Establishes "New Jersey Right to Try for Individualized Treatments Act."

A5231

ASSEMBLY, No. 5231

STATE OF NEW JERSEY

222nd LEGISLATURE

�

INTRODUCED JUNE 8, 2026

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.