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.
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.
Founder & CEO of The Hargan Group
Eric D. Hargan is the Founder and CEO of The Hargan Group, a healthcare consulting firm. Eric previously served as the Deputy Secretary of the Department of Health and Human Services (HHS) from 2017 to 2021; he also served as Acting Secretary for several months in 2017-2018. HHS is the largest department in the federal government and has an annual budget of more than $1.3 trillion and over 80,000 employees across 26 divisions. As Deputy Secretary, he oversaw the development and approval of all HHS, CMS and FDA regulations and significant guidances, as well as the day-to-day operations and management of the department, and he led policy and strategy development. From 2003 to 2007, Mr. Hargan also served at HHS in a variety of capacities, including holding the position of Acting Deputy Secretary.
Scott K. Ginsburg Professor of Health Law & Policy, Georgetown University
David A. Hyman, M.D., J.D., is the Scott K. Ginsburg Professor of Health Law & Policy at Georgetown University. Professor Hyman focuses his research and writing on the regulation and financing of health care. He teaches or has taught health care regulation, civil procedure, insurance, medical malpractice, law & economics, professional responsibility, and tax policy.
While serving as Special Counsel to the Federal Trade Commission, Professor Hyman was principal author and project leader for the first joint report ever issued by the Federal Trade Commission and Department of Justice, “Improving Health Care: A Dose of Competition” (2004). He is also the author of Medicare Meets Mephistopheles, which was selected by the U.S. Chamber of Commerce/National Chamber Foundation as one of the top ten books of 2007, and the co-author (with Charles Silver) of Overcharged: Why Americans Pay Too Much for Health Care (2018). He has published widely in student-edited law reviews and peer-reviewed medical, health policy, law, and economics journals.
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.
Director, Digital Media, Communications and Fellow, R Street Institute
Shoshana Weissmann manages R Street’s social media, email marketing and other digital assets. She also works on occupational licensing reform, social media regulatory policy, Section 230 and other issues, and has written for various publications, including The Wall Street Journal and USA Today.
Shoshana most recently managed digital communications for Opportunity Lives, a group that highlighted positive stories and policy solutions. Before that, she managed social media and wrote for The Weekly Standard. Earlier in her career, she managed digital communications for the America Rising PAC, where her strategy was highlighted in a piece that appeared in The New York Times.
She is on the board of The Conservation Coalition and a member of the Federalist Society’s Regulatory Transparency Project’s state and local and emerging technology working groups.
She lives in Washington, D.C. and has a stuffed sloth named James Madisloth, and she enjoys the Snapchat hot dog.
Explainer 62 - FDA's Regulation of Laboratory Developed Tests
Joel Zinberg
For many years FDA has claimed the authority to regulate Laboratory Developed Tests, that is...
Topics
COVID Vaccination Mandate?
Disability accommodation and collective bargaining entanglements certainly matter, but there probably are better explanations for...
Capital Conversations: COVID-19 and FDA; Medical, Legal, and Regulatory Perspectives
Stacy Cline Amin, Stephen Cox, Anand Shah
During the COVID-19 pandemic, the United States Food and Drug Administration (FDA) has sought to...
Capital Conversations: Eric Hargan, Deputy Secretary of the Department of Health and Human Services (HHS)
Eric D. Hargan
Join us as the U.S. Department of Health and Human Services Deputy Secretary Eric Hargan...
Deep Dive Episode 98 – Regulatory Reforms and the COVID Pandemic
David Hyman, Roger D. Klein, Shoshana Weissmann
Governments at all levels are figuring out how to make sure sick people are treated...