type: timeline_event The FDA announced it would eliminate the longstanding requirement for two independent clinical studies to approve new drugs, moving to a single-trial default to accelerate approvals. The two-study requirement had been a cornerstone of drug safety since the thalidomide crisis of the 1960s, ensuring that drug efficacy findings could be independently replicated before exposing millions of patients.
Critics warned the change prioritizes pharmaceutical industry profits over patient safety, as single studies are more susceptible to statistical anomalies, hidden biases, and unreplicated results. The FDA under Trump appointee Marty Makary has systematically loosened safety standards across multiple domains, following a pattern of regulatory capture in which the agency tasked with protecting public health instead serves the commercial interests of the industries it is supposed to oversee.