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

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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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.

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

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

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:

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.

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 National Academies who worked on this project. Their great commitment and skills have been essential to the work of the committee and its product.

Contents

ACRONYMS AND ABBREVIATIONS

SUMMARY

1 INTRODUCTION

Rationale and Study Charge

Looking Back to Look Forward: Historical Perspectives of PHEMCE

About This Report

Concluding Remarks

References

2 DELIVERING ON PHEMCE’S MISSION

PHEMCE’s Mission and Scope

Guiding Principles for PHEMCE

Concluding Remarks

Recommendations

References

3 ENSURING THAT PHEMCE DECISIONS AND RECOMMENDATIONS ARE DEFENSIBLE

Sound Business Practices

Priority Setting

Evaluation and Accountability

Data Systems and Technology

Concluding Remarks

Recommendations

References

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

Partnership Levers

Public Health Supply Chains and Stockpiling Considerations

Global Considerations and Synergies

Concluding Remarks

Recommendations

References

5 LEGAL AND POLICY CONSIDERATIONS UNDERLYING PHEMCE OPERATIONS AND IMPLEMENTATION

Brief Overview of the Federal Emergency Legal Landscape

PHEMCE Regulatory Options

Addressing and Solving Emergency Legal Issues in Real Time

Recommendation

References

APPENDIXES

A STUDY METHODS

B COMMITTEE AND STAFF BIOSKETCHES

C DISCLOSURE OF UNAVOIDABLE CONFLICTS OF INTEREST

Boxes and Figures

BOXES

S-1 Summary of Recommendations

1-1 Statement of Task

3-1 PHEMCE Prioritization Framework

FIGURES

1-1 PHEMCE operating structure

1-2 PHEMCE stakeholder engagement structure

1-3 PHEMCE requirements setting process

4-1 Supply chain actor and potential partnership levers

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Acronyms and Abbreviations

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