Erika Lietzan

About Erika Lietzan

Professor Lietzan, who also holds a courtesy appointment in the College of Health Sciences,focuses her scholarship and teaching primarily in the areas of FDA law, 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 most recently published article considered the impact of the Loper Bright decision on FDA, taking into account the agency’s track record in court both before after the Chevron decision that it overruled.  Another recent article examined the role of petitioning in the modern administrative state, and this fall she is completing a project that assesses fifty years of petitions filed with FDA (from July 1975 to July 2025).  Another project, which built 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; and a review of the costs and benefits of regulating, under the new drug approval framework, medical product innovation that emerges from academic medical settings.

Professor Lietzan is a Senior Fellow at the Administrative Conference of the United States (ACUS) and previously served as both a public member of the agency and Chair of its Committee on Administration and Management.  ACUS is a 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.

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 FDA law.

Areas of Expertise

  • Administrative Law
  • Food and Drug Law
  • Health Law
  • Intellectual Property Law
  • Marijuana/Cannabis Law
  • Public Health Law
  • Vaccine Regulation

Educational Background

  • BA with honors, University of North Carolina,'90
  • MA, University of California, '92
  • JD cum laude, Duke Law School, '95

Recent Publications

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