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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
Monday, July 3: John R. Graham, Pacific Research Institute
Wednesday, July 5: David Gratzer, Manhattan Institute
Thursday, July 6: Henry Miller, Hoover Institution
Friday, July 7: Benjamin Zycher, Manhattan Institute

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

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Required Reading

History

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

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Counterpoints

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

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Other Perspectives

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)

Dr. Andrew C. Von Eschenbach, Acting FDA Commissioner, speech before the
Food and Drug Law Institute Annual Conference
, 4-6-06

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

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Recent Initiatives

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

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Links

American Enterprise Institute

Faster Cures

Cato Institute

Tufts Center for the Study of Drug Development

In the Pipeline

Food and Drug Administration

AEI-Brookings Joint Center for Regulatory Studies

ConsumerReports.org

Public Citizen

Pharmaceutical Research and Manufacturers of America (PhRMA)

Biotechnology Industry Organization

Center for Medicine in the Public Interest

Critical Path Institute

U.S. Senate Committee on Health Education Labor & Pensions

U.S. House of Representatives, Subcommittee on Health

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Prescription for Progress

Prescription for Progress:
The Critical Path for Drug Development

by Robert Goldberg, Ph.D. and Peter Pitts

AVAILABLE IN REALVIDEO

History

Counterpoints

Other Perspectives

Recent Initiatives

Links

Medical Progress

Intellectual Property
Rights & Innovation

Global Health & Bio-terrorism

Prescriptions for Policy

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