Effective Public Health
Committee on Reviewing the Public Health Emergency
Medical Countermeasures Enterprise
Board on Health Sciences Policy
Health and Medicine Division
A Consensus Study Report of
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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: 978-0-309-27148-6
International Standard Book Number-10: 0-309-27148-7
Digital Object Identifier: https://doi.org/10.17226/26373
Library of Congress Catalog Number: 2021951364
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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.
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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
1 See Appendix C, Disclosure of Unavoidable Conflicts of Interest.
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
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
AMANDA ARNOLD, Arizona State University
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.
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 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
Looking Back to Look Forward: Historical Perspectives of PHEMCE
2 DELIVERING ON PHEMCE’S MISSION
3 ENSURING THAT PHEMCE DECISIONS AND RECOMMENDATIONS ARE DEFENSIBLE
4 ENGAGING NONFEDERAL AND PRIVATE-SECTOR PARTNERS AND STAKEHOLDERS IN PHEMCE’S MISSION
Incorporating Nonfederal and Private-Sector Partners and Stakeholders into PHEMCE Decision Making
Public Health Supply Chains and Stockpiling Considerations
Global Considerations and Synergies
5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING PHEMCE OPERATIONS AND IMPLEMENTATION
Brief Overview of the Federal Emergency Legal Landscape
Addressing and Solving Emergency Legal Issues in Real Time
B COMMITTEE AND STAFF BIOSKETCHES
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Acronyms and Abbreviations
|ACIP||CDC Advisory Committee on Immunization Practices|
|ASPR||Assistant Secretary for 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 Medicare & Medicaid Services|
|COI||conflict of interest|
|COVID-19||coronavirus disease 2019|
|CSC||crisis standards 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 Program Team|
|IRB||institutional review board|
|KPI||key performance indicator|
|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 Service 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|
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