By Dorit Rubinstein Reiss
As promising data emerges for COVID-19 vaccines in clinical trials, two manufacturers of these vaccines, Pfizer and Moderna, have submitted requests for Emergency Use Authorizations (EUA).
An EUA would allow vaccines to be used before full FDA approval, during the time that COVID-19 is an emergency.
The promise of a safe, effective vaccine offers a glimmer of hope not just for individuals around the world affected by the pandemic, but also for businesses large and small that have struggled with closures and public health-related changes to operations. A natural question that has emerged as private businesses contemplate a return to normalcy is whether they can mandate that employees and customers receive these vaccines authorized for emergency use.
In the past, members of FDA and CDC have said that the answer is no. However, the answer may not be so clear. This post looks at the relevant statutory provision to examine whether an EUA can accommodate mandates.
The provision is section 360bbb-3 (e)(1)(A)(ii)(III) of the Food, Drug and Cosmetics Act – 21 U.S.C. 564, “Authorization for medical products for use in emergencies,” which says:
(e)Conditions of authorization
With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), 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:
(ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(III) 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.
On its face, this seems to suggest that as part of the EUA, the Secretary of HHS should require, in the conditions of the EUA, that individuals be told that they can refuse the product – in this case the vaccine. This would imply that mandates are not allowed. This disclosure is a “required condition” of an EUA, which means the issue needs to be directly addressed in the authorization.
In support of this interpretation is the fact that this is how the FDA interprets the act, and agency interpretations are, in some cases, given deference by the courts (more on that below). (See this guidance document, at p. 24.)
Further supporting that interpretation is the fact that another statutory provision – 10 U.S.C. §1107a – allows the President to waive the requirement that people be told that they can accept or refuse the product for members of the armed forces, but only if “…the President determines, in writing, that complying with such requirement is not in the interests of national security.” The specific waiver implies that for those not in the armed forces, and in other circumstances, the condition cannot be waived, and a mandate cannot be imposed.
There are also good policy reasons to suggest that for products approved on an Emergency Use Authorization, where full data from clinical trials is not yet available, a mandate is undesirable. Imposing a mandate when there is still substantial uncertainty about the risk/benefit profile of the product is much trickier than for a licensed product. With more uncertainty, people deserve a choice that is not too onerous, and having to choose between a job – especially in this economy – and a vaccine, or between, for example, flying abroad and a vaccine, may be a very onerous choice.
There are, however, arguments against this position.
First, the statute requires the Secretary to address the issue – but does not clearly say the Secretary has to allow consequences-free refusal of the product. In fact, because the statute says that the Secretary needs to inform people of the “consequences, if any, of refusing administration of the product,” it suggests that the Secretary has the discretion to allow such consequences – and hence, that the Secretary has discretion to permit mandates (something the Secretary may or may not do).
Second, while agencies do get deference to interpretation in some circumstances, in this case, the discretion to set the conditions is given to the Secretary, not the FDA, so there may be questions on whether the FDA’s position here deserves deference.
Further, the interpretation by FDA is embodied in a guidance document – not a formal rule. In administrative law terms, this is an interpretive rule. And such interpretive rules do not automatically get Chevron deference. The jurisprudence on when they do or do not get Chevron deference is very unclear – that is the line of cases not so fondly named “The Mead Mess” by scholars.
Third, following the FDA’s interpretation means the statute – in passing, and without saying it directly – would require the Secretary to prohibit private business across the United States from setting employment conditions or safety conditions. That’s not impossible – the federal government has the power to approve these products, fully or through an EUA, and the power to limit use is part of that approval – but it is also not obvious, because it is a large imposition on private business that may not always be justified. A discretionary grant of authority is just as reasonable.
Further, the policy arguments can also go both ways. The United States federal government arguably has mishandled limiting the spread of COVID-19. States have imposed limits on gatherings and business activity, and businesses have suffered. The federal government offered some support, but it is arguably less than what is needed. As a result, businesses are in a position where they may have been forced to close, and are likely losing customers that are afraid to venture in because of fears of infection. If vaccine mandates can improve safety, increase customer willingness to come in, and help businesses reopen, refusing them permission to impose mandates – while not giving them sufficient financial aid to stay afloat – is unfair. Finally, not all EUA are equal in terms of the level of data provided; in this case, the data behind the Moderna and Pfizer vaccines appears unusually promising. That might make allowing businesses to choose whether to impose mandates more reasonable.
What can we say, then?
At the very least, the act seems to require the Secretary to expressly address, in the conditions of the EUA, whether or not people may refuse vaccines, and what may be consequences of refusal.
That means that as part of granting an EUA, the Secretary has to directly address whether private businesses may impose mandates, and with what exceptions. This will not be an area where businesses have the usual freedom to impose conditions.
There is an argument that the Secretary does not have the discretion to allow mandates. But there is an argument, too, that the Secretary has the discretion to allow businesses to require vaccines and impose consequences for refusal.
I think there is enough ambiguity here to allow the Secretary discretion. But whether or not the Secretary should allow mandates is a policy question, and a hard one.