July 28, 2021

The Biden Justice Department issued an opinion on July 6, 2021, in which they state that COVID-19 vaccine mandates are not illegal, in spite of law and administrative rules that appear to indicate otherwise.

The memo addresses 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.”

The memo begins by stating, as background, “Section 564 of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360bbb-3,1 authorizes the Food and Drug Administration (“FDA”) to issue an “emergency use authorization” (“EUA”) for a medical product, such as a vaccine, under certain emergency circumstances.  This authorization permits the product to be introduced into interstate commerce and administered to individuals even when FDA has not approved the product for more general distribution pursuant to its standard review process.  Section 564 directs FDA—“to the extent practicable” given the emergency circumstances and “as the [agency] finds necessary or appropriate to protect the public health”—to impose “[a]ppropriate” conditions on each EUA.  FDCA § 564(e)(1)(A).  Some of these conditions are designed to ensure that recipients of the product “are informed” of certain things, including “the option to accept or refuse administration of the product.” [Emphasis Added.]

The memo then discusses how the “option notice” has been implemented.  They say, “Since December 2020, FDA has granted EUAs for three vaccines to prevent coronavirus disease 2019 (“COVID-19”).  In each of these authorizations, FDA imposed the “option to accept or refuse” condition by requiring the distribution to potential vaccine recipients of a Fact Sheet
that states:  “It is your choice to receive or not receive [the vaccine].  Should you decide not to receive it, it will not change your standard medical care.”  [Emphasis added.]

Following in the memo are multiple paragraphs in which legal gymnastics are employed to arrive at an opinion that the option to refuse, as a practical matter, is meaningless.  They say, “The information conveyed pursuant to the “option” clause continues to be a true statement about a material fact of importance to potential vaccine recipients—virtually all such persons continue to have the “option” of refusing the vaccine in the sense that there is no direct legal requirement that they receive it.  See Bridges, 2021 WL 2399994, at *2 (noting that an employer’s vaccination policy was not “coercive” because an employee “can freely choose to accept or refuse a COVID-19 vaccine; however, if she refuses, she will simply need to work somewhere else”)” [Emphasis added.]

The memo further states, “(“[E]xisting vaccination mandates—as they are typically structured—generally do not interfere with . . . an individual’s right to refuse in that context.  Rather, they impose secondary consequences—often in the form of exclusion from certain desirable activities, such as schools or employment—in the event of refusal.

You can read the full opinion, here:  https://www.justice.gov/olc/file/1415446/download


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