Areas of Expertise
- Administrative Law
- Copyright Law
- Drug and Device Law
- FDA Law
- Fraud and Abuse Law
- Health Law
- Intellectual Property Law
- Legislation (lobbying and government relations)
- Marijuana/Cannabis Law
- Patent Law
- Public Health Law (Bioterrorism)
- Trade Secret Law
- Vaccine Regulation (Vaccine Injury)
About Erika Lietzan
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
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. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. 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 was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. 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).
Professor Lietzan 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 also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
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.
Testimony to House of Representatives Judiciary Committee – 7/27/17
Latest News Featuring Erika Lietzan
- Professor Lietzan Named a “Best Lawyer in America”
- Professor Lietzan Presents Paper at Law and Biosciences Workshop
- Professor Lietzan Speaks About Top Cases in Food and Drug Law
- Professor Lietzan Lectures on the Hatch-Waxman Amendments
- Professor Lietzan Quoted in Article about CBD
Latest Publications from Erika Lietzan
- Access Before Evidence and the Price of FDA’s New Drug Authorities
- The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling
- The History and Political Economy of the Hatch-Waxman Amendments
- Paper Promises for Drug Innovation
- A Solution in Search of a Problem at the Biologics Frontier