Opinions from the Office of Legal Counsel (OLC) are not typically of much interest to private employers. (You may or may not have even heard of the OLC.) After all, the Office’s role is to advise the Executive branch. However, a recently released OLC opinion addresses a question preying on many minds: Is it lawful for employers to mandate a COVID-19 vaccine even when the vaccine has not received full approval from the Food and Drug Administration, the federal agency responsible for the safety and efficacy of vaccines?
Without much fanfare, the OLC decided to tackle this question head-on. 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. Specifically, the OLC opinion explores the question of whether the current Emergency Use Authorization (EUA) status of the COVID-19 vaccines would preclude public or private entities from mandating those vaccines. OLC concludes that it does not.
OLC opinions are not binding on the courts. Nor are they entitled to a particular level of judicial deference, especially in the context of a dispute not directly involving the federal government. However, employers will find the OLC opinion of particular interest for two reasons. First, the opinion provides a thorough legal assessment of the EUA provisions at issue. Second, it succinctly previews the Biden administration’s position on the matter. In fact, only a few days after the opinion was released to the public, the administration announced that federal workers would be required to either be vaccinated or tested for COVID-19 weekly. Therefore, it is a worthwhile exercise to explore the opinion in detail.
In recent weeks, a small but growing number of companies and other entities have announced that they will mandate vaccines, with or without certain alternatives for the unvaccinated, such as weekly testing. This trend largely began with hospitals and universities, where the risks of transmission are higher. Public employers are now getting into the game. In addition to the federal sector, New York City recently announced that city workers must be vaccinated or tested weekly starting September 13. In the same announcement, Mayor de Blasio encouraged private employers to follow suit.
All of these actions presume that it is lawful for employers to mandate the vaccines. But is it? There are many pieces to this question, but perhaps the most significant revolves around the fact that the vaccines have not been approved under the FDA’s standard process.
The Food, Drug, and Cosmetic Act (FDCA) regulates the introduction or delivery of drugs and biological products into interstate commerce. Typically, a new vaccine would need to go through a lengthy review process before it is approved for general use by the population. The COVID-19 vaccines instead have been issued under an EUA. Broadly speaking, an EUA permits the FDA to authorize the use of medical products during a public health emergency using a more abbreviated review process.
Under the FDCA, the FDA (which has been delegated authority from the Secretary of Health and Human Services), is responsible to establish certain “conditions” of an EUA:
With respect to the emergency use of an unapproved product, the Secretary [of Health and Human Services], to the extent practicable … 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.
Section 564 FDCA, 21 U.S. Code §360bbb-3(e)(1)(A) (emphasis added).
Pursuant to this section, the FDA required that a fact sheet be made available to recipients of the three authorized COVID-19 vaccines. The fact sheets include a statement that “[i]t is your choice to receive or not receive the [Pfizer-BioNTech] COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.”
Some challengers to vaccine mandates have pointed to the language of §564 to argue that the implication that an individual may “refuse” the vaccine means that an employer may not require the vaccine of its employees. The OLC opinion, which is shared with the FDA, squarely rejects this argument.
OLC begins by exploring the history of EUAs. Prior to 2004, the FDCA did not contain a mechanism to bypass the standard drug approval process and swiftly get a new drug to the general population in the face of an emergency. Commentators worried that the existing FDCA process would hinder the ability of the nation to react sufficiently quickly to events such as a biological attack (e.g., anthrax) or an outbreak like Ebola. In 2004, in order to address these concerns, Congress added language enabling the FDA to issue EUAs. Since then, dozens of EUAs have been issued, even prior to the COVID-19 outbreak.
OLC next dissects the plain text of §564 and surrounding sections. The Office concludes that, by its own terms, §564 only requires that individuals be “informed” of certain information, and does not restrict whether a public or private entity can mandate the vaccine. As OLC notes,
if Congress had intended to restrict entities from imposing EUA vaccination requirements, it chose a strangely oblique way to do so, embedding the restriction in a provision that on its face requires only that individuals be provided with certain information (and grouping that requirement with other conditions that are likewise informational in nature).
OLC also reasons that §564 concerns only entities that actually distribute or administer a drug subject to an EUA, and then only in the context of carrying out that role. In other words, in the government’s view, §564 speaks to what information a healthcare provider needs to provide to a person in the context of delivering a vaccine, but not in the capacity of the provider as an employer of that individual. Furthermore, §564 does not absolutely mandate that the FDA include language about an option to accept or refuse the drug in all cases. The language only provides that the FDA establish such an informational condition “to the extent practicable” and “as the Secretary finds necessary or appropriate to protect the public health.”
The “option” of accepting or refusing the vaccine referenced in §564 exists, says OLC, separate and apart from any “secondary consequences” such as termination of employment. OLC also cites to the as-yet only reported judicial ruling on an employer’s COVID-19 vaccine mandate. In Bridges v. Houston Methodist Hosp., No. 4:21-cv-01774 (S.D. Tex. June 12, 2021), the court granted a hospital’s motion to dismiss a complaint challenging the hospital’s mandatory vaccination policy for staff. The court rejected the argument that the hospital’s vaccine mandate violated §564, concluding that it did not apply to private employers. The court also rejected the employees’ wrongful termination claim, noting that Texas did not recognize a claim for wrongful termination in violation of public policy, and even if it did, public policy clearly favors vaccination against COVID-19.
Implications for Employers
So what can employers take away from the OLC opinion? Especially as paired with the ruling in Bridges, employers can feel a little better about the prospect of a staff vaccine mandate withstanding potential legal challenges based on EUA status. As mentioned earlier, while the OLC opinion is neither binding nor authoritative, it is nevertheless well-reasoned and indicative of the Biden administration’s view on this topic.
However, employers considering a vaccine mandate should still proceed carefully. The OLC opinion itself flags that it does not address the impact of the Americans with Disabilities Act (ADA) and other equal employment opportunity laws. Employers should consult with counsel and the EEOC’s updated guidance regarding reasonable accommodations for individuals who have documented medical or religious objections to the vaccine. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. In addition, employers with employees represented by one or more unions should consult with counsel regarding any obligations to bargain with the union over a vaccine policy in light of their specific collective bargaining agreement language.
Editor’s Note: After the original publication of this article in the August 5 issue of the New York Law Journal, the Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine as Comirnaty.
Reprinted with permission from the August 5 issue date of the “New York Law Journal” © 2021 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or reprints@alm.com.
