Amended in Assembly July 13, 2015

Amended in Senate May 5, 2015

Amended in Senate April 14, 2015

Senate Bill No. 149

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 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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the Federal Food, Drug, and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 begin delete a terminal disease, end delete begin insert an immediately life-threatening disease or condition, end insert as specified. begin delete The bill would require a manufacturer that provides an investigational drug, biological product, or device to an eligible patient to report specified data to the State Department of Public Health. end delete 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, but 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 begin delete device. end delete begin insert device end insert begin insert if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited institutional review board, and would require the institutional review board to biannually report specified information to the State Department of Public Health, among others. end insert

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:

begin insert

(a) “Consulting physician” means a physician and surgeon
licensed under the Medical Practice Act or an osteopathic
physician and surgeon licensed under the Osteopathic Act who
performs all of the following:

end insert begin insert

(1) Examines the qualified individual and his or her relevant
medical records.

end insert begin insert

(2) Confirms, in writing, the physician’s diagnosis and
prognosis.

end insert begin insert

(3) Verifies, in the opinion of the consulting physician, that the
eligible patient is competent, acting voluntarily, and has made an
informed decision.

end insert begin delete

(a)

end delete

begin insert (b) end insert  “Eligible patient” means a person to whom all of the
following conditions apply:

(1) He or she has begin delete a terminal disease as determined by that
person’s physician and a consulting physician. end delete begin insert an immediately
life-threatening disease or condition. end insert

(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.

begin delete

(b)

end delete

begin insert (c) end insert  “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.

begin delete

(c)

end delete

begin insert (d) end insert  “Health facility” has the same meaning as in Section 1250.

begin insert

(e) “Immediately life-threatening disease or condition” means
a stage of disease in which there is a reasonable likelihood that
death will occur within a matter of months.

end insert begin delete

(d)

end delete

begin insert (f) end insert  “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.

begin delete

(e)

end delete

begin insert (g) end insert  “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 begin delete terminal illness, end delete
begin insert immediately life-threatening disease or condition, end insert but does not
include a primary care physician.

begin delete

(f)

end delete

begin insert (h) end insert  “State regulatory board” means the Medical Board of
California or the Osteopathic Medical Board of California.

begin delete

(g) “Terminal disease” means an incurable and irreversible
disease that has been medically confirmed and will, according to
reasonable medical judgment, result in death within six months of
diagnosis.

end delete begin insert

(i) (1) “Written, informed consent” means a written document
that has been approved by the physician’s institutional review
board or an accredited independent institutional review board, is
signed by an eligible patient, or his or her legally authorized
representative when the patient lacks the capacity to consent, and
is attested to by the patient’s physician and a witness that, at a
minimum, does all of the following:

end insert begin insert

(A) Explains the currently approved products and treatments
for the immediately life-threatening disease or condition from
which the patient suffers.

end insert begin insert

(B) Attests to the fact that the patient, or his or her legally
authorized representative when the patient lacks the capacity to
consent, concurs with the patient’s physician in believing that all
existing approved and conventionally recognized treatments are
unlikely to prolong the patient’s life.

end insert begin insert

(C) Clearly identifies the specific proposed investigational drug,
biological product, or device that the patient is seeking to use.

end insert begin insert

(D) Describes the potentially best and worst outcomes of using
the investigational drug, biological product, or device and
describes the most likely outcome. This description shall include
the possibility that new, unanticipated, different, or worse
symptoms might result and that death could be hastened by the
proposed treatment. The description shall be based on the
physician’s knowledge of the proposed treatment in conjunction
with an awareness of the patient’s condition.

end insert begin insert

(E) Clearly states that the patient’s health benefit plan, if any,
and health care provider are not obligated to pay for the
investigational drug, biological product, or device or any care or
treatments consequent to use of the investigational drug, biological
product, or device.

end insert begin insert

(F) Clearly states that the patient’s eligibility for hospice care
may be withdrawn if the patient begins curative treatment and that
care may be reinstated if the curative treatment ends and the
patient meets hospice eligibility requirements.

end insert begin insert

(G) Clearly states that in-home health care may be denied if
treatment begins.

end insert begin insert

(H) States that the patient understands that he or she is liable
for all expenses consequent to the use of the investigational drug,
biological product, or device, and that this liability extends to the
patient’s estate, except as otherwise provided in the patient’s health
benefit plan or a contract between the patient and the manufacturer
of the drug, biological product, or device.

end insert begin insert

(2) Written, informed consent for purposes of this article shall
be consistent with the informed consent requirements of the
Protection of Human Subjects in Medical Experimentation Act
(Chapter 1.3 (commencing with Section 24170) of Division 20).

end insert

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.

begin insert

(d) If the clinical trial for an investigational drug, biological
product, or device is closed due to the lack of efficacy or for
toxicity, the investigational drug, biological product, or device
shall not be offered. If notice of closure of a clinical trial is given
for an investigational drug, biological product, or device taken by
an eligible patient outside of a clinical trial, the manufacturer and
the patient’s physician shall notify the patient of the information
from the safety committee of the clinical trial.

end insert

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 begin delete pursuant to this article. end delete begin insert if the recommendation or
prescription is consistent with protocol approved by the physician’s
institutional review board or an accredited independent
institutional review board. end insert

(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.

111546.4.  

(a)  begin delete A manufacturer that provides an investigational
drug, biological product, or device to an eligible patient pursuant
to Section 111546.2 shall end delete begin insert A physician’s institutional review board
or an accredited institutional review board shall biannually end insert report
all of the following information to the State Department of Public
begin delete Health: end delete begin insert Health, the Medical Board of California, and the
Osteopathic Medical Board of California: end insert

(1) The number of requests made for an investigational drug,
biological product, or device.

(2) The number of requests that were approved.

(3) The duration of treatments.

(4) The success or failure of the investigational drug, biological
product, or device in treating the begin delete terminal disease end delete begin insert immediately
life-threatening disease or condition end insert with which the eligible patient
was diagnosed.

(5) Any adverse event for each investigational drug, biological
product, or device.

(6) Costs paid by each eligible patient for each investigational
drug.

(7) The begin insert physician and end insert consulting physician’s diagnosis and
prognosis, and verification that the eligible patient is competent,
acting voluntarily, and has made an informed decision, or that the
consulting physician has determined that the person is not an
eligible patient.

(b) The information collected shall be confidential and shall be
collected in a manner that protects the privacy of the patient, the
patient’s family, and any medical provider or pharmacist involved
with the patient under the provisions of this part.