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)]
Stokes HB No. 891
Abstract: Authorizes access to investigational drugs, biological products, and devices for
terminally ill patients.
Proposed law establishes findings concerning barriers that terminally ill patients may face in
access to potentially life-preserving treatments.
Proposed law provides the following definitions for purposes of proposed law:
(1)"Eligible patient" means a person who meets all of the following criteria:
(a)Has a terminal illness.
(b)As determined by the person's physician, has no comparable or satisfactory
treatment options that are approved by the U.S. Food and Drug Administration
and available to diagnose, monitor, or treat the person's disease or condition, and
the probable risk to the person from the investigational drug, biological product,
or device is not greater than the probable risk from the person's disease or
condition.
(c)Has received a prescription or recommendation from his physician for an
investigational drug, biological product, or device.
(d)Has given his consent in writing for the use of the investigational drug, biological
product, or device; or, if he is a minor or lacks the mental capacity to provide
consent, a parent or legal guardian has given consent in writing on his behalf.
(e)Has documentation from his physician indicating that he has met the requirements
provided in proposed law.
(2)"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 approved clinical trial, but has not been approved for general use by the
U.S. Food and Drug Administration and remains under investigation in a clinical trial.
(3)"Terminal illness" means a disease that, without life-sustaining procedures, will result in
death in the near future or a state of permanent unconsciousness from which recovery is unlikely. Provides that this diagnosis shall be confirmed by a second independent
evaluation by a board-certified physician in an appropriate speciality.
Proposed law authorizes manufacturers of investigational drugs, biological products, and devices
to make available those drugs, products, and devices to eligible patients. Provides, however, that
nothing in proposed law shall be construed to require provision of any drug, product, or device
by a manufacturer.
Proposed law authorizes a manufacturer to provide an investigational drug, biological product, or
device to an eligible patient with or without compensation.
Proposed law authorizes health insurers to provide coverage for the cost of an investigational
drug, biological product, or device. Specifies that nothing in proposed law shall be construed to
require such coverage by health insurers.
Proposed law provides that a physician who prescribes an investigational drug, biological
product, or device pursuant to proposed law shall be immune from civil liability, including but
not limited to any cause of action arising under medical malpractice provisions of present law,
for any adverse outcome resulting from a patient's use of the investigational drug, biological
product, or device pursuant to proposed law.
Proposed law provides that proposed law shall be known and may be cited as the Right To Try
Act.
(Adds R.S. 40:1300.381-1300.385)
Summary of Amendments Adopted by House
Committee Amendments Proposed by House Committee on Health and Welfare to the
original bill.
1. In the set of criteria for a person to be considered an "eligible patient" pursuant to
proposed law, deleted consideration by the person of all other treatment options
approved by the U.S. Food and Drug Administration (FDA); and added in lieu thereof
determination by a physician that the person has no comparable or satisfactory FDA-
approved treatment options available, and the probable risk from the investigational
treatment is not greater than the probable risk from the disease or condition.
2. Relative to consent for types of treatment provided for in proposed law, deleted
requirement that the consent the patient gives in writing be informed consent.
3. Revised definition of "terminal illness" in proposed law to provide that such illness be
one that, without life-sustaining procedures, will result in death in the near future or a
state of permanent unconsciousness from which recovery is unlikely. Provided that
this diagnosis shall be confirmed by a second independent evaluation by a board- certified physician in an appropriate speciality.
4. Deleted provision prohibiting the La. State Board of Medical Examiners from
revoking, failing to renew, or taking any other action against the license of a physician
based solely upon the physician's recommendation regarding or prescription for or
treatment with an investigational drug, biological product, or device.
5. Added provision establishing that a physician who prescribes an investigational drug,
biological product, or device pursuant to proposed law shall be immune from civil
liability, including but not limited to any cause of action arising under medical
malpractice provisions of present law, for any adverse outcome resulting from a
patient's use of the investigational drug, biological product, or device.
6. Deleted provision establishing a fine of $1,500 or less to be imposed upon any
official, employee, or agent of the state who blocks or attempts to block a patient's
access to an investigational drug, biological product, or device provided for in
proposed law.
7. Made technical changes.
House Floor Amendments to the engrossed bill.
1. Relative to consent that a parent or legal guardian gives on behalf of a minor or a
person lacking mental capacity to give consent for treatment provided for in proposed
law, deleted requirement that the consent the parent or guardian gives in writing be
informed consent.
2. In provisions relative to the clinical trial that a drug, product, or device must complete
pursuant to proposed law, added provision stipulating that such trial is a United States
Food and Drug Administration approved clinical trial.
3. Deleted legislative declaration indicating that allowing for the provisions of proposed
law to apply to patients with nonterminal illnesses furthers the purpose of proposed
law.