Category: Prof. Erika Lietzan ⋅ Page 1

Professor Lietzan named a “Best Lawyer in America” for 2020

Professor Erika Lietzan has again been named a “Best Lawyer in America” in both FDA Law and Biotechnology & Life Sciences. This marks the seventh year in a row for FDA Law and the thirteenth year in a row for Biotechnology Law. The Best Lawyers honor is meant to identify the top 5 percent of practicing attorneys in the United…

Professor Lietzan Among New Public Members of the Administrative Conference

Professor Erika Lietzan has been appointed as one of eight new public members of the Administrative Conference of the United States (ACUS). ACUS is an independent federal agency dedicated to improving the administrative process through consensus-driven applied research and providing nonpartisan expert advice and recommendations for federal agency procedures. Its public members are academics, practicing lawyers, and other experts drawn…

Professor Lietzan publishes in Yale Journal of Health Policy, Law, and Ethics

Professor Erika Lietzan has published a new article, Early Access to Unapproved Medicines in the United States and France, 19 Yale J. Health Pol’y L. & Ethics (2020). She, along with co-author Isabelle Moine-Dupuis, wrote about the new U.S. law on early access to experimental medicine. Lietzan and Moine-Dupuis explore the historical, legal, and cultural differences in the early access systems…

Professor Lietzan speaks at The Federalist Society’s COVID-19 & the Law Conference

Professor Erika 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…

Professor Lietzan lectures at World Intellectual Property Organization summer program

On June 12, Professor Erika Lietzan delivered a lecture on intellectual property in the life sciences sector as part of the WIPO-CPIP Summer School. This exclusive two-week summer course provides a deep dive into IP law and policy for students, professionals, and government officials from around the world. Professor Lietzan explained what makes intellectual property law and policy different in…

Professor Lietzan’s FDA Expertise Sought by National & International Media

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)…

Professor Lietzan speaks to Akron law students about perils of patent reform

At a recent event at the University of Akron School of Law, Professor Erika Lietzan spoke about what she called the “assault on drug patents,” including patent reform activity in Congress as well as proposals to prevent drug companies from patenting any changes or improvements to their drugs after approval (so called “one and done” proposals).  She explained that medical…

Professor Lietzan continues to write about the FDA regulation of CBD products

In a recent editorial for Drug Discovery Today, “A special exception for CBD in foods and supplements?”, Professor Erika Lietzan and co-author Patricia J. Zettler,  write about the emerging cannabidiol (CBD) market. They explain that most foods and dietary supplements containing CBD – even CBD from hemp — violate FDA’s “drug exclusion rules.” FDA has not been taking enforcement action,…

Professor Lietzan’s Research Analyzes Patent Terms for New Medicine

A recent article in Bloomberg Law, U.S. Patent System Crimps Drug Innovation for Toughest Diseases, looks at the research of Professor Erika Lietzan and Kristina M.L. Acri about how the development of new drugs is affected by the U.S. patent system. Their research will be published in a forthcoming article. Their empirical research looked at 642 approved drugs to determine…

Professor Lietzan Named a “Best Lawyer in America”

Professor Erika Lietzan has again been named a “Best Lawyer in America”  in both FDA Law and Biotechnology & Life Sciences. This marks the sixth year in a row for FDA Law and the twelfth year in a row for Biotechnology Law. The Best Lawyers honor is meant to identify the top 5 percent of practicing attorneys in the United…