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

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.

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.

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.

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.

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.