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 Engrossed 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.
(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))