1. The manufacturer of an investigational drug, biological product or device may provide or make available the investigational drug, biological product or device to a patient in this State who has been diagnosed with a life-threatening or severely debilitating disease or condition if a physician has prescribed or recommended the investigational drug, biological product or device to the patient as authorized pursuant to NRS 630.3735 or 633.6945 .
2. The manufacturer of an individualized investigational treatment may provide or make available the individualized investigational treatment to a patient in this State who has been diagnosed with a life-threatening or severely debilitating disease or condition if:
(a)The manufacturer operates within a health care institution that:
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1. The manufacturer of an investigational drug, biological product or device may provide or make available the investigational drug, biological product or device to a patient in this State who has been diagnosed with a life-threatening or severely debilitating disease or condition if a physician has prescribed or recommended the investigational drug, biological product or device to the patient as authorized pursuant to NRS 630.3735 or 633.6945 .
2. The manufacturer of an individualized investigational treatment may provide or make available the individualized investigational treatment to a patient in this State who has been diagnosed with a life-threatening or severely debilitating disease or condition if:
(a) The manufacturer operates within a health care institution that:
(1) Operates under a Federalwide Assurance for the protection of human subjects pursuant to 45 C.F.R. Part 46; and
(2) Is subject to all Federalwide Assurance regulations, policies and guidelines, including, without limitation, renewals and updates; and
(b) A physician has prescribed or recommended the individualized investigational treatment to the patient as authorized pursuant to NRS 630.3735 or 633.6945 .
3. A manufacturer who provides or makes available an individualized investigational treatment or investigational drug, biological product or device, as applicable, to a patient pursuant to subsection 1 may:
(a) Provide the investigational drug, biological product or device to the patient without charge; or
(b) Charge the patient only for the costs associated with the manufacture of the individualized investigational treatment or investigational drug, biological product or device, as applicable.
4. A manufacturer that provides or makes available an individualized investigational treatment or investigational drug, biological product or device to a patient pursuant to subsection 1 or 2 shall:
(a) Establish a hotline that operates 24 hours a day, 7 days a week, including holidays, for patients who develop adverse effects or symptoms.
(b) On or before January 1, April 1, July 1 and October 1 of each year, or, if that date falls on a Saturday, Sunday or legal holiday, the next business day thereafter, submit to the Board of Medical Examiners and the State Board of Osteopathic Medicine a report summarizing information concerning the individualized investigational treatments or the investigational drugs, biological products or devices provided or made available to patients of physicians licensed by the board to which the report is submitted during the immediately preceding calendar quarter. The report must include, without limitation:
(1) The number of patients who received the individualized investigational treatment or the investigational drug, biological product or device;
(2) Where applicable, the average number of doses received by patients;
(3) The name of the individualized investigational treatment or the investigational drug, biological product or device and, where applicable, the investigational new drug number assigned by the United States Food and Drug Administration;
(4) The disease or condition that the individualized investigational treatment or the investigational drug, biological product or device is intended to treat;
(5) The uses for which the individualized investigational treatment or the investigational drug, biological product or device was provided or made available; and
(6) Any known adverse effects or symptoms associated with the administration of the individualized investigational treatment or the investigational drug, biological product or device.
5. An officer, employee or agent of this State shall not prevent or attempt to prevent a patient from accessing an individualized investigational treatment or investigational drug, biological product or device that is authorized to be provided or made available to a patient pursuant to this section. Counseling, advice or a recommendation from a physician consistent with medical standards of care is not a violation of this subsection.
6. This section does not create a private cause of action against the manufacturer of an individualized investigational treatment or investigational drug, biological product or device, or against any other person or entity involved in the care of a patient who uses an individualized investigational treatment or investigational drug, biological product or device for any harm done to the patient resulting from the individualized investigational treatment or investigational drug, biological product or device, if the manufacturer or other person or entity is complying in good faith with the provisions of this section and has exercised reasonable care.
7. Notwithstanding any provision of law to the contrary, if a patient dies while being treated with an individualized investigational treatment or investigational drug, biological product or device, the heir or heirs of the deceased patient must not be held personally liable for any outstanding debt related to such treatment.
8. A violation of any provision of this section, except for subsection 4, is a misdemeanor.
9. If a manufacturer fails to comply with the provisions of subsection 4 and such failure is not caused by excusable neglect, technical problems or other extenuating circumstances, the manufacturer is liable for a civil penalty to be recovered by the Attorney General in an amount of $5,000 for each day of such failure. The Attorney General shall deposit any civil penalties collected pursuant to this subsection with the State Treasurer for credit to the State General Fund.
10. As used in this section:
(a) “Biological product” has the meaning ascribed to it in 42 U.S.C. § 262.
(b) “Individualized investigational treatment” means a drug, biological product or device that is unique to and produced exclusively for use by an individual patient based on the genetic profile of the patient, including, without limitation, by an analysis of the genomic sequence of the patient, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins or metabolites. The term includes, without limitation, individualized gene therapy, antisense oligonucleotides and individualized neoantigen vaccines.
(c) “Investigational drug, biological product or device” means a drug, biological product or device that:
(1) Has successfully completed Phase 1 of a clinical trial;
(2) Has not been approved by the United States Food and Drug Administration; and
(3) Is currently being tested in a clinical trial that has been approved by the United States Food and Drug Administration.
(d) “Life-threatening disease or condition” has the meaning ascribed to it in 21 C.F.R. § 312.81, as interpreted by any guidance of the United States Food and Drug Administration.
(e) “Severely debilitating disease or condition” has the meaning ascribed to it in 21 C.F.R. § 312.81, as interpreted by any guidance of the United States Food and Drug Administration.