key: cord-0872550-dtfmcqh6
authors: Johnson, Walter G; Marchant, Gary E
title: Legislating in the Time of a Pandemic: Window of Opportunity or Invitation for Recklessness?
date: 2020-06-15
journal: J Law Biosci
DOI: 10.1093/jlb/lsaa042
sha: 10df06c6556a7ad49a085c24c29eb94415da44af
doc_id: 872550
cord_uid: dtfmcqh6

The COVID-19 epidemic has been exacerbated by failures in diagnostic testing for the virus in the United States. In response to these problems, two bills have been introduced in Congress to not only reform emergency use of diagnostic tests, but to fundamentally reform diagnostics regulation in non-emergencies. There has been a long-standing recognition that current U.S. regulation of diagnostics is outdated and problematic, and the history of public health legislation is that emergencies and crises have been the primary motivating factor to break Congressional inertia and to implement new legislation. Thus, the COVID-19 may create a useful “window of opportunity” to pass much-needed legislative reform of diagnostic regulation in both emergency and non-emergency contexts. At the same time, rushing radical legislative changes, especially if they have not been subject to careful stakeholder engagement and Congressional deliberation in advance, is precarious and could result in reckless and disruptive changes. We review and apply the historical lessons of legislating in response to a crisis and conclude the one but not both of the pending legislative proposals may satisfy the criteria for an appropriate opportunistic change for diagnostics regulation.

The delay in providing widespread diagnostic testing has significantly exacerbated the extent and consequences of the COVID-19 epidemic in the United States. 1 Even when tests were available, a notable proportion were reported to give inaccurate results. 2 In response to these failures, two bills were immediately introduced in Congress to revise the FDA approval process for diagnostic tests. The bipartisan Verifying Accurate Leading-edge IVCT Development results may cause them to forgo beneficial interventions or undergo unnecessary and potentially harmful ones. 6 Ensuring these goals generally involves applying two standards, (1) analytical validity, referring to how accurately and precisely a diagnostic measures its intended analyte and

(2) clinical validity, describing how well a diagnostic can characterize or predict a patient's health status. 7 Yet, applying high standards to diagnostics, especially should clinical validity call for complex clinical trials, may delay access to valuable diagnostics and undercut potentially beneficial innovation.

Balancing these interests has become more challenging with the emergence of molecular diagnostics technologies, which test for various "-omics" such as genomics or microbiomics.

Such testing enables new diagnostics possibilities such as predicting the risk and severity of a patient developing a condition or how an individual might respond to an intervention. These innovations rely on tools such as algorithms and reference databases to measure and interpret their analyte, which pose more complicated analytical and clinical validity questions than more routine tests. 8 

The current regulatory landscape struggles to comprehensively manage these concerns for molecular diagnostics, treating diagnostics differently based primarily on whether the test is sold as a kit or offered in-house by a laboratory, rather than based on risk. Since the 1970s, the FDA has applied its three-tiered, risk-based regulatory scheme for medical devices to products called in vitro diagnostics (IVDs). 9 These IVDs are testing kits which manufacturers produce to market and sell to clinical laboratories and physician offices. In the mid-2010s, several legislative proposals were floated to resolve these regulatory issues. 14 One particular proposal, beginning with an effort by the Diagnostic Test Working

Group and evolving into the VALID Act, aimed to strike compromises by incorporating all diagnostics (including LDTs) into products called in vitro clinical tests (IVCTs) subject to relatively flexible FDA review. This bill has gained the most support to date both within and outside of Congress and, under Commissioner Gottlieb, the FDA also supported some form of the compromise identified by the VALID Act. 15 Over a several year period, multiple successive drafts of the planned legislation were circulated to stakeholders and then revised based on the feedback. In March 2019, one expert observer wrote that "the VALID Act enjoys bipartisan and bicameral support and, after years of discussion between Congress, FDA, labs, patients, and other interested stakeholders, seems poised to be enacted before the end of the current

Congress." 16 By January 2020, the legislation was ready to be introduced in the following few 

several weeks passed before a revised EUA could be granted. The largest private diagnostics developers did not receive EUAs until mid-March 2020, 23 due in part to requirements for evidence of effectiveness. As the severity of the pandemic and political scrutiny increased, the FDA relaxed its EUA requirements for diagnostics several times. These efforts included permitting some CLIA-certified laboratories to validate and use LDTs prior to communicating with the FDA. 24 However, the early enforcement decisions and lack of early engagement with industry had already discouraged many clinical laboratories from developing or seeking authorization for LDTs, 25 and the delayed availability of testing during the initial weeks of the pandemic significantly exacerbated the spread of the virus in the U.S.

The U.S. legislative process for any given issue is characterized by static inertia interrupted by an occasional "policy window" opened by external changes or events that suddenly catapult a specific issue to the forefront of Congressional attention. 26 The U.S.

Congress is confronted by thousands of potential issues it could and should address and, even without political polarization and partisan gridlock, it is impossible for Congress to legislate on every item meriting attention. For most issues, statutory change is not possible without some type of crisis or dramatic event to create a window of opportunity by triggering Congressional

attention, and even that attention might be fleeting. As such, advocates of change need to strike quickly. 27

The history of public health and safety legislation in the United States is characterized by this dynamic of "punctuated equilibrium" 28long periods of static intransience interrupted by brief flurries of rapid change, often instigated by some crisis or tragedy. Indeed, virtually every major change in the legislative authority of public health regulatory agencies such as the FDA and EPA was enacted in response to public health tragedies or crises due at least in part to regulatory failures or omissions.

Peter Barton Hutt, For both the FDA and EPA then, the primary regulatory statutes were promulgated after high-profile tragedies that sparked intense and immediate public, media, and Congressional concern. In some cases, the underlying problem was well-known to legislators, and extensive 50 Another observation is that after a crisis, the representatives introducing corrective bills tend to have more extreme positions than the authors of bills enacted during non-crisis periods, which tilts legislation adopted in response to tragedies to be more sweeping and path-breaking than legislation adopted in less urgent times. 51

The COVID-19 pandemic has created such a policy window for reforming U.S. diagnostics regulation, a debate which had been sputtering for several years but had been unable to get across "the finishing line." The crisis here was foreseeable yet largely underrepresented in the diagnostics debate, which instead has centered on regulation for non-emergencies, while

recent epidemics have seen the CDC successfully develop and deploy testing. Now, the pandemic and the weak U.S. testing response has created a window of opportunity to discuss diagnostics regulation generally, prompting two bills to be floated.

The VITAL Act identifies FDA overregulation of diagnostics, especially LDTs, as the key issue which precipitated the poor COVID-19 testing rollout. 52 This proposal would leverage lawmaker attention to use improved laboratory quality standards, rather than FDA, to oversee

LDTs and embolden clinical laboratories to develop diagnostics for any potential future need. 53 The VALID Act would instead advance a robust new regulatory regime for the FDA to manage all diagnostics as IVCTs, building on positions with bipartisan support such as risk-based premarket review of IVCTs and some form of optional management-based regulation for test developers. 54 The VALID Act contains a freshly added special standard for declared public health emergencies, allowing test developers to use their self-validated diagnostics while still seeking emergency authorization from FDA. 55 These provisions for emergencies could appeal to lawmaker interest in addressing the testing issues observed during the pandemic to catalyze more fundamental regulatory reform for diagnostics even during non-emergencies.

Though crises can throw open policy windows, legislating during a disaster also creates an invitation to recklessly establish, modify or disrupt regulatory regimes. Emergency decision-

making typically bypasses procedural norms around holding hearings, engaging with stakeholders, and justifying the purpose of decisions through written reports. 56 Substantively, emergency policymaking may result in regulatory norms or programs poorly calibrated to the longer-term and complex set of stakeholder interests and policy concerns at play. Specifically in food and drug crisis decision-making, Peter Barton Hutt comments "[a]s is often true under those conditions, the legislation has been shaped as much by public emotion as rational policy design." 57 Accordingly, legislatures tend to underregulate a problem before a crisis occurs, but often overregulate after disaster strikes. 58 This overcompensation can result in mis-calibrated tradeoffs between complicated sets of interests and values, potentially limiting the effectiveness or efficiency of subsequent regulation.

The tendency towards short-term thinking and possibility of limited legislative history or analysis in emergency policymaking can make implementation, interpretation, and adjudication challenging for regulators and courts, especially in the years following the conclusion of the crisis. 59 The emergence of the 510(k) pathway for medical device clearance provides one such example, where the FDA found statutory provisions calling for "performance standards" for medium-risk devices too onerous and largely abandoned them in favor of "substantial equivalence" reviews. 60 Decreased participation in crisis decision-making can also jeopardize the long-term legitimacy of norms or programs established during emergencies. Legislating during a crisis grants stakeholders a shorter window to provide comments or feedback on proposed norms

and, depending on how the crisis impacts them, stakeholders may have less capacity to comment at all.

Lawmaking in the wake of the terrorist attacks of September 11, 2001 offers a cautionary tale for making broad oversight changes during or immediately after a crisis. In particular, the USA PATRIOT Act was enacted barely six weeks following the attacks. 61 The statute established a multifaceted regulatory regime for counterterrorism with sweeping new surveillance powers, the added crime of "domestic terrorism" to enforce, and targeted restrictions for immigrants. Numerous civil society and political entities retrospectively criticized these measures over civil liberties and privacy concerns, drawing on constitutional norms and policy arguments on limited effectiveness and discriminatory outcomes. 62 Ultimately, the criminal regulatory system set up appeared grounded in emotion and crisis overreaction as much as, or more than, sound policy and legal analysis, 63 and may have unnecessarily and disparately infringed on rights without effectively promoting national security.

The Patriot Act illustration offers another related lesson, that emergency decision-making can prompt an abrupt and durable shift in regulatory goals, values, and motivations. Immediately prior to 9/11, the Federal Trade Commission (FTC) and other stakeholders had been promoting the adoption of enforceable data protection rules to promote privacy at the dawn of the internet age. 64 However, Zuboff illustrates how the crisis-driven urgency, combined with the politically

damaging perception that the U.S. was unable to forecast the 9/11 attack, resulted in rapid legislative moves to bolster surveillance and data-sharing by both public and private entities. 65 Proposed privacy plans were scrapped in an instant, casting aside the growing normative support for data protection rules immediately prior to the crisis. This shift in values and goals affected not only lawmakers, but also regulators at the FTC, who backed away from broader data protection activities and advocacy to support narrower and more acceptable data security initiatives. 66 The conversation around promoting digital privacy protections then fell dormant for over a decade.

In the case of diagnostics regulation, a similar swing in values could occur with the pandemic, modulating not only emergency rules but also more general regulatory norms for after the crisis. The diagnostics debate has long been balanced on the fulcrums of safety versus innovation, consumer protection versus patient access, and overregulation of LDTs versus regulatory fairness between IVDs and LDTs. However, the public health costs of a slow COVID-19 testing rollout fused with widespread frustration over the FDA's stunted approach towards

suddenly created an acute crisis and called attention primarily to counterterrorism, this pandemic has scaled up into an emergency enduring for months and requires legislative attention on everything from economic policy to medical equipment production. 68 The acute demands on lawmakers from various policy domains during the months-long pandemic have no doubt contributed to Congress's decision not to legislate immediately on diagnostics regulation. Still, there will be a need for Congress to address diagnostics, sooner or later, as a result of the perceived COVID-19 diagnostic testing problems.

The current COVID-19 crisis creates a double-edged sword between opportunity and opportunism. Synthesizing lessons described above from prior legislative activities during emergencies suggests several criteria for evaluating whether public health reforms during a pandemic will likely lead to a measured, legitimate regulatory regime. These criteria include satisfying procedural norms, diverse stakeholder engagement, rigorous policy analysis, and consistency with pre-crisis values and balances of complex, competing interests.

On one hand, the VITAL Act excavates a deregulatory approach to LDT oversight which some stakeholders advanced in 2015 without gaining significant traction. 69 The draft would reprioritize innovation, patient access, and easing burdens on clinical laboratories as the preeminent values for diagnostics oversight, 70 On the other hand, the VALID Act would create different standards for diagnostics in ordinary and emergency settings, though recent justifications for the bill have also focused on flexibility, innovation, and access. Upon releasing the updated draft VALID Act in early March 2020, its sponsors promoted the proposal based on the flexible emergency norms the bill would create. 71 Here, the need and support for a "fix" to the emergency diagnostics authority problem is being leveraged to create a comprehensive regulatory scheme for non-emergency oversight of diagnostics. The VALID Act and its earlier versions have gone through several years of deliberation and refinement, taking into account the views of the relevant stakeholders and the FDA, and building bipartisan support in both the Senate and the House. Moreover, the VALID Act addresses the well-recognized double-track problem with the current regulatory system that has not been fixed due to legislative inertia and a crowded Congressional agenda.

The VALID Act has already been the subject of extensive policy analysis, broad stakeholder engagement, and lawmaking procedures and would keep intact a balance between various competing values and interests for diagnostics regulation struck prior to the pandemic.

Using the window of opportunity created by COVID-19, with the demonstrated urgency to reform emergency norms, to enact the comprehensive reform of diagnostics regulation provided by the VALID Act would therefore exemplify the type of crisis-based lawmaking that has been successful in the past to create much of our public health legislation. 71 Office of Rep. Larry Bucshon, Lawmakers Introduce Legislation to Expand Nation's Diagnostic Testing Capabilities (Mar. 5, 2020), https://bucshon.house.gov/news/documentsingle.aspx?DocumentID=3841 (The "legislation would . . . overhaul how the FDA reviews and approves diagnostics . . .

[giving] laboratories greater flexibility to respond to public health emergencies while continuing to keep patients safe.").

Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

The Lost Month: How Failure to Test Blinded the U.S. to Covid-19

Environmental Protection Regulation

An exception is the Deepwater Horizon tragedy, which did not result in any legislative response, notwithstanding substantial pressure for such change. See Jaime Eagan, Never Waste a Good Crisis: Deepwater Horizon and a Call for Congressional Action

The Catastrophic Model of Risk Regulation and the Regulatory Legacy of Three Mile Island and Love Canal, 15 PENN

The Emergency Planning and Community Right to Know Act of 1986: Analysis and Update, 6

Rand Paul Introduces VITAL Act to Speed Availability of Testing in Health Emergencies

See generally Cary Coglianese & David Lazer, Management-Based Regulation: Prescribing Private Management to Achieve Public Goals

§ 3 (proposing "Sec. 587A(5) Emergency use."). The FDA's strategy during the pandemic ultimately began to take this type of approach

Unorthodox Rulemaking, 115 COLOM. L. REV. 1789

PUBLIC HEALTH EFFECTIVENESS OF THE FDA 510(K) CLEARANCE PROCESS: BALANCING

Act: Safety, Innovation, and Resources in the Implementation of Medical Device Legislation, 12

Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of

Whose Liberty? Whose Security? The USA PARTIOT Act in the Context of COINTELPRO and the Unlawful Repression of Political Dissent, 81 OR

Seven Weeks: The Making of the USA PATRIOT Act

FAIR INFORMATION PRACTICES IN THE ELECTRONIC MARKETPLACE: A REPORT TO CONGRESS

Rahm Emanuel once said "[y]ou never want a serious crisis to go to waste

THE FIGHT FOR A HUMAN FUTURE AT THE NEW FRONTIER OF POWER

Key Things in the $2 Trillion Coronavirus Stimulus Package

Proposal for Modernization of CLIA Regulations for Laboratory Developed Testing Procedures (LDPs)

See Office of Sen. Rand Paul, supra note 52