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SB 282

Health Care - As enacted, enacts the "Individualized Investigational Treatment Act." - Amends TCA Title 53 and Title 63.

114th Regular Session (2025-2026) Introduced by Bo Watson

Tennessee law authorizes eligible seriously ill patients to access experimental medical treatments outside FDA approval processes, effective July 1, 2025.

Pub. Ch. 45
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Bill Summary · SB 282

Legislative bill overview

SB 282 enacts Tennessee's "Individualized Investigational Treatment Act," which amends state health care law to establish procedures for patients to access experimental or investigational treatments outside of standard FDA approval pathways. The law creates a framework allowing eligible patients with serious illnesses to pursue investigational therapies when conventional treatments have been exhausted or are unavailable.

Why is this important

This legislation addresses the tension between patient autonomy and medical regulation by potentially expanding access to unproven treatments for terminally or seriously ill patients. It affects how Tennessee residents navigate end-of-life care decisions and interact with pharmaceutical companies, while raising questions about medical safety standards and informed consent protections.

Potential points of contention

  • Patient safety vs. access: Investigational treatments lack proven safety and efficacy data, creating risk of harm, false hope, or financial exploitation for vulnerable patients
  • Pharmaceutical company incentives: Companies may lack motivation to complete formal FDA trials if patients can access drugs through this pathway, potentially slowing standard approval processes
  • Insurance and cost implications: Unclear whether insurers must cover investigational treatments, potentially creating disparities in access based on ability to pay out-of-pocket

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

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