The U.S. Department of Justice (DOJ) recently published an opinion[1] addressing whether entities, including employers, may require vaccinations for COVID-19 using vaccines approved by the Food and Drug Administration (FDA) under its Emergency Use Authorization (EUA) approval process.[2][3]
The opinion clarifies the DOJ’s position that statutory language in the Food, Drug, and Cosmetic Act (FD&C Act) that requires that COVID-19 vaccine recipients “are informed . . . of the option to accept or refuse administration of the product”[4] (i.e., the “option” clause) does not prohibit employers from requiring that their employees be vaccinated for COVID-19 using COVID-19 vaccines approved under the EUA.[5]
The purpose of this bulletin is to analyze the DOJ opinion and provide guidance to employers as to how the opinion affects their authority to require COVID-19 vaccinations.
Requirements Related to the Administration of Drugs/Vaccines Approved Under the EUA
New drugs, including vaccines[6], must receive FDA approval prior to their distribution and administration in the United States.[7] Because drugs approved under the EUA are not subject to the FDA’s full approval process, the parties that manufacture, distribute, and administer such drugs must comply with certain special rules and requirements.
In pertinent part, the FD&C Act provides the following with respect to drugs approved under the EUA:
With respect to the emergency use of an unapproved product, the Secretary . . . shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following: . . . Appropriate conditions 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.[8]
Under this statutory provision, the party administering a drug approved under the EUA must inform the drug’s recipient of the option to refuse the administration of the drug or vaccine (the “option” clause).[9]
The inclusion of the option clause in the FD&C Act led some to speculate that the Act precluded employers from requiring COVID-19 vaccinations (if, as is the case at present, the only available COVID-19 vaccines are approved under the EUA[10]) and provided individuals a private right to sue their employer if the employer required such vaccinations.[11]
Plain Language Does Not Prohibit Vaccination Requirements
In its analysis, the DOJ first examined the plain language of the option clause.
The DOJ stated that the Act only requires that potential recipients be “informed” of certain information, including “the option to accept or refuse administration of the product.”[12] The DOJ concluded that the common definition of the term “inform”, meaning to “give (someone) facts or information; tell” should apply in this context, absent any indication otherwise.[13]
As a result, the DOJ indicated that the manufacturers of the COVID-19 vaccines satisfy this condition by providing recipients of the vaccines a FDA fact sheet listing information about the vaccines and that recipients have a “choice to receive or not receive” the vaccine.
The DOJ then noted that the statutory provision does not include any language purporting to restrict employers from requiring COVID-19 vaccinations.[14]
Limited Scope Does Not Extend to Cover Employers
The DOJ then reviewed the scope of the statutory provision and its potential application to employers.
The pertinent portion of the statute provides the following:
This section only has legal effect on a person who carries out an activity for which an authorization under this section is issued.[15]
The DOJ concluded that this section of the FD&C Act is limited to the entity that actually administers the vaccine, and it does not extend to non-administering parties, such as employers.[16] The DOJ stated that “[t]his provision expressly forecloses any limitation on the activities of the vast majority of entities who would insist upon vaccination requirements.”[17]
While the DOJ stated that an employer that administers COVID-19 vaccines would be subject to the FD&C Act conditions, including that they provide information to the recipients of the vaccine, the DOJ also clarified that such employers still would not be precluded by the FD&C from requiring that their employees be vaccinated for COVID-19.[18]
Contextual Understanding of the Option Clause
The DOJ next reviewed the context in which the option clause appears.
The DOJ provided that, in addition to the option clause, vaccine recipients must also be informed 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.” Further, the DOJ provided that the FD&C Act includes two other provisions to which individuals be informed: that FDA “has authorized the emergency use of the product” and of “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown.”[19]
The DOJ stated that, in sum, these provisions require only that certain factual information, primarily medical in nature, be conveyed to potential recipients of the vaccine, and that these provisions do not restrict other parties from imposing COVID-19 vaccination requirements.[20]
Legislative Authority and Possible Intent
Finally, the DOJ reviewed Congress’s authority in amending the FD&C Act and the possible legislative intent of their 2003 amendments adding the EUA and the option clause.[21]
The DOJ provided that, if Congress intended to restrict the conduct of employers, it had the authority to do so,[22] but that the option clause would be a “strangely oblique way to do so.”[23] After reviewing the legislative history of the 2003 amendments, the DOJ indicated that Congress does not appear to offer any clear explanation as to why it included the option clause, speculating that it was possibly intended as a variation on the “informed consent” requirement or to ensure that potential recipients did not misunderstand the likely impact of their refusal.
The DOJ then stated that the option to refuse administration of a drug approved under an EUA did not preclude potentially harsh “secondary consequences”, such as exclusion from employment.[24] The opinion noted that the FDA has the ability to warn recipients “of the consequences, if any, of refusing administration of the product”, and that the FDA has discretion to supplement the required information disclosures to address any specific consequences.[25]
The DOJ’s Conclusion
After completing its analysis of the pertinent provision of the FD&C Act, the DOJ concluded that the Act “does not prohibit public or private entities from imposing vaccination requirements, even when the only vaccines available are those authorized under EUAs.”[26]
The Implications of the DOJ Opinion on Mandatory Vaccination Requirements
Many employers are requiring or considering requiring COVID-19 vaccinations for employees who report to the employers’ physical worksites and places of employment. The opinion provides employers with useful authority to support such requirements as it provides that, according to the DOJ, there is no restriction under the FD&C Act to employers imposing a vaccination requirement.
In the event that an employee challenges its employer’s COVID-19 vaccination requirement on the grounds that the FD&C Act’s option clause provides a right to refuse vaccination, the employer may respond that employees do have a choice and may refuse. However, that choice entails secondary consequences, including exclusion from the workplace[27] or potential termination if the employee can no longer perform essential duties of the job remotely.
Employers should note that many other factors may influence an employer’s ability to mandate vaccinations, including statutory obligations under the Americans with Disabilities Act (ADA), Title VII of the Civil Rights Act of 1964 (Title VII), the Fair Employment and Housing Act (FEHA) and any collective bargaining obligations. Before an employer imposes a COVID-19 vaccination requirement or policy, the employer should contact legal counsel to discuss the legal issues implicated in order to ensure compliance with the pertinent laws.
LCW attorneys are familiar with COVID-19 vaccination issues and are ready to assist employers should they wish to adopt such a requirement.
[1] Department of Justice (DOJ), 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 (DOJ Opinion) [45 Op. O.L.C. __ ] (July 6, 2021) [https://www.justice.gov/olc/file/1415446/download (Last viewed on August 1, 2021)]. The DOJ wrote its opinion on July 6, 2021 but did not publish the opinion until last week.
[2] Since the beginning of the public health emergency caused by COVID-19, the Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for three (3) COVID-19 vaccines: (1) Pfizer/BioNTech; (2) Moderna; and (3) Johnson & Johnson (Janssen). See Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability, 86 Fed. Reg. 28,608 (May 27, 2021) (Janssen); Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability, 86 Fed. Reg. 5200 (Jan. 19, 2021) (Pfizer and Moderna).
[3] Before 2003, the FD&C Act provided only one regulatory approval process by which the FDA could authorize drugs for distribution and sale. In response to concerns about biological and chemical warfare and the spread of communicable diseases, in 2003, Congress amended the FD&C Act in order to provide for the EUA. The amendments established an expedited review and approval process for drugs necessary to address a present or impending emergency.
[4] 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
[5] The District Court for the Southern District of Texas has gone so far as to deny employees a right to sue over alleged violations of the FD&C Act, where their employer required vaccination against COVID-19. Although the plaintiffs have appealed to the Fifth Circuit, the District Court’s reasoning is consistent with the DOJ opinion. See Bridges v. Houston Methodist Hosp. (S.D. Tex., June 12, 2021, No. CV H-21-1774) 2021 WL 2399994.
[6] See FD&C Act § 201(g); 21 U.S.C. § 321(g); 42 U.S.C. § 262(i)(1).
[7] See FD&C Act §§ 301(a) and 501(a); 21 U.S.C. §§ 331(a) and 355(a); 42 U.S.C. § 262(a).
[8] 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
[9] See 21 U.S.C. § 360bbb-3(e)(1)(A) for additional requirements that apply to EUAs.
[10] See footnote 2.
[11] See Bridges v. Houston Methodist Hosp. (S.D. Tex., June 12, 2021, No. CV H-21-1774) 2021 WL 2399994. The District Court clarifies that the FD&C Act “does not provide [employees] a private opportunity to sue . . . [their] employer[s]” in the event that the employer requires that employees be vaccinated for COVID-19 as term and condition of employment. Employers should note that this decision was issued by a Federal District Court in Texas and therefore is not precedential in California, but that a court of competent jurisdiction in California may nevertheless find it persuasive should such a court adjudicate a comparable claim. Employers should also note that the decision is pending appeal in the Fifth Circuit, and that its ultimate persuasive character may change depending on the appeal’s outcome.
[12] DOJ Opinion, supra, footnote 1, at p. 7.
[13] DOJ Opinion, supra, footnote 1, at p. 8.
[14] DOJ Opinion, supra, footnote 1, at pp. 8-9.
[15] 21 U.S.C. § 360bbb-3(l).
[16] DOJ Opinion, supra, footnote 1, at p. 8.
[17] Id., emphasis added.
[18] See DOJ Opinion, supra, foot 1, at pp. 8-9. This special bulletin focuses on the option clause from 21 U.S.C. § 360bbb-3 and the DOJ Opinion. It does not address other factors that may influence an entity’s ability to mandate COVID-19 vaccinations.
[19] 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).
[20] NOTE: The DOJ Opinion also found that the language of 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) gives the FDA discretion to modify, or even change, which notification requirements apply to a given EUA. However, any modifications or changes (such as removing the requirement to inform recipients of their option to accept or refuse) must be justified by the facts and circumstances of the emergency. See DOJ Opinion, supra, footnote 1, at pp. 11-12. Here, it appears that the FDA has not modified or changed any of the requirements significantly, instead opting to follow the provisions of Section 360bbb-3.
[21] See footnote 3, supra.
[22] DOJ Opinion, supra, footnote 1, at pp. 9-10.
[23] DOJ Opinion, supra, footnote 1, at p. 9.
[24] DOJ Opinion, supra, footnote 1, at p. 11.
[25] DOJ Opinion, supra, footnote 1, at p. 12.
[26] DOJ Opinion, supra, footnote 1, at p. 18, emphasis added.
[27] See DOJ Opinion, supra, footnote 1, at pp. 11-12.
This Special Bulletin is published for the benefit of the clients of Liebert Cassidy Whitmore. The information in this Special Bulletin should not be acted upon without professional advice.
