ENROLLED
ACT No. 292
2017 Regular Session
HOUSE BILL NO. 179
BY REPRESENTATIVES STOKES, BAGLEY, BILLIOT, BROADWATER, CHANEY,
CONNICK, COX, HENSGENS, HOFFMANN, HORTON, JACKSON, JOHNSON,
LEBAS, LYONS, MARINO, DUSTIN MILLER, MORENO, NORTON, POPE,
REYNOLDS, RICHARD, SIMON, STAGNI, AND THOMAS AND SENATORS
ALARIO, ALLAIN, APPEL, BARROW, BISHOP, BOUDREAUX, CARTER,
CHABERT, CLAITOR, COLOMB, CORTEZ, DONAHUE, ERDEY, FANNIN,
GATTI, HEWITT, JOHNS, LAFLEUR, LAMBERT, LONG, LUNEAU,
MARTINY, MILKOVICH, MILLS, MIZELL, MORRELL, MORRISH, PEACOCK,
PERRY, PETERSON, RISER, GARY SMITH, JOHN SMITH, TARVER,
THOMPSON, WALSWORTH, WARD, AND WHITE
1 AN ACT
2 To 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.
9 Be 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
11 reenacted to read as follows:
12 §1169.2. Legislative findings
13 The Legislature of Louisiana hereby finds and declares the following:
14 * * *
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1 (3) The standards of the United States Food and Drug Administration for the
2 use of investigational drugs, biological products, and devices may deny the benefits
3 of potentially life-saving treatments or devices to terminally ill patients.
4 * * *
5 §1169.3. Definitions
6 As used in this Subpart, the following terms have the meaning ascribed to
7 them in this Section:
8 (1) "Eligible patient" means a person to whom all of the following criteria
9 apply:
10 * * *
11 (d)(i) Has given his consent in writing for the use of the investigational drug,
12 biological product, or device; or, if he is a minor or lacks the mental capacity to
13 provide consent, a parent or legal guardian has given consent in writing on his
14 behalf.
15 (ii) A person who can understand and comprehend spoken English but is
16 physically unable to talk or write may be deemed as meeting the criteria of this
17 Subparagraph if he is competent and able to indicate consent by other means.
18 * * *
19 (2)(a) "Investigational drug, biological product, or device" means a drug,
20 biological product, or device that has successfully completed phase one of a United
21 States Food and Drug Administration approved clinical trial, but has not been
22 approved for general use by the United States Food and Drug Administration and
23 remains under investigation in a clinical trial.
24 (b) Notwithstanding Subparagraph (a) of this Paragraph, for purposes of this
25 Subpart, "investigational drug, biological product, or device" shall include any
26 device possessing the following characteristics regardless of whether it has
27 successfully completed phase one of a United States Food and Drug Administration
28 approved clinical trial:
29 (i)(aa) If of a robotic nature, the device is designed such that any failure in
30 a multitude of continuous tests of its internal subsystems should cause motion to
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1 stop, consistent with the Guidelines For Robotics Safety from the Occupational
2 Safety and Health Administration of the United States Department of Labor
3 (Directive Number STD 01-12-002).
4 (bb) For purposes of this Item, "robotic nature" shall mean capable of
5 independent motion or moving the user.
6 (ii) The device has all of the following features for intentional control:
7 (aa) The motion of the device responds to specific controls from the user.
8 (bb) The device has no machine state in which motion continues without a
9 specific command from the user.
10 (iii) The device has an emergency stop button which allows an assistant to
11 force the motion of the device to stop.
12 * * *
SPEAKER OF THE HOUSE OF REPRESENTATIVES
PRESIDENT OF THE SENATE
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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