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David Kessler is Dean of the Yale School of Medicine
and Commissioner of the U.S. Food and Drug Administration from 1990-1997.
Dr. Kessler received his B.A. from Amherst College, M.D. from Harvard
Medical School, and his J.D. from the University of Chicago Law
School, where he was associate editor of the law review. From 1984-1990
he was the Medical Director of the hospital of the Albert Einstein
College of Medicine, and on the faculty in the departments of Pediatrics
and of Epidemiology and Social Medicine. During that time he also
earned an Advanced Professional Certificate in Management from the
NYU Graduate School of Business Administration. Dr. Kessler is Vice
Chair of the Committee on Health, Safety and Food R&D of the
National Council on Science and Technology; the Forum on Drug Development
and Regulation and the AIDS Roundtable of the Institute of Medicine;
the National Task Force on AIDS Drug Development; and the Office
of Science and Technology Policy Federal Coordinating Council for
Science, Engineering and Technology.
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Protecting Human Health -
Government Regulation of Drugs and Tobacco
April 7-11, 1999 at
the University of Oklahoma
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The regulation of drugs, tobacco and chemicals requires a prediction
based upon scientific data of the probable health consequences
of the agent. The process of regulation entails judgments that
affect many different constituencies that hold opposing interests.
Rapid decisions to permit use of a new drug that turns out to
be effective and safe represents one "win-win" outcome.
The consumer obtains an effective therapeutic agent and the
developer/manufacturer obtains permission to sell the profit
from this agent. However, rapid decision making may increase
the risk of overlooking or failing to develop important data
on toxicity and delays in decision making may mean that people
die unnecessarily. Regulation can also be seen as limiting individual
freedom to consume products that we "like." On what
basis should the government regulate tobacco and drugs? This
seminar addressed issues of regulation including an examination
of how regulatory decisions are made, how scientific data used
in the risk assessment process are obtained, how scientific
data are interpreted, how exposure assessment is conducted.
Issues of humane use in the case of otherwise untreatable illness
and of personal freedom was discussed.
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The Class Reading List: (These books and articles supplied
by OSLEP)
Cancer Wars, Robert N. Proctor, HarperCollins,
1996.
Reading Packet of articles and reviews on risk
assessment and basic toxicology.
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