The FDA has the regulatory authority to determine which pharmaceutical drugs, medical products and devices can legally be prescribed, marketed and distributed in the United States. The agency employs a stringent approval process to ensure safety and effectiveness.
But good intentions can yield harmful outcomes. Over time, approval rates for new drugs and devices have declined. The costs associated with approval have risen. Increasingly, more Americans travel overseas to receive unapproved treatments to avoid waiting for the FDA’s approval.
These and other factors suggest it might be time to ask the question: is the FDA itself safe and effective? FDAReview puts the FDA on trial.
We, along with a numerous and diverse consensus of scholars, argue that the costs the FDA places on the US medical system almost certainly exceed its benefits. FDAReview provides a detailed history of the FDA’s development, a collection of quotes from economists who have studied the FDA, a glossary of terms, and a reference section with many web links. We also provide a review of current FDA reform proposals and numerous examples of how markets can (and already do) provide solutions to problems under the FDA’s purview.
Our regularly updated blog tracks the FDA’s latest initiatives, reviews the findings of current research examining FDA effectiveness, illustrates how and where advances in technology provide healthcare-related solutions, and demonstrates where private efforts can substitute for FDA regulation. Unbeknownst to many, markets frequently outpace and outperform the FDA in delivering safe and effective medical products and services.
Raymond J. March is Director of FDAReview.org, a Research Fellow at the Independent Institute, and Assistant Professor of Economics and Faculty Fellow in the Center for the Study of Public Choice and Private Enterprise at North Dakota State University. He received his M.A. and Ph.D. in agricultural and applied economics from Texas Tech University and he has been Assistant Professor of Economics at San Jose State University and Adam Smith Fellow at the Mercatus Center at George Mason University.
His research examines the public and private provision and governance of healthcare in the United States, particularly in pharmaceutical markets. Dr. March’s scholarly articles have appeared in such journals as the Journal of Institutional Economics, Journal of Entrepreneurship and Public Policy, and International Review of Economics, and his popular articles have been published in The Hill, RealClearHealth, and elsewhere.
Daniel B. Klein is a Research Fellow at the Independent Institute and Professor of Economics at George Mason University. He received his Ph.D. in economics from New York University and he has been an Associate Professor of Economics at Santa Clara University; a Visiting Fellow in the Social Philosophy and Policy Center at Bowling Green State University; Visiting Scholar at the City University in Stockholm; Assistant Professor of Economics, University of California, Irvine; and Visiting Scholar, Department of Economics, Stanford University. He is co-editor of the Independent Institute’s web site, FDAReview.org and General Director of the Civil Society Institute.
His books include Curb Rights: A Foundation for Free Enterprise in Urban Transit; What Do Economists Contribute?; Reputation: Studies in the Voluntary Elicitation of Good Conduct; A Plea to Economists Who Favor Liberty: Assist the Everyman; Assurance and Trust in a Great Society; and Three Libertarian Essays. His articles have appeared in Planning and Markets, The Independent Review, Constitutional Political Economy, Knowledge, Technology and Policy, Economic Inquiry, Journal of Transport Economics and Policy, Economics & Philosophy, Journal of Economic Behavior and Organization, Journal of Economic History, Economics and Politic, Law & Society Review, and other scholarly journals.
Alexander Tabarrok is a Senior Fellow and former Research Director for the Independent Institute, Assistant Editor of The Independent Review, Bartley J. Madden Chair in Economics at the Mercatus Center, and Associate Professor of Economics at George Mason University. He received his Ph.D. in economics from George Mason University, and he has taught at the University of Virginia and Ball State University. Co-author (with Daniel Klein) of The Independent Institute web site, FDAReview.org, Dr. Tabarrok is the editor of The Independent Institute books, Entrepreneurial Economics: Bright Ideas from the Dismal Science (Oxford University Press), The Voluntary City: Choice, Community, and Civil Society (with David Beito and Peter Gordon, University of Michigan Press), and Changing the Guard: Private Prisons and the Control of Crime.
His papers have appeared in the Journal of Law and Economics, Public Choice, Economic Inquiry, Journal of Health Economics, Journal of Theoretical Politics, The American Law and Economics Review, Kyklos, and many other journals. Dr. Tabarrok is an author of the monograph, An Analysis of Proposals for Constitutional Change in New Zealand and he has contributed chapters to a number of books. Dr. Tabarrok is the recipient of the Snavely Award, and he has been an Earhart Foundation Fellow and George A. and Frances Ball Foundation Fellow. Articles by Dr. Tabarrok have appeared in magazines and newspapers across the United States.
Dr. Raymond J. March
Research Fellow and Director, FDAReview.org
100 Swan Way
Oakland, CA 94621-1428
The authors wish to thank Robert Gaukel and Masha Rumer for research assistance and Nicholas Stehle, Rod Martin, Paul Theroux, and Penny Burbank for help designing and maintaining the web page.
The Board of Readers is composed of economists, lawyers, and medical experts who have conducted and published independent, academic studies on the FDA. Although no member of the Board of Readers is necessarily in agreement with everything in FDAReview.org, the Board members have carefully reviewed the web site and approve broadly of its analysis and judgment.
- Dale H. Gieringer, Ph.D., Director, California NORML
- Robert Higgs, Ph.D., Senior Fellow in Political Economy, Independent Institute, and Founding Editor and Editor at Large, The Independent Review
- Sam Kazman, J.D., General Counsel, Competitive Enterprise Institute
- Henry I. Miller, M.D., former Robert Wesson Fellow in Scientific Philosophy and Public Policy, Hoover Institution, Stanford University; Founding Director, Office of Biotechnology, U.S. Food and Drug Administration.
- Sam Peltzman, Ph.D., Ralph and Dorothy Keller Distinguished Service Professor Emeritus of Economics at the Booth School of Business, University of Chicago
- Paul H. Rubin, Ph.D., Samuel Candler Dobbs Professor of Economics and Law, Emory University