September 25, 2020
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
Alison Bateman-House, Ph.D., M.P.H.
Assistant Professor, Division of Medical Ethics
NYU Grossman School of Medicine
Luciana Borio, M.D.
Former Director for Medical and Biodefense Preparedness, National Security Council
Former Acting Chief Scientist, Food and Drug Administration
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
Nathan Cortez, J.D.
Callejo Endowed Professor, Gerald J. Ford Research Fellow
SMU Law School
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
William B. Feldman, M.D., D.Phil.
Fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital
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 P. Forman, M.D., M.B.A.
Professor of Radiology & Public Health (Health Policy)
Yale University
Adriane Fugh-Berman, M.D.
Professor
Department of Pharmacology and Physiology, Georgetown University Medical Center.
Gregg Gonsalves, Ph.D.
Assistant Professor in Epidemiology of Microbial Diseases
Yale University
Jeremy A. Greene, M.D., Ph.D.
Professor of Medicine and the History of Medicine
Johns Hopkins University School of Medicine
Lawrence O. Gostin, J.D.
University Professor
Georgetown University Law Center
Bishal Gyawali, M.D., Ph.D.
Affiliated Researcher, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital
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
Robert M. Kaplan, Ph.D.
Distinguished Research Professor
UCLA Fielding School of Public Health
Peter G. Lurie, M.D., M.P.H.
President, Center for Science in the Public Interest
Michelle M. Mello, J.D., Ph.D.
Professor of Law and Professor of Medicine
Stanford University
Efthimios Parasidis, J.D., M.B.E.
Professor of Law and Public Health
Ohio State University
Rita F. Redberg, M.D., M.Sc.
Professor of Medicine
University of California-San Francisco
Margaret Foster Riley, J.D.
Professor of Law
University of Virginia School of Law
Benjamin N. Rome, M.D.
Fellow, Program On Regulation, Therapeutics, And Law
Harvard Medical School/Brigham and Women’s Hospital
Joseph S. Ross, M.D., M.H.S.
Professor of Medicine
Yale University
Ameet Sarpatwari, Ph.D., J.D.
Assistant Professor of Medicine
Harvard Medical School/Brigham and Women’s Hospital
Ryan Schwarz, M.D., M.B.A.
Instructor of Medicine
Harvard Medical School/Brigham and Women’s Hospital
Michael Sinha, M.D., J.D., M.P.H.
Fellow, Harvard-MIT Center for Regulatory Science
Harvard Medical School
Eric Topol, M.D.
Director, Scripps Research Translational Institute
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
Diana Zuckerman, Ph.D.
President, National Center for Health Research
The original letter is available here