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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise. Washington, DC: The National Academies Press. doi: 10.17226/26373.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise Board on Health Sciences Policy Health and Medicine Division A Consensus Study Report of PREPUBLICATION COPY: UNCORRECTED PROOFS

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by a contract between the National Academy of Sciences and the Office of the Assistant Secretary for Preparedness and Response (75A50121C00061). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/26373 Library of Congress Catalog Number: XXXXXXXXXX Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2021 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. Ensuring an effective public health emergency medical countermeasures enterprise. Washington, DC: The National Academies Press. https://doi.org/10.17226/26373. 2 PREPUBLICATION COPY: UNCORRECTED PROOFS

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. 3 PREPUBLICATION COPY: UNCORRECTED PROOFS

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. 4 PREPUBLICATION COPY: UNCORRECTED PROOFS

COMMITTEE ON REVIEWING THE PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE1 GIGI GRONVALL (Co-Chair), Senior Scholar, Johns Hopkins Center for Health Security, Associate Professor in the Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health ALAN I. LESHNER (Co-Chair), Chief Executive Officer Emeritus, American Association for the Advancement of Science JEFFREY BAKER, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals; retired from appointment as Deputy Director, Office of Biotechnology Products, U.S. Food and Drug Administration BRENDAN CARR, Endowed Chair, Mount Sinai Professor in Emergency Medicine, Icahn School of Medicine at Mount Sinai and the Mount Sinai Health System BARUCH FISCHHOFF, Howard Heinz University Professor, Department of Engineering and Public Policy, Institute for Politics and Strategy, Carnegie Mellon University JAMES G. HODGE, JR., Peter Kiewit Foundation Professor of Law, Sandra Day O’Connor College of Law; Director of the Center for Public Health Law and Policy, Arizona State University ANJALI JOSHI, Former Vice President of Product Management, Google KENT E. KESTER, Former Vice President and Head, Translational Science and Biomarkers, Sanofi Pasteur MONIQUE K. MANSOURA, Executive Director, Global Health Security and Biotechnology, The MITRE Corporation TIA POWELL, Dr. Shoshanah Trachtenberg Frackman Chair in Biomedical Ethics, Albert Einstein College of Medicine, Montefiore Health System ROBIN ROBINSON, Chief Scientific Officer, RenovaCare LAUREN SAUER, Associate Professor, University of Nebraska Medical Center JULIE SWANN, Department Head and A. Doug Allison Distinguished Professor, Edward P. Fitts Department of Industrial and Systems Engineering, North Carolina State University; Affiliate/Adjunct, Biomedical Engineering, North Carolina State University and University of North Carolina at Chapel Hill W. CRAIG VANDERWAGEN, Partner, East West Protection, LLC PATRICIA J. ZETTLER, Associate Professor, Moritz College of Law, The Ohio State University Study Staff LISA BROWN, Study Director EMMA FINE, Associate Program Officer MATTHEW MASIELLO, Associate Program Officer SHALINI SINGARAVELU, Associate Program Officer MARGARET MCCARTHY, Research Associate MELVIN JOPPY, Senior Program Assistant ANDREW M. POPE, Senior Director, Board on Health Sciences Policy 1 NOTE: See Appendix C, Disclosure of Unavoidable Conflicts of Interest. 5 PREPUBLICATION COPY: UNCORRECTED PROOFS

Consultants REBECCA FREED, Senior Legal Researcher, Center for Public Health Law and Policy, Arizona State University JENNIFER PIATT, Research Scholar, Center for Public Health Law and Policy, Arizona State University Science Writer AMANDA ARNOLD, Arizona State University 6 PREPUBLICATION COPY: UNCORRECTED PROOFS

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: PHYLLIS ARTHUR, Biotechnology Innovation Organization LUCIANA BORIO, Council on Foreign Relations GREG BUREL, Hamilton Grace LLC MARIANNE GAUSCHE-HILL, Los Angeles County EMS Agency PINAR KESKINOCAK, Georgia Institute of Technology NICOLE LURIE, Coalition for Epidemic Preparedness Innovations JEWEL MULLEN, The University of Texas at Austin TARA O’TOOLE, In-Q-Tel GERALD PARKER, Texas A&M University Health Science Center SARAH PARKER, Virginia Tech Carilion School of Medicine GOVIND PERSAD, Sturm College of Law STEPHEN C. REDD, Centers for Disease Control and Prevention MATTHEW WYNIA, University of Colorado Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by BRUCE N. CALONGE, The Colorado Trust, and LEWIS R. GOLDFRANK, New York University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. 7 PREPUBLICATION COPY: UNCORRECTED PROOFS

Preface The U.S. experience during the COVID-19 pandemic, particularly early on, has emphasized the imperative for an effective, well-coordinated national emergency medical countermeasures (MCMs) preparedness and response system. Many government agencies and nongovernmental stakeholders and partners are by necessity involved in responding to public health emergencies (PHEs), and their work must be well organized and well equipped. This point has been made, as when considering U.S. performance during emergencies, such as the SARS or H1N1 epidemics. It was reiterated in the recent White House pandemic plan, American Pandemic Preparedness: Transforming Our Capabilities, calling for a mission control to handle PHEs. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) was formalized by Congress to serve this function, to ensure that the responders to a PHE have the MCM products, facilities, supply chains, and workforce that comprise the capabilities and capacities needed to save lives. However, agreement is widespread that PHEMCE has fallen short of its mandate over the years, and a series of reports have offered recommendations to make it more responsive to its mission. Moreover, in response to COVID-19, the overall U.S. MCM preparedness and response system has evolved substantially and largely independently of PHEMCE, as seen in Operation Warp Speed. This report was commissioned by the Health and Human Services Office of the Assistant Secretary for Preparedness and Response to consider ways, in light of the national COVID-19 experience, to re-envision PHEMCE into the efficient and effective coordinating body it was intended to be to serve the nation in times of crisis. This committee was convened by the National Academies of Sciences, Engineering, and Medicine to conceptualize this re-envisioned PHEMCE. Toward that end, the committee offers here a series of recommendations that we believe will set PHEMCE back on its intended course. Not all of our recommendations are novel; unfortunately, several were noted in earlier analyses but not addressed. They should be. Central to this re-envisioning of PHEMCE is the need to make clear the mission, authority, and responsibilities of the coordinating bodies responsible for PHEMCE’s decisions and directives. PHEMCE and its representative members must also be empowered to carry out their mission without overly long delays for approvals and implementation. PHEMCE members should be held accountable for their performance according to meaningful metrics, and its activities should be as transparent as possible, to build public confidence that conflicts of interest are avoided and its mission is appropriately addressed. It is essential that PHEMCE is seen as a true partner to the various stakeholders and implementing organizations central to its mission. We are deeply grateful to our colleagues on this committee who have worked so hard and diligently under a very short time line. We are particularly grateful to the superb staff of the 9 PREPUBLICATION COPY: UNCORRECTED PROOFS

National Academies who worked on this project. Their great commitment and skills have been essential to the work of the committee and its product. Gigi Gronvall, Co-Chair Alan I. Leshner, Co-Chair Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise 10 PREPUBLICATION COPY: UNCORRECTED PROOFS

Contents ACRONYMS AND ABBREVIATIONS 15 SUMMARY 17 1 INTRODUCTION 29 Rationale and Study Charge, 29 Looking Back to Look Forward: Historical Perspectives of PHEMCE, 31 About This Report, 36 Concluding Remarks, 38 References, 38 2 DELIVERING ON THE PHEMCE MISSION 41 PHEMCE Mission and Scope, 41 Guiding Principles for PHEMCE, 42 Concluding Remarks, 47 Recommendations, 48 References, 48 3 ENSURING THAT PHEMCE DECISIONS AND RECOMMENDATIONS ARE DEFENSIBLE 51 Sound Business Practices, 51 Priority Setting, 53 Evaluation and Accountability, 55 Data Systems and Technology, 56 Concluding Remarks, 57 Recommendations, 57 References, 57 4 ENGAGING NONFEDERAL AND PRIVATE-SECTOR PARTNERS AND STAKEHOLDERS TO EXECUTE PHEMCE MISSION 59 Incorporating Nonfederal and Private-Sector Partners and Stakeholders into PHEMCE Decision Making, 60 Partnership Levers, 64 Public Health Supply Chains and Stockpiling Considerations, 66 Global Considerations and Synergies, 68 Concluding Remarks, 68 Recommendations, 68 References, 70 5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING PHEMCE OPERATIONS AND IMPLEMENTATION 73 Brief Overview of the Federal Emergency Legal Landscape, 73 PHEMCE Regulatory Options, 77 Addressing and Solving Emergency Legal Issues in Real Time, 82 11 PREPUBLICATION COPY: UNCORRECTED PROOFS

Recommendation, 84 References, 85 APPENDIXES A STUDY METHODS 91 B COMMITTEE AND STAFF BIOSKETCHES 103 C DISCLOSURE OF UNAVOIDABLE CONFLICTS OF INTEREST 115 12 PREPUBLICATION COPY: UNCORRECTED PROOFS

Boxes and Figures BOXES 1-1 Statement of Task, 30 3-1 PHEMCE Prioritization Framework, 54 FIGURES 1-1 PHEMCE operating structure, 33 1-2 PHEMCE stakeholder engagement structure, 34 1-3 PHEMCE requirements setting process, 35 4-1 Supply chain actor and potential partnership levers, 65 13 PREPUBLICATION COPY: UNCORRECTED PROOFS

Acronyms and Abbreviations ACIP CDC Advisory Committee on Immunization Practices ASPR Assistant Secretary of Preparedness and Response BARDA Biomedical Advanced Research and Development Authority BLA biologics license application CAG Countermeasures Acceleration Group CBRN chemical, biological, radiological, and nuclear CDC Centers for Disease Control and Prevention CLIA Clinical Laboratory Improvement Amendments CMS Centers for Medicaid & Medicare Services COI conflict of interest COVID-19 coronavirus disease 2019 CSC Crisis Standard of Care DARPA Defense Advanced Research Projects Agency DHS U.S. Department of Homeland Security DoD U.S. Department of Defense DPA Defense Production Act EEC Enterprise Executive Committee ESC Enterprise Senior Council EUA Emergency Use Authorization FDA U.S. Food and Drug Administration FDCA Federal Food, Drug, and Cosmetic Act FEMA Federal Emergency Management Agency GAO U.S. Government Accountability Office HHS U.S. Department of Health and Human Services HSPD Homeland Security Presidential Directive IOM Institute of Medicine IPT integrated programs team IRB institutional review board KPI key performance indicators 15 PREPUBLICATION COPY: UNCORRECTED PROOFS

LDT laboratory-developed test MCM medical countermeasure NBSB National Biodefense Science Board NDA new drug application NEA National Emergencies Act NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health NVAC National Vaccine Advisory Committee OCR HHS Office for Civil Rights OHRP HHS Office for Human Research Protections OMB Office of Management and Budget OWS Operation Warp Speed PAHPA Pandemic and All-Hazards Preparedness Act PAHPRA Pandemic and All-Hazards Preparedness Reauthorization Act PHE public health emergency PHEMCE Public Health Emergency Medical Countermeasures Enterprise PHSA Public Health Services Act PPE personal protective equipment PREP Act Public Readiness and Emergency Preparedness Act QMS quality management system R&D research and development SIP strategy and implementation plan SNS U.S. Strategic National Stockpile USDA U.S. Department of Agriculture VA U.S. Department of Veterans Affairs WHO World Health Organization WMD weapon of mass destruction WMD MCM Weapon of Mass Destruction Medical Countermeasures 16 PREPUBLICATION COPY: UNCORRECTED PROOFS

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The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response.

Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.

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