On FDA 'Guidance for Industry' documents as regulatory fraud coordination tools for US government and pharmaceutical co-conspirators.
Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law
Important new post from Sasha Latypova:
July 26, 2024 - New FDA guidance for pharma on "countering misinformation" online. FDA authorizes pharmas to lie when needed, promising non-enforcement of pharmaceutical marketing regs. I interpret this as we are winning the information war. (Sasha Latypova)
…The FDA is guiding the manufacturers to lie and “debunk” these detected harms by waving hands around “but it was a very high dose”!
From my experience, in normal, non fraudulent pharmaceutical R&D setting you have 2 choices after your animals died or had fetal damage at a “high dose”:
1) redo the study with a dose that is more representative of the human exposure at therapeutic levels;
2) kill the drug program.
In both cases, the entire class of medicine becomes suspect for fetal abnormalities, and all subsequent programs are under greater scrutiny for this issue. At a minimum, concentration-response justifications must be provided for the selected doses in animals and humans.
They were nowhere to be found in the 2000+ pages of garbage “nonclinical package” from Pfizer and Moderna I wasted a few weeks of my life on!
That’s because it is not possible to dose mRNA in a controlled manner (this explains why Pfizer is 30 mg and Moderna is 100mg per dose in humans for the same thing - dosages are meaningless with mRNA products)….
I posted a comment:
My understanding is that all FDA "Guidance for Industry" documents, going back to the mid-1980s, when they started issuing them [called “Points to Consider” at that time] are instructions to pharmaceuticals, from FDA, about how the pharmaceuticals should ignore FDA regulations (because the regulations are non-regulations), and how they should engage in performative acts designed to look similar to compliance, and how FDA will (on its own side) pretend to establish and enforce regulatory standards, but actually not establish or enforce them.
The language tricks typically involve the term "discretion," leaving whether or not to enforce an alleged standard to FDA discretion (and they choose not to), or involve juxtapositions of "shall" and "may" language, such as regulations that state FDA "shall" issue a license for a product, and "may" inspect the premises where those are produced.
FDA, in its discretion, does not inspect and does not establish or enforce standards.
Similar examples to this new one about misinformation, include
January 2017 Guidance for Industry 187 - "Regulation of Intentionally Altered Genomic DNA in Animals"
"FDA has not and does not intend to enforce INAD and NADA requirements for: (1) animals of nonfood-producing species whose genomes have been intentionally altered that are regulated by other government agencies or entities, such as insects whose genomes have been intentionally altered that are under APHIS oversight; and (2) animals of nonfood-producing species whose genomes have been intentionally altered that are raised and used in contained and controlled conditions such as laboratory animals with intentionally altered genomes used in research institutions."
and
January 2018 Guidance for Industry - "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application"
"FDA does not intend to take action for violations of section 351 of the PHS Act or sections 502(f)(1) or 582 of the FD&C Act if a state-licensed pharmacy, a federal facility, or an outsourcing facility mixes, dilutes, or repackages a biological product in accordance with the conditions described below, and any applicable requirements. In addition, FDA does not intend to take action for violations of section 501(a)(2)(B) of the FD&C Act when a state-licensed pharmacy or a Federal facility mixes, dilutes, or repackages a biological product in accordance with the conditions described below, and any applicable requirements..."
