Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA

by Daniel P. Carpenter

How the FDA became the world's most powerful regulatory agency

The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.

Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.

Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Genres: Nonfiction, Science, History, Politics, Business, Health Care, Health

856 pages, Hardcover

First published April 12, 2010

Reviews

[Erika · Rating 4 out of 5]

Engaging writing. Had some interesting information that was new to me, despite working 18 years in the field. I am a bit worried that his devotion to the thesis that the agency's history can be understood through the lens of its reputation/image may be too cramped. Procrustean bed in some instances, perhaps. On back stories, and additional factors influencing decisions, and antecedents for things, he is excellent. I worry that he is not always on firm ground with "why" things happened one way or another, particularly when he shoehorns it into his thesis. Definitely worth reading and seeing the history from this angle.

[Diane Wu · Rating 5 out of 5]

Every one should read this book and understand the power of the institution that determines what drugs go inside your body and under what conditions you should be allowed to die.

The FDA is one of the most powerful institutions in our lives, arguably more powerful than the federal government.

[Angel Lajeunesse · Rating 4 out of 5]

Challenging, but worth the effort

Some what of a tough read. However, it is loaded with facts and history. It's a good book that's definitely worth the read. Reading it a second time helps clarify some of the ideas

[Beth Haynes · Rating 5 out of 5]

Long, Detailed. But an excellent history of the development of the regulatory power of teh FDA adn teh role of reputation in legitimizing its growth of power.