Lee E. Teitelbaum Utah Law Review Symposium - Fireproofing the FDA: Power, Politics, and Public Health
DATE: Friday, September 26 2025
TIME: 8:30 am - 4:30 pm MST
LOCATION: College of Law and Virtual Event
Lee E. Teitelbaum Utah Law Review Symposium
Fireproofing the FDA: Power, Politics, and Public Health
ABOUT THE EVENT:
This symposium will explore a revitalization of the FDA’s original missions—public health and consumer protection—by probing the intersection of politics, public health, and power at the organization. The FDA is currently facing political interference as well as cuts to its staff and budget that could compromise its ability to appropriately vet medical products. At the same time, FDA experts have observed that the agency needs significant reform to meet U.S. needs in the 21st century.
This convening will emphasize the “how”: the methods and approaches to strengthen medical product vetting while defending the FDA from interference. These goals bear some tension—and yet law and policy are well familiar with managing competing goals. Lessons for how the FDA can be “fireproofed,” drawing from FDA history, administrative law, political science, or other regulatory agencies, are encouraged. At the same time, changes to the way FDA operates may be needed to optimize the review of medical products on behalf of public health and innovation.
See previous Law Review Symposiums »
AGENDA:
8:30 a.m. – Check-in (Note: Agenda is still being updated)
9:00 a.m. – Welcome
Daniel G. Aaron, University of Utah S.J. Quinney College of Law
Grant Boyden, Editor-in-Chief, Utah Law Review
Dean Elizabeth Kronk Warner, University of Utah S.J. Quinney College of Law
9:15 a.m. – PANEL: Improving the Safety and Effectiveness of Medical Products
This panel will discuss the law behind FDA’s regulatory standards for drugs and medical devices and identify gaps and opportunities for reform.
Shannon Brownlee, Journalist
Sara Gerke, University of Illinois Urbana-Champaign College of Law
George Horvath, University of California College of the Law, San Francisco
Moderator: Jim Ruble, University of Utah College of Pharmacy
10:15 a.m. – Break
10:45 a.m. – PANEL: FDA, Politics, and Public Health
This panel will examine how the FDA interfaces with law and politics, including legal processes in the executive branch and Congress.
Sarah Karlin-Smith, Citeline’s Pharma Pink Sheet
Patti Zettler, The Ohio State University Moritz College of Law
Lewis Grossman, American University Washington College of Law
Joseph Daval, Program on Regulation, Therapeutics, and Law, Harvard Medical School
Moderator: Teneille Brown, S.J. Quinney College of Law, University of Utah
12:00 p.m. – Lunch
1:15 – 1:30 p.m. – Dr. Rita Redberg, University of California, San Francisco School of Medicine
1:30 p.m. – PANEL: The Current Crisis at the FDA
This panel will examine the current crisis of confidence in the FDA, the administrative law backdrop, and how the law could be changed to protect against similar events in the future.
Lizzy Lawrence, STAT News
Rachel Sachs, Washington University School of Law
Nathan Cortez, SMU Dedman School of Law
Jordan Paradise, Loyola University Chicago School of Law
Moderator: Avery E. Emery, S.J. Quinney College of Law, University of Utah
2:45 p.m. – Break
3:00 p.m. – PANEL: Repairing the FDA
This panel will offer concrete solutions to improve the functioning of the FDA.
Anjali Deshmukh, Seton Hall Law School
Michael Sinha, Saint Louis University School of Law
Reshma Ramachandran, Yale School of Medicine
Phillip Singer, University of Utah
Moderator: Robert Harrison, S.J. Quinney College of Law, University of Utah
4:15 p.m. – Closing Remarks
SPEAKER BIOS:
Teneille Brown is the James I. Farr Professor of Law at the S.J. Quinney College of Law, the Director of the Center for Law and the Biomedical Sciences (LABS) and the Associate Dean for Faculty Research. She is also an adjunct in the Department of Internal Medicine/Center for Health Ethics, Arts, and Humanities (CHeEtAH). She graduated from the University of Michigan Law School, and completed three post-doctoral fellowships at Stanford, one in the Center for Law and the Biosciences, one on the MacArthur Project for Law and Neuroscience, and one at the Stanford Center for Biomedical Ethics. Her research is highly interdisciplinary. It spans a wide range of issues at the intersection of law, genetics, neuroscience, social psychology, philosophy, medicine, and ethics. Her work has been published in Science and the Stanford Law Review, and highlighted in the New York Times, the Wall Street Journal and on national NPR outlets. Professor Brown teaches Torts and Evidence.
Shannon Brownlee is an award-winning and internationally known essayist, writer, and speaker whose work has appeared in such outlets as the New York Times Sunday Magazine, TIME, the Atlantic, Slate, the Sunday Times of London, and the Washington Post. Her book Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer, which was published in 2007, was named the best economics book of the year by the New York Times and sparked a movement in healthcare and healthcare policy research. She was a Bernard L. Schwartz Fellow at the New America Foundation and served as acting director of the Health Policy Program before becoming senior vice president of the Lown Institute, a healthcare think tank in Boston. Brownlee is now the senior advisor to the president of the Lown Institute. She is a lecturer in the Department of Policy and Management at the George Washington School of Public Health and holds a masters degree in Marine Science from the University of California. She contributes regularly to the Washington Monthly but spends most of her time in her pottery studio. She is married to Greg Garcia, former assistant secretary for cybersecurity and telecommunications at the Department of Homeland Security. They have one child.
Nathan Cortez is the Co-Director of the Tsai Center for Law, Science and Innovation, the inaugural Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies, a former Associate Dean of Research, and a Gerald J. Ford Research Fellow. He teaches and writes in the areas of health law, administrative law, and FDA law. His varied research focuses on emerging markets in health care and biotechnology, regulatory theory, government uses of information, and First Amendment regulation of corporate and commercial speech. Professor Cortez has also become one of the world’s leading legal scholars on medical device regulation, particularly devices that rely on artificial intelligence (A.I.) or machine learning. He has published two recent books: Food and Drug Law (5th edition, 2022) (with Peter Barton Hutt, Lewis Grossman, Erika Lietzan, and Patti Zettler); and Readings in Comparative Health Law and Bioethics (3rd edition, 2019) (with Glenn Cohen and Tim Jost).
Professor Cortez presents his research around the world, to governments, regulators, professional societies, industry, and fellow academics. He has presented work at the law schools of Harvard, Yale, and Stanford, among others, and at the medical schools of Harvard, Stanford, and Vanderbilt, among others. His work is recognized internationally and has been translated into Chinese. Professor Cortez is part of several grant-funded projects sponsored by the U.S. and Canadian governments. He also provides frequent commentary to the media, including the Associated Press, Chicago Tribune, CNN, the Los Angeles Times, the New York Times, NPR, Science, WIRED, and the Washington Post.
Professor Cortez co-founded the Texas Legal Scholars Workshop and the SMU Food Law Forum. He has been a peer reviewer for top legal and medical publications, including Health Affairs, The Lancet, The New England Journal of Medicine, the Oxford and Cambridge University Presses, and the Yale Law Journal. He has been a consultant for the Administrative Conference of the United States (ACUS).
Before joining the SMU faculty, Professor Cortez practiced with the Washington D.C. law firm Arnold & Porter, as part of its pharmaceutical, health care, and biotech practice. He represented clients in health care regulatory matters, with a special emphasis on health care fraud and abuse, FDA enforcement, privacy, and the Medicare and Medicaid programs. He represented clients during litigation, in corporate transactions, during agency enforcement actions, and during congressional investigations and hearings. He received his B.A. from the University of Pennsylvania and his J.D. from Stanford.
Dr. Anjali Deshmukh is an Assistant Professor of Law at Seton Hall University Law School and a board-certified pediatrician. Her interdisciplinary research and teaching focuses on the impact of pharmaceutical law and regulatory policies on patient health outcomes, particularly for children. She draws on quantitative empirical methods in addition to normative and doctrinal analysis to understand judicial review and regulation of evolving technologies, including cell and gene therapies, regenerative medicine, and AI. Her research has or will appear in Cardozo Law Review, Boston University Law Review, Tennessee Law Review, Health Affairs, and Journal of Law Medicine and Ethics amongst others. In 2023, she was recognized by the American Society for Law, Medicine, and Ethics as a Health Law Scholar.
Before joining Seton Hall Law School, she was an Assistant Professor of Law at Georgia State University College of Law, a fellow at the Program on Regulation Therapeutics and the Law at Brigham and Woman’s Hospital, a pharmaceutical litigation associate at Wilson Sonsini Goodrich and Rosatti, and extern to the Hon. Lucy H. Koh. She holds a J.D. from Stanford Law School, M.D. from Vanderbilt School of Medicine and A.B. from Dartmouth College.
Avery Emery graduated from the S.J. Quinney College of Law in May 2025. They now serve as the S.J. Quinney Health and Environmental Law Fellow.
Sara Gerke is an Associate Professor of Law and Richard W. & Marie L. Corman Scholar at the College of Law, as well as an Associate Professor at the European Union Center, at the University of Illinois Urbana-Champaign. Her current research focuses on the ethical and legal challenges of artificial intelligence and big data for health care and health law in the United States and Europe.
Professor Gerke is leading several research projects funded by the NIH and the European Union (Horizon Europe). She has over 80 publications in health law and bioethics, especially AI and digital health. Her work has appeared in leading law, medical, scientific, and bioethics journals, including The George Washington Law Review, New England Journal of Medicine, JAMA, Science, Nature Medicine, BMJ, The American Journal of Bioethics, and the Hastings Center Report. Her work has been covered in media venues such as The Wall Street Journal, The Economist, The Times, Forbes, Scientific American, Bloomberg Law, CBC, USA Today, and others.
Before joining Illinois, Professor Gerke was an Assistant Professor of Law at Penn State Dickinson Law and was promoted early to Associate Professor of Law in 2024. Previously, she served as a Research Fellow in Medicine, Artificial Intelligence, and Law at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, where she oversaw the day-to-day work of the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL). Before that, Professor Gerke was the General Manager of the Institute for German, European and International Medical Law, Public Health Law and Bioethics of the Universities of Heidelberg and Mannheim (IMGB).
Lewis Grossman is the Ann Loeb Bronfman Professor of Law at American University Washington College of Law. He teaches and writes in the areas of food and drug law, health law, American legal history, and civil procedure. He was a Visiting Professor of Law at Harvard Law School during the winter term in January 2025. He has also been a Visiting Professor of Law at Cornell Law School, a Law and Public Affairs (LAPA) Fellow at Princeton University, and a Visiting Research Scholar at Texas A&M University’s Institute for Healthcare Access.
Prior to joining the American University faculty, Professor Grossman was an associate at Covington & Burling LLP in Washington, D.C. Before that, he clerked for Chief Judge Abner Mikva of the U.S. Court of Appeals for the D.C. Circuit.
Professor Grossman is the author of Choose Your Medicine: Freedom of Therapeutic Choice in America (Oxford University Press 2021). His scholarship has appeared in the Cornell Law Review, Iowa Law Review, Wisconsin Law Review, Law and History Review, Yale Journal of Health Policy, Law & Ethics, and Administrative Law Review, among others. He has also published in medical and scientific journals, including The New England Journal of Medicine and Science, and has contributed chapters to volumes published by Oxford University Press, Cambridge University Press, and Columbia University Press. In addition, Professor Grossman is the co-author of Food and Drug Law: Cases and Materials, the leading text in the field. He has served as a member or legal consultant on five committees of the Health and Medicine Division (formerly the Institute of Medicine) of the National Academies of Sciences, Engineering, and Medicine. He recently represented a national group of food and drug law scholars that submitted amicus briefs in the U.S. Supreme Court and other courts defending FDA’s approval and regulation of the abortion drug mifepristone.
Professor Grossman earned his Ph.D. in History from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a J.D magna cum laude from Harvard Law School and a B.A. summa cum laude from Yale University.
George Horvath is an Associate Professor of Law at UC Law San Francisco. His scholarship combines his background as a practicing physician and medical scholar with empirical and doctrinal legal analysis to study the fraught intersections of law and health care. His work examines the ways in which statutory, regulatory, and implementation choices about the FDA’s role in regulating medical devices and drugs has impacted safety and innovation. His work also explores the ways in which multiple regulatory systems function together to create “emergent” regulatory systems whose effects on medical products are often quite different from those of any one system. Professor Horvath has been selected as a St. Louis University/American Society of Law, Medicine and Ethics Health Law Scholar (2022), a Loyola Chicago Wiet Life Sciences Law Scholar (2017, 2019, 2021, 2022), and an American Association of Law Schools Section on Law, Medicine, and Health Care New Voice in Health Law (2022).
Prior to his legal career, Professor Horvath earned his M.D. at Temple University Medical School and practiced as a cardiologist specializing in the treatment of heart rhythm disorders. He authored or co-authored over twenty articles that were published in the Journal of the American College of Cardiology, Circulation, Archives of Internal Medicine, and other medical journals.
Jordan Paradise researches and publishes on the intersection of law, science, and technology. Her primary focus is in the life science realm, examining legal and policy issues in the development and regulation of pharmaceuticals, medical devices and innovations in medicine. Recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes. Her publications have appeared in both peer-reviewed and legal publications.
Previously, Professor Paradise served as the Schering-Plough Professor of Law at Seton Hall University School of Law in New Jersey where she was a faculty member of both the Center for Health & Pharmaceutical Law & Policy and the Gibbons Institute for Law, Science & Technology. From 2005-2009, she was the Associate Director of Research & Education for the Joint Degree Program in Law, Health & the Life Sciences and the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota Law School. She was also an adjunct associate professor of law, a research associate in the Center for Bioethics, and the faculty editor-in-chief of the Minnesota Journal of Law, Science & Technology during her time at the University of Minnesota.
Dr. Rita F. Redberg is a cardiologist who practices general and preventive cardiology. She is passionate about helping her patients adopt healthful lifestyle behaviors to reduce their heart disease risk and stay healthy. She also has an interest in promoting high-value health care, an approach that emphasizes delivering appropriate treatments while avoiding tests or therapies with no known benefits.
In her research, Redberg looks at how the assessment of medical technology’s safety and effectiveness influences – and is influenced by – public health policy. In particular, she studies high-risk medical devices and women’s inclusion in clinical trials for such devices.
As editor of JAMA Internal Medicine, a journal of the American Medical Association, from 2009 to 2023, she spearheaded the publication’s new focus on health care reform and less-is-more medicine, a movement to reduce unnecessary interventions.
Redberg earned her medical degree from the Perelman School of Medicine at the University of Pennsylvania. She completed a residency in internal medicine and a fellowship in cardiology at Columbia University Medical Center. She completed a fellowship in noninvasive cardiology at the Mount Sinai Health System. She also has a master’s degree in health policy and administration from the London School of Economics and Political Science.
Rachel Sachs is a Professor of Law at Washington University in St. Louis. She is a scholar of innovation policy, exploring the intersection of health law, food and drug regulation, and patent law. Her work analyzes problems of innovation and access to new health care technologies. Professor Sachs’ scholarship has appeared in journals that include the Duke Law Journal, the NYU Law Review, the Michigan Law Review, the Harvard Law Review, the New England Journal of Medicine, the Journal of the American Medical Association, and Health Affairs.
Professor Sachs served in the Biden-Harris Administration as a Senior Advisor at the Department of Health and Human Services Office of the General Counsel, Centers for Medicare and Medicaid Services Division. She has testified before the United States House of Representatives Committee on Energy and Commerce and the United States House of Representatives Committee on Ways & Means. She currently serves as a Non-Resident Fellow at the Brookings Institution.
Prior to joining Washington University in St. Louis, Professor Sachs was an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and a Lecturer in Law at Harvard Law School. She also clerked for the Honorable Richard A. Posner of the United States Court of Appeals for the Seventh Circuit. She received her J.D. magna cum laude from Harvard Law School and a Master of Public Health from the Harvard School of Public Health. She received her A.B. in Bioethics from Princeton University.
Associate Professor Michael Sinha has a background in law, medicine, and public health. He joined the faculty at SLU LAW in 2022. Prior to coming to SLU LAW, he served in various research and teaching roles at Harvard Medical School, Northeastern University School of Law, and Loyola University Chicago School of Law. Originally from St. Louis, Dr. Sinha completed his undergraduate degree in biophysical chemistry from Dartmouth College in New Hampshire before returning to St. Louis to conduct research in medical oncology at Washington University School of Medicine. He then completed a combined M.D./J.D. program at Southern Illinois University and trained in internal medicine in Connecticut and Massachusetts.
During his clinical training, Dr. Sinha earned an M.P.H. in Law and Public Health from Harvard T.H. Chan School of Public Health. While in Boston, he renewed his focus on health law research and scholarship through fellowships at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and the Harvard-MIT Center for Regulatory Science at Harvard Medical School. He continues as Affiliated Faculty at PORTAL and is a Core Partner at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen.
Patti Zettler is the John W. Bricker Professor of Law at The Ohio State University Moritz College of Law and a faculty member of Ohio State’s Drug Enforcement and Policy Center and its Comprehensive Cancer Center. From November 2023 to January 2025, Professor Zettler was on leave from Ohio State to serve as Deputy General Counsel to the U.S. Department of Health and Human Services (HHS), covering the FDA portfolio. In that role, she helped to advance and implement key FDA regulations and policies, worked on litigation involving FDA, and advised HHS, FDA, and others across the U.S. government on a wide range of issues.
In her academic work, Professor Zettler is a prolific scholar with over 65 articles in scientific journals and traditional law reviews, including the New England Journal of Medicine, JAMA, and Science. She also has served as a member of the Food and Drug Law Institute’s Board of Directors, a member of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) Board on Health Sciences Policy as well as on NASEM committees, and as chair of the International Society of Cell & Gene Therapy’s (ISCT) Committee on the Ethics of Cell and Gene Therapy and its subcommittee on expanded access.
Before entering academics, Professor Zettler served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA. She received her undergraduate and law degrees from Stanford University, both with distinction.
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