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 historical circumstances surrounding enactment of the Hatch-Waxman (generic drug) statute, on incentives to continue studying already approved drugs, on the competitive landscape for innovative biological medicines and their biosimilar copies, and on the relationship between the length of the new drug R&D process and incentives to innovate.  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 deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010.  She has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004.  And 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 received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history.  She hold 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 Featured on Webcast about New Uses for Established Drugs

Professor Lietzan Speaks About FDA Regulation of Direct-to-Consumer Genetic Testing

Professor Lietzan Speaks at Conference about New Uses of Established Drugs

Professor Lietzan Presents Research Examining Impact of Pharmaceutical Regulation

Professor Lietzan Speaks on Panel at Supreme Court IP Review

More News on Prof. Erika Lietzan

Most Recent Publications

The Political Economy of the Hatch-Waxman Amendments, __ SETON HALL REVIEW __ (forthcoming).

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).

Antitrust Abuses and the FDA Approval Process: Statement Before the Committee on the Judiciary’s Subcommittee on Regulatory Reform, Commercial, and Antitrust Law U.S. House of Representatives,

The Drug Innovation Paradox, University of Missouri School of Law Legal Studies Research Paper No. 2017-12.

More Publications By Erika Lietzan