Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021.
By
Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.
FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.
This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.
Pandemic politics
The actions of former President Donald Trump during the coronavirus pandemic demonstrate the perils of playing politics with science. The Trump administration repeatedly tried to assert control over multiple health agencies’ decision-making processes, often for political reasons, in ways that interfered with agency scientists’ objective and empirical analysis. Emails between members of the administration reflect a deliberate effort to intimidate and silence health policy officials, whose pleas for the public to wear masks were criticized by White House officials as attempts to “embarrass the President.” In September 2020, HHS Secretary Alex Azar issued a memo asserting authority over FDA’s power to issue new rules for food and drug products, including for vaccines. This was after HHS had published a separate memo, not written by CDC officials, on CDC’s website in August, stating that individuals exposed to COVID-19 do not need to be tested if they show no symptoms; the memo was removed from CDC’s website a month later. And President Trump himself publicly disparaged health experts throughout the pandemic, criticizing members of the “deep state” on Twitter and demanding that a vaccine be ready in time for Election Day.
These efforts have infiltrated the EUA process as well. Trump pressured FDA intensely to authorize chloroquine and hydroxychloroquine, anti-malarial drugs that many believed could pose a considerable risk for COVID-19 patients. An EUA came only days after Trump publicly endorsed the drugs; FDA revoked it weeks later. Public health experts expressed similar concern over the timing of FDA’s decision to authorize SARS-CoV-2 convalescent plasma—on the eve of the Republican National Convention. Even the decision to grant the first EUA for a COVID-19 vaccine, developed by Pfizer-BioNTech, proved to be controversial: White House Chief of Staff Mark Meadows allegedly threatened to terminate FDA Commissioner Stephen Hahn if the vaccine was not authorized later that day.
Values in times of crisis
On the one hand, we have witnessed the perils of a White House exploiting its power over executive agencies, allowing political interests to interfere with traditional scientific and regulatory practices. On the other hand, there is value in having technical experts answer to elected officials—especially when those experts are faced with decisions that go beyond empirical data and involve questions of value and the common good.
It is not a given that regulators’ approach to administrative decision making is always the right one. In the late 1980s, for example, with the AIDS crisis raging in the United States, health experts discovered that a drug called DDI could benefit AIDS patients unable to tolerate other medications, such as AZT. FDA regulators took a risk-averse approach, refusing to authorize a drug lacking formal approval. Dr. Fauci, then NIAID Director, believed that the opportunity to save lives greatly outweighed the risks of departing from protocol. Impatient with FDA’s lack of initiative, he therefore proposed a new “parallel track” process to provide DDI to patients while continuing clinical trials of the drug as part of the formal approval process. While other measures to circumvent FDA’s lengthy approval process already existed, this one got the attention of President George H.W. Bush, whose support encouraged FDA regulators to make DDI available to those in need.
Such ethical issues are not unique to FDA. Emergencies such as COVID-19 expose the conflicting values that underlie regulatory decision making. These issues reflect broader debates involving fundamental and opposing visions of the good. This is most obvious when considering debates over state-level allocation of COVID-19 vaccines. For example, Dr. Robert Wachter and Ashish Jha have argued that skipping the required second dose of the vaccine, and reallocating those doses to others, would expedite vaccination for a larger number of people, promoting herd immunity for the collective while maintaining high levels of efficacy for those receiving their first dose. President Joe Biden has expressed enthusiasm for this proposal, yet it has prompted backlash from others who believe that doing so is not certain to be effective and would impose too great a risk on those who otherwise would receive a second dose out of expediency for the collective.
Similarly, many have argued that giving scarce doses of the vaccine to incarcerated persons would prevent further transmission of the virus, protect those in crowded conditions with poor access to healthcare, and reduce the shockingly high rate of COVID-related deaths in prison; others object that convicted criminals do not deserve to be prioritized over law-abiding citizens. And whereas some would argue that vaccinating those most likely to disregard public health protocols, such as wearing masks and social distancing, could potentially prevent the virus from being transmitted to those at greater risk, others would object on principle to rewarding reckless behavior.
These same sorts of fundamental values, and the clashes between them, are at play in FDA’s decisions as to whether to issue EUAs to products such as vaccines in the first place. Even when FDA appears to be making empirical judgments about the benefits and costs of a given product, its decision whether to authorize that product will inevitably come down to a value judgment—one that takes a stance as to what sorts of risks FDA is justified in imposing on the public for the sake of a potentially promising solution.
Judgment calls and FDA’s emergency powers
FDA’s emergency powers are not as clear cut under the enacting statute as one might expect. The Project Bioshield Act of 2004, which amended the FD&C Act to provide for EUA authority, requires a declaration of a national emergency warranting FDA to grant EUAs for emergency countermeasures. It requires that FDA regulators reasonably believe a given product may be effective in responding to a given emergency, and that the known and potential benefits of authorizing the product outweigh the known and potential risks of doing so. But the statute is silent as to what sorts of risks and benefits FDA is permitted or required to consider: should they be strictly physiological, as one might assume? Or can they reflect broader, contextual issues, such as disparate social and economic influences on health and other matters of fairness and justice — often referred to as “health equity?”
Moreover, the statute offers no guidance as to what standard of value FDA should apply in weighing the benefits and risks, or as to what constitutes an acceptable tradeoff. Without a set of guiding principles for what is largely a moral decision, FDA is left to apply its own ethical and policy principles under the guise of an empirical analysis.
There are different ways for FDA regulators to conceptualize their values in granting EUAs. One would maximize the total number of lives saved at any cost; this approach is most nominally consistent with the language of the statute, and also lends itself to the cost-benefit framework used and respected in other areas of regulatory decision making. (Others would measure in terms of life years instead of lives.) An alternative view would take a precautionary, duty-based approach and seek to minimize active harm done to anyone as a result of authorizing a given product—an attitude many still hold in light of the Thalidomide tragedy of the 1950s. Yet another approach would prioritize personal liberty and individuals’ ability to weigh costs and benefits for themselves. Without surfacing these competing values and taking a more systematic approach to them, FDA’s value judgments will remain implicit and unexamined, and are more likely to come down to the particular intuitions and norms endorsed by those signing off on the decision.
Even without overt political interference, FDA has been forced to make difficult choices in exercising its discretion to grant EUAs. In the spring of 2020, for example, FDA decided to address widespread testing shortages by granting “umbrella” EUAs for a wide range of tests (along with masks and other devices), allowing those products to come to market before going back and reviewing them on an individual basis. This decision reflected a judgment by FDA regulators that the benefit of more widely available testing was worth the risk of allowing inaccurate tests to come to market. One can easily imagine other regulators coming to the opposite conclusion: that they have a categorical and overarching duty not to let through any products that could mislead the public or contribute to widespread confusion. This decision did not derive from the law; it derived from FDA regulators’ interpretation of their duties under the law in light of their own ethical values. Thus, while the decision to issue an umbrella EUA might seem to have reflected an empirical calculation of risks and benefits, it actually was more in the nature of a value-laden judgment call by FDA.
Future directions
It is important that agencies such as FDA clarify the proper limits and scope of their decision making, including the normative principles underlying their analysis, in both ordinary and emergency situations. Doing so would increase the transparency and accountability of the regulatory process. It would also make FDA’s decision making more systematic and consistent — reducing the risk either that individual regulators will differ drastically in their value judgments, or that agencies as a whole will apply implicit values and norms that are at odds with other areas of government.
Several potentially helpful steps come to mind. First, agencies such as FDA can make a regular practice of publishing value statements for the general public and other government actors. To the extent that agencies already publish similar statements, it might be useful for them to place greater and more specific emphasis on the ethical norms guiding their decision making. FDA’s 2021 mission statement, for instance, does not include a statement of ethical values or concrete decision-making principles. FDA’s 2020 Investigation Operations Manual contains a statement of broad values such as accountability and commitment to public health; mission statements released with respect to public health emergencies would benefit from including a more specific set of substantive ethical values and other relevant decision-making principles. Doing so might help to promote accountability and transparency by making clear to stakeholders what values are guiding those agencies’ interpretation of their discretion under the law, especially when making high-stakes decisions in times of emergency.
Second, elected officials might consider providing clearer guidance on what norms and values should guide agency decision making in high-stakes situations, either generally or in specific cases. For example, when authorizing FDA to grant EUAs in times of emergency, the declaration by the HHS secretary might include a brief, publicly-available guidance document dictating any normative principles that FDA should prioritize in weighing empirical evidence to decide whether to grant an EUA. As it stands, HHS publishes its authorizations of EUA power in the Federal Register with no accompanying guidance. To the extent that more detailed instructions are handed down to FDA officials, they should be made available to the public and include a detailed normative framework reflecting any policy principles that HHS believes should guide FDA’s decision making. Even if such documents ultimately have no binding power — and even if FDA ends up making particular decisions that diverge from them — this would provide a more objective reference point for assessing FDA’s use of its discretion under the law, and would reflect a more rigorous attempt to grapple with the role of value judgments in the regulatory process.
Third, the challenges FDA has faced in applying its EUA authority during COVID-19 call for a more critical and comprehensive examination of the role that ethical norms and value judgments play throughout law and government. Numerous episodes over the course of the pandemic demonstrate the role that outside interests can have in guiding health agencies’ decision making. One of the most prominent themes of the last four years has been the Trump administration’s threat to norms of democratic governance, and the ways in which it has revealed both how much we depend on unwritten norms, and how fragile those norms can be. Indeed, the very notion of the rule of law is itself a value embodied as a norm — one that the law does not legitimate, but rather depends on for its legitimacy.
There is a limit to how much meaningful reform will be possible without confronting more realistically the actual and substantial influence that private moral intuitions play in lawmakers’ and policymakers’ interpretation of their own powers under the law. That will require difficult discussions about which sorts of ethical values we endorse—and, in turn, what we ultimately value as a society.
Such questions might seem too lofty for, and inconsistent with, the urgent pragmatism needed in times of emergency. But as current debates over vaccine allocation demonstrate, the answers to these questions have grave implications for the public welfare and are far from obvious. COVID-19 will not be our last national health crisis, and the decisions we make now will influence who lives and dies in emergencies to come. Neither our body of laws, nor the empirical techniques used by agency experts, can answer these questions for us. It is up to us as citizens in a democratic society to decide what matters most.
