Section 564 - (Slip Opinion) - MEMORANDUM OPINION FOR THE DEPUTY COUNSEL TO THE PRESIDENT:

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

https://www.justice.gov/olc/file/1415446/download

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.

Federal law generally prohibits anyone from introducing or delivering for introduction into interstate commerce any “new drug” or “biological product” unless and until FDA has approved the drug or product as safe and effective for its intended uses. See, e.g., FDCA §§ 301(a), 505(a), 21 U.S.C. §§ 331(a), 355(a); 42 U.S.C § 262(a). A vaccine is both a drug and a biological product. See FDCA § 201(g), 21 U.S.C § 321(g); 42 U.S.C. § 262(i)(1). Consistent with section 564, we will generally refer to it here as a “product.” See FDCA § 564(a)(4)(C) (defining “product” to mean “a drug, device, or biological product”)

In 2003, Congress addressed a problem raised in emergency situations where “the American people may be placed at risk of exposure to biological, chemical, radiological, or nuclear agents, and the diseases caused by such agents,” but where, “[u]nfortunately, there may not be approved or available countermeasures to treat diseases or conditions caused by such agents,” even though “a drug, biologic, or device is highly promising in treating [such] a disease or condition.” H.R. Rep. No. 108-147, pt. 1, at 2 (2003)

” Such a cabined investigational new drug (“IND”) exemption does not, however, allow the widespread dissemination of a drug for general public use in response to an emergency. See H.R. Rep. No. 108-147, pt. 1, at 2.

Congress enacted a version of the Project BioShield legislation’s EUA provision in the National Defense Authorization Act for Fiscal Year 2004 as section 564 of the FDCA. See Pub. L. No. 108-136, § 1603(a), 117 Stat. 1392, 1684 (2003) (codified at 21 U.S.C. § 360bbb-3)

***The distribution of EUAs are contemplated under a martial or military context. The insertion of Section 564 within Federal Defense Legislation cannot be ignored. 

**See, e.g., Lagos v. United States, 138 S. Ct. 1684, 1688–89 (2018) (relying on the canon of “noscitur a sociis, the well-worn Latin phrase that tells us that statutory words are often known by the company they keep”).

The statute then lists a number of such conditions, including “[a]ppropriate conditions designed to ensure that individuals to whom the product is administered are informed” of certain information.

This information includes the fact that FDA “has authorized the emergency use of the product,” “the significant known and potential benefits and risks of such use,” and “the extent to which such benefits and risks are unknown.” Id. § 564(e)(1)(A)(ii)(I)–(II). Most relevant here, section 564(e)(1)(A)(ii)(III) directs FDA to impose conditions on an EUA “designed to ensure that individuals to whom the product is administered are informed . . . of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

In the same section of the 2004 National Defense Authorization Act, Congress also enacted another provision, codified as 10 U.S.C. § 1107a, which is specific to the U.S. military and which expressly refers to the “option to accept or refuse” condition described in section 564(e)(1)(A)(ii)(III). 

Pub. L. No. 108-136, sec. 1603(b)(1), § 1107a, 117 Stat. at 1690. Subsection (a) of this law provides that when an EUA product is administered to members of the armed forces, “the condition described in section 564(e)(1)(A)(ii)(III) . . . and required under paragraph (1)(A) or (2)(A) of such section 564(e), designed to ensure that individuals are informed of an option to accept or refuse administration of a product, may be waived only by the President” and “only if the President determines, in writing, that complying with such requirement is not in the interests of national security.” 10 U.S.C. § 1107a(a)(1)

We conclude that section 564(e)(1)(A)(ii)(III) concerns only the provision of information to potential vaccine recipients and does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to EUAs.

**In the sense used here, the word “inform” simply means to “give (someone) facts or information; tell.” New Oxford American Dictionary 891 (3d ed. 2010); see also, e.g., Webster’s Third New International Dictionary 1160 (2002) (similar). Consistent with this understanding, the conditions of authorization that FDA imposed for the COVID-19 vaccines require that potential vaccine recipients receive FDA’s Fact Sheet, see, e.g., Pfizer EUA Letter at 6, 9, which states that recipients have a “choice to receive or not receive” the vaccine, see, e.g., Pfizer Fact Sheet at 5. Neither the statutory conditions of authorization nor the Fact Sheet itself purports to restrict public or private entities from insisting upon vaccination in any context.

**Cf. Bridges, 2021 WL 2399994, at *2 (explaining that section 564 “confers certain powers and responsibilities to the Secretary of [HHS] in an emergency” but that it “neither expands nor restricts the responsibilities of private employers”) 

***… and by extension private municipalities, organizations, associations, or definable collection of an entity either imposing, offering, or extending support to, or for, human research, in any manner…

Section 564(l) provides that “this section [i.e., section 564] only has legal effect on a person who carries out an activity for which an authorization under this section is issued…