Areas of Expertise

About Erika Lietzan

Professor Lietzan focuses her scholarship and teaching primarily in the areas of FDA law (and health law more generally), administrative law, and intellectual property. She 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.

Professor Lietzan’s latest article examines the role of petitioning in the modern administrative state, grounded in part in review of thousands of petitions FDA has received since the summer of 1975. Another recent article, which builds off a report she prepared as a consultant to the Administrative Conference of the United States, explores the history of federal agency user fees, examines user fee design and implementation across the full range of federal agencies, and offers recommendations for user fee design in the future. Other significant papers in recent years have included an exhaustive history of generic drug substitution and the evolving relationship among pharmacy professionals, medical professionals, and patients over the 20th century; a history of and analysis of the broader sociocultural context for expanded access policies for unapproved medicines in the United States and France; a review of the costs and benefits of regulating, under the new drug approval framework, medical product innovation that emerges from academic medical settings; and an exploration of the plausible regulatory pathways for cannabis-derived medical and non-medical products.

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. 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.

In private practice, Professor Lietzan 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. 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).

Latest News Featuring Erika Lietzan

• Professors Mitchell, Freyermuth and Lietzan win 2024 Mizzou Law Faculty Awards
• Professor Lietzan Speaks at Food & Drug Law Institute Annual Meeting
• Professor Lietzen Fall 2023 Scholarship Recap
• Prof. Lietzan named to Best Lawyers List
• Are Drug Companies the Villain?

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