ENROLLED
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ACT No. 346
Regular Session, 2014
HOUSE BILL NO. 891
BY REPRESENTATIVES STOKES AND SIMON
AN ACT1
To enact Part LXXV of Chapter 5 of Title 40 of the Louisiana Revised Statutes of 1950, to2
be comprised of R.S. 40:1300.381 through 1300.386, relative to access to treatment3
for terminally ill patients; to provide for findings, definitions, intent, and4
construction; to authorize provision of certain pharmaceutical and therapeutic5
products by manufacturers; to specify that gratuitous provision and insurance6
coverage of certain treatments are not required; to provide for limitation of liability;7
to prohibit actions against licenses of physicians in specific instances; and to provide8
for related matters.9
Be it enacted by the Legislature of Louisiana:10
Section 1. Part LXXV of Chapter 5 of Title 40 of the Louisiana Revised Statutes of11
1950, comprised of R.S. 40:1300.381 through 1300.386, is hereby enacted to read as12
follows:13
PART LXXV. ACCESS TO TREATMENT FOR TERMINALLY ILL PATIENTS14
§1300.381. Short title15
This Part shall be known and may be cited as the "Right To Try Act".16
§1300.382. Legislative findings17
The Legislature of Louisiana hereby finds and declares the following:18
(1) The process of approval for investigational drugs, biological products,19
and devices in the United States often takes many years.20
(2) A patient who has a terminal illness does not have the luxury of waiting21
until an investigational drug, biological product, or device receives final approval22
from the United States Food and Drug Administration.23 ENROLLEDHB NO. 891
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(3) The standards of the United States Food and Drug Administration for the1
use of investigational drugs, biological products, and devices may deny the benefits2
of potentially life-saving treatments to terminally ill patients.3
(4) A patient with a terminal illness has a fundamental right to attempt to4
preserve his own life by accessing available investigational drugs, biological5
products, and devices.6
(5) Whether to use available investigational drugs, biological products, or7
devices is a decision that rightfully should be made by the patient with a terminal8
illness in consultation with his physician, and is not a decision to be made by the9
government.10
§1300.383. Definitions11
As used in this Part, the following terms have the meaning ascribed to them12
in this Section:13
(1) "Eligible patient" means a person to whom all of the following criteria14
apply:15
(a) Has a terminal illness.16
(b) As determined by the person's physician, has no comparable or17
satisfactory treatment options that are approved by the United States Food and Drug18
Administration and available to diagnose, monitor, or treat the person's disease or19
condition, and the probable risk to the person from the investigational drug,20
biological product, or device is not greater than the probable risk from the person's21
disease or condition.22
(c) Has received a prescription or recommendation from his physician for an23
investigational drug, biological product, or device.24
(d) Has given his consent in writing for the use of the investigational drug,25
biological product, or device; or, if he is a minor or lacks the mental capacity to26
provide consent, a parent or legal guardian has given consent in writing on his27
behalf.28
(e) Has documentation from his physician indicating that he has met the29
requirements provided in this Part.30 ENROLLEDHB NO. 891
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(2) "Investigational drug, biological product, or device" means a drug,1
biological product, or device that has successfully completed phase one of a United2
States Food and Drug Administration approved clinical trial, but has not been3
approved for general use by the United States Food and Drug Administration and4
remains under investigation in a clinical trial.5
(3) "Terminal illness" means a disease that, without life-sustaining6
procedures, will result in death in the near future or a state of permanent7
unconsciousness from which recovery is unlikely. This diagnosis shall be confirmed8
by a second independent evaluation by a board-certified physician in an appropriate9
speciality.10
§1300.384. Availability of drugs, biological products, and devices; costs; insurance11
coverage12
A.(1) A manufacturer of an investigational drug, biological product, or13
device may make available such drug, product, or device to eligible patients in14
accordance with the provisions of this Section.15
(2) Nothing in this Section shall be construed to require a manufacturer to16
make available any drug, product, or device.17
B. A manufacturer may do any of the following:18
(1) Provide an investigational drug, biological product, or device to an19
eligible patient without receiving compensation.20
(2) Require an eligible patient to pay the costs of or associated with the21
manufacture of the investigational drug, biological product, or device.22
C.(1) A health insurance issuer may choose to provide coverage for the cost23
of an investigational drug, biological product, or device.24
(2) Nothing in this Section shall be construed to require a health insurance25
issuer to provide coverage for the cost of any investigational drug, biological26
product, or device.27
§1300.385. Limitation of liability28
Notwithstanding any provision of law to the contrary, a physician who29
prescribes an investigational drug, biological product, or device to an eligible patient30 ENROLLEDHB NO. 891
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pursuant to the provisions of this Part shall be immune from civil liability, including1
but not limited to any cause of action arising under R.S. 40:1299.41 et seq., for any2
adverse action, condition, or other outcome resulting from the patient's use of the3
investigational drug, biological product, or device.4
§1300.386. Action against physician license prohibited 5
Notwithstanding any provision of law to the contrary, the Louisiana State 6
Board of Medical Examiners shall not revoke, fail to renew, or take any other action7
against the license of a physician issued pursuant to the provisions of R.S. 37:1261,8
et seq. based solely upon the recommendation of the physician to an eligible patient9
regarding, or prescription for, or treatment with, an investigational drug, biological10
product, or device when such recommendation, prescription, or treatment is11
undertaken in strict conformance with the provisions of this Part.12
Section 2. The Louisiana State Law Institute is hereby directed to redesignate the13
numbers of the Sections of statute enacted by this Act in a manner that comports with the14
technical recodification provisions of the Act which originated as House Bill No. 667 of this15
2014 Regular Session of the Legislature.16
SPEAKER OF THE HOUSE OF REPRESENTATI VES
PRESIDENT OF THE SENATE
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED: