Senate File 2323 - Introduced SENATE FILE 2323 BY COMMITTEE ON TECHNOLOGY (SUCCESSOR TO SSB 3170) (COMPANION TO HF 2290) A BILL FOR An Act relating to the right to try Act. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 5892SV (1) 90 pf/ko
S.F. 2323 Section 1. Section 144E.2, Code 2024, is amended to read as 1 follows: 2 144E.2 Definitions. 3 As used in this chapter : 4 1. Eligible facility means an institution operating under 5 a federalwide assurance for the protection of human subjects 6 pursuant to 42 U.S.C. 289(a) and 45 C.F.R. pt. 46, and 7 subject to the federalwide assurance laws, rules, policies, and 8 guidelines including renewals and updates. 9 1. 2. Eligible patient means an individual who meets all 10 of the following conditions specified under paragraph a or 11 b : 12 a. (1) Has a terminal illness, attested to by the patients 13 treating physician. 14 b. (2) Has considered and rejected or has tried and failed 15 to respond to all other treatment options approved by the 16 United States food and drug administration. 17 c. (3) Has received a recommendation from the individuals 18 physician for an investigational drug, biological product, or 19 device. 20 d. (4) Has given written informed consent for the use of 21 the investigational drug, biological product, or device. 22 e. (5) Has documentation from the individuals physician 23 that the individual meets the requirements of this subsection 24 paragraph a . 25 b. (1) Has a life-threatening or severely debilitating 26 illness, attested to by the patients treating physician. 27 (2) Has considered all other treatment options currently 28 approved by the United States food and drug administration. 29 (3) Has received a recommendation from the individuals 30 physician for an individualized investigational treatment, 31 based on an analysis of the patients genomic sequence, human 32 chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, 33 gene products such as enzymes and other types of proteins, or 34 metabolites. 35 -1- LSB 5892SV (1) 90 pf/ko 1/ 9
S.F. 2323 (4) Has given written informed consent for the use of the 1 individualized investigational treatment. 2 (5) Has documentation from the individuals physician that 3 the individual meets the requirements of this paragraph b . 4 3. Individualized investigational treatment means a drug, 5 biological product, or device that is unique to, and produced 6 exclusively for use by, an individual patient, based on the 7 individual patients own genetic profile. Individualized 8 investigational treatment includes but is not limited to 9 individualized gene therapy, antisense oligonucleotides, and 10 individualized neoantigen vaccines. 11 2. 4. Investigational drug, biological product, or 12 device means a drug, biological product, or device that has 13 successfully completed phase 1 of a United States food and drug 14 administration-approved clinical trial but has not yet been 15 approved for general use by the United States food and drug 16 administration and remains under investigation in a United 17 States food and drug administration-approved clinical trial. 18 3. 5. Terminal illness means a progressive disease 19 or medical or surgical condition that entails significant 20 functional impairment, that is not considered by a treating 21 physician to be reversible even with administration of 22 treatments approved by the United States food and drug 23 administration, and that, without life-sustaining procedures, 24 will result in death. 25 4. 6. Written informed consent means a written document 26 that is signed by the patient, a parent of a minor patient, or a 27 legal guardian or other legal representative of the patient and 28 attested to by the patients treating physician and a witness 29 and that includes , at a minimum, all of the following: 30 a. If the patient is an eligible patient as specified in 31 subsection 2, paragraph a : 32 (1) An explanation of the products and treatments approved 33 by the United States food and drug administration for the 34 disease or condition from which the patient suffers. 35 -2- LSB 5892SV (1) 90 pf/ko 2/ 9
S.F. 2323 b. (2) An attestation that the patient concurs with the 1 patients treating physician in believing that all products 2 and treatments approved by the United States food and drug 3 administration are unlikely to prolong the patients life. 4 c. (3) Clear identification of the specific proposed 5 investigational drug, biological product, or device that the 6 patient is seeking to use. 7 d. (4) A description of the best and worst potential 8 outcomes of using the investigational drug, biological product, 9 or device and a realistic description of the most likely 10 outcome. The description shall include the possibility that 11 new, unanticipated, different, or worse symptoms might result 12 and that death could be hastened by use of the proposed 13 investigational drug, biological product, or device. The 14 description shall be based on the treating physicians 15 knowledge of the proposed investigational drug, biological 16 product, or device in conjunction with an awareness of the 17 patients condition. 18 e. (5) A statement that the patients health plan or 19 third-party administrator and provider are not obligated to 20 pay for any care or treatments consequent to the use of the 21 investigational drug, biological product, or device, unless 22 they are specifically required to do so by law or contract. 23 f. (6) A statement that the patients eligibility for 24 hospice care may be withdrawn if the patient begins curative 25 treatment with the investigational drug, biological product, 26 or device and that hospice care may be reinstated if this 27 treatment ends and the patient meets hospice eligibility 28 requirements. 29 g. (7) A statement that the patient understands that the 30 patient is liable for all expenses consequent to the use of 31 the investigational drug, biological product, or device and 32 that this liability extends to the patients estate unless 33 a contract between the patient and the manufacturer of the 34 investigational drug, biological product, or device states 35 -3- LSB 5892SV (1) 90 pf/ko 3/ 9
S.F. 2323 otherwise. 1 b. If the patient is an eligible patient as specified in 2 subsection 2, paragraph b : 3 (1) An explanation of the currently approved products and 4 treatments for the disease or condition from which the patient 5 suffers. 6 (2) An attestation that the patient concurs with the 7 patients treating physician in believing that all currently 8 approved and conventionally recognized products and treatments 9 are unlikely to prolong the patients life. 10 (3) Clear identification of the specific proposed 11 individualized investigational treatment that the patient is 12 seeking to use. 13 (4) A description of the best and worst potential outcomes 14 of using the individualized investigational treatment 15 and a realistic description of the most likely outcome. 16 The description shall include the possibility that new, 17 unanticipated, different, or worse symptoms might result 18 and that death could be hastened by use of the proposed 19 individualized investigational treatment. The description 20 shall be based on the treating physicians knowledge of 21 the proposed individualized investigational treatment in 22 conjunction with an awareness of the patients condition. 23 (5) A statement that the patients health plan or 24 third-party administrator and provider are not obligated to 25 pay for any care or treatments consequent to the use of the 26 individualized investigational treatment, unless they are 27 specifically required to do so by law or contract. 28 (6) A statement that the patients eligibility for hospice 29 care may be withdrawn if the patient begins curative treatment 30 with the individualized investigational treatment and that 31 hospice care may be reinstated if this treatment ends and the 32 patient meets hospice eligibility requirements. 33 (7) A statement that the patient understands that the 34 patient is liable for all expenses consequent to the use of 35 -4- LSB 5892SV (1) 90 pf/ko 4/ 9
S.F. 2323 the individualized investigational treatment and that this 1 liability extends to the patients estate, unless a contract 2 between the patient and the manufacturer of the individualized 3 investigational treatment states otherwise. 4 Sec. 2. Section 144E.3, Code 2024, is amended to read as 5 follows: 6 144E.3 Manufacturer and eligible facility rights. 7 1. A manufacturer of an investigational drug, biological 8 product, or device or a manufacturer operating within, and in 9 compliance with all requirements applicable to, an eligible 10 facility may make available , and an eligible patient , as 11 applicable under section 144.1, subsection 2, paragraph a 12 or b , may request from a manufacturer of an investigational 13 drug, biological product, or device, or a manufacturer 14 operating within, and in compliance with all requirements 15 applicable to, an eligible facility, the manufacturers 16 investigational drug, biological product, or device , or the 17 manufacturers individualized investigational treatment under 18 this chapter . This chapter does not require a manufacturer 19 of an investigational drug, biological product, or device , or 20 of an individualized investigational treatment to provide or 21 otherwise make available the investigational drug, biological 22 product, or device , or the individualized investigational 23 treatment to an eligible patient. 24 2. A An eligible facility, or a manufacturer described 25 in subsection 1 , that is in compliance with all applicable 26 requirements, may do any of the following: 27 a. Provide an investigational drug, biological product, or 28 device , or an individualized investigational treatment to an 29 eligible patient , as applicable under section 144.1, subsection 30 2, paragraph a or b , without receiving compensation. 31 b. Require an eligible patient , as applicable under section 32 144.1, subsection 2, paragraph a or b , to pay the costs 33 of, or the costs associated with, the manufacture of the 34 investigational drug, biological product, or device , or the 35 -5- LSB 5892SV (1) 90 pf/ko 5/ 9
S.F. 2323 individualized investigational treatment . 1 Sec. 3. Section 144E.4, Code 2024, is amended to read as 2 follows: 3 144E.4 Treatment coverage. 4 1. This chapter does not expand the coverage required of an 5 insurer under Title XIII, subtitle 1 . 6 2. A health plan, third-party administrator, or 7 governmental agency may , but is not required to, provide 8 coverage for the cost of an investigational drug, 9 biological product, or device, the cost of an individualized 10 investigational treatment, or the cost of services related to 11 the use of an investigational drug, biological product, or 12 device , or an individualized investigational treatment under 13 this chapter . 14 3. This chapter does not require any governmental agency 15 to pay costs associated with the use, care, or treatment of a 16 patient with an investigational drug, biological product, or 17 device , or an individualized investigational treatment . 18 4. This chapter does not require a hospital licensed under 19 chapter 135B or other health care facility to provide new or 20 additional services , unless approved by the hospital or other 21 health care facility . 22 Sec. 4. Section 144E.5, Code 2024, is amended to read as 23 follows: 24 144E.5 Heirs not liable for treatment debts. 25 If a patient dies while being treated by with an 26 investigational drug, biological product, or device, or 27 an individualized investigational treatment, the patients 28 heirs are not liable for any outstanding debt related to the 29 treatment or lack of insurance due to the treatment , unless 30 otherwise required by law . 31 Sec. 5. Section 144E.6, Code 2024, is amended to read as 32 follows: 33 144E.6 Provider recourse. 34 1. To the extent consistent with state law, the board of 35 -6- LSB 5892SV (1) 90 pf/ko 6/ 9
S.F. 2323 medicine created under chapter 147 shall not revoke, fail 1 to renew, suspend, or take any action against a physicians 2 license based solely on the physicians recommendations to 3 an eligible patient regarding access to or treatment with an 4 investigational drug, biological product, or device , or an 5 individualized investigational treatment . 6 2. To the extent consistent with federal law, an entity 7 responsible for Medicare certification shall not take action 8 against a physicians Medicare certification based solely on 9 the physicians recommendation that a patient have access to 10 an investigational drug, biological product, or device , or an 11 individualized investigational treatment . 12 Sec. 6. Section 144E.7, Code 2024, is amended to read as 13 follows: 14 144E.7 State interference. 15 An official, employee, or agent of this state shall not 16 block or attempt to block an eligible patients access to an 17 investigational drug, biological product, or device , or to an 18 individualized investigational treatment . Counseling, advice, 19 or a recommendation consistent with medical standards of care 20 from a licensed physician is not a violation of this section . 21 Sec. 7. Section 144E.8, Code 2024, is amended to read as 22 follows: 23 144E.8 Private cause of action. 24 1. This chapter shall not create a private cause of action 25 against a manufacturer of an investigational drug, biological 26 product, or device or an individualized investigational 27 treatment, against an eligible facility, or against any other 28 person or entity involved in the care of an eligible patient 29 using the investigational drug, biological product, or device , 30 or the individualized investigational treatment for any harm 31 done to the eligible patient resulting from the investigational 32 drug, biological product, or device, or the individualized 33 investigational treatment, if the manufacturer , eligible 34 facility, or other person or entity is complying in good faith 35 -7- LSB 5892SV (1) 90 pf/ko 7/ 9
S.F. 2323 with the terms of this chapter and has exercised reasonable 1 care. 2 2. This chapter shall not affect any mandatory health care 3 coverage for participation in clinical trials under Title XIII, 4 subtitle 1 . 5 EXPLANATION 6 The inclusion of this explanation does not constitute agreement with 7 the explanations substance by the members of the general assembly. 8 This bill relates to Code chapter 144E, the right to try Act. 9 Under current law, an eligible patient under the Code 10 chapter is, in part, a person who has a terminal illness. 11 Under the bill, an eligible patient also includes, in part, 12 a person who has a life-threatening or severely debilitating 13 illness. 14 Under current law, the Code chapter applies to an 15 investigational drug, biological product, or device, 16 meaning a drug, biological product, or device that has 17 successfully completed phase I of a United States food and 18 drug administration (FDA)-approved clinical trial but has not 19 yet been approved for general use by the FDA and that remains 20 under investigation in an FDA-approved clinical trial. Under 21 the bill, the Code chapter also applies to an individualized 22 investigational treatment, meaning a drug, biological product, 23 or device that is unique to and produced exclusively for use 24 by an individual patient based on the individual patients 25 own genetic profile and includes individualized gene therapy, 26 antisense oligonucleotides, and individualized neoantigen 27 vaccines. 28 The bill amends the definition under the Code chapter for 29 written informed consent to reflect the changes made to 30 eligible patient and the application of the Code chapter to 31 individualized investigational treatments. 32 The bill provides a definition of eligible facility to 33 mean an institution that is operating under a federalwide 34 assurance for the protection of human subjects pursuant 35 -8- LSB 5892SV (1) 90 pf/ko 8/ 9
S.F. 2323 to federal law. The bill amends provisions relating to a 1 manufacturers rights under the Code chapter to also apply to 2 eligible facilities. The bill provides that a manufacturer 3 of an investigational drug, biological product, or device 4 or a manufacturer operating within, and in compliance with 5 all requirements applicable to, an eligible facility may 6 make available, and an eligible patient may request from a 7 manufacturer of an investigational drug, biological product, or 8 device, or a manufacturer operating within, and in compliance 9 with all requirements applicable to, an eligible facility, the 10 manufacturers investigational drug, biological product, or 11 device, or the manufacturers individualized investigational 12 treatment. However, the Code chapter does not require a 13 manufacturer of an individualized investigational treatment 14 to provide or otherwise make available the individualized 15 investigational treatment to an eligible patient. The bill 16 provides that an eligible facility or a manufacturer that is 17 in compliance with all applicable requirements may provide 18 an individualized investigational treatment to an eligible 19 patient without receiving compensation, or require an eligible 20 patient to pay the costs of, or the costs associated with, the 21 manufacture of the individualized investigational treatment. 22 The bill makes conforming changes in the Code chapter to 23 reflect the bills provisions. 24 The bill does not amend Code section 144E.9, which 25 provides that the Code chapter shall not be construed to 26 allow a patients treating physician to assist the patient in 27 committing or attempting to commit suicide. 28 -9- LSB 5892SV (1) 90 pf/ko 9/ 9