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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
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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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”).
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).
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).
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.