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Daniel Carpenter. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton Studies in American Politics: Historical, International, and Comparative Perspectives. Princeton, N.J.: Princeton University Press, 2010. xx + 802 pp. Ill. $75.00 (cloth, 978-0-691-14179-4), $29.95 (paperbound, 978-0-691-14180-0).
In this ambitious tome, political scientist Daniel Carpenter attempts to build some general arguments about regulation in the United States upon the historical foundation of drug regulation by the Food and Drug Administration (FDA). The United States is not under-regulated, he argues: the FDA has led the world in stringency of drug regulation, establishing processes emulated by agencies abroad. In the United States, the agency has accumulated formidable power of its own, in contrast to the predictions of capture theory (in which regulators serve the interests of regulated industry's leaders). Nor has it obeyed the whims of Congress or the fickle masses. For Carpenter, the FDA has built its autonomous power by earning the respect of the medical and scientific elites, the courts, politicians, and the general public. That power is exerted by reputation, such that few challenge it. That is, the drug industry determines its actions according to what they think the FDA will do, mostly to avoid conflict; doctors mostly accept FDA judgments even if they sometimes grumble; and consumers mostly trust FDA decisions.
A key historical foundation on which all this depends is the argument that we should see the FDA as an activist agency that, since its inception in 1906 has consistently taken initiative not just to constrain the drug industry to protect public...