Florida 2026 Session Status: Introduced 1 R cosponsors

SB 1552 — Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases

Last action — Died in Health Policy

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  1. 1
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill has been introduced in the Senate. Introduced January 09, 2026. It must pass committee before a floor vote.

Next likely step: a committee referral and hearing.

Prognosis

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Where this bill stands today.

Odds of enactment

Low

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Summary

Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases; Citing this act as the “Promising Pathways Act"; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments, if certain requirements are met; requiring the Department of Health to establish and maintain a patient registry for specified purposes; encouraging health insurers and health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizing licensed physicians and eligible facilities to receive reimbursement for the prescription or administration of experimental treatments if certain requirements are met; requiring manufacturers of experimental treatments to provide for a specified temporary price concession set by the department, etc.

Bill Text

How this bill changes current law

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AI-generated reading aid from the bill's amendatory text — verify against the official bill.

The bill establishes a regulated pathway for providing experimental treatments to patients with terminal conditions and life-threatening rare diseases in Florida.

  • Section 499.0295, F.S.

    Experimental treatments for terminal conditions and life-threatening rare diseases.—

    This section is newly established to define the context and regulations for experimental treatments.

  • Section 499.0295, F.S.

    (1) The Legislature finds that residents of this state with terminal conditions and life-threatening rare diseases may benefit from access to experimental treatments that have demonstrated initial human safety but are not yet approved by the United States Food and Drug Administration.

    States the legislative intent to allow access to potentially beneficial experimental treatments.

  • Section 499.0295, F.S.

    (2) It is the intent of the Legislature to: (a) Create a safe, regulated, and transparent pathway to experimental treatments through licensed state institutions with board oversight. (b) Condition payment on evidence development. (c) Encourage coverage parity by state-regulated health plans. (d) Align temporary pricing during the conditional period with the maturity of clinical evidence.

    Defines the legislative intents for the regulation and facilitation of access to experimental treatments.

  • Section 499.0295, F.S.

    (3) As used in this section, the term: (e) 'Eligible patient' means a person who: 1.a. Has a terminal condition that is attested to by the treating physician and confirmed by a board-certified physician in an appropriate specialty for that condition; or b. Has a life-threatening rare disease that is attested to by the treating physician and confirmed by a board-certified physician in an appropriate specialty. 2. Has considered and exhausted all other treatment options currently approved by the United States Food and Drug Administration.

    Defines criteria for patients eligible to receive experimental treatments.

  • Section 499.0295, F.S.

    (4) A physician licensed under chapter 458 or chapter 459 may prescribe to an eligible patient an experimental treatment pursuant to this section.

    Authorizes licensed physicians to prescribe experimental treatments to eligible patients.

  • Section 499.0295, F.S.

    (5) A platform or master protocol must be approved by an IRB under which treating physicians and eligible facilities may adapt dosing, sequencing, or combinations of authorized experimental treatments.

    Establishes requirements for an Institutional Review Board (IRB) approval for administering experimental treatments.

  • Section 499.0295, F.S.

    (6)(a) The department shall establish and maintain a patient registry for the collection and analysis of experimental treatment outcomes under this section.

    Mandates the establishment of a registry to track the outcomes of patients receiving experimental treatments.

  • Section 499.0295, F.S.

    (8) The Department of Health shall take appropriate steps to ensure patient safety and efficacy of treatment in compliance with all applicable laws.

    Establishes a mandate for the Department of Health to oversee the safety and efficacy of treatments.

Action History

  1. Died in Health Policy

  2. Introduced

  3. Referred to Health Policy; Appropriations Committee on Health and Human Services; Appropriations

  4. Filed

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 163 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (163)

163 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

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Frequently asked questions

What does SB 1552 do?
Experimental Treatments for Terminal Conditions and Life-threatening Rare Diseases; Citing this act as the “Promising Pathways Act"; authorizing licensed physicians to prescribe and eligible facilities to administer experimental treatments, if certain requirements are met; requiring the Department of Health to establish and maintain a patient registry for specified purposes; encouraging health insurers and health maintenance organizations to provide specified insurance coverage for experimental treatments; authorizing licensed physicians and eligible facilities to receive reimbursement for the prescription or administration of experimental treatments if certain requirements are met; requiring manufacturers of experimental treatments to provide for a specified temporary price concession set by the department, etc.
Who sponsors SB 1552?
SB 1552 is sponsored by Burgess, Danny (Republican).
What is the current status of SB 1552?
This bill has been introduced in the Senate. Introduced January 09, 2026. It must pass committee before a floor vote.
Where can I track SB 1552?
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Last checked for changes 2 months ago · updated continuously

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