Areas of Expertise

About Erika Lietzan

Professor Lietzan focuses her scholarship and teaching primarily in the areas of health law and policy (with a special focus on FDA regulation), administrative law, and intellectual property.  She is a prolific scholar, with more than 40 published book chapters and articles in legal and scientific journals.

Professor Lietzan is a public member of the Administrative Conference of the United States (ACUS), an independent federal agency that convenes to discuss and recommend on improvements to public administration, management, and administrative procedure, serving on its Committee on Regulation.  She has also been an elected member of the American Law Institute since 2006.  And she 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.

Professor Lietzan most recent project — as a consultant for ACUS — entailed exploring the history of federal agency user fees, examining user fee design and implementation across the full range of federal agencies, and offering recommendations for user fee design in the future. She is currently working on a series of articles that examine the role of petitioning in the modern administrative state, grounded in part in review of the more than 6000 petitions FDA has received since the summer of 1975.  Other significant papers in recent years included a meticulous debunking of the empirical case for claims that drug companies engage in evergreening, and an exhaustive history of generic drug substitution and the evolving relationship among pharmacy professionals, medical professionals, and patients over the 20th century.  Some of her other work has explored the history of and broader sociocultural context for expanded access (compassionate use) policies for unapproved medicines in the United States and France, the costs and benefits of regulating medical product innovation that emerges from academic medical settings, and plausible regulatory pathways for cannabis-derived medical and non-medical products.

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.  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).  In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting companies regulated by FDA.  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.

Professor Lietzan received a bachelor’s degree from the University of North Carolina, from which 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.

Latest News Featuring Erika Lietzan

• Professor Lietzen Fall 2023 Scholarship Recap
• Prof. Lietzan named to Best Lawyers List
• Are Drug Companies the Villain?
• Prof. Lietzan publishes new paper on why medical device companies rarely renew patents
• Prof. Erika Lietzan Re-appointed to ACUS, Named to Best Lawyer in America List

Latest Publications from Erika Lietzan

• User Fee Programs: Design Choices and Processes
• Solutions Still Searching for a Problem: A Call for Relevant Data to Support “Evergreening” Allegations
• The Case of the Missing Device Patents, or: Why Device Patents Matter
• Ignoring Drug Trademarks
• Distorted Drug Patents