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SB 237

Individualized investigational treatment.

2025 Regular Session Introduced by Ed Charbonneau and 1 co-sponsor

SB 237 permits Indiana residents with terminal/serious illnesses to access FDA-unapproved investigational treatments when standard options fail.

Senator Charbonneau added as second author
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Bill Summary · SB 237

Legislative bill overview

SB 237 establishes a framework allowing Indiana residents with terminal or serious illnesses to access investigational treatments that have not yet received FDA approval. The bill creates a "right to try" pathway, enabling patients to use experimental drugs, biologics, and medical devices outside of standard clinical trial protocols when conventional treatments have been exhausted.

Why is this important

This bill addresses the tension between patient autonomy and regulatory safety protocols. Terminally ill patients often have limited options and argue they should have the right to attempt experimental treatments when nothing else works. Conversely, such access raises questions about informed consent, data collection, manufacturer liability, and whether hope for unproven treatments might delay patients from pursuing palliative care.

Potential points of contention

  • Informed consent standards: How robust must disclosures be about unknown risks when patients are desperate and vulnerable?
  • Manufacturer protections vs. patient recourse: The extent of liability shields for companies providing investigational treatments and whether injured patients can seek damages
  • FDA coordination: Whether state-level right-to-try laws create regulatory conflicts and how they affect the federal approval process for gathering safety data
  • Healthcare equity: Concerns that access to expensive investigational treatments may be limited to wealthy patients, creating a two-tiered system
  • Insurance coverage: Whether insurers must cover experimental treatments and associated medical monitoring

Compiled from official sources — confirm details with the bill’s official record.

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