21 USC 360bbb-3(e)(3) and 360bbb-3a(c): federal law authorizing HHS Secretary to waive current Good Manufacturing Practices (cGMP) for EUA products.
Relevant to public discussion of whether growing body of sequencing evidence of “adulteration” of Pfizer, Moderna and other mRNA platform technology products, opens new opportunities for litigation.
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Related Bailiwick reporting and analysis:
June 9, 2022 - COVID-19 injectable bioweapons as case study in legalized, government-operated domestic bioterrorism. “…There are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.” 21 USC 360bbb-3a(c). 2013…”
Feb. 9, 2023 - On the significance of 21 USC 360bbb-3(k): "use" of EUA products "shall not constitute clinical investigation." “…If any FDA regulations had been legally operative, then the whole project would have been stopped by FDA long before human sham-trials could even begin…The aggregate evidence for the intent and function of 21 USC 360bbb-3(k) as a blanket waiver of the American drug regulation system to facilitate and pre-cover-up a covert, criminal bioweapons production and deployment program — can be summed up as "the dog that didn't bark."…
Feb. 16, 2023 - Written artifacts of informational warfare. Truth, lies, war crimes and objective, observable realities. “…Specific to contracts — and in collaboration with Brook Jackson, Sasha Latypova and a few other people I trust — I’ve compared and contrasted the terms and conditions as written on the pages, with the observable, objective realities about which terms and conditions have been fulfilled by the purportedly responsible parties, and enforced by the counter-parties who have purported standing to enforce the terms. And which terms and conditions have been neither fulfilled nor enforced…In sum, the contract provisions purportedly requiring those things, were not enforced by the contract parties with standing to enforce…I’ve therefore concluded that all of the written artifacts produced and published by governments and government contractors operating the medical martial law system (the kill box) are dual-use documents.
They contain some truths and some lies. The true provisions are written with the intent to convey real contractual obligations among the parties: terms and conditions that will be fulfilled by the responsible party, and if he or she fails, will be enforced by the counter parties, through their exercise of contractual rights to extract financial or other penalties. The false provisions are written with the intent to convey the illusion of contractual obligations to non-parties. They list terms and conditions that will never be fulfilled or enforced by the contract parties. Those terms and conditions are listed for the sole purpose of misleading the public…”
April 28, 2023 - Draft discovery materials for civil and criminal cases. “…Requests for Production of Documents…Signed, dated, unredacted ATI-DOD-Pfizer Project Agreement 2011-003 under OTA W15QKN-16-9-1002, defined at p. 9 of July 20, 2020 Base Agreement, under which Pfizer is the Project Agreement Holder (“PAH”)…Signed, dated, unredacted documents recording the dates on which President Trump and/or President Biden invoked or extended suspension, under 50 USC 1515, of all prohibitions on DOD testing, production, transport, stockpiling and use of chemical and biological weapons and delivery systems, and/or suspended all Congressional, international, state, local and other notice and reporting provisions…Interrogatories…Did the HHS Secretary waive cGMP requirements for Covid-19 injectable biochemical weapons? If so, produce the signed and dated document by which this waiver was effectuated…”
Oct. 23, 2023 - On civil suits against Pfizer for “contamination” of Covid-19 biochemical weapons.
Oct. 15, 2023 - Some county and state lawmakers are starting to get better informed and more concerned.
21 USC 360bbb-3. Authorization for medical products for use in emergencies
21 USC 360bbb-3(e). Conditions of authorization.
21 USC 360bbb-3(e)(3). Good manufacturing practice; Prescription
With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—
(A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 or 360j(f)(1) of this title, and including relevant conditions prescribed with respect to the product by an order under section 360j(f)(2) of this title;
(B) requirements established under subsection (b) or (f) of section 353 of this title or under section 354 of this title; and
(C) requirements established under section 360j(e) of this title.
21 USC 360bbb-3a - Emergency use of medical products.
21 USC 360bbb-3a(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).
I haven’t yet located documents purporting to be HHS Secretary authorization of waivers, limitations or deviations from cGMP for the manufacture of the biochemical weapons injected into Americans and people around the world as “Covid-19 vaccines.”
I have seen waiver documents pertaining to other EUA products, including ventilators:
March 24, 2020 - FDA Letter of Authorization, EUA, ventilators, by HHS Rear Admiral Denise Hinton, FDA Chief Scientist. (Section III at p. 7)
There are several possible reasons why I haven’t found HHS waiver/limitation/deviation of cGMP documents for “Covid-19 vaccines.”
One is that the documents are in the Federal Register somewhere, on an HHS website somewhere, or even in my research hard-drive with searchable keywords but I just haven’t found them.
Another possibility is that the documents have been scanned into the Federal Register without being converted to OCR format (Optical Character Recognition), so keyword searches don’t produce hits.
This is the format in which the Dec. 11, 2020 (Pfizer) and Dec. 18, 2020 (Moderna) FDA Letters of Authorization were entered into the Federal Register:
Jan. 19, 2021 Federal Register - 2020.12.11 HHS FDA RADM Denise Hinton EUA, Pfizer eff 2020.12.11, Moderna eff 2020.12.18 dated 2021.01.12 86 FR 5200
A third possibility is that the HHS waiver/limit/deviation from cGMP documents are classified as national security records not subject to public disclosure.
I have seen provisions in the Dec. 11, 2020 (Pfizer) and Dec. 18, 2020 (Moderna) Federal Register notices by Rear Admiral Denise Hinton, that could be construed as requiring cGMP compliance.
See Section III, Item I, Conditions of Authorization, at p. 8/20 for Pfizer Letter of Authorization, and Section III, Item I, Conditions of Authorization, at p. 17/20 for Moderna. The provisions look like this:
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These provisions can only be construed as requiring cGMP compliance, if observers ignore the knowledge painfully gained from Brook Jackson’s whistleblower case: that there are public-facing contracts and regulatory documents listing otherwise applicable terms and conditions, and also as-yet-undisclosed contracts, authorizations, notices and other regulatory documents that nullify, void, waive, limit or authorize deviation from the otherwise-applicable, otherwise-enforceable terms and conditions in the public-facing documents, rendering them inapplicable and unenforceable.
Three years into the covert biochemical warfare being waged by the US Government through the Department of Defense, Advanced Technologies Inc., Medical CBRN Defense Consortium, and contractors including Pfizer and Moderna, cGMP regulations remain observably unenforced.
New lawsuits filed on the basis of mounting evidence that the products have been throughout, and are still being “adulterated” should take these legal facts into account.
Plaintiffs should draft the complaints so as to give HHS Secretary Xavier Becerra and Attorney General Merrick Garland opportunities to cite 21 USC 360bbb-3(e)(3) and 21 USC 360bbb-3a(c) in their defenses, and produce the signed, dated, unredacted authorization documents through which former HHS Secretary Alex Azar and/or current HHS Secretary Becerra waived, limited or authorized deviation from cGMP regulations for manufacture of “Covid-19 vaccines.”
County and state lawmakers considering action to protect and defend the people living in their political jurisdictions from further attacks — for example, by banning use of mRNA products, halting all “vaccination” programs, and seizing contraband vials stored at pharmacies and in transit across state borders — should also take 21 USC 360bbb-3(e)(3) and 21 USC 360bbb-3a(c) into account.
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