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.
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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.
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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