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

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. 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. Some images inside the book are unavailable due to digital copyright restrictions. Introduction : The Gatekeeper -- Reputation And Regulatory Power -- Reputation And Gatekeeping Authority : The Federal Food, Drug, And Cosmetic Act Of 1938 And Its Aftermath -- The Ambiguous Emergence Of American Pharmaceutical Regulation, 1944-1961 -- Reputation And Power Crystallized : Thalidomide, Frances Kelsey, And Phased Experiment, 1961-1966 -- Reputation And Power Institutionalized : Scientific Networks, Congressional Hearings, And Judicial Affirmations, 1963-1986 -- Reputation And Power Contested : Emboldened Audiences In Cancer And Aids, 1977-1992 -- Reputation And The Organizational Politics Of New Drug Review -- The Governance Of Research And Development : Gatekeeping Power, Conceptual Guidance, And Regulation By Satellite -- The Other Side Of The Gate : Reputation, Power, And Post-market Regulation -- The Détenté Of Firm And Regulator -- American Pharmaceutical Regulations In International Context : Audiences, Comparisons, And Dependencies -- Conclusion : A Reputation In Brief. Daniel Carpenter. Includes Bibliographical References And Index. Content: Introduction: The gatekeeper -- Reputation and regulatory power -- Reputation and gatekeeping authority : the federal Food, Drug, and Cosmetic Act of 1938 and its aftermath -- The ambiguous emergence of American pharmaceutical regulation, 1944-1961 -- Reputation and power crystallized : thalidomide, Frances Kelsey, and phased experiment, 1961-1966 -- Reputation and power institutionalized : scientific networks, congressional hearings, and judicial affirmations, 1963-1986 -- Reputation and power contested : emboldened audiences in cancer and AIDS, 1977-1992 -- Reputation and the organizational politics of new drug review -- The governance of research and development : gatekeeping power, conceptual guidance, and regulation by satellite -- The other side of the gate : reputation, power, and post-market regulation -- The détenté of firm and regulator -- American pharmaceutical regulations in international context : audiences, comparisons, and dependencies -- Conclusion: A reputation in brief. This work traces the history of FDA regulation of pharmaceutical, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.