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.  She recently completed a historical and empirical examination of the new drug research and development paradigm in the United States and the relationship between the length of that process and incentives to innovate. Her other recent academic papers have focused on innovation and competition in the marketplace for biological medicines, the incentive for generic drug applicants to challenge innovator patents, data exclusivity for drug and biological medicine innovators, and mandatory disclosure to the public and competitors of clinical data in drug applications. Other papers have included 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. Professor Lietzan has also published 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 a partner at Covington & Burling in Washington, DC. In practice, she represented individual companies and trade associations, handling both complex legal problems and broader legislative and regulatory policy questions. Her 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. Professor Lietzan was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014, working as outside counsel (and sometimes lobbyist) for various individual 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 she co-authored 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 Food & Drug Law Institute and served for many years in the leadership of the Science and Technology Section of the American Bar Association. She is also 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 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 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

Pan American Journal of Public Health Publishes Letter from Professor Lietzan

Professor Lietzan Named Best Lawyer in FDA Law and Biotechnology Law

More News on Prof. Erika Lietzan

Most Recent Publications

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.

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).

More Publications By Erika Lietzan