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The Pandemic All-Hazards Preparedness Act, or PAHPA, was originally introduced into law with the intention to ensure the United States would be prepared for public health emergencies, including pandemics and bioterrorist attacks. This law is set to expire in September of this year. It is noteworthy that this will be the first reauthorization of PAHPA since the COVID-19 pandemic swept across the world. This year’s reauthorization is scheduled to renew funding for the Administration for Strategic Preparedness and Response (ASPR), which oversees the Biomedical Advanced Research and Development Authority (BARDA) and other entities that work to ensure the nation’s medical and public health preparedness for, response to, and recovery from disasters and other public health emergencies.
Why was PAHPA Introduced?
On December 19, 2006, President George W. Bush signed PAHPA into law, however the origins of the law date back to the 9/11 attacks in 2001 which revealed flaws in public health infrastructure including medical preparedness and response times by agencies during emergencies. Since the attacks, Congress has passed various laws including the 2002 Bioterrorism Act and the 2004 Project BioShield Act. As funding for the Bioterrorism Act was nearing expiration, Congress was looking for an enhanced version of the legislation which took into consideration the lessons learned from the 9/11 terrorist attacks, hurricanes Katrina, Rita, and Wilma (2005) and the threat of an influenza pandemic. The Act is scheduled to be reauthorized every five years, with its current expiration date on September 30, 2023. It was previously reauthorized in 2013 and 2019.
The 2019 Act
In June 2019, President Trump signed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) into law. PAHPAIA made amendments to the Public Health Service Act, including enhancing the authorities of the Secretary of Health and Human Services, Assistant Secretary for Preparedness and Response, and the Director of the Centers for Disease Control and Prevention to prepare for and respond to public health emergencies. PAHPAIA encouraged the stockpiling of critical medical supplies and products and the development of new medical countermeasures (MCMs), which are products such as drugs, vaccines, diagnostic tests, and personal protective equipment for use in a public health emergency. PAHPAIA also established and recognized key interagency collaborations between FDA and other agency partners by formalizing FDA roles and responsibilities.
Funding for the Hospital Preparedness Program (HPP) and the Public Health Emergency Preparedness Cooperative Agreement was reauthorized as well. HPP is a vital tool to help hospitals prepare for the wide array of threats they face, and hospitals across the country are advocating for its reauthorization at a robust and sustainable level.
Project BioShield received increased funding, from $2.8 billion over five years to $7.1 billion over ten years; however, Congress has not yet appropriated these funds, and funding for the project is currently being appropriated on an annual basis instead.
More information on the 2019 Act and its titles can be found HERE.
- Title I: Strengthening the National Health Security Strategy
- Title II: Improving Preparedness and Response
- Title III: Reaching All Communities
- Title IV: Prioritizing a Threat-Based Response
- Title V: Increasing Communication In Medical Countermeasure Advanced Research And Development
- Title VI: Advancing Technologies For Medical Countermeasures
- Title VII: Miscellaneous Provisions
The Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act), signed by President Biden in December 2022, partially sets the stage for the 2023 reauthorization of PAHPA. The PREVENT Pandemics Act focused on improving strategy and coordination among public health preparedness agencies, strengthening the supply chain and government stockpiles of medical products, and authorizing the Advanced Research Projects Agency for Health (ARPA-H) to accelerate innovation in health and medicine. Similar themes will likely arise during the reauthorization process of PAHPA.
The PAHPA reauthorization of 2023 is scheduled to renew funding for the Administration for Strategic Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA). ASPR is an Operating Division in the Department of Health and Human Services (HHS) that leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and other public health emergencies. As an Operating Division, ASPR can mobilize a coordinated national response more efficiently and effectively during future disasters and emergencies with greater operational capabilities.
BARDA is one of ASPR’s program offices and handles the development of vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as: chemical, biological, radiological, and nuclear (CBRN) accidents, incidents, and attacks; pandemic influenza (PI); and emerging infectious diseases (EID). During the COVID-19 pandemic, BARDA was part of Operation Warp Speed and worked with domestic and global partners to develop and distribute vaccines among other MCMs.
ASPR also manages the Strategic National Stockpile (SNS) which contains supplies, medicines, and devices that can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient. The SNS was used during the monkeypox outbreak of 2022 to distribute vaccines and antiviral drugs originally developed under BARDA’s supervision for smallpox. Although ASPR was able to distribute these vaccines, the SNS did not have as many doses as experts recommended, which slowed efforts to contain the outbreak. Some vaccine doses had also expired. Now that the distribution of these vaccines and antivirals has occurred, the SNS is asking Congress for the funds to replenish their supplies in preparation for another potential outbreak of monkeypox, smallpox, or a related public health threat.
This year’s reauthorization of PAHPA is a chance for Congress to examine the responses to COVID and monkeypox and find areas where the nation’s available resources and options can be strengthened for the next possible public health emergency. Reps. Richard Hudson (R-NC) and Anna Eshoo (D-CA) are expected to lead the effort to reauthorize PAHPA in the House. Sen. Bob Casey (D-PA) is expected to partner with Sen. Bill Cassidy (R-LA) on the Senate’s PAHPA reauthorization bill.
- Over 1.12 million Americans to date have died of the coronavirus, making the COVID-19 pandemic one of the deadliest in American history (2/22/23)
- International Monetary Fund expects that the COVID-19 pandemic will cost the global economy more than $12.5 trillion through 2024
- The median global GDP dropped by 3.9% from 2019 to 2020
- The 2022-2023 flu season has been the worst since the start of the COVID pandemic, with estimates of 16,000-48,000 deaths (1/13/23)
- Administration for Strategic Preparedness and Response (ASPR) is an Operating Division in the Department of Health and Human Services that leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and other public health emergencies.
- Biomedical Advanced Research and Development Authority (BARDA) is one of ASPR’s program offices and handles the development of vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
- Strategic National Stockpile (SNS) is the United States’ storage supply of antibiotics and vaccines. Within 12 hours of declaration of a national emergency, the division will distribute a ‘push package’ of pharmaceutical and medical supplies to local health authorities in affected areas that may be overwhelmed by the crisis.
- Office of the Assistant Secretary of Preparedness and Response is an office that was created by PAHPA that focuses on: identifying gaps and inefficiencies in preparedness activities, coordinating grants, carrying out drills to address gaps in policies, and providing updates on response activities.
Links to Other Resources
- Administration for Strategic Preparedness & Response – About ASPR
- Administration for Strategic Preparedness & Response – Pandemic and All-Hazards Preparedness and Advancing Innovation Act
- Akin Gump Strauss Hauer & Feld LLP – Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization
- Food & Drug Administration – MCM-Related Counterterrorism Legislation
- Holland & Knight – H&K Health Dose: January 5, 2023
- KFF – Economic Impact of COVID-19 on PEPFAR Countries
- MedicalCountermeasures.gov – Project BioShield
- Politico – Before monkeypox outbreak, U.S. officials knew for years they didn’t have enough of key shot
- Time – It’s Not Just You: The Flu Is Bad This Year