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The Business and Politics Behind the Drugs We Take and the Food We Eat
Wiley
March 2006
On Sale: February 25, 2006
338 pages ISBN: 0471610917 EAN: 9780471610915 Hardcover
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Non-Fiction
"Americans count on this agency to make sure that we have a
steady stream of wonderful new pills that are potent and
perfectly safe at the same time, as well as a supermarket
full of goodies we can gobble up without worrying about food
poisoning."
--From the Introduction Because of the importance of what it regulates, the FDA
comes under tremendous pressure from powerful food and drug
companies, determined consumer groups, and demanding
politicians. But the pressure goes far beyond the ordinary
lobbying of Washington trade groups. Its mandate--over one
quarter of the national economy--brings the FDA into the
middle of some of the most important and contentious issues
of modern society. From the price of prescription drugs and the dangers of
genetically engineered food, to debates over teenage
pregnancy and the role of government itself, Inside the FDA
takes you on an intriguing journey into the world of today's
most powerful consumer agency. Through scores of interviews
with FDA employees and professionals familiar with the FDA,
as well as real-world stories, healthcare and business
expert Fran Hawthorne shows you how and why this agency
makes some of its most controversial decisions. She
discusses why the FDA fails to catch the dangers of drugs
like Vioxx before they hit the market, and goes behind the
story of Martha Stewart and the revolutionary cancer drug
Erbitux to show how the FDA's handling of that drug may
jeopardize its ability to keep up with future scientific
developments. In a time when companies continue to accuse the FDA of
nitpicking and needless paperwork, while consumers complain
that the agency bows to industry pressure by prematurely
approving risky products, Inside the FDA digs deep to reveal
the truth about an agency that affects our daily lives more
than any other single entity in the world. Inside you'll discover: * How the FDA will face its first case of embryonic
stem-cell research
* Why the FDA goes so easy on foods that are genetically
engineered
* How dangerous drugs like Vioxx get past the FDA's
safety measures
* When off-label prescribing--taking a drug that has
been approved only for Condition A and prescribing it for
Condition B--is dangerous, and when it may be lifesaving
* Why the FDA let drug ads on TV
* What it's like to launch a biotech firm and try to
move a brand-new drug through the FDA
* Why the FDA's role is growing more and more beyond
science and into public policy
Inside the FDA takes a closer look at the practices, people,
and politics of this crucial watchdog in light of the
competing pressures and trends of modern society, revealing
what the FDA is supposed to do, what it actually does--and
fails to do--who influences it, and how it could better
fulfill its mandate. The decisions that the FDA makes are
literally life and death. Inside the FDA provides a
sophisticated account of how this vitally important agency
struggles to balance bureaucracy and politics with its
overriding mission to promote the country's health.
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