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On US-FDA worldwide non-regulation of Covid-19 vaccines construed as gene therapies.
Comment posted to Julian Gillespie's Substack.
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Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law
Julian Gillespie, writing at Substack:
April 18, 2024 - FDA hid GMO status of Covid drugs (Julian Gillespie)
KW comment:
In my view, the GMO aspect is moot for several reasons, that can be summed up as: there are no legal requirements that FDA do anything at all substantively related to biological product regulation.
1. Under PREP and EUA law, during declared ‘public health emergency,’ in effect since 2020, FDA has no legal obligation to apply or enforce cGMP or any other rules governing product safety and efficacy during development, testing, manufacture, distribution and use, and no legal obligations to provide truthful information to the public.
FDA’s function is to simulate/falsify regulatory oversight, not to conduct true regulatory oversight, so as to get intentionally-toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.
2. Under US biological product regulation law generally (non-emergency conditions in effect since 1944), FDA has no legal obligation to apply or enforce cGMP or other drug development, manufacturing and use laws, to any biological products, including all vaccines, and including all “GMO” products.
Again, FDA’s function is simply to simulate regulatory oversight, not to actually regulate products, so as to get intentionally-toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.
3. Under Mutual Recognition Agreements, regulators in Australia, EU, and other participating countries are relieved of all regulatory obligations they would otherwise have, and are authorized to accept as true, the assertions of fake US-FDA regulators, who are themselves authorized to accept as true, the unsupported claims of the manufacturers, so as to get intentionally toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.
Some documents:
1998 Mutual Recognition Agreement, Australia-EU, especially re: batch “self-certification.”
March 12, 2001 - EU EC Directive 2001/18, On the deliberate release into the environment of genetically modified organisms
Nov. 6, 2001 - EU EC Directive 2001/83, On the Community code relating to medicinal products for human use
March 31, 2004 - EU EC Regulation 726/2004, Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
May 6, 2009 - EU EC Directive 2009/42, On the contained use of genetically modified micro-organisms
Jan. 19, 2017 - Mutual Recognition Agreement, EU-US, Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practice (GMPs) - “…Article 9, Batch Testing: In the EU…the qualified person will be relieved of responsibility for carrying out the [batch testing] controls laid down in Article 51 paragraph 1 of Directive 2001/83/EC [human drugs] and in Article 55 paragraph 1 of Directive 2001/82/EC [veterinary drugs] provided that these controls have been carried out in the United States, the product was manufactured in the United States and that each batch/lot is accompanied by a batch certificate (in alignment with the WHO certification scheme on the quality of medicinal products) issued by the manufacturer [self-]certifying that the product complies with requirements of the marketing authorization and signed by the person responsible for releasing the batch/lot…”
July 14, 2020 - Vaccine against COVID-19: [European] Council adopts measures to facilitate swift development - “…The derogation provides that most operations related to the conduct of clinical trials will not require a prior environmental risk assessment or consent. These operations include packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19…The regulation also clarifies that certain provisions of Directives 2001/18/EC and 2009/41/EC are not applicable when member states grant access to medicinal products containing or consisting of GMOs in certain exceptional and urgent situations…”
July 15, 2020 - EU Regulation 1043, On the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease
Related:
March 8, 2024 - Regulatory simulations at home and abroad: Mutual Recognition Agreements. Part 1 of series on legal links connecting domestic and international non-regulation of non-medicines.
March 24, 2024 - Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals. Public health and regulatory systems have consistently hidden those truths behind false claims about effects of vaccines; legalized non-regulation of biological product manufacturing. (Part 4 of series) - “…When signed and ratified by national governments, MRAs authorize national regulators — including drug regulators — to be "relieved of" their regulatory obligations and instead, recognize and rely on the regulatory decisions of other countries' regulators, especially the US Food and Drug Administration. The two systems interlock.
Under the legal terms of MRA treaties, US-FDA can be legally construed as the sole regulator for worldwide drug manufacturing and distribution systems. Under the legal terms of the US-FDA drug regulation system, all biological product manufacturing can be legally conducted with no substantive disclosure, monitoring or enforcement of rules controlling purity, sterility, safety, potency, efficacy, raw materials, manufacturing processes, or chemical and biological composition of finished, packaged, distributed products…”
June 13, 2024 - Parsing "Yay, we did it!" informational misdirection campaigns. “…International Mutual Recognition Agreements (MRAs) absolve federal drug regulators of non-US countries of legal responsibility for cGMP manufacturing regulation, transferring regulatory functions to US-FDA [serving as] global drug non-regulator under US laws exempting biological products, vaccines and EUA countermeasures from cGMP compliance…”
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