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HB 4789

Health: other; individualized investigational treatment for certain patients suffering from a life-threatening or severely debilitating illness; provide for. Amends title & secs. 1, 2, 3, 4, 5, 6 & 7 of 2014 PA 345 (MCL 333.26451 et seq.) & adds sec. 2a.

2025-2026 Regular Session Introduced by Greg Alexander and 17 co-sponsors

Michigan bill expands Right to Try law access, allowing more terminally ill patients to use unapproved experimental treatments outside FDA-regulated clinical trials.

bill electronically reproduced 08/21/2025
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Bill Summary · HB 4789

Legislative bill overview

HB 4789 amends Michigan's existing "Right to Try" law (2014 PA 345) to expand access to investigational treatments for patients with life-threatening or severely debilitating illnesses. The bill modifies eligibility criteria, requirements, and procedures for patients to obtain unapproved drugs, biologics, and devices outside standard clinical trial pathways.

Why is this important

Right to Try laws raise fundamental questions about patient autonomy, medical safety, and regulatory oversight. These amendments could significantly affect how terminally ill Michigan patients access experimental treatments, potentially creating tensions between compassionate access and the FDA's drug approval process designed to protect public health.

Potential points of contention

  • Safety vs. access trade-off: Expanded access to unapproved treatments bypasses standard safety testing; supporters emphasize patient choice while critics worry about unproven side effects and exploitation of desperate patients
  • Regulatory tension: States expanding Right to Try laws may conflict with federal FDA authority and the controlled approval process that determines which treatments are safe and effective
  • Liability and data collection: Unclear standards for tracking outcomes and adverse events when treatments occur outside clinical trials, potentially leaving gaps in safety monitoring and complicating future treatment decisions

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

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