美国食品药品管理局的新优惠券计划在安全问题,员工损失和政治压力中加速药物批准. FDA's new voucher program speeds drug approvals amid safety concerns, staff losses, and political pressure.

林业发展局在马蒂·马卡里专员领导下发起的新的国家优先购买券方案正在加速批准与国家优先事项挂钩的治疗药物,但已引起人们对其科学规范与法律基础的广泛关切。 The FDA's new National Priority Voucher program, launched under Commissioner Marty Makary, is accelerating drug approvals for treatments tied to national priorities, but has sparked widespread concern over its scientific rigor and legal foundation. 尽管有人声称进行了基于证据的审查,但由于尚未解决的权力问题,机构高层官员仍拒绝批准药物,最后决定由Mallika Mundkur博士作出。 Despite claims of evidence-based reviews, top agency officials have declined to approve drugs due to unresolved authority issues, leaving final decisions to Dr. Mallika Mundkur. 这个计划与白宫争取药品价格交易的努力相关, 造成员工混乱, 近20%的毒品中心员工因辞职或裁员而失业。 The program, linked to White House efforts to secure drug pricing deals, has caused staff turmoil, with nearly 20% of the drug center’s workforce lost to resignations or layoffs. 由于安全考虑,包括病人死亡,一些药物审查被推迟。 批评者警告说,批准政治化会危及病人安全和机构的信誉。 Several drug reviews have been delayed due to safety concerns, including a patient death, and critics warn the politicization of approvals risks patient safety and the agency’s credibility.