In this blog, we explore legal and policy issues associated with the U.S. Food and Drug Administration (FDA), an important and (we think) particularly interesting agency that has broad powers to achieve its public health mission and jurisdiction over roughly 25% of the consumer economy. As some readers will know, the title of our blog, “Objective Intent,” comes from FDA regulations that define “intended use.” This title both pays homage to the critical role that a product’s intended use plays in many FDA controversies and reflects our hope that this blog will serve as a space for objective reflection on FDA issues by legal academics.
Erika Lietzan is a law professor at the University of Missouri School of Law in Columbia, Missouri and was, before that, a partner in the FDA practice group of Covington & Burling LLP. She teaches and writes about drug and device law, food law and policy, administrative law, and intellectual property. Erika has deep expertise in the regulation of drugs, biological products, and medical devices but over the course of 18 years in private practice handled matters spanning the full scope of FDA law — including regulation of conventional foods, dietary supplements, cosmetics, human cell and tissue products, tobacco products, and animal drugs. Her work was wide-ranging, from life-cycle management and strategy issues, to regulatory strategy and advocacy, to high-stakes white collar defense, to congressional investigations, briefing in products liability cases, and international regulatory policy work. More information about her scholarship and prior practice (and a CV) can be found here. Her research can be found here, and she tweets at @lietzan.
Patti Zettler is a law professor at The Ohio State University Moritz College of Law, a faculty member of the Drug Enforcement & Policy Center housed at the College of Law, and a member of The Ohio State University Comprehensive Cancer Center. She teaches and writes about the FDA, health law and policy, legislation and regulation, and torts. Prior to joining Ohio State, she was a faculty member of the Center for Law, Health & Society at Georgia State University College of Law. She also served as a fellow at the Center for Law and the Biosciences at Stanford Law School, and, before entering academics, as an associate chief counsel in the FDA’s Office of the Chief Counsel. In that role, she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, and advisory committees. Additionally, she bioethics experience through work at the Program in Medical Ethics at the University of California San Francisco and at the Department of Bioethics at the National Institutes of Health. She received her undergraduate and law degrees from Stanford, both with distinction. More information about her work, including links to her research and a CV, can be found here. She tweets at @pzettler.