The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) and the Novel Coronavirus Pandemic of 2020
National Security Law Firm
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a federal law that provides funding and infrastructure for several health security programs that could be critical during the novel coronavirus (COVID-19) pandemic.
As the novel coronavirus (COVID-19) pandemic continues to have a greater and greater impact on life in the United States, companies in a broad range of industry sectors will be called upon to help protect the public at large and, eventually, restore a sense of normalcy. On March 18, 2020, President Trump issued an Executive Order invoking the Defense Production Act, and this is likely to be just the first of several major steps toward engaging the private sector to help fight the pandemic.
Another law that has the potential to have a major impact on the fight against the novel coronavirus (COVID-19) in the United States is the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). As explained by the U.S. Food and Drug Administration (FDA):
“The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) contains key legal authorities to sustain and strengthen our Nation’s preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats. . . . Its provisions further FDA’s mission of fostering the development and availability of drugs, vaccines, and devices (also referred to as medical countermeasures, or MCMs) for use in these emergencies. . . .
“[PAHPRA] not only support[s] and facilitate[s] government partners’ pre-event planning efforts and pre-positioning of MCMs, but also help[s] to facilitate MCM development and the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat.”
Additionally, as discussed by the U.S. Department of Health & Human Services’ Office of the Assistant Secretary for Preparedness and Response, PAHPRA also serves the practical purpose of, “reauthorize[ing] certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness.” Many of these programs remain in effect today and can potentially be utilized to fight the novel coronavirus (COVID-19) pandemic, including:
- National Health Security Strategy
- Assistant Secretary for Preparedness and Response
- Modernization of the National Disaster Medical System
- Temporary reassignment of State and local personnel during a public health emergency
- Improving State and local public health security
- Hospital preparedness and medical surge capacity
- Enhancing situational awareness and biosurveillance
- Enhancing MCM review and accelerating MCM advanced research and development
4 Key Aspects of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a lengthy and complex statute, and the challenges of understanding its implications during the novel coronavirus (COVID-19) pandemic are further exacerbated by the fact that the law references and reauthorizes various provisions of several other federal laws. Broadly speaking, however, in addition to reauthorizing the federal health security programs listed above (among others), PAHPRA serves to facilitate the government’s response to national health emergencies such as the novel coronavirus pandemic in four key respects.
As identified by the Association of State and Territorial Health Officials (ASTHO), these include:
1. Leadership and Management of National Preparedness and Response Efforts
PAHPRA establishes the U.S. Department of Health and Human Services (DHHS) as the agency with primary responsibility for leading and managing the nation’s public health emergency preparedness and response efforts, and it requires DHHS to maintain the National Health Security Strategy. It also requires DHHS to give due consideration to the special needs of at-risk individuals during public health crises such as the novel coronavirus (COVID-19) pandemic.
2. Ensuring Sufficient Capacity for Health Safety Preparedness
PAHPRA seeks to ensure adequate capacity to fight public health crises through (i) state and local emergency preparedness, (ii) supporting the public health workforce, and (iii) maintaining nationwide situational awareness during pandemics and other emergencies. As summarized by ASTHO, this includes:
- Providing “expand[ed] grant programs for state and local public health emergency preparedness activities;”
- “[Establishing] a demonstration loan repayment program for eligible National Health Service Corps participants;” and,
- “[Authorizing] the creation of a near-real-time electronic nationwide public health situational awareness capability though an interoperable network to share data to enhance early detection and rapid response to public health emergencies.”
3. Ensuring Medical Surge Capacity
PAHPRA requires DHHS to take the steps necessary in order to, “provide medical surge capacity to local communities and analyz[e] the potential for using federal facilities as healthcare facilities during public health emergencies,” and to take other appropriate measures to ensure adequate surge capacity in the event of a national health safety emergency.
4. Establishment of the Biomedical Advanced Research and Development Authority (BARDA)
PAHPRA established the Biomedical Advanced Research and Development Authority (BARDA) and the Biodefense Medical Countermeasure Development Fund, which DHHS is directed to utilize for development contracts with MCM and other critical healthcare product manufacturers and suppliers.
Legal Considerations for Companies Supporting the Fight Against the Novel Coronavirus Under PAHPRA
For healthcare providers, medical device suppliers, and other companies engaged to support the fight against the novel coronavirus (COVID-19) under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, there are several legal considerations that will need to be addressed. Examples of the legal issues facing companies working with the FDA and DHHS under PAHPRA include:
1. Contracting with DHHS and Other Federal Agencies
Government contracting presents a host of compliance issues, and these issues cannot be overlooked even in times of crisis. Companies that contract DHHS and other federal agencies during the novel coronavirus (COVID-19) pandemic must have the appropriate policies, procedures, and other controls in place to ensure that their personnel do not engage in conduct that could lead to prosecution for federal government contract fraud.
2. Coordinating with Local, State, and Federal Administrative Agencies
Likewise, when coordinating with local, state, and federal authorities during the novel coronavirus (COVID-19) pandemic, companies must ensure that they are compliant with all applicable rules, laws, and regulations. Company leaders and representatives must be familiar with the relevant protocols as well, and this is one area in particular where it can help to have retired federal agents on your company’s compliance and response team.
3. FDA Compliance for MCMs and Other Medical Products
When working with the FDA to secure approvals for MCMs and other medical products, companies must be carefully attuned to the compliance issues and legal ramifications involved. FDA compliance is a complex area; and, while measures will be taken to speed up certain aspects of the FDA approval process during the novel coronavirus (COVID-19) pandemic, there will still be various compliance risks that companies will need to navigate successfully.
4. Telehealth Compliance
Telehealth compliance is another area that will be very different during the novel coronavirus (COVID-19) pandemic. The line between true telemedicine and virtual consultations will be blurred; and, while more patients will have access to care without needing to attend in-person visits—both for their own health safety and for the good of the American population as a whole—healthcare providers working with DHHS and other agencies will need to remain vigilant about staying on the right side of the line.
5. Maintaining Health Data Privacy and Addressing Other Legal and Regulatory Compliance Concerns
Whether working with patients on-site in coordination with local, state, or federal authorities or providing telehealth services, companies will also need to remain vigilant about protecting the privacy of patients’ health data – and ensuring adequate data security in general. Not only is this a compliance matter; but, unfortunately, there is a high likelihood that hackers will seek to exploit vulnerabilities during the novel coronavirus outbreak as well.
6. Protecting Employees, Patients, and Vendors from the Novel Coronavirus (COVID-19)
Of course, when coordinating response efforts, communicating with the FDA, providing MCMs and related services, and otherwise operating pursuant to PAHPRA, companies need to remain duly focused on protecting their employees, patients, vendors, and others from the novel coronavirus. There are various issues that must be addressed from an employment law perspective, and companies must implement adequate prevention protocols to mitigate risk in other contexts as well.
7. Staying Current on Legal and Regulatory Developments During the Novel Coronavirus Pandemic
Finally, as the situation continues to develop, new executive orders, laws, and regulations will continue to define what companies can and must do during the novel coronavirus (COVID-19) pandemic. Companies operating under PAHPRA will need to stay up-to-date on these developments, and they will need to be prepared to update, modify, and redefine their compliance efforts as necessary.
Contact the Federal Coronavirus Pandemic Response Team With Expertise on National Security at Oberheiden P.C.
Is your company working with local, state, or federal health authorities pursuant to PAHPRA? If so, contact the senior attorneys and former FBI agents on our federal coronavirus pandemic response team who have expertise on nation security. We can help you establish and maintain compliance as you fight COVID-19. To speak with a member of our team in confidence, call 888-680-1745 or request a complimentary needs assessment online now.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.