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 food and drug regulation, intellectual property, and administrative law.  Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.

Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC.  In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies.  This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010.  She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).

Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.

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

Testimony to House of Representatives Judiciary Committee – 7/27/17

Latest News

Professor Lietzan Presents Paper at Law and Biosciences Workshop

Professor Lietzan Speaks About Top Cases in Food and Drug Law

Professor Lietzan Lectures on the Hatch-Waxman Amendments

Professor Lietzan Quoted in Article about CBD

Professor Lietzan Quoted by CBS News on Pharmaceutical Manufacturing Recall

More News on Prof. Erika Lietzan

Most Recent Publications

Access Before Evidence and the Price of FDA’s New Drug Authorities, 53 UNIVERSITY OF RICHMOND LAW REVIEW __ (forthcoming 2019).

The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling, 69 AMERICAN UNIVERSITY LAW REVIEW 823 (2019).

The History and Political Economy of the Hatch-Waxman Amendments, 49 SETON HALL REVIEW 53 (2018).

Paper Promises for Drug Innovation, 25 GEORGE MASON LAW REVIEW __ (forthcoming 2018).

A Solution in Search of a Problem at the Biologics Frontier, 2018 UNIVERSITY OF ILLINOIS LAW REVIEW ONLINE 19 (2018).

More Publications By Erika Lietzan