Therapeutic cultures: Pharmaceutical regulation and medical politics in the United States and German

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Globalization has gradually imposed uniformity on accounting practices, standards for weights and measures, and other dimensions of international trade during the past fifty years. Official demands for pharmaceutical safety and efficacy are likewise becoming standard across the globe. Advocates for rapid access to medicines anticipate that “safe” and “effective” drugs soon will transfer easily between countries. A closer look at the United States and Germany, countries with similarly advanced systems for medical research, testing and patient care, challenges this assumption. Drug regulation in these two countries exhibits differences that are puzzling in light of expectations for convergence of government authority, professional roles, and citizen capacity related to economic and technological developments.

First, American regulators have delineated a strict boundary between premarket testing and market approval, while their German counterparts have adopted a more flexible approach that blurs the distinction between pre- and post-market oversight. Second, government officials in the United States closely monitor clinical trials and determine testing methods, whereas the medical profession holds a monopoly on the design and oversight of drug safety testing in Germany. Third, patients in the United States increasingly challenge expert risk assessments and demand greater access to drugs, even in early stages of clinical trials. These aspects of patient activism are strikingly absent from Germany.

In order to explain these divergences in regulatory approaches and testing methods, this study proposes a shift from viewing regulatory outcomes as dependent only on state structure to examining a wider therapeutic culture that emerges from a network of relations among the state, the medical profession, the pharmaceutical industry, and patients. Differences between the United States and Germany are described in chapters covering regulatory laws, clinical trials, and systems for monitoring adverse reactions.

For each of these areas, different political constructions of “the patient” in the two therapeutic cultures produced variation in government policies and in the distribution of power among key social actors. The embedding of politics in supposedly apolitical features of drug safety testing and regulation suggests that processes of globalization will need to accommodate persisting social and political variation even when technical standardization has been achieved.