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Page 1 of 4 Re: The Urgent Need to Reauthorize PAHPA Dear Leaders Schumer and McConnell, Speaker Johnson, and Leader Jeffries, On behalf of the undersigned organizations, we write to express our strong desire to see the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorized before the end of the calendar year in the same bipartisan fashion it has been supported since the original authorization 17 years ago. As you know, PAHPA underpins Department of Health and Human Services (HHS) agencies, programs, and funding authorizations for addressing national health security threats. PAHPA created the HHS Assistant Secretary for Preparedness and Response (now the Administration for Strategic Preparedness and Response) and the Biomedical Advanced Research and Development Authority (BARDA) and provides important congressional oversight and direction to federal programs related to early warning, prevention, preparedness, and response. This overall framework expired on September 30, 2023, requiring stopgap, temporary extensions in the continuing resolution, which expires on November 17. We encourage Congress to include a comprehensive five-year PAHPA reauthorization in the next moving legislative vehicle. The last three PAHPA bills all shared major recurring themes: they all adjusted to the changing threat landscape, focused on challenges identified since the prior bill, and considerably strengthened our nation’s health security with each reauthorization. Our nation’s changing health security threat landscape and the federal government’s responsibility to protect the American people demand that we work together now to find a strong bipartisan path forward to reauthorize this critical legislation. Whether the next health security threat is naturally occurring, the result of an accident, or intentionally caused, our country must be in a better position to prevent, prepare for, and respond to such incidents. Failing to reauthorize PAHPA would have serious effects on our country’s economic wellbeing, national security, and health security given the rapidly changing threat landscape. November 14, 2023 The Honorable Charles Schumer Majority Leader US Senate S-221 Capitol Building Washington, DC 20510 The Honorable Mike Johnson Speaker of the House US House of Representatives H-232 Capitol Building Washington, DC 20515 The Honorable Mitch McConnell Minority Leader US Senate S-230 Capitol Building Washington, DC 20510 The Honorable Hakeem Jeffries Minority Leader US House of Representatives H-204 Capitol Building Washington, DC 20515 Page 2 of 4 We are hopeful that PAHPA will remain a strong bipartisan legislative framework, as it has always been. We stand ready to assist you in whatever ways we can to help get this important law reauthorized this year. Sincerely (in alphabetical order), 1Day Sooner Acadian Ambulance Service, Inc. Adaptive Phage Therapeutics Aequor Inc. American Ambulance Association America’s Essential Hospitals American College of Emergency Physicians American College of Surgeons American Hospital Association American Lung Association American Pharmacies American Public Health Association American Society for Microbiology Arizona Bioindustry Association, Inc. (AZBio) Association for Professionals in Infection Control and Epidemiology Association of Maternal & Child Health Programs Association of State and Territorial Health Officials Asthma and Allergy Foundation of America AstraZeneca Pharmaceuticals ATCC (American Type Culture Collection) Atea Pharmaceuticals, Inc. Bavarian Nordic Big Cities Health Coalition BioCT BioForward Wisconsin BioKansas BioNJ Biotechnology Innovation Organization (BIO) Bugworks Cencora Colorado BioScience Association Council of State and Territorial Epidemiologists Council of State Bioscience Associations (CSBA) CSL Seqirus Emergency Department Practice Management Association Emergent BioSolutions Federation of American Scientists FluGen Inc. Georgia Bio Gerontological Society of America Ginkgo Bioworks Global Health Investment Corporation Global Health Technologies Coalition Gryphon Scientific GSK Health Industry Distributors Association (HIDA) Healthcare Distribution Alliance Page 3 of 4 Healthcare Leadership Council Healthcare Ready Helix HIMSS (Healthcare Information and Management Systems Society) HIV Medicine Association IAVI (International AIDS Vaccine Initiative) Illinois Biotechnology Innovation Organization Infectious Diseases Society of America INOVIO Pharmaceuticals Institute for Progress Johns Hopkins Center for Health Security Life Sciences PA Locus Biosciences Mallinckrodt Marked By Covid MassBio McKesson Medical Alley Medical Countermeasures Coalition Missouri Biotechnology Association (MOBIO) National Association of County and City Health Officials National Immigration Law Center New Mexico Biotechnoiogy & Biomedical Association (NMBio) New Orleans BioInnovation Center NewYorkBIO NightHawk Biosciences Novavax Ochsner Health Ohio Life Sciences Association Oklahoma Bioscience Association PDS Biotechnology PharmaJet Inc. Premier Inc. Public Health Accreditation Board Research!America SAB Biotherapeutics, Inc. Sanofi SecureBio Shionogi Inc. SIGA Technologies, Inc. Society for Public Health Education Soligenix, Inc. Technologies for Pandemic Defense Texas Healthcare & Bioscience Institute Tonix Pharmaceuticals Trinity Health TrippBio, Inc. Trust for America’s Health United States Pharmacopeia (USP) University of Hawaii University of Maryland School of Medicine Valneva USA Vaxxas Inc Virginia Biotechnology Association Page 4 of 4 Chair Cathy McMorris Rodgers Energy & Commerce Committee US House of Representatives Ranking Member Frank Pallone Energy & Commerce Committee US House of Representatives cc: Chair Bernie Sanders Health, Education, Labor & Pensions Committee US Senate Ranking Member Bill Cassidy Health, Education, Labor & Pensions Committee US Senate

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Thursday, the US Food and Drug Administration (FDA) announced its approval of the first vaccine to prevent the disease caused by the chikungunya virus. The Ixchiq vaccine, developed by Valenva, is approved for adults at increased risk of exposure to the virus. It was previously granted fast-track and breakthrough therapy designations from FDA. Chikungunya is a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. FDA is requiring that Valneva perform a post-market study to continue to monitor the vaccine’s safety and side effects.With support from Medicines for Malaria Venture (MMV), Kenyan manufacturer Universal Corporation Ltd has received prequalification from the World Health Organization (WHO) for sulfadoxine-pyrimethamine plus amodiaquine (SPAQ), an antimalarial drug used to prevent seasonal malaria in children during peak transmission periods. This approval, which makes UCL only the sixth African pharmaceutical company to have a product WHO-prequalified, will allow Africa to reduce reliance on imported generic versions of the drug from India and China. In the face of a myriad of barriers to quality local drug production and a persistently high burden of malaria cases and deaths, the approval will also make it easier for other African companies to enter the market and attract major buyers, as well as ensure the accessibility and availability of the drug where it is most needed and free up national resources to dedicate to other aspects of the malaria response.A new study found that more than half of tuberculosis (TB) patients in South Africa receiving treatment with a bedaquiline-containing regimen had isolates resistant to the drug, which was introduced in South Africa in 2012 and has recently become part of all standard drug-resistant TB regimens globally. The study is one of the first to report individual-level bedaquiline resistance gain over time among patients in a setting with a bedaquiline-containing regimen as the standard treatment. The results highlight the need for drug-susceptibility testing capacity to accompany the scale-up of new drugs like bedaquiline to monitor the emergence of drug resistance.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Wednesday, the Global Antibiotic Research and Development Partnership (GARDP) announced the results of a successful phase 3 trial, conducted in collaboration with Innoviva Specialty Therapeutics and supported by the National Institute of Allergy and Infectious Diseases, which found that a single dose of a first-in-class oral antibiotic, zoliflodacin, was as safe and effective as standard therapy for treating uncomplicated urogenital gonorrhea. The growing resistance of the gonorrhea bacteria to many classes of antibiotics has left only one remaining globally recommended treatment available as an option. Zoliflodacin, if approved, could not only help address those rising cases because studies have shown that it is active against multi-drug resistant gonorrhea strains, but the antibiotic will also simplify treatment because it is one pill rather than an injection and a pill like the current standard therapy. Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to develop prototype vaccines against an arenavirus called Junin virus, which causes Argentine hemorrhagic fever. The project is aimed at kickstarting the broader development of vaccines for arenaviruses, which include the virus that causes Lassa fever, one of CEPI’s priority pathogens. CEPI will invest $25 million in the development of early prototypes of viral vector and mRNA vaccines against the Junin virus, as well as the improvement of the ChAdOx viral vector technology, part of the broader partnership between CEPI and Oxford to support vaccine development for a variety of viral families with future epidemic or pandemic potential. In a recent study, researchers have identified a new molecule in cells that is necessary for the Ebola and Marburg viruses to infect and spread in the body and that is also involved in SARS-CoV-2 infections. This discovery could eventually lead to new antiviral drugs for Ebola and Marburg, among other viral infections. The molecular, CCZ1, is a protein that regulates the transport of other molecules by cells. Researchers from the Karolinska Institutet and Institute of Molecular Biotechnology used advanced stem cell libraries and lab-grown organs to study how viruses infect the human liver and blood vessels and ultimately demonstrate how CCZ1 operates as a key factor in their spread through the body. 

GHTC contributed the below input to a World Health Organization (WHO) Science Division consultation around a new framework to align and expedite the two interrelated processes of prequalifying novel products and issuing technical guidelines to recommend use.GHTC feedback for new World Health Organization Prequalification evaluation procedure for novel productsThe Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. GHTC has been focused on possible improvements to the WHO prequalification program (PQ) for several years and published a report last year together with Duke University that highlighted some of the perceived pain points and areas of opportunity.GHTC welcomes the updated guidance that WHO will apply parallel, rather than sequential processes, in its guidelines development and prequalification and/or emergency use listing (EUL) to all new and novel health products that it needs to assess. Many of our members and partners have outlined the reliance on guidelines being the first step in the process as a major bottleneck for innovative products and highlighted how it adds significantly to timelines, delaying access to critical new health technologies in low- and middle-income countries (LMICs).The following outlines questions GHTC hopes will be answered as part of the consultation process and general feedback on what should be considered as part of this consultation, or where there could be opportunity for additional clarification:Regulatory agencies in LMICs Questions we hope this consultation will address: How will this new procedure intersect with other shifts in the global regulatory ecosystem? How will PQ look beyond the traditional high-income country stringent regulators and start to integrate emerging regulatory authorities with higher maturity levels into this new PQ process?Will WHO work with global procurers to help assess how they can diversify their quality assessment portfolio?Beyond PQ review of dossiers to inform global procurement, and amid national and regional regulatory strengthening efforts, how will PQ reposition its role in assessing products manufactured in one geography for use in other markets (e.g. African made products which might be procured at a national or regional level in Asia)? GHTC contributions:Strengthen other regulatory agencies in LMICs: GHTC continues to hear from partners that they are concerned about additional regulatory barriers coming into play as new bodies, such as the African Medicines Agency (AMA) start to operationalize, and hopes WHO can play an essential role in harmonization (e.g. concerns of a product going sequentially through review by a stringent regulatory authority, PQ, AMA and then a lower maturity regulatory body before a product can be introduced). As WHO PQ develops its new framework for novel products, consideration needs to be given to other regulatory authorities, especially in LMICs, and how their product review can help promote local manufacturing. There could be some countries and regional blocks where WHO Listed Authority (WLA) Level could bypass PQ or significantly expedite PQ approval using maturity levels as markers of expertise. Promoting harmonization and operationalizing of national regulatory efforts (i.e. through AMA) would limit the remit and need for a completely centralized PQ gateway and free up bandwidth within WHO’s PQ team to provide more regulatory technical assistance to national regulatory authorities.Reviewing protocols between global procurers, regulators, and PQ: Across consultations we have done with product developers, national regulators and private sector organizations, there is a lack of consensus on how PQ should interact with global procurers. Some stakeholders are calling on global procurers to diversify the mechanisms to review and approve products. PQ could be one of a menu of mechanisms procurers could leverage for new health products, reducing bottlenecks. On the other hand, many stakeholders see PQ as a critical step before global procurement and would like WHO to update its protocols when working with other regulatory agencies to speed up approvals without sacrificing safety, efficacy, or reviews for programmatic suitability.Limiting the scopeQuestions we hope this consultation will address: How will the WHO PQ team handle prioritization for their pipeline?How can WHO ensure that it reviews based on global needs, and that when products see smaller changes or updates, WHO is not restarting the whole review process (e.g. not going through an entirely new dossier review when the casing of a diagnostic is changed by the manufacturer)?Might there be any types of products that will not require PQ or that can go through an expedited review after being approved through another WLA 3+ body?GHTC contributions:Update protocols for triaging generic versus innovative product dossiers: To ensure that PQ can focus and prioritize products with the greatest need and to fill health product gaps, PQ should work with WLA 3+ regulators to develop a category of health products which may not need to go through a full PQ assessment (e.g. generics where bioequivalents and CNC have been demonstrated). Having a more formalized abridged process for generics would enable PQ to better leverage its technical expertise and limited bandwidth to focus on reviewing novel or innovative product dossiers.Living policy guidelines Questions we hope this consultation will address: How will WHO work internally between the various divisions to ensure clarity for outside stakeholders on the interaction between PQ and policy teams for guidelines?How can WHO ensure that even with the new parallel process, there are no artificial bottlenecks for updating or making changes to guidelines?GHTC contributions:Further develop protocols for living guidelines: To increase uptake of innovative products, support and advise on the expansion of interim or “living” guidelines, similar to those issued recently for COVID-19 therapeutics and treatments for drug-resistant tuberculosis, for other innovator or novel products to expedite opportunities to address real-time needs.