Late last month, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI) was signed into law.[1] The Act is a much anticipated reauthorization of the Pandemic and All-Hazards Preparedness Act, originally passed in 2006.[2] The legislation is a key development in strengthening the country’s ability to respond to bio-threats, disasters, and other national emergencies by defining federal program initiatives and funding states and private researchers. PAHPAI-authorized grants allow for the research and development of biodefense measures and the stockpiling of preparedness supplies.

PAHPAI continues several initiatives and implements new programs and priorities, reflecting that countermeasure development and procurement and emergency response programs remain critical components of public health preparedness. Perhaps most importantly, PAHPAI includes significant appropriations for these initiatives. The key appropriations implemented in the 2019 legislation include:

  • Public Health Security Grants. PAHPAI authorizes the Secretary of Health and Human Services to award grants to states, consortiums of states, or other public entities to conduct activities to achieve the preparedness goals described by the National Health Security Strategy.[3] These activities can include research, development, and planning, related to a series of strategic goals, including the integration of private and public medical capabilities, development of public health security strategies and medical response strategies, maintaining coordination and continuity of operations in the event of a national emergency, and the creation of resiliency strategies for public health crises. In particular, the 2019 National Health Security Strategy includes two new preparedness goals: (1) response to zoonotic diseases in plants or animals; and (2) domestic response to global health threats originating abroad, such as the recent Zika or Ebola outbreaks. PAHPAI appropriates $685 million per year for these grants through 2023.[4]
  • Biomedical Advanced Research and Development Authority (BARDA). This authority, housed in the Department of Health and Human Services, is tasked with awarding and administering contracts, grants and cooperative agreements and entering into other transactions (“OTAs”) to produce, through advanced research and development or procurement, measures to counteract threats from three particular sources: (1) chemical, biological, radiological, or nuclear (“CBRN”) and infectious disease-related threats; (2) threats that will or may potentially become a pandemic; and (3) threats that may present treatment complications, such as resistance to current treatments. BARDA is funded by the Biodefense Medical Countermeasure Development Fund, and PAHPAI appropriates $611.7 million per year for this fund through 2023.[5] In addition to this funding, PAHPAI increases the threshold for OTA approvals to $100 million.[6]
  • The Strategic National Stockpile (SNS). PAHPAI once again authorizes the Secretary of Health and Human Services to work with the Director of the Centers for Disease Control and the Secretary of Homeland Security to maintain a stockpile of biodefense instruments, including drugs, vaccines, and medical devices to combat potential emergencies. In addition to creating and maintaining the stockpile, the Department of Health and Human Services is tasked with conducting an annual threat-based review of the SNS, including an evaluation of CBRN threats and the adequacy of planned countermeasures. These reviews must be conducted on an “ongoing basis.” The Act appropriates $610 million per year through 2023 for the preservation of the stockpile.[7]
  • BioShield Special Reserve Fund. This Fund allows for the procurement of countermeasures intended to combat CBRN threats. PAHPAI appropriates $7.1 billion for this fund through fiscal year 2028.[8] The Secretary of Health and Human Services is authorized to use this fund in two restricted circumstances: (1) payment to a vendor for advanced development of a CBRN countermeasure; or (2) payment to a vendor for a direct procurement of such a countermeasure.
  • Funding for the Assistant Secretary for Preparedness and Response. First established in PAHPA, the Assistant Secretary for Preparedness and Response (“ASPR) within the Department of Health and Human Services is tasked with leading all matters related to public health and medical preparedness and public health emergency response at the federal level. PAHPAI assigns the ASPR new duties as well ─ to address threats that pose a significant risk to public health and national security, particularly strains of pandemic influenza. PAHPAI appropriates $250 million per year through 2023, intended specifically to fund the confrontation of this threat.[9]

The legislation also includes appropriations for additional initiatives to facilitate military and civilian preparedness, including the National Disaster Medical System[10], the Military and Civilian Partnership for Trauma Readiness Grant Program[11], and Hospital Preparedness Program.[12]

PAHPAI is but one signal of continuing congressional emphasis on biodefense and preparedness measures. On June 26, 2019, the Subcommittee on National Security of the House Committee on Oversight and Reform held a hearing to discuss U.S. government and healthcare system readiness to respond to naturally occurring pandemics and biological attacks, as well as the increasing threat of antimicrobial-resistant diseases. Together, these developments reflect a need for, and commitment to, increased preparedness planning and countermeasure development, as well as continuing opportunities for industry members in this area.

 

[1] Pub. L. No. 116-22, __ Stat. __ (June 24, 2019) (to be codified in scattered sections of 42 U.S.C.)

[2] Pub. L. No. 109-417, 120 Stat. 2831 (2006).

[3] See Pub. L. No. 116-22, § 101.

[4] See id. § 202.

[5] See id. § 504.

[6] See id. § 602.

[7] See id. § 403.

[8] See id. § 504.

[9] See id. § 404.

[10] See id. § 301.

[11] See id. § 204.

[12] See id. § 202.

Tags: BARDA, Biodefense, BioShield, countermeasures, funding, PAHPA, PAHPAI
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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
  • the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

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Photo of Brooke Stanley Brooke Stanley

Brooke Stanley helps companies of all sizes navigate the complex issues that arise from doing business with federal, state, and local governments. She routinely advises on a broad range of issues, including compliance with procurement and financial assistance regulations, contract negotiation and formation…

Brooke Stanley helps companies of all sizes navigate the complex issues that arise from doing business with federal, state, and local governments. She routinely advises on a broad range of issues, including compliance with procurement and financial assistance regulations, contract negotiation and formation, organizational conflicts of interest, flow-down requirements, equitable adjustments, claims and disputes, and small business issues. Brooke leverages her prior experience soliciting, negotiating, and administering government contracts for the United States Navy in crafting creative yet practical solutions for clients.

Brooke regularly assists clients in negotiating both procurement contracts and non-traditional agreements, such as other transaction agreements and cooperative research and development agreements. She has particular expertise assisting clients in protecting their intellectual property and confidential or proprietary information when negotiating with the government, including with respect to intellectual property rights and Freedom of Information Act issues.

In addition, Brooke frequently advises both government contractors and private equity firms in transactional matters, from preparing for sale or purchase to due diligence, negotiating transaction documents, and navigating pre- and post-closing activities. Her expertise in nuanced government contracting compliance issues helps clients understand, mitigate and manage material risks in such transactions.

Prior to entering private practice, Brooke clerked for the Honorable Susan G. Braden of the United States Court of Federal Claims.

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