Soviet pharmaceutical regulation (1918–1990)

Abstract

What counts as robust evidence for drug regulators is influenced by social, political and cultural factors. A dramatic example of culture and politics shaping regulatory science can be found in the history of pharmaceutical testing in the Union of Soviet Socialist Republics (USSR or Soviet Union) before 1990. Regulators in the USSR did not rely on the 4-phase clinical trial model introduced in the West in the 1960s. This model was not officially supported in the USSR, because it was considered wasteful and too remote from clinical realities. In fact, several core characteristics of Western regulatory science, such as randomization, double blinding and the use of placebos, were publicly rejected in the USSR as unethical and exploitative of research participants.1 The Soviet drug testing system prioritized testing “in the real world” and thus represented an alternative to what ultimately became the global gold standard. With the collapse of communism and the postsocialist transition in the early 1990s, Russia embraced the Western model and completely abandoned the older Soviet system for testing drugs.2 This article interprets Soviet drug regulation as an expression of prevailing political forces that shaped what counted as authoritative knowledge.