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Bill

HB 1139

allow individualized investigative treatments for patients with life-threatening or debilitating diseases or conditions.

2025 Regular Session Introduced by Bobbi Andera and 9 co-sponsors

South Dakota allows terminally ill patients access to investigational treatments not yet approved by the FDA, enabling compassionate use outside standard trial requirements.

Signed by the Governor on 2025-03-31 H.J. 554
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Bill Summary · HB 1139

Legislative bill overview

HB 1139 permits patients with life-threatening or debilitating diseases to access investigational treatments outside standard clinical trial pathways, commonly known as "Right to Try" legislation. The bill allows individuals to use unapproved drugs, biologics, and medical devices that have completed preliminary safety testing but not final FDA approval.

Why is this important

This legislation directly affects terminally ill patients and their families by potentially expanding access to experimental treatments when conventional options have been exhausted. It reflects a broader national debate about patient autonomy, medical innovation timelines, and the balance between safety oversight and compassionate access to experimental therapies.

Potential points of contention

  • Safety vs. autonomy trade-off: Investigational treatments lack full safety and efficacy data; patients may experience harmful side effects or false hope without proven benefit
  • FDA authority and consistency: Creates a state-level pathway that may conflict with or undermine federal drug approval processes designed to protect public health
  • Economic and liability concerns: Unclear who bears financial responsibility for adverse outcomes; manufacturers may face liability questions for unapproved treatments
  • Equity issues: Access may depend on ability to afford experimental treatments and navigate complex medical systems, potentially creating disparities in availability

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

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