American Domestic Bioterrorism Program
Building the case to prosecute members of Congress, presidents, HHS secretaries and federal judges for treason under 18 USC 2381.
Research and organizing tool first posted April 28, 2022, subject to ongoing revision as new information comes to light. Last updated July 30, 2022. PDF version (6/14/2022).
I started looking closely at the legal architecture supporting the Covid national prison panopticon on Jan. 30, 2022, after hearing Attorney Todd Callender’s interview, which provided information about the American domestic legal framework; how it fit with the oddly-coordinated pandemic story told by governments worldwide; and how it relates to the World Health Organization International Health Regulations of 2005 at the center.
I wrote up the interview:
Prior to that day, I’d spent a lot of time, with increasing confusion and alarm and despair, trying to figure out why the U.S. Constitutional legal system hadn’t put a stop to the nonsense as its nonsensicality became obvious to so many people.
Why did it continue, with no end in sight, and not even a glimpse of a path to the end?
Since then, as I’ve dug into Callender’s analysis following the supporting paper trails, I’ve learned why, and how.
A whole lot of things that once were federal and state crimes and civil rights violations have been legalized by Congress through legislative, statutory revisions to the United States Code, signed by US Presidents, and implemented at the administrative, regulatory level by the Department of Health and Human Services through the Code of Federal Regulations.
I’ve reported on those findings in small bits and pieces, connecting the laws to court cases, executive orders, guidance documents for industry and researchers, academic papers, intellectual property patents, regulatory amendments, psychological manipulation programs, geopolitical developments and other facts as they’ve floated across my field of view.
I think the critical decay began around 1983, when the ‘public health emergencies’ section was added to the 1944 Public Health Service Act, although the 1944 PHSA itself represented an additional militarization of human medicine in the United States.
Most of the worst laws have been passed since 2000 — just before 9/11 and the US Department of Defense false flag anthrax attacks.
They are listed below, with links to the full text of each law, and a short summary of what I understand about how each one fits into the overall scheme.
The basic goal of the architects, which has been achieved, was to set up legal conditions in which all governing power in the United States could be automatically transferred from the citizens and the three Constitutional branches into the two hands of the Health and Human Services Secretary, effective at the moment the HHS Secretary himself declared a public health emergency, legally transforming free citizens into enslaved subjects.
That happened on Jan. 31, 2020, in effect as of Jan. 27, 2020 through the present day.
In other words: 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 on behalf of the World Health Organization and its financial backers.
Timelines covering the five years immediately before the biowar declaration:
Run-up to the American bioterrorist State’s Jan. 31, 2020 declaration of war - Part 1 - Published May 25, 2022
Run-up to the American bioterrorist State’s Jan. 31, 2020 declaration of war - Part 2 - Published June 3, 2022
GLOBAL GOVERNANCE BACKDROP
1944 - Bretton Woods Agreement established World Bank and International Monetary Fund.
1945/10/24 - United Nations established, treaty ratified by US Congress.
1945/11/20 - Nuremberg trials began.
1946/07/22 - World Health Organization Constitution adopted and signed by 61 nations at International Health Conference in New York, to enter into force as of 04/07/1948. WHO Constitution amendments passed by World Health Assembly 02/03/1977 ; 01/20/1980 ; 07/11/1994 ; 09/15/2005.
1946/10/01 - Nuremberg trials concluded.
1947/10/30 - General Agreement on Tariffs and Trade (GATT) treaty signed. Went into effect 01/01/1948.
1948 - UN Universal Declaration of Human Rights, part of International Bill on Human Rights
1949/06/18 - George Orwell published 1984.
1951/05/25 - World Health Organization World Health Assembly adopted first International Sanitary Regulations. Effective date: 10/01/1952. Revised and renamed International Health Regulations in 1969. Revised again 1973, 1981, 2005. Draft revisions under review 2022.
1952/09/14 - Pope Pius XII speech On the Moral Limits of Medical Research and Treatment, given to First International Congress on Histopathology of the Nervous System. “Insofar as the moral justification of the experiments rests on the mandate of public authority, and therefore on the subordination of the individual to the community, of the individual’s welfare to the common welfare, it is based on an erroneous explanation of this principle. It must be noted that, in his personal being, man is not finally ordered to usefulness to society. On the contrary, the community exists for man.”
1952/10/01 - WHO International Sanitary Regulations enter into force in WHO member states.
1961/01/17 President Dwight Eisenhower Farewell Address, warning of military-industrial-Congressional complex and the “danger that public policy could itself become the captive of a scientific-technological elite.”
1968/07/25 - Pope Paul VI papal encyclical Humanae Vitae re: abortion and contraception.
1969 - WHO International Sanitary Regulations, in effect since 10/01/1952, revised and renamed International Health Regulations. Revised again 1973, 1981, 2005. Draft revisions under review 2022.
1972-1975 - United Nations Convention on Prohibition of Biological Weapons opened for signing (1972) and went into effect (1975). Left major loophole for biological and chemical agents developed for ‘protective’ or ‘prophylactic’ purposes.
1992 - United Nations hosted the UN Conference on Environment and Development, commonly called the Earth Summit, in Rio de Janeiro, Brazil.
179 participating nations adopted Agenda 21 (later renamed Agenda 30), laying out plans for depopulation, elimination of private property, and elimination of borders and national sovereignty. Implicitly defined living human beings as biological weapons of mass destruction, against which lethal chemical and biological agents could be construed as ‘protective’ and ‘prophylactic’ and therefore exempt from 1975 UN Convention on Prohibition of Biological Weapons.
1994 - United Nations Framework Convention on Climate Change was also opened for nation-states to sign at the 1992 conference. By 1994, enough nations had signed for the convention to enter into force.
1994 - September 1994, United Nations hosted the International Conference on Population and Development in Cairo, Egypt. 179 nation-states signed on to a 20-year Programme of Action for depopulation, which was extended in 2010 to cover 2014-2034.
AMERICAN IMPLEMENTATION - EXECUTIVE ORDERS SIGNED BY PRESIDENTS & HHS SECRETARIES
1933/04/05 - Executive Order 6102 signed by President Franklin D. Roosevelt, under state of emergency (Great Depression). Ratified by Congress through House Joint Resolution 192. Forbade the hoarding 'of gold or silver coin or bullion or currency,' confiscated gold held by private individuals, to remove the constraint on the Federal Reserve (1913 Federal Reserve Act) preventing it from increasing the money supply.
1952/09/27 - Executive Order 10399 signed by President Harry Truman, establishing the US Surgeon General as the “health administrator” for the World Health Organization on American soil, under 1948 WHO Constitution and 1951 WHO International Sanitary Regulations. 17 Federal Register 8648.
1953/03/12 - Reorganization Plan No. 1 of 1953 transmitted to Congress by President Dwight Eisenhower, putting sovereignty relinquishment through WHO International Sanitary Regulations, as operated by Surgeon General through the Department of Health, Education and Welfare (later renamed Health and Human Services) into US Code at 42 USC 202. Published in Federal Register 04/11/1953, 18 Federal Register 2053.
1966/04/25 - Reorganization Plan No. 3 of 1966. US Surgeon General’s authorities transferred to Secretary of Health, Education and Welfare department, effective 06/25/1966. 31 Federal Register 8855.
1971/08/15 - President Richard Nixon directed the Treasury Secretary to suspend, with some exceptions, the convertibility of the dollar into gold or other reserve assets, ordering the gold window to be closed such that foreign governments could no longer exchange their dollars for gold, and issued Executive Order 11615 (pursuant to the Economic Stabilization Act of 1970), imposing a 90-day freeze on wages and prices in order to counter inflation.
1974/12/31 - Nixon and Congress legalized private ownership of gold, reversing 1933 prohibition. PL 93-373.
1974/12/10 - National Security Study Memorandum 200 (NSSM 200), Henry Kissinger, re: global depopulation as US geopolitical strategy.
1975/11/26 - President Gerald Ford endorsement of depopulation plan NSSM 200 through National Security Decision Memorandum 314
1979/04/18 - Belmont Report on ethics of human subjects research.
1983/12/22 - Executive Order 12452 signed by President Ronald Reagan. Specified communicable diseases subjecting citizens to forcible apprehension and detention, under Health and Human Services Secretary’s quarantine authority through PHSA, 42 USC 264b, including "Cholera or suspected Cholera, Diphtheria, infectious Tuberculosis, Plague, suspected Smallpox, Yellow Fever, and suspected Viral Hemorrhagic Fevers (Lassa, Marburg, Ebola, Congo-Crimean, and others not yet isolated or named).”
2001/09/23 - Executive Order 13224 signed by President George W. Bush. Blocking property and prohibiting transactions with persons who commit, threaten to commit or support terrorism. List maintained by Office of Foreign Assets Control, US Dept. of Treasury.
2003/04/04 - Executive Order 13295 signed by President George W. Bush. Added symptomatic SARS to list of quarantinable communicable diseases.
2005/04/01 - Executive Order 13375 signed by President George W. Bush. Added symptomatic influenza to list of quarantinable communicable diseases
2007/05/04 - President George W. Bush National Security Presidential Directive 51.
2014/07/31 - Executive Order 13674 signed by President Barack Obama, adding asymptomatic, suspected SARS to list of quarantinable communicable diseases.
2019/02/11 - Executive Order 13859 signed by President Donald Trump: Maintaining American Leadership in Artificial Intelligence. Directed and prioritized federal agency collaboration with industry for AI research and development.
2019/09/19 - Executive Order 13887 signed by President Donald Trump: Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. Directed and prioritized federal agency collaboration with industry for rapid-deployment mRNA/DNA/LNP/nanotech bioweapon platforms misclassified as public health protection:
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.
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, effective Feb. 4, 2020. Deployment of the domestic bioterrorism program against all American citizens under Covid-19 pretext.
1913-1982 AMERICAN IMPLEMENTATION - STATUTES
1913/12/23 - Federal Reserve Act. Created Federal Reserve Bank, central banking system in United States.
1921/11/23 - Sheppard-Towner Maternity and Infancy Protection Act. Established status of American-born babies — human beings — as collateral for national debt owed to international bankers; program operated through birth certificates/security bonds filed with state registries of vital statistics. Expired 1929, replaced by 1935 Social Security Act.
1933/06/05 - House Joint Resolution 192. Congress declared bankruptcy of US government; ratified President Roosevelt’s Executive Order 6102 suspending gold standard; pledged lives of American people (registered at birth through Social Security program) as collateral/debt slaves to international bankers, against national debt.
1935 Social Security Act - PL 74-271. 49 Stat. 620. Social Security Act is also the law governing Medicare and Medicaid, which are among the authorization and funding pathways through which ‘breakthrough’ devices and drugs, fast-track products, products eligible for accelerated approval and other FDA- classified products are developed, manufactured and used on humans. Amendments to SSA since 1983 and pending, have expanded/will further expand the novel drug and device/bioweapon classes eligible for fast-tracked federal research and deployment funding within the Medicare/Medicaid programs.
1938 Federal Food Drug and Cosmetic Act - PL 75-717. 52 Stat. 1040. (21 pages.) 21 USC 9 et seq. Original law passed “to prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.”
1944 Public Health Service Act - PL 78-410. 58 Stat. 682. (39 pages.) 42 USC 201 et seq. Consolidated, centralized and militarized the American public health system that had developed within several agencies since the Revolution.
1946/06/11 - Administrative Procedures Act, PL 79-404. 60 Stat. 237. 5 USC 551. Set up the framework for the administrative state to operate within a de facto executive branch dictatorship, through the “committed to agency discretion” override of both the legislative process and judicial review.
1947 National Security Act - 61 Stat. 499. Set up precursors to Federal Emergency Management Agency (FEMA).
1948 US Information and Educational Exchange Act (Smith-Mundt). PL 80-402. 62 Stat. 6. Set up programs for US propaganda distribution in foreign countries; limited use of government propaganda on American population. ‘Modernized’ to authorize domestic propaganda in 01/02/2013 National Defense Authorization Act.
1948/06/14 - World Health Organization Constitution accepted by US Congress resolution. PL 643, 22 USC 290, 64 Stat. 441.
1949/04/04 - US Senate ratified North Atlantic Treaty Organization (NATO) treaty. Treaty in effect as of 08/24/1949
1969/06/09 - US Senate hearing on DOD appropriations, testimony by Dr. Donald MacArthur on development of “new infective microorganisms which could differ in certain important aspects from any known disease-causing organisms. Most important of these is that it might be refractory to the immunological and therapeutic processes upon when we depend to maintain our relative freedom from infectious disease.”
1969/11/19 - Armed Forces Appropriations Act. PL 91-121, 83 Stat. 209. DOD use of human subjects for experiments in chemical and biological weapons. Section 409.
1970/08/15 - Economic Stabilization Act of 1970 (PL 91-379, 84 Stat. 799, Authorized the President to stabilize prices, rents, wages, salaries, interest rates, dividends and similar transfers as part of a general program of price controls within the American domestic goods and labor markets. Used by Nixon in August 1971.
1971/12/22 - National Cancer Act. PL 92-216, 85 Stat. 778.
1974 Disaster Relief Act. PL 93-288. Another statute creating precursors to FEMA.
1974 National Research Service Award Act. PL 93-348. 88 Stat. 342. Title II set up commission to study bioethics and protection of human subjects. Led to Belmont Report, published April 1979.
1977/07/30 - Department of Defense Appropriations Authorization Act of 1978. PL 95-79, 91 Stat. 323. Use of military personnel as research subjects for biological and chemical weapons. Title VIII, Section 808
1979/10/17 - Health, Education and Welfare Department renamed Health and Human Services Department. PL 96-88, 93 Stat. 695. From that point to the present, the Secretary of Health and Human Services has exercised authorities under the WHO Constitution and WHO International Health Regulations, as transferred from Surgeon General to HEW Secretary in 1966.
1980 Comprehensive Environmental Response, Compensation and Liability Act. PL 96-510, 94 Stat. 2767. Superfund Act. Set up federal programs for cleanup of toxic chemical dumpsites.
1982/12/21 - Congressional Reports Elimination Act. PL 97-375, 96 Stat. 1822. Re DOD use of human subjects in chemical and biological weapons research. Title II, Section 203(a).
1983-2019 AMERICAN IMPLEMENTATION - STATUTES
1983 Public Health Service Act Amendment - PL 98-49, 97 Stat. 245. (2 pages.) Amended Public Health Service Act (at 42 USC 247d) to add Section 319, ‘Public Health Emergencies’ granting new powers to Health and Human Services Secretary and establishing a $30 million slush fund called the Public Health Emergencies Fund. Summary posted April 20, 2022.
1986 Emergency Planning and Community Right to Know Act. PL 99-499. Part of Superfund Amendments and Reauthorization Act. Related to toxic chemicals and federal government authority.
1986 State Comprehensive Mental Health Services Plan Act - PL 99-660 (73 pages). Title III - National Childhood Vaccine Injury Act. 100 Stat. 3755. Amended Public Health Service Act (42 USC 201 et seq) to add Title XXI, 42 USC 300aa et seq, including Subtitle 1, establishing and funding a National Vaccine Program, and Subtitle 2, granting vaccine manufactures legal immunity for injuries and deaths caused by their products, and establishing and funding a tax revenue/public debt-funded National Vaccine Injury Compensation Program.
1988 Health Omnibus Programs Extension Act - PL 100-607. 102 Stat. 3048. (126 pages.) Established National Center for Biotechnology Information under Public Health Service Act; outlined and funded HIV-AIDS research under direction of NIH/NIAID/Fauci; increased funding for the Public Health Emergencies Fund to $45 million.
1988 Robert T. Stafford Disaster Relief and Emergency Act - PL 100-707. Amended 1974 Disaster Relief Act, FEMA law.
1990 Biological Weapons Antiterrorism Act of 1989. PL 101-298, 104 Stat. 201. Added 18 USC 175. "(a) IN GENERAL.—Whoever knowingly develops, produces, stockpiles, transfers, acquires, retains, or possesses any biological agent, toxin, or delivery system for use as a weapon, or knowingly assists a foreign state or any organization to do so, shall be fined under this title or imprisoned for life or any term of years, or both…"(b) DEFINITION.—For purposes of this section, the term 'for use as a weapon' does not include the development, production, transfer, acquisition, retention, or possession of any biological agent, toxin, or delivery system for prophylactic, protective, or other peaceful purposes.”
1992 Alcohol, Drug Abuse, Mental Health Administration (ADAMHA) Restructuring Act - PL 102-321, 106 Stat. 323. (120 pages). Expanded drug abuse prevention and treatment programs; reorganized HHS subdivisions.
1992 Preventative Health Amendments - PL 102-531. 106 Stat. 3504. (40 pages.) Changed name from Centers for Disease Control to Centers for Disease Control and Prevention.
1993 National Institutes of Health Revitalization Act, PL 103-43. (98 pages)
1993 Religious Freedom Restoration Act, PL 103-141, 107 Stat. 1488. (3 pages). Codified Constitutional protections for free exercise of religion under First Amendment. Related to military personnel requests for religious exemptions from vaccine mandates, not accepted by DOD.
1994 Violent Crime Control and Law Enforcement Act. Clinton Crime Bill. PL 103-322, 108 Stat. 1796. (356 pages). Expanded American prison state, by expanding predicates for incarcerating nonviolent civilians for long sentences, increasing funding for prison construction/operation, and law enforcement officers.
1996 Antiterrorism and Effective Death Penalty Act; Illegal Immigration Reform and Immigrant Responsibility Act; Prison Litigation Reform Act. Related to court stripping: Congress passing laws to remove federal courts’ oversight power regarding legislative and executive acts, eliminate checks and balances. See ACLU report, Oct. 2001, Upsetting Checks and Balances: Congressional Hostility Toward the Courts in Times of Crisis.
1997 National Defense Authorization Act for FY98 - PL 105-85, 111 Stat. 1915 (450 pages). Section 1078, “Restrictions on the use of human subjects for testing of chemical or biological agents,” repealed and replaced a 1977 section of 50 USC Chapter 32, the Chemical and Biological Warfare Program. The 1977 provision (50 USC 1520) had added a requirement that DOD report to Congress about DOD human experimentation programs. In 1997, Congress replaced 1520 with 1520a, purportedly to prohibit DOD conducting experiments on soldiers without the individual soldiers informed consent. It was passed by Congress in response to public outrage over injuries and deaths caused by mandated anthrax injections of soldiers during and after the 1991 Gulf War. However, the authority for federal government experimentation on non-consenting human beings continued; Congress simply transferred the program to the Food Drug and Cosmetics Act, 21 USC 360bbb (see below, passed three days after the NDAA) under declared emergency situations (Emergency Use Authorizations/EUA).
1997 Food and Drug Administration Modernization Act - PL 105-115, 11 Stat. 2296. (86 pages). Added new section to Federal Food Drug and Cosmetics Act (21 USC 9) to expand access to investigational drugs and devices during emergency situations (21 USC 360bbb - “EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS”). This was the beginning of the Emergency Use Authorization framework that culminated in the federal government’s psychological, social and economic coercion program aimed at universal injection of all American citizens with products marketed as Covid-19 vaccines, operational from mid-2020 to the present.
1998 Omnibus Consolidated and Emergency Supplemental Appropriations for FY1999 - PL 105-277. (920 pages). 112 Stat. 2681- 358: Established the National Pharmaceutical Stockpile, later renamed the Strategic National Stockpile. Appropriated $51,000,000, “to remain available until expended…for pharmaceutical and vaccine stockpiling activities at the Centers for Disease Control and Prevention.” Moved forward, politically, by March 1998 Washington DC tabletop exercise on smallpox epidemic.
2000 Public Health Improvement Act - PL 106-505, 114 Stat. 2314. (38 pages). Title I, Public Health Threats and Emergencies Act, reworked and expanded Section 319 of Public Health Service Act, 42 USC 247d (the Public Health Emergencies section first added in 1983). Appropriated funding and established a working group on bioterrorism ‘countermeasures’ research and development.
2001 Authorization for Use of Military Force - PL 107–40; 115 Stat. 224. Passed under the 1973 War Powers Act, 50 U.S. Code § 1541, and construed as putting the United States in a permanent state of war (Global War on Terror) with no limitations in time or geographically.
2001 Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Act - PL 107-56, 115 Stat. 272 (132 pages). Amended 18 USC 2331 - Definitions section of 18 USC 113B - Terrorism - to add “domestic terrorism,” defined as activities that “(A) involve acts dangerous to human life that are a violation of the criminal laws of the United States or of any State; (B) appear to be intended—(i)to intimidate or coerce a civilian population; (ii) to influence the policy of a government by intimidation or coercion; or (iii) to affect the conduct of a government by mass destruction, assassination, or kidnapping; and (C) occur primarily within the territorial jurisdiction of the United States.” There is plenty of evidence to prosecute and convict Fauci, Baric, Gates, Daszak and others under this criminal statute. However, this is also why the conspirators used the FBI to infiltrate the January 6, 2021 Washington DC election protests, to ensure breach of the Capitol and subsequent arrests and indefinite detentions of non-violent trespassers, to create predicates to steer and shape national panic about domestic terrorism exclusively defined as civilians challenging the legitimacy of government officials and acts, to steer public anger and distrust away from government agents killing, maiming and imprisoning civilians.
2002 Public Health Security and Bioterrorism Preparedness and Response Act - PL 107-188, 116 Stat. 594 (105 pages). Major amendments to Public Health Service Act (42 USC 201) and Federal Food Drug and Cosmetics Act (21 USC 9). This law fully constructed and expanded funding for the federal government’s domestic bioterrorism apparatus headquartered at the CDC, disguising it as a program to protect Americans from non-state actors. Sections included National Preparedness and Response Planning, Coordinating, and Reporting; Strategic National Stockpile; Development of Priority Countermeasures (i.e. fast-tracking approval of drugs and devices without standard safety testing, efficacy testing, and regulatory compliance); Improving State, Local, and Hospital Preparedness for and Response to Bioterrorism and Other Public Health Emergencies; Emergency Authorities (i.e. federal quarantine power); Controls on Dangerous Biological Agents and Toxins; Safety and Security of Food and Drug Supply; Drinking Water Security and Safety. Coincidentally also in 2002, HHS-NIH-funded (grant no. AI23946-08) University of North Carolina researcher and Fauci colleague Ralph Baric filed a US patent (7,279,372) on methods to make bat coronaviruses more lethal to humans, noting that “the US government has certain rights to this invention.” More on that.
2002 Homeland Security Act - PL 107-296, 116 Stat. 2135. (187 pages.) Established Department of Homeland Security as a cabinet-level administrative arm of the executive branch. Expanded militarization of domestic surveillance and law enforcement. Title V: established a Directorate of Emergency Preparedness and Response within Department of Homeland Security, headed by an Undersecretary. Strengthened crosslinks between DHS and other federal agencies: Health and Human Services, Federal Emergency Management Agency (FEMA), Department of Defense, Department of Justice and Department of Agriculture, to build and operate a public-health-predicated martial law system.
2003 National Defense Authorization Act (NDAA). PL 108-136, 117 Stat. 1392. Added section 21 USC 360bbb-3 - AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES to 1997 EUA program: 21 USC 360bbb - EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
2004 Project Bioshield Act - PL 108-276, 118 Stat. 835. (30 pages.) Amendments to Public Health Service Act (42 USC 201) and Federal Food Drug and Cosmetics Act (21 USC 9). Amended and expanded 21 USC 360bbb (first adopted in PL 105-115 in 1997), relating to authorization for investigational drugs and devices to be used in emergencies (Emergency Use Authorization). Established program for ‘qualified countermeasure’ research, procurement, contracting, manufacture, use and liability exemptions. Expanded authority of NIAID Director (Fauci). Appropriated $640,000,000 for the Strategic National Stockpile for FY2002, $590,000,000 for smallpox vaccine development for FY2002, and $5,593,000,000 for “procurement of security countermeasures.” Expanded HHS power to subject citizens to involuntary relocation and indefinite detention on communicable disease predicates. Expanded coordination among Secretary of Health and Human Services, Secretary of Defense and Secretary of Homeland Security.
2005 Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act - PL 109-148. (154 pages). 119 Stat. 2818, Division C at last 14 pages: Public Readiness and Emergency Preparedness (PREP) Act. Amended Public Health Service Act (42 USC 201). Established power of Secretary of Health and Human Services, during self-declared public health emergency under Section 319, to unilaterally issue declarations recommending “manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures.” 42 USC 247d-6d(b). Added more detail on liability shields for pandemic and epidemic products and security countermeasures. Set pre-suit hurdle requiring HHS to first bring claims against defendants, and bar private claims until after HHS claims resolved, if and only if defendant found liable. Set liability standard at willful misconduct, “establishing a standard…more stringent than negligence in any form or recklessness,” requiring proof defendant 1) intentionally engaged in misconduct 2) proximate to victim’s injury or death. Established just-following-orders defense for vaccinators and others in the chain of distribution. Established court-alternative, tax-and-debt-funded Covered Countermeasure Process Fund, similar to Vaccine Injury Compensation Fund established in 1986 for products on childhood vaccine schedule. Another provision of the DOD Supplemental Emergency Appropriation funded the Public Health and Social Service Emergency Fund (PHSSEF), a slush fund under the control of the Secretary of Health and Human Services, with $3.3 billion to start.
2006 Pandemic and All-Hazards Preparedness Act. PL 109-417, 120 Stat. 2878. (51 pages). Fulfilled many of the requirements of the World Health Organization International Health Regulations of 2005, by further consolidating and centralizing power in federal Health and Human Services Secretary’s hands. Created new HHS department, led by new Assistant Secretary for Preparedness and Response (counterpart to the DHS Director of Emergency Preparedness and Response position created in 2002). Established rules for coordination among HHS, Secretary of Defense, Secretary of Veterans Affairs, Secretary of Transportation and “any other relevant federal agency.” Established national framework subordinating state, county, tribal and local public health and law enforcement systems to federal agencies. Expanded surveillance programs. Clarified definitions of qualified countermeasure, security countermeasure, and infectious disease for purposes of 2004 Project Bioshield Act. Established Biomedical Advanced Research and Development Authority (BARDA) division under HHS, “to facilitate a broad-based approach to emergency medical countermeasure-related activities,” including $1,070,000,000 appropriation. Tools included HHS authority to limit competition among manufacturers of pandemic products as defined under 2004 Project Bioshield Act.
2007 John Warner Defense Authorization Act - PL 109-364, 120 Stat. 2095. (439 pages). Section 1076 amended 1807 Insurrection Act, (10 USC 333, renumbered as 10 USC 253), providing exemptions to 1878 Posse Comitatus Act, to expand the authority of federal government to deploy US military on American soil against American citizens during “natural disaster, epidemic, or other serious public health emergency, terrorist attack or incident, or other condition in any State or possession of the United States.” Repealed the following year.
2007 National Institute of Health Reform Act - PL 109-482, 120 Stat. 3675. (29 pages). Reorganization, consolidation of power and funding.
2008 National Defense Authorization Act - PL 110-181. (602 pages). 122 Stat. 325: Section 1068 repealed 2007 amendments to Insurrection Act which had expanded exemptions to 1878 Posse Comitatus Act limits on US Presidents’ power to deploy the military domestically.
2009 Biologics Price Competition and Innovation Act. Title VII of Affordable Care Act (ObamaCare). Related to the legal, approval/authorization, labelling and marketing differences among ‘biosimilars,’ BLA (Biologics License Application) products, and EUA products regulated by FDA.
2011 Act to Amend Title 35, United States Code, to Provide for Patent Reform - PL 112-29, 125 Stat. 340. Section 33 limited the authority of the US patent office under 35 USC 101, to prohibit issuing of patents “directed to or encompassing a human organism.” Related to 1980 Chakrabarty and 2013 Myriad Supreme Court precedents authorizing patents on genetically-modified living organisms and modified genetic material.
2012 National Defense Authorization Act - PL 112-81, Section 1021. Codified authority for US President to order military arrest and indefinite detention of American civilians without charge or trial under 10 USC 801 et seq. (Uniform Code of Military Justice), to the extent the 2001 Authorization for Use of Military Force (PL 107–40; 115 Stat. 224, passed under the 1973 War Powers Act, 50 U.S. Code § 1541) is construed as putting the United States in a permanent state of war (Global War on Terror).
2012 Food and Drug Administration Safety and Innovation Act - PL 112-144, 126 Stat. 993. (140 pages). Amendments to Federal Food, Drug, and Cosmetic Act (21 USC 9) regarding user-fee programs for prescription drugs and medical devices, generic drugs and biosimilars, and for other purposes. See August 2014 FDA Decisions for Investigational Device Exemption: Clinical Investigations Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and FDA Staff, January 2017 Emergency Use Authorization of Medical Products and Related Authorities Guidance for Industry and Other Stakeholders and July 2021 Department of Justice 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, for federal government’s position on legal status and regulatory control differences between Emergency Use Authorization (EUA) products, Investigational New Drugs (IND) and Investigational Device Exemptions (IDE).
2013 National Defense Authorization Act (NDAA) - PL 112-239, 126 Stat. 1957. (682 pages). At Section 1078, “modernized” Smith-Mundt Act of 1948 to authorize domestic deployment of propaganda by the US government, on the American population.
2013 Pandemic and All-Hazards Preparedness Reauthorization Act - PL 113-5, 127 Stat.161. (37 pages). Renewed and updated 2006 Pandemic and All-Hazards Preparedness Act, with amendments to Public Health Service Act (42 USC 201) and Federal Food Drug and Cosmetics Act (21 USC 9). Added sections 564A and 564B to the FDCA to further authorize emergency use of approved products in emergencies and products held for emergency use. Amended definitions of covered countermeasures and qualified pandemic and epidemic products in Section 319F-3 of PHSA (2005 PREP Act provisions). Extended definitions to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.
2015 Medicare Access and CHIP Reauthorization (MACRA) Act. PL 114-10. (95 pages) Largest changes to health care system since 2010 Affordable Care Act (ObamaCare). Section 511 directed HHS to clarify how changes to human subjects protections under 1991 Common Rule would apply to Medicare and Medicaid “clinical data registries.” Related to ‘real world evidence’ with no legal protections for human subjects, replacing traditional clinical trial procedures that did have legal protections for human subjects.
2016 National Defense Authorization Act. PL 114-92, 129 Stat. 893. Section 815 added the ‘prototype’ contracting language to Title 10, Military Law (10 USC 2371b, later renumbered 10 USC 4021), authorizing Department of Defense to contract with pharmaceutical corporations to conduct otherwise illegal medical experiments on the American and global public without notice or consent. First two posts on this topic: 05/25/2022 and 05/26/2022.
2016 21st Century Cures Act (Cures Act 1.0) - PL 114-255, 130 Stat. 1033 (312 pages). Updated and expanded Public Health Service Act, 42 USC 201, “to accelerate the discovery, development, and delivery of 21st century cures.” Provided (Section 3022, 130 Stat. 1097) for ‘real world evidence’ instead of clinical trials as grounds for FDA authorizing general use of experimental products, transforming Americans into human subjects and our communities into unmonitored, unregulated experimental test sites. Provided (Section 3023 and 3024, 130 Stat. 1098) broad authority for HHS Secretary to waive or alter human subject protections and informed consent requirements, by transferring each individual human subject’s risk-benefit assessment authority to the HHS Secretary, who can preemptively decide, for all subjects collectively, without knowledge of individual health conditions or conscientious beliefs, and without the subjects’ knowledge or consent, that risk is ‘minimal.’
2017 National Defense Authorization Act - PL114-328, 130 Stat. 2509. Established DOD Defense Security Cooperation Agency (DSCA) and Director of DSCA, with authority to coordinate and synchronize US military with foreign military forces, and conduct domestic military campaigns in violation of the 1878 Posse Comitatus Act. 10 USC 382. See 01/23/2017 Department of Homeland Security Biological Incident Annex to the Response and Recovery Federal Interagency Operational Plans at p. 70, stating that 10 USC 382 “permits Department of Defense to provide support to the Department of Justice under certain circumstances in emergency situations involving Weapons of Mass Destruction, including biological weapons and materials.”
2017 FDA Reauthorization Act - PL 115-52. 131 Stat. 1005 (86 pages)
2017 Act to amend FDCA EUA statute, 21 USC 360bbb-3. PL 115-92, 131 Stat. 2023. (3 pages). Provided for “Additional Emergency Uses for Medical Products to Reduce Deaths and Severity of Injuries Caused by Agents of War”
2018 National Defense Authorization Act - PL 115-91. Section 716 added subsection (d) to 10 USC 1107a, re: EUA product use in military. But see FDCA amendment, PL 115-92 (above) passed same day, which immediately repealed 10 USC 1107a(d) while adding new FDCA section on military use of EUAs.
2019 Pandemic and All-Hazards Preparedness and Advancing Innovation Act - PL 116-22, 133 Stat. 905 (61 pages). Amended Public Health Service Act (42 U.S.C. 201), further consolidating federal power in HHS Secretary’s hands during public health emergencies, further merging public health and law enforcement systems, and further subordinating state, tribal, county and municipal governments and American civilians to direct federal control.
2020 - Present - COVID PRETEXT EXECUTIVE ORDERS, DECLARATIONS & STATUTES
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.
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, effective Feb. 4, 2020. Deployment of the domestic bioterrorism program against all American citizens under Covid-19 pretext.
2020 Coronavirus Preparedness and Response Supplemental Appropriations Act - PL 116-123, 134 Stat. 146 (12 pages). $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 Families First Coronavirus Response Act - PL 116-127, 134 Stat. 178. (43 pages). $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 Coronavirus Aid, Relief, and Economic Security (CARES) Act - PL 116-136, 134 Stat. 281. (335 pages) 15 USC 9001. $2.2 trillion in corporate and small business loans, household stupport 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 Paycheck Protection Program and Health Care Enhancement Act - PL 116-139, 134 Stat. 620 (12 pages). $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 Consolidated Appropriations Act - PL 116-260, 134 Stat. 1182 (5,593 pages). $2.3 trillion spending bill, including $900 billion for Covid programs.
2021 Orange Book Transparency Act - PL 116-290, 134 Stat. 4889. (5 pages) Amendments to patent law under Federal Food Drug and Cosmetics Act, (21 USC 9)
2021 American Rescue Plan/Consolidated Appropriations Act. PL 117-2. Title XIV, Section 1401, Covid-19 Consumer Protection Act. Criminalized advocacy of alternative treatments under Federal Trade Commission provisions.
2022 Consolidated Appropriations Act - PL 117-103. Passed Congress March 15, 2022. $1,274,678,000 for the Public Health and Social Services Emergency Fund (first funded 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.”
PENDING FEDERAL LEGISLATION as of Summer 2022
2022 National Defense Authorization Act - Pending, HR4350. Section 6438 - Global Health Security Act. Authorizes, creates, funds globalized military-health structure, linking US military to global genocide apparatus operating under WHO frameworks.
2022 Covid Supplemental Appropriations Act - Pending, HR7007. Authorizes $10.6 billion for Covid bioweapon development and deployment, including “up to $9,850,000,000 to Biomedical Advanced Research and Development Authority [BARDA, established 2006] for advanced research and development, manufacturing, production, and purchase, at the discretion of the Secretary of Health and Human Services, of vaccines, therapeutics, diagnostics, and supplies.”
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 program. Program to be developed by committee comprised of 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 genomic testing program for children and teens (corroborating evidence that 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.
2006-2022 - REGULATIONS, RULES, GUIDANCE DOCUMENTS & REPORTS
2006/11/28 - HHS FDA Guidance: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Effects (25 pages)
2007/07/01 - HHS FDA Guidance: Emergency Use Authorization of Medical Products (20 pages)
2009/11/18 - HHS FDA Workshop Summary - Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model (94 pages) - “At the workshop, participants noted that EUA has a broader use beyond enabling the use of an unapproved product or extending the use of an approved product to populations for which it was not approved. In particular, it can also be used to address labeling requirements and other challenges that arise because of constraints inherent in a public health response. ‘From a legal perspective, there are a lot of situations where EUA helps get past all those requirements,’ said [Susan E. Sherman, J.D., M.S., is a senior attorney with the Office of the General Counsel, HHS] ‘You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.’ ”
2011/01 - HHS FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (19 pages)
2014/08/19 - HHS FDA Guidance: Decisions for Investigational Device Exemption Clinical Investigations (19 pages)
2016/09/21 - HHS Final Rule - HHS Clinical Trials Registration and Results. 81 FR 64981 (177 pages)
2016/10/24 - HHS Workshop Summary - The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile. (143 pages)
2017/01/13 - HHS FDA Guidance: Emergency Use Authorization of Medical Products and Related Authorities. (49 pages)
2017/01/19 - HHS Final Rule - Federal Policy for the Protection of Human Subjects. 82 FR 7149. (126 pages) Joint rule by 16 federal agencies, subsequently adopted by other agencies. Revised 1991 Common Rule, which had been developed based on 1947 Nuremberg Code and 1978 Belmont Report.
2017/01/19 HHS Final Rule - Control of Communicable Diseases Final Rule. 82 FR 6890. (89 pages)
2017/08 - HHS FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. (17 pages)
2018/06/19 - HHS Final Rule - Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period. 83 FR 28497 (24 pages)
2019/05/22 - Congressional Research Service Opinion: An Overview of State and Federal Authority to Impose Vaccination Requirements (Version 2, 4 pages)
2021/04/02 - Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination (Version 1, 14 pages)
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 FR 64075 (7 pages) [that] “have the potential to pose a severe threat to public health and safety.” 42 CFR 73.3. US-HHS definition change may be an attempt to forestall accountability efforts 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 (PHEIC) legal framework would be nullified, instead bringing to bear 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 - 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.
2022/02/07 - Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination. (46 pages)
2022/05/17 - Congressional Research Service Opinion: State and Federal Authority to Mandate COVID-19 Vaccination. (Version 9, 47 pages)
2022/05/17 - Congressional Research Service Opinion: Status of Federal COVID-19 Vaccination Mandate Litigation. (Version 7, 5 pages)
AMERICAN IMPLEMENTATION - JUDICIAL PRECEDENTS
Timeline (1819-2022) of Supreme Court cases, related state cases and treatises on issues of individual liberty, bodily integrity, personal sovereignty and related moral issues.
Key legal markers eroding personal sovereignty principles have been laid by SCOTUS during Covid
May 2020 - South Bay United Pentecostal Church v. Newsom, 590 US __, (2020). SCOTUS denied role for federal judiciary in Constitutional review of executive and legislative acts taken during declared public health emergencies.
January 2022 - Missouri v. Biden (21 A 240), Louisiana v. Biden (21 A. 241), 595 US __, (2022). SCOTUS asserted federal funding for hospitals and nursing homes voids Constitutional protection for employees individual bodily integrity and informed consent to medical treatment.
February 2022 - Dobbs v. Jackson Women's Health, leaked draft opinion by Justice Samuel Alito. SCOTUS poised to explicitly deny the principle of Constitutionally-protected inalienable individual rights to personal privacy, conscience, bodily integrity, or liberty, against State exercise of authority.
COVID-19 injectable bioweapons as 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 the 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.
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, adopted 1997 and amended 2003, 2004, 2005, 2013, 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:
There is no stopping condition.
EUA products are exempt from laws regulating researcher use of investigational, experimental drugs, devices and biologics on human beings.
EUA products are exempt from laws regulating physician use of approved drugs, devices and biologics as medical treatments for patients.
There are no manufacturers of experimental products (EUA products are not part of any clinical investigation, and therefore not experimental.)
There are no government or private contracts for purchase of experimental products; there are only contracts for ‘large scale vaccine manufacturing demonstrations.’
There is no act of administration of any experimental products.
There are no nurses or pharmacists administering experimental products.
There are no human subjects (of experiments) or patients (of physicians providing treatment) receiving experimental products: no victims.
There is no party responsible for the wellbeing of recipients after administration of EUA products.
There is no treatment group and no control group.
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).
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, bullet point above.
There are no Institutional Review Boards supervising administration of the experimental products.
There are no safety standards for EUA products.
There are no efficacy standard for EUA products. See 21 USC 360bbb-3(c)(2)(A), 1997, 2004, re: ‘may be effective’
There are no clinical investigators studying the effects of EUA products on human subjects.
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.
There is no coordinated, public, federal government monitoring of recipients after receiving the products for adverse effects and deaths.
There is no coordinated, public, federal government data collection or analysis.
There is no legal requirement for medical supervision during product administration.
There is no legal requirement for recipient monitoring after product administration.
‘Real world evidence’ — mass administration of products to general public, followed by 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.
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.
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).
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)
One of the factors to be considered by HHS secretary in making determinations about EUA products (qualified security countermeasures) and 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)
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.
There are no labeling requirements regarding the contents or ingredients in EUA products. 21 USC 360bbb-3(e)(2)(B)(ii). 2004.
There is no limitation of administration of EUA products past their expiration dates.
There cannot be clinical trial fraud, because there are no clinical investigations, no investigational drugs, no investigators and no human subjects.
There are no marketing standards.
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.
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.
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.
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.
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.