特朗普签署第14401号行政令，加速严重精神疾病创新疗法的研究与审批
2026年4月18日，美国总统特朗普在白宫签署第14401号行政令，要求联邦机构加速严重精神疾病创新疗法的研究与审批，把包括 ibogaine（伊博格因）化合物在内的迷幻类药物列为重点方向。
行政令列出的数据说，美国有逾1,400万成年人患有严重精神疾病，其中约800万人靠处方药物治疗；美国自杀率在2000年至2018年间上升了37%；退伍军人每年自杀逾6,000人，自杀率是非退伍军人成年人的两倍多。行政令说，不少重度抑郁、物质使用障碍等患者对标准治疗反应不完全或会复发，现有研究体系还没有产出能带来持久改善的新疗法。
在审批方面，行政令要求食品药品管理局（FDA）局长向已获得突破性疗法认定、符合条件的迷幻类药物发放国家优先审评券；FDA 与缉毒局要为符合条件的患者建立依《尝试权法》使用迷幻类药物的通道，包括开具处方的医生与研究人员所需的一级管制物质处理授权。
在资金与协作方面，行政令要求卫生与公众服务部通过卫生高级研究计划局，从现有资金中拨出至少5,000万美元，与已设立或正在设立迷幻药物项目的州政府合作，并提供技术援助与数据共享；卫生与公众服务部、FDA 还要与退伍军人事务部签署数据共享备忘录，增加临床试验参与与真实世界证据积累。
行政令还要求司法部长对已成功完成三期临床试验、用于严重精神疾病的一级管制物质产品及时启动重新分类审查，以便获批产品能尽快调整其管制等级。
关联：特朗普签署第14390号行政令，打击针对美国人的网络犯罪与诈骗
Trump Signs Executive Order 14401 to Accelerate Medical Treatments for Serious Mental Illness
On April 18, 2026, President Donald J. Trump signed Executive Order 14401 at the White House, directing federal agencies to accelerate innovative research models and appropriate drug approvals for serious mental illness, with psychedelic drugs, including ibogaine compounds, named as a focus.
The order states that more than 14 million American adults have a serious mental illness and about 8 million are on prescription medication for these conditions; that suicide rates rose 37 percent from 2000 to 2018; and that more than 6,000 veterans die by suicide each year, at a rate more than twice that of non-veteran adults. It says many patients with major depressive disorder, substance use disorder, and other serious illnesses relapse or do not fully respond to standard therapies, and that the research system has yet to produce approved therapies delivering enduring improvement for the most complex patients.
On approvals, the order directs the Commissioner of Food and Drugs to provide Commissioner's National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designation. The FDA and the Drug Enforcement Administration are to establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act, including Schedule I handling authorizations for treating physicians and researchers.
On funding and collaboration, the Secretary of Health and Human Services, through the Advanced Research Projects Agency for Health, is to allocate at least $50 million from existing funds to support state governments that have enacted or are developing psychedelic-drug programs, with technical assistance and data sharing. HHS, the FDA, and the Department of Veterans Affairs are to sign data-sharing memoranda to increase clinical trial participation and real-world evidence generation.
The order also directs the Attorney General to initiate and complete review of any Schedule I product that has successfully completed Phase 3 trials for a serious mental health disorder, so that rescheduling, if appropriate, can proceed as quickly as practicable once the product is approved.
Related: Trump Signs Executive Order 14390 to Combat Cybercrime and Fraud Targeting Americans
来源：白宫
发布：GSM·美国（发布链接）
图片来源：GSM 行政令统一模板（美国总统行政令）
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