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

Philip J. Hilts (Author)

Book Description

ISBN-10: 037540466X | ISBN-13: 978-0375404665 | Publication Date: March 25, 2003 | Edition: 1

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. Hilts takes us back to the FDA’s beginnings, when it confronted businesses that acknowledged no limitations on what could be brought to market or on the claims they could make for a product. With the coming of the FDA, our government, for the first time, was able to force the removal of toxic elixirs from the shelves and to insist on accurate labeling.

We see the subsequent fights the FDA waged, and won, for mandatory testing, and against such conservatives as—in our own time—Ronald Reagan and Newt Gingrich, who tried to curtail regulation. We see how the FDA protected the American consumer from thalidomide and other lethal pharmaceuticals, how it took on the tobacco industry, and how it stumbled in confronting the deadly mysteries of AIDS. And we are given, as well, a litany of extraordinary corporate excesses that the FDA has exposed and successfully battled.

Protecting America’s Health shows society adapting to both the burgeoning of science and technology and the ascendancy of the capitalist market. It makes startlingly clear the essential role the FDA has played in maintaining and protecting the quality of life—and health—to which the American public has long been accustomed.

Editorial Reviews

From Publishers Weekly

A century ago, store shelves were filled with products that were rotten, useless or even deadly. Today, we can be relatatively confident that "no cholesterol" on a product label really means what it says, and that the terms "fresh," "beef" and "reduces fever" accurately describe a product's contents or use. These protections, now taken for granted, have been the work of what is arguably the nation's most important regulatory agency, the Food and Drug Administration. Hilts (Scientific Temperaments), a health and science reporter who's written for the Washington Post and the New York Times, wonderfully documents the history of the FDA from its start in the administration of Teddy Roosevelt through various crises and triumphs to the deregulatory climate of recent years. From the start, FDA officials battled entrenched business interests. Industry argued that regulation hurt profits, stymied research and kept potentially beneficial products from reaching markets quickly. How the FDA doggedly prevailed against this tide of opposition is a story of persistence, political maneuvering and make-it-up-as-you-go pragmatism. As Hilts shows, strong policies often emerged in the wake of tragedies or scandals: the case of thalidomide, a drug introduced in the late 1950s as a sedative and to relieve morning sickness but that caused pregnant women to give birth to severely deformed infants (the number is conservatively estimated at 8,000), shocked the world and led to congressional hearings and a strict new drug approval law. Even so, industry continues to lobby aggressively against regulation. Hilts has little sympathy for industry's point of view and has the facts to support this position. As the federal government once again starts talking about cuts, this book offers a sober reminder of the importance of maintaining vigorous protections against the dangers of profit-motivated decisions. Photos not seen by PW.
Copyright 2003 Reed Business Information, Inc.

From Library Journal

A health/science reporter for the New York Times, Hilts tracks the growth of the federal agency charged with protecting our health.
Copyright 2002 Reed Business Information, Inc.

See all Editorial Reviews

Product Details

• Hardcover: 416 pages
• Publisher: Knopf; 1 edition (March 25, 2003)
• Language: English
• ISBN-10: 037540466X
• ISBN-13: 978-0375404665
• Product Dimensions: 9.5 x 6.6 x 1.4 inches
• Shipping Weight: 1.6 pounds
• Average Customer Review: 4.4 out of 5 stars  See all reviews (10 customer reviews)
• Amazon Best Sellers Rank: #1,024,321 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

12 of 12 people found the following review helpful:

5.0 out of 5 stars Excellent History of FDA, May 11, 2003

By A Customer

This review is from: Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (Hardcover)

This is an excellent, well researched history of the U.S. Food and Drug Administration and the modern pharmaceutical industry. Hilts does a good job of explaining the complex and technical new drug approval process for the general public. The author builds a solid case for well controlled clinical trials as a necessity for approving new drugs and biologics that are both safe and effective. He documents the history of pharmaceutical disasters from Elixer of Sulfanilimide and Thalidomide, to Rezulin.

Although the book focuses on the regulation of drugs, there is also a good overview of important developments in medical devices and food, including the battles over food labeling and silicone-filled breast implants. Hilts gives a fascinating account of political efforts to curb the agency including dirty tricks during the Nixon administration and more current deregulation efforts by conservatives in Congress. The author is a journalist who has worked for the Washington Post and New York Times. It is well written and easy to read. The book is a must for understanding the FDA.

11 of 11 people found the following review helpful:

5.0 out of 5 stars Fascinating look inside the FDA, May 24, 2003

By 

Robert Ehrlich (florida) - See all my reviews
(REAL NAME)   

This review is from: Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (Hardcover)

Hilts has written a masterful account of the history of the FDA. It is an amazing tale of the health protections we now take for granted. The FDA as we know it is a relatively modern creation. Just 50 years ago the basic safety of our drugs was in question since no efficacy and safety testing was in place. There was no such thing as clinicial trials. Hilts takes us through the evolution of the FDA from a shoestring operation to its massive size today.

What is evident is that the FDA, flaws and all, still is the only barrier between the public and sometimes ethically challenged businesses. Often criticized as slow and anti-business it is clear that the FDA has tried to do what is right most of the time. At times the book reads like a novel when describing instances of deadly foods or drugs being sold to the public. For those who criticize the FDA, it is well worth reading to establish the historical context. It is clear Mr. Hilts is no friend of industry and this must be noted in reviewing his book. Sometimes only the worst of American business is noted, with little credit to the life saving miracle drugs produced by industry. That said Mr. Hilts book should be read by all those who deal with the FDA.

4 of 4 people found the following review helpful:

5.0 out of 5 stars Plus Ca Change, May 18, 2005

By 

Henry Greenspan "Henry Greenspan, Ph.D." (Ann Arbor, MI United States) - See all my reviews
(REAL NAME)   

Amazon Verified Purchase

This review is from: Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (Hardcover)

Hilts' readable book is the best introduction I know to the history and politics of FDA regulation. That history, as Hilts retells it, is a spiral. Clearly, there have been significant regulatory innovations since the days of T.R., and Hilts takes us through the key turning points. At the same time, the same core arguments about the virtues of regulation and the virtues of free markets recur.

Specialists will find some of the retelling oversimplified, and Hilts' own position (some will say "bias") is always clear. Nonetheless, there is no better first immersion into these issues, a terrific foundation for more nuanced analysis.