Patricia J Zettler, JD
Academic Title: John W. Bricker Professor of Law
Research Program: Cancer Control
About Me
More info forI am an associate professor at The Ohio State University Moritz College of Law and a faculty member of Ohio State’s Drug Enforcement and Policy Center. I am also a member of the Cancer Control Program at the OSUCCC – James, where my research focuses on FDA law and policy.
Cancer-relevant areas of interest include the intersection of state/local and FDA regulation; First Amendment constraints on government regulation of tobacco and drug industry speech; ethical and legal questions regarding cancer patients’ non-trial pre-approval access to investigational drugs; cannabis and psychedelic decriminalization and regulation; and questions regarding the scope of FDA jurisdiction (e.g., which things the FDA can regulate, and which things are properly considered drugs vs. tobacco products).
My work has been published in peer-reviewed scientific journals, including New England Journal of Medicine, JAMA, Science, Journal of Clinical Oncology, JAMA Oncology, and EMBO Molecular Medicine, as well as in leading legal journals. I am also a coauthor of the 5th edition of Food and Drug Law: Cases and Materials (with Peter Barton Hutt, the late Richard A. Merrill, Lewis A. Grossman, Nathan Cortez, and Erika Lietzan).
I currently serve on the Food and Drug Law Institute’s Board of Directors and on the International Society of Cell & Gene Therapy’s Committee on the Ethics of Cell and Gene Therapy, chairing its subcommittee on expanded access. Before my academic career, I was an associate chief counsel at the FDA.
Education & Training
More info forDoctorate - JD
- Stanford Law School
Stanford, CA
USA
- Stanford Law School
Academic Office & Contact Information
More info forAcademic Office:
55 W 12th Ave
Columbus, Ohio 43210-1391Email:
zettler.25@osu.eduPublications
More info forMay 21, 2024Stem Cells, Cell Therapies and Bioengineering in Lung Biology and Diseases 2023.
Hynds RE, Magin CM, Ikonomou L, Aschner Y, Beers MF, Burgess JK, Heise RL, Hume PS, Krasnodembskaya AD, Mei SHJ, Misharin AV, Park JA, Reynolds SD, Tschumperlin DJ, Tanneberger AE, Vaidyanathan S, Waters CM, Zettler PJ, Weiss DJ, Ryan AL
Am J Physiol Lung Cell Mol Physiol
May 10, 2024The Legal Landscape for Opioid Treatment Agreements.
Svirsky L, Howard D, Fried M, Richards N, Thomas N, Zettler PJ
Milbank Q
March 18, 2024Spree Bar, a vaping system delivering a synthetic nicotine analogue, marketed in the USA as 'PMTA exempt'.
Jordt SE, Jabba SV, Zettler PJ, Berman ML
Tob Control
November 14, 2023Clinician Perspectives on Opioid Treatment Agreements: A Qualitative Analysis of Focus Groups.
Richards N, Fried M, Svirsky L, Thomas N, Zettler PJ, Howard D
AJOB Empir Bioeth
September 1, 2023International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products.
Ikonomou L, Cuende N, Forte M, Grilley BJ, Levine AD, Munsie M, Rasko JEJ, Turner L, Bidkhori HR, Ciccocioppo R, Grignon F, Srivastava A, Weiss DJ, Zettler P, Levine BL, ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT)
Cytotherapy
April 25, 2023An International Society for Cell & Gene Therapy working group short report on the future of expanded access to unapproved cell and gene therapies.
Zettler PJ, Ikonomou L, Levine AD, Turner L, Grilley B, Roxland BE
Cytotherapy
May 8, 2022Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.
Cuende N, Ciccocioppo R, Forte M, Galipeau J, Ikonomou L, Levine BL, Srivastava A, Zettler PJ
Cytotherapy
May 25, 2021ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.
Lovell-Badge R, Anthony E, Barker RA, Bubela T, Brivanlou AH, Carpenter M, Charo RA, Clark A, Clayton E, Cong Y, Daley GQ, Fu J, Fujita M, Greenfield A, Goldman SA, Hill L, Hyun I, Isasi R, Kahn J, Kato K, Kim JS, Kimmelman J, Knoblich JA, Mathews D, Montserrat N, Mosher J, Munsie M, Nakauchi H, Naldini L, Naughton G, Niakan K, Ogbogu U, Pedersen R, Rivron N, Rooke H, Rossant J, Round J, Saitou M, Sipp D, Steffann J, Sugarman J, Surani A, Takahashi J, Tang F, Turner L, Zettler PJ, Zhai X
Stem Cell Reports