Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat
Author(s): Fran Hawthorne (Author)
Publisher: Wiley
Publication Date: February 18, 2005
Edition: 1st
Language: English
Print length: 354 pages
ISBN-10: 1119086752
ISBN-13: 9781119086758
Book Description
The forces that shape America’s most powerful consumer agency
Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-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 “designer” babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today’s most powerful consumer agency.
In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments.
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 it influences, 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.
Editorial Reviews
From the Inside Flap
Praise for INSIDE THE FDA
“A clear-eyed, thoughtful look at an agency that regulates a quarter of the U.S. economy and, more than any other, has the safety of the American public in its hands. Inside the FDA makes plain how powerful and controversial the Food and Drug Administration has become. People seeking to understand the government’s role in health care and the biotech revolution would be wise to read Ms. Hawthorne’s book.” Elizabeth MacBride Health-care writer and former managing editor of Crain’s New York Business
“Controversy lives on the FDA’s doorstep, and it knocks loudlyas it did recently with Vioxxwhen a drug it approves is involved in consumer deaths. Fran Hawthorne has written a vivid and compelling account of the pressures from politicians, industry, and consumers; the scientific uncertainties; the risk-reward compromises; and the constantly changing legal landscape that influences the agency’s life-and-death decisions. Since these pressures are not likely to diminish, it is all but inevitable that another Vioxx will slip past the scientists of this powerful, public-spirited but imperfect institution.” Clem Morgello Former senior editor and columnist at Newsweek, and former senior editor at Dun’s Review
Praise for THE MERCK DRUGGERNAUT
“[Hawthorne] understands and communicates the incredible complexity of discovering new drugs and introducing them to the market.” The New York Times
From the Back Cover
Praise for INSIDE THE FDA
“A clear-eyed, thoughtful look at an agency that regulates a quarter of the U.S. economy and, more than any other, has the safety of the American public in its hands. Inside the FDA makes plain how powerful and controversial the Food and Drug Administration has become. People seeking to understand the government’s role in health care and the biotech revolution would be wise to read Ms. Hawthorne’s book.” Elizabeth MacBride Health-care writer and former managing editor of Crain’s New York Business
“Controversy lives on the FDA’s doorstep, and it knocks loudly as it did recently with Vioxx when a drug it approves is involved in consumer deaths. Fran Hawthorne has written a vivid and compelling account of the pressures from politicians, industry, and consumers; the scientific uncertainties; the risk-reward compromises; and the constantly changing legal landscape that influences the agency’s life-and-death decisions. Since these pressures are not likely to diminish, it is all but inevitable that another Vioxx will slip past the scientists of this powerful, public-spirited but imperfect institution.” Clem Morgello Former senior editor and columnist at Newsweek, and former senior editor at Dun’s Review
Praise for THE MERCK DRUGGERNAUT
“[Hawthorne] understands and communicates the incredible complexity of discovering new drugs and introducing them to the market.” The New York Times
About the Author
FRAN HAWTHORNE is Senior Contributing Editor of Institutional Investor and has connections deep within the business and finance communities. Hawthorne has been covering health care and business for more than twenty years for Fortune, Crain’s New York Business, and other publications, and she now writes regularly for such newspapers and magazines as the New York Times, Worth, and Self. She is the author of The Merck Druggernaut, which is also published by Wiley.
Wow! eBook
