BILL NUMBER: AB 159	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 13, 2015

INTRODUCED BY   Assembly Member Calderon
    (   Coauthors:   Assembly Members 
 Brown,   Daly,   Lackey,   Obernolte,
  Olsen,   and Waldron   ) 
    (   Coauthors:   Senators   Allen,
  Anderson,   and Stone   ) 

                        JANUARY 21, 2015

   An act to add Article 4.5 (commencing with Section 111548) to
Chapter 6 of Part 5 of Division 104 of the Health and Safety Code,
relating to drugs and devices.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 159, as amended, Calderon. Investigational drugs, biological
products, and devices.
   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that approval has not been withdrawn, terminated, or suspended or the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 would permit a manufacturer of an investigational drug,
biological product, or device to make the product available to
eligible patients with  terminal illnesses,   a
serious or immediately life-threatening disease or condition, 
as specified. The bill would authorize, but not require, a health
benefit plan, as defined, to provide coverage for any investigational
drug, biological product, or device made available pursuant to these
provisions. The bill would 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, provided that the recommendation or
prescription is consistent with medical standards of care. The bill
would prohibit a state agency from altering any recommendation made
to the federal Centers for Medicare and Medicaid Services regarding a
health care provider's certification to participate in the Medicare
or Medicaid program based solely on the recommendation from an
individual health care provider that a patient have access to an
investigational drug, biological product, or device. The bill would
prohibit an official, employee, or agent of the state from blocking
an eligible patient's access to the investigational drug, biological
product, or device pursuant to the bill's provisions.
   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 4.5 (commencing with Section 111548) is added
to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code,
to read:

      Article 4.5.  Right to Try Act


   111548.  This article shall be known and may be cited as the Right
to Try Act.
   111548.1.  In this article, unless the context otherwise requires,
the following definitions shall apply:
   (a) "Eligible patient" means a person who meets all of the
following conditions:
   (1) Has a  terminal illness.   serious or
immediately life-threatening disease or condition. 
   (2) Has considered all other treatment options currently approved
by the United States Food and Drug Administration.
   (3) Has been unable to participate in a clinical trial for the
 terminal illness   serious or immediately
life-threatening disease or condition  identified in paragraph
(1) within 100 miles of his or her home or has not been accepted to
that clinical trial within one week of completion of the clinical
trial application process.
   (4) Has received a recommendation from his or her physician for an
investigational drug, biological product, or device.
   (5) Has given written informed consent for the use of the
investigational drug, biological product, or device, or if he or she
lacks the capacity to consent, his or her legally authorized
representative has given written informed consent on his or her
behalf.
   (6) Has documentation from his or her physician attesting 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) (1) "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 or in which premature
death is likely without early treatment.  
   (2) "Serious disease or condition" means a disease or condition
associated with morbidity that has a substantial impact on day-to-day
functioning.  
   (c) 
    (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. 
   (d) 
    (e)  "Physician" means a physician and surgeon licensed
under the Medical Practice Act or an osteopathic physician and
surgeon licensed under the Osteopathic Act. 
   (e) 
    (f)  "State regulatory board" means the 
California  Medical Board  of California  or the
Osteopathic Medical Board of California. 
   (f) "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. 
   (g)  (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 where the patient lacks the
capacity to consent, and attested to by the patient's physician and a
witness that, at a minimum, does all of the following: 
   (1) 
    (A   )  Explains the currently approved
products and treatments for the  terminal illness 
 serious or immediately life-threatening disease or condition
 from which the patient suffers. 
   (2) 
    (   B)  Attests to the fact that the patient,
or where the patient lacks the capacity to consent, his or her
legally authorized representative, concurs with the patient's
physician in believing that all currently approved and conventionally
recognized treatments are unlikely to prolong the patient's life.

   (3) 
    (   C)  Clearly identifies the specific
proposed investigational drug, biological product, or device that the
patient is seeking to use. 
   (4) 
    (   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. 
   (5) 
    (   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. 
   (6) 
    (   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. 
   (7) 
    (   G)  Clearly states that in-home health care
may be denied if treatment begins. 
   (8) 
    (   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). 
   111548.2.  (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 both 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.
   (c) (1) This article does not expand or otherwise affect the
coverage provided under Sections 1370.4 and 1370.6 of this code,
Sections 10145.3 and 10145.4 of the Insurance Code, or Sections
14087.11 and 14132.98 of the Welfare and Institutions Code.
   (2) This article does not require a health benefit plan to provide
coverage for the cost of any investigational drug, biological
product, or device, or the costs of services related to the use of an
investigational drug, biological product, or device under this
article. A health benefit plan may provide coverage for an
investigational drug, biological product, or device made available
pursuant to this section.
   (d) If an eligible patient dies while being treated by an
investigational drug, biological product, or device made available
pursuant to this article, the patient's heirs are not liable for any
outstanding debt related to the treatment or lack of insurance for
the treatment.
   111548.3.  (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, provided that the recommendation or prescription is
consistent with medical standards of care.
   (b) A state agency shall not alter any recommendation made to the
federal Centers for Medicare and Medicaid Services regarding a health
care provider's certification to participate in the Medicare or
Medicaid program based solely on the recommendation from an
individual health care provider that a patient have access to an
investigational drug, biological product, or device.
   (c) An official, employee, or agent of this state shall not block
or attempt to block an eligible patient's access to an
investigational drug, biological product, or device pursuant to this
article. Counseling, advice, or a recommendation consistent with
medical standards of care from an individual licensed under Division
2 (commencing with Section 500) of the Business and Professions Code
shall not be considered a violation of this section.
   (d)  A violation of this section shall not be subject to Chapter 8
(commencing with Section 111825).
   111548.5.  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 done to the eligible
patient resulting from the investigational drug, biological product,
or device, so long as the manufacturer or other person or entity is
complying in good faith with the terms of this article, unless there
was a failure to exercise reasonable care.