Legal and Policy Considerations Underlying PHEMCE Operations and Implementation
Just as identifying, assessing, and resolving scientific and operational issues associated with medical countermeasures (MCMs) are critical to the success of a re-envisioned Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), effectively assessing, implementing, and solving legal and policy issues is crucial, particularly because PHEMCE relies on active and integrated contributions from multiple federal agencies, state and local governments, and industry partners. PHEMCE’s collective goal of generating MCMs essential to national security and preparedness depends on numerous laws that govern their development, production, assessment, and approval. Distributing and using these MCMs in real-time public health emergencies (PHEs) pose additional legal and policy challenges because emergency declarations can shift legal norms and temporarily change powers at all levels of government (as documented later). A critical performance objective underlying PHEMCE initiatives is the ability of public and private sectors to conceptualize, create, and distribute MCMs using emergency authorities, as seen during the COVID-19 pandemic and prior PHEs. Meeting this objective is challenging. Actual or perceived legal and regulatory barriers during declared emergencies can obstruct or derail laudable program goals. Appropriately implementing and enforcing existing legal authorities, leveraging untested legal preparedness strategies, and developing new policies to address emerging issues related to MCM production and distribution can be precarious. Yet, as described in later examples, substantial opportunities also arise in declared national emergencies when an array of invoked powers at the federal and state/territorial levels enables new or flexible approaches. When used effectively and within
constitutional boundaries, these powers provide options to ensure timely execution and implementation of PHEMCE initiatives. Substantial regulatory issues related to operationalizing PHEMCE include MCM product development and approval and concerns among nongovernmental partners (e.g., manufacturers, distributors). Assessing and solving law and policy questions in real time through flexible regulatory standards, emergency waivers, liability protections, and other options are vital to execution and accountability.
BRIEF OVERVIEW OF THE FEDERAL EMERGENCY LEGAL LANDSCAPE
Since its inception in 2006 (HHS, 2015), PHEMCE has integrated multiple federal, state, and nongovernmental agencies and partners charged with developing, producing, and distributing timely MCMs in response to extensive public health threats (e.g., emerging infectious diseases, nuclear exposures, natural disasters). Each threat implicates varying federal laws and policies. PHEMCE’s efforts to determine appropriate leadership, roles, and responsibilities among extensive partners will be subject to ongoing shifts in the federal emergency legal landscape shaped by legislative, executive, and judicial responses to the COVID-19 pandemic.
The Trump and Biden administrations have responded to the pandemic through an unprecedented series of emergency declarations, executive orders, and extensions of national security interests altering the scope and balance of federal and state PHE powers. Extensive federal emergency authorities are reflected in expansive federal acts enacted by Congress during the pandemic, including the (1) Families First Coronavirus Response Act1 (March 18, 2020); (2) Coronavirus Aid, Relief, and Economic Security Act2 (March 27, 2020); (3) Paycheck Protection Program and Healthcare Enhancement Act3 (April 24, 2020); (4) Consolidated Appropriations Act4 (December 27, 2020); and (5) American Rescue Plan Act (March 11, 2021).5 Collectively, these laws authorized new federal public health interventions and provided massive economic relief to individuals and businesses.
1 Families First Coronavirus Response Act, Pub. L. No. 116-127, 134 Stat. 178 (2020).
2 CARES Act, Pub. L. No. 116-136, 134 Stat. 281 (2020).
3 Paycheck Protection Program and Healthcare Enhancement Act, Pub. L. No. 116-139, 134 Stat. 620 (2020).
4 Consolidated Appropriations Act, Pub. L. No. 116-260 (2020).
5 American Rescue Plan Act, Pub. L. No. 117-2, 135 Stat. 2 (2021).
Extent and Scope of Presidential National Security Powers
Substantial congressional enactments during the COVID-19 pandemic are coupled with a strengthening reliance on national security designations and powers uniquely and constitutionally vested in the federal government.6 Presidents Trump7 and Biden characterized the pandemic as a national security threat (akin to prior classifications for other emerging infectious diseases) (Fidler, 2003; White House, 2021b). These classifications help mobilize federal responses internationally8 and authorize greater control over domestic responses impacting the nation’s health. In concert with express federal powers authorized by national emergency declarations (noted later), the president can (1) coordinate effective plans and responses on issues implicating national security and (2) allocate materials, services, and facilities to promote national defense and control market forces in crises.9 The Project BioShield Act in 2004,10 for example, authorized the DHS secretary to issue material threat determinations for chemical, biological, radiological and nuclear (CBRN) threats and fund essential development of MCM11 (including Operation Warp Speed [OWS]) (Scott, 2020).
National and State Emergency Declarations
National security powers are augmented through federal emergency declarations issued during the COVID-19 pandemic. Congress has vested considerable emergency powers and corollary funding in the president and other federal agencies via various laws, including the (1) Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act),12 (2) National Emergencies Act (NEA),13 (3) Public Health Service Act (PHSA),14 (4) Pandemic and All-Hazards Preparedness Act (PAHPA)15 (renewed in 2013 and 2019), (5) Public Readiness and Emergency Preparedness (PREP) Act,16 and (6) Defense Production Act (DPA)17 (discussed below).
6 U.S. CONST., art. 1 § 8, art. 2 § 2, art. 4 § 4.
7 Executive Order 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, 85 Fed. Reg. 49929 (Aug. 6, 2020).
8 Foreign Assistance Act, 22 U.S.C.A. § 2151 (1974); Exec. Order No. 13155, 65 Fed. Reg. 30521 (May 12, 2000).
9 Defense Production Act of 1950, 50 U.S.C. §§ 4501–4568 (2015).
10 Project BioShield Act of 2004, 42 U.S.C. § 247d-6b (2004).
11 42 U.S.C. § 247d-6b(c)(2) (2012).
12 42 U.S.C.A. § 5121 et seq. (West 2020).
13 50 U.S.C.A. §§ 1601, 1621, 1622, 1631, 1641, 1651 (West 2020).
14 42 U.S.C.A. § 201 et seq. (2020).
15 Pub. L. No. 109-417, 120 Stat. 2831 (2006).
16 42 U.S.C. § 247d-6d (2012).
17 50 U.S.C. § 4501 et seq.
These laws authorize the federal government to declare states of “emergency,”18 “disaster,”19 or “PHE”20 to invoke extensive federal powers related to emerging infectious diseases and other substantial threats. PHSA specifically authorizes federal declarations of PHE in response to “significant outbreaks of infectious diseases or bioterrorist attacks.”21 On January 31, 2020, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar declared a PHE in response to COVID-19 (HHS, 2020a); with this 90-day declaration (renewed several times), HHS rapidly executed specific grants and contracts, conducted and supported disease investigation and response efforts (ASPR, 2019), and waived specific health laws inhibiting emergency response efforts (after national emergency declarations).22 Coextensive with his PHE declaration, Secretary Azar also issued an emergency declaration via the PREP Act.23 Through providing substantial liability protections and extensive preemption of conflicting state-based laws, it can help facilitate real-time development and manufacturing of qualified MCM through public–private partnerships.
On March 13, 2020, President Trump issued concurrent national emergency and disaster declarations under the Stafford Act and NEA (FEMA, 2020). These declarations, carried over by the Biden administration, enable substantial federal response powers and options through the U.S. Department of Homeland Security (DHS), HHS, the U.S. Department of Defense (DoD), and other agencies (CRS, 2020c). The Stafford Act declaration, for example, directed FEMA to coordinate state disaster-relief administration and allocate public assistance grants to state, territorial, tribal, and local governments to aid in response and recovery (FEMA, 2019, 2021). Grant recipients are held to specific federal procurement requirements that preempt conflicting state or local rules for contracting. Federal PHE powers were accompanied by state-based emergency declarations. Between February 29 and March 15, 2020, every state and major territory declared varied states of emergency, disaster, or PHE—a first in U.S. history (Hodge et al., 2021). Consistent invocations of state-level emergency declarations did not, however, result in uniformity of public health responses. Differentiation in legal approaches among state and local governments has led to repeated calls for greater federal direction and authorities, especially through the Biden administration.
18 42 U.S.C.A. §§ 5170, 5122(1) (West 2020).
19 42 U.S.C.A. § 401 (West 2020).
20 42 U.S.C.A. § 247d(a) (West 2020).
21 42 U.S.C.A. § 247d(a) (West 2020).
22 42 U.S.C. § 1320b-5 (West, 2020).
23 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020).
Defense Production Act
DPA24 authorizes the president to direct private-sector entities to prioritize federal contracts25 and allocate materials, services, and facilities if “necessary or appropriate to promote the national defense” (Siripurapu, 2021). Crafted by Congress to address wartime economic mobilization and control efforts, DPA has been used extensively to support PHE efforts during the COVID-19 pandemic. In March 2020, President Trump ordered private companies to produce ventilators and PPE for federal disbursement to hospitals (White House, 2020). Substantial products were manufactured and allocated due to this executive order both initially and during the Biden administration. President Trump also invoked DPA to prevent hoarding and increase production of essential health supplies. With presidential approval, HHS leveraged DPA to expedite production and shipment of COVID-19 tests to nursing homes (HHS, 2020c). In January 2021, President Biden invoked the act via executive order directing federal agencies to address vaccination supply shortages and accelerate vaccine manufacturing and delivery (White House, 2021a). Though purposeful, invocations of DPA can impact other market forces, leading to disruptions of critical supply chains of components needed for medical or other products.
Federal Conditional Spending Powers
In addition to its substantial PHE powers vested through Congress, the federal government can also dictate or shape subnational emergency responses through the “power of the purse.” Congress may lawfully impose myriad conditions on the disbursement of federal funds to which public- and private-sector recipients generally must adhere to gain or keep access, subject to some constitutional limits.26 Conditions on federal funds must (1) serve some general purpose, (2) clearly lay out choices and conditions, (3) be related to some national project or program, (4) avoid inducing recipients to engage in unconstitutional acts (e.g., First Amendment violations),27 and (5) not entail compulsion or mandates to accept the funds. Coercive tactics employed under this last factor are rare. However, in a 2012 case reviewing the Patient Protection and Affordable Care Act, the U.S. Supreme Court clarified that an “all or nothing” approach to encourage state Medicaid expansion constituted compulsion.28 Using conditional spending powers via PHEMCE offers extensive possibilities, particularly
24 50 U.S.C. § 4501 et seq.
25 50 U.S.C. § 4511.
26South Dakota v. Dole, 483 U.S. 203 (1987).
27Agency for International Development v. Alliance for Open Society International, 570 U.S. 205 (2013).
28NFIB v. Sebelius, 567 U.S. 519 (2012).
when federally produced MCM (e.g., COVID-19 PPE and vaccines) may be distributed to state, tribal, or local governments (Robbins et al., 2020).
Under principles of federalism and supremacy (Hodge, 2021),29 federal law may expressly or impliedly preempt (or override) state law (Hodge et al., 2017). The scope of federal preemption was illustrated during the COVID-19 pandemic via PREP Act declarations, which supplant state or local actions contravening federal directives related to MCM (Office of the Secretary, 2021). In October 2020, for example, Nevada health authorities attempted to restrict use of a federally authorized COVID-19 test deemed inaccurate in nursing facilities (Wu, 2020). ASPR responded that the PREP Act declaration overrode Nevada’s objections (Evans and Clayton, 2020b). “Under federal law,” clarified a senior ASPR official, “PREP Act coverage preempts any state or local provision of law or legal requirement that prohibits or effectively prohibits … licensed [HCWs] from administering or prescribing FDA [U.S. Food and Drug Administration]-authorized COVID-19 tests” (Office of the Secretary, 2020a). The PREP Act declaration was amended to preempt contrary state laws related to medical licensure and personnel needed to distribute and administer vaccinations (Office of the Secretary, 2020b), despite traditional reservations of licensure to state-based professional regulatory boards (CDC, 2021).
PHEMCE REGULATORY OPTIONS
MCMs, such as vaccines, antiviral drugs, diagnostics, and PPE (FDA, n.d.-b), are core to PHEMCE’s functions (CRS, 2020a).30 MCMs are developed, authorized, procured, and distributed within a complex regulatory landscape involving many agency partners. This section considers (1) spending on MCM research and procurement, (2) the regulation of MCM research and FDA marketing authorization pathways, and (3) certain legal concerns facing nongovernmental partners in MCM manufacturing and distribution.
MCM Research Support and Procurement
Effective government research support and procurement can help ensure MCM development, particularly when private manufacturers lack sufficient profit incentives to enter the market (CRS, 2020a). PHEMCE makes recom-
29 U.S. Const. art. IX.
30 42 U.S.C. § 300bb-10a(c).
mendations to ASPR on MCM research and procurement, while its agency partners play key roles in supporting MCM research and regulatory science and procuring the end products.31 For example, the National Institutes of Health (NIH) funds a wide range of basic biomedical research and assists with responses to new infectious diseases through the National Institute of Allergy and Infectious Diseases (NIAID). The Biomedical Advanced Research and Development Authority (BARDA) supports advanced research and development of MCM manufacturing capabilities and procures FDA-authorized MCMs under its Project BioShield authorities (HHS, 2017). FDA financially supports MCM regulatory science research and provides input and guidance on MCM development before authorization. FDA’s statutory authorities also provide postmarket incentives for products, such as market exclusivity periods awarded for new MCMs.
Multiple challenges include (1) providing sufficient research support; (2) procuring products in fair, well-documented, and efficient ways; (3) making sure supplies are available for the SNS; (4) minimizing COI (noted earlier); and (5) providing adequate incentives and certainty to industry (GAO, 2021). During the pandemic, PHEMCE agency partners sought to streamline research and provide regulatory certainty to industry partners—such as through NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines public–private partnership and FDA’s Coronavirus Treatment Acceleration Program for clinical trials (FDA, 2021a; NIH, 2020). Not every research program will yield a safe and effective MCM, and significant questions remain regarding the commercial viability of MCM development, even with government support. In 2019, for example, the antibiotic company Achaogen declared bankruptcy despite receiving tens of millions of dollars from BARDA to support drug development (and FDA approval for the drug in 2018) (Alder and Lee, 2019; Årdal et al., 2020). As another example, beginning in 2015 and with support from BARDA, companies began developing vaccine candidates for Zika, but that work ultimately stalled shortly thereafter when the epidemic waned; no vaccine is approved as of 2021.
MCM Development and Authorization
FDA authorization is generally required before “drugs,” “biological products,” or “device” MCMs may be distributed.32,33 In implementing its authorization processes during PHEs, FDA is faced with the difficult task of balancing the urgent need for timely access to MCMs with the need for rigorous evidence about safety and effectiveness. Producing sufficient data
31 42 U.S.C. § 300hh-10a.
32 21 U.S.C. § 321(g), (h).
33 42 U.S.C. § 262(i).
for FDA authorization can be difficult or time-consuming, and the regulatory landscape is complex. But FDA can use legal flexibility and regulatory tools to clarify and accelerate the processes. Moreover, requiring rigorous evidence of safety and effectiveness is critical to protect people from unsafe or ineffective MCMs and ensure generating necessary information about MCMs’ effects (Eisenberg, 2006). This, in turn, encourages developing effective products (and discourages the clinical use of ineffective ones) (Gottlieb, 2021; London and Kimmelman, 2020).
MCM studies are typically subject to federal requirements for human subjects research (HSR) under the Common Rule—implemented by the HHS Office for Human Research Protections (OHRP)—and FDA regulations.34 The Common Rule applies to HSR funded by Common Rule agencies (and research conducted at institutions that have agreed to conduct all of their research in compliance with the Common Rule). FDA regulations apply to studies of drug, biological product, and device safety and effectiveness.35 Both sets of regulations include similar requirements for informed consent and institutional review board (IRB) oversight.36,37,38 MCM research is overseen by local IRBs responsible for reviewing HSR protocols and determining if they adhere to federal, state, and local regulations. Each IRB develops its own procedures supporting this process (Ford et al., 2021).
FDA and OHRP recognize the need for enhanced regulatory flexibility in emergencies (HHS, 2020b). They possess legal tools to help streamline research and IRB review in emergencies while maintaining research integrity and protecting human welfare. Existing authorities allow agencies to waive regulatory requirements, exercise discretion not to enforce certain requirements, or clarify legal interpretations (Fernandez Lynch et al., 2020). During COVID-19, for example, FDA issued initial guidance (subsequently revised) to help sponsors and researchers conduct clinical trials amid possible disruptions caused by the pandemic and related public health measures (FDA, 2020a).
Regulatory pathways can also be expedited during PHEs through predeveloped protocols, prepositioned through a central or single IRB across large research networks or a national emergency trials network (Gottlieb, 2021). This may include platform protocols where investigational therapeutics or devices can be dropped in and swapped out as needed. Other
34 45 CRF 46.
35 21 CFR part 312; 21 CFR part 812.
36 21 CFR 50.
37 21 CFR 56.
38 45 CFR part 46.
strategies, such as patient registries and adaptive trials, can also be useful. Nevertheless, concerns remain about a lack of national coordination in research efforts (Gottlieb, 2021). Ensuring sufficient evidence generation about MCM and participants’ safety is paramount to PHEMCE’s ongoing ability to be operational and effectively responsive in an emergency.
Rapid reviews of HSR that ensure systematic underlying procedures for evidence collection and subject protection are critical to initiating research during PHEs. However, the approach and procedure must be cultivated in advance to ensure that PHEMCE is as effective as possible. Existing emergency clinical research networks could develop template nondisclosure agreements, material transfer agreements, and reliance agreements to operationalize pre-placed protocols efficiently and effectively (Kraft et al., 2019).
FDA Authorization Pathways
Although certain products needed during PHEs may not require FDA authorization, such as blood (FDA, 2018a,b), authorization is legally required for most MCMs covered by PHEMCE’s work. The regulatory routes for FDA authorization of MCMs include (1) routine paths available in non-emergency periods, such as drug, biological product, or device approval and nontrial preapproval access, and (2) Emergency Use Authorization (EUA) paths available only when the HHS secretary formally declares that “circumstances exist justifying the authorization” based on a declared PHE, domestic emergency, military emergency, or material threat.39
Such authorizations are needed even if a MCM is already approved for a use different than the emergency issue for which it would be distributed from the SNS. For example, early in the COVID-19 pandemic, FDA issued an EUA for hydroxychloroquine and chloroquine—drugs already approved for other uses, such as malaria—to “allow [the] products donated to the SNS to be distributed and used” for COVID-19 patients. But FDA also may, in some circumstances, choose to exercise its discretion not to enforce authorization requirements, as the agency did for certain COVID-19 tests.
Drug and Biological Product Approval
For new drugs, therapeutic biological products, and vaccines, the typical route to market is FDA approval of a new drug application (NDA) or a biologics license application (BLA) based on evidence that the product is safe and effective for its intended use and on assurances of its quality.40 To make the necessary showing of safety, effectiveness, and quality, manu-
39 21 U.S.C. § 360bbb-3(b).
40 21 U.S.C. § 355(d); 42 U.S.C. § 262.
facturers typically generate significant information about their products through preclinical testing and clinical trials in humans and provide detailed chemistry, manufacturing, and control data.41 Some exceptions and means for speeding the process do exist. For example, FDA regulations permit MCM approval based solely on animal studies when human effectiveness studies would be unethical, and FDA guidance encourages certain uses of vaccine platforms to expedite product development (CBER, 2020).42 FDA can also complete its review of NDAs or BLAs on rapid timelines during PHEs, as it did when approving the Pfizer/BioNTech COVID-19 vaccine (FDA, 2021c, n.d.-a).
Device Approval and Clearance
The statutory pathways to FDA authorization for devices (e.g., ventilators, personal protective equipment [PPE], diagnostics) are more varied than for drugs and biological products. The Federal Food, Drug, and Cosmetic Act (FDCA) requires FDA to organize all devices into one of three categories, based on risk level and the regulatory controls necessary to mitigate risk. The riskiest “class III” devices typically go through a premarket approval process like that for drugs and biological products described earlier. The lowest-risk “class I” devices generally do not require premarket authorization.43 Most devices, however, are “class II,” moderate-risk devices, which can include surgical gowns, ventilators, and masks (CRS, 2020b). Class II devices typically do not require premarket approval. Instead, they generally undergo less-burdensome premarket clearance processes, such as FDA clearance of a “510(k)” submission demonstrating that the device is “substantially equivalent” to a legally marketed predicate device.44
Specific device categories are subject to additional regulatory regimes. For example, the National Institute for Occupational Safety and Health (NIOSH) and FDA have overlapping jurisdiction over disposable respiratory protective devices. NIOSH-approved N95 masks do not require a 510(k) clearance (FDA, 2017). Diagnostic tests are another example. In addition to FDA oversight, clinical laboratories performing diagnostic testing are regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). These labs must obtain a CLIA certification from CMS. Moreover, FDA’s jurisdiction over laboratory-developed tests (LDTs) (in vitro diagnostic tests designed, manufactured, and used within a single laboratory) has long been
41 21 CFR § 314.50; 21 CFR § 601.2.
42 21 U.S.C. § 360bbb-4(d); 21 CFR part 314 subpart I; 21 CFR part 601 subpart H.
43 CFR Title 21.
44 21 U.S.C. § 360(k); 21 U.S.C. § 360c(f)(1).
controversial, and FDA has historically declined enforcements for them (CRS, 2019; Evans and Clayton, 2020a).
Nontrial Preapproval Access
The FDCA and FDA regulations also provide pathways for seriously and terminally ill patients to access unapproved products for treatment use outside clinical trials even in non-emergencies, including the “expanded access” pathway (FDA, 2021b). Under this pathway, a sponsor may request FDA authorization to provide an investigational drug, biological product, or device outside clinical trials in certain circumstances.45 During the Ebola outbreak in 2014–2015, Zmapp was provided to patients through an expanded access program (Kraft et al., 2019). Although FDA authorization is required, FDA grants the overwhelming majority of requests, usually within days or sometimes even hours (Jarow et al., 2017a,b). In 2018, the federal Right to Try Act created an additional pathway for nontrial preapproval access for drugs (but not devices) that does not require FDA authorization.46 The “right to try” pathway, however, has rarely been used and does not appear to have been used for MCMs. Additionally, both pathways pose a risk of thwarting enrollment in necessary trials, as happened with the expanded access program through which COVID-19 patients accessed convalescent plasma (Sachs, 2020), and restrict what sponsors may charge for MCMs.47
Emergency Use Authorizations
In emergencies, FDA may issue EUAs permitting the distribution of unapproved drugs, biological products, or devices, or allowing unauthorized uses of already authorized products (Zettler et al., 2021). Various criteria must be met for FDA to issue an EUA, including that “it is reasonable to believe” that “the product may be effective” for the relevant condition—a lower standard than legally required for FDA approval (FDA, 2020c).48 This lower bar creates the regulatory flexibility necessary to allow quick distribution of promising products in emergencies. At the same time, federal law permits FDA to set a higher evidentiary bar for EUAs, as it seemingly did for COVID-19 vaccines (CBER, 2020).
FDA also has broad power over products under EUAs.49 For instance, FDA may require that information about a product’s safety and effective-
45 21 U.S.C. § 360bbb-0a; 21 CFR part 312 subpart I; 21 CFR § 812.36.
46 S.204—Emergency Relief for Federal Workers Act of 2019.
47 21 U.S.C. § 360bbb-0a(b); 21 CFR §§ 312.8, 312.305(a)(3).
48 21 U.S.C. § 360bbb-3.
49 21 U.S.C. § 360bbb-3; https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3808328 (accessed September 3, 2021).
ness be collected and analyzed, determine which health care professionals may administer a product, and restrict the patient populations that may receive a product. While EUAs are only effective for the duration of the secretary’s declaration, FDA has wide discretion to revoke or revise EUAs based on emerging scientific and public health information as seen repeatedly during the COVID-19 pandemic.
Legal Challenges Facing Nongovernmental Partners
Nongovernmental partners, including industry, health care professionals and entities, and the public, face numerous legal challenges and concerns underlying PHEMCE’s mission (noted elsewhere in this chapter). Some concerns relate directly to MCM development and authorization. For example, MCM manufacturers may need to protect proprietary information to preserve future market share and profits, while scientific understanding would be advanced by sharing and fostering collaboration among multiple manufacturers and regulators. PHEMCE partner agencies have implemented programs to help balance these competing needs, such as the Critical Path Institution public–private partnership. PAHPA permits HHS, in certain circumstances, to engage in collaborative activities with multiple MCM manufacturers that may otherwise violate antitrust laws (Zettler et al., 2021). Nevertheless, challenges remain, such as with sharing manufacturing knowledge for COVID-19 vaccines. Intellectual property rights provide another example of critical legal concerns (BIO, 2021; Branswell, 2018). In May 2021, the Office of the U.S. Trade Representative announced support for a proposed World Trade Organization waiver of COVID-19 vaccine intellectual property protections (USTR, 2021). Although some experts have argued that the proposal would have little effect on manufacturers’ profits, industry partners may be reticent about entering the MCM market under such broad waivers (McMurray-Heath, 2021).
ADDRESSING AND SOLVING EMERGENCY LEGAL ISSUES IN REAL-TIME
Much of the legal landscape, authority, and flexibility underlying PHEMCE’s work are a result of statutory and regulatory changes in the aftermath of PHEs. Following the September 11, 2001, attack and subsequent anthrax letters, for example, Congress passed the Project BioShield Act of 2004, which created a special fund for HHS to procure MCMs and amended the FDCA to create the EUA pathway for MCMs (ASPR, 2010). Ongoing reforms to emergency laws and policies based on prior experiences, however, do not alone ensure a well-functioning, or adequate, legal response to emergencies. Real-time facts during the COVID-19 pandemic, for example,
present novel legal and regulatory questions about the scope, extent, and interrelationship of federal and state powers in a federalist system of government. The legal environment itself changes with emergency declarations or new statutory authorities. Flexibility and extensive discretion provided to government actors during declared emergencies enable nimble, timely responses but can also lead to confusion (Hodge and Anderson, 2008).
Various legal and regulatory tools available to PHEMCE agencies can help identify and mitigate actual or perceived regulatory barriers to MCM development, authorization, procurement, and distribution. For example, to clarify agency positions and reduce uncertainty, agencies can issue guidance or seek public input through public meetings/workshops. Early in the pandemic, FDA and OHRP issued guidance—albeit perhaps insufficiently—to explain the agencies’ interpretations of regulatory requirements for COVID-19 research, such as describing how to conduct the informed consent process with infectious COVID-19 patients (Fernandez Lynch et al., 2020). Similarly, before COVID-19 vaccine EUAs were issued, FDA issued guidance on its expectations for the kinds of evidence needed to support such EUAs and held public advisory committee meetings.
Using legal tools quickly, effectively, and appropriately in emergencies is essential to PHEMCE’s work. Through “legal triage,” multiple actors must assess and “prioritize legal issues and solutions in real time that facilitate legitimate public health responses.” Identifying legal issues and crafting meaningful solutions are critical components of public health legal preparedness and response (Hodge, 2006, p. 631). “Regulatory readiness”—or the awareness and use of significant flexibilities among PHEMCE agencies pursuant to their statutory authorities in emergencies—helps ensure improved preparedness and response, as seen throughout the COVID-19 pandemic. For example, regulatory readiness would include being well positioned to quickly identify areas of legal flexibility for research regulation and implement policies that would enable innovative research approaches, such as registries to capture real-world evidence or coordinated trials. These legal skills do not arise via happenstance. Cultivating a culture and organizational structure through which agency and industry attorneys align with other PHEMCE personnel to generate legally supportable paths to accomplish PHEMCE’s mission is key to its successful implementation (Wion, n.d.).
Federal Waiver or Suspension of Conflicting Legal Requirements
A premier example of legal triage, including regulatory readiness, relates to the power of the federal (and state) governments to temporarily waive or suspend existing legal requirements to promote efficient and effective interventions. Waiver of federal laws can simultaneously operate to suspend conflicting state laws through concepts of supremacy and preemption
(as discussed above). The Social Security Act (SSA) § 1135 is illustrative. It vests the HHS secretary with broad waiver authority when two distinct federal emergency declarations are in effect: (1) a declaration of emergency by the secretary via the PHSA and (2) either a Stafford Act or NEA declaration by the president (SSA, n.d.).50 On March 13, 2020, after PHSA, Stafford Act, and NEA emergencies were declared, HHS Secretary Azar invoked SSA § 1135 to waive certain federal requirements applicable to Medicare, Medicaid, the Children’s Health Insurance Program, the Health Insurance Portability and Accountability Act Privacy Rule, and the Emergency Medical Treatment and Active Labor Act (ASPR, 2020).
Liability Risks and Protections
One of the most contentious issues related to emergency response efforts involves personal and entity liability. Governments and other quasi-governmental entities may largely be immune from claims grounded in failures to act to prevent the spread of infectious diseases or other consequences of PHEs under principles of sovereign immunity or federal or state torts claims acts. Private health care employees, emergency responders, or other workers or volunteers and entities involved in effectuating PHEMCE objectives, however, are understandably concerned about potential liability for actions, or failures to act, leading to injuries or deaths during emergencies (IOM, 2012). Pervasive concerns over such liability can diminish participation in response efforts or lead to detrimental, defensive practices (Carrier et al., 2013). No single, national standard protects workers, volunteers, and entities from all potential liability in emergency responses. Rather, a patchwork of federal, state, and local laws provides protections for acts of ordinary negligence in various circumstances. After a PREP Act declaration, for example, immunity from liability is extended to covered persons and entities involved in the domestic development, distribution, and administration of MCMs51 (with unclear protections for federally supported vaccines or other MCMs exported internationally and certain off-label uses of approved MCMs). Virtually no political or legal support exists for protections to immunize or indemnify practitioners or entities for gross negligence, willful or wanton misconduct, criminal behaviors, or, for governmental actors, unconstitutional interventions.
Patients or others seeking recourse for injuries during emergencies may rely on victim compensation funds. The Countermeasures Injury Compensation Program, authorized via the PREP Act (HHS, 2021), provides limited benefits to individuals claiming specific injuries related to MCMs
50 42 U.S.C. § 1320b-5(g)(1).
51 42 U.S.C.A. §§ 319F-3(a)(1), § 247d-6d(a)(1).
recommended by HHS during a declared emergency (ASTHO, 2021). As with PREP Act protections, some areas of coverage are uncertain, such as off-label uses of approved COVID-19 vaccines (deSante-Bertkau et al., 2021). The National Vaccine Injury Compensation Program pays eligible individuals for injuries connected to specifically listed vaccines authorized by Congress (subject to change) (HRSA, n.d.).
Measures Regulating Allocations and Distributions
One of the core objectives of PHEMCE is to help ensure that allocations and distributions of MCMs are fair and equitable. Meeting this objective presents challenging legal and ethical issues (see Chapter 2). Real-time efforts to expeditiously distribute these resources to persons in need can exacerbate health disparities among specific racial, ethnic, disabled, or older populations. Preventing such outcomes is key. The National Academies produced guidance on the ethical distribution of COVID-19 vaccines prior to their introduction in the U.S. market (NASEM, 2020), which informed the ethical principles for allocation adopted by CDC’s ACIP (McClung et al., 2020), which ACIP later endorsed. However, when vaccines were distributed to states, allocations to their populations only partly adhered to national guidance. Some state approaches diverged directly from explicit CDC directions. Antidiscrimination measures impacted allocations of MCMs and health services in other contexts as well. Almost from the beginning, disability- and other rights-based groups opposed vaccine allocation plans and crisis standards of care (CSC) implementation on legal grounds. On March 28, 2020, HHS’s Office for Civil Rights (OCR) issued guidance on the application of civil rights laws during the COVID-19 emergency.52 It later launched multiple investigations of state-based CSC plans alleging violations of federal antidiscrimination laws (including the Americans with Disabilities Act [Fink, 2020],53 Rehabilitation Act,54 and Civil Rights Act of 1964).55 Additional concerns regarding discrimination based on age, race, color, national origin, limited English proficiency, religion, and sex also arose, leading to additional OCR guidance and substantial policy modifications by states, localities, and hospitals (Piatt and Hodge, 2021). Navigating these and other rights-based requirements to specific distribution and allocation efforts through PHEMCE is essential to (1) ensure equity of benefits across at-risk populations (consistent with constitutional principles of equal
52 Bulletin: Civil Rights, HIPAA & the Coronavirus Disease 2019, HHS OCR (Mar. 28, 2020).
53 42 U.S.C. §§ 12101–12213 (2012).
54 29 U.S.C. § 701 et seq.
55 Pub. L. 88-352, 78 Stat. 241.
protection) and (2) justify specific allocations or governmental policies (consistent with procedural or substantive due process).
RECOMMENDATION 11. IDENTIFY, ASSESS, AND RESOLVE THE LEGAL BARRIERS THAT MAY IMPEDE PHEMCE OBJECTIVES.
The Assistant Secretary for Preparedness and Response and the U.S. Department of Health and Human Services’ Office of the General Counsel in consultation with outside legal experts should regularly identify, assess, and resolve the perceived or actual legal barriers that may continue to impede PHEMCE objectives.
This assessment should also occur outside crises and should include the foundational regulatory framework underlying PHEMCE operations and its mission as well as real-time needs and capabilities required to support its emergency implementation. Flexibility and transparency should be cultivated to foster open dialogue, communication, and sharing creative options within the legal and regulatory framework supporting PHEMCE, particularly, but not exclusively, in declared emergencies when real-time decisions and solutions may be compromised absent advanced review and consideration.
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