Bill Text: NJ A5231 | 2026-2027 | Regular Session | Introduced
Bill Title: Establishes "New Jersey Right to Try for Individualized Treatments Act."
Sponsorship: Partisan Bill (Republican 1)
Status: (Introduced) 2026-06-08 - Introduced, Referred to Assembly Health Committee [A5231 Detail]
Download: New_Jersey-2026-A5231-Introduced.html
Sponsored by:
Assemblyman PAUL KANITRA
District 10 (Monmouth and Ocean)
SYNOPSIS
Establishes "New Jersey Right to Try for Individualized Treatments Act."
CURRENT VERSION OF TEXT
As introduced.
An Act concerning access to certain forms of health care treatment and supplementing Title 26 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. This act shall be known and may be cited as the "New Jersey Right to Try for Individualized Treatments Act."
2. As used in this act:
"Eligible facility" means a facility that has been approved for a Federalwide Assurance (FWA) and is in compliance with federal Protection of Human Subjects regulations under 45 CFR Part 46.
"Individualized investigational treatment" means drugs, biological products, or devices that are unique to and produced exclusively for use by an individual patient, based on his or her genetic profile. "Individualized investigational treatment" shall include, but shall not be limited to, individualized gene therapy antisense oligonucleotides, and individualized neoantigen vaccines.
"Life-threatening or severely debilitating illness" shall have the same meaning as provided in 21 CFRs.312.81 that has been attested to by a licensed physician.
3. a. A manufacturer operating within an eligible facility shall be permitted to make available an individualized investigative treatment.
b. (1) A patient shall be permitted to request an individualized investigational treatment from an eligible facility or manufacturer operating within an eligible facility.
(2) In order to submit a request for an individualized investigational treatment pursuant to this section, the patient shall have:
(a) a life-threatening or severely debilitating illness;
(b) considered all other treatment options currently approved by the United States Food and Drug Administration, in consultation with a physician licensed and in good standing in New Jersey;
(c) received a prescription or recommendation for an individualized investigational treatment from a physician licensed and in good standing in New Jersey; and
(d) given informed, written consent for the use of the individualized investigational treatment, provided that, if the patient is a minor or otherwise lacks capacity to provide informed consent, a parent or legal guardian may provide informed, written consent on the patient's behalf.
(3) In order to give informed, written consent, a patient shall read and sign a form that contains the following:
(a) an explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;
(b) an attestation that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;
(c) clear identification of the specific proposed individualized investigational drug, biological product, or device that the patient is seeking to use;
(d) a description of the potentially best and worst outcomes of using the individualized investigational drug, biological product, or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms that might result and that death could be hastened by the proposed treatment. The description shall be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition;
(e) a statement that the patient's health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the individualized investigational drug, biological product, or device, unless specifically required to do so by law;
(f) a statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational drug, biological product, or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; and
(g) a statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational drug, biological product, or device and that this liability extends to the patient's heirs, except as provided in section 4 of this act, and unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.
c. An eligible facility or manufacturer operating within an eligible facility shall be permitted to:
(1) provide an individualized investigational drug, biological product, or device to an eligible patient without receiving compensation; and
(2) require an eligible patient to pay the costs of, or the costs associated with, manufacturing the investigational drug, biological product, or device.
4. If a patient dies as
a result of treatment received pursuant to the provisions of this act, the
patient's heirs shall not be liable for any outstanding debt related to the
cost of the treatment.
5. Any official, employee, or agent of a State or local government who attempts to block treatment that would be provided pursuant to the provisions of this act is a disorderly person.
6. Except in the case of gross negligence, recklessness, or willful misconduct, a health care facility or health care provider shall not be liable in any criminal or civil action or subject to adverse licensure or other administrative disciplinary action for adverse consequences resulting from acts or omissions that are consistent with the provisions of this act.
7. A government medical assistance program or private health insurer may, but shall not be required to, provide coverage for the cost of an investigational drug, biological product, or device furnished to a patient pursuant to this section.
8. This act shall take effect immediately.
STATEMENT
This bill establishes the "New Jersey Right to Try for Individualized Treatments Act."
A manufacturer operating within an eligible facility shall be permitted to make available an individualized investigative treatment.
The bill defines "eligible facility" to mean a facility that has been approved for a Federalwide Assurance (FWA) and is in compliance with federal Protection of Human Subjects regulations under 45 CFR Part 46. "Individualized investigational treatment" means drugs, biological products, or devices that are unique to and produced exclusively for use by an individual patient, based on his or her genetic profile. "Individualized investigational treatment" includes, but is not limited to, individualized gene therapy antisense oligonucleotides, and individualized neoantigen vaccines. "Life-threatening or severely debilitating illness" is to have the same meaning as provided in 21 CFRs.312.81 that has been attested to by a licensed physician.
A patient is to be permitted to request an individualized investigational treatment from an eligible facility or manufacturer operating within an eligible facility. In order to submit a request for an individualized investigational treatment, the patient is to have: a life-threatening or severely debilitating illness; considered all other treatment options currently approved by the United States Food and Drug Administration, in consultation with a physician licensed and in good standing in New Jersey; received a prescription or recommendation for an individualized investigational treatment from a physician licensed and in good standing in New Jersey; and given informed, written consent for the use of the individualized investigational treatment, as provided in the bill, provided that, if the patient is a minor or otherwise lacks capacity to provide informed consent, a parent or legal guardian may provide informed, written consent on the patient's behalf.
An eligible facility or manufacturer operating within an eligible facility is to be permitted to: provide an individualized investigational drug, biological product, or device to an eligible patient without receiving compensation; and require an eligible patient to pay the costs of, or the costs associated with, manufacturing the investigational drug, biological product, or device.
