The Ultra-Secret American Domestic Bioterrorism Program EXPOSED

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Posted on April 6, 2023, by State of the Nation

“Congress and US Presidents legalized and funded the overthrow of the U.S. Constitution, the U.S. government, and the American people, through a massive domestic bioterrorism program relabeled as a public health program, conducted by the HHS Secretary and Secretary of Defense on behalf of the World Health Organization and its financial backers.”

Editor’s Note: For those who don’t even have time to read the “Executive Summary”, please consider the following excerpt taken from the irrefutable exposé posted below in its entirety.

The preceding distillation has since proven completely true by the execution of OPERATION COVID-19, a bio war launched against the American people in January of 2020 utilizing the SARS-CoV-2 bioweapon (not a coronavirus), as well as by the subsequent implementation of the Covid Super Vaccination Agenda which saw the deployment of highly weaponized variations of the COVID-19 ‘vaccines’ (not a vaccine).

State of the Nation
April 6, 2023

American Domestic Bioterrorism Program

2020 – Present – Presidents Donald J. Trump, Joseph R. Biden

  • 2020/01/27 – US Secretary of Health and Human Services Determination that a Public Health Emergency Exists. Signed Jan. 31, 2020, effective Jan. 27, 2020. Renewed every 90 days since then. Also signed a ‘declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of this novel coronavirus.’ The determination and declaration were recorded in the Federal Register as taking effect on Feb. 4, 2020. 85 Federal Register 7316.
  • 2020/01/30 – WHO Director-General Tedros Adhanom Ghebreyesus declared the Covid-19 outbreak a “public health emergency of international concern,” (PHEIC) triggering the legal obligations of WHO member states under the 2005 International Health Regulations, to suspend national sovereignty and constitutional rights of citizens using the implementing domestic statutes and regulations they had adopted in compliance with the WHO IHR.
  • 2020/02/04 – US Secretary of Health and Human Services Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. 85 Federal Register 15198 (6 pages). Issued March 10, 2020, retroactive to Feb. 4, 2020. Deployment of the domestic bioterrorism program against all American citizens under the Covid-19 pretext.
  • 2020/03/01 – HHS Centers for Medicare and Medicaid Services (CMS) COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. Exempted health care providers from patient care standards and regulations that would legally apply in non-pandemic circumstances; authorized stripping patients of their rights to have family members and pastors/rabbis visit them and advocate for them in the hospital or nursing home; supported hospital demands that law enforcement officers remove family and pastors from the premises by force; created conditions for death protocols of restraint, withheld water and nutrition, forcible administration of Remdesivir and forcible connection to ventilators under the ICD-10 codes.
  • 2020/03/06 – Congress and President Trump passed Coronavirus Preparedness and Response Supplemental Appropriations Act – PL 116-123, 134 Stat. 146. $8.3 billion to Health and Human Services, Centers for Disease Control and Prevention, National Institute of Health, National Institute of Allergy and Infectious Diseases, Food and Drug Administration, Small Business Administration, Department of State, and US Agency for International Development, for research and development of vaccines, therapeutics and diagnostics and other Covid programs.
  • 2020/03/10 – US Secretary of Health and Human Services Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. 85 Federal Register 15198 (6 pages). Issued March 10, 2020, retroactive to Feb. 4, 2020. Deployment of the domestic bioterrorism program against all American citizens under the Covid-19 pretext.
  • 2020/03/11 – WHO Secretary-General press conference: “We have therefore made the assessment that COVID-19 can be characterized as a pandemic.”
  • 2020/03/13 – PanCAP Adapted U.S. Government Covid-19 Response Plan.
  • 2020/03/13 – President Trump issued a Stafford Act declaration under the 1988 Stafford Act, and signed Proclamation 9994, Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID–19) Outbreak, under the 1975 National Emergencies Act. Renewed every year since, most recently by Biden in Feb. 2022. 85 Federal Register 15337.
  • 2020/03/18 – President Trump signed Executive Order 13909, Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID–19. 85 Federal Register 16227.
  • 2020/03/18 – Congress and President Trump passed the Families First Coronavirus Response Act – PL 116-127, 134 Stat. 178. $3.5 billion for Covid mass testing, supplemental nutrition (Department of Agriculture), sick leave, family medical leave, and unemployment compensation (Department of Labor) programs.
  • 2020/03/24 – HHS Secretary Alex Azar issued a Declaration of Emergency Use
    Authorization, declaring “that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as
    medical devices.” 85 Federal Register 17335.
  • 2020/03/26 – President Trump signed Executive Order 13910, Preventing Hoarding of Health and Medical Resources To Respond to the Spread of COVID–19. 85 Federal Register 17001.
  • 2020/03/27 – President Trump signed Executive Order 13911, Delegating Additional Authority Under the Defense Production Act With Respect to Health and Medical Resources To Respond to the Spread of COVID–19. 85 Federal Register 18403
  • 2020/03/27 – Congress and President Trump passed Coronavirus Aid, Relief, and Economic Security (CARES) Act – PL 116-136, 134 Stat. 281. 15 USC 9001. $2.2 trillion in corporate and small business loans, household support and unemployment insurance, tax deferrals, aid to state and local governments, aid to universities and colleges, aid to K-12 schools, aid to hospitals and veterans programs, airline loans and grants, and $10 billion for “Operation Warp Speed.”
  • 2020/04/24 – Congress and President Trump passed Paycheck Protection Program and Health Care Enhancement Act – PL 116-139, 134 Stat. 620. $75,000,000,000 for Public Health and Social Services Emergency Fund (first funded in 2005), “to remain available until expended, to prevent, prepare for, and respond to coronavirus, domestically or internationally” plus $25,000,000,000 for research, development, and deployment of Covid-19 tests.
  • 2020/05/19 – Advisory Opinion on the PREP Act and the March 10, 2020, Declaration Under the Act, April 17, 2020, as modified on May 19, 2020, by Robert P. Charrow of HHS Office of General Counsel. Legal opinion on statutory liability shields.
  • 2020/05/29 – Supreme Court ruled in South Bay United Pentecostal Church v. Newsom, 590 US __, (2020), denying the role of the federal judiciary in the Constitutional review of executive and legislative acts taken during declared public health emergencies. Semi-reversed on rehearing, February 2021.
  • 2020/07/20 – DOD-Pfizer Base Agreement, through Advanced Technology International; 2020/07/21 – DOD-Pfizer Statement of Work, through Advanced Technology International. Pfizer later argued (04/22/2022, Jackson v. Ventavia, Motion to Dismiss) that “Because of pandemic-related exigencies, the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.]…The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.” 10 USC Section 2371 renumbered 10 USC 4022, 01/01/2021
  • 2020/08/26 – HHS CDC Advisory Committee on Immunization Practices Meeting Summary Report. On p. 56 – “Dr. Cohn reminded everyone that under a EUA, vaccines are not allowed to be mandatory. Therefore, early in the vaccination phase individuals will have to have consented and cannot be mandated to be vaccinated.” [Attorney Johnsen cited this interpretation of Section 564 in a footnote on p. 7 of her 07/06/2021 slip opinion, immediately citing the judge’s 06/12/2021 order in Bridges v. Houston Methodist as “summarily rejecting” the argument.]
  • 2020/12/27 – Consolidated Appropriations Act – PL 116-260, 134 Stat. 1182. $2.3 trillion spending bill, including $900 billion for Covid programs.
  • 2021/01/05 – Orange Book Transparency Act – PL 116-290, 134 Stat. 4889. Amendments to patent law under Federal Food Drug and Cosmetics Act, (21 USC 9)
  • 2021/01/12 – FDA Chief Scientist Rear Admiral Denise Hinton Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID–19 Pandemic; Availability, effective Dec. 11, 2020, for Pfizer; Dec. 18, 2020, for Moderna. 86 Federal Register 5200.
  • 2021/01/21 – HHS Secretary Norris Cochrane notifies state governors that the federal government will give 60 days' notice before terminating the ‘“determination that a public health emergency exists” first issued by HHS Secretary Alex Azar effective 01/27/2020.
  • 2021/03/11 – Congress and President Biden passed American Rescue Plan/Consolidated Appropriations Act. PL 117-2, 135 Stat. 4. Section 7401, Covid-19 Consumer Protection Act. Criminalized advocacy of alternative treatments under Federal Trade Commission provisions.
  • 2021/04/02 – Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination (Version 1) by Wen W. Shen
  • 2021/06/12 – Texas federal judge ruled in Bridges v. Houston Methodist Hospital, 543 F. Supp. 3d 525 (S.D. Tex. 2021), finding that informed consent doesn’t apply to hospital workers, because the injections are government-authorized under FDA Emergency Use Authorization, therefore not part of experimental clinical trials or ordinary medical treatments, therefore hospital employees cannot be legally construed as human subjects or ordinary patients, therefore they have no individual, Constitutional liberties; rights to privacy and against government violation of bodily integrity; or rights to be secure in their persons against warrantless search and seizure.
  • 2021/06/25 – FDA EUA Pfizer Fact Sheet addressing “option to accept or refuse.” This is only one of many versions issued between December 2020 and the present; it’s the one cited by Attorney Johnsen in her legal opinion.
  • 2021/07/06 – Dawn Johnsen, Deputy Attorney General, published DOJ Opinion: Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization. Related to the federal government’s position on the legal status and regulatory control differences between Emergency Use Authorization (EUA) products, Investigational New Drugs (IND), and Investigational Device Exemptions (IDE).
  • 2021/07/16 – Roman Catholic Pope Francis issued Traditions custodes, attempting to abrogate Pope Benedict’s 2007 Summorum Pontificum, and revoke the right of Catholic priests and faithful to celebrate the pre-1962, Traditional Latin Mass.
  • 2021/07/29 – President Biden directed the Department of Defense to “look into how and when they will add COVID-19 vaccination to the list of required vaccinations for members of the military.”
  • 2021/08/24 – Department of Defense order from Secretary of Defense Lloyd Austin, vaxx mandate on military personnel in Army, Navy, Air Force, Marines, and Coast Guard.
  • 2021/09 – HHS FDA Guidance: Real-World Data – Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
  • 2021/09/09 – President Biden signed Executive Order 14042, vaxx mandate on federal contractors. 86 Federal Register 50985.
  • 2021/09/09 – President Biden signed Executive Order 14043, vaxx mandate on federal employees. 86 Federal Register 50989.
  • 2021/09/09 – President Biden issued a directive to the Department of Labor Occupational Safety and Health Administration (OSHA), a vax mandate on private employers with more than 100 employees.
  • 2021/09/17 – President Biden signed Executive Order 14047, adding measles to the list of quarantinable communicable diseases authorizing the HHS Secretary to use force to apprehend and detain people under 42 USC 264(b) and 42 CFR 70.6. 86 Federal Register 52591.
  • 2021/11 – HHS FDA Guidance: Real-World Data – Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
  • 2021/11/05 – President Biden issued a directive to the Department of Health and Human Services Center for Medicare and Medicaid Services (CMS), a vax mandate on healthcare workers at hospitals, nursing homes, and other federally-funded facilities.
  • 2021/11/17 – HHS Interim Final Rule – Possession, Use, and Transfer of Select Agents and Toxins—Addition of SARS–CoV/SARS–CoV–2 Chimeric Viruses Resulting From Any Deliberate Manipulation of SARS–CoV–2 To Incorporate Nucleic Acids Coding for SARS–CoV Virulence Factors to the HHS List of Select Agents and Toxins. 86 Federal Register 64075. Chimeric, lab-weaponized SARS-CoV-2 added to the list of agents that “have the potential to pose a severe threat to public health and safety” under 42 CFR 73.3. Attempt to block accountability by preemptively reclassifying bioweapons as legally identical to pandemics, to block international law claims brought under the theory that SARS-CoV-2 is a bioweapon and not a pandemic. If classified as a bioweapon, the Public Health Emergency of International Concern (international) and public health emergency (federal) legal frameworks would be nullified, instead bringing to bear federal and international laws prohibiting chemical and biological weapons.
  • 2021/12/02 – HHS Final Rule – National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table – 86 Federal Register 68423. Added vaccines recommended for pregnant women to the list of vaccines subject to the 1986 VICP compensation scheme, so as add another hurdle to civil suits against Covid-19 injection manufacturers, even though the products had not yet been added to the childhood vaccine schedule that otherwise governs access to VICP scheme. Because CDC does recommend them for pregnant women.
  • 2021/12/27 – Congress and President Biden passed National Defense Authorization Act FY2022 – PL 117-81, 135 Stat. 1541. Section 716, established a military vax tracking system, including refusals, under 10 USC 1110 (originally re anthrax vax). Section 6501, authorized US government to engage with Bill Gates Coalition for Epidemic Preparedness Innovations (CEPI). More coverage.
  • 2022/01/13 – Supreme Court ruled in Missouri v. Biden (21 A 240), Louisiana v. Biden (21 A. 241), 595 US __, (2022), asserting federal funding for hospitals and nursing homes voids Constitutional protection for employees' individual bodily integrity and informed consent to medical treatment.
  • 2022/02/07 – Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination
  • 2022/02/10 – Supreme Court leaked draft opinion in Dobbs v. Jackson Women’s Health, leaked draft opinion by Justice Samuel Alito. SCOTUS is poised to explicitly deny the principle of Constitutionally-protected inalienable individual rights to personal privacy, conscience, bodily integrity, or liberty, against State's exercise of authority. The final ruling was issued on 06/24/2022.
  • 2022/03/09 – President Biden signed Executive Order 14067, Ensuring Responsible Development of Digital Assets, on Central Bank Digital Currencies)
  • 2022/03/15 – Congress and President Biden passed Consolidated Appropriations Act – PL 117-103, 136 Stat. 49. $1,274,678,000 for the Public Health and Social Services Emergency Fund (HHS slush fund established in 2005). $780,000,000 for new domestic bioweapons production, classified as ‘security countermeasures’ under the Public Health Service Act as amended by 2004 Project Bioshield Act, 42 USC 247d-6b(c)(1)(B); $845,000,000 to stock the Strategic National Stockpile established 1998, controlled by the CDC within HHS 42 USC 247d-6b(a); $300,000,000 “to prepare for or respond to an influenza pandemic,” including federally-funded construction or renovation of privately-owned pharmaceutical manufacturing facilities, if the Secretary of Health and Human Services finds such construction or renovation necessary; $1,000,000,000 to establish ARPA-H: Advanced Research Program Agency – Health, to conduct research and development of bioweapons misbranded as public health measures; $3,880,000,000 to US Agency for International Development (US-AID) for programs mislabeled as ‘Global Health Programs,’ including immunization programs, HIV/AIDS programs, The GAVI Alliance [population-control zealot Bill Gates’ Global Alliance for Vaccines and Immunization] and a multilateral vaccine development partnership, for, among other projects, “experimental contraceptive drugs, devices and medical procedures.”
  • 2022/05/17 – Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination. (Version 9)
  • 2022/05/17 – Congressional Research Service Opinion: Status of Federal COVID-19 Vaccination Mandate Litigation. (Version 7)
  • 2022/06/24 – Dobbs v. Jackson Women Health SCOTUS decision released.
  • 2022/07/15 – HHS Secretary Xavier Becerra extended the 01/27/2020 determination that a ‘public health emergency’ exists.
  • 2022/07/22 – HHS Secretary Xavier Becerra elevated Administration for Strategic Preparedness and Response (ASPR) from the staff division to the operating division, still under HHS Assistant Secretary Dawn O’Connell.
  • 2022/09/12 – President Biden signed Executive Order 14081 – Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. 87 Federal Register 56849.
  • 2022/09/28 – HHS-FDA Proposed Rules: Protection of Human Subjects and
    Institutional Review Boards. 87 Federal Register 58733
  • 2022/10/13 – HHS Secretary Xavier Becerra extended the 01/27/2020 determination that a ‘public health emergency’ exists.
  • 2022/10/13 – Boston University researchers, funded by Fauci’s NIAID, publish a preprint paper on their gain-of-function/DURC research combining the toxicity of the original Wuhan strain of SARS-CoV-2 with the increased transmissibility of the Omicron variant to achieve 80% mortality in transgenic, humanized mice expressing the ACE-2 receptor. Role of a spike in the pathogenic and antigenic behavior of SARS-CoV-2 BA.1 Omicron
  • 2022/10/18 – President Biden National Security Memorandum (NSM-15) on Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security and National Biodefense Strategy Implementation Plan.
  • 2022/12/23 – NDAA for FY2023. PL 117-263. Section 5955: Global Health Security and International Pandemic Prevention, Preparedness and Response Act of 2022. Authorizes expands and funds globalized military-health structure linking the US military to global genocide apparatus operating under WHO frameworks.
  • 2022/12/29 – Consolidated Appropriations Act for FY2023. PL 117-328. Many federal and state-level public health/martial law authorization and funding provisions are included. H.R. 2617-419: “Public Health and Social Services Emergency Fund. For expenses necessary to support activities related to countering potential biological, nuclear, radiological, chemical, and cybersecurity threats to civilian populations, and for other public health emergencies, $1,647,569,000, of which $950,000,000…for expenses necessary to support advanced research and development…of the Biomedical Advanced Research and Development Authority.” H. R. 2617-420 – $1,500,000,000 for ARPA-H: Advanced Research Projects Agency for Health. Section 2235 at H.R. 2617-1297, One Health Framework: “coordination mechanism at the Federal level to strengthen One Health collaboration related to prevention, detection, control, and response for zoonotic diseases and related One Health work across the Federal Government.”

Pending legislation

List last reviewed Summer 2022. Some of these laws may have been passed in the 2023 NDAA, 2023 Consolidated Appropriations Act or other Congressional acts.

  • 2022 Research Investment to Spark the Economy (RISE) ACT – Pending, S.289. Senate counterpart to Cures 2.0 Act/HR6000, Title V, Section 502. Authorizes billions in funding for the Departments of Agriculture, Commerce, Defense, Education, Energy, the Interior, Health and Human Services, and Transportation, National Aeronautics and Space Administration (NASA), National Science Foundation, and Environmental Protection Agency to provide support for research regarding COVID-19 (i.e., coronavirus disease 2019) or research disrupted by the COVID-19 pandemic. Support may be used to provide supplemental funding to extend the duration of a grant…that was awarded prior to enactment, or to expand the purposes of such a grant; issue awards to research the effects of the current pandemic and potential future pandemics; and provide flexibility on awards to account for facility closures or other limitations during the COVID-19 public health emergency.
  • 2022 PASTEUR Act – Pending, HR 3932. (41 pages). Pioneering Anti-microbial Subscriptions To End Upsurging Resistance Act. Would create subscription-based procurement contracts between the US government and pharmaceutical corporations for ongoing, open-ended development, purchase, and deployment of drugs alleged to treat antibiotic-resistant infections. Appropriates $11 billion for the program. Program is to be developed by a committee comprised of the National Institute of Allergy and Infectious Diseases, Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority, Food and Drug Administration, Centers for Medicare & Medicaid Services, Veterans Health Administration, and Department of Defense.
  • 2022 Cures 2.0 Act – Pending, HR6000. (173 pages.) Would legally establish Covid-infection injury and Covid-19 bioweapon injection injury as “long Covid,” (erasing injection-caused injury as a separate diagnostic classification) and appropriate research and treatment funding; would establish a genomic testing program for children and teens (corroborating evidence that the government developed the bioweapons to cause listed harms and anticipates observing those effects in the population); would establish pharmacogenetic consulting and other programs.
  • Title V, Section 502 is House counterpart to S.289, RISE Act (see above), to authorize billions in funding for the Departments of Agriculture, Commerce, Defense, Education, Energy, the Interior, Health and Human Services, and Transportation, National Aeronautics and Space Administration (NASA), National Science Foundation, and Environmental Protection Agency to provide support for research regarding COVID-19 (i.e., coronavirus disease 2019) or research disrupted by the COVID-19 pandemic.

COVID-19 injectable bioweapons as a case study in legalized, government-operated domestic bioterrorism. Or: why there won’t be any civil suits or compensatory damages for injured victims or survivors of dead victims.

Since first realizing the implications of the many Congressional statutes and Health and Human Services regulations adopted to create and operate the bioterrorism program, mostly between 1997 and the present, I’ve been intermittently finding the specific citations for each statement while researching related issues.

Some statements are simply logical deductions from the first premise, corroborated by the observable actions and inactions of Food and Drug Administration officials as the observable injuries and deaths mount up in the American people.

Others are specifically written into the laws, but I don’t yet have the citations because I’ve prioritized my research time investigating other issues related to the bioterrorism program.

I’m posting the information as I understand it today [June 9, 2022], despite those limitations, in case it’s useful for readers who also follow FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) reporting by Toby Rogers, Igor Chudov, Steve Kirsch, Jessica Rose, and others.

They continue to rightly raise public awareness and alarm about FDA’s ongoing failure to protect the public from Emergency Use Authorized (EUA) products.

But they don’t address the main reason why FDA is acting as it is.

FDA is not pulling the EUA products from the market or stopping the ‘vaccination’ campaign because Health and Human Services Secretary Xavier Becerra and FDA Commissioner Robert Califf are running the US government’s bioterrorism program jointly with Defense Secretary Lloyd Austin, Department of Justice Attorney General Merrick Garland, Department of Homeland Security Secretary Alejandro Majorkas, Pfizer CEO Albert Bourla, Moderna CEO Stephane Bancel, and World Health Organization Director-General Tedros Adhanom Ghebreyesus.

Main Premise

Use of EUA-covered medical countermeasure (MCM) products including masks, PCR tests, mRNA and DNA injections, and other drugs, devices, and biologics, once designated as such by the Secretary of Health and Human Services (March 10, 2020, retroactive to February 4, 2020) “shall not be considered to constitute a clinical investigation.” 21 USC 360bbb-3(k). FDA EUA law was adopted in 1997 and amended in 2003, 2004, 2005, 2013, and 2017.

This is true no matter how untested, unmonitored, unsafe, or ineffective they are, no matter whether their harmfulness to human health and uselessness for infection control are known before use, or discovered afterward.

Legal implications derived from the main premise:

  1. There is no stopping condition.
  2. EUA products are exempt from laws regulating researcher use of investigational, experimental drugs, devices, and biologics on human beings.
  3. EUA products are exempt from laws regulating physician use of approved drugs, devices, and biologics as medical treatments for patients.
  4. There are no manufacturers of experimental products (EUA products are not part of any clinical investigation, and therefore not experimental.)
  5. There are no government or private contracts for the purchase of experimental products; there are only contracts for ‘large-scale vaccine manufacturing demonstrations.’
  6. There is no act of administration of any experimental products.
  7. There are no nurses or pharmacists administering experimental products.
  8. There are no human subjects (of experiments) or patients (of physicians providing treatment) receiving experimental products: no victims.
  9. There is no party responsible for the well-being of recipients after the administration of EUA products.
  10. There is no treatment group and no control group.
  11. Human beings administering EUA products have no informed consent obligations to provide information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See 21 USC 360bbb-3(e)(1)(A)(ii)) waiving informed consent for unapproved products (2004); 21 USC 360bbb-3(e)(2)(A) waiving informed consent for unapproved use of an approved product (2004); 21 USC 355(i)(4) waiving informed consent for experimental products classified by HHS as ‘minimal risk’ drugs (2016); 21 USC 360j(g)(3)(D)(i) waiving informed consent for experimental ‘minimal risk’ devices (2016).
  12. Human beings receiving EUA products have no informed consent rights to receive information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See citations and bullet points above.
  13. There are no Institutional Review Boards supervising the administration of the experimental products.
  14. There are no safety standards for EUA products.
  15. There is no efficacy standards for EUA products. See 21 USC 360bbb-3(c)(2)(A), 1997, 2003, 2004, re: ‘may be effective.’
  16. There are no clinical investigators studying the effects of EUA products on human subjects.
  17. There are no doctors, nurses, or other treatment providers providing experimental treatment to their patients subject to the Hippocratic Oath (“first do no harm”) using EUA products.
  18. There is no coordinated, public, federal government monitoring of recipients after receiving the products for adverse effects and deaths.
  19. There is no coordinated, public, federal government data collection or analysis.
  20. There is no legal requirement for medical supervision during product administration.
  21. There is no legal requirement for recipient monitoring after product administration.
  22. ‘Real world evidence’ — mass administration of products to the general public, followed by a collection of private/proprietary information about the effects, from health insurance systems, government databases (Medicare, Medicaid, Defense Medical Epidemiology Database, Veterans Health Administration), and other private databases — is authorized for the purposes of FDA regulatory decisions. See 21 USC 355g. 2016.
  23. There is no requirement for individual prescriptions to be written prior to dispensing EUA products, and products dispensed without prescriptions “shall not be deemed adulterated or misbranded.” See 21 USC 360bbb-3a(d). 2013.
  24. Manufacturers, as contractors, are considered HHS employees for purposes of legal immunity under Federal Tort Claims Act. See 42 USC 247d-6a(d)(2)(A).
  25. DOD is authorized to contract with pharmaceutical corporations to conduct ‘prototype’ experiments on the general public, and under such contracts, is exempt from legal obligation to comply with Good Clinical Practices or other FDA regulations. See 10 USC 2371b (2015), renumbered 10 USC 4022 (Jan. 1, 2021, effective Jan. 1, 2022)
  26. One of the factors to be considered by the HHS secretary in making determinations about EUA products (qualified security countermeasures) and the use of Special Reserve Fund/Strategic National Stockpile appropriations to procure them is “whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.” See 42 USC 247d-6b (c)(5)(B)(iii)
  27. 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.” See 21 USC 360bbb-3a(c). 2013.
  28. There are no labeling requirements regarding the contents or ingredients in EUA products. 21 USC 360bbb-3(e)(2)(B)(ii). 2004.
  29. There is no limitation of administration of EUA products past their expiration dates.
  30. There cannot be clinical trial fraud, because there are no clinical investigations, no investigational drugs, no investigators and no human subjects.
  31. There are no marketing standards.
  32. There cannot be consumer fraud, because the only legal parties to the financial transactions are the US government (DOD) as buyer; the US government (HHS) as regulator authorizing exemptions from consumer protection laws that otherwise apply to medical products; and the pharmaceutical corporations as sellers, contracted to develop and manufacture the products. There are no commercial pharmaceutical products, no commercial marketplace, and no commercial market consumers.
  33. There is no access to courts for judicial review of the facts or law relating to HHS Secretary declarations of EUA products, which are committed to agency discretion. See 42 USC 247d-6d(b)(7). 2005.
  34. There is no access for plaintiffs, to civil courts for judicial review, and no entity to whom civil liability can attach, for injuries and deaths caused by declared covered countermeasures, unless and until FDA/HHS and/or Attorney General/DOJ file enforcement action against manufacturers and prove willful misconduct proximate to injury or death, but HHS and DOJ have operated the EUA product program together with the manufacturers since inception, and will not prosecute their co-conspirators. See 42 USC 247d-6d. 2005.
  35. Even if there were access to courts for judicial review, and a fact-finder found evidence of harms caused by administration of products to recipients, and even evidence that those who caused the harms, by developing, manufacturing, distributing and/or administering the EUA products, knew the EUA products were toxic and knew their own actions were harmful, “just following orders” is an authorized, legal defense. See 42 USC 247d-6d(c)(4). 2005.

Summary:

There are no actions that can be legally classified as crimes or civil torts; there are no medical battery or homicide victims, or plaintiffs; and there are no medical batterers or murderers. Because legally, nothing has been done, and no one has done anything, to anyone else.

The recursive loop can be infinite, as covered countermeasures are developed, authorized, and deployed, through HHS Secretary EUA declarations, as treatments for complications from prior countermeasures.