FDA announces single-trial drug approval default in New England Journal of Medicine op-ed

FDA Commissioner Martin Makary and CDER oncology director Vinay Prasad announced a fundamental change to FDA drug approval standards through an article in the New England Journal of Medicine on February 18, 2026. The article, titled "Rethinking the Evidence Standard for Drug Approval," declared that a single pivotal trial would become the default for drug approval, reversing the two-trial standard that had been FDA practice since the 1960s. The announcement bypassed the Administrative Procedure Act's notice-and-comment rulemaking process. Yale professor Joseph Ross immediately criticized the move, saying "using a journal article to announce major policy is not how you do notice-and-comment rulemaking." Hundreds of biostatisticians and clinical researchers subsequently published responses questioning the statistical rationale.