美国食品和药物管理局正在快速追踪稀有疾病药物, The FDA is fast-tracking rare-disease drugs with weak evidence, raising safety and efficacy concerns.

林业发展局正在加速批准证据较弱的稀有疾病药物,依靠案例报告和科学的可信度而不是有力的临床试验,引起人们对病人安全和治疗效果的关切。 The FDA is accelerating approvals for rare-disease drugs with weaker evidence, relying on case reports and scientific plausibility instead of robust clinical trials, sparking concerns over patient safety and treatment efficacy. 虽然95%的罕见疾病患者缺乏经批准的治疗方法,但批评者警告该机构在政治和工业压力的驱动下转变,有可能批准无效或有害治疗,特别是因为后续研究往往无法证实最初的承诺。 While 95% of rare disease patients lack approved therapies, critics warn the agency’s shift—driven by political and industry pressure—risks approving ineffective or harmful treatments, especially as follow-up studies often fail to confirm initial promises.