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The FDA's Sleight Of Hand

Could simple modal verbs impede possible recompense?

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JJ Starky
Nov 14, 2022
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Right, then. We’ve established the hordes of medical service executives, Big Pharma representatives, chief health officials, and politicians that make up Global Science™ spouted overt misinformation about testing and safety. That much is obvious.

Part one of our collaborative investigation with Dystopian Down Under explaining the whats and hows is now available:

Dystopian Down Under
"The largest global vaccination trial ever"
In part one of the pandemic policies review by Dystopian Down Under (Australia) x The Stark Naked Brief (UK): They were wrong to flout the ethical primacy of valid consent, coercing the population into a medical experiment. There are 3 ways in which our leaders denied the public the opportunity to give valid consent, which is a legal and ethical requireme…
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3 years ago · 16 likes · 7 comments · Rebekah Barnett and The Stark Naked Brief

But what we have not discussed is how these regulatory bodies neatly wove abstract language into their Emergency Use Authorisations (EUAs) that could see officials avoid potential legal castigation if prosecuted for fraudulence. The FDA’s advertising rules on the latest boosters are a case in point.

On August 31st 2022, the FDA amended its Emergency Use Authorisation for the Moderna and Pfizer-BioNTech bivalent boosters. Thereafter, all promotions of these products had to disclose the following per the FDA’s authorisation conditions. For the Pfizer-BioNTech for example:

Earlier this month, the FDA published two videos of Dr Peter Marks encouraging citizens to get the new booster:

And what did he miss out - you guessed it - all of the aforementioned rules. In short, Marks, the FDA’s Vaccine Division Director, appears to have broken the agency’s own EUA conditions. In either video does he disclose these products are pending FDA approval or licensing. Nor did he cite emergency use.

Or did he break the rules? Note:

In a US Court of Appeals ruling from 2018 concerning PM Law Ltd v Motorplus Ltd, the court ruled the word “shall” does not create a contractual obligation. They further concluded when drafting commercial contracts that the word is too ambiguous because it expresses either a future intention or an obligation in light of the surrounding context. In short, it is far too flimsy.

We wouldn’t blame the cynics among our readership to presume they deliberately laid this out as a preemptive pathway for circumvention…

Could this one modal verb prevent possible litigation?


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By JJ Starky · Launched 3 years ago
Concise, investigative reports on the defining political issues of our time. Showing rather than telling. Former political strategist. Part-time citizen journalist. Based in 🇬🇧.
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