Elephant

Montana has enacted the nation's most expansive "right-to-try" law, letting any resident—not just terminally ill patients—access experimental drugs that have only completed Phase I trials showing basic safety, without proven effectiveness. This breaks sharply from federal right-to-try rules, including those signed during Trump's first term, which require patients to have exhausted approved treatments.

Biotech startups see Montana as a workaround to the FDA's costly approval process. Infinita, a company tied to a deregulated zone in Honduras and led by CEO Niklas Anzinger, runs the only review board approving treatments so far, charging companies a application fee; it approved its first treatment last month. Critics, including patient advocates, warn of conflicts of interest and unproven claims reaching vulnerable patients. The program's future depends on whether the FDA intervenes—an open question, especially with HHS Secretary Robert F. Kennedy Jr., who has touted his own use of unapproved treatments, expressing support for expanded access. FDA officials met with industry and patient groups in June but gave no commitment on enforcement.