# Montana implements experimental drug regulations Biotech companies can now offer early-stage drugs directly to patients. - **Source:** [MIT Technology Review](https://www.technologyreview.com) - **Published:** 2026-07-31 - **Original article:** - **On Brifing:** https://brifing.si/s/3f3889d2-a2df-465e-965c-181c749cb3c9 ## Montana's new experimental drug law Montana has established a new legal framework allowing biotech companies to provide early-stage drugs to patients. Companies can apply for approval with drugs tested on as few as 10 healthy volunteers by paying $12,500. A newly formed review board will evaluate these drugs before they're sold through experimental treatment clinics. The first clinics are expected to open by the end of this year, creating a novel pathway for drug access. ## Patient stories drove the legislation The law was influenced by families battling untreatable conditions. Brody DeVault, born in 2023 with creatine transporter deficiency, represents many hoping for experimental treatments. His family seeks access to a drug only tested in animals and few humans. While doctors can't prescribe it yet, the new law enables direct company access. Such cases highlight the desperate need that shaped Montana's groundbreaking policy. ## Controversial access model Montana's 'right-to-try' law theoretically allows access for any consenting adult who can pay. While longevity communities celebrate this, ethicists warn about potential dangers with limited safety data. The law removes traditional safeguards, raising concerns about exploitation. With minimal efficacy evidence required, unexpected side effects could emerge, creating complex medical and ethical challenges. ## Emerging experimental treatment market The regulation aims to position Montana as an experimental medicine hub. Biotech firms gain opportunities to commercialize products before completing full trials. This could create new funding models, especially for rare disease research. However, questions remain about affordability and equitable access. The policy may particularly benefit small biotechs focusing on niche therapeutic areas. ## Ethical dilemmas intensify Experts caution against potential exploitation of vulnerable patients. While unproven, these treatments represent last hopes for terminal cases. Montana's model walks a fine line between innovation and patient protection. The lack of traditional oversight mechanisms makes proper informed consent processes absolutely critical. ## Potential global implications If successful, Montana's approach could influence other jurisdictions. Forty US states already have right-to-try laws, but Montana's version significantly expands access. Widespread adoption could fundamentally alter drug development, especially for rare diseases and oncology. The model may accelerate treatments to market while challenging conventional regulatory wisdom. ## Regulation and safety mechanisms The new system relies on an independent review board for safety assessments, though with far less data than FDA requirements. Companies must collect and share adverse event reports. Long-term outcome tracking will be crucial for evaluating the model's viability. This balance between access and safety represents uncharted territory in medical regulation. ## Transforming healthcare paradigms Montana's radical move challenges traditional drug development. Early access programs could reshape clinical trial financing and design. Success might popularize 'fail fast' approaches across pharma. However, robust safeguards against abuse are essential. This experiment could either revolutionize patient access or serve as cautionary tale about deregulation. ## Sources covering this story - https://www.technologyreview.com/2026/07/31/1140999/the-download-montanas-right-to-try-law-anthropic-hacks/ — --- _Summary written by Brifing from the original reporting. Copyright in the original article belongs to its publisher; read the full piece at the link above._