This section defines key terms for individualized investigational treatment and sets the conditions for an eligible patient and a valid written informed consent.
§1300.72. Definitions As used in this Part, the following terms have the meanings ascribed to them: (1) "Eligible facility" means an institution that is operating with a Federalwide Assurance for the Protection of Human Subjects, in accordance with 42 U.S.C. 289(a) and 45 CFR Part 46, and an eligible facility that is subject to the Federalwide Assurance for the Protection of Human Subjects laws, regulations, policies, and guidelines, including renewals and updates. (2) "Eligible patient" means an individual who meets all of the following conditions: (a) Has considered all other treatment options currently approved by the United States Food and Drug Administration. (b) Has received a recommendation from his physician for an individualized investigational treatment, based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as enzymes and other types of proteins, or metabolites. (c) Has a life-threatening, severely debilitating illness or serious disease or condition associated with morbidity that has a substantial impact on day-to-day functioning and is attested to by the patient's treating physician. (d) Has given written, informed consent for the use of the investigational drug, biological product, or device. (e) Has documentation from his physician that the patient meets the requirements of this Part. (3) "Individualized investigational treatment" means drugs, biological products, or devices that are unique to and produced exclusively for use for an individual patient, based on his own genetic profile. (a) "Individualized investigational treatment" includes but is not limited to individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines. (b) "Individualized investigational treatment" does not include any drug, biological product, or device derived from human primary or secondary embryonic stem cells or cell lines, or tissues or cells derived from abortion, but does include any drug, biological product, or device derived from human perinatal tissues, cells, and secreted factors not obtained from an abortion. (4) "Life-threatening or severely debilitating illness," has the same meaning as provided in 21 CFR 312.81, or any successor law or regulation, as applicable. (5) "Written, informed consent" means a written document that is signed by the patient, or if the patient is a minor, by any person authorized to consent in accordance with the Louisiana Medical Consent Law, R.S. 40:1159.1, et seq., and attested to by the patient's physician and a witness and that, at a minimum, includes all of the following: (a) An explanation of the currently approved products and treatments for the illness, disease, or condition from which the patient suffers. (b) An attestation that the patient concurs with his 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)(i) 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. (ii) The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. (iii) 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 they are specifically required to do so by law or contract. (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. (g) A statement that the patient understands that the patient 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 estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise. Acts 2024, No. 750, §1.