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Inside the FDA. The Business and Politics Behind the Drugs We Take and the Food We Eat

  • ID: 3329305
  • Book
  • 288 Pages
  • John Wiley and Sons Ltd
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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


"[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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Introduction v

Chapter 1: Case Study: Chasing Cancer 1

Chapter 2: Beyond Science 23

Chapter 3: The First 100 Years 35

Chapter 4: "You Don′t Know Which Agency Is in Charge" 65

Chapter 5: Truckloads of Paper 79

Chapter 6: Case Study: The Return of Thalidomide 109

Chapter 7: How Picky Is the FDA? 123

Chapter 8: How Powerful Is Industry? 143

Chapter 9: Case Study: The Death of Monica George 179

Chapter 10: When Consumers Get Angry 191

Chapter 11: A Political Pawn 209

Chapter 12: FDA and DNA 233

Chapter 13: The FDA Meets Madison Avenue 253

Chapter 14: Frivolous Drugs? 273

Chapter 15: The Next 100 Years 285

Acknowledgments 309

Notes 311

Bibliography 329

Index 333

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Fran Hawthorne
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