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 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.

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.