Patricia J. Zettler, B.A., J.D.
Education
- BA, Stanford University
- JD, Stanford University
Biography
Patricia J. Zettler is a nationally-recognized expert on the U.S. Food and Drug Administration (FDA) and food and drug law. She serves as the John W. Bricker Professor of Law, as Acting Academic Director of the Drug Enforcement & Policy Center at Moritz College of Law (spring 2025), and as a member of the Cancer Control Program at The Ohio State University Comprehensive Cancer Center. Professor Zettler teaches courses related to administrative law, tort law, FDA law, and public health.
Professor Zettler is a prolific scholar with over 60 articles in scientific journals and traditional law reviews, including the New England Journal of Medicine, JAMA, Indiana Law Journal, Boston University Law Review, and NYU Law Review. Her work has covered various topics including stem cell interventions, opioids, cannabis products, tobacco and nicotine products, COVID-19 countermeasures, non-trial access to investigational drugs, and citizen science. She also is a co-author of the 5th edition of Food and Drug Law: Cases and Materials. Zettler’s research has won multiple prizes, including the 2023 Early Career Distinguished Scholar Award at The Ohio State University and the 2015 Health Law Scholar Award from the American Society of Law, Medicine, and Ethics.
From November 2023 to January 2025, Professor Zettler was on leave from the University while she served as Deputy General Counsel to the U.S. Department of Health & Human Services (HHS), covering the FDA portfolio. In that role, she helped to advance and implement key FDA regulations and policies, worked with the Department of Justice on litigation involving FDA, and advised HHS, FDA, and others across the federal government on a wide range of issues. Before her academic career, Professor Zettler served as an associate chief counsel in FDA’s Office of the Chief Counsel. She also has held academic appointments at Stanford Law School and Georgia State University College of Law.
Additionally, Professor Zettler has served on the Food and Drug Law Institute’s (FDLI) Board of Directors, the National Academies of Sciences, Engineering, and Medicine’s (NASEM) Health Sciences Policy Board, and the Ohio State Bar Association’s Administrative Agency Law Specialty Board. She also has chaired the International Society of Cell & Gene Therapy’s Committee on the Ethics of Cell and Gene Therapy, and its subcommittee on expanded access to investigational cell and gene interventions.
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Reshma Ramachandran, Rachel E. Sachs & Patricia J. Zettler, Opportunities and Risks of a Single-Trial Default for FDA Drug Approval, 7 JAMA Health Forum e262756 (2026)
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Larisa Svirsky, Martin Fried, Minseo Kim, Sarah R. MacEwan, Nathan Richards, Patricia J. Zettler & Dana Howard, Reasonable Exceptions From Unreasonable Policies: Requiring Treatment Agreements for Long-Term Opioid Therapy and Exemptions for Cancer and Terminal Illness, Bioethics 1 (2026)
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Patricia J. Zettler & Rachel Sachs, Evaluating the Case Against FDA Independence, 2026 Utah L. Rev. 911 (2026)
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Darren Mays, Russell B. Clayton, Alayna P. Tackett, Patricia J. Zettler & Elise M. Stevens, Social media, addiction, and youth mental health, 62 The Lancet Regional Health - Americas (2026)
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Martin Fried, Shivam Joshi, Nicole Thomas, Nathan Richards, Larisa Svirsky, Patricia J. Zettler & Dana Howard, Treatment Agreements do not Change Clinicians’ Permissive Attitudes of Cannabis Use Among Patients on Long-term Opioid Therapy, J. Gen. Internal Medicine. 1 (Nov. 2024) (online first)
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Sven Eric Jordt, Sairam V. Jabba, Patricia J. Zettler & Micah L. Berman, Spree Bar, a Vaping System Delivering a Synthetic Nicotine Analogue, Marketed in the United States as “PMTA Exempt”, Tobacco Control (March 2024) (online first)
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Patricia J. Zettler, Shyanika Rose, Andy Tan, Raglan Maddox, Priti Bandi, Micah L. Berman et al., Editorial, Commercial Tobacco and Nicotine Industry-funded Research Has No Place in SRNT and Nicotine & Tobacco Research, 26 Nicotine & Tobacco Res. 963 (2024)
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Megan E. Roberts, Joanne G. Patterson, Brittney L. Keller-Hamilton, Amy K. Ferketich, Jill M. Singer & Patricia J. Zettler, JUUL and its ‘Action Network’ Attempt to Prevent a Local Flavour Ban, 33 Tobacco Control e138 (2024)
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Larisa Svirsky, Dana Howard, Martin Fried, Nathan Richards, Nicole Thomas & Patricia J. Zettler, The Legal Landscape for Opioid Treatment Agreements, 102 The Milbank Q. 632 (2024)
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Robert E. Hynds, Chelsea M. Magin, Laertis Ikonomou, Yael Aschner, Michael F. Beers, Janette K. Burgess, Rebecca L. Heise, Patrick S. Hume, Anna D. Krasnodembskaya, Shirley H.J. Mei, Alexander V. Misharin, Jin-Ah Park, Susan D.Reynolds, Daniel Tschumperlin, Alicia E. Tanneberger, Sriram Vaidyanathan, Christopher M. Waters, Patricia J. Zettler et al., Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases 2023, 327 Am. J. Physiology - Lung Cellular & Molecular Physiology L327 (2024) (summary of presentations at the 2023 Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases Conference)
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Rachel E. Sachs, W. Nicholson Price & Patricia J. Zettler, Rethinking Innovation at FDA, 104 B.U. L. Rev. 513 (2024)
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Patricia J. Zettler et al., An International Society for Cell & Gene Therapy Working Group Short Report on the Future of Expanded Access to Unapproved Cell and Gene Therapies, 25 Cytotherapy 712 (2023)
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Brittney Keller-Hamilton, Hayley Curran, Elise M. Stevens, Patricia J. Zettler, Darren Mays & Amy K. Ferketich, Effects of “Tobacco Free” Language in Warning Labels on Perceptions of Electronic Cigarettes and Nicotine Pouches among Young Adult Men: A Randomized Trial, 58 Substance Use & Misuse 1302 (2023)
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Lewis Grossman, Patricia J. Zettler, Eli Y. Adashi & I. Glenn Cohen, The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit’s Decision for Abortion Access and the U.S. Food and Drug Administration, 176 Ann. Internal Med. 1666 (2023)
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Laertis Ikonomou, Natividad Cuende, Miguel Forte, Bambi Grilley, Aaron D. Levine, Megan Munsie, John E.J. Rasko, Leigh Turner, Hamid R. Bidkhori, Rachele Ciccocioppo, Felix Grignon, Alok Srivastava, Daniel J. Weiss, Patricia J. Zettler et al., Key Considerations to Support Evidence-Based Cell and Gene Therapies and Oppose Marketing of Unproven Products, 25 Cytotherapy 920 (2023)
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Patricia J. Zettler, Eli Y. Adashi & I. Glenn Cohen, Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation, 388 N. Eng. J. Med. E29 (2023)
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Patricia J. Zettler, Micah L. Berman, et al. et al., External Review of FDA Regulation of Opioid Analgesics (2023)
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Erika Lietzan & Patricia J. Zettler, Medicines, in Chemical Risk Governance (2023)
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Timothy D. Lytton & Patricia J. Zettler, Regulation of Chemicals in Food, in Chemical Risk Governance (2023)
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Micah L. Berman & Patricia J. Zettler, Synthetic Nicotine: Science, Global Legal Landscape and Regulatory Considerations (2023)
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Greer Donley & Patricia J. Zettler, Response to Listening to Mifepristone, 80 N.Y.U. Ann. Surv. Am. L. 63 (2023)
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Nathan Richards, Martin Fried, Larisa Svirsky, Nicole Thomas, Patricia J. Zettler & Dana Howard, Clinician Perspectives on Opioid Treatment Agreements: A Qualitative Analysis of Focus Groups, AJOB Empirical Bioethics (2023)
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Natividad Cuende, Rachele Ciccocioppo, Miguel Forte, Jacques Galipeau, Laertis Ikonomou, Bruce L. Levine, Alok Srivastava & Patricia J. Zettler, Patient Access to and Ethical Considerations of the Application of the European Union Hospital Exemption Rule for Advanced Therapy Medicinal Products, 24 Cytotherapy 686 (2022)
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Alexis R. Miranda, Joanne G. Patterson, Devin LaPolt, Ruva P. Rumano, Alexa M. Reynoso, Micah L. Berman, Brittney L. Keller-Hamilton, Megan E. Roberts, Amy Ferketich & Patricia J. Zettler, A Call for Regulatory Clarity: “Switch” and “Quit Smoking” Marketing among Online Disposable E-Cigarette Sellers, 61 Harv. Pub. Health Rev. 56 (2022)
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Patricia J. Zettler, State Regulation of Biomedical Citizen Science, 7 Citizen Sci. Theory & Prac. 43 (2022)
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Patricia J. Zettler & Ameet Sarpatwari, State Restrictions on Mifepristone Access—The Case for Federal Preemption, 386 New Eng. J. Med. 705 (2022)
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Govind Persad, Patricia J. Zettler & Holly Fernandez Lynch, Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues, 149 Pediatrics e2021054578 (2022)
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Peter Barton Hutt , Richard A. Merrill, Lewis Grossman, Nathan Cortez, Erika Lietzan & Patricia J. Zettler, Food and Drug Law ((5th ed., 2022)
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Patricia J. Zettler, Annamarie Beckmeyer, Beatrice L. Brown & Ameet Sarpatwari, Mifepristone, Preemption, and Public Health Federalism, 9 J.L. & Biosciences lsac037 (2022)
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Patricia J. Zettler, The FDA’s Power Over Non-Therapeutic Uses of Drugs and Devices, 78 Wash. & Lee L. Rev. 379 (2021)
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Patricia J. Zettler, Micah L. Berman & Efthimios Parasidis, Drug and Vaccine Development and Access, in Assessing Legal Responses to COVID-19 (2021)
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Jacob S. Sherkow & Patricia J. Zettler, EpiPen, Patents, and Life and Death, 96 N.Y.U. L. Rev. Online 164 (2021)
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Patricia J. Zettler, Eli Y. Adashi & I. Glenn Cohen, A Divisive Ruling on Devices—Genus Medical Technologies v. FDA, 385 New Eng. J. Med. 2409 (2021)
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Patricia J. Zettler & Seema K. Shah, Broader Implications of Eliminating FDA Jurisdiction Over Execution Drugs, 111 Am. J. Pub. Health 1764 (2021)
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Patricia J. Zettler, Christi J. Guerrini & Jacob S. Sherkow, Finding a Regulatory Balance for Genetic Biohacking, in Consuming Genetics: Ethical and Legal Considerations of New Technologies (2021)
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Joanne G. Patterson, Devin T. LaPolt, Alexis R. Miranda, Patricia J. Zettler, Micah L. Berman et al., Switching Stories: User Testimonials on juul.com Continue to Contradict JUUL's Switch ≠ Cessation Narrative, 30 Tobacco Control e37 (2021)
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Patricia J. Zettler, Micah L. Berman & Efthimios Parasidis, Drug and Vaccine Development and Access, in Covid-19 Playbook: Legal Recommendations for a Safer, More Equitable Future (2021)
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Efthimios Parasidis, Micah L. Berman & Patricia J. Zettler, Assessing COVID-19 Emergency Use Authorizations, 76 Food & Drug L.J. 441 (2021)
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Micah L. Berman, Patricia J. Zettler & Efthimios Parasidis, Law and Ethics During a Public Health Crisis, 3 Ohio J. Pub. Health 3 (2020)
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Louiza Kalokairinou, Patricia J. Zettler, Ashwini Nagappan, Moira A. Kywekuk & Anna Wexler, The Promise of Direct-to-Consumer COVID-19 Testing: Ethical and Regulatory Issues, 7 J.L. & Biosciences 1 (2020)
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Patricia J. Zettler & Erika Lietzan, Regulating Medical Devices in the United States, in Oxford Handbook on Comparative Health (2020)
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Erika Lietzan & Patricia J. Zettler, Regulating Medicines in the United States, in Oxford Handbook on Comparative Health (2020)
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Christi J. Guerrini, Jacob S. Sherkow, Michelle N. Meyer & Patricia J. Zettler, Transparency is Key to Ethical Vaccine Research—Response, 370 Sci. 6523 (2020)
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Lisa M. Rasmussen, Christi J. Guerrini, Todd Kuiken, Camille Nebeker, Alex Pearlman, Sarah B. Ware, Anna Wexler & Patricia J. Zettler, Realizing Present and Future Promise of DIY Biology and Medicine through a Trust Architecture, 50 Hastings Center Rep. 10 (2020)
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Patricia J. Zettler & Erika Lietzan, A Special Exception for CBD in Foods and Supplements?, 25 Drug Discovery Today 467 (2020)
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Y. Tony Yang, Patricia J. Zettler & Theodore Wagener, New Graphic Tobacco Warnings and the First Amendment, 6 JAMA Oncology 473 (2020)
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Patricia J. Zettler, What Lies Ahead for FDA Regulation of tDCS Products?, 3 J.L. & Biosciences 318 (2016)
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Holly Fernandez Lynch, Neal W. Dickert, Patricia J. Zettler, Steven Joffe & Emily A. Largent, Regulatory Flexibility for COVID-19 Research, 7 J.L. & Biosciences 1 (2020)
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Christi J. Guerrini, Jacob S. Sherkow, Michelle N. Meyer & Patricia J. Zettler, Self-experimentation, Ethics, and Regulation of Vaccines, 369 Sci. 1570 (2020)
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Christi J. Guerrini, Evan Spencer & Patricia J. Zettler, DIY CRISPR, 97 N.C. L. Rev. 1399 (2019)
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Y. Tony Yang & Patricia J. Zettler, FDA’s Regulatory Shift on Direct-to-Consumer Genetic Tests for Cancer Risk, 125 Cancer 12 (2019)
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Holly Fernandez Lynch, Ameet Sarpatwari, Robert H. Vonderheide & Patricia J. Zettler, Right to Try Requests and Oncologists’ Gatekeeping Obligations, 38 J. Clinical Oncology 111 (2019)
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Christi J. Guerrini, Anna Wexler, Patricia J. Zettler & Amy L. McGuire, Biomedical Citizen Science of Something Else? Reflections on Terms and Definitions, 19 Am. J. Bioethics 17 (2019)
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Patricia J. Zettler, Christi Guerrini & Jacob S. Sherkow, Regulating Genetic Biohacking, 365 Sci. 34 (2019)
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Jacob S. Sherkow, Patricia J. Zettler & Henry T. Greely, Is It ‘Gene Therapy’?, 5 J.L. & Biosciences 786 (2018)
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Patricia J. Zettler, Natalie Hemmerich & Micah L. Berman, Closing the Regulatory Gap for Synthetic Nicotine Products, 59 B.C. L. Rev. 1933 (2018)
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Holly Fernandez Lynch, Patricia J. Zettler & Ameet Sarpatwari, Promoting Patient Interests in Implementing the Federal Right to Try Act, 320 JAMA 869 (2018)
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Micah L. Berman, Patricia J. Zettler & David Ashley, Anticipating Industry Arguments: The FDA’s Authority to Reduce Nicotine Levels in Cigarettes, 133 Pub. Health Rep. 502 (2018)
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Emily Jung, Patricia J. Zettler & Aaron S. Kesselheim, Prevalence of Publicly Available Expanded Access Policies, 104 Clinical Pharmacology & Therapeutics 1016 (2018)
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Patricia J. Zettler, Margaret Foster Riley & Aaron S. Kesselheim, Implementing a Public Health Perspective in FDA Drug Regulation, 73 Food & Drug L.J. 221 (2018)
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Amy Zarzeczny, Harold Atkins, Judy Illes, Jonathan Kimmelman, Zubin Master, Julie M. Robillard, Jeremy Snyder, Leigh Turner, Patricia J. Zettler & Timothy Caulfield, The Stem Cell Market & Policy Options: A Call for Clarity, 5 J.L. & Biosciences 743 (2018)
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Patricia J. Zettler, Pharmaceutical Federalism, 92 Ind. L.J. 845 (2017)
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Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, 78 Ohio St. L.J. 1053 (2017)
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Patricia J. Zettler, tDCS Research in a World with FDA Regulation, 8 Am. J. Bioethics Neuroscience 1 (2017)
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Patricia J. Zettler & Erin Fuse Brown, The Challenge of Paying for Cost-Effective Cures, 23 Am. J. Managed Care 62 (2017)
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Patricia J. Zettler, Compassionate Use of Experimental Medicines: Who Should Decide?, 7 EMBO Molecular Med. 1248 (2015)
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Patricia J. Zettler, Toward Coherent Federal Oversight of Medicine, 52 San Diego L. Rev. 427 (2015)
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Patricia J. Zettler, Jacob S. Sherkow & Henry T. Greely, 23andMe, the Food and Drug Administration, and the Future of Genetic Testing, 174 JAMA Internal Med. 403 (2014)
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Patricia J. Zettler & Henry T. Greely, The Strange Allure of State Right-to-Try Laws, 174 JAMA Internal Med. 1885 (2014)
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Seema Shah & Patricia J. Zettler, From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy, 10 Yale J. Health Pol'y L. & Ethics 135 (2010)
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Michelle Oberman, Patricia J. Zettler & Leslie E. Wolf, Where Stem Cell Research Meets Abortion Politics: Limits on Buying and Selling Human Oocytes, in Baby Markets: Money and the New Politics of Creating Families (2010)
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Patricia J. Zettler, Leslie E. Wolf & Bernard Lo, Establishing Procedures for Institutional Oversight of Stem Cell Research, 82 Acad. Med. 6 (2007)
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Sara L. Swenson, Patricia J. Zettler & Bernard Lo, ‘She Gave It Her Best Shot Right Away’: Patient Experiences of Patient-Centered and Biomedical Communication, 61 Patient Educ. & Counseling 200 (2006)
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Bernard Lo, Patricia J. Zettler et al., A New Era in the Ethics of Human Embryonic Stem Cell Research, 23 Stem Cells 1454 (2005)
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Sara L. Swenson, Stephanie Buell, Patricia J. Zettler, Martha White, Delaney C. Ruston & Bernard Lo, Patient-Centered Communication: Do Patients Really Prefer It?, 19 J. Gen. Internal Med. 1069 (2004)
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