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

• 1 Differences among clinical trials, FDA expanded access, and federal and state right to try in eligibility, drug stage, oversight, and consent
• 2 FDA's expanded access overhaul, the 45 minute application form, about 99% approval rate, and roughly 2,000 annual requests
• 3 Federal right to try requires a drug to complete phase one, needs no IRB, allows charging direct costs, and manufacturers may refuse
• 4 Montana SB 535 establishes licensure for experimental treatment centers, lets providers supply experimental drugs, may reduce clinical trial enrollment, and regulations are pending

Based on transcript analysis