Within the EUA framework, science is irrelevant to the regulatory process of approving drugs
The brilliant Sasha Latypova has penetrated the legal framework surrounding the FDA’s issuance of experimental medical products onto the public. In this article, she explains how drug companies can issue experimental products and be legally protected from harm regardless whether those injected are harmed or killed. If you read this article carefully, and listen to the video (I will post the link below) it becomes evident that profit is much more important to the federal government regulatory agencies than safety.
Here is an except Sasha found in the United States Code, 21 USC 360bbb-3a: Emergency use of medical products
Text contains those laws in effect on December 2, 2023
From Title 21-FOOD AND DRUGS
CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V-DRUGS AND DEVICES
Part E-General Provisions Relating to Drugs and Devices
(c) Current good manufacturing practice
(1) In general
The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including requirements under section 351 or 360j(f)(1) of this title or applicable conditions prescribed with respect to the eligible product by an order under section 360j(f)(2) of this title.
(2) Effect
Notwithstanding any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1).”
Public Health officials and pharma companies, if they are covered under the PREP act, also receive full immunity from prosecution no matter how many deaths or adverse reactions are experienced by individuals as a result of these medical products.
How do you like them apples?
Sasha explains in her article how this process works. If you take the time to read it slowly and carefully you will understand how vitally important it is to do your own research before ingesting ANY product released by pharma companies.
The experimental mRNA vaccines, for example, were issued under Emergency Use Authorization and so do not legally require testing for long-term effects, as was the case before the pandemic.
Here is the complete article, meticulously researched and with explanations and graphs. The above is only a brief explanation.
Here is the video explaining the article.
Before you begin, here are some definitions:
MCM – Medical Counter Measures. From the CDC website: “”Medical countermeasures (MCMs) are medicines and medical supplies that can be used to diagnose, prevent, or treat diseases related to chemical, biological, radiological, or nuclear (CBRN) threats. MCMs can include Biologic products – vaccines, blood products, and antibodies,
Drugs – antimicrobial or antiviral drugs
Devices – diagnostic tests to identify threat agents and personal protective equipment (PPE)”
IRB – Institutional Review Board. Wikipedia defines IRB as follows: “An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research done at that institution to ensure that the projects are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans...”
BLA – Biologics License Application
EUA – Emergency Use Authorization
There are two legal pathways for a medical product to be distributed: BLA and EUA. BLA is the gold standard where testing, clinical trials, and long term studies are necessary. EUA is also a legal pathway, but it gets around safety and effectiveness testing.