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From the Editor On June 30, 2006, the U.S. Food and Drug Administration celebrated its 100th anniversary. Today, at the threshold of its second century, the FDA is widely admired as one of the world's leading regulatory authorities, and is considered the "gold standard" for drug and device approvals. In reality, the FDA has many responsibilities beyond monitoring the sale of safe and effective drugs and medical devices. It is also responsible for regulations affecting cosmetics, food safety, and veterinary drugs, to name just a few of its other responsibilities. In fact, FDA regulations affect about 25 cents of every consumer dollar spent in the U.S., or $1 trillion annually. But its role in the development and approval of new medicines remains the agencies best known and most controversial function. One hundred years after Upton Sinclair's muck-racking novel, The Jungle, led to the birth of the FDA, the agency is the continuing target of Congressional hearings, media exposes, and relentless criticism from virtually all quarters. But, one might wonder, why is a mere regulator the subject of so much alternating scorn (it approves too many dangerous drugs) and anxiety (it approves too few new medicines)? To answer this question, Medical Progress Today, convened a panel of experts to review the agency's role in the approval of new medicines, and to examine why it remains the subject of much ongoing scrutiny. Over the course of the next week, each of our author's will submit an original op-ed reflecting on the agency's mission and track record, and hopefully explain why the agency's second century may be as turbulent as its last. Friday, June 30, 2006: Richard
A. Epstein, University of Chicago Law School We have also included, below, links to a wide range of writings on the history and evolution of the FDA that we hope captures something of the higlights of the debate surrounding the FDA's function and serve as a primer on the issues involved. This symposium is not intended as the final word on the FDA, but as an introduction to an important public policy discussion. Featured Commentary How Safe and Effective is the FDA?, Richard A. Epstein, 6-30-06 Required Reading FDA
Centennial, 1906-2006, Protecting and Promoting Public Health Promoting Safe and Effective Drugs for 100 Years, Michelle Meadows, FDA Consumer, 1-1-06 Milestones in U.S. Food and Drug Law History, FDA Backgrounder, 5-3-99 Modernizing the FDA: An Incremental Revolution, Richard Merrill, Health Affairs, 3-1-99 Ailing Agency - The F.D.A. and Safety; A Guardian of U.S. Health is Buckling Under Stress, Philip Hilts, New York Times, 12-4-89 A Golden Anniversary of Consumer Protection, Frank Young, FDA Consumer, 6-1-88 Red Tape for the Dying: The Food and Drug Administration and AIDS, Sam Kazman, Heritage Foundation, 4-8-88 Top Democrat Finds F.D.A.'s Efforts Have Plunged, New York Times, 6-27-06 Highlights and a Hidden Hazard - The FDA's New Labeling Regulations, Jerry Avorn and William Shrank, New England Journal of Medicine, 6-8-06 (Subscription Required) The FDA at 100: Are You That Much Safer?, Consumer Reports, 6-1-06 FDA Woes, Merrill Goozner, AARP Bulletin, 5-1-06 The FDA At Work: Cutting-Edge Science Promoting Public Health, FDA Consumer, Philip Hilts, 1-1-06 What Ails the FDA? Payola, Marcia Angell, MD, Boston Globe, 3-10-05 The Truth About the Drug Companies, Marcia Angell, MD, The New York Review of Books, 7-15-04 Of Pills and Profits: In Defense of Big Pharma, Peter Huber, Commentary, 8-1-06 Streamlining Drug Approval, Robert Goldberg and Peter Pitts, Washington Times, 6-22-06 Post-Vioxx, Drug Industry Eyes More Transparency, Peter Benesh, Investor's Business Daily, 6-16-06 American Medical Association Speech, Scott Gottlieb, Food and Drug Administration, 6-12-06 How
Safe is Too Safe: Public Safety Versus Innovation at the FDA, The
Milken Institute Review, 6-1-06 (Subscription Required) Playing Catch-Up: The FDA, Science, and Drug Regulation, John Calfee, American Enterprise Institute, 3-28-06 Innovation Drug Development in the Context of FDA Regulation, John Calfee, American Enterprise Institute, 2-1-06 Memo to Von Eschenbach, Kenneth I. Kaitin, Pharmaceutical Executive, 1-1-06 The
Future of Protecting and Promoting Public Health, Dr. Andrew C. Von
Eschenbach , FDA Consumer, 1-1- 06 Critical Path Initiative: A Conversation with Janet Woodcock, MD, Applied Clinical Trials, 9-1-05 The Promise of Personalized Health Care: Why and How To Encourage Diversity and Choice, Christina Sochacki and Robert E. Moffit, Ph.D., 7-20-05 FDA's Drug Approval Process: Up to the Challenge?, Scott Gottlieb, MD, American Enterprise Institute, Government Testimony, 3-1-05 The Price of Too Much Caution, Scott Gottlieb, MD, American Enterprise Institute, 12-22-04 Public
Health and the Placebo: The Legacy of the 1906 Pure Food and Drugs Act,
Russell S. Sobel, Cato Journal, 12-1-02 The FDA Needs a Big Dose of Economics, Alexander Tabarrok and Daniel B. Klein, Independent Institute, 10-5-02 Why
Should FDA Regulate Drugs?, Tamar Nordenberg, FDA Consumer,
9-1-97 Reforming FDA Policy: Lessons From the AIDS Experience, Joanna E. Siegel and Marc J. Roberts, Regulation, 9-1-91 Bill Proposes Overhaul of FDA Safety Process: Many Changes Would Be Funded by Drug Makers, The Boston Globe, 6-21-06 (Subscription Required) Senators to Propose New Safety Tactics For FDA, The Wall Street Journal, 6-21-06 Prescription for Progress: The Critical Path to Drug Development, Manhattan Institute, 6-8-06 The
Critical Path to New Medical Products National
Cancer Institute Challenge Goal National Institute of Health - Roadmap for Medical Research Institute of Medicine (IOM) Clinical Research Roundtable IOM Assessment of the U. S. Drug Safety System FDA's 2007 Budget Request, Highlights Mission Priorities and Fiscal Responsibility Tufts Center for the Study
of Drug Development AEI-Brookings
Joint Center for Regulatory Studies Pharmaceutical Research
and Manufacturers of America (PhRMA) Biotechnology Industry
Organization Center for Medicine in the Public Interest U.S. Senate Committee
on Health Education Labor & Pensions U.S. House of Representatives, Subcommittee on Health
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