2026-09-14 16:23:12 / 路透社
2020年8月29日，美国马里兰州银泉市美国食品药品监督管理局总部外的标识。路透社/安德鲁·凯利/ 获取授权许可，打开新标签页
9月14日（路透社）——美国食品药品监督管理局（FDA）将于周一举行公开听证会，收集关于致幻剂潜在治疗用途的反馈，这是唐纳德·特朗普政府数月来推动加快开发用于严重精神疾病治疗方法的最新举措。
此次听证会是4月份启动的更广泛推动计划的一部分，当时特朗普下令美国食品药品监督管理局重点关注将致幻剂药物项目纳入其优先审评券计划。
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该行政令还指示FDA与毒品执法管理局合作，根据一项法律为部分患者开辟获取试验性治疗的途径，该法律允许某些重症患者寻求实验性疗法，并加强与退伍军人事务部的合作。
自那时起，FDA已向三家开发致幻剂疗法的公司颁发了优先审评券：一张用于治疗难治性抑郁症的裸盖菇素，一张用于重度抑郁症的裸盖菇素，还有一张用于治疗创伤后应激障碍的亚甲二氧甲基苯丙胺（即“摇头丸”主要成分之一）。
此次听证会聚焦于可能影响致幻疗法测试和交付方式的实际问题，包括从业者培训与资质、患者筛查与监测、可及性与报销、诊所容量以及长期安全数据收集。
FDA表示，此次听证会不征求针对个别药物申请、管制物质归类或致幻剂合法化的意见。
听证会上，医生、退伍军人、药剂师和治疗师敦促监管机构为致幻辅助疗法建立明确的安全和准入标准。
专家表示，任何获批的致幻疗法都必须在治疗过程中配备经过培训的工作人员，同时辅以适当的筛查、后续护理和社区支持。
正在开发基于 LSD 疗法的Definium Therapeutics公司首席执行官罗伯特·巴罗对路透社表示，此次听证会为监管机构、临床医生和患者之间“持续的公开对话”提供了“绝佳机会”。
他表示，监管机构和行业应将致幻剂“视作普通的药物开发、普通的科学、普通的医学”，而非需要特殊对待的异常新颖类别。
就在听证会举行前几天，包括FDA药物评估和研究中心主任迈克尔·戴维斯在内的高级FDA官员在《新英格兰医学杂志》上发表了一篇论文，概述了开发和批准致幻药物的框架，并表示该机构正在针对重度抑郁症和创伤后应激障碍等难治病症“应对这一时刻”。
美国精神病学协会表示，其“赞赏FDA就致幻剂的潜在治疗用途举行公开听证会并与联邦合作伙伴进行协调”。
“FDA对安全性和有效性的判定……必须仍是未来任何临床应用的基础。”
杰富瑞分析师表示，该框架表明FDA愿意考虑采用灵活的试验设计，以应对包括“功能性破盲”在内的挑战——即药物明显的精神活性效应会向参与者暴露他们所接受的治疗组别。
政府的支持引发了投资者对该领域的新兴趣，行业高管告诉路透社，这可以改善FDA与毒品执法管理局之间的协调，有助于减少监管延迟，尽管研究人员指出，获批疗法可能仍需数年时间。
分析师表示，监管机构、临床医生和开发商在安全、有监督的推出方面持续保持一致，将对AtaiBeckley、Compass Pathways (CMPS.O)、Definium Therapeutics (DFTX.O)、Helus Pharma (HELP.NLB)和GH Research (GHRS.O)等公司有利。
Helus首席执行官迈克尔·哈尔斯特德表示：“科学在不断进步，监管机构、研究人员和临床医生之间持续进行深思熟虑的互动，对于推进这些极具前景的新疗法至关重要。”
由卡迈勒·乔杜里和普扬·辛格在班加罗尔报道；奥罗拉·埃利斯和希尔皮·马jumdar编辑
FDA holds public hearing on psychedelic drugs as Trump-driven push gathers pace
2026-09-14 16:23:12 / Reuters
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/ Purchase Licensing Rights, opens new tab
Sept 14 (Reuters) – The U.S. FDA is holding a public hearing on Monday to gather feedback on the potential therapeutic use of psychedelic drugs, the latest step in a months-long push by President Donald Trump’s administration to speed up development of the treatments for serious mental illnesses.
The hearing is part of a broader push launched in April, when Trump ordered the U.S. Food and Drug Administration to focus on qualifying psychedelic drug programs for its priority-voucher program.
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The order also directed the FDA to work with the Drug Enforcement Administration on a pathway for some patients to obtain investigational treatments under a law, which allows certain seriously ill patients to seek experimental therapies, and to increase collaboration with the Department of Veterans Affairs.
Since then, the FDA has issued priority vouchers to three companies developing psychedelic-based treatments, one for psilocybin for treatment-resistant depression, another for psilocybin for major depressive disorder and a third for methylone for post-traumatic stress disorder.
The hearing focuses on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and the collection of long-term safety data.
The FDA said it was not seeking views on individual drug applications, the scheduling of controlled substances or the legalization of psychedelics.
Doctors, veterans, pharmacists and therapists during the hearing urged the regulator to establish clear safety and access standards for psychedelic-assisted therapies.
Experts said any approved psychedelic treatment must include trained staff in the room during sessions, along with proper screening, follow-up care and community support.
Robert Barrow, CEO of Definium Therapeutics, which is developing an LSD-based therapy, told Reuters that the hearing offers “a nice opportunity for that continuing public dialogue” among regulators, clinicians and patients.
He said regulators and industry should treat psychedelics “like it’s normal drug development, normal science, normal medicine,” rather than as an unusually novel category requiring special treatment.
Just days before the hearing, senior FDA officials, including Michael Davis, head of the agency’s Center for Drug Evaluation and Research, published a paper in the New England Journal of Medicine outlining a framework for developing and approving psychedelic drugs and saying the agency was “meeting this moment” on hard-to-treat conditions such as major depressive disorder and PTSD.
The American Psychiatric Association said it “appreciates the FDA’s public hearing and coordination with federal partners on the potential therapeutic use of psychedelics.”
“The FDA’s determination of safety and effectiveness… must remain the foundation for any future clinical use.”
Jefferies analysts said the framework suggested the FDA was willing to consider flexible trial designs to address challenges including “functional unblinding,” when a drug’s noticeable psychoactive effects reveal to participants which treatment they received.
The administration’s support has stirred fresh investor interest in the sector, with industry executives telling Reuters it could improve coordination between the FDA and the Drug Enforcement Administration and help reduce regulatory delays, even as researchers noted that approved treatments were still likely years away.
Continued alignment among regulators, clinicians and developers on a safe, supervised rollout should benefit AtaiBeckley , Compass Pathways (CMPS.O), Definium Therapeutics (DFTX.O), Helus Pharma (HELP.NLB), and GH Research (GHRS.O), analysts said.
Helus CEO Michael Halstead said “the science continues to advance, and continued thoughtful engagement among regulators, researchers and clinicians is critical to advancing these promising new treatments.”
Reporting by Kamal Choudhury and Puyaan Singh in Bengaluru; Editing by Aurora Ellis and Shilpi Majumdar
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