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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation

Knopf, 2003


Emerging out of the era of the robber barons and Theodore Roosevelt's desire to "civilize capitalism," the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. In the almost one hundred years since, it has evolved from a squad of eleven inspectors dogging dishonest tradesmen into America's most important regulatory agency, keeping tabs on the products of about 95,000 businesses and more than $1 trillion worth of goods annually.


This book shows how the agency combats self-serving political and industrial interests and protects Americans from hazardous medicines, medical devices, and foodstuffs while enforcing rigorous scientific standards. It describes how controlled scientific experiments became the basis -- explicitly and legally -- for making government policy. It was the first time any nation had done this, and led the way to using science as a basis for policy around the world.


Named a New York Times Notable Book of the Year, Dr. Jerome Groopman wrote in the New Republic that it is "a genuinely important book, rich in history, accurate in detail, unflinching in analysis." Dr. Sherwin Nuland in the New York Times Book Review said that Hilts "writes with both a historian's attention to dissection and analysis and with the flourish and vividness of an experienced journalist aware of the drama inherent in the story he is telling."