Partner, Hunton Andrews Kurth LLP
Michael J. Edney is head of the white collar criminal defense practice at Hunton Andrews Kurth LLP and partner in its Washington office. He guides clients through all aspects of government regulation, criminal and regulatory investigations, and civil litigation.
Mr. Edney vigorously defends corporations and individuals facing government agency inquiries and prosecutorial threats. Mr. Edney has represented clients before the Department of Justice, the Department of the Treasury and its Office of Foreign Assets Control (OFAC), the Department of State, the Department of Commerce, the Department of Defense, the Department of Health and Human Services, the Securities and Exchange Commission (SEC), the Commodities Futures Trading Commission (CFTC), the National Security Agency (NSA), congressional committees, and other government entities. In 2014, for example, Mr. Edney successfully negotiated a resolution of what was then the largest non-bank trade sanctions investigation in United States history, along with a resolution of charges under the Foreign Corrupt Practices Act (FCPA).
When companies encounter allegations of wrongdoing, Mr. Edney has conducted many internal investigations on their behalf, while carefully avoiding disruption of the client's important business operations. He has worked extensively with the Audit Committees and senior management of public companies to determine how to comprehensively resolve suggestions of misconduct.
President, Center for Individual Rights
Todd Gaziano is the President of the Center for Individual Rights. Mr. Gaziano received his J.D. in 1988 from the University of Chicago Law School, where he was a John M. Olin Fellow in Law and Economics. He received his B.A. from West Virginia University, summa cum laude in 1985. He was selected as a Truman Scholar from West Virginia while an undergraduate.
Mr. Gaziano’s previous legal work includes service as a law clerk for U.S. Court of Appeals for the Fifth Circuit Judge Edith Jones, as an attorney in the U.S. Department of Justice Office of Legal Counsel, as a chief subcommittee counsel in the U.S. House of Representatives, as a Houston trial attorney, and as a chief corporate legal officer. He also served a six-year term as commissioner on the U.S. Commission on Civil Rights (2008-2013), where he helped conduct oversight and investigations of civil rights agencies.
For most of the last 25 years, Mr. Gaziano was a legal scholar and public interest law leader, promoting individual liberty in the Supreme Court and Congress. From 1997 to 2013, he was the founding director of the Edwin Meese Center for Legal and Judicial Studies at The Heritage Foundation. From 2014 until he joined CIR, he was the Chief of Legal Policy and Strategic Research, and Director of the Center for the Separation of Powers, at Pacific Legal Foundation.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.
Former CEO, Vascular Solutions
Howard Root is the recently-retired Chief Executive Officer of Vascular Solutions, Inc., a company he founded in 1997, took public in 2000, and grew into a worldwide medical device company that he sold to Teleflex for $1 billion in February 2017. Over the company’s 20 years, Howard led Vascular Solutions in inventing, developing and launching over 100 new medical devices that are used daily to improve the lives of patients suffering from cardiovascular disease. In 2014, Vascular Solutions and Howard were indicted on felony charges alleging the company’s salespeople had promoted off-label an FDA-cleared medical device that made up only 0.1% of the company’s sales and never harmed a single patient. After surviving an arduous legal process, with 121 attorneys charging $25 million in legal fees, in February 2016 the jury returned a verdict of not guilty on all charges, even though the defense didn’t call a single witness to testify in the four-week trial.
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.
Vice President, Edwin Meese III Institute for the Rule of Law, Advancing American Freedom
John G. Malcolm oversees Advancing American Freedom’s work to increase understanding of the Constitution and the rule of law as Vice President of the organization’s Edwin Meese III Institute for the Rule of Law. Malcolm brings to the challenge a wealth of legal expertise and experience in both the public and private sectors.
Prior to joining Advancing American Freedom in 2025, Malcolm was the Vice President of the Institute for Constitutional Government and the Director of the Meese Center for Legal and Judicial Studies at the Heritage Foundation. Prior to joining Heritage in 2012, Malcolm was general counsel at the U.S. Commission on International Religious Freedom, as well as a distinguished practitioner in residence at Pepperdine Law School. From 2004 to 2009, Malcolm was executive vice president and director of worldwide anti-piracy operations for the Motion Picture Association.
Malcolm served as a deputy assistant attorney general in the Department of Justice’s Criminal Division from 2001 to 2004, where he oversaw sections on computer crime and intellectual property, domestic security, child exploitation and obscenity, and special investigations. Immediately prior to that, he was a founding partner in the Atlanta law firm of Malcolm & Schroeder, LLP.
From 1990 to 1997, Malcolm was an assistant U.S. attorney in Atlanta, assigned to the fraud and public corruption section, and also an associate independent counsel, investigating fraud and abuse in the Department of Housing and Urban Development. He was honored with the Director’s Award for Superior Performance for his work in connection with the successful prosecution of Walter Leroy Moody Jr., who assassinated an 11th Circuit judge and the head of the Savannah chapter of the NAACP.
A graduate of Harvard Law School and Columbia College, Malcolm began his career as a law clerk to a federal district court judge and a federal appellate court judge, and as an associate at the Atlanta-based law firm of Sutherland, Asbill & Brennan (new Eversheds Sutherland).
Malcolm, who resides in Washington, D.C., serves on the Board of Trustees of the Washington National Opera and is a Senate-confirmed member of the Board of Directors of the Legal Services Corporation, the largest funder of civil legal aid in the United States.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.
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.
Former CEO, Vascular Solutions
Howard Root is the recently-retired Chief Executive Officer of Vascular Solutions, Inc., a company he founded in 1997, took public in 2000, and grew into a worldwide medical device company that he sold to Teleflex for $1 billion in February 2017. Over the company’s 20 years, Howard led Vascular Solutions in inventing, developing and launching over 100 new medical devices that are used daily to improve the lives of patients suffering from cardiovascular disease. In 2014, Vascular Solutions and Howard were indicted on felony charges alleging the company’s salespeople had promoted off-label an FDA-cleared medical device that made up only 0.1% of the company’s sales and never harmed a single patient. After surviving an arduous legal process, with 121 attorneys charging $25 million in legal fees, in February 2016 the jury returned a verdict of not guilty on all charges, even though the defense didn’t call a single witness to testify in the four-week trial.
Deep Dive Episode 26 – Is the FDA’s Rule on Cigars & Vaping Products Constitutional?
Regulatory Transparency Project Teleforum
TeleforumIntroduction to the FDA & Health Working Group
David Hyman
David Hyman is the Chairman of RTP's FDA & Health working group and Professor of...
The Problem with the Proliferation of Collateral Consequences
John G. Malcolm
Note from the Editor: This article discusses collateral consequences of criminal convictions and argues that...
Off-Label Promotion and Free Speech in Medicine
Christina Sandefur
Federal regulation strictly limits how pharmaceutical companies share information about the legal use of their...
Deep Dive Episode 17 – Off-Label Promotion and Free Speech in Medicine
Regulatory Transparency Project Teleforum
TeleforumThe FDA, the Trump Administration, and the Right to Try
Denver, ColoradoSandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast
Erika Lietzan
On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc. consolidated with...
Cardiac Arrest: A Cautionary Tale
Howard Root
Howard Root started Vascular Solutions, a medical device company, from scratch. Fifteen years later, his...
Deep Dive Episode 8 – Cardiac Arrest: A Cautionary Tale
Regulatory Transparency Project Teleforum
TeleforumTopics
Fixing How FDA Regulates Diagnostic Lab Tests
Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is...