This comprehensive, authoritative, and insightful history of the US Food and Drug Administration enables a reader to understand how the FDA garnered power over one of the most powerful industries in the world; the myriad forces that have influenced FDA decisions; and the social and political factors that shaped the FDA and those that continually buffet it. The story of the FDA is a tale of gradual accretion of authority, influenced from time to time by legislation, and punctuated not only by occasional national drug disasters but also by some almost calamitous near misses.

The book is a lesson on the numerous constituencies upon which a government agency relies to preserve and maintain its reputation. It is an impressive and moving story about government employees who have served the public well by approving drugs with proved efficacy and safety, basing decisions on solid science, often under criticism from industry, legislators, academics, professional societies, disease based organisations, and patients.

But it is also a story of how science and a reputation based on rigorous scientific conduct is not necessarily sufficient to sustain an …