HLS 17RS-420 ORIGINAL
2017 Regular Session
HOUSE BILL NO. 179
BY REPRESENTATIVE STOKES
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
HEALTH SERVICES: Provides relative to devices authorized for use by the Right To Try
Act
1 AN ACT
2To amend and reenact R.S. 40:1169.2(3) and 1169.3(1)(d) and (2), relative to investigational
3 drugs, products, and devices for use by terminally ill patients pursuant to the Right
4 To Try Act; to revise certain definitions and legislative findings of such law; to
5 provide relative to consent for the use of investigational drugs, biological products,
6 or devices; to authorize the prescription and use of certain devices which have not
7 completed phase one of a federally approved clinical trial; and to provide for related
8 matters.
9Be it enacted by the Legislature of Louisiana:
10 Section 1. R.S. 40:1169.2(3) and 1169.3(1)(d) and (2) are hereby amended and
11reenacted to read as follows:
12 §1169.2. Legislative findings
13 The Legislature of Louisiana hereby finds and declares the following:
14 * * *
15 (3) The standards of the United States Food and Drug Administration for the
16 use of investigational drugs, biological products, and devices may deny the benefits
17 of potentially life-saving treatments or devices to terminally ill patients.
18 * * *
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HB NO. 179
1 §1169.3. Definitions
2 As used in this Subpart, the following terms have the meaning ascribed to
3 them in this Section:
4 (1) "Eligible patient" means a person to whom all of the following criteria
5 apply:
6 * * *
7 (d)(i) Has given his consent in writing for the use of the investigational drug,
8 biological product, or device; or, if he is a minor or lacks the mental capacity to
9 provide consent, a parent or legal guardian has given consent in writing on his
10 behalf.
11 (ii) A person who can understand and comprehend spoken English but is
12 physically unable to talk or write may be deemed as meeting the criteria of this
13 Subparagraph if he is competent and able to indicate consent by other means.
14 * * *
15 (2)(a) "Investigational drug, biological product, or device" means a drug,
16 biological product, or device that has successfully completed phase one of a United
17 States Food and Drug Administration approved clinical trial, but has not been
18 approved for general use by the United States Food and Drug Administration and
19 remains under investigation in a clinical trial.
20 (b) Notwithstanding Subparagraph (a) of this Paragraph, for purposes of this
21 Subpart, "investigational drug, biological product, or device" shall include any
22 device possessing the following characteristics regardless of whether it has
23 successfully completed phase one of a United States Food and Drug Administration
24 approved clinical trial:
25 (i)(aa) If of a robotic nature, the device is designed such that any failure in
26 a multitude of continuous tests of its internal subsystems should cause motion to
27 stop, consistent with the Guidelines For Robotics Safety from the Occupational
28 Safety and Health Administration of the United States Department of Labor
29 (Directive Number STD 01-12-002).
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HB NO. 179
1 (bb) For purposes of this Item, "robotic nature" shall mean capable of
2 independent motion or moving the user.
3 (ii) The device has all of the following features for intentional control:
4 (aa) The motion of the device responds to specific controls from the user.
5 (bb) The device has no machine state in which motion continues without a
6 specific command from the user.
7 (iii) The device has an emergency stop button which allows an assistant to
8 force the motion of the device to stop.
9 * * *
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 179 Original 2017 Regular Session Stokes
Abstract: Amends the Right To Try Act to provide for means of consent and to include
certain devices within the law's definition of "investigational drug, biological
product, or device".
Present law known as the "Right To Try Act" authorizes the prescription of investigational
drugs, biological products, and devices to certain terminally ill patients who have given
informed written consent to investigational treatment and who meet other criteria necessary
to be deemed "eligible patients" pursuant to present law.
Proposed law retains present law and stipulates that a person who can understand and
comprehend spoken English but is physically unable to talk or write may be deemed as
meeting the criteria of present law relative to consent if he is competent and able to indicate
consent by other means.
Present law provides that for purposes of present law, "investigational drug, biological
product, or device" means a drug, biological product, or device that has successfully
completed phase one of a U.S. Food and Drug Administration (FDA) approved clinical trial,
but has not been approved for general use by the FDA and remains under investigation in
a clinical trial.
Proposed law provides that notwithstanding present law, "investigational drug, biological
product, or device" shall include any device possessing the following characteristics
regardless of whether it has successfully completed phase one of an FDA approved clinical
trial:
(1)If of a robotic nature (defined to mean capable of independent motion or moving the
user"), the device is designed such that any failure in a multitude of continuous tests
of its internal subsystems should cause motion to stop, consistent with applicable
federal guidelines for robotics safety.
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HB NO. 179
(2)The device has all of the following features for intentional control:
(a)The motion of the device responds to specific controls from the user.
(b)The device has no machine state in which motion continues without a
specific command from the user.
(3)The device has an emergency stop button which allows an assistant to force the
motion of the device to stop.
(Amends R.S. 40:1169.2(3) and 1169.3(1)(d) and (2))
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are additions.