FDA's prior guidance. If it's truly as clear as the CEO claims, the case could be strong. If it's more ambiguous or based on informal discussions, it becomes much weaker."
And more:
"The most viable legal route appears to be a lawsuit under the Administrative Procedure Act (APA), 5 U.S.C. § 706, arguing the FDA acted "arbitrarily and capriciously" by:
Change-in-position doctrine violation: The recent Supreme Court case FDA v. Wages and White Lion Investments (2025) established that when the FDA changes its position from pre-decisional guidance without adequate explanation, this can violate the APA"
I think it would set a good precedent for future FDA interactions. Shifting regulatory sands are very bad for innovation.
I work on housing in California. One of the worst things about it is discretion. When the rules are vague or so restrictive that everyone needs an exception, applicants have to schmooze the decision making bodies. People wind up bribing their neighbors to not oppose the project. It's awful.
You should be able to build what the General Plan lets you build, whether or not the mayor likes you.
And you should be able to get approval for your drug if it meets clear standards, whether or not some FDA bureaucrat hates you.
It is absolutely bonkers to me that Moderna ran a huge trial without knowing if the FDA would accept it. And the FDA didn't tell them! They had to go on vibes! This system is insane!
yep. Didn't realize also applies to housing
(companies being afraid to sue the FDA is also a bad thing!)
I think this whole article pre-supposes a good faith disagreement about vaccine development. Given everything else we know, it seems much more likely that this is driven by generalized anti-vax sentiment. Why this particular vaccine from this particular company ended up getting hit, who can say, but something like this happening is overall unsurprising given what the political reality is.
And yes, obviously that is in reality even worse then your worse case scenario.
I addressed this here:
"One might argue that the current decision was motivated by a long-standing skepticism of the current administration towards mRNA vaccines. This wouldn’t make the decision any better, but at least it could give us hope that it’s an isolated incident.
Unfortunately, the problem seems to extend beyond mRNA vaccines. This is not the first late-stage reversal under the current FDA. In November 2025, biotech company uniQure announced that the FDA had reversed its prior position on the company’s gene therapy AMT-130 for Huntington’s disease. Although the agency had previously indicated that Phase 1/2 data—compared against an external natural history control—could support a Biologics License Application (BLA) under the accelerated approval pathway, it now determined that the existing data are insufficient for submission.
The shift came despite promising results showing statistically significant slowing of disease progression and supportive biomarker improvements. CEO Matt Kapusta expressed surprise, noting that the feedback represented a “drastic change” from guidance provided in late 2024."
I guess I don't understand why this would give us hope it's an isolated incident. Being anti-vax is not disconnected from being anti-pharmaceuticals, in fact there's a huge overlap. So on the contrary, we should expect more capricious actions like this, for reasons that don't have anything to do with sincere scientific disputes.
The FDA cannot change FDA acceptance of study guidelines at the end of all trials for a product.
Otherwise, the FDA has become squirrelly.
I am not in the science field but see this as a potential problem for any new medications and research in the future.
Yea, this creates issues far beyond this one program.
The FDA has been beyond corrupt for a long time in many ways. Full of revolving-door bureaucrats and lobbyists who make a fortune approving drugs that kill and along with big-food have made the US the sickest nation on the planet. It's about time this is being brought to an end after millions have died from this criminal enterprise.