BILL NUMBER: SB 149 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 14, 2015
INTRODUCED BY Senator Stone
( Coauthor: Senator Anderson
)
JANUARY 29, 2015
An act to add Article 4.1 (commencing with Section 111546) to
Chapter 6 of Part 5 of Division 104 of the Health and Safety Code,
relating to drugs and devices.
LEGISLATIVE COUNSEL'S DIGEST
SB 149, as amended, Stone. Investigational drugs, biological
products, or devices: right to try.
Existing law, the federal Food, Drug, and Cosmetic Act, prohibits
a person from introducing into interstate commerce any new drug
unless the drug has been approved by the federal
United States Food and Drug Administration (FDA). Existing
law requires the sponsor of a new drug to submit to the FDA an
investigational new drug application and to then conduct a series of
clinical trials to establish the safety and efficacy of the drug in
human populations and submit the results to the FDA in a new drug
application.
Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates
the packaging, labeling, and advertising of drugs and devices and is
administered by the State Department of Public Health. A violation of
that law is a crime. The Sherman Food, Drug, and Cosmetic Law
prohibits, among other things, the sale, delivery, or giving away of
a new drug or new device unless either the department has approved a
new drug or device application for that new drug or new device and
that approval has not been withdrawn, terminated, or suspended or the
drug or device has been approved pursuant to specified provisions of
federal law, including the federal Food, Drug, and Cosmetic Act.
The Medical Practice Act provides for the licensure and regulation
of physicians and surgeons by the Medical Board of California and
requires the board to take action against a licensee who is charged
with unprofessional conduct. The Osteopathic Act provides for the
licensure and regulation of osteopathic physicians and surgeons by
the Osteopathic Medical Board of California and requires the board to
enforce the Medical Practice Act with respect to its licensees.
This bill, among other things, would permit a manufacturer of an
investigational drug, biological product, or device to make the
product available to eligible patients with terminal illnesses, as
specified. The bill would provide that the act does not require a
health benefit plan, as defined, or governmental agency to provide
coverage for the cost of any investigational drug, biological
product, or device made available pursuant to these provisions. The
bill would authorize a health benefit plan to provide coverage for an
investigational drug, biological product, or device. The bill would
also prohibit the Medical Board of California and the Osteopathic
Medical Board of California from taking any disciplinary action
against the license of a physician based solely on the physician's
recommendation to an eligible patient regarding, or prescription for,
or treatment with, an investigational drug, biological product, or
device.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Article 4.1 (commencing with Section 111546) is added
to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code,
to read:
Article 4.1. Right to Try Act
111546. This article shall be known and may be cited as the Right
to Try Act.
111546.1. In this article, unless the context otherwise requires,
the following definitions shall apply:
(a) "Eligible patient" means a person to whom all of the following
conditions apply:
(1) He or she has a terminal illness as determined by that person'
s physician and a consulting physician.
(2) His or her physician has determined that the person has no
comparable or satisfactory United States Food and Drug Administration
approved treatment options available to diagnose, monitor, or treat
the disease or condition involved, and that the probable risk to the
person from the investigational drug, biological product, or device
is not greater than the probable risk from the disease or condition.
(3) He or she has received a prescription or recommendation from
his or her physician for an investigational drug, biological product,
or device.
(4) He or she has given written informed consent for the use of
the investigational drug, biological product, or device, or if he or
she is a minor or lacks the capacity to provide informed consent, his
or her parent, legal guardian, or legally authorized representative
has given written informed consent on his or her behalf.
(5) He or she has documentation from his or her physician that the
patient has met the requirements of this subdivision.
(b) "Health benefit plan" means any plan or program that provides,
arranges, pays for, or reimburses the cost of health benefits.
"Health benefit plan" includes, but is not limited to, a health care
service plan contract issued by a health care service plan, as
defined in Section 1345 of this code, and a policy of health
insurance, as defined in Section 106 of the Insurance Code, issued by
a health insurer.
(c) "Health facility" has the same meaning as in Section 1250.
(d) "Investigational drug, biological product, or device" means a
drug, biological product, or device that has successfully completed
phase one of a clinical trial approved by the United States Food and
Drug Administration, but has not been approved for general use by the
United States Food and Drug Administration and remains under
investigation in a clinical trial approved by the United States Food
and Drug Administration.
(e) "Physician" means a physician and surgeon licensed under the
Medical Practice Act or an osteopathic physician and surgeon licensed
under the Osteopathic Act, and who is providing medical care or
treatment to the eligible patient for the terminal illness, but does
not include a primary care physician.
(f) "State regulatory board" means the California
Medical Board of California or the Osteopathic
Medical Board of California.
(g) "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.
111546.2. (a) Notwithstanding Section 110280, 111520, or 111550,
a manufacturer of an investigational drug, biological product, or
device may make available the manufacturer's investigational drug,
biological product, or device to an eligible patient pursuant to this
article. This article does not require that a manufacturer make
available an investigational drug, biological product, or device to
an eligible patient.
(b) A manufacturer may do any of the following:
(1) Provide an investigational drug, biological product, or device
to an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of or associated
with the manufacture of the investigational drug, biological product,
or device.
(3) Require an eligible patient to participate in data collection
relating to the use of the investigational drug, biological product,
or device.
(c) (1) Except as otherwise required by law, this article does not
require a health benefit plan or any state agency to provide
coverage for the cost of any investigational drug, biological
product, or device.
(2) A health benefit plan may provide coverage for an
investigational drug, biological product, or device.
111546.3. (a) Notwithstanding any other law, a state regulatory
board shall not revoke, fail to renew, or take any other disciplinary
action against a physician's license based solely on the physician's
recommendation to an eligible patient regarding, or prescription
for, or treatment with, an investigational drug, biological product,
or device pursuant to this article.
(b) Notwithstanding any other law, a state agency shall not take
any action against a health facility's license based solely on the
facility's participation in the treatment by or use of an
investigational drug, biological product, or device pursuant to this
article.
(c) A violation of this article shall not be subject to Chapter 8
(commencing with Section 111825).
(d) This article does not create a private cause of action against
a manufacturer of an investigational drug, biological product, or
device, or against any other person or entity involved in the care of
an eligible patient using the investigational drug, biological
product, or device, for any harm to the eligible patient resulting
from the investigational drug, biological product, or device so long
as the manufacturer or other person or entity complies in good faith
with the terms of this article and exercises reasonable care.