| | | Not really pertinent to your comment, but....here is a portion from the Federal Registry on the EUA for the CV "vaccines" with four "circumstances that justify EUA"....Seems a stretch unless you assume that CV was released intentionally....but of course they write and interpret the Code as suits their purpose.
Of note, the FD&C code was amended in January 2017 to add the EAU authorization...what DOESN'T stink about this whole mess?
fda.gov
TheLastRefuge Retweeted
FoiaFan
@15poundstogo
·
6h
I don't get it. How does the vaccination of five-year-olds even remotely approach the statutory standard required for emergency use authorizations, as stated here? I've been called a creative legal thinker, but this is way, way beyond me.
t.co
I. Background Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product. Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations:
(1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a, chemical, biological, radiological, or nuclear (‘‘CBRN’’) agent or agents;
(2) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act sufficient to affect national security or the health and security of United States citizens living abroad;
(3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or
(4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents
Based on any of these four determinations, the Secretary of HHS may then declare that circumstances exist that justify the EUA, at which point the FDA Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FD&C Act are met. The Office of the Assistant Secretary for Preparedness and Response, HHS, requested that the FDA, HHS, issue an EUA for drugs and biological products to allow the Department to take response measures based on information currently available about the virus that causes COVID–19. The determination of a public health emergency, and the declaration that circumstances exist justifying emergency use of drugs and biological products by the Secretary of HHS, as described below, enable the FDA Commissioner to issue an EUA for drugs and biological products for emergency use under section 564 of the FD&C Act. II. Determination by the Secretary of Health and Human Services On February 4, 2020, pursuant to section 564 of the FD&C Act, I determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019–nCoV). The virus is now named SARS–CoV–2, which causes the illness COVID–19. III. Declaration of the Secretary of Health and Human Services On March 27, 2020, on the basis of my determination of a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves the novel (new) coronavirus, I declared that circumstances exist justifying the authorization of emergency use of drugs VerDate Sep<11>2014 18:31 Mar 31, 2020 Jkt 250001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices 18251 and biological products during the COVID–19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Notice of the EUAs issued by the FDA Commissioner pursuant to this determination and declaration will be provided promptly in the Federal Register as required under section 564 of the FD&C Act. Dated: March 27, 2020. Alex M. Azar II, Secretary. [FR Doc. 2020–06905 Filed 3–30–20; 2:00 pm] |
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