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January 26, 2020

Note: Justice Talking's grant funding expired in 2008 and the project has been closed. This website is an archive of the entire run of Justice Talking shows through June 30, 2008.
It is no longer being maintained. We apologize for any stale or broken links.
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Photo by: Gary L. Gehman
Drug Approval and the FDA
Last Featured: 4/18/2005

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Note: Justice Talking ceased production on June 30 of 2008. Link information on this site is not maintained and is provided for historical interest only. Although correct when posted, The Annenberg Public Policy Center makes no claim as the the accuracy or continued availability of any third party web links found on this site.

Vioxx is the latest of a growing number of FDA-approved products that were later found to have serious, even fatal, side effects. Since the advent of quicker testing in the 1990s, the agency has shortened many drug approval times from years to months. Efficiency in government is laudable, but is it coming at the expense of public safety? FDA administrators testified in Congress that the U.S.drug review process is still the world’s gold standard and can be trusted. Others question a system that allows companies to pay for product testing that hurries drugs to market.

Dr. Robert Spiegel is Senior Vice President, Medical Affairs and Chief Medical Officer at the Schering-Plough Research Institute. He is chair of Schering-Plough’s Clinical & Preclinical Safety Surveillance Committee (CPSSC). Prior to his current position, Dr. Spiegel was Senior Vice President of Clinical Research. He is also Adjunct Assistant Professor in the Department of Medicine at NYU Medical Center in New York, NY. Dr. Spiegel received his M.D. at the University of Pennsylvania and completed a Fellowship in Medical Oncology at the National Cancer Institute.

Dr. Alastair Wood is Associate Dean, Professor of Medicine, and Professor of Pharmacology at Vanderbilt University School of Medicine in Nashville, Tennessee. Dr. Wood was the drug therapy editor of The New England Journal of Medicine from 1992 through 2004, and is on the editorial boards of Clinical Pharmacology and Therapeutics and The British Journal of Clinical Pharmacology. Dr. Wood received his medical degree from St. Andrew's University and Dundee Medical School in Scotland.

Closing Quote
"If we are suffering illness, poverty or misfortune, we think we shall be satisfied on the day it ceases. But there too, we know it is false. As soon as one has gotten used to not suffering, one wants something else."

— Simon Weil

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Justice Talking’s last broadcast & podcast was June 30, 2008.
21 CFR Food & Drug
Public Citizen
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American Society of Health-System Pharmacists
Drug Safety Monitor
Medline Plus
FDA Advisory Committee
Consumers Union – Petition
Journal of the American Medical Association
Drug Safety Alliance
Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
by Fran Hawthorne
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
by Philip J. Hilts
Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases
by Michael Kremer, Rachel Glennerster
The Law and Infectious Disease
Is There a Right to Health Care?
Have Health Officials Become the Diet Police?