Erika Lietzan

Erika Lietzan specializes in regulation of drugs and biological products, with a particular focus on aspects that have an intellectual property component: biosimilar regulation and policy (domestically and abroad); the Hatch-Waxman amendments; data and market exclusivities; innovator lifecycle strategy; generic (180-day) exclusivity; and patent linkage. She also specializes in the regulation of clinical trials; access issues (e.g., shortages, counterfeiting, pedigrees, importation, and online pharmacy); and issues with a substantial constitutional law component, including First Amendment and Takings Clause issues. Ms. Lietzan taught food and drug law at Georgetown University Law Center in 2010. She has conducted numerous training programs (through FDLI) in drug law at FDA, for instance on post-approval regulation of biologics and intellectual property issues associated with FDA regulation. She has served as an expert witness in two cases, one involving Hatch-Waxman issues and one involving a wide range of FDA regulatory and state pharmacy and medical practice law issues. She has testified before a state agency on First Amendment issues, and she has given nearly 60 additional speeches on a wide variety of topics at professional conferences, workshops, and conventions. Topics include preemption of product liability cases involving FDA-approved products; law and policy relating to clinical trial data disclosure; commercial speech principles as applied in the biopharmaceutical space; expanded access and compassionate use regulations and policy considerations; and prescription drug diversion and abuse. Ms. Lietzan is an elected member of the American Law Institute. She is also past chair of the Biotechnology Committee of the American Bar Association (Science & Technology Section). REPRESENTATIVE MATTERS Representation of various innovative biopharmaceutical companies with respect to biosimilar legislation and implementation of biosimilar pathways worldwide. Advice to and representation of PhRMA in international, federal, and state matters including with respect to follow-on biologics, drug safety, preemption, Hatch-Waxman reform, prescription drug marketing, direct-to-consumer advertising, clinical trials, importation, and ex-US pricing and reimbursement procedures. Preparation of amicus briefs, including in Wyeth v. Levine (for PhRMA and BIO); drafting regulatory briefs in major product liability actions and other civil litigation. PREVIOUS EXPERIENCE PhRMA, Assistant General Counsel (September 2002 – April 2005) HONORS AND RANKINGS Best Lawyers, Washington, DC Biotechnology Law Lawyer of the Year (2012) Best Lawyers in America, Biotechnology Law (2006–present) Washington DC Super Lawyers, FDA (2012-2013) The International Who's Who of Life Sciences Lawyers (2012) American Law Institute, Member MEMBERSHIPS AND AFFILIATIONS ABA, Science & Technology Section (2002-present) Food and Drug Law Institute: Austern Writing Awards Committee (2013-present); Board of Directors (2008–2012), Food & Drug Law Journal, Editorial Advisory Board (2004–2008) AHLA, Life Science Practice Group, Regulatory Group Co-Chair (2007–2012) ABA/AAAS, National Conference of Lawyers & Scientists (2003–2009), Co-Chair (2006–2009) ABA, Special Committee on Bioethics & the Law (2006–2009)