American Enterprise Institute

1150 Seventeenth St., NW

Washington, DC 20036

202-862-5826

ebatman@aei.org

American Enterprise Institute

1150 Seventeenth Street, N.W.

Washington, DC 20036

202-862-4870

John E. Calfee is a resident scholar at AEI. He previously worked on the economics of consumer protection--including advertising and marketing, the tort liability system, tobacco, and other topics--at the Bureau of Economics at the Federal Trade Commission. He has taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University and spent a year as a visiting senior fellow at the Brookings Institution. Mr. Calfee’s academic articles and opinion pieces cover a variety of topics, including tort liability, advertising and information, Food and Drug Administration (FDA) regulation, and the pharmaceutical market. His op-eds have run in the Wall Street Journal, the Philadelphia Inquirer, the Los Angeles Times, and numerous other newspapers and magazines. His recent scholarly publications have appeared in Clinical Pharmacology and Therapeutics, Health Affairs, and the Supreme Court Economic Review. He has published three short books: Fear of Persuasion: A New Perspective on Advertising and Regulation (AEI Press, 1997); Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000); and Biotechnology and the Patent System: Balancing Innovation and Property Rights, with Claude Barfield (AEI Press, 2007). He has also testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; the Vioxx episode; and, most recently, FDA oversight of drug safety.

Joseph H. Golec is an associate professor of finance at the University of Connecticut. After teaching finance at Clark University in Worcester, Massachusetts, he joined the Finance Department at the University of Connecticut in 2000. He teaches investments, finance theory, and health care finance. His research looks at investments, mutual funds, and health care/pharmaceutical finance. Most recently he has examined how pharmaceutical and biotechnology R&D is affected by reimportation, European price controls, threats of U.S. price controls, and follow-on biologics.

Scott Gottlieb, M.D., is a practicing physician and a resident fellow at AEI. A leading expert in health care policy, Dr. Gottlieb's work focuses on providing insights into the economic, regulatory, and technological forces driving the transformation of health care today. From 2005 to 2007, Dr. Gottlieb served as Food and Drug Administration (FDA) deputy commissioner and, from 2003 to 2004, as a senior adviser to then-FDA commissioner Mark McClellan and as the FDA's director of medical policy development. A recipient of numerous medical association awards, Dr. Gottlieb is the author of more than three hundred articles that have appeared in leading medical journals, as well as the Wall Street Journal, the New York Times, USA Today, and Forbes. Dr. Gottlieb has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on CNBC. Previously, Dr. Gottlieb worked as a health care analyst for the investment bank Alex Brown & Sons and authored the Forbes-Gottlieb Medical Technology Letter and the Gilder Biotech Report. Dr. Gottlieb has testified as an expert witness on health and regulatory matters before the U.S. Senate and House of Representatives and members of the Japanese Diet.

Mark B. McClellan, M.D., is a senior fellow and director of the Engelberg Center for Health Care Reform at the Brookings Institution. He has a highly distinguished record in public service and in academic research. He is the former administrator for the Centers for Medicare & Medicaid Services (2004-2006) and the former commissioner of the Food and Drug Administration (2002-2004). He also served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House (2001-2002). In these positions, he developed and implemented major reforms in health policy. In the Clinton administration, Dr. McClellan was deputy assistant secretary of the Treasury for economic policy from 1998 to 1999, supervising economic analysis and policy development on a range of domestic policy issues. Dr. McClellan was also an associate professor of economics and associate professor of medicine (with tenure) at Stanford University, from which he was on leave during his government service. He directed Stanford’s Program on Health Outcomes Research and was also associate editor of the Journal of Health Economics and coprincipal investigator of the Health and Retirement Study, a longitudinal study of the health and economic status of older Americans. His academic research has been concerned with the effectiveness of medical treatments in improving health, the economic and policy factors influencing medical treatment decisions and health outcomes, the impact of new technologies on public health and medical expenditures, and the relationship between health status and economic well-being. He has twice received the Kenneth J. Arrow Award for Outstanding Research in Health Economics. Dr. McClellan is a member of the Institute of Medicine of the National Academy of Sciences, a research associate at the National Bureau of Economic Research, and a former visiting scholar at AEI.

Henry Olsen is vice president and director of the National Research Initiative (NRI). He disseminates and publicizes the Institute’s work to the academic community; works with AEI’s visiting, adjunct, and NRI research fellows; commissions and supervises NRI projects; and oversees the production of NRI publications. Mr. Olsen previously served as vice president for programs at the Manhattan Institute and as a judicial clerk to the chief judge of the U.S. Court of Appeals for the Sixth Circuit Danny J. Boggs.

Sean Tunis is the founder and director of the Center for Medical Technology Policy in San Francisco, where he works with health care decision makers, experts and stakeholders to improve the value of clinical research on new and existing medical technologies. He consults with a range of domestic and international health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research and technology policy. Previously, Dr. Tunis was the director of the Office of Clinical Standards and Quality and chief medical officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health coverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies, quality standards for Medicare and Medicaid providers, quality measurement and public reporting initiatives, and the Quality Improvement Organization program. Before joining CMS, Dr. Tunis was a senior research scientist with the Technology Assessment Group. He has also served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy development regarding pharmaceutical and device regulation.

John A. Vernon is a professor in the Department of Health Policy and Management at the University of North Carolina at Chapel Hill, where he also holds appointments in the Kenan-Flagler Business School and the UNC School of Pharmacy. Prior to joining the faculty at UNC, he was a professor in the Finance Department in the School of Business at the University of Connecticut and a visiting professor at the Wharton School of Business at the University of Pennsylvania. He is the former senior economic policy advisor to the Office of the Commissioner at the U.S. Food and Drug Administration and is a Faculty Research Fellow with the National Bureau of Economic Research. He has twice testified before the United States Senate on issues related to the economics of pharmaceutical price regulation. His research has appeared in such journals as the Journal of Law and Economics, the Journal of Financial and Quantitative Analysis, the International Journal of Healthcare Finance and Economics, Health Economics, Inquiry, the Southern Economic Journal, and Regulation. He recently guest-edited a special issue of the journal Managerial and Decision Economics devoted to the economics of the pharmaceutical industry. Vernon frequently advises both government and industry on a broad range of issues affecting the pharmaceutical industry.