@SecKennedy
Dear Secretary Kennedy,
Please use your authority to terminate the PREP Act emergency declaration for covid pandemic, as there is none in reality. Please investigate the misuse and abuse of the federal law utilized in the "pandemic response" (described below) that has resulted in the greatest human tragedy in the world in recorded history and completely destroyed public trust in the government health agencies.
All covid injections on the market today are EUA Countermeasures, due to current PREP Act emergency declaration for covid public health emergency extended by the previous administration to December 31, 2029!
https://public-inspection.federalregister.gov/2024-29108.pdf
All covid vaccines and other EUA drugs and devices, no matter how advertised (falsely declared FDA approved) are non-investigational EUA Countermeasures under this law. These products pose severe risk of harm to the public due to absence of any enforceable pharmaceutical regulations.
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), medical countermeasures have been exempted from testing using Good Laboratory Practices, Good Clinical Practices, including informed consent.
Under federal law, FDA must formally approve any new investigational 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 clinical research (trials). This 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 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 radically different, non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process[3].
The EUA pathway is used only when the United States Secretary of Health and Human Services declares an emergency[4].
By law, the EUA status 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 pharmaceutical regulatory standards are applicable in an enforceable way.
FDA has the discretion to issue an EUA if, in the sole opinion of the HHS secretary, the product “may be effective” in treating the relevant disease or condition[6]. No other criteria for approval apply in an enforceable way. There is no strict requirement to conduct clinical trials prior to authorization. In addition, due to the unenforceability of the pharmaceutical regulations and non-investigational status of the product, regulated human clinical trials are not legally possible, as none of the clinical trial human subject protections can be ensured.
FDA will approve EUA products on incomplete/non-existent information based on an opinion that “known and potential benefit of the product” may “outweigh
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 a medical countermeasure precludes collection of the regulated clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure while it remains non-investigational.
There is no strict requirement for an Investigational New Drug exemption (IND), nor institutional review board (IRB) approval of a clinical trial protocol and informed consent forms. Thus, the EUA process makes it impossible to obtain meaningful informed consent from the recipients of the product.
Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks.”[9] However, given that formal regulated clinical trials are neither required nor possible for a non-investigational EUA product, there is no effective way to collect and collate reliable and scientifically valid information on risks and benefits of an EUA, thus making the informed consent mandated by Congress meaningless.
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. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”[10]
In summary, the process by which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary’s opinion, which requires no supporting scientific evidence. Misrepresentations of safety, efficacy or contents of EUA products are allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.
[1] See, e.g., 21 U.S.C. § 355 (drugs); 42 U.S.C. § 262 (biologics).
[2]CFR Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.
[3]Section 564 FD&C Act. Note that the EUA pathway should not be confused with the “Expanded Access Use” regulatory pathway which is often colloquially referred to as an “emergency use”. The expanded access is an investigational pathway and is regulated in the same manner as all normal drug approvals. (21 CFR 312.310-320)
[4] 21 U.S.C. § 360bbb-3(a)(1), (b).
[5] 21 USC 360bbb-3(k): If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].
[6] 21 U.S.C. § 360bbb-3(c)(2)(A)
[7] 21 U.S.C. § 360bbb3(c)(2)(B)
[8] 21 U.S.C. § 355(d)(2); See also 42 U.S.C. § 262(a)(2)(RB) (biologic approved only if it actually “is . . . safe”).
[9] 21 U.S.C. § 360bbb-3(e)(1)(A)(II)
[10] 21 USC 360bbb-3a(c).
r. The post vaccination syndrome patients seem to have different immune responses, latent viruses are reactivated and the spike protein is still there almost 2 years after vaccination (it should be gone very quickly.)
