A watchdog group warns that the FDA’s shift toward “one pivotal trial” approval pathways could increase the risk of ineffective drugs reaching market. In a Center for Science in Public Interest letter published in the New England Journal of Medicine, CSPI argues that single-trial decisions—augmented by confirmatory evidence—may not consistently preserve efficacy. CSPI cites an independent assessment of pivotal trials for 21 drugs approved in 2018–2021 under the previous two-trial standard, suggesting those therapies would likely have lacked a second study to establish efficacy. The dispute centers on how modern analytics should compensate for fewer randomized efficacy data points.