HF4034 (Legislative Session 94 (2025-2026))
Right to Try Act modified for individualized investigational treatments.
AI Generated Summary
Purpose
- The bill amends the Right to Try Act to allow access to individualized investigational treatments under defined conditions, clarifies responsibilities for patients, doctors, and manufacturers, and sets protections around cost, liability, and licensing.
Key definitions and terms
- Individualized investigational drug, biological product, or device treatment: a product that has completed phase 1 of a clinical trial but is not FDA-approved for general use, is under investigation in an FDA trial, and is uniquely produced for a specific patient based on that patient’s genetic profile. Includes, but is not limited to, individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines.
- Eligible patient: a patient who meets the criteria in the bill’s subdivision on eligibility (see below).
- Terminal illness: a condition likely to lead to death in a short time despite current FDA-approved treatments and life-sustaining procedures.
- Lifethreatening or severely debilitating: terms defined in federal regulations referenced by the bill.
Main provisions and how it works
- Eligibility (who can access): For a patient to access an individualized investigational treatment, a physician must document in writing that:
- the patient has a terminal, lifethreatening, or severely debilitating illness;
- the patient has considered all FDA-approved treatment options;
- there is a prescription or physician recommendation for an investigational treatment based on analysis of the patient’s genomic sequence and related genetic information;
- the patient (or, if under 18 or lacking mental capacity, a parent or guardian) has given written informed consent.
- Availability (who can provide the treatment): A manufacturer may decide to make an individualized investigational treatment available to eligible patients, but is not required to do so.
- Costs (what it may cost): A manufacturer may provide the treatment without payment, but may also require the patient to pay manufacturing costs. If the patient dies during treatment, the manufacturer cannot seek to recover manufacturing costs from the patient’s heirs.
- Professional licensing (implications for providers): Health care providers will not face civil penalties or disciplinary action from licensing boards solely for prescribing, recommending, or providing treatment under this act, provided they comply with its requirements.
- Coverage and cost responsibilities: Nothing in the act requires private insurance, government programs, or other payors to cover the costs of the treatment.
- Liability protections: The act does not create a new private cause of action against health care providers or entities for harms related to the treatment, as long as they comply with the act’s requirements.
- Exception for corrections system: The act does not apply to a person in custody unless the department’s medical director approves the individualized treatment.
- Severability: If any part of the act is found invalid, the rest remains in effect.
Significant changes from current law
- Expands the Right to Try framework to explicitly allow individualized, patient-specific treatments that are in early FDA clinical trials but not yet approved for general use.
- Requires genomic-based justification and explicit informed consent, strengthening the role of physician judgment and patient autonomy within a defined legal framework.
- Clarifies that manufacturers are not required to provide such treatments, while allowing them to charge manufacturing costs.
- Establishes liability and coverage boundaries to limit additional legal or financial exposure for providers and insurers.
- Adds an exception for the corrections system, with medical director oversight.
Practical implications
- More patients with difficult-to-treat conditions could access experimental, personalized treatments if a manufacturer chooses to offer them and a physician approves.
- The process emphasizes informed consent and genomic-backed rationale, while protecting providers from certain penalties and limiting insurance coverage obligations.
- There is a clear balance between patient access, manufacturer discretion, cost responsibility, and legal protections.
Relevant Terms - Right to Try Act - individualized investigational drug - individualized investigational biological product - individualized investigational device treatment - FDA approval - phase 1 - terminal illness - lifethreatening - severely debilitating - eligible patient - genomic sequence - genetic profile - informed consent - physician prescription/recommendation - manufacturer - costs of manufacturing - professional licensing - liability - coverage - severability - exception for corrections - medical director - custody/corrections system
Bill text versions
- Introduction PDF PDF file
Actions
| Date | Chamber | Where | Type | Name | Committee Name |
|---|---|---|---|---|---|
| March 05, 2026 | House | Action | Introduction and first reading, referred to | Health Finance and Policy |
Citations
[
{
"analysis": {
"added": [
"Defines 'Eligible patient' and 'Individualized investigational drug, biological product or device treatment.'",
"Specifies that such treatment is for a drug/biological product or device that has completed phase 1 but not FDA-approved for general use and is unique to an individual patient.",
"Incorporates CFR references for 'lifethreatening' (21 CFR 312.81a) and 'severely debilitating' (21 CFR 312.81b)."
],
"removed": [],
"summary": "Defines key terms used in the Right to Try Act, including eligible patient, individualized investigational drug/biological product or device treatment, terminal illness, lifethreatening, and severely debilitating, with CFR cross-references.",
"modified": [
"Revises definitions to align with an individualized investigational approach under the Right to Try framework."
]
},
"citation": "151.375",
"subdivision": "Subd.2"
},
{
"analysis": {
"added": [
"Requires physician documentation in writing that the patient has a terminal illness, lifethreatening, or severely debilitating condition."
],
"removed": [],
"summary": "Establishes eligibility criteria for a patient to access an individualized investigational drug/biological product or device treatment under the act.",
"modified": [
"Defines conditions and processes for eligibility including physician consultation and consent requirements."
]
},
"citation": "151.375",
"subdivision": "Subd.3"
},
{
"analysis": {
"added": [
"Authorizes manufacturers to make the treatment available to eligible patients under this section at their option."
],
"removed": [],
"summary": "Addresses availability of the individualized investigational treatment by manufacturers.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.4"
},
{
"analysis": {
"added": [
"Allows a manufacturer to provide the treatment without compensation.",
"Allows a manufacturer to require the patient to pay costs associated with manufacturing.",
"Specifies penalties related to cost recovery after patient death (no collection from heirs)."
],
"removed": [],
"summary": "Covers costs associated with the treatment.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.5"
},
{
"analysis": {
"added": [
"Clarifies that health care providers shall not face civil penalties or disciplinary action solely for prescribing/recommending or providing treatment under this section."
],
"removed": [],
"summary": "Relates to professional licensing.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.6"
},
{
"analysis": {
"added": [
"States that the section does not require costs to be covered by private health coverage, state public programs, state employee programs, or programs for inmates."
],
"removed": [],
"summary": "Addresses coverage of costs.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.7"
},
{
"analysis": {
"added": [
"Provides that there is no separate private cause of action against health care providers or entities as long as they comply with this section."
],
"removed": [],
"summary": "Liability provisions.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.8"
},
{
"analysis": {
"added": [
"Excludes application of the section to a person in the custody of the commissioner of corrections unless approved by the department's medical director."
],
"removed": [],
"summary": "Exception clause.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.9"
},
{
"analysis": {
"added": [
"Provides severability of the section; invalidity of one provision does not affect others."
],
"removed": [],
"summary": "Severability clause.",
"modified": []
},
"citation": "151.375",
"subdivision": "Subd.10"
},
{
"analysis": {
"added": [
"Used to interpret 'lifethreatening' as defined by CFR 21—IND-related definitions."
],
"removed": [],
"summary": "Defines 'lifethreatening' for purposes of the act using federal regulations.",
"modified": []
},
"citation": "21 CFR 312.81a",
"subdivision": ""
},
{
"analysis": {
"added": [
"Used to interpret 'severely debilitating' as defined by CFR 21—IND-related definitions."
],
"removed": [],
"summary": "Defines 'severely debilitating' for purposes of the act using federal regulations.",
"modified": []
},
"citation": "21 CFR 312.81b",
"subdivision": ""
}
]Progress through the legislative process
In Committee