Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise (2021) / Chapter Skim
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5 Legal and Policy Considerations Underlying PHEMCE Operations and Implementation
5 Legal and Policy Considerations Underlying PHEMCE Operations and Implementation
Pages 67-88
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From page 67... ...
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)
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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.
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. National and State Emergency Declarations National security powers are augmented through federal emergency declarations issued during the COVID-19 pandemic.
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, 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.
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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)
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. 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)
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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.
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. 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)
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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]
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. Device Approval and Clearance The statutory pathways to FDA authorization for devices (e.g., ventilators, personal protective equipment [PPE]
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. 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)
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. 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.
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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 facili tate legitimate public health responses." Identifying legal issues and crafting meaningful solutions are critical components of public health legal prepared ness and response (Hodge, 2006, p.
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.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)
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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]
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2010. The Public Health Emergency Medical Countermeasures Enterprise review: Transforming the en terprise to meet long-range national needs.
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2020c. Emergency authorities under the National Emergencies Act, Stafford Act, and Public Health Service Act.
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. FEMA (Federal Emergency Management Agency)
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2017. 2017–2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
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2020b. Third amendment to declaration under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.
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2020. Memorandum on order under the Defense Production Act regarding General Motors Company.
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