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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
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Sales rank 444,962
Customers rating (based on 8 reviews)
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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.
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| Publisher | Knopf | | Release date | 03/2003 | | Availability | | | Edition | Hardcover |
| | List price | $26.95 | | Our price | n/a | | Used price | from $2 |
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 Excellent introduction to an important agency
This book is one of the few ones available on the FDA that is not a polemical attack on the agency. This agency, which is short on man-power and funds, is tasked with an incredibly daunting mission, i.e. to ensure the health of most foods, drugs, and cosmetics. Hilts provides a good history of the agency, often focusing on various individuals involved at all levels, which I liked. He talks about parties affected in various ways by FDA actions, such as consumers, patients, pharmaceutical companies, doctors, politicians, etc.. The only thing I felt misssing was a little more criticism of the FDA. No institution can be perfect or be completely staffed with ideal employees, and Hilts seems to limit his critiques of the FDA to outsiders, particularly politicians and corporations, while not focusing on any legitimate internal problems. But nevertheless I highly recommend to anyone wanting an overview of this critical area of regulation and of the players involved.
Great for classroom use.
I have used this text in my public administration ethics class for two years and I am using it again this year (Fall'05). Few works I have employed as texts present the ethical issues actually faced by administrators and their intimate relationship to public policy as well as this book does. It is well written and certainly speaks directly to students in a way that gets and holds their attention.Finally, recent events have born out Hilt's findings concerning the drug industry dispite critics who appear to resent his conclusions on an ideological basis.
Plus Ca Change
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.
 A Much Better Book
Hilts is a journalist so perhaps he can be forgiven for writing such a biased book, although to give him credit, he does not seem to even try to hide his bias, which makes the book a kind of comedy.
A much better (and thinner) book on the FDA is written by a former FDA regulator and a M.D., To America's Health, by Henery Miller.
Great intro to public health regulation
Sorry the other reviewer didn't like this, but as an FDA employee when Reagan would not allow the regulation of unpasturized cheese, where the listeria bacteria consumed in it caused the deaths of dozens of babies and pregnant women, I have to agree with the author. That cheese example is just the beginning; it doesn't include the dozens children who died after it was clear that aspirin use in children with fever caused the deadly Reye syndrome and the administration refused to allow FDA to put warning instructions on the label. It does not include the dozens of children who were poisoned by pills in easy-opening containers (iron pills look like candy and overdoses not treated promptly are irreversibly fatal). This book does name courageous industry people as well as public servants. It can open your eyes to the critical role the government played in assuring the availability of penicillin during WWII and vaccines today. It is the history of germs and cures in the US in a plain-spoken format.
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