Areas of Expertise
- Administrative Law
- Food and Drug Law
- Health Law
- Intellectual Property Law
- Marijuana/Cannabis Law
- Public Health Law
- Vaccine Regulation
About Erika Lietzan
Professor Lietzan focuses her scholarship and teaching primarily in the areas of health law and policy, administrative law, and intellectual property. She is a prolific scholar, with more than 40 published book chapters and articles in legal and scientific journals. Some of her recent scholarship has focused on 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 pathways forward for cannabis-derived medical and non-medical products.
Her most recent paper — relating to the history of generic drug substitution and the evolving relationship among pharmacy professionals, medical professionals, and patients over the 20th century — is forthcoming in the Wake Forest Law Review. Professor Lietzan also has deep expertise relating to the intersection of pharmaceutical patent law and the administrative state. She won an award for her 2018 paper on the history and political economy of the Hatch-Waxman (generic drug) statute, and her exhaustive empirical examination of new drug patent term restoration, which used a dataset she compiled from PTO and FDA sources, was published in the Washington Law Review last year. She is currently exploring the patent incentive for innovation in medical devices.
Professor Lietzan is a public member of the Administrative Conference of the United States, an independent federal agency that works on improvements to public administration, management, and administrative procedure. She has also been a 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. She held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
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, where 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
- Prof. Lietzen named Best Lawyer in America in FDA and Biotechnology & Life Sciences Law
- Professor Lietzan elected as a member of the CREDIMI
- Professor Lietzan Appointed to Food and Drug Law Leadership Positions
- Professor Lietzan named a “Best Lawyer in America” for 2020
- Professor Lietzan Among New Public Members of the Administrative Conference
Latest Publications from Erika Lietzan
- Ignoring Drug Trademarks
- Distorted Drug Patents
- Early Access to Unapproved Medicines in the United States and France,
- The “Evergreening” Metaphor in Intellectual Property Scholarship
- Access Before Evidence and the Price of FDA’s New Drug Authorities