Erika Lietzan

Associate Professor of Law

BA with honors, University of North Carolina,'90
MA, University of California, '92
JD cum laude, Duke Law School, '95

Curriculum Vitae (PDF)

Professor Lietzan researches, writes, and teaches primarily in the areas of drug and device regulation, intellectual property, and administrative law. Some of her recent academic scholarship has focused on the impact of the new biosimilars law on innovation and competition in biological medicines, on the incentive for generic drug applicants to challenge innovator patents, on data exclusivity for drug and biological medicine innovators, and on mandatory release to the public and competitors of clinical data in drug applications. She has also written significant pieces about the preemption of failure to warn suits against drug companies and about conflicts of interest on FDA’s advisory committees. For practitioners, she has written book chapters on the regulation of biosimilar biological products and the regulation of drug and device clinical trials, as well as more than a dozen shorter pieces for a variety of other publications, including two empirical pieces on judicial review of FDA action.

Professor Lietzan brings to her scholarship, and her teaching, eighteen years of private practice experience, eight of them as an equity partner at Covington & Burling LLP in Washington, DC. At Covington she specialized in FDA regulation of drugs, biologics, and medical devices. She represented both individual companies and trade associations, thus handling both complex legal problems and broader legislative and regulatory policy questions. Her work was wide-ranging, from lifecycle 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. Professor Lietzan was involved in every major amendment to the FDCA between 1997 and 2014, working as outside counsel (and sometimes lobbyist) for various individual biopharmaceutical companies as well as the trade association, PhRMA. She was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010 (creating a pathway for approval of biosimilars), from initial thinking as early as 2002 through negotiation of the primary legislative language in 2006 and 2007, passage in 2009, and enactment in 2010. After enactment, working with two colleagues, she published a comprehensive “legislative history” of this process in the Food and Drug Law Journal. She also worked with individual companies and trade associations on implementation issues from 2010 through 2014.

Professor Lietzan is an elected member of the American Law Institute.  She serves in the leadership of the Science and Technology Section of the American Bar Association and in the leadership of the Food and Drug Law Institute, and she is an active member of the American Health Lawyers Association, the American Intellectual Property Law Association, and the American Society of Law, Medicine, and Ethics.

Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history.  She received a master’s degree in intellectual history from UCLA and a law degree with high honors from Duke Law School.

Latest News

Professor Lietzan Discusses Executive Order’s Possible Impact on Food and Drug Administration

Professor Lietzan Presents “The Drug Innovation Paradox”

Proposed Legislation Reflects a Misunderstanding of Drug Safety Programs: Professor Lietzan in The Hill

Mizzou Law Faculty Member Receives Thomas Edison Innovation Fellowship

FDA’s Approval of Drug Fell Within Legal Authority: Professor Lietzan

More News on Prof. Erika Lietzan

Most Recent Publications

The Uncharted Waters of Competition and Innovation in Biological Medicines, 44 FLORIDA STATE UNIVERSITY LAW REVIEW __ (forthcoming 2017).

A Second Look at the CREATES Act: What’s Not Being Said, 17 FEDERALIST SOCIETY REVIEW 28 (2016).

The Law of 180-Day Exclusivity with Julia Post, 71 FOOD AND DRUG LAW JOURNAL 327 (2016).

The Myths of Data Exclusivity, 20 LEWIS AND CLARK REVIEW 91 (2015)

Medical Biotechnology: Premarket and Postmarket Regulation, editor, (ABA, 2015)

More Publications By Erika Lietzan