current affairs

As with many institutions, the FDA servers a perceived needed purpose. This book is a history of why the agency was needed and its design. It is filled with horror stories and how the FDA came to the rescue. Some of these stories even scared me as I recognized the products and or brands. The chapter "Capitalism in Crisis" reads more like a political statement against capitalism than a "FDA is out to help" statement.
What they do not say is that the FDA is the Government to the point that they can carry guns and badges. Now with the fast pace of drugs and device invention the FDA is needed more than ever. The other side of the coin is that thy have become an unwatched agency that can and does set its own rules to how a business can do their job down to describing the data field that are to be stored in their computer. Their regulations read like a phone book of conflicting statements (with no recourse). And you can be shut down on a whim if you do not follow the regulations as interpreted by their agent as they are the law.
The book contains an excellent set of notes. They are divided in to chapters. And there is a fair index. For people that like pictures there are eight pages of monochrome photographs.
The author has written several articles on medicine for various periodicals.

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.