蒙大拿州卫生与人类服务部已最终确定规则，允许经过初步测试的生物技术公司向知情同意的消费者出售实验性药物[1]。与其他司法管辖区不同，蒙大拿州的扩展知情同意权规定对患者类型没有限制，不仅限于绝症患者，而是向包括寻求预防性或延寿疗法的任何人开放这些药物[1]。该州已设立首个独立审查委员会对申请进行评估，首批应用已提交[1]。
新规则自2025年7月25日生效[1]。根据规定，生物技术公司需支付12,500美元获得审查委员会的批准[1]。审查委员会由蒙大拿州持证医生、科学家专家和伦理学家组成[1]。与美国食品药品监督管理局的扩展获取通道仅允许收回成本不同，公司在蒙大拿州可设定任何价格出售实验性药物[1]。
蒙大拿州在2015年首次通过知情同意权法案，2023年将其扩展至所有患者[1]。第二部相关法案于2025年4月通过并同月被采纳[1]。WinSanTor和Ceres Brain Therapeutics等生物技术公司已提交或考虑提交申请[1]。
Montana has moved forward with an expanded right-to-try law that permits biotech companies with preliminary test results to sell experimental medications to informed consumers [1]. Unlike similar programs in other jurisdictions, Montana's framework does not restrict access to terminally ill patients, instead allowing any person—including those seeking preventive or life-extension therapies—to obtain these drugs [1].
The state's Department of Health and Human Services has finalized the rules governing the program, and an independent review committee has been established to evaluate applications [1]. Companies must pay $12,500 to submit applications for committee approval [1]. The committee comprises licensed physicians, scientists, and ethicists from Montana [1]. The original right-to-try law was first enacted in 2015, then expanded in 2023 to include all patients rather than only those with terminal diagnoses [1]. A second legislative measure passed in April 2025 and was adopted that same month, with the new rules taking effect on July 25, 2025 [1].
A significant distinction between Montana's approach and the federal FDA's expanded access pathway is pricing authority [1]. Companies may set any price for experimental drugs under Montana's system, whereas the FDA's program requires cost recovery only [1]. This comes as median prices for rare disease drugs have reached $218,872 in recent years [1], and approximately 17 percent of drugs fail to demonstrate sufficient safety in phase three trials [1]. Two biotech firms, WinSanTor and Ceres Brain Therapeutics, have already submitted or are considering submitting applications under the new framework [1].