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 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..."
St. James the Greater. Guido Reni
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