Professor Erika 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.
Various media outlets have reached out to her for her expertise on the FDA and the approval process during the COVID-19 pandemic.
Bloomberg Law, June 24, 2020: Trump in Danger Zone if Agencies Rush to Make Virus Rules Stick
Bloomberg, April 11, 2020: False Negatives Raise Doctors’ Doubts About Coronavirus Tests
Science, April 7, 2020: Former FDA leaders decry emergency authorization of malaria drugs for coronavirus
Pharmalot, March 12, 2020: A quarantined Ted Cruz proposes to speed approvals for coronavirus drugs and vaccines
PolitiFact.org, March 6, 2020: Trump wrongly blames Obama for limits on coronavirus testing
FactCheck.org, March 6, 2020: Trump’s Misplaced Blame on Obama for Coronavirus Tests
TPM (Talking Points Memo), March 5, 2020: The Trump Coronavirus Team Keeps Falsely Blaming Obama For Testing Disaster
June 12, 2020: Professor Lietzan spoke at The Federalist Society’s COVID-19 & the Law Conference, contributing to the panel Regulation or “Don’t Let a Good Crisis Go to Waste.” She focused on decisions by regulators to de-regulate during the crisis — decisions to exercise enforcement discretion, to waive paperwork requirements, and to remove otherwise applicable restrictions — including decisions made by FDA in regards to medical products. She pointed out that regulation should always address a problem and that a rational regulatory approach balances the costs of regulating with the benefits achieved. And she argued that the last six months have generated important information that can help policymakers and the public reflect — later — on the costs and benefits of the regulatory requirements that were temporarily lifted or adjusted. Thoughtful reflection when the crisis subsides may lead to better evidence-based approaches to regulation. The virtual conference was June 11-12 and consisted of six panels covering a range of legal issues related to the COVID-19 pandemic. Each panel is available to watch as a webinar, accessible through the main conference website. Professor Lietzan’s panel is linked above; she appears around the 23-minute mark.
April 20, 2020: “Isolated by the Law, Part 2,” a virtual, asynchronous symposium hosted by Wake Forest Law School, the Wake Forest Center for Bioethics, Health & Society and the Wake Forest Journal of Law and Policy. Professor Lietzan will discuss the FDA process and its goals of robust proof of safety and effectiveness, the tradeoffs involved, and the reasons people sometimes seek earlier access, along with COVID-19 and the use of possible (unapproved) therapies for treatment.