Tools for illuminating, defying and dismantling kill-box anti-laws: Latypova memo on legal status of EUA countermeasures.
I hope to put together a more concise, easier-to-use set of tools for readers interested in working to inform others about, defy/disobey and dismantle the illegitimate, unjust kill-box laws at the individual, workplace, school, county, state and federal levels.
Easier to use, I mean, than my previous attempt:
Feb. 21, 2023 - Reconstitution starter pack
I’ll try to post several of the tools separately this week, and then combine them in a single post that’s better organized than the February 2023 one.
Below is a memo written by Sasha Latypova, for use in educating doctors, pharmacists, employers, school officials, sheriffs, county commissioners, state lawmakers and others.
Also, I encourage Bailiwick readers to read Debbie Lerman’s detailed, well-sourced two-part series on Department of Defense (DoD) and Department of Health and Human Services (HHS) use of EUA, OTA, and PREP Act law for the development, production and use of “Covid-19 vaccines.”
Dec. 6, 2023 - Covid mRNA Vaccines Required No Safety Oversight (Debbie Lerman, Brownstone Institute)
Jan. 14, 2024 - Covid mRNA Vaccines Required No Safety Oversight: Part Two (Debbie Lerman, Brownstone Institute)
In my view, the answer to Lerman’s interspersed questions — about why legal frameworks allegedly devised by Congress, signed by US Presidents and instrumentalized by Cabinet secretaries (through regulations), to enable rapid deployment of military prototypes during deadly CBRN WMD attacks on military personnel, have been used to develop, produce and use “Covid-19 vaccines” on civilians during an allegedly natural outbreak of a communicable disease that causes mild or no illness in most people — is that “vaccines” are and were from the beginning, military weapons intended to harm recipients, and civilians are among the intended targets of these intentionally-lethal weapons.
Sasha Latypova recently drafted a Memo Re EUA Countermeasures to send to your doctor, pharmacist, employer, school, sheriff, county commissioner and state lawmakers.
Text below, citations omitted.
PDF - Memo Re EUA Countermeasures for doctors, pharmacists, employers, schools, sheriffs, county commissioners and state lawmakers, with citations, for offline storage, printing, delivery to doctors, pharmacists, employers, schools, sheriffs, county commissioners and state lawmakers.
Memo Re EUA Countermeasures to send to your doctor, pharmacist, employer, school, sheriff, county commissioner and state lawmakers
Purpose: To clarify the legal status of EUA Medical Countermeasures (MCMs)
Summary: The process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence.
Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law.
Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.
Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), EUA MCMs have potentially been exempted from testing using Good Laboratory Practices, Good Clinical Practice, including informed consent, and from being assessed to determine if Risk Evaluation and Mitigation Strategies (REMS) are necessary.
Safety regulations governing the manufacture, shipment, holding, dispensing, administration and labeling do not necessarily apply to MCMs, rather, they are subject to an opinion by FDA and HHS officials without proper Congressional or judicial review for the duration of HHS-declared emergency. The declaration of emergency is likewise without properly defined stopping criteria, nor Congressional or judicial review.
Under federal law, FDA must approve any new drug product prior to a manufacturer introducing it into interstate commerce. [1] This process requires manufacturer to open an Investigational New Drug application and obtain an exemption from the FDA for its use in regulated investigational clinical research (trials). This normal regulated process is therefore referred to as an “investigational” regulatory pathway. It requires a manufacturer to conduct regulated clinical research (trials) under the IND, obtaining Institutional Review Board’s (IRB) approval for clinical trial protocols, independent safety monitoring oversight, and properly executed informed consent from clinical trial volunteers. In addition, manufacture of the drugs and biologics subject to the investigational status is regulated by the current Good Manufacturing practices (cGMP) [2]
EUA Medical Countermeasures are a radically different, defined in law as non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process [3].
The EUA process is used only when the United States Secretary of Health and Human Services declares an emergency[4].
By law, the EUA process is non-investigational[5]: while the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical regulatory standards are applicable in an enforceable way.
FDA has the discretion to issue an EUA if the applicant shows that its product “may be effective” in treating the relevant disease or condition [6]. It is important to emphasize the no other criteria for approval apply in an enforceable way.
FDA will approve EUA products on incomplete information so long as the applicant shows that the “known and potential benefit of the product” merely “outweigh[s] the known and potential risks” [7] and considers it unlikely that “comprehensive effectiveness data” will be available before an EUA grant. In contrast, for an investigational drug (under normal regulatory approval process) the FDA “shall” deny approval if the applicant “do[es] not show that such drug is safe.” [8]
Therefore, the EUA status of an MCM precludes collection of the investigational (subject to IRB and informed consent) clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure.
The EUA process precludes meaningful informed consent from the recipients of the product: while Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks,” [9] formal regulated clinical trials are neither required nor possible for a non-investigational EUA product. Thus, there is no reliable and scientifically valid information on risks and benefits of an EUA, especially for extremely novel technologies such as mRNA shots.
Furthermore, there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no lot-release testing and no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices (cGMP). EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.” [10]
In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence.
Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law.
Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.
