Bill Text: CA SB149 | 2015-2016 | Regular Session | Amended


Bill Title: Investigational drugs, biological products, or devices: right to try.

Spectrum: Partisan Bill (Republican 2-0)

Status: (Failed) 2016-11-30 - From Assembly without further action. [SB149 Detail]

Download: California-2015-SB149-Amended.html
BILL NUMBER: SB 149	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JULY 13, 2015
	AMENDED IN SENATE  MAY 5, 2015
	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 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that approval has not been withdrawn, terminated, or suspended or the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  a terminal
disease,   an immediately life-threatening disease or
condition,  as specified.  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.  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  device.
  device   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, am  ong others. 
   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) "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:  
   (1) Examines the qualified individual and his or her relevant
medical records.  
   (2) Confirms, in writing, the physician's diagnosis and prognosis.
 
   (3) Verifies, in the opinion of the consulting physician, that the
eligible patient is competent, acting voluntarily, and has made an
informed decision.  
   (a) 
    (b)  "Eligible patient" means a person to whom all of
the following conditions apply:
   (1) He or she has  a terminal disease as determined by
that person's physician and a consulting physician.   an
immediately life-threatening disease or condition. 
   (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) 
    (c)  "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) 
    (d)  "Health facility" has the same meaning as in
Section 1250. 
   (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.  
   (d) 
    (f)  "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) 
    (g)  "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,   immediately life-threatening disease
or condition,  but does not include a primary care physician.

   (f) 
    (h)  "State regulatory board" means the Medical Board of
California or the Osteopathic Medical Board of California. 
   (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.
 
   (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:  
   (A) Explains the currently approved products and treatments for
the immediately life-threatening disease or condition from which the
patient suffers. 
   (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.  
   (C) Clearly identifies the specific proposed investigational drug,
biological product, or device that the patient is seeking to use.
 
   (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.  
   (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.  
   (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.  
   (G) Clearly states that in-home health care may be denied if
treatment begins.  
   (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.  
   (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). 
   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. 
   (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.

   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.   if the
recommendation or prescription is consistent with protocol approved
by the physician's institutional review board or an accredited
independent institutional review board. 
   (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)  A manufacturer that provides an
investigational drug, biological product, or device to an eligible
patient pursuant to Section 111546.2 shall   A physician'
s institutional review board or an accredited institutional review
board shall biannually  report all of the following information
to the State Department of Public  Health:  
Health, the Medical Board of California, and the Osteopathic Medical
Board of California: 
   (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
  immediately life-threatening disease or condition
 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  physician and  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.
                                
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