The Ever Evolving Access to Experimental Treatments: Expanded Access to Medical Tourism in Montana

Experimental treatments offer hope to patients suffering from debilitating diseases or conditions when no approved treatments are available. Given the uncertain risk benefit analysis for experimental treatments, and the requirements that must be met to gain access to experimental treatments undergoing clinical trials, or under the United States Food and Drug Administration's ("FDA's") Expanded Access program, patient access to those treatments has unsurprisingly been limited. 

In response, beginning in 2014, forty-one states and the federal government, have enacted more permissive laws to provide eligible patients with the "right to try"  experimental treatments under review but not yet approved by the FDA . This program first briefly explores  various avenues for patients to seek access to experimental treatments, including Montana's right to try law as amended in 2023 to remove the requirement for a patient to be terminally ill to access experimental drugs.  The program will then focus on the potential impact of Montana's 2025 SB 535, which provides a scheme for the registration and licensing of experimental treatment centers, and the status of implementing regulations.

Learning Objectives: 

1. Identify the various avenues (e.g., clinical trials, FDA expanded access program, federal or state right to try laws) by which eligible patients can access experimental treatments

2. Follow the evolution of Montana's right to try law greatly expanding the right to try experimental treatments

3. Grasp various implications that can arise from Montana's establishing a framework for licensing experimental treatment centers for treating patients with experimental drugs