Associate Professor Erika Lietzan, JD

Member of International Advisory Board, GaBI Journal

Associate Professor of Law, University of Missouri School of Law, USA
Professor Lietzan received a Bachelor’s degree from the University of North Carolina, USA, in 1990, where she graduated with honours in history. She received a Master’s degree in intellectual history from the University of California in 1992, and then a law degree with high honours from Duke Law School in 1995, graduating fifth in her class.

Professor Lietzan is currently an Associate Professor of Law at the University of Missouri School of Law, where she teaches courses in the areas of drug and device regulation and intellectual property. She She has also taught food and drug law at the George Mason University School of Law (Spring 2014) and drug and device law at the Georgetown University Law Center (Spring 2010).

Between 1992 and 1995, she served as a law clerk to the Honorable Gerald B Tjoflat of the United States Court of Appeals for the Eleventh Circuit before joining Covington & Burling in 2002 as an associate, where in 2006 she became a partner. In addition to her tenure at Covington, she served as an Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America, in Washington, DC.

In private practice, Professor Lietzan specialized in the regulation of drugs, biological products, and medical devices. She had a broad ranging practice that ultimately included regulatory and strategic counselling, advocacy in courts and before federal agencies, legislative drafting and lobbying, advice and assistance with international trade policy and non-US legislation and regulation, service as an expert witness on regulatory and intellectual property issues, transactional and licensing work, and white collar defence. She played a key role representing the innovative industry in the multi-year negotiation leading to the Biologics Price Competition and Innovation Act and is known internationally for her expertise in the law, regulation and public policy relating to generic drugs and biosimilar biologicals. She also served on the Covington Evaluation Committee (assessing candidates for promotion to partnership) for several years and was responsible for professional development of associates in her practice group for many years.

She is an elected member of the American Law Institute. She also serves in the leadership of the Science and Technology Section of the American Bar Association, now chairing its Life Sciences Division, which includes the Biotechnology Committee (which she chaired for many years), Medical Device Committee, and several other committees. She also served as (pro bono) general counsel of the FDA Alumni Association for several years, and she was a member of the board of directors of the Food and Drug Law Institute, now serving on its Drugs and Biologics Committee. She also consulted for IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data in 2014.

Professor Lietzan served as an editor of the American Bar Association’s treatise, Biotechnology and the Law, and she has written more than a dozen shorter pieces for a variety of other publications, including two empirical pieces on judicial review of the US Food and Drug Administration (FDA) decisions. She researches and writes primarily in the areas of drug and device regulation, intellectual property and administrative law. She has published 16 science and law journal articles on, among other things, the release of safety and effectiveness data in drug marketing applications, generic drug exclusivity under the Hatch-Waxman Act, preemption of failure to warn suits against biopharmaceutical manufacturers, conflicts of interest on advisory committees serving the FDA, and the disgorgement remedy theory for violations of the Federal Food, Drug, and Cosmetic Act. She has written several books, monographs and book chapters, including on the law and policy of biosimilar biological products, federal regulation of clinical trials and the application of First Amendment principles to health claims on foods and dietary supplements.

Professor Lietzan is a frequent public speaker at law school and regulatory conferences on drug and biological regulatory and intellectual property issues. She has presented at over 50 professional conferences, workshops and webinars, where she gave presentations, among others, on topics of regulatory standards and expectations for biosimilar biological medicines, biosimilars development, naming, labelling, interchangeability and substitution, and clinical data transparency initiatives. Professor Lietzan has also given presentations at several private workshop and invited talks. She regularly comments for trade press journals on the FDA and intellectual property law.

Professor Lietzan has been consistently voted by her peers in the bar as one of the ‘Best Lawyers in America’ in both biotechnology law and US FDA law. She received the award for Washington DC Biotech Lawyer of the Year 2011, and Washington DC Super Lawyers and Rising Stars in years 2012–2014. She has also received an award for International Who’s Who of Life Sciences Lawyers in 2013, and Who’s Who in America in 2014

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