Case 2:21-cv-00702-CLM Document 15 Filed 07/19/21 Page 55 of 67
iii. The Emergency Declaration and the EUAs are “Final” Agency Action In order to be deemed “final”, an agency action (1) “must mark the consummation of the agency’s decision-making process — it must not be of a merely tentative or interlocutory nature” and (2) “must be one by which rights or obligations have been determined, or from which legal consequences will flow.” United States Corps of Eng’rs v. Hawkes Co., 136 S.Ct. 1807, 1813 (2016) (quoting Bennett v. Spear, 520 U.S. 154, 177-178 (1997)). After fact-finding and consultation, the DHHS Secretary declared, under § 360bbb–3(b), that there is an emergency. Once issued, his declaration remained valid for a period of time and was serially renewed. The declaration is not merely “advisory in nature.” Id. It represents the “consummation of the decision-making process” with respect to whether or not an emergency exists. The declaration also gives rise to “‘direct and appreciable legal consequences.’” Id. at 1814. The declaration paved the way for Pfizer, Moderna and Janssen to apply for EUAs for their experimental Vaccines, for the DHHS Secretary and his designee the FDA Commissioner to adjudicate and approve their EUA applications, and for the Vaccines to be released into interstate commerce and injected into millions of Americans. The FDA Commissioner engaged in fact-finding and made vital determinations that the statutory criteria for issuing the Vaccine EUAs required by § 360bbb–3(c) were met, and that the conditions of authorization for the Vaccine EUAs required by § 360bbb–3(e) were also met. On that basis, the Vaccine EUAs were issued. The issuance of the Vaccine EUAs represents the “consummation of the decision-making process” with respect to whether or not EUAs will be granted, and also gave rise to “‘direct and appreciable legal consequences’” since millions of people have been injected with these experimental Vaccines while their manufacturers have made billions of dollars in revenues under an immunity shield.
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