Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat / Edition 1

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"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

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Product Details

  • ISBN-13: 9780471610915
  • Publisher: Wiley
  • Publication date: 2/25/2005
  • Edition number: 1
  • Pages: 338
  • Sales rank: 434,037
  • Product dimensions: 6.00 (w) x 9.00 (h) x 0.94 (d)

Meet 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.

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Table of Contents



Chapter One: Case Study - Chasing Cancer.

Chapter Two: Beyond Science.

Chapter Three: The First 100 Years.

Chapter Four: “You Don’t Know Which Agency Is in Charge”.

Chapter Five: Truckloads of Paper.

Chapter Six: Case Study – The Return of Thalidomide.

Chapter Seven: How Picky Is the FDA?

Chapter Eight: How Powerful Is Industry?

Chapter Nine: Case Study — The Death of Monica George.

Chapter Ten: When Consumers Get Angry.

Chapter Eleven: A Political Pawn.

Chapter Twelve: FDA and DNA.

Chapter Thirteen: The FDA Meets Madison Avenue. 

Chapter Fourteen: Frivolous Drugs?

Chapter Fifteen: The Next 100 Years.


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Customer Reviews

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Sort by: Showing all of 4 Customer Reviews
  • Anonymous

    Posted August 19, 2012

    Medicine cat den

    Medicine cat den

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  • Anonymous

    Posted June 12, 2006

    no original content

    a disappointing compilation of the work of others. nothing original, creative, or insightful here. one would do better reading some of the references quoted.

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  • Anonymous

    Posted September 18, 2005

    Fascinating, Informative Look at the Food & Drug Administration (FDA)

    'Inside the FDA' is a thoughtful, balanced, and well-researched look inside the controversial and troubled Food and Drug Administration. Author Fran Hawthorne is an experienced business journalist and her skills are evident here. Digging into the FDA's complex and conflicting world, the book provides an informative picture of FDA's bureaucratic, political, and scientific drivers. Ms. Hawthorne does an excellent job of laying out what the FDA is suppose to do, what is really does, and where and why it fails. It makes for a great read.

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  • Anonymous

    Posted May 7, 2012

    No text was provided for this review.

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