Deep Dive Episode 209 – Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
Regulatory Transparency Project's Fourth Branch Podcast
Regulatory Transparency Project's Fourth Branch Podcast
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug Administration's authority to decide which drugs are available only by prescription. Their solution: leaving the decision to the drugs' manufacturers. This Regulatory Transparency Project program featured Michael Cannon, former FDA official Joshua Sharfstein, and moderator Dan Troy discussing prescription drugs, nonprescription drugs, and who decides.
Featuring:
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As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.
Director of Health Policy Studies, Cato Institute
Michael F. Cannon is the Cato Institute’s director of health policy studies. His scholarship spans public health; regulation of clinicians, medical facilities, pharmaceuticals, and medical devices; employer‐sponsored and other private health insurance; Medicare; Medicaid; CHIP; the Veterans Health Administration; medical malpractice litigation; administrative law; international health systems; political philosophy; and more. Cannon is “an influential health‐care wonk” (Washington Post) and “the most famous libertarian health care scholar” (Washington Examiner). Washingtonian magazine named Cannon one of Washington, DC’s “Most Influential People” in 2021, 2022, and 2023.
Cannon has appeared on ABC, Al Jazeera, BBC, CBS, CNN, CNBC, C‑SPAN, Fox News Channel, NPR, and other broadcast media. His articles have appeared in the Wall Street Journal; the New York Times; USA Today; the Washington Post; the Los Angeles Times; SCOTUSBlog; Forum for Health Economics and Policy; JAMA Internal Medicine; Health Matrix: Journal of Law‐Medicine; Harvard Health Policy Review; the Yale Journal of Health Policy, Law, and Ethics; the Journal of Health Politics, Policy and Law; and Quinnipiac Health Law Journal. His latest book is Recovery: A Guide to Reforming the U.S. Health Sector.
Cannon was previously a domestic policy analyst for the U.S. Senate Republican Policy Committee, where he advised the Senate leadership on health, education, labor, welfare, and the Second Amendment. He is a member of the Board of Advisers of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group.
Cannon holds an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia.
Vice Dean for Public Health Practice and Community Engagement, Bloomberg School of Public Health, Johns Hopkins University
Dr. Joshua M. Sharfstein is Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the Director of the Bloomberg American Health Initiative. He is the author of the Public Health Crisis Survival Guide: Leadership and Management in Trying Times, and the co-author of The Opioid Epidemic: What Everyone Needs to Know.
Previously, Dr. Sharfstein served as Secretary of the Maryland Department of Health and Mental Hygiene from January 2011 to December 2014. In this position, he led efforts to align Maryland’s health care system with improved health outcomes, culminating in the adoption of a revised payment model for all hospital care for Maryland residents. He also oversaw the development of a statewide health improvement process with 18 local public-private coalitions and the reshaping of state’s approach to health information exchange, long-term care, and behavioral health.
From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration, where he oversaw the agency’s successful performance management and transparency initiatives. From December 2005 to March 2009, as Commissioner of Health for Baltimore City, Dr. Sharfstein led innovative efforts that contributed to major declines in both overdose deaths and infant mortality rates. From July 2001 to December 2005, as minority professional staff and health policy advisor for Congressman Henry A. Waxman, Dr. Sharfstein was engaged in a wide range of oversight and legislative activities on health care topics, including emergency preparedness, HIV, and the politicization of science.
Dr. Sharfstein graduated summa cum laude with an A.B. in Social Studies from Harvard College in 1991. From August 1991 to August 1992, he worked on public health projects in Guatemala and Costa Rica with a Frederick Sheldon Prize Fellowship. He graduated from Harvard Medical School in 1996, from the Boston Combined Residency Program in Pediatrics at Boston Medical Center and Children’s Hospital in 1999, and from the fellowship in general academic pediatrics at the Boston University School of Medicine in 2001.
Dr. Sharfstein is an elected member of the Institute of Medicine (2014) and fellow of the National Academy of Public Administration (2013). He serves on the editorial board of the Journal of the American Medical Association. His awards have included the Jay S. Drotman Memorial Award from the American Public Health Association (1994), Public Official of the Year from Governing Magazine (2008) and the Circle of Commendation Award from the Consumer Product Safety Commission (2013).
Dr. Sharfstein lives with his family in Baltimore, Maryland.
Managing Director, Berkeley Research Group
Dan Troy is the Managing Director at Berkeley Research Group.
Prior to that, he was the Chief Business Officer, Chief Administrative Officer, and General Counsel of Valo in Boston, Massachusetts.
Prior to joining Valo, he served as the Senior Vice President & General Counsel of GlaxoSmithKline and was a member of its Corporate Executive Team. Dan joined GSK in September 2008 and was responsible for leading the company’s legal department in protecting GSK’s intellectual property; managing litigation; supporting business development transactions; and business compliance and risk management. In 2012, Dan led the integration team following the acquisition of Human Genome Sciences, which later resulted in the launch of Benlysta, the first lupus treatment in 50 years. Dan led GSK’s Contributions Committee in the US and also led the Government Affairs, Public Policy and Patient Advocacy team from 2012 until 2014.
Prior to joining GSK, he was a Partner at the Washington law firm Sidley Austin LLP, where he principally represented pharmaceutical companies and trade associations on matters related to the US Food and Drug Administration (FDA) and government regulations. Dan was formerly Chief Counsel for the FDA, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
Dan has chaired the American Bar Association's Section of Administrative Law and is a member of the American Law Institute. He currently chairs the US Chamber of Commerce Litigation Center. He has also chaired the Civil Justice Reform Group, as well as the PhRMA Law Section Executive Committee. He was the 2012 CPR Corporate Leadership Award recipient and, in 2013, was named a 'Legend in the Law' at the Burton Awards.
Dan holds a B.S. in Industrial and Labor Relations from Cornell University and a J.D. from Columbia University School of Law, where he was a member of the Law Review and a Kent Scholar. After graduation from law school, he was a law clerk for the US Circuit Court of Appeals for the District of Columbia Circuit.