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Montana's "Right to Try" law, recently expanded by 2025 Senate Bill 535, allows access to experimental treatments that have completed Phase I FDA clinical trials, moving beyond the traditional requirement of terminal illness. The new law establishes a licensing framework for specialized "experimental treatment centers" to provide these therapies and collects 2% of these centers' net profits to fund access for other Montana residents. This expansion aims to increase access but also raises concerns about safety oversight and the potential for adverse events given the limited testing of these drugs.

Key Aspects of Montana's Right to Try:

• Expanded Eligibility:
• Unlike many Right to Try laws, Montana's statute does not require patients to have a life-threatening illness, allowing access for any condition.
  
  
  
• Experimental Treatment Centers:
• A licensing system is in place for facilities that specialize in providing these treatments.
  
  
  
• Funding Mechanism:
• Licensed centers must dedicate 2% of their annual profits to improve access for Montana residents.
  
  
  
• What Qualifies:
• An "experimental treatment" is an investigational drug, biologic, or device that has successfully completed Phase I of clinical trials but is not yet fully FDA-approved.
  
  
  

Purpose and Potential Implications:

• Increased Access:
• The law is designed to provide more Montanans with access to new and unproven therapies.
  
  
  
• Medical Tourism Hub:
• By removing some traditional restrictions, Montana is positioning itself as a destination for patients seeking these treatments.
  
  
  
• Safety Concerns:
• Critics have raised alarms that allowing treatments after only Phase I trials poses significant risks, as severe side effects may only be discovered in later phases.
  
  
  
• Regulatory Oversight:
• While a framework for licensed centers is being established, the specific details of safety and reporting mechanisms are still developing.

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