Republished with some modification.
I have decided to read this book to become more familiar with the FDA's role and its impact on BioPharma. And also because the author, Fran Hawthorne's writing style is quite easy to follow and isn't boring.
Of course, similar to her earlier book about pharma company Merck, Fran Hawthorne's writing failings are in its content. This book, rather than being "inside the FDA" is more better described as "about the FDA".
The author provided short overview how FDA was established and how it is accomplishing its duty to keep the public safe from poor quality drugs or food. However, it is based on publicly available information that does not really explain how is works.
In addition, since the book was published in 2004, it is probably outdated. The book simply reinforces long-held public opinion that politics does play a role in how FDA, as a federal agency, does it's work. Rather being totally "objective", it appears that FDA's visions undergo modification whenever new directors are appointed.
Another topic discussed in this book is the FDA's approval process. The book tend to imply that FDA reviewers are near "perfect" scientists whose opinions should be followed strictly no matter what. This is, of course, the most unrealistic scenario.
posted by David UsharauliTweet