Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
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.
Managing Director, Alvarez & Marsal Healthcare Industry Group
With prior service as Deputy General Counsel of the U.S. Department of Health and Human Services and as Executive Vice President and General Counsel of Tenet Healthcare, he brings more than 20 years of experience in addressing challenging healthcare issues in government and private industry.
Mr. Urbanowicz regularly advises boards of directors, senior management, investors and lenders of health care organizations facing significant regulatory, compliance, financial or operating challenges. His clients include healthcare providers, payors and suppliers.
Recent engagements include: serving as a federally-appointed hospital restructuring and safety monitor; compliance and operational improvements for publicly-traded and not-for-profit Medicare Advantage plans, Medicare Prescription Drug Plans (PDP) and Medicaid managed care companies; renegotiating of government debt for a major hospital system; restructuring advisory services to the Medicaid program of a large state; numerous internal and government investigations involving healthcare providers including: academic health systems, medical device companies, pharmaceutical manufacturers, long term care hospital companies, hospice providers, dental services companies and disease management companies.
Mr. Urbanowicz also serves on the board of directors of Maxim Healthcare Services, one of the nation’s largest home health services companies, and chairs the company’s compliance committee.
As Deputy General Counsel of HHS, from 2001 to 2003, Mr. Urbanowicz served as the senior legal adviser to the Secretary of Health and Human Services on significant federal healthcare policy issues including Medicare and Medicaid provider payment and fraud and abuse enforcement policy. He was part of the team that drafted the historic Medicare Prescription Drug Act of 2003.
During his tenure at Tenet, Mr. Urbanowicz was responsible for successfully resolving several major federal criminal investigations and civil lawsuits facing Tenet by the U.S. Department of Justice, the Securities and Exchange Commission, and the HHS Office of Inspector General. Prior to his government service, he was a partner in the law firm of Locke, Liddell & Sapp.
Mr. Urbanowicz earned a bachelor of arts’ degree and a Juris Doctor degree from Tulane University. He is admitted to the bars of the District of Columbia, the U.S. Supreme Court and the Louisiana Supreme Court, and is a member of the American Law Institute.
A Second Look at the CREATES Act: What’s Not Being Said
Erika Lietzan
Note from the Editor: This article critically discusses the CREATES Act, which is currently pending...
Constitutional Implications of an “Individual Mandate” in Health Care Reform
Dennis G. Smith, Peter Urbanowicz
The Federalist Society takes no position on particular legal or public policy initiatives. Any expressions...
2002 National Lawyers Convention
The Constitution, National Security, and Foreign Affairs
Washington, DC