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 begin delete federal end delete begin insert Federal end insert 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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the begin delete federal end delete begin insert Federal end insert 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 insert a end insert terminal begin delete illnesses, end delete begin insert disease, end insert as specified. begin insert 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 insert 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 begin delete provisions. The bill end delete begin insert provisions, but end insert 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 begin delete illness end delete begin insert disease end insert 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 Medical Board of
California or the Osteopathic Medical Board of California.

begin delete

(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.

end delete begin insert

(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 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.

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.

begin insert

begin insert 111546.4. end insert   

(a) A manufacturer that provides an investigational
drug, biological product, or device to an eligible patient pursuant
to Section 111546.2 shall report all of the following information
to the State Department of Public Health:

(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 terminal disease 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 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.

end insert