Bill Text: NJ A3487 | 2022-2023 | Regular Session | Introduced
Bill Title: Establishes "New Jersey Right to Try-Plus Act" permitting terminally ill patients access to certain investigational and off-label treatments.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Introduced - Dead) 2022-03-08 - Introduced, Referred to Assembly Health Committee [A3487 Detail]
Download: New_Jersey-2022-A3487-Introduced.html
Sponsored by:
Assemblyman RONALD S. DANCER
District 12 (Burlington, Middlesex, Monmouth and Ocean)
SYNOPSIS
Establishes "New Jersey Right to Try-Plus Act" permitting terminally ill patients access to certain investigational and off-label treatments.
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-Plus Act."
2. The Legislature finds and declares that:
a. Patients facing a terminal illness are frequently willing and anxious to explore a broader range of experimental, untested, and unconventional treatments, in the hope there may be options to treat or even cure an otherwise intractable illness.
b. These additional treatment options may include the use of investigational drugs, biological products, and devices that have not yet received approval from the United States Food and Drug Administration (FDA), as well as FDA-approved drugs, biological products, and devices that have not received FDA approval for use in treating the patient's particular illness.
c. The process of securing FDA approval for investigational drugs, biological products, and devices often takes many years. Similarly, it would be prohibitively expensive and time-consuming to require FDA-approved drugs, biological products, and devices to complete the full FDA approval process in order to be used in medically appropriate ways that are not identified on the approved FDA label.
d. Drugs, biological products, and devices approved by the FDA may be safely and legally used for "off-label" purposes, and the off-label use of the products is often necessary to provide needed care. Approximately 50 percent of cancer patients receive some type of "off label" drug in their treatment. The FDA and the federal Department of Health and Human Services recognize the wide variety of effective "off-label" uses of FDA-approved drugs. Information on the appropriate "off-label" use of FDA-approved drugs is obtained from compendia published by the United States Pharmacopoeial Convention, the American Medical Association, and the American Society of Hospital Pharmacists. In addition, scientific studies of "off-label" use of drugs published in recognized peer-reviewed professional journals provide information on appropriate uses of "off-label" drugs.
e. Patients who are terminally ill do not have the luxury of waiting until an investigational drug, biological product, or device receives final FDA approval. In the case of a public health emergency, such as the coronavirus disease 2019 (COVID-19) pandemic, an illness may be too new for researchers to fully understand the most effective treatment protocols, and resources may be stretched too thin to conduct clinical trials within the time left to a patient living with a terminal illness.
f. All patients, including patients who are terminally ill, have a right to self-determination in the course of their medical care, and the right to request non-conventional treatment options that may save their lives or improve their quality of life during the last stages of a terminal illness.
g. The off-label use of FDA-approved drugs, biological products, and devices, and the use of investigational drugs, biological products, and devices, is a decision that should be made by the patient in consultation with the patient's health care provider, based on the best information available, and with full awareness of the potential risks, benefits, and consequences to the patient and the patient's family.
h. It is, therefore, the intent of the Legislature to ensure patients who are terminally ill have access to treatment options that include the use of investigational drugs, biological products, and devices, as well as off-label uses of FDA-approved drugs, biological products, and devices.
3. As used in this act:
"Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration.
"Terminal illness" means a medical condition that results in a patient's life expectancy being 12 months or less as determined by a physician.
4. a. A manufacturer of an investigational drug, biological product, or device may make the manufacturer's investigational drug, biological product, or device available to patients pursuant to this act. Nothing in this act shall be construed to require a manufacturer to make an investigational drug, biological product, or device available.
b. In order to submit a request for an investigational drug, biological product, or device pursuant to this section, the patient shall have:
(1) a terminal illness;
(2) 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;
(3) received a prescription or recommendation for an investigational drug, biological product, or device from a physician licensed and in good standing in New Jersey; and
(4) given informed, written consent for the use of the investigational drug, biological product, or device, 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.
c. A request for the use of an investigational drug, biological product, or device shall include documentation from the physician issuing the prescription or recommendation for the investigational drug, biological product, or device pursuant to paragraph (3) of subsection b. of this section indicating the person has met the requirements of subsection b. of this section.
d. Upon receipt of a request from a patient who meets the requirements of subsection b. of this section, a manufacturer may:
(1) provide the investigational drug, biological product, or device to the patient without receiving compensation; or
(2) require the patient to pay the costs associated with the manufacture of the investigational drug, biological product, or device.
e. 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.
f. Except in the case of gross negligence, recklessness, or willful misconduct, a physician who assists a patient with a request for, or who treats a patient using, an investigational drug, biological product, or device pursuant to this section 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 taken by the physician consistent with the provisions of this section.
5. a. Upon request by a patient who meets the requirements of subsection b. of this section, a hospital licensed pursuant to P.L.1971, c.136 (C.26:2H-1) shall provide and administer to the patient any drug, biological product, or device approved by the United States Food and Drug Administration, regardless of whether the drug, biological product, or device has been approved by the United States Food and Drug Administration for the treatment of the patient's disease, illness, or condition, and regardless of whether the drug, biological product, or device is part of the hospital's treatment protocols for the patient's disease, illness, or condition.
b. A patient shall be eligible for the provision and administration of a drug, biological product, or device pursuant to subsection a. of this section if the patient has:
(1) a terminal illness;
(2) provided a written attestation to having received and reviewed the patient package insert, medication guide, instructions for use, or comparable patient-oriented labeling required by the United States Food and Drug Administration;
(3) received a prescription or recommendation for the drug, biological product, or device from a physician licensed and in good standing in New Jersey, which physician need not be employed by, under contract with, or affiliated with the hospital; and
(4) given informed, written consent for the use of the drug, biological product, or device for a purpose other than those stated in the labelling approved by the United States Food and Drug Administration, 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.
c. The patient shall submit to the hospital, along with a written request for the provision and administration of a drug, biological product, or device pursuant to subsection a. of this section, documentation indicating the person has met the requirements of subsection b. of this section.
d. The physician providing the prescription or recommendation for the drug, biological product, or device pursuant to this section may provide the patient with additional informational materials concerning treatment using the drug, biological product, or device that the physician determines to be relevant, which informational materials may be based on or incorporate informational materials available from a national or global health authority, including, but not limited to, the United States Food and Drug Administration, the federal Centers for Disease Control and Prevention, the World Health Organization, the European Centre for Disease Prevention and Control, or one or more published peer-reviewed studies. Any additional informational materials provided to the patient pursuant to this subsection shall be included in the documentation submitted to the hospital pursuant to subsection c. of this section.
e. Except in the case of gross negligence, recklessness, or willful misconduct, a hospital, a health care practitioner or staff member providing services at or through the hospital, and any physician unaffiliated with the hospital, who assists a patient with a request for, or who furnishes or administers, a drug, biological product, or device to a patient pursuant to this section, 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 taken by the hospital, health care practitioner, staff member, or physician consistent with the provisions of this section.
6. Any official, employee, or agent of a State or local government who attempts to block or who does block access of an eligible patient to an investigational drug, biological product, or device pursuant to section 4 of this act or to the use of a drug, biological product, or device pursuant to section 5 of this act is a disorderly person.
7. This act shall take effect immediately.
STATEMENT
This bill would establish the "New Jersey Right to Try-Plus Act," pursuant to which patients who are terminally ill would be permitted to request access to investigational drugs, biological products, and devices that have not yet been approved by the United States Food and Drug Administration (FDA), as well as to off-label treatments using FDA-approved drugs, biological products, and devices.
The sponsor believes that any person suffering from a terminal illness deserves the right to try any medicine or other treatment that the person believes may be able to save his or her life. The sponsor holds that no person or entity should be able to deny a terminal patient the ability to exercise his or her own judgement on the matter, with the advice of the patient's physician and with the patient's informed consent. In such a case, no person or entity should be subject to any legal liability for the patient's decision, except in cases of gross negligence, recklessness or willful misconduct.
To request the use of an investigational drug, biological product, or device, the patient will be required to: have a medical condition that results in a life expectancy of less than 12 months; have consulted with a physician and considered all other treatment options currently approved by the FDA; have received a prescription or recommendation for the investigational drug, biological product, or device from a physician licensed and in good standing in New Jersey; and give informed, written consent to use of the investigational drug, biological product, or device. The physician authorizing the patient for the investigational drug, biological product, or device will be required to document that the patient has met these requirements.
The bill requires that the investigational drug, biological product, or device has successfully completed phase one of an FDA-approved clinical trial and remains under investigation in an FDA-approved clinical trial. Nothing in the bill would compel a manufacturer to make an investigational drug, biological product, or device available to a patient; however, if the manufacturer chooses to make the drug, biological product, or device available, the manufacturer will be permitted to either provide the drug, biological product, or device without compensation or require the patient pay the costs associated with its manufacture. Government medical assistance programs and private health insurers would not be required to provide coverage for the cost of an investigational drug, biological product, or device, but private insurers would be permitted to provide coverage if they so choose.
Except in the case of gross negligence, recklessness, or willful misconduct, a physician who assists a patient with a request for, or who treats a patient using, an investigational drug, biological product, or device pursuant to the bill will 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 taken by the physician consistent with the bill.
With regard to off-label uses of FDA-approved drugs, biological products, and devices, the bill would require a hospital to provide and administer to a patient, upon request, any FDA-approved drug, biological product, or device, regardless of whether the drug, biological product, or device has been approved by the FDA for the treatment of the patient's disease, illness, or condition, and regardless of whether the drug, biological product, or device is part of the hospital's treatment protocols for the patient's disease, illness, or condition.
A patient will be eligible for the off-label use of a drug, biological product, or device under the bill if the patient has: (1) a medical condition that results in a life expectancy of less than 12 months; (2) provided a written attestation to having received and reviewed the patient package insert, medication guide, instructions for use, or comparable patient-oriented labeling required by the FDA; (3) received a prescription or recommendation for the drug, biological product, or device from a physician licensed and in good standing in New Jersey, which physician need not be employed by, under contract with, or affiliated with the hospital; and (4) given informed, written consent for the off-label use of the drug, biological product, or device. The patient will be required to submit documentation to the hospital that these requirements are met along with the request for the off-label use of the drug, biological product, or device.
The physician providing the prescription or recommendation for the drug, biological product, or device may provide the patient with additional informational materials concerning treatment using the drug, biological product, or device that the physician determines to be relevant, which informational materials may be based on or incorporate informational materials available from a national or global health authority. Any additional informational materials provided to the patient are to be included in the documentation submitted to the hospital.
Except in the case of gross negligence, recklessness, or willful misconduct, a hospital, a health care practitioner or staff member providing services at or through the hospital, and any physician unaffiliated with the hospital, who assists a patient with a request for, or who furnishes or administers, a drug, biological product, or device to a patient for an off-label use pursuant to the bill, will 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 taken by the hospital, health care practitioner, staff member, or physician consistent with the provisions of the bill.
Any official, employee, or agent of a State or local government who blocks or attempts to block an eligible patient's access to an investigational or off-label use of a drug, biological product, or device would be a disorderly person, which offense is punishable by imprisonment for up to six months, a $1,000 fine, or both.
