The Food and Drug Administration, the oldest comprehensive consumer protection agency in the U.S. federal government, is charged with protecting the public health. Under this mandate, it regulates drugs and medical devices for their safety and effectiveness. But is it a failing mandate? It's long been argued that the FDA's long and costly approval processes stifle innovation and keep life-changing treatments from the market. But the question remains: when it comes to public health, is it ever okay to sacrifice safety for speed?
Jerry Avorn, M.D., is a professor of Medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital. An internist, geriatrician, and drug epidemiologist, he studies the intended and adverse effects of prescription drugs, physician prescribing practices, and medication policy. Dr. Avorn pioneered the "academic detailing" approach to continuing medical education, in which non-commercial, evidence-based information about drugs is provided to doctors through educational outreach programs run by public-sector sponsors. Such programs are now in use in the U.S., Canada, Australia, and Europe. He has served as a member of the Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines and is the author or co-author of over 400 papers in the medical literature on medication use and its outcomes, and of the book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, now in its 11th printing.
David R. Challoner, M.D. is vice president emeritus for Health Affairs of the University of Florida. Dr. Challoner has held leadership and health policy positions in many national organizations including the Association of American Medical Colleges where he holds Distinguished Service membership, the American Medical Association where he served as chairman of the Section on Medical Schools, and the American Federation for Clinical Research where he served as President. From 1988-1990, he was appointed by President Reagan to chair the President's Committee on the National Medal of Science. He also served as chairman of the membership committee, as a member of the governing council of the Institute of Medicine and as a member of the governing board of the National Research Council. He received the 2010 Walsh McDermott Medal of the IOM for Distinguished Service. He chaired the IOM's Committee on the Public Health Effectiveness of the FDA 510K Clearance Process (2011).
John Donvan is a correspondent for ABC News Nightline. He has served as ABC White House Correspondent, along with postings in Moscow, London, Jerusalem and Amman.
Scott Gottlieb is a practicing physician and resident fellow at the American Enterprise Institute, a private, nonpartisan, not-for-profit institution dedicated to research and education on issues of government, economics and social welfare.
From 2005 to 2007, Dr. Gottlieb served as deputy commissioner of the Food and Drug Administration and before that, between 2003 and 2004, as the FDA’s director of medical policy development and senior advisor to the FDA commissioner. He left FDA in the spring of 2004 to work on implementation of the new Medicare Drug Benefit as a senior adviser to the administrator of the Centers for Medicare and Medicaid Services, where he supported the agency's policy work on quality improvement and coverage and payment decision-making.
Dr. Gottlieb has authored more than 300 articles that have appeared in leading medical journals as well as the Wall Street Journal, New York Times, USA Today, and Forbes. He has held editorial positions at the British Medical Journal and the Journal of the American Medical Association and appears regularly as a guest commentator on CNBC.
He earned his B.A. in economics from Wesleyan University and his M.D. from the Mount Sinai School of Medicine. Dr. Gottlieb practices medicine as an attending physician at Stamford Hospital in Connecticut where he is an internist on the hospital’s inpatient medical wards.
Peter Huber is a senior fellow at the Manhattan Institute writing on the issues of drug development, energy, technology, and the law. Before joining the Manhattan Institute, Huber served as an assistant and later associate professor at MIT for six years. He clerked on the D.C. Circuit Court of Appeals for Ruth Bader Ginsburg, and then on the U.S. Supreme Court for Sandra Day O'Connor. Huber also is a partner at the Washington, D.C. law firm of Kellogg, Huber, Hansen and Todd. He is the author of The Bottomless Well (2005), co-authored with Mark P. Mills, and the forthcoming book, The Cure in Code. Huber earned his law degree from Harvard University and a doctorate in mechanical engineering from MIT.
Using a grim illustration of what happens when medical devices are not properly regulated, Dr. David Challoner of the University of Florida explains why the FDA plays an important role in patient safety.
Dr. Scott Gottlieb of the American Enterprise Institute and Dr. Jerry Avorn of Harvard Medical School debate the role the government plays in maintaining public safety and delivering effective medicine.