Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (review)

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 health but actually to inform the content of pharmaceutical R&D, and medical research more generally, by promulgating particular ideas and practices in its regulations. That is, the agency in important ways runs ahead of medical and scientific opinion, actively shaping and advancing standards of medical research that others voluntarily adopt (Carpenter calls this conceptual power). This is a hard historical argument to make, and Carpenter has pursued it by energetically mining primary sources in FDA internal documents, the congressional record, and the trade press. However, it logically requires that the FDA's position be compared to biomedical opinion outside the Beltway, and this is where problems emerge.

For instance, Carpenter underplays the role of the elite "therapeutic reformer" (Harry Marks's term) medical academics of the AMA Council on Pharmacy and Chemistry in establishing the regulatory agenda the FDA would follow. He does describe how that Council helped lobby for the premarket safety testing authority that the FDA acquired in 1938. However, he hardly mentions the Council's three prior decades of work as a regulator in establishing the standards of toxicity testing used by the agency once it took over that role by statutory authority. To illustrate the FDA's initiative in promulgating high safety standards, Carpenter offers a 1958 agency memo demanding new toxicity studies for a novel tranquilizer from Winthrop Labs, in which the FDA asks for a pathology and hematology workup on sixty to seventy rats given a full year of the drug at several high dosages, and also eight dogs given six months of drug. But if this is strict regulation, why did Penn pharmacologist Edward Krumbhaar conduct a similar set of chronic, multispecies toxicity tests at Smith, Kline & French's request twenty-two years earlier, to win the AMA Council's Seal of Approval for advertising its new stimulant amphetamine? The FDA's 1958 action on Winthrop's tranquilizer looks less like hypervigilant policing and more like a deserved scolding for a firm trying to market drugs without what, by the standards of the late 1950s, had become rudimentary evidence of safety.

True enough, the AMA Council is hard to study as its records remain essentially secret. But there are other instances of overstatement. Carpenter treats the FDA's post-thalidomide issuance of rules on informed consent as an example of heightened agency activism and the extraordinarily high standards imposed by Frances Kelsey, head of the new Investigative Drug Branch established in 1963. He is...