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.
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.
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[ 2.9 ms ] story [ 19.2 ms ] threadThen, 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.
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
That tells a lot about who pays for healthcare in the US.