Senior Fellow, Competitive Enterprise Institute
Joel M. Zinberg, M.D., J.D. is a senior fellow with the Competitive Enterprise Institute. He is a native New Yorker who recently completed two years as General Counsel and Senior Economist at the Council of Economic Advisers in the Executive Office of the President. He practiced general and oncologic surgery in New York for nearly 30 years at the Mount Sinai Hospital and Icahn School of Medicine where he is an Associate Clinical Professor of Surgery. He has been involved with health policy issues and the interaction between law and medicine for his entire career. Dr. Zinberg taught for 10 years at the Columbia University Law School as a Lecturer in Law where he created a course on the legal, policy and ethical issues surrounding organ transplantation. He served for many years on the New York State Board of Professional Medical Conduct and on Mount Sinai's Ethics Committee and Institutional Review Board. He is past President and Trustee of the New York County Medical Society. Between 2015 and 2017 he was a Visiting Scholar at the American Enterprise Institute.
Dr. Zinberg has written for publications as varied as the Journal of the American Medical Association, the Bulletin of the American College of Surgeons, the Wall Street Journal, City Journal and law reviews. He is the author of book chapters on legal and policy issues in organ transplantation.
He received his J.D. degree from the Yale Law School, his M.D. from the Columbia University College of Physicians and Surgeons and his B.A. in economics with High Honors, Phi Beta Kappa, from Swarthmore College.
Partner and Co-Chair, Public Policy Group, Shook Hardy & Bacon LLP
Mark Behrens co-chairs Shook's Washington, DC-based Public Policy Practice Group and is a leading national expert on civil justice issues with over thirty years of experience. A substantial part of his practice is working to improve the civil litigation environment through state and federal legislation; in the courts through amicus curiae briefs; through legal scholarship and judicial education; and in the court of public opinion.
Mark is actively involved in civil justice reform efforts at the federal and state levels. He has testified before the U.S. Congress and most state legislatures on behalf of business and civil justice organizations. Mark also has an active amicus brief practice specializing in tort liability and civil justice issues. He has authored or co-authored over 150 amicus briefs in cases before the United States Supreme Court and federal and state appellate courts on behalf of business, civil justice, and defense lawyer organizations. In addition, Mark routinely files comments on behalf of business, civil justice, and defense lawyer organizations regarding potential changes to federal and state court rules. He chairs the International Association of Defense Counsel’s (IADC) Civil Justice Response Committee and serves on the Board of Directors of Lawyers for Civil Justice (LCJ).
Mark is a member of the American Law Institute (ALI). He received his J.D. in 1990 from Vanderbilt University Law School, where he was a member of the Vanderbilt Law Review. He received his B.A. in economics from the University of Wisconsin in 1987.
Assistant Attorney General, Office of Legal Counsel, U.S. Department of Justice
T. Elliot Gaiser is the Office of Legal Counsel’s 27th Assistant Attorney General. He was nominated by President Donald Trump on April 29, 2025, confirmed by the United States Senate on July 30, 2025, and sworn in as AAG by Attorney General Pam Bondi on August 4, 2025.
Prior to joining the Office of Legal Counsel, Mr. Gaiser served as the 11th Solicitor General of Ohio. In that role, he represented his home state and its agencies before the Supreme Court of the United States, the United States Court of Appeals for the Sixth Circuit, the Supreme Court of Ohio, and other state and federal courts. He also advised Ohio Attorney General Dave Yost on significant legal and constitutional matters important to the people of Ohio.
Mr. Gaiser clerked for Justice Samuel A. Alito, Jr. of the Supreme Court of the United States, Judge Neomi Rao of the United States Court of Appeals for the D.C. Circuit, and Judge Edith H. Jones of the United States Court of Appeals for the Fifth Circuit. In the private sector, Mr. Gaiser worked at the law firms Jones Day, Boyden Gray, and Gibson Dunn. He graduated from the University of Chicago Law School and Hillsdale College. He is also a husband and father.
Chief Counsel, U.S. Food and Drug Administration; Deputy General Counsel, Department of Health and Human Services
Stacy Cline Amin serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. Stacy serves as the senior legal advisor to the Commissioner, FDA leadership, the HHS General Counsel and Departmental leadership on FDA regulatory and litigation matters. Stacy leads an office of 165 lawyers and support staff that provide counseling and litigation support to the agency.
Stacy previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. In that role, Stacy advised on critical matters arising under the Food Drug and Cosmetic Act, helped lead the Administration's efforts to combat the opioid crisis, led multi-agency teams in the evaluation of high profile administrative actions, and successfully coordinated litigation strategy with the Department of Justice.
Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. In Congress, Stacy frequently advised on Food Drug and Cosmetic Act issues and led bipartisan and bicameral investigations to promote patient safety and global public health. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013 and the 21st Century Cures Act of 2016.
Earlier in her career, she served as an Associate at Sullivan & Cromwell LLP and as a law clerk to the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit. She graduated cum laude from Harvard Law School and summa cum laude from The George Washington University.
Attorney General, Alaska
Stephen J. Cox serves as the 28th Attorney General of the State of Alaska, where he oversees the state’s legal affairs and serves as the chief prosecutor with oversight of all district attorneys, general counsel to the Governor and executive branch, and represents the State in all civil and criminal cases in federal and state court. He brings to the role a proven record of public service at the highest levels of the U.S. Department of Justice, combined with deep experience in Alaska’s private sector and community life.
Before his appointment, he was Senior Vice President, Chief Legal and Strategy Officer of Bristol Bay Industrial—an investment platform of the Bristol Bay Native Corporation—acting as the chief legal officer for the industrial services portfolio on behalf of the Alaska Native shareholders in the Bristol Bay region. In that role, he led legal, compliance, and strategic planning for major energy, infrastructure, and utility projects across the State and in the Lower 48.
Earlier in his career, beginning in 2011, Cox served as in-house counsel for Apache Corporation, where he was the principal attorney for Apache Alaska and focused on new ventures and exploratory work in Cook Inlet, including seismic initiatives and ongoing regulatory coordination with state agencies.
Cox is deeply rooted in Anchorage’s community and faith life. He and his family attend Holy Family Old Cathedral in downtown Anchorage and support Mission Alaska, the Dominican friars’ outreach ministry under the Western Dominican Province. He was the founding board president and chairman of a new classical school in South Anchorage.
On the national stage, Cox held senior leadership roles in the U.S. Department of Justice under the Trump Administration. As Deputy Associate Attorney General, he co-chaired the DOJ’s Regulatory Reform Task Force and the Working Group on Corporate Enforcement and Accountability, and helped implement landmark policies aimed at curbing regulatory overreach and aligning enforcement with fairness and oversight. Later, as U.S. Attorney for the Eastern District of Texas, he oversaw prosecutions and civil litigation spanning 43 counties, prioritizing healthcare fraud, elder fraud, and violent crime while ensuring enforcement remained transparent and fair.
Earlier in his career, Cox practiced complex litigation at a major international law firm, served as counselor to the Director of U.S. Immigration and Customs Enforcement, and helped lead the William H. Webster Commission, which reviewed FBI counterterrorism intelligence and operations following the Fort Hood tragedy.
He began his legal career with a clerkship for Judge J. L. Edmondson of the U.S. Court of Appeals for the Eleventh Circuit. Cox earned a B.S. in Computer Science from Texas A&M University and a J.D., summa cum laude, from the University of Houston Law Center. He and his wife, Cristina, are raising their three children in Anchorage, and have made Alaska their home.
Operating Advisor, Clayton, Dubilier & Rice
Anand Shah, MD, is an Operating Advisor at private equity firm Clayton, Dubilier & Rice. Dr. Shah develops and identifies potential investment opportunities in the healthcare industry with a focus on health care services, including the provider, payer, and HCIT sectors. He also serves as an advisor to the firm’s portfolio companies.
A nationally recognized physician leader and health policy expert, Dr. Shah has extensive healthcare experience in the senior-most levels of the U.S. government, private sector, and as a physician. He was previously the Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration (FDA). Dr. Shah led consensus policy development for fit-for-purpose programs including Advanced Manufacturing, the Coronavirus Treatment Acceleration Program, Covid vaccine development, digital health, consumer protection, and decentralized clinical trials. During the Covid pandemic, he led FDA’s policy development for preparedness and recovery efforts. Dr. Shah represented FDA with top-level policy makers of the White House and Cabinet, Governors and local governments, and regularly led briefings with Congressional leadership.
He previously served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS). As Senior Medical Advisor, he was the primary counselor for agency-wide policy related to medical and scientific innovation. Dr. Shah established consensus on several critical policy initiatives including aligning payment and prevention to increase Medicare beneficiaries’ access to novel antimicrobials, expanding patients’ access to cell and gene therapies, and streamlining Medicare access to breakthrough technologies. As the Chief Medical Officer of the Center for Medicare & Medicaid Innovation (CMMI), Dr. Shah led the clinical design of novel value-based payment and service delivery models including those for primary and specialty care.
Dr. Shah specializes in the early detection, surveillance, and treatment of prostate cancer, and previously developed and led a survivorship clinic for patients on cancer clinical trials at the National Institutes of Health. His scientific track record includes publications in the New England Journal of Medicine, JAMA, Health Affairs, Cancer, and Nature Reviews Drug Discovery. Dr. Shah is an Adjunct Professor with the Department of Medical Ethics and Health Policy and an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania.
Dr. Shah was chief resident during his radiation oncology residency at Columbia University. He concurrently earned his MD from the University of Pennsylvania and an MPH in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics. He also served as a Canada-U.S. Fulbright Scholar.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
Mike Jayne is an attorney for the U.S. Department of Education. Previously, he worked for the Mercatus Center at George Mason University.
Chief Counsel, U.S. Food and Drug Administration; Deputy General Counsel, Department of Health and Human Services
Stacy Cline Amin serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. Stacy serves as the senior legal advisor to the Commissioner, FDA leadership, the HHS General Counsel and Departmental leadership on FDA regulatory and litigation matters. Stacy leads an office of 165 lawyers and support staff that provide counseling and litigation support to the agency.
Stacy previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. In that role, Stacy advised on critical matters arising under the Food Drug and Cosmetic Act, helped lead the Administration's efforts to combat the opioid crisis, led multi-agency teams in the evaluation of high profile administrative actions, and successfully coordinated litigation strategy with the Department of Justice.
Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. In Congress, Stacy frequently advised on Food Drug and Cosmetic Act issues and led bipartisan and bicameral investigations to promote patient safety and global public health. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013 and the 21st Century Cures Act of 2016.
Earlier in her career, she served as an Associate at Sullivan & Cromwell LLP and as a law clerk to the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit. She graduated cum laude from Harvard Law School and summa cum laude from The George Washington University.
Attorney General, Alaska
Stephen J. Cox serves as the 28th Attorney General of the State of Alaska, where he oversees the state’s legal affairs and serves as the chief prosecutor with oversight of all district attorneys, general counsel to the Governor and executive branch, and represents the State in all civil and criminal cases in federal and state court. He brings to the role a proven record of public service at the highest levels of the U.S. Department of Justice, combined with deep experience in Alaska’s private sector and community life.
Before his appointment, he was Senior Vice President, Chief Legal and Strategy Officer of Bristol Bay Industrial—an investment platform of the Bristol Bay Native Corporation—acting as the chief legal officer for the industrial services portfolio on behalf of the Alaska Native shareholders in the Bristol Bay region. In that role, he led legal, compliance, and strategic planning for major energy, infrastructure, and utility projects across the State and in the Lower 48.
Earlier in his career, beginning in 2011, Cox served as in-house counsel for Apache Corporation, where he was the principal attorney for Apache Alaska and focused on new ventures and exploratory work in Cook Inlet, including seismic initiatives and ongoing regulatory coordination with state agencies.
Cox is deeply rooted in Anchorage’s community and faith life. He and his family attend Holy Family Old Cathedral in downtown Anchorage and support Mission Alaska, the Dominican friars’ outreach ministry under the Western Dominican Province. He was the founding board president and chairman of a new classical school in South Anchorage.
On the national stage, Cox held senior leadership roles in the U.S. Department of Justice under the Trump Administration. As Deputy Associate Attorney General, he co-chaired the DOJ’s Regulatory Reform Task Force and the Working Group on Corporate Enforcement and Accountability, and helped implement landmark policies aimed at curbing regulatory overreach and aligning enforcement with fairness and oversight. Later, as U.S. Attorney for the Eastern District of Texas, he oversaw prosecutions and civil litigation spanning 43 counties, prioritizing healthcare fraud, elder fraud, and violent crime while ensuring enforcement remained transparent and fair.
Earlier in his career, Cox practiced complex litigation at a major international law firm, served as counselor to the Director of U.S. Immigration and Customs Enforcement, and helped lead the William H. Webster Commission, which reviewed FBI counterterrorism intelligence and operations following the Fort Hood tragedy.
He began his legal career with a clerkship for Judge J. L. Edmondson of the U.S. Court of Appeals for the Eleventh Circuit. Cox earned a B.S. in Computer Science from Texas A&M University and a J.D., summa cum laude, from the University of Houston Law Center. He and his wife, Cristina, are raising their three children in Anchorage, and have made Alaska their home.
Operating Advisor, Clayton, Dubilier & Rice
Anand Shah, MD, is an Operating Advisor at private equity firm Clayton, Dubilier & Rice. Dr. Shah develops and identifies potential investment opportunities in the healthcare industry with a focus on health care services, including the provider, payer, and HCIT sectors. He also serves as an advisor to the firm’s portfolio companies.
A nationally recognized physician leader and health policy expert, Dr. Shah has extensive healthcare experience in the senior-most levels of the U.S. government, private sector, and as a physician. He was previously the Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration (FDA). Dr. Shah led consensus policy development for fit-for-purpose programs including Advanced Manufacturing, the Coronavirus Treatment Acceleration Program, Covid vaccine development, digital health, consumer protection, and decentralized clinical trials. During the Covid pandemic, he led FDA’s policy development for preparedness and recovery efforts. Dr. Shah represented FDA with top-level policy makers of the White House and Cabinet, Governors and local governments, and regularly led briefings with Congressional leadership.
He previously served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS). As Senior Medical Advisor, he was the primary counselor for agency-wide policy related to medical and scientific innovation. Dr. Shah established consensus on several critical policy initiatives including aligning payment and prevention to increase Medicare beneficiaries’ access to novel antimicrobials, expanding patients’ access to cell and gene therapies, and streamlining Medicare access to breakthrough technologies. As the Chief Medical Officer of the Center for Medicare & Medicaid Innovation (CMMI), Dr. Shah led the clinical design of novel value-based payment and service delivery models including those for primary and specialty care.
Dr. Shah specializes in the early detection, surveillance, and treatment of prostate cancer, and previously developed and led a survivorship clinic for patients on cancer clinical trials at the National Institutes of Health. His scientific track record includes publications in the New England Journal of Medicine, JAMA, Health Affairs, Cancer, and Nature Reviews Drug Discovery. Dr. Shah is an Adjunct Professor with the Department of Medical Ethics and Health Policy and an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania.
Dr. Shah was chief resident during his radiation oncology residency at Columbia University. He concurrently earned his MD from the University of Pennsylvania and an MPH in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics. He also served as a Canada-U.S. Fulbright Scholar.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
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