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the book was published in 2004, it is probably outdated.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 Usharauli
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