蒙大拿州通过了SB535法案，在特定条件下允许医生为患者提供完成FDA第一阶段临床试验的实验性治疗1。该法案规定，治疗必须获得州注册私人审查委员会批准、在持证诊所进行、患者需提供知情同意，且所有不良事件需报告1。这项立法的核心创新在于允许治疗赞助方和诊所对患者收费，突破了现有《知情权法案》和《扩大获取途径》中禁止收费的限制1。
该法案旨在解决生物技术行业面临的融资困难。根据2015年《PLOS ONE》的研究，约68%的失败临床试验因商业原因而非安全性或有效性问题而停止1。第一阶段完成后，只有约10%的药物最终获批1，同时药物开发成本每9年翻倍1。作为该法案的推动者之一，相关人士已通过其公司组建了第一个审查委员会1。经济学家Alex Tabarrok将该创新评价为"我有生之年最重要的药物批准监管创新"1。
Montana has passed Senate Bill 535, which establishes a framework for administering experimental therapies to patients outside of clinical trials under specific regulatory conditions 1. The law permits physicians to offer treatments that have completed FDA Phase 1 trials to patients who provide informed consent at licensed clinics, provided the therapy receives approval from a state-registered ethics review board and adverse events are reported 1.
A significant innovation in the legislation is that it allows both treatment sponsors and clinics to charge patients for these therapies, marking the first time such fees have been permitted in compassionate use frameworks 1. This policy addresses what the biotech industry refers to as the "valley of death"—the financing challenge companies face between Phase 1 completion and subsequent development stages 1. According to research cited in the law's context, approximately 68 percent of failed clinical trials are terminated for commercial reasons rather than safety or efficacy concerns 1. Additionally, drug development costs have doubled approximately every nine years, and only about 10 percent of Phase 1 drugs advance to approval 1.
The law's author, who contributed ideas to the legislation and implemented it through their company, has already assembled the first state-registered ethics review board under the new framework 1. Economist Alex Tabarrok has characterized the measure as "the most important drug approval regulatory innovation in my lifetime" 1.
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