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EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted
and is intended to be omitted in the law.
SECOND REGULAR SESSION
SENATE BILL NO. 1454
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR BROWN (16).
6202S.02I KRISTINA MARTIN, Secretary
AN ACT
To repeal section 191.480, RSMo, and to enact in lieu thereof one new section relating to
alternative therapies.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Section 191.480, RSMo, is repealed and one new 1
section enacted in lieu thereof, to be known as section 191.480, 2
to read as follows:3
191.480. 1. For purposes of this section, the 1
following terms shall mean: 2
(1) "Eligible patient", a person who meets all of the 3
following: 4
(a) Has a terminal condition or illness, a life- 5
threatening condition or illness, or a severely debilitating 6
condition or illness; 7
(b) Has considered all other treatment options 8
currently approved by the United States Food and Drug 9
Administration and all relevant clinical trials conducted in 10
this state; 11
(c) Has received a prescription or recommendation from 12
the person's physician for an investigational drug, 13
biological product, or device; 14
(d) Has given written informed consent which shall be 15
at least as comprehensive as the consent used in clinical 16
trials for the use of the investigational drug, biological 17
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product, or device or, if the patient is a minor or lacks 18
the mental capacity to provide informed consent, a parent or 19
legal guardian has given written informed consent on the 20
patient's behalf; and 21
(e) Has documentation from the person's physician that 22
the person has met the requirements of this subdivision; 23
(2) "Investigational drug, biological product, or 24
device", a drug, biological product, or device, any of which 25
are used to treat the patient's terminal condition or 26
illness, life-threatening condition or illness, or severely 27
debilitating condition or illness, that has successfully 28
completed phase one of a clinical trial but has not been 29
approved for general use by the United States Food and Drug 30
Administration and remains under investigation in a clinical 31
trial[. The term shall not include Schedule I controlled 32
substances]; 33
(3) "Life-threatening condition or illness", a disease 34
or condition: 35
(a) Where the likelihood of death is high unless the 36
course of the disease or condition is interrupted; and 37
(b) With potentially fatal outcomes, where the end 38
point of clinical trial analysis is survival; 39
(4) "Severely debilitating condition or illness", a 40
disease or condition that causes major irreversible 41
morbidity; 42
(5) "Terminal condition or illness", a disease or 43
condition that without life-sustaining procedures will 44
result in death in the near future or a state of permanent 45
unconsciousness from which recovery is unlikely. 46
2. A manufacturer of an investigational drug, 47
biological product, or device may make available the 48
manufacturer's investigational drug, biological product, or 49
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device to eligible patients under this section. This 50
section does not require that a manufacturer make available 51
an investigational drug, biological product, or device to an 52
eligible patient. A manufacturer may: 53
(1) Provide an investigational drug, biological 54
product, or device to an eligible patient without receiving 55
compensation; or 56
(2) Require an eligible patient to pay the costs of or 57
associated with the manufacture of the investigational drug, 58
biological product, or device. 59
3. This section does not require a health care insurer 60
to provide coverage for the cost of any investigational 61
drug, biological product, or device. A health care insurer 62
may provide coverage for an investigational drug, biological 63
product, or device. 64
4. This section does not require the department of 65
corrections to provide coverage for the cost of any 66
investigational drug, biological product, or device. 67
5. Notwithstanding any other provision of law to the 68
contrary, no state agency or regulatory board shall revoke, 69
fail to renew, or take any other action against a 70
physician's license issued under chapter 334 based solely on 71
the physician's recommendation to an eligible patient 72
regarding prescription for or treatment with an 73
investigational drug, biological product, or device. Action 74
against a health care provider's Medicare certification 75
based solely on the health care provider's recommendation 76
that a patient have access to an investigational drug, 77
biological product, or device is prohibited. 78
6. If a provision of this section or its application 79
to any person or circumstance is held invalid, the 80
invalidity does not affect other provisions or applications 81
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of this section that can be given effect without the invalid 82
provision or application, and to this end the provisions of 83
this section are severable. 84
7. If the clinical trial is closed due to lack of 85
efficacy or toxicity, the drug shall not be offered. If 86
notice is given on a drug, product, or device taken by a 87
patient outside of a clinical trial, the pharmaceutical 88
company or patient's physician shall notify the patient of 89
the information from the safety committee of the clinical 90
trial. 91
8. Except in the case of gross negligence or willful 92
misconduct, any person who manufactures, imports, 93
distributes, prescribes, dispenses, or administers an 94
investigational drug or device to an eligible patient with a 95
terminal condition or illness, a life-threatening condition 96
or illness, or a severely debilitating condition or illness 97
in accordance with this section shall not be liable in any 98
action under state law for any loss, damage, or injury 99
arising out of, relating to, or resulting from: 100
(1) The design, development, clinical testing and 101
investigation, manufacturing, labeling, distribution, sale, 102
purchase, donation, dispensing, prescription, 103
administration, or use of the drug or device; or 104
(2) The safety or effectiveness of the drug or device. 105
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