Existing federal law prohibits the introduction of a drug or biological product into interstate commerce if the drug or biological product has not received approval from the United States Food and Drug Administration. (21 U.S.C. § 355; 42 U.S.C. § 262) Existing federal regulations allow expanded access to investigational drugs and biological products for patients who have a life-threatening or severely debilitating disease or condition, or a serious or immediately life-threatening illness, under certain circumstances. (21 C.F.R. Part 312, Subparts E and I) Existing Nevada law authorizes the manufacturer of an investigational drug, biological product or device, upon the prescription or recommendation of a physician, to provide or make available the investigational drug, biological product or device to a patient who has been diagnosed with a terminal condition that will, without the administration of life-sustaining treatment, result in death within 1 year. (NRS 454.690) Existing law authorizes a physician to issue a prescription or recommendation for an investigational drug, biological product or device if the physician has: (1) diagnosed the patient with a terminal condition; (2) consulted with the patient and the patient and physician have determined that no treatment currently approved by the United States Food and Drug Administration is adequate to treat the terminal condition; and (3) obtained informed, written consent to the use of the investigational drug, biological product or device from the patient or his or her representative, parent or guardian. (NRS 630.3735, 633.6945) Sections 2, 4 and 7 of this bill: (1) remove the requirement that a patient be diagnosed with a terminal condition before a physician is authorized to prescribe or recommend, and a manufacturer is authorized to provide, an investigational drug, biological product or device; and (2) instead require the patient to be diagnosed with a life-threatening or severely debilitating disease or condition before such actions are authorized. Section 2 additionally: (1) authorizes the manufacturer of an individualized investigational treatment to make the treatment available to such a patient under similar conditions to an investigational drug, biological product or device if the manufacturer operates in a facility that meets certain federal requirements for the protection of human subjects; and (2) defines “individualized investigational treatment” to mean 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. Sections 4 and 7 authorize a physician to prescribe or recommend an individualized investigational treatment under similar conditions to those under which a physician is authorized to recommend an investigational drug, biological product or device, except that sections 4 and 7 require the physician to additionally conduct certain biochemical analyses. Section 2 requires a manufacturer that provides or makes available an individualized investigational treatment or investigational drug, biological product or device to establish a hotline for patients who develop adverse effects or symptoms. Section 2 also requires such a manufacturer to submit quarterly reports to the Board of Medical Examiners and the State Board of Osteopathic Medicine summarizing the individualized investigational treatments or investigational drugs, biological products or devices provided to patients of physicians who are licensed by those boards. Section 2 establishes an administrative penalty to be imposed against a manufacturer that fails to submit the required report. Section 2 also provides that 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 are not personally liable for any outstanding debt related to such treatment. Existing law makes it a misdemeanor for any officer, employee or agent of this State to prevent or attempt to prevent a patient from accessing an investigational drug, biological product or device if certain requirements are met. (NRS 454.690) Section 2 additionally: (1) provides that counseling, advice or a recommendation from a physician consistent with medical standards of care is not a violation; and (2) makes it a misdemeanor for such an officer, employee or agent to prevent or attempt to prevent a patient from accessing an individualized investigational treatment if the same requirements are met. Sections 4 and 7 revise the requirements concerning the informed, written consent that a physician is required to obtain before prescribing or recommending an individualized investigational treatment or an investigational drug, biological product or device. Sections 4 and 7 also require a physician who prescribes or recommends an individualized investigational treatment or an investigational drug, biological product or device to provide the patient with a form that contains certain information concerning: (1) the individualized investigational treatment or investigational drug, biological product or device; and (2) the treatment of adverse effects or symptoms caused by the individualized investigational treatment or investigational drug, biological product or device. Sections 4 and 7 require such a physician to report to the Board of Medical Examiners or the State Board of Osteopathic Medicine, as appropriate, if a patient dies or is hospitalized as the result of using an individualized investigational treatment or investigational drug, biological product or device. Sections 4 and 7 require those boards to submit to the Legislature a biennial summary of the information reported to those boards pursuant to sections 2, 4 and 7 concerning individualized investigational treatments and investigational drugs, biological products and devices. Sections 4 and 7 additionally authorize those boards to adopt regulations to ensure the safety and efficacy of individualized investigational treatments and investigational drugs, biological products and devices. Existing law: (1) generally makes it a misdemeanor for any person to possess, procure, obtain, process, produce, derive, manufacture, sell, offer for sale, give away or otherwise furnish any drug which may not be lawfully introduced into interstate commerce under the Federal Food, Drug and Cosmetic Act; and (2) exempts from that criminal penalty a person who engages in certain acts to make an investigational drug or biological product available when certain requirements are met. (NRS 454.351) Section 1 of this bill additionally exempts from the criminal penalty a manufacturer who provides an individualized investigational treatment. Existing law provides that a physician or person engaged in the practice of professional nursing who procures or administers a controlled substance or dangerous drug is not subject to professional discipline if the controlled substance or dangerous drug is an investigative drug or biological product prescribed by a physician. (NRS 630.306, 632.347, 633.511) Sections 3, 5 and 6 of this bill additionally exempt such persons from professional discipline if the substance is an individualized investigational treatment. Section 8 of this bill provides that the provisions of this bill expire on July 1, 2027. Section 7.5 of this bill authorizes a patient who is being treated with an individualized investigational treatment or an investigational drug, biological product or device on June 30, 2027, to continue to receive such treatment on and after July 1, 2027, regardless of whether the patient remains eligible to receive such treatment.

Statutes affected:
As Introduced: 454.351, 454.690, 630.306, 630.3735, 632.347, 633.511, 633.6945
Reprint 1: 454.351, 454.690, 630.306, 630.3735, 632.347, 633.511, 633.6945
BDR: 454.351, 454.690, 630.306, 630.3735, 632.347, 633.511, 633.6945