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

by Philip J. Hilts (Author) "ONE DAY in the fall of 1992, novelist Diane Ayres, a diminutive darkhaired woman of some sturdiness and intensity, was told by her gynecologist that..." (more)
Key Phrases: poison squad experiments, drug lag, drug off the market, United States, New York, White House (more...)

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: 4.0 out of 5 stars See all reviews (8 customer reviews)
• Amazon.com Sales Rank: #771,888 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

11 of 11 people found the following review helpful:

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

By A Customer

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.

9 of 9 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)

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.

3 of 3 people found the following review helpful:

5.0 out of 5 stars Plus Ca Change, May 19, 2005

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

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.