Dear Chief Justice Roberts:
The Coalition for the Life Sciences (CLS), an organization that represents over 50,000 biomedical researchers from academia, private research institutes, and industry, strongly endorses the expertise and authority of the U.S. Food and Drug Administration (FDA), which is charged with gathering and applying scientific evidence and knowledge to evaluate the safety and efficacy of medicines in the United States. We respectfully urge the Court to reverse the lower court ruling to suspend the FDA’s approval of mifepristone which has been proven to be safe and effective.
We are deeply concerned that the April 7th decision by District Judge Matthew Kacsmaryk fundamentally undermines the bipartisan authority granted to the FDA by Congress, displacing scientific data with apparent judicial whim and political bias. The FDA approval process is painstaking and rigorous, requiring multiple steps that demand extensive pre-clinical research and results from carefully-designed clinical trials, providing quantitative measure of the benefits and risks of drugs and medical devices. Additionally, through ongoing post-market monitoring, the FDA captures effects or concerns undetected prior to widespread use, and inserts warnings or even withdraws approval if merited.
It is an unprecedented step for the district court to invalidate a longstanding approval for a drug with a history of safe and effective use. Allowing the district court’s decision to stand would set a dangerous precedent, inviting political agendas to reverse public access to rigorously researched, FDA-validated life-saving medications.
The FDA’s science-based approach protects public health and promotes public trust in our healthcare system. The CLS strongly supports the FDA review process as the gold standard for evaluating and approving medicines, and for ensuring safe and effective therapies that advance public well-being.
Thank you for your attention to this matter of critical importance.
Sincerely,
Keith R. Yamamoto
Chair, Coalition for the Life Sciences
President, American Association for the Advancement of Science
Vice Chancellor for Science Policy and Strategy, UCSF
Director, UCSF Precision Medicine
Professor, Cellular & Molecular Pharmacology
Elizabeth McNally MD PhD
Professor and Director, Center for Genetic Medicine
Northwestern University Feinberg School of Medicine
American Academy of Arts and Sciences
U.S. National Academy of Medicine
Association of American Physicians (Past President)
American Society for Clinical Investigation (Past President)
Shirley M. Tilghman, Ph.D.
President emerita
Professor of Molecular Biology and Public Affairs Emerita
Princeton University
H. Robert Horvitz, PhD
Professor of Biology, MIT
Howard Hughes Medical Institute
Nobel Prize in Physiology or Medicine, 2002
U.S. National Academy of Sciences
U.S. National Academy of Medicine
American Academy of Arts and Sciences
Genetics Society of America (past president)
Carol W. Greider, Ph.D.
Distinguished Professor of
Molecular, Cell & Developmental Biology
University of California Santa Cruz
& University Professor Johns Hopkins University
U.S. National Academy of Sciences
U.S. National Academy of Medicine
American Academy of Arts and Sciences
Nobel Laureate in Physiology or Medicine, 2009
Rebecca D. Burdine, Ph.D.
Professor of Molecular Biology
Princeton University
Fellow of the American Association for the Advancement of Science
Richard P. Lifton, M.D., Ph.D.
President
Head of Laboratory of Human Genetics and Genomics
The Rockefeller University
Breakthrough Prize in Life Sciences, 2014
U.S. National Academy of Sciences
U.S. National Academy of Medicine
American Academy of Arts and Sciences
Martin Chalfie, Ph.D.
University Professor
Columbia University
Nobel Prize in Chemistry, 2008
U.S. National Academy of Sciences
U.S. National Academy of Medicine
American Academy of Arts and Sciences
Tony Wynshaw-Boris, MD, PhD
James H. Jewell MD ’34 Professor of Genetics
Chair, Department of Genetics and Genome Sciences
Case Western Reserve University School of Medicine
American Society of Human Genetics Past President (2020)
Harold Varmus, MD
Lewis Thomas University Professor, Cornell University
Nobel Prize in Physiology or Medicine, 1989
Former Director, National Institutes of Health and National Cancer Institute
National Academies of Science and Medicine
Judith Kimble, PhD
Vilas Professor of Biochemistry
HHMI Investigator
National Academy of Sciences
American Academy of Arts and Sciences
American Philosophical Society
Genetics Society of America (Past President)
Society of Developmental Biology (Past President)
Sue Biggins, PhD
Director, Division of Basic Sciences
Fred Hutchinson Cancer Center
HHMI Investigator
National Academy of Sciences
American Academy of Arts and Sciences
Thomas D. Pollard, MD
Sterling Professor Emeritus of Molecular Cellular and Developmental Biology
Yale University
Visiting Professor, University of California, Berkeley
National Academies of Science and Medicine
American Academy of Arts and Sciences
Biophysical Society (Past President)
American Society for Cell Biology (Past President)
Daniel A. Colón Ramos, PhD
McConnell Duberg Professor of Neuroscience and Cell Biology
Director, Wu Tsai Center for Neurodevelopment and Plasticity
U.S. National Academy of Medicine
Hollis T. Cline, PhD
Professor and Chair, Department of Neuroscience
Director, Dorris Neuroscience Center
Hahn Professor of Neuroscience
The Scripps Research Institute
Fellow, American Association for the Advancement of Science
U.S. National Academy of Science
Society for Neuroscience, Past President
Enrique M. De La Cruz
Yale University
Chair and Professor of Molecular Biophysics & Biochemistry
Head of Branford College
Fellow, American Association for the Advancement of Sciences
Fellow, American Society for Biochemistry and Molecular Biology
Connecticut Academy of Science and Engineering
Steven E. Hyman, MD
Harvard University Distinguished Service Professor
Core Institute Member, Broad Institute of Harvard and MIT and
Director of the Stanley Center for Psychiatric Research
US National Academy of Medicine
Fellow, American Association for the Advancement of Science
Fellow, American Academy of Arts and Sciences
Society for Neuroscience (Past President)
Director (1996-2001) US National Institute of Mental Health
Provost (2001-2011) Harvard University
