We, the undersigned experts in regulatory science and medicine, are concerned about decisionmaking at the FDA related to the COVID-19 crisis. We are writing because there have been a number of headlines recently about the adequacy of the FDA’s evidentiary standards related to COVID-19 vaccines and its authority to make science-driven assessments about vaccine approval or authorization without improper political influence.
 
The FDA must remain one of the preeminent public health institutions in the world, as it has been for decades. The FDA’s scientists are highly trained and respected in their fields and perform essential work in protecting Americans from unsafe or ineffective medical products through rigorous evaluation. But in recent months, their ability to do this work in a fair and impartial way appears to have been compromised by political pressure, resulting in several regulatory actions that have threatened the public credibility of the agency.

As it is about to review COVID-19 vaccines, it is crucial that the FDA reassure the American public that its evaluation will be fair, transparent, and rigorous. Otherwise, doubts about the integrity of the process and the trustworthiness of its conclusions will undermine critical efforts to protect the public health. We therefore call on you to re-affirm the following principles that must guide this process:

• FDA’s decisions regarding COVID-19 vaccines must be independent of any partisan political influence. Decisions about whether to approve a vaccine or to issue emergency use authorizations must be made based only on competent, careful review of high-quality data by the FDA’s scientists, consistent with regulatory standards and after a careful balancing of benefits and harms and consideration of potential intended and unintended consequences.
• The data and reasoning on which FDA bases its actions must be transparent and made reasonably available at the time the decision is made. The statistical approach used to assess a vaccine or treatment should be defined and key limitations to the data explained.
• FDA decisions should be presented dispassionately and even-handedly in a way that clinicians and patients can understand, with no exaggeration of the benefits or minimization of harms of any approved or authorized product.
• If preliminary decisions must be made on quickly changing or evolving data, a clear follow-up plan must be presented at the time of the decision, explaining how necessary additional data will be collected, the time frame for this work, and the process for re-evaluating the initial decision, and clarity about key open questions. The FDA must enforce these timelines and be ready to modify or reverse its initial decision if better data require doing so.

All Americans should defend the right of the FDA to continue to do its rigorous work efficiently and carefully. Pressuring the agency to approve products that have not met standards for safety and efficacy – whether drugs, blood products, medical devices, diagnostic tests, or vaccines – may appear to some to be politically expedient. In the long run, doing so will undermine the FDA’s mission to protect the public, a task to which FDA staff have long been committed. It will not benefit patients and may lead to serious harms, and risks doing irreparable harm to your agency, one of the nation’s most vital resources in the fight against COVID-19 and other health threats.

In view of the current public health emergency and concerns raised by the public and the broader scientific community over FDA’s recent COVID-related decisions, we call on you to:

1. Insist that the President and his White House advisers refrain from criticizing federal scientists, their scientific conclusions, measurements, or methodologies;
2. Refrain from making any decisions about a COVID-19 vaccine EUA before sharing the key data and consultation with scientists from the following agencies/groups: the NIAID, the NIH, the CDC, FDA’s Vaccines and Related Products Advisory Committee, and the Infectious Diseases Society of America. Given how politicized this decision has become, seeking their input and taking seriously their objections before issuing an EUA will do a great deal to affirm public trust that has been lost in the process;
3. At the time of any vaccine EUA or approval, disclose the review memos prepared by the FDA’s Office of Vaccine Research and Review and the scientific basis of authorization, and provide a pathway for qualified researchers to access important datasets;
4. Commit again to refusing to issue an EUA or approval for a COVID-19 vaccine only on the basis of changes to surrogate measures that are not currently well established, such as anti-SARS-CoV-2 antibody levels, unless there are meaningful changes to clinical endpoints.;
5. Only issue a vaccine EUA or approval after developing a formal public plan for continued testing and monitoring of use of the vaccine for both effectiveness and safety;
6. Establish a 3-month deadline for formal re-evaluation of any EUA or accelerated approval to determine whether these decisions should be revoked or modified, as well as the criteria that would lead to such revocation;
7. Ensure that all announcements of FDA decisions on EUAs or approvals are made only by qualified scientists;
8. Commit to publicly challenging claims by any government officials that are inconsistent with the evidence evaluated by FDA scientists in issuing its decisions.

Signed (affiliations provided for identification purposes only):

Aaron S. Kesselheim, M.D., J.D., M.P.H.
Professor of Medicine
Harvard Medical School/Brigham and Women’s Hospital

Jerry Avorn, M.D.
Professor of Medicine
Harvard Medical School/Brigham and Women’s Hospital

G. Caleb Alexander, M.D.
Professor of Epidemiology and Medicine
Johns Hopkins Bloomberg School of Public Health

Andrew D. Althouse, Ph.D.
Assistant Professor of Medicine and Clinical & Translational Science
University of Pittsburgh

Aparna Anderson, Ph.D.
Chief Scientific Officer
Statistics Collaborative

Alejandra Avalos Pacheco, Ph.D., M.Sc.
Postdoctoral research fellow
Harvard Medical School/Dana Farber Cancer Institute

Sheriza Baksh, Ph.D., M.P.H.
Postdoctoral Fellow
Johns Hopkins University

Karen Bandeen-Roche, Ph.D.
Hurley-Dorrier Professor and Chair of Biostatistics
Johns Hopkins Bloomberg School of Public Health

Stefan Baral M.D., M.P.H., F.R.C.P.C.
Associate Professor
Johns Hopkins Bloomberg School of Public Health

Colleen L. Barry, Ph.D., M.P.P.
Fred and Julie Soper Professor and Chair, Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health

Alison Bateman-House, Ph.D., M.P.H.
Assistant Professor, Division of Medical Ethics
NYU Grossman School of Medicine

Barbara E. Bierer, M.D.
Professor of Medicine
Harvard Medical School

Robert C. Bollinger M.D., M.P.H.
Professor
Johns Hopkins University

Luciana Borio, M.D.
Former Director for Medical and Biodefense Preparedness, National Security Council
Former Acting Chief Scientist, Food and Drug Administration

Alain Braillon, M.D, Ph.D.
High Council for Public Health (France)
French Ministry of Health

Bruce Brown, M.D., F.A.C.C.
Board Certified Cardiologist
SouthCoast Hospitals Group, Wareham Cardiology

Suanna Steeby Bruinooge, M.P.H.
Division Director, Research Strategy and Operations
American Society of Clinical Oncology

Scott Burris, J.D.
Professor of Law and Public Health
Temple University

Arthur Caplan, Ph.D.
Director, Division of Medical Ethics
NYU Grossman School of Medicine

Daniel P. Carpenter, Ph.D.
Allie S. Freed Professor of Government
Harvard University

David D. Celentano, Sc.D., M.H.S.
Professor and Chair of Epidemiology
Johns Hopkins School of Public Health

Christopher G. Chute, M.D. Dr.PH.
Bloomberg Distinguished Professor of Medicine, Public Health, and Nursing
Johns Hopkins University

Jason Connor, Ph.D.
President & Lead Statistical Scientist
ConfluenceStat LLC

Nathan Cortez, J.D.
Callejo Endowed Professor, Gerald J. Ford Research Fellow
SMU Law School

Gregory Curfman, M.D.
Deputy Editor, JAMA
American Medical Association

Christopher E. Czerwonka, J.D.
Special Professor of Health Law & Policy/Volunteer Adult Medicine Ethics Committee Member
Hofstra University School of Law/Northwell Health

Nils Daulaire, M.D., M.P.H.
Distinguished Visiting Scholar
Harvard T.H. Chan School of Public Health

Rishi J. Desai, Ph.D.
Assistant Professor
Harvard Medical School/Brigham and Women’s Hospital

Neal Dickert, M.D., Ph.D.
Associate Professor of Medicine
Emory University School of Medicine

Kelly K. Dineen, R.N., J.D., Ph.D.
Associate Professor
Creighton University

Kevin M. Dirksen, M.Div., M.Sc., HEC-C
Senior Ethicist; Director of Ethics Education
Providence Center for Health Care Ethics

David Dore, Pharm.D., Ph.D.
Adjunct Assistant Professor of Health Services, Policy & Practice
Brown University School of Public Health

Peter Doshi, Ph.D.
Associate Professor of Pharmaceutical Health Services Research
University of Maryland School of Pharmacy

Susan S. Ellenberg, Ph.D.
Professor of Biostatistics, Medical Ethics and Health Policy
Perelman School of Medicine, University of Pennsylvania

Scott S. Emerson, M.D., Ph.D.
Professor Emeritus of Biostatistics
University of Washington

Steven Epstein, Ph.D.
John C. Shaffer Professor, Department of Sociology
Northwestern University

William B. Feldman, M.D., D.Phil.
Fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital

Robert I. Field, J.D., M.P.H., Ph.D.
Professor of Law and Professor of Health Management and Policy
Drexel University

Alan Fisher Dr.PH.
Biostatistician
Kinexum

Thomas R. Fleming, Ph.D.
Professor of Biostatistics
University of Washington

Howard P. Forman, M.D., M.B.A.
Professor of Radiology & Public Health (Health Policy)
Yale University

Leslie Francis, J.D., Ph.D.
Distinguished Professor of Law and Philosophy
University of Utah

Adriane Fugh-Berman, M.D.
Professor
Department of Pharmacology and Physiology, Georgetown University Medical Center.

Erin C. Fuse Brown, J.D., M.P.H.
Associate Professor of Law, Director of the Center for Law, Health & Society
Georgia State University College of Law

Lance Gable, J.D., M.P.H.
Associate Professor of Law
Wayne State University Law School

Mithat Gonen, Ph.D.
Chief of Biostatistics
Memorial Sloan Kettering Cancer Center

Gregg Gonsalves, Ph.D.
Assistant Professor in Epidemiology of Microbial Diseases
Yale University

Lisa Gonzalez, D.V.M., M.D., M.P.H.
Sr. Clinical Project Specialist
Greater New York Hospital Association

Lawrence O. Gostin, J.D.
University Professor
Georgetown University Law Center

Jeremy A. Greene, M.D., Ph.D.
Professor of Medicine and the History of Medicine
Johns Hopkins University School of Medicine

Rajesh K. Gupta, Ph.D.
Former Deputy Division Director, CBER, FDA
Biologics Quality & Regulatory Consultants, LLC

Ravi Gupta, M.D.
Fellow, National Clinician Scholars Program
University of Pennsylvania

Bishal Gyawali, M.D., Ph.D.
Affiliated Researcher, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital

Clara Han, M.D., Ph.D.
Associate Professor of Anthropology
Johns Hopkins University

Frank E Harrell, Jr., Ph.D.
Professor of Biostatistics
Vanderbilt University

Yaniv Heled, LL.B., LL.M. J.S.D.
Associate Professor
Georgia State University College of Law

Matthew Herder, J.S.M. LL.M.
Director, Health Law Institute
Schulich School of Law, Dalhousie University

Jay Herson, Ph.D.
Senior Associate
Johns Hopkins Bloomberg School of Public Health

Juan Hincapie-Castillo, Pharm.D., Ph.D.
Assistant Professor
University of Florida

Christina S. Ho, J.D., M.P.P.
Professor of Law
Rutgers Law School

Diane E. Hoffmann, J.D., M.Sc.
Professor of Law
University of Maryland Carey School of Law

Amelia Dale Horne, B.S., M.A., M.P.H., Dr.PH.
Former Chief, Vaccine Evaluation Branch, Division of Biostatistics (retired)
CBER, US Food & Drug Administration

Laertis Ikonomou, Ph.D.
Associate Professor
University at Buffalo, SUNY

Peter D. Jacobson, J.D., M.P.H.
Professor Emeritus of Health Law and Policy
University of Michigan School of Public Health

Steven Joffe, M.D., M.P.H.
Founders Professor of Medical Ethics and Health Policy and Professor of Pediatrics
University of Pennsylvania Perelman School of Medicine

Emma J Kagel, J.D., M.B.E.
Founder
Bioethics Alliance

Jonathan Kahn, J.D., Ph.D.
Professor of Law and Biology
Northeastern University

Robert M. Kaplan, Ph.D.
Distinguished Research Professor
UCLA Fielding School of Public Health

Jennifer Karlin, M.D., Ph.D.
Assistant Professor
UC Davis

Sanjay Kaul, M.D.
Cardiologist
Cedars-Sinai Medical Center

Lisa Kearns, M.S., M.A.
Senior Researcher, Division of Medical Ethics
NYU Grossman School of Medicine

Ryan David Kennedy, Ph.D.
Associate Professor
Johns Hopkins Bloomberg School of Public Health

Stacie Kershner, J.D.
Associate Director, Center for Law, Health & Society
Georgia State University College of Law

Bahareh Khatibi, M.D.
Associate Clinical Professor
University of California, San Diego

Anna Katherine Krawisz, M.D.
Cardiology Fellow
Beth Israel Deaconess Medical Center

Hussain Lalani, M.D. M.P.H.
Internal Medicine Resident Physician
UT Southwestern Medical Center

Stephan Lanes, Ph.D., M.P.H.
Principal Scientist
HealthCore

Nancy Lange-Vaidya, M.D.
Faculty
Harvard Medical School and Brigham and Women’s Hospital

Kate L. Lapane, M.S., Ph.D., F.I.S.P.E.
Associate Dean and Division Chief of Epidemiology
University of Massachusetts Medical School

Joel Lexchin M.Sc., M.D.
Professor Emeritus
York University, Toronto, Canada

Ana Lita, Ph.D.
Co-Founder and Executive Director
Global Bioethics Initiative

Noelle LoConte, M.D.
Associate Professor of Medicine
University of Wisconsin

Alex John London, Ph.D.
Clara L. West Professor of Ethics and Philosophy
Carnegie Mellon University

Peter G. Lurie, M.D., M.P.H.
President, Center for Science in the Public Interest

Holly Fernandez Lynch, J.D., M.Be.
John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics
Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

Howard Mann, M.D.
Professor of Radiology
University of Utah

Mason Marks, M.D., J.D.
Assistant Professor of Law, Gonzaga University
Edmond J. Safra/Petrie-Flom Center Fellow in Ethics of Technological and Biomedical Innovation, Harvard Law School

Jonathan Marron, M.D. M.P.H.
Pediatric oncologist, bioethicist, researcher
Dana-Farber Cancer Institute, Harvard Medical School

Larissa May, M.D.
Professor of Emergency Medicine
University of California Davis

Amy McGuire, J.D., Ph.D.
Director, Center for Medical Ethics and Health Policy
Baylor College of Medicine

Mark R. McLellan, Ph.D.
Vice President for Research & Innovation and Past Chair of the FDA Science Board
University of North Texas

Hemalkumar B. Mehta, Ph.D.
Assistant Professor of Epidemiology
Johns Hopkins Bloomberg School of Public Health

Michelle M. Mello, J.D., Ph.D.
Professor of Law and Professor of Medicine
Stanford University

Jon F. Merz, M.B.A., J.D., Ph.D.
Associate Professor
Perelman School of Medicine at the University of Pennsylvania

Jennifer Miller, Ph.D.
Assistant Professor
Yale School of Medicine

Christine Mitchell R.N., M.S., M.T.S.
Executive Director
Harvard Medical School Center for Bioethics

J. Mario Molina, M.D.
Adjunct Professor
Claremont Graduate University

Thomas J. Moore, A.B.
Professorial Lecturer
The George Washington University Milken Institute School of Public Health

Meghan Bridgid Moran, Ph.D.
Associate Professor, Department of Health, Behavior & Society
Johns Hopkins Bloomberg School of Public Health

Anna Morgan, MPH, RN
Program Manager
Brigham and Women's Hospital

Huseyin Naci, Ph.D.
Associate Professor of Health Policy
London School of Economics and Political Science

David C. Norris, M.D.
Precision-Medicine Methodologist
Precision Methodologies, LLC

Elizabeth Ogburn, Ph.D.
Associate Professor of Biostatistics
Johns Hopkins Bloomberg School of Public Health

Kevin Outterson, J.D.
Professor of Law
Boston University

Efthimios Parasidis, J.D., M.B.E.
Professor of Law and Public Health
Ohio State University

Ravi Parikh, M.D., M.P.H.
Chairman/Retina Specialist
Manhattan Retina and Eye/NYU Langone Health

Chandni Patel, M.D., M.B.A.
Assistant Clinical Professor
Childrens Hospital of Philadelphia

Kenneth R Paterson MB ChB FRCP (Glas, Edin, Lond) FFPM
Honorary Senior Research Fellow
University of Glasgow

Andrew Pekosz, Ph.D.
Professor
Johns Hopkins Bloomberg School of Public Health

Nancy Pire-Smerkanich, Dr.Sc.
Assistant Professor/Dept of Regulatory & Quality Sciences
University of Southern California

James E. Polli, Ph.D.
Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics
University of Maryland, Baltimore

Reshma Ramachandran, M.D., M.P.P.
National Clinician Scholars Program Fellow
Yale University

Leah Rand, D.Phil.
Fellow
Brigham and Women’s Hospital and Harvard Medical School

Sara Rasmussen M.D., Ph.D.
Associate Professor of Surgery
University of Washington

Laura Ravasi, M.D., Ph.D.
Medical Director
Advanced Accelerator Applications

Rita F. Redberg, M.D., M.Sc.
Professor of Medicine
University of California-San Francisco

Lucas Richert, Ph.D.
Associate Professor and George Urdang Chair in the History of Pharmacy
University of Wisconsin-Madison

Margaret Foster Riley, J.D.
Professor of Law
University of Virginia School of Law

Jessica Ritchie, MPH
Senior Project Manager
Yale New Haven Hospital

Karen A. Robinson, Ph.D.
Professor of Medicine
Johns Hopkins University

Christopher Robertson, J.D., Ph.D.
Professor and N. Neal Pike Scholar
Boston University

Frank W. Rockhold, Ph.D.
Professor of Biostatistics and Bioinformatics
Duke University

Benjamin N. Rome, M.D.
Fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital

Kathleen Romero, M.D.
Faculty
Sinai Hospital of Baltimore

Michael Rosenblum, Ph.D.
Associate Professor of Biostatistics
Johns Hopkins Bloomberg School of Public Health

James Niels Rosenquist M.D., Ph.D.
Instructor of Psychiatry
Massachusetts General Hospital and Harvard Medical School

Joseph S. Ross, M.D., M.H.S.
Professor of Medicine
Yale University

Beth E. Roxland, J.D., M.Bioethics
Senior Advisor on Law, Policy & Bioethics
Roxland Consultants Ltd.

Ina Roy-Faderman, M.D., Ph.D.
Faculty
Oregon State University

Estelle Russek-Cohen, Ph.D.
Former Division Director, Biostatistics
CBER, FDA

Rachel Sachs, J.D., M.P.H.
Associate Professor of Law
Washington University in St. Louis

George M. Samaras, Ph.D., D.Sc.
Managing Partner
Samaras & Associates, Inc.

Ana Santos Rutschman, S.J.D., LL.M.
Assistant Professor of Law
Saint Louis University

Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor of Medicine
Harvard Medical School/Brigham and Women’s Hospital

Nicolas Sawyer, M.D., M.B.A.
Assistant Professor of Emergency Medicine, Emergency Medicine Health Policy Fellowship Director
UC Davis School of Medicine

Karl Schwartz, MFA formerly: patient representative to FDA, president of PAL, CIRB member, NCI Steering Cmt, Vail Methods Workshop faculty. http://lymphomation.org Independent patient advocate

Ryan Schwarz, M.D., M.B.A.
Instructor of Medicine
Harvard Medical School/Brigham and Women’s Hospital

Jodi Segal, M.D., M.P.H.
Professor of Medicine
Johns Hopkins University School of Medicine

Seema K. Shah, J.D.
Associate Professor
Northwestern University/Lurie Children’s Hospital

Michael Sinha, M.D., J.D., M.P.H.
Fellow, Harvard-MIT Center for Regulatory Science
Harvard Medical School

Roy Smythe, M.D.
CEO, SomaLogic
SomaLogic, Inc.

Robert Steinbrook, M.D.
Professor Adjunct of Internal Medicine
Yale School of Medicine

Ariel Stern, Ph.D.
Poronui Associate Professor of Business Administration
Harvard Business School

Frances Stewart, M.D.
Captain (Retired), Medical Corps, United States Navy
Walter Reed National Military Medical Center

Susan Stewart, J.D.
Chief Regulatory Officer
Kaleido Biosciences

Christopher Tanski, Pharm.D.
Medical Science Liaison
Johnson and Johnson

Eric Topol, M.D.
Director, Scripps Research Translational Institute

Michael R. Ulrich, J.D., M.P.H.
Assistant Professor of Health Law, Ethics, and Human Rights
Boston University

Simon Vandekar, Ph.D.
Assistant Professor
Vanderbilt University Medical Center

Victor Van de Wiele, LL.B., LL.M.
Research consultant & former fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women's Hospital

Liza Vertinsky, Ph.D., J.D.
Associate Professor
Emory University School of Law

Agnes Vitry, Ph.D.
Senior Lecturer
University of South Australia

Matthew B. Wallenstein, M.D.
Neonatologist
Canterbury District Health Board, New Zealand

Bryan Walsh, J.D.
Fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital

Sidney D. Watson, J.D.
Professor
Saint Louis University School of Law

Stephen Weber, M.D.
Senior Medical Consultant
M Squared Associates

Danielle M. Wenner, Ph.D.
Associate Professor of Philosophy and Associate Director, Center for Ethics & Policy
Carnegie Mellon University

Gregory Whitman, M.D., LL.M., M.P.H.
Health Law Physician
Blended Value Health

Almut Winterstein, Ph.D., F.I.S.P.E.
Professor & Chair, Pharmaceutical Outcomes & Policy
University of Florida

Janet Wittes, Ph.D.
President, Statistics Collaborative

Steven Woloshin, M.D., M.S.
Professor of Medicine and Community and Family Medicine, Dartmouth Institute for Health Policy and Clinical Practice and the Lisa Schwartz Foundation for Truth in Medicine

Olivier Wouters, Ph.D.
Assistant Professor of Health Policy
London School of Economics and Political Science

Karen Zaks, D.A.C.V.P., M.S., D.V.M.
Veterinary Pathologist

Ann Zauber, Ph.D.
Member and Attending
Memorial Sloan Kettering Cancer Center

Patricia J. Zettler, J.D.
Associate Professor of Law
The Ohio State University

Diana Zuckerman, Ph.D.
President, National Center for Health Research