Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.

Zwischen Gesundheit und Wirtschaft: Normen und Interessenkonflikte in der behördlichen Arzneimittelregulierung im Deutschen Reich 1871–1945

The article deals with the question of why the German authorities failed to reform drug regulation between 1871 and 1945, although it was urgently required due to the fundamental pharmaceutical change. The German drug regulation was initially dominated by non-state actors. The state was faced with numerous and powerful actors who represented completely different interests and standards, especially in health and economic policy. On the one hand, the reform of pharmaceutical law was blocked because the authorities were unable to balance these multiple normativities. On the other hand, the reform was complicated by external, non-medical norms and constraints.