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蒙大拿州通过了一项名为 SB535 的法律。该法案在“有权尝试”（Right to Try，指在获得知情同意后，基于已有的第一阶段安全性数据等信息，提前获得药物使用许可）的基础上更进一步，解决了相关法律存在的问题。 Alex Tabarrok 称其为“我一生中药物审批领域最重要的监管创新”（https://marginalrevolution.com/marginalrevolution/2026/06/montanas-sb535-and-a-potential-biotech-renaissance-in-america.html）。该法案曾在此处发布但未获通过（https://news.ycombinator.com/item?id=48559525）。版主建议发布此文。我为该法律贡献了想法，并正在通过我的公司实施。我投资生物技术多年，目睹了许多公司的挣扎。我曾试图在 Prospera 建立生物技术生态系统作为替代方案，但认为时机尚早，现在我认为蒙大拿州是证明这一点的最佳地点。 **为何存在此法：** 当 FDA 批准了不好的药物时，会有人承担责任。当 FDA 延迟批准好的药物时，死亡是统计上的，没有人受到指责（“无形墓地”）。因此，激励机制是过度谨慎，这也是为何每九年批准一种药物的成本大约翻一番（“Eroom 定律”）。创始人常在第一阶段后陷入“死亡谷”：补助金不再可用，商业资金则要求药物能够通过下一阶段试验的保证。只有约 10% 的第一阶段后药物获得批准，但 68% 的试验失败并非因为安全性或有效性不足，而是出于商业原因（Williams et al., PLOS ONE 2015）。联邦的“有权尝试”和“扩大使用”并未解决此问题。联邦改革非常困难。 **蒙大拿州允许什么：** 医生可以在试验之外给予实验性治疗，前提是：该治疗已完成 FDA 第一阶段试验并在活跃的 IND（新药临床试验申请）下进行；州注册的私人审查委员会（ETRB）已批准方案；治疗在州许可的诊所进行；同意书的签署超过联邦标准，并且需要报告不良事件。关键在于：申办方和诊所可以收费。 **为何这次不同：** 风险回报比是症结所在。“有权尝试”和“扩大使用”不允许申办方收费，因此治疗患者意味着承担风险和费用。蒙大拿州是第一个允许 IND 阶段药物申办方为该风险定价的州法。如今的试验招募是一种价格控制体系：每位患者的成本约为 5 万至 10 万美元，通常对支付给患者的费用有上限（“不当诱导”），也有下限（在“有权尝试”/“扩大使用”中，仅按成本收费，不得盈利）。蒙大拿州取消了这两项限制（我知道这会引发大量争论，我们来讨论一下）。因此，这不是一个为所欲为的局面，额外的自由伴随着严格的监管。ETRB 是蒙大拿州对 IRB（机构审查委员会）的翻版：进行安全性审查、同意书审查、强制性结果报告，并且不能向患者隐瞒安全信息。这就是事实的资金筹措机制。 **公司现在可以做什么：** 如果您拥有处于“死亡谷”中的第一阶段资产：治疗患者，协商付款，获取真实世界数据，并利用这些数据优化您的第二/三阶段设计。 **披露：** 我的公司组建了第一个 ETRB。该模式是收取审查费，类似于 IRB；不持有申请方的股权，不按结果付费；利益冲突政策和委员会成员信息公开；在申请方同意的情况下公布决策函；要求提交年度结果报告。 **反对意见：** * **有人受伤怎么办？** 与试验和常规护理一样：通过美国法律体系，寻求法律救济。 * **FDA 会叫停吗？** FDA 尚未表示不会，但历史上 FDA 会打击灰色市场诊所，而不是州法律；我们正在寻求安全港，但一些公司并未等待。 * **江湖骗术？** 坏人想在暗中行事，而蒙大拿州让这变得困难。 **需要什么：** 拥有第一阶段及以上资产的生物技术公司，愿意在获得 FDA 完全批准之前进行尝试，以积累能让该机构接受的证据——目的不是跳过 FDA，而是降低数据成本。以及前 FDA 审查员、IND 运营者、IRB 成员，告诉我们这个模式存在哪些问题。我很乐意回答任何问题。

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Montana passed a law called SB535. It builds on right-to-try (pre-approval access with informed consent, Phase 1 safety data etc.) but goes much further, fixing problems with those laws.Alex Tabarrok called it "the most important regulatory innovation in drug approval in my lifetime" (https://marginalrevolution.com/marginalrevolution/2026/06/montanas-sb535-and-a-potential-biotech-renaissance-in-america.html). Was posted here but died in /new (https://news.ycombinator.com/item?id=48559525). The mods suggested this post.I contributed ideas to the law and am now implementing it through my company. I invested in biotech for years and watched companies struggle. I built the biotech ecosystem in Prospera as an alternative, concluded it was too early, and now think Montana is the best place to prove this.Why this exists: When FDA approves a bad drug, heads roll. When it delays a good one, the deaths are statistical and nobody gets blamed ("invisible graveyard"). So the incentive is overcaution, which is why the cost per approved drug has roughly doubled every 9 years for decades ("Eroom's Law"). Founders are in the "Valley of Death" around Phase 1: grants are no longer available, and commercial money wants assurance the drug will pass the next trial. Only ~10% of post-Phase 1 drugs get approved, but 68% of failed trials don’t stop because they found lack of safety or efficacy but commercial reasons (Williams et al., PLOS ONE 2015). Federal Right to Try and Expanded Access haven't fixed this. Federal reform is super-hard.What Montana allows: A physician can give an experimental treatment outside a trial if: it completed FDA Phase 1 under an active IND; a state-registered private review board (ETRB) approved the protocol; it's delivered at a state-licensed clinic; consent exceeds the federal standard & adverse events need to be reported. The key is: sponsors and clinics can charge.Why this time it's different: The risk-reward ratio is what's broken. Right to Try and Expanded Access don't let sponsors charge, so treating a patient is risk plus expense. Montana is the first state law where sponsors of IND-stage drugs can price in that risk. Trial recruitment today is a price-control system: per-patient cost is around $50-100k, typically has a ceiling upward on what it can pay patients ("undue inducement") and a floor downward (no profit, only at cost in RTT / EA). Montana removes both (I know this will lead to lots of debate, let’s have it.)So this is not a free for all, the additional liberties come with tough oversight. An ETRB is Montana's version of an IRB: safety review, consent, mandatory outcome reporting, and you can't withhold safety information from patients. That’s the truth-funding mechanism.What companies can do now: If you have a Phase 1 asset stuck in the Valley of Death: treat patients, negotiate payment, get real-world data, use it to sharpen your Phase 2/3 design.Disclosure: my company formed the first ETRB. The model is review fees, like an IRB; no equity in applicants, no payment by outcome; COI policy and board bios public; decision letters published with applicant consent; annual outcome report required.Objections:- Someone gets hurt? Same as trials and ordinary care: US legal system, legal recourse.- FDA shuts it down? They haven't said they won't, but historically FDA goes after grey-market clinics, not state laws; we're asking for safe harbor, but some companies aren't waiting.- Snake oil? Bad actors want to fly under the radar, and Montana makes that hard.What's needed: Biotechs with Phase 1+ assets willing to move before full FDA assurance, to build the evidence that gets the agency on board - the point is not to skip FDA, but to reduce the cost of data. And ex-FDA reviewers, IND operators, IRB members telling us where this breaks.Happy to answer anything.

HN 读者分享：蒙大拿州新生物技术法律的内部视角