Bill > A1236

Introduced Session

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.

Committee Categories

Alex Sauickie (R)*,  Dawn Fantasia (R), 

Introduced, Referred to Assembly Health Committee (on 01/09/2024)

Official Document