Indiana § 16-42-26-5 - Causes of action

§ 16-42-26-5. Causes of action

Sec. 5. This chapter does not create a cause of action against a manufacturer of an investigational drug, biological product, or device for any harm to a qualified patient resulting from use of an investigational drug, biological product, or device.

As added by P.L.2-2015, SEC.3.

IC 16-42-26.5Chapter 26.5. Individualized Investigational Treatment

16-42-26.5-1"Eligible facility" 16-42-26.5-2"Individualized investigational treatment" 16-42-26.5-3"Life threatening or severely debilitating disease" 16-42-26.5-4Qualification requirements 16-42-26.5-5Written informed consent 16-42-26.5-6Availability of individualized investigational treatment 16-42-26.5-7Liability for outstanding debt 16-42-26.5-8Prohibition on disciplinary actions for recommending individualized investigational treatment 16-42-26.5-9Effect on clinical trial laws

IC 16-42-26.5-1"Eligible facility" Sec. 1. As used in this chapter, "eligible facility" means an entity that operates under the Federalwide Assurance for the Protection of Human Subjects in accordance with 42 U.S.C. 289(a) and 45 CFR 46.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-2"Individualized investigational treatment" Sec. 2. As used in this chapter, "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 individual's own genetic profile. The term includes individualized gene therapy, antisense oligonucleotides (ASO), and individualized neoantigen vaccines.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-3"Life threatening or severely debilitating disease" Sec. 3. As used in this chapter, "life threatening or severely debilitating disease" has the meaning described in 21 CFR 312.81.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-4Qualification requirements Sec. 4. An individual must meet the following requirements in order to qualify as an eligible patient under this chapter:

(1) Has been diagnosed with a life threatening or severely debilitating disease, as attested by the individual's physician.

(2) Has considered other treatment options currently approved by the United States Food and Drug Administration.

(3) Has received a recommendation from the individual's physician for an individualized investigational treatment based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products, or metabolites.

(4) Has given written informed consent as set forth in section 5 of this chapter for the use of the individualized investigational treatment.

(5) Has documentation from the individual's physician that the individual meets the requirements of this section.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-5Written informed consent Sec. 5. (a) Written informed consent as required under section 4(4) of this chapter must include the following:

(1) An explanation of the currently approved products and treatments for the individual's disease or condition.

(2) An attestation by the individual of the individual's life threatening or severely debilitating disease and that the individual concurs with the individual's physician that all currently approved treatments are unlikely to prolong the individual's life or improve the individual's life threatening or severely debilitating disease.

(3) A clear identification of the specific individualized investigational treatment proposed to be used to treat the individual.

(4) A description of the best and worst outcomes, including the most likely outcome, resulting from use of the individualized investigational treatment of the individual's life threatening or severely debilitating disease.

(5) A statement acknowledging that new, unanticipated, different, or worse symptoms or death may result from the proposed treatment.

(6) A statement that the individual's health insurance may not be obligated to pay for any care or treatment and that the patient may be liable for all expenses of the treatment unless specifically required to do so by contract or law.

(7) A statement that eligibility for hospice care may be withdrawn if the individual begins individualized investigational treatment and does not meet hospice care eligibility requirements.

(8) A statement that the individual or the individual's legal guardian consents to the individualized investigational treatment for the life threatening or severely debilitating disease.

(b) The description of outcomes described in subsection (a)(4) must be based on the treating physician's knowledge of both the individualized investigational treatment and the individual's life threatening or severely debilitating disease.

As added by P.L.215-2025, SEC.30. Amended by P.L.23-2026, SEC.153.

IC 16-42-26.5-6Availability of individualized investigational treatment Sec. 6. (a) A manufacturer operating within an eligible facility and in accordance with federal law may make available to an eligible patient the manufacturer's individualized investigational treatment from an eligible facility.

(b) Nothing in this chapter may be construed to require a manufacturer of an individualized investigational treatment to make the individualized investigational treatment available to an eligible patient.

(c) A manufacturer of an individualized investigational treatment may do any of the following:

(1) Provide an individualized investigational treatment to an eligible patient without receiving compensation.

(2) Require an eligible patient to pay the costs of or associated with the manufacture of the individualized investigational treatment.

(d) This chapter does not create a cause of action against a manufacturer of an individualized investigational treatment for any harm to an eligible patient resulting from use of an individualized investigational treatment.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-7Liability for outstanding debt Sec. 7. If an eligible patient dies while being treated with an individualized investigational treatment, the eligible patient's heirs are not liable for any outstanding debt related to the individualized investigational treatment.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-8Prohibition on disciplinary actions for recommending individualized investigational treatment Sec. 8. The medical licensing board of Indiana may not revoke, suspend, fail to renew, or take any other disciplinary action against a physician licensed under IC 25-22.5 based solely on the physician's recommendations to an eligible patient concerning access to or treatment with an individualized investigational treatment.

As added by P.L.215-2025, SEC.30.

IC 16-42-26.5-9Effect on clinical trial laws Sec. 9. This chapter does not affect coverage for clinical trials set forth in IC 5-10-8-15, IC 12-15-5-9.2, IC 27-8-25, or IC 27-13-7-20.2.

As added by P.L.215-2025, SEC.30.

IC 16-42-27Chapter 27. Drugs: Overdose Intervention Drugs

16-42-27-1"Prescriber" 16-42-27-2Prescribing or dispensing of overdose intervention drug without examination; requirements; administration of drug; exemption from practice of medicine; entities acting under standing order; statewide standing order; immunity from prosecution 16-42-27-3Immunity of provider, pharmacist, individual, entity