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Too Important for the Bureaucrats: Rethinking Risk and Regulatory Presumptions in Times of Crisis

Published online by Cambridge University Press:  18 August 2021

James Toomey
James Toomey*
Affiliation:
Climenko Fellow & Lecturer on Law, Harvard Law School. J.D. Harvard Law School, magna cum laude; B.A., Cornell University, summa cum laude
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Extract

The posture of American regulation of medicine is negative—we assume that a new drug is unsafe and ineffective until it is proven safe and effective.1 This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law.2 It is defensible, if debatable, in many ordinary circumstances.3 But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply.

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Articles
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American Journal of Law & Medicine , Volume 47 , Issue 2-3 , July 2021 , pp. 249 - 263
Copyright
© 2021 The Author(s)

I. INTRODUCTION

The posture of American regulation of medicine is negative—we assume that a new drug is unsafe and ineffective until it is proven safe and effective.Footnote 1 This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law.Footnote 2 It is defensible, if debatable, in many ordinary circumstances.Footnote 3 But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply.

It is not hard for us to imagine, for instance, a deadly epidemic raging across the country.Footnote 4 Drug-makers have developed vaccine candidates—it’s very plausible they’ll work, very unlikely they’ll cause substantial harm.Footnote 5 While we wait for three phases of clinical trial results, hundreds of thousands will die.Footnote 6 It’s conceivable that the best thing to do is begin vaccination campaigns immediately, or at least earlier than full Phase III trial results. But under American drug law, with its negative posture and inadequate emergency provisions, that would not be on the table.Footnote 7

wThis Article considers the challenge of emergency normative decision-making—a fundamental challenge of democratic legal design—in the context of authorization of new drugs or vaccines in public health emergencies. I conclude, for the same reasons of political theory that apply in the analogous context of emergency military decision-making, that the President ought to have the authority to deviate from the normative heuristics of our drug law in emergencies. This is so for two reasons. First, because emergency decision-making must happen quickly and decisively, it is best situated in one person. Second, normative decisions are political decisions, and in democracies we make political decisions through electoral processes. If we are to situate emergency decision-making in one person, it ought to be the most broadly democratically responsive federal official—the President.

Because, however (and unlike the military context), the President’s constitutional authority in public health emergencies is debatable,Footnote 8 and the current emergency provisions in our drug laws are inadequate, the federal drug laws should be amended to grant the President clear statutory authority to deviate from the ordinary process of premarket approval where necessary to combat public health emergencies. In short, just as we recognize that war is too important to be left to the generals, notwithstanding their military expertise, we ought to recognize that balancing risk and reward in public health emergencies is too important to be left to the scientists, and value Presidential control over the Food and Drug Administration (“FDA”) just as we value civilian control of the Pentagon.

The argument proceeds in four parts. First in Part II, I summarize the negative posture of U.S. drug law, and explain the inadequacies of the current emergency provisions. In Part III, I argue that the decision to authorize or not authorize a new drug is fundamentally a normative one, though of course one that takes account of descriptive predicates. Part IV argues that a statutory grant of authority to the President to deviate from the negative presumption is the best move, if necessarily an imperfect one. Finally, I address the two most powerful counterarguments to this conclusion—that it politicizes science and that it prevents us from learning about medical treatments through complete clinical testing.

II. THE NEGATIVE POSTURE OF DRUG LAW IN THE UNITED STATES

The negative posture of federal regulation of drugs and medicine is established in the Food, Drug and Cosmetic Act (“FDCA”), which states that “[n]o person shall introduce or deliver into interstate commerce any new drug, unless an approval … is effective with respect to such drug.”Footnote 9 And the FDA—the agency charged with enforcing the FDCA—may only issue an approval upon “substantial evidence” of the drug’s safety and efficacy.Footnote 10 This “substantial evidence” standard has been codified by regulation into the standard three-phases of clinical testing.Footnote 11 Thus, new drugs are assumed unsafe and ineffective until robustly proven otherwise; their use is prohibited in the same way if there is incomplete evidence of their safety and efficacy just as if there were proof that they were unsafe and ineffective. As many scholars have noted, this regulatory posture is a particular instance of the “precautionary principle” of public health and international environmental law, which conservatively favors government regulation to maintain the status quo in conditions of uncertainty.Footnote 12

The FDCA provides for a limited emergency exception to this presumption (the Emergency Use Authorization, or “EUA,” provisions). The Act authorizes the Secretary of Health and Human Services (“HHS”) (who has delegated the authority to the Commissioner of the FDA)Footnote 13 to determine “that there is a public health emergency … that affects … national security … and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents.”Footnote 14 Under these circumstances, the Secretary may authorize an unapproved new drug where three conditions are met: (1) the public health threat “can cause a serious or life-threatening disease or condition;” (2) “based on the totality of scientific evidence available to the Secretary … it is reasonable to believe that … the product may be effective … or … the known and potential benefits of the product … outweigh the known and potential risks of the product;” and (3) “there is no adequate, approved, and available alternative to the product.”Footnote 15 In an emergency, then, the FDCA lowers the evidentiary burden from “substantial evidence” to “reasonable belief.”Footnote 16

The EUA provisions suffer from three essential shortcomings that prevent them from adequately addressing the challenges of emergency normative decision-making. First, the text and the context of these provisions suggest that they were primarily designed for terrorist attacks against the United States,Footnote 17 and some commentators have argued that the FDA’s reliance on EUAs in the 2020 coronavirus pandemic has been inappropriate for that reason.Footnote 18 Second, although the EUA provisions mention a number of executive officials, including the Secretary of Defense and the Secretary of Homeland Security, they do not refer to the President.Footnote 19 This diffusion of responsibility facilitates buck-passing and diminishes political accountability. We saw this happen in the 2020 coronavirus pandemic, where it was unclear to the public who was responsible for issuing more controversial EUAs for hydroxychloroquine and convalescent plasma and on the basis of what evidence.Footnote 20

Finally, while the EUA provisions lower the evidentiary threshold from “substantial evidence” to “reasonable belief,” they do not account for the possibility that we may want our normative decision-making in an emergency to account for values other than a narrow cost-benefit analysis.Footnote 21 In other words, the EUA provisions make approval less burdensome within the essentially utilitarian framework of the FDCA, but do not contemplate deviating from that framework. In making specific, case-by-case normative decisions in emergencies, however, we may want our decision-makers to be free to consider a broader range of values.Footnote 22

III. THE NORMATIVITY OF AUTHORIZING NEW DRUGS

Philosophers distinguish between two kinds of claims—“descriptive” claims and “normative” ones.Footnote 23 Descriptive claims “address the way the world is, was, or will be.”Footnote 24 They are empirically verifiable statements about facts in the world—or probabilistic, predictive claims about future facts about the world.Footnote 25 We resolve descriptive questions primarily through the scientific method, a tool for clarifying and crystalizing facts of reality.Footnote 26 In contrast, normative claims “speak to how the world ought to be.”Footnote 27 They are ethical claims about what we should do.Footnote 28 We resolve normative questions, in contrast to descriptive ones, through philosophy and politics.Footnote 29

The question of the conditions under which a new drug ought to be authorized is a normative question, not a descriptive one.Footnote 30 It is a claim about how our government ought to behave—what levels of risk are tolerable, whether and how much the government should protect individuals from themselves, and the extent to which harms caused or prevented by drugs are similar to or different from other harms.Footnote 31 To be sure, this normative analysis must take account of descriptive predicates. Science can, and must, tell us what the potential risks and rewards of the product are and estimate their probabilities based on studies that have been conducted and our understanding of the way the world works.Footnote 32 But it cannot tell us what to do with that information—whether to demand further studies and greater confidence or to authorize the drug on the basis of what we have. To do so requires us to consider a range of values, balancing the value of potentially saving lives now against risks to lives in the future,Footnote 33 our commitments to libertarianism or paternalism,Footnote 34 the value of information in itself or instrumentally,Footnote 35 and many others. Thus, the decision to authorize or not authorize a new drug—in contrast to determinations about the physical properties of a drug—is irreducibly normative.Footnote 36

From this perspective, the negative posture of American drug regulation is a normative presumption—a conservative posture based on the ethical premise that it is ethically better for the government to forcibly maintain the status quo until an alternative to it is definitively proven better than to gamble on the risks concomitant with novel technologies.Footnote 37 Moreover, it is a normative heuristic, justified in general rather than with reference to particular cases. Some particular drugs may, of course, have relatively low risk and a higher probability of success than others.Footnote 38 In our general design of an administrative state, however, normative heuristics like this are entirely justifiable and even necessary—after all, basic financial and logistic constraints make it effectively impossible to conduct an individualized normative assessment for every drug proffered for approval to the FDA.Footnote 39

To the extent that we are justified in adopting normative heuristics to guide the decision whether to authorize drugs in general, the negative presumption we have settled on is defensible, if certainly not the only conceivable one.Footnote 40 Its descriptive premises are plausible—most hypothesized new drugs turn out to be ineffective,Footnote 41 and history is replete with examples of new substances causing substantial harm, including death, to human bodies.Footnote 42 Its normative assumption that harm caused by active deviation from the status quo is worse than the harms endemic to the status quo is plausible and widely believed,Footnote 43 albeit not without controversy.Footnote 44 In other words, the negative posture of American drug law is a defensible heuristic normative principle for the background design of a regulatory regime.

But this conservative stance can misfire in a public health emergency, requiring the government to make normative decisions that are suboptimal under a variety of ethical frameworks. An emergency is a set of circumstances that in their nature justify addressing that set of circumstances before anything else.Footnote 45 This is because the emergency threatens the fundamentals of the economic, social, and political order without which other aspirations would be meaningless.Footnote 46 What is at stake in an emergency is, in Lincoln’s words, whether society itself will “go to pieces,” after which other societal goals would seem futile—reducing income inequality doesn’t mean much in a war of all against all.Footnote 47 This prioritization of addressing the emergency makes available resources for case-by-case decision-making where we might otherwise rely on heuristics.Footnote 48 And because the emergency is by definition an unanticipated set of circumstances, it is characterized by its specificity—by the need to address its particular challenges in a bespoke and context-specific way.Footnote 49

The long and the short of all this is that in an emergency, the government ought to consider whether to authorize specific hypothesized treatments on the merits of the specific question rather than deferring to heuristic generalizations.Footnote 50 The negative posture of our drug law may plainly fail when the decision to authorize a particular drug is considered on its own merits.Footnote 51 Through the lens of the utilitarian moral framework that animates the administrative state in general,Footnote 52 for instance, it may be that a particular hypothesized treatment has a strong probability of success and relatively low stakes for failure. Vaccines for COVID-19 may have been an example of this, even the novel mRNA ones—their mechanisms of action were both plausible and hotly anticipated.Footnote 53 Historically, the only deaths caused by vaccines have been caused by contamination, a risk the premarket approval requirements of the FDCA are not designed to mitigate anyway.Footnote 54 Moreover, under utilitarian moral frameworks, use of a vaccine could be justified even if it caused death in some fraction of those inoculated, so long as it was less deadly than the virusFootnote 55—in the case of SARS-CoV-2, killing fewer than 0.5% of people to whom it was administered.Footnote 56 If indeed a vaccine were deadlier than that, we would know relatively quickly, and could prohibit its further use.Footnote 57

More generally, however, in making specific normative evaluations in an emergency, we may want to consider values beyond the utilitarian background of the administrative state.Footnote 58 Some of these considerations might be general values that we think of differently in emergencies—individual freedom against governmental compulsion, allocating risks of harm across different segments of society, weighing the present against the future. It may be much easier, for example, for those of us who can work from home to wait for a robustly-tested vaccine than for those who must interact with others, and perhaps our decision-makers ought to take that into account. Some values may be unique to emergency contexts—whether there’s a deontological value in the preservation or continuity of the legal order, for instanceFootnote 59—or may even be unique to specific emergencies—how do we weigh the less tangible harms of social distancing against the intangible benefit of robust scientific knowledge, for example?

The answers to these questions are not obvious, nor can they be planned for definitively in advance. They are normative questions. And they are normative questions so context-specific that pre-existing heuristics cannot answer them. Simply relying on the negative presumption of the FDCA to govern the decision whether to authorize a hypothesized new treatment in an emergency can result in indefensible decision-making—under utilitarianism or a variety of plausible ethical frameworks.

In sum, decisions to authorize or not authorize new drugs—though they necessarily accommodate descriptive predicates—are normative.Footnote 60 By their nature, emergencies justify case-by-case normative decision-making. And when analyzed on a case-by-case basis, the negative presumption embedded in the FDCA may fail to plausibly resolve that normative question—in certain emergencies, with respect to certain hypothesized drugs, under certain circumstances. With these conclusions, the question of how such case-by-case normative decisions should be made is one of institutional design, to which we now turn.

IV. PRESIDENTIAL EMERGENCY DECISION-MAKING

In democracies, we answer normative questions through majoritarian political processesFootnote 61—although in a liberal democracy this principle only applies to most normative questions, most of the time.Footnote 62 Therefore, normative decisions about the threshold of proof required for new drug authorization should be allocated to a politically responsive entity. If the decision-maker makes a normative decision that most people disagree with—recklessly authorizes a drug or vaccine that causes more harm than good, for example—we want to be able to replace them with someone who will make a decision with which more people will agree.

The United States Constitution establishes two branches intended to be responsive to electoral majorities in different ways—Congress and the President.Footnote 63 At a high level of abstraction, Congress, through its legislative power, resolves normative questions in the generality,Footnote 64 while the President resolves these questions in the particular applicationFootnote 65 and the emergency.Footnote 66 Congress declares war and the President commands its conduct;Footnote 67 Congress passes criminal laws and the President exercises prosecutorial discretion.Footnote 68

On the normative question of whether new drugs should be authorized for the treatment of a disease, our government has followed this prescription in part—Congress has legislated in the generality, establishing a negative presumption that places a burden of “substantial evidence” on the proponent of the new drug.Footnote 69 But it has not recognized particular authority in the President to authorize new drugs in emergency situations.Footnote 70 It should.

There are two essential reasons that the President is the best office in which to situate normative emergency decision-making, in public health crises as in war. The first is that because emergencies require immediate response, decision-making authority should be situated in one person, who can respond more quickly and decisively than a collective group like Congress, or even the various committees of the FDA.Footnote 71 The second is that because normative questions are political, and political questions in democracies are resolved through electoral processes, the one person in whom we situate this power should be the most politically accountable—and the President is the only federal official elected by the country as a whole.Footnote 72 Of course the President—elected for four-year terms by the Electoral College—is not perfectly politically accountable.Footnote 73 But he is the most, and to the extent that the need for immediacy justifies situating emergency decision-making in one individual, the President is the best.

Moreover, the same reasons of political theory that justify granting the President command of the military forces, authority over the conduct of war, and the capacity to respond swiftly to military threats to national security justify similarly granting him emergency decision-making in public health emergencies.Footnote 74 The conduct of war, like the conduct of a pandemic, involves countless normative decisions, particularly decisions that balance risks and rewards, determine how bad the risks are and what sorts of things qualify as rewards. Indeed, throughout the 2020 coronavirus pandemic, decision-makers have leaned heavily on rhetorical comparisons to war.Footnote 75 In war, we recognize that the President will make decisions based on limited information. We accept that a particular strike, say, may not work, may kill more people than it saves, and may, ultimately, have been a bad idea. But we recognize this kind of decision-making as a necessity in military emergencies. And we are comfortable vesting it in the President, the only individual elected by the country as a whole.

In a public health crisis, as in war, decision-makers are making choices on the basis of limited—and sometimes deeply flawed—information.Footnote 76 They are weighing risks to blood, treasure, prestige, ethics, morale, and values against potential good outcomes measured in the same. For the same reasons that we feel the President ought to have emergency decision-making authority to defend against military threats to national security, similar standards should govern the President’s ability to make decisions in a public health emergency. Just as we recognize that, in the famous words of Georges Clemenceau, “war is too important to be left to the generals,”Footnote 77 pandemic response is too important to be left to the scientist-bureaucrats.

As discussed above, the FDCA vests limited emergency powers in the Secretary of HHS.Footnote 78 Under the “unitary executive” theory, some may see this as tantamount to a vesting of power to the President.Footnote 79 As a practical matter, however, the Secretary of HHS has delegated EUA authority to the FDA, and it is the FDA making EUA determinations, not the Secretary, and certainly not the President.Footnote 80 Moreover, the Supreme Court has never recognized plenary presidential authority over executive officials,Footnote 81 and the notion that the President as a constitutional matter has the power to direct executive agents is contestable and contested.Footnote 82 Moreover, the EUA provisions purport to render the determination of whether a particular drug should be authorized an empirical rather than a normative question—altering the evidentiary threshold, but not the broader regulatory posture.Footnote 83 From this perspective, the EUA provisions are analogous to Congress’s purporting to give the Secretary of Defense a comprehensive playbook for directing the conduct of war—a bad idea, even if it could be constitutional.Footnote 84

Therefore, the FDCA should be amended to expressly authorize the President to override the FDA’s new drug approval—or EUA—process on an individualized level in emergencies. Doing so would comport with the general structure of our government, accord with the analogy between normative decision-making in public health emergencies and war, resolve the limitations of the current emergency decision-making structure, and sidestep the constitutional question of whether the President would possess the authority anyway.

More generally, the reasoning behind this change would not necessarily require altering the relationship between the President and independent federal agencies such as the Federal Reserve Board.Footnote 85 The reason for this is straightforward—emergency decision-making in public health crises like pandemics is more like emergency decision-making in war than the kinds of decisions encountered by independent agencies—decisions of monetary policy, say.Footnote 86 As in war, pandemics threaten the short-term loss of human life.Footnote 87 At stake in war and pandemics is widespread political and economic disruption. These decisions are quintessentially executive and necessarily immediate.Footnote 88 In contrast, decisions of monetary policy—no matter how controversial or consequential—are made over the course of months or years.Footnote 89 Where decisions do not need to be made immediately and do not require the exercise of substantial executive authority, legislatures may be justified in adopting heuristic normative principles—with the FDA or the Federal Reserve—and delegating their execution to specified multimember committees.Footnote 90 It is only when decisions must be made immediately—when emergencies threaten the fundamentals—that they must be vested in one person, who ought not be anyone other than the President.Footnote 91

As with any presidential emergency power, the constraints on the exercise of the power to authorize particular drugs in public health emergencies will be fundamentally political.Footnote 92 This entails a familiar suite of risks. It is possible that in future pandemics we will happen to have—as we did in this one—a President singularly unequipped to meet the demands of the moment.Footnote 93 But there are good reasons to believe that political constraints will be enough, or at least the best we could hope for. President Trump lost his bid for re-election and it is plausible that but for his handling of the pandemic, he would have won.Footnote 94 Similarly, a President who recklessly authorizes a dangerous drug, fails to monitor and adjust as evidence of its danger is revealed, and, ultimately, makes a crisis worse rather than better will, no doubt, pay at the polls. On the other hand, a President who acts decisively, based on sound scientific guesswork and a willingness to take limited risks for potentially powerful rewards, quickly launching a vaccination plan that works will be hailed a hero, and would be one.

V. COUNTERARGUMENTS

A. The Politicization of Science

Perhaps the most significant concern with granting the President authority to authorize new drugs in emergencies—made all the more acute by President Trump’s egregious mishandling of the COVID pandemic—is that doing so risks the “politicization of science.”Footnote 95 Politicization of science—which we might define as making descriptive claims purportedly backed by the scientific method in fact driven by exogenous normative commitments rather than a commitment to descriptive truth—is a serious concern.Footnote 96 To make informed decisions under any normative framework, we must understand descriptive facts about the world, and the scientific method—which gives no credence to what we want to be true—is the best method we have for establishing those facts.Footnote 97 We ought to design institutions to limit normative interference in scientific processes. But this principle does not preclude situating emergency drug-authorization authority in the President.

Indeed, the argument that the FDA’s drug-authorization decision should be insulated from President commits the very sin it hopes to avoid—it conflates descriptive questions about the potential risks and rewards of a particular drug with normative questions of what to do with that information. As discussed above, the decision to authorize or not authorize a drug is always normative.Footnote 98 The authorization decision—as opposed to inquiries into the physical nature of a substance and its interaction with human biology—is supposed to be political. And it always has been—the negative posture of the FDCA is a normative, political choice just as much as deviating from it would be, though because it applies in general it has appropriately been made by Congress rather than the President.Footnote 99

From this perspective, the FDA’s theoretical role, as an administrative agency composed of scientific experts, has always been simply to answer scientific questions about how proffered drugs affect humans.Footnote 100 The decision of what to do with that information is a normative one that Congress has already answered in general and, I argue, the President ought to answer in emergencies. The best way to avoid the politicization of science is to ensure a clear-headed conceptual distinction between the questions science can answer and those it cannot. This counterargument risks public confusion about the distinction between normative and descriptive claims by suggesting that the decision to authorize a new drug is one scientists are competent to answer and could hasten rather than inhibit the politicization of science.

Indeed, the coronavirus pandemic offered ample evidence that lack of clarity about the limits of science to resolve normative questions can contribute to the rejection of descriptive claims because of exogenous normative commitments. For example, it seems that one of the reasons for politicization of issues such as mask-wearing during the 2020 pandemic was due to a substantial portion of the population perceiving that the experts urging mask-wearing were politically biased—that is, that public health experts were promoting mask-wearing for normative reasons that only purported to be descriptive.Footnote 101 In this situation, the outcome (disbelief in the descriptive scientific evidence of mask-efficacy) may have been the result of a perception of the mingling of scientific and normative recommendations from scientists, not (as the politicization-of-science counterargument would assume) from the interference of the President in the normative aspects of a public-health decision-making process.Footnote 102

Finally, it is true that President Trump made knowingly false descriptive claims during the COVID-19 pandemic.Footnote 103 But it is unclear the extent to which this phenomenon either arose from or contributed to broader concerns about the politicization of science as distinct from more narrow concerns about a particular mendacious President. President Trump made knowingly false descriptive claims about all sorts of things.Footnote 104 Our entire constitutional order assumes that the President will fulfill their duties in good faith.Footnote 105 Where a President fails to do so, the appropriate remedies are impeachment or voting them out, the latter of which appears to have operated effectively in the case of President Trump.Footnote 106 To the extent that a President ignores that constitutional duty, we have far larger problems, and far more powerful remedies, than anything as narrow as the President’s statutory relationship with the FDA.

B. Compromising Clinical Trials

Finally, some commentators have argued against deviating from the “substantial evidence” standard in emergency situations on the grounds that doing so would compromise clinical trials, and result in it taking longer for us to learn about the safety and efficacy of the treatment.Footnote 107 It is true that if we were to authorize a vaccine prior to the completion of Phase III trials, we may lose the opportunity to ever conduct a large-scale, randomized, double-blind, placebo-controlled study of safety and efficacy.Footnote 108 These are important informational costs to early authorization. Moreover, early authorization could diminish public confidence in vaccines in both the short and long term.Footnote 109 But the question of how much those costs matter is a normative one. And as a normative one, it should be answered by the President rather than the scientists.

It is plausible that, in a pandemic, the value of information determined to the gold standard of scientific confidence is at its lowest ebb. That is, it may be that what matters is whether we can actually lower the death rate or limit transmission, not whether we understand how we are doing so, nor whether we know for sure that the result is not attributable to the placebo effect or some exogenous behavioral variable. What matters could be whether healthcare workers are continuing to be infected with SARS-CoV-2 or not, and whether our hospitals are overflowing with dying patients or not. These things can be measured whether or not their cause can be robustly determined. Similarly, it’s conceivable that permitting people who want to vaccinate themselves to do so is more important than ensuring general confidence in vaccination.

Of course, many would disagree, and argue that knowledge matters in this context as much as elsewhere, that it is only by knowing how the virus works that we can devise better long-term strategies to limit its spread, and that conceding any uncertainty about safety to the anti-vaccine movement is a defeat.Footnote 110 This argument is at least as plausible. But distinguishing between these alternatives is a normative determination. It may well be that in some circumstances, it makes sense to try everything immediately (we could imagine this not being particularly controversial if a novel pathogen had the contagiousness of measles and the lethality of Ebola), and other situations (perhaps the SARS-CoV-2 pandemic itself) where we can credibly anticipate that containment will never work and that the virus’s lethality is simply not enough to deviate from our ordinary standards of knowledge-acquisition.Footnote 111 But weighing which kind of situation we are in is precisely the normative balancing the political process is designed to accomplish.

In a democracy, the people ought to have a say in the tradeoffs we make between the acquisition of scientific knowledge and the risky but tangible prospect of ending a pandemic sooner rather than later.

VI. CONCLUSION

Extraordinary times—including public health emergencies—call for extraordinary measures. But one of the unquestioned assumptions in the 2020 coronavirus pandemic was that the United States would have to wait for at least preliminary data from three phases of clinical trials to use vaccines that we knew from the beginning were very unlikely to be as harmful as the virus and which quite plausibly could work. Maybe that was right in these particular circumstances. But this Article argues that it did not have to be so. Instead, to prepare for future pandemics, the FDCA should be amended to recognize the President’s authority to modify the FDA approval process—or, alternatively, the EUA process—in an emergency.

Footnotes

†

I thank Fran Miller, Christopher Robertson, my anonymous peer reviewers and the editorial and symposium team at the American Journal of Law and Medicine for helpful comments and questions that have substantially strengthened the piece.

References

1 See 21 U.S.C. § 355(a) (2018) (requiring approval by the Food & Drug Administration before a new drug can be sold).

2 See Lawrence O. Gostin & Lindsay F. Wiley, Public Health Law: Power, Duty, Restraint 68-69 (3d ed. 2016) (discussing the precautionary principle’s application in policymaking where scientific uncertainty exists).

3 See Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food & Drug Law: Cases & Materials 642-644 (4th ed. 2014) (describing the development of the negative presumption in American drug law); see also Cass R. Sunstein, Beyond the Precautionary Principle, 151 U. Pa. L. Rev. (2003) 1003, 1003 (“The salutary moral and political goals of the precautionary principle should be promoted through other, more effective methods.”).

4 See generally Nicholas A. Christakis, Apollo’s Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live (2020) (describing the effects of the 2020 COVID-19 pandemic in the U.S.).

5 See Anne Trafton, Explained: Why RNA Vaccines for Covid-19 Raced to the Front of the Pack, MIT News (Dec. 11, 2020), https://news.mit.edu/2020/rna-vaccines-explained-covid-19-1211 [https://perma.cc/FR94-66EZ] (explaining how mRNA vaccines “stimulate the immune system to mount a response, without posing any risk of infection”).

6 See Tommy Beer, November’s Grim Covid-19 Totals: More Than 4.3 Million Infections and 37,000 Americans Killed, Forbes (Dec. 1, 2020, 4:47 PM), https://www.forbes.com/sites/tommybeer/2020/12/01/novembers-grim-covid-19-totals-more-than-43-million-infections-and-37000-americans-killed/?sh=285772e16acb [https://perma.cc/7TQB-J9CD] (reporting that 268,000 Americans had died of COVID-19 before widespread vaccinations began).

7 See, e.g., Robert Kuznia, The Timetable for a Coronavirus Vaccine is 18 Months. Experts Say That’s Risky, CNN (Apr. 1, 2020, 2:14 PM), https://www.cnn.com/2020/03/31/us/coronavirus-vaccine-timetable-concerns-experts-invs/index.html [https://perma.cc/F8CH-E838].

8 See Leslie E. Gerwin, Planning for Pandemic: A New Model for Governing Public Health Emergencies, 37 Am. J.L. & Med. 128, 141-42 (2011) (noting that enforcement of emergency orders by the Executive is neither explicitly authorized or prohibited in the Constitution).

9 21 U.S.C. § 355(a) (2018). Vaccines and other biologics are regulated by the Public Health Service Act, which adopts “a regulatory regime similarly rigorous to that for drugs, including premarket review by FDA for safety and effectiveness.” Hutt, Merrill & Grossman, supra note 3, at 135; see also 42 U.S.C. § 262 (2018) (FDA biologic license requirements for new vaccines). This Article is focused on the drug and biologic approval process, which is distinct from that for medical devices. See generally 21 U.S.C. § 360e (providing premarket approval procedures for medical devices).

10 21 U.S.C. § 355(d).

11 See Investigational New Drug Application, 21 C.F.R. §§ 312.20–.21 (2020).

12 See Noah M. Sachs, Rescuing the Strong Precautionary Principle from Its Critics, 2011 U. Ill. L. Rev. 1285, 1290 (2011) (describing “[t]he Food and Drug Administration’s review process for new drugs [as] just one of myriad examples” of “Strong Precaution” in U.S. law); see also Wiley & Gostin, supra note 2, at 68-69 (“Given the potential costs of inaction, the failure to implement preventive measures requires justification.”).

13 See Agata Dabrowska, Cong. Research Serv., IF10745, Emergency Use Authorization and FDA’s Related Activities 2 (2018).

14 21 U.S.C. § 360bbb-3(b)(1)(C).

15 Id. §§ 360bbb-3(c)(1)–(3).

16 Id.

17 This can be seen in the provisions’ emphasis on emergencies implicating national security. For instance, the EUA provisions have four potentially triggering emergencies—(1) “a domestic emergency … involving a heightened risk of attack” (2) “a military emergency” (3) “a public health emergency … that affects … national security or the health and security of United States citizens living abroad” and (4) “the identification of a material threat … sufficient to affect national security or the health and security of United States citizens living abroad.” Id. §§ 360bbb-3(b)(1)(A)–(D). Moreover, the provisions were originally enacted as part of a counterterrorism package “[i]n response to the September 11, 2001 terrorist attacks, and subsequent anthrax attacks.” Elizabeth Y. McCuskey, FDA in the Time of COVID-19, 45 Admin. & Reg. L. News 7, 7 (2020); see also Barbara J. Evans & Ellen Wright Clayton, Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle, 130 Yale L.J. Forum 78, 80 (2020). As a textual matter, however, pandemics would seem to meet the triggering condition, and the FDA has interpreted the provisions that way in prior pandemics. See Emergency Use Authorizations for Medical Devices, U.S. Food & Drug Admin., https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices [https://perma.cc/2T77-TM2T] (listing EUAs issued to combat Zika and Ebola epidemics).

18 See Matthew W. McCarthy, David Oshinsky & Arthur Caplan, Make Pre-Approval Covid-19 Vaccines Available Through Expanded Access, Not an EUA, Stat (Nov. 9, 2020), https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ [https://perma.cc/2WXW-MBPX] (noting that “the intent of emergency use authorization” was “designed for counterterrorism measures to address chemical, biological, radiological, and nuclear hazards—not necessarily a pandemic”).

19 See 21 U.S.C. § 360bbb-3.

20 See Marisa Taylor & Aram Roston, Exclusive: Pressed by Trump, U.S. Pushed Unproven Coronavirus Treatment Guidance, Reuters (Apr. 4, 2020, 1:52 PM), https://www.reuters.com/article/us-health-coronavirus-usa-guidance-exclu/exclusive-pressed-by-trump-u-s-pushed-unproven-coronavirus-treatment-guidance-idUSKBN21M0R2 [https://perma.cc/A96S-4X38].

21 See Sachs, supra note 12, at 1314.

22 Id.

23 See Bart Streumer, Are Normative Properties Descriptive Properties?, 154 Phil. Stud. 325, 326 (2011).

24 Adam J. Kolber, How to Fix Legal Scholarmush, 95 Ind. L.J. 1191, 1196 (2020).

25 Id.

26 See Deborah M. Hussey Freeland, Law & Science: Toward a Unified Field, 47 Conn. L. Rev. 529, 538 (2014).

27 Kolber, supra note 24, at 1196-97.

28 See id.

29 See David L. Faigman et al., 1 Mod. Sci. Evidence § 4.4 (2021) (noting that “philosophers, theologians, and literary scholars” address “normative questions”).

30 See Sachs, supra note 12, at 1320-21 (noting that decisions about thresholds for acceptable levels of risk are “fundamental value choices”).

31 Id.

32 Id. at 1321 (“Legislatures should consider knowable tradeoffs where they can be quantified, but they should also view their role as more than utility maximizers, summing up individual preferences.”).

33 See generally Derek Parfit, Reasons & Persons 351-441 (1986) (philosophically analyzing how to weigh the effects of current decisions on future lives).

34 Compare Robert Nozick, Anarchy, State, and Utopia 33 (1974) (analyzing libertarian constraints prohibiting aggression against other individuals), with Richard H. Thaler & Cass R. Sunstein, Nudge: Improving Decisions about Health, Wealth, and Happiness 37 (2008) (describing how people are “nudge-able” and want an authority to make choices requiring deep thinking for them).

35 See generally Duncan Pritchard, Alan Miller & Adrian Haddock, The Nature and Value of Knowledge: Three Investigations (2010).

36 Cf., e.g., I. Glenn Cohen, What (if Anything) Is Wrong with Human Enhancement? What (if Anything) Is Right with It?, 49 Tulsa L. Rev. 645, 677 (2014) (describing the “FDA’s premarket approval regime” as one normative solution to questions regarding “the scope of justified paternalism … and of parens patriae state interventions”).

37 See Gostin & Wiley, supra note 2, at 68-69; Sachs, supra note 12, at 1303 (noting that default rules regulating risk are not “value neutral”).

38 For example, in the COVID-19 pandemic, vaccines based on more traditional designs were initially seen as more promising than unproven mRNA technologies. See Jennifer Abbasi, COVID-19 and mRNA Vaccines—First Large Test for a New Approach, 324 JAMA 1125, 1125 (2020); see also Jenny Strasburg & Joseph Walker, AstraZeneca-Oxford Covid-19 Vaccine Up to 90% Effective in Late-Stage Trials, Wall St. J. (Nov. 23, 2020, 3:29 PM), https://www.wsj.com/articles/astrazeneca-oxford-covid-19-vaccine-up-to-90-effective-in-late-stage-trials-11606116047 [https://perma.cc/SS4G-62Q6].

39 See Sachs, supra note 12, at 1320 (“In federal toxics policy, the legislative task is not to perform a utilitarian calculus on the costs and benefits of banning or restricting specific chemicals. It is to determine the best legislative architecture for assessing and managing the risks of the universe of 84,000 chemicals that have been introduced into commerce.”); see also Stillwell v. Office of Thrift Supervision, 569 F.3d 514, 519 (D.C. Cir. 2009) (“An agency need not suffer the flood before building the levee.”).

40 See Hutt, Merrill & Grossman, supra note 3, at 642-44 (describing the development of the negative presumption in American drug law).

41 See Attila A. Seyhan, Lost in Translation: The Valley of Death Across Preclinical and Clinical Divide – Identification of Problems and Overcoming Obstacles, 4 Translational Med. Comm., no. 18, 2019, at 4 (2019) (“80 to 90% of research projects fail before they ever get tested in humans and for every drug that gains FDA approval, more than 1000 were developed but failed. Almost 50% of all experimental drugs fail in Phase III trials.”).

42 See, e.g., Barbara Sibbald, Death but One Unintended consequence of Gene-Therapy Trial, 164 Can. Med. Ass’n J. 1612, 1612 (2001) (discussing the death of Jesse Gelsinger four days after injection of an experimental gene therapy).

43 See U.N. Conference on Environment & Development, Rio Declaration on Environment and Development, U.N. Doc. A/CONF.151/26/Rev. 1 (Vol. I), annex I (Aug. 12, 1992) (reaffirming a twenty-year old environmental declaration and applying a “precautionary approach” to protect the environment). See generally Edmund Burke, Reflections on the Revolution in France (Batoche Books 1999) (1790).

44 See Cass R. Sunstein, The Laws of Fear, 115 Harv. L. Rev. 1119, 1160 (2002) (reviewing Paul Slovic, The Perception of Risk (2000)). See generally Frank B. Cross, Paradoxical Perils of the Precautionary Principle, 53 Wash. & Lee L. Rev. 1285 (1996).

45 See generally Karin Loevy, What is an Emergency? The Legal Politics of Defining the ‘Undefinable’, 22 ILSA J. Int’l & Comp. L. 155 (2015).

46 See Bhagat Singh v. King Emperor, (1931) 58 IA 169 (India) (defining “emergency” as “a state of matters calling for drastic action”); The Federalist No. 23, at 106-07 (Alexander Hamilton) (Terence Ball ed., 2003) (emphasis removed) (“[I]t is impossible to foresee or define the extent and variety of national exigencies, or the correspondent extent and variety of the means which may be necessary to satisfy them. The circumstances that endanger the safety of nations are infinite.”); Carl Schmitt, Political Theology: Four Chapters on the Concept of Sovereignty 6 (George Schwab, trans., University of Chicago Press 2005) (1922) (“The exception … can at best be characterized as a case of extreme peril, a danger to the existence of the state, or the like.”); see also Loevy, supra note 45, at 160-175 (summarizing theories of the emergency).

47 See Abraham Lincoln, July 4th Message to Congress (July 4, 1861), https://millercenter.org/the-presidency/presidential-speeches/july-4-1861-july-4th-message-congress [https://perma.cc/HA64-RLRZ].

48 The Federalist No. 23, supra note 46, at 107 (noting that in emergency decision-making “the means ought to be proportioned to the end”).

49 Id. (“The circumstances that endanger the safety of nations are infinite.”); see also Oren Gross, “Once More unto the Breach”: The Systemic Failure of Applying the European Convention on Human Rights to Entrenched Emergencies, 23 Yale J. Int’l L. 437, 439 n.7 (1998) (quoting Int’l Law Ass’n [ILA], Report of the Sixty-First Conference Held at Paris, at 59 (1984)) (“[E]ach [emergency case has to be judged on its own merits taking into account the overriding concern for the continuance of a democratic society.”).

50 Cf. Schmitt, supra note 46, at 7 (noting that in emergency situations “[t]he most guidance the constitution can provide is to indicate who can act in such a case”).

51 See Sachs, supra note 12, at 1325 (observing that “the spread of contagious disease” may be an instance in which the Precautionary Principle ought not apply).

52 See Mark D. Steedman, Taming Leviathan, 52 Tulsa L. Rev. 621, 631 (2017) (quoting Anne M. Kornhauser, Debating the American State: Liberal Anxieties and the New Leviathan, 1930-1970 181 (2015)) (highlighting previous scholars who argued for a moral framework to augment utilitarianism as “a rough stand-in for a critique of the administrative state”).

53 See, e.g., Mark Terry, Moderna Therapeutics Sets Record for Biggest Biotech IPO, BioSpace (Dec. 7, 2018), https://www.biospace.com/article/moderna-therapeutics-biggest-ipo-in-biotech-history/ [https://perma.cc/G7F6-LA37] (observing that Moderna set the record for the biggest biotech initial public offering (IPO) as of 2018 due to public optimism regarding its “focus[] on messenger RNA (mRNA) therapeutics,” including vaccines).

54 See Vaccine Safety: Historical Vaccine Safety Concerns, Ctr. for Disease Control & Prevention (last updated Sept. 4, 2020), https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html [https://perma.cc/85F4-GNT4] (listing the “Cutter incident” with the novel polio vaccine, which killed 10, as the only incident where vaccination has been robustly linked to death).

55 See John Stuart Mill, Utilitarianism 55 (Roger Crisp ed., Oxford University Press 1998) (1861) (“The creed which accepts as the foundation of morals, Utility, or the Greatest Happiness Principle, holds that actions are right in proportion as they tend to promote happiness, wrong as they tend to produce the reverse of happiness.”).

56 See COVID-19 Pandemic Planning Scenarios, Ctr. for Disease Control & Prevention (last updated Mar. 19, 2021), https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html [https://perma.cc/TR63-MC3A].

57 Cf. Harvey I. Miller & Gregory Conko, The Science of Biotechnology Meets the Politics of Global Regulation, Issues Sci. & Tech. Online, Fall 2000, at 49 (“If the precautionary principle had been applied decades ago to innovations such as polio vaccines and antibiotics, … that precaution would have come at the expense of millions of lives lost to infectious diseases.”).

58 See Sachs, supra note 12, at 1314 (“Utilitarian welfare maximization need not be the driving goal of every regulatory regime, and the Strong Precautionary Principle can incorporate a wider variety of goals and values.”).

59 See Oren Gross & Fionnuala Ní Aoláin, Law in Times of Crises: Emergency Powers in Theory and Practice 4-10 (2006).

60 Supra notes 30-36 and accompanying text.

61 See Fabienne Peter, Democratic Legitimacy and Proceduralist Social Epistemology, 6 Pol., Phil. & Econ. 329, 330 (2007) (discussing justifications in political philosophy for the democratic principle that majorities generally resolve value judgments and the doctrinal shift “towards the normative requirements implicit in the idea of democracy”); see also Sachs, supra note 12, at 1291 (“Legislators may opt for a Strong Precautionary framework for a variety of legitimate [and normative] reasons, including protection of crucial ecosystem functions, protection of future generations, or providing government review over the location or size of activities that may harm the public.”).

62 See United States v. Carolene Products, 304 U.S. 144, 153 n.4 (1938) (noting that majorities may be restrained by the Constitution where “prejudice against discrete and insular minorities … tends seriously to curtail the operation of those political processes ordinarily to be relied upon to protect minorities”).

63 See U.S. Const., art. I, § 1 (vesting the legislative power in an elected bicameral Congress); U.S. Const. art. II, § 1 (vesting the executive power in the elected President).

64 See Zachary S. Price, Enforcement Discretion and Executive Duty, 67 Vand. L. Rev. 671, 676 (2014) (“[T]he central legislative task is to formulate general laws and policies for the executive and judicial branches to implement.”); see also Sachs, supra note 12, 1320 (“Congress must determine what decision-making procedures and default rules should be put in place for all chemical substances subject to the statute.”).

65 See Price, supra note 64, at 675 (“[S]ome degree of enforcement discretion is a natural incident of the core executive function of applying general rules to particular cases.”).

66 See Leslie E. Gerwin, Planning for a Pandemic: A New Model for Governing Public Health Emergencies, 37 Am. J.L. & Med. 128, 142 (2011) (“The Constitution’s silence on the government’s authority during a national emergency does not mean that the President must await congressional permission before acting.”).

67 See U.S. Const. art. I, § 8 (granting Congress the power to declare war); U.S. Const. art. II, § 2 (providing that the President is Commander-in-Chief “of the Army and Navy of the United States”).

68 See generally Price, supra note 64 (discussing the historical relationship between executive enforcement discretion and Congress’s prerogative to prescribe general laws).

69 21 U.S.C. § 335(a)–(d) (2018).

70 See id. § 360bbb-3(b).

71 See Bhagat Singh v. King Emperor, (1931) 58 IA 169 (India) (emphasis added) (“A state of emergency … connotes a state of matters calling for drastic action which is to be judged as such by someone… . Emergency demands immediate action.”); Clinton Rossiter, Constitutional Dictatorship: Crisis Government in the Modern Democracies 5 (1979) (emphasis removed) (“[T]he complex system of government of the democratic constitutional state is essentially designed to function under normal, peaceful conditions.”); Schmitt, supra note 46, at 5 (emphasis added) (“Sovereign is he who decides on the exception.”).

72 See Steven G. Calabresi, Some Normative Arguments for the Unitary Executive, 48 Ark. L. Rev. 23, 38 (1989) (“Energy in the executive is defended here as being essential for both foreign policy reasons and to protect the polity as a whole from factional strife.”); Jack H. McCall Jr. & Brannon P. Denning, Mission Im-posse-ble: The Posse Comitatus Act and Use of the Military in Domestic Law Enforcement, 39 Tenn. B.J. 26, 27 (2003) (“From its founding, this nation has largely viewed civilian control over the military as a critical and distinguishing feature of American democracy.”).

73 See, e.g., Sanford Levinson, Our Undemocratic Constitution: Where the Constitution Goes Wrong (And How We the People Can Correct It) 7-8, 45, 156 (2006).

74 See U.S. Const. art. II, § 2 (“The President shall be Commander in Chief of the Army and Navy of the United States.”); Brennan Center for Justice, A Guide to Emergency Powers and Their Use 2 (2019); Lawrence O. Gostin et al., Presidential Powers and Response to COVID-19, 323 JAMA 1547, 1547 (2020).

75 See Joseph Guzman, Fauci: ‘The Cavalry Is Coming’ with Coronavirus Vaccine, but Public Health Measures Are Still Needed, Hill: Changing Am. (Nov. 12, 2020), https://thehill.com/changing-america/well-being/prevention-cures/525714-fauci-the-cavalry-is-coming-with-coronavirus [https://perma.cc/E5GJ-NNML].

76 See, e.g., Daniela Hernandez, Sarah Toy & Caitlin McCabe, New Playbook for Covid-19 Protection Emerges After Year of Study, Missteps, Wall Street J. (Jan. 26, 2021, 12:09 PM), https://www.wsj.com/articles/new-playbook-for-covid-19-protection-emerges-after-year-of-study-missteps-11611680950 [https://perma.cc/SCF3-BUNZ].

77 See Sanford Levinson, Identifying “Independence”, 86 B.U. L. Rev. 1297, 1307 (2006).

78 21 U.S.C. § 360bbb-3 (2018).

79 See Steven G. Calabresi & Kevin H. Rhodes, The Structural Constitution: Unitary Executive, Plural Judiciary, 105 Harv. L. Rev. 1153, 1158 (1992) (“Unitary executive theorists claim that all federal officers exercising executive power must be subject to the direct control of the President.”).

80 See Sheila Kaplan, In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A., N.Y. Times (Sept. 19, 2020), https://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html [https://perma.cc/Z2XZ-XZ2H] (criticizing an assertion of authority by Secretary of HHS Alex Azar over FDA).

81 See Morrison v. Olson, 487 U.S. 654, 657-58 (1988) (affirming Congressional limits on the President’s authority to remove an executive officer).

82 See Lawrence Lessig & Cass R. Sunstein, The President and the Administration, 94 Colum. L. Rev. 1, 2-3 (1994).

83 See 21 U.S.C. § 360bbb-3(c)(1)-(3).

84 See Michael Stokes Paulsen, Drone On: The Commander in Chief Power to Target and Kill Americans, 38 Harv. J.L. & Pub. Pol’y 43, 55 (2015) (“The buck stops with the President.”).

85 See generally Peter Conti-Brown, The Institutions of Federal Reserve Independence, 32 Yale J. on Reg. 257 (2015).

86 See Seila Law LLC v. Consumer Fin. Prot. Bureau, 140 S. Ct. 2183, 2199-200 (2020) (suggesting that independent agencies may only be constitutional where they “do not wield substantial executive power”). For the reasons discussed in Part III, supra, the decision to authorize a drug in an emergency is substantial executive power.

87 Excess Deaths Associated with COVID-19, Ctrs. for Disease Control & Prevention (last updated Apr. 7, 2021), https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm [https://perma.cc/S6J4-M6WZ] (reporting at least 549,810 excess deaths from February 1, 2020, to April 7, 2021 compared to a normal year).

88 Seila Law LLC, 140 S. Ct. at 2200 (noting that “quintessentially executive power” may not be constitutionally exercised by independent agencies).

89 See Christine Kexel Chabot, Is the Federal Reserve Constitutional? An Originalist Argument for Independent Agencies, 96 Notre Dame L. Rev. 1, 7-14 (2020) (discussing the deliberative process of decision-making of the Federal Reserve’s most independent “Open Market Committee”).

90 See Seila Law LLC, 140 S. Ct. at 2197 (“We hold that the CFPB’s leadership by a single individual removable only for inefficiency, neglect, or malfeasance violates the separation of powers.”); cf. Sachs, supra note 12, at 1320.

91 Siela Law LLC, 140 S. Ct. at 2197.

92 See Eric A. Posner & Adrian Vermeule, Terror in the Balance: Security, Liberty, and the Courts 54-55 (2007) (discussing political constraints on the abuse of presidential power in emergencies).

93 See Lori Aratani, Oversight Report Says Trump Coronavirus Response a ‘Failure’, Wash. Post (Oct. 30, 2020, 5:00 PM), https://www.washingtonpost.com/local/trafficandcommuting/trump-coronavirus-response-failure/2020/10/29/cb58e066-1a15-11eb-82db-60b15c874105_story.html [https://perma.cc/EZ4D-HNG7].

94 See Ashley Parker, Josh Dawsey, Matt Viser & Michael Scherer, How Trump’s Erratic Behavior and Failure on Coronavirus Doomed His Reelection, Wash. Post (Nov. 7, 2020), https://www.washingtonpost.com/elections/interactive/2020/trump-pandemic-coronavirus-election/ [https://perma.cc/Z9WU-4LLN].

95 See Robert M. Califf, et al., Seven Former FDA Commissioners: The FDA Should be an Independent Federal Agency, 38 Health Aff. 84, 84-86 (2019).

96 See Genevieve P. Kanter, Science Journal Editors Shouldn’t Contribute to Politicizing Science, StatNews (Oct. 23, 2020), https://www.statnews.com/2020/10/23/science-journal-editors-shouldnt-contribute-to-politicizing-science/ [https://perma.cc/2NVP-3GZ5].

97 See generally, e.g., Karl Popper, Objective Knowledge: An Evolutionary Approach 360 (1972) (defending falsification as a method of discerning descriptive truth).

98 Supra notes 30-36 and accompanying text.

99 See Sachs, supra note 12, at 1307-08, 1320.

100 See Shelby Baird, Don’t Try This at Home: The FDA’s Restrictive Regulation of Home-Testing Devices, 67 Duke L.J. 383, 388 (2017) (arguing that the FDA’s regulatory authority is grounded in its scientific expertise).

101 See Bryan Walsh & Alison Snyder, Scientists Caught Between Pandemic and Protests, Axios (June 10, 2020), https://www.axios.com/black-lives-matter-protests-coronavirus-science-15acc619-633d-47c2-9c76-df91f826a73c.html [https://perma.cc/95PF-3CBQ] (attributing differences in trusts of scientists among republicans and democrats to the endorsement by public health officials of widespread protests following the death of George Floyd).

102 See David Wallace-Wells, People Don’t Trust Public-Health Experts Because Public-Health Experts Don’t Trust People, N.Y. Mag.: Intelligencer (June 20, 2020), https://nymag.com/intelligencer/2020/06/american-public-health-experts-coronavirus-masks.html [http://web.archive.org/web/20201225031338/https://nymag.com/intelligencer/2020/06/american-public-health-experts-coronavirus-masks.html] (attributing skepticism of public health expertise to normative public health decision-making early in the pandemic).

103 See Christian Paz, All the President’s Lies About the Coronavirus, Atlantic (Nov. 2, 2020), https://www.theatlantic.com/politics/archive/2020/11/trumps-lies-about-coronavirus/608647/ [https://perma.cc/P86D-WYSQ] (compiling President Trump’s lies during the COVID pandemic).

104 See, e.g., Daniel Dale, The 15 Most Notable Lies of Donald Trump’s Presidency, CNN Pol. (Jan. 16, 2021, 9:28 AM), https://www.cnn.com/2021/01/16/politics/fact-check-dale-top-15-donald-trump-lies/index.html [https://perma.cc/VX92-Y4C6].

105 See U.S. Const. art. II, § 3 (providing that the President “take Care that the Laws be faithfully executed”); War Powers: Hearings Before the Subcomm. on Nat’l Sec. and Sci. Devs. of the Comm. on Foreign Affairs, 93rd Cong. PAGE NUMBER (1973) (statement of Alexander Bickel, Professor of Law, Yale Law Sch.) (noting that the War Powers Resolution rests on “the assumption that in the future Presidents will act in good faith to discharge their duty to execute the law”).

106 See Amber Phillips & Peter W. Stevenson, What Happens Next in Trump’s Impeachment?, Wash. Post: The Fix (Feb. 12, 2021, 5:00 PM), https://www.washingtonpost.com/politics/interactive/2021/trump-impeachment-guide/ [https://perma.cc/LE4K-SEJ7].

107 See David Cyranoski, Why Emergency COVID-Vaccine Approvals Pose a Dilemma for Scientists, 588 Nature 18, 18 (2020) (discussing concern among scientists that early approval compromises the ability to learn about the safety and efficacy of the vaccine).

108 See McCarthy, Oshinsky & Caplan, supra note 18.

109 See Kyle Thomson & Herschel Nachlis, Emergency Use Authorizations During the COVID-19 Pandemic: Lessons From Hydroxychloroquine for Vaccine Authorization and Approval, 324 JAMA 1282, 1283 (2020).

110 See McCarthy, Oshinsky & Caplan, supra note 18.

111 See Christakis, supra note 4, at xiv.