BILL NUMBER: AB 159	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  APRIL 28, 2015
	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 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that approval has not been withdrawn, terminated, or suspended or the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 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.   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.  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) "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 shall perform all of
the following:  
   (A) Examine the qualified individual and his or her relevant
medical records.  
   (B) Confirm in writing the primary physician's diagnosis and
prognosis.  
   (C) Verify, 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 who meets all of
the following conditions:
   (1) Has a 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
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  primary
 physician  and a consulting 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  primary  physician
 and a consulting physician  attesting 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)  (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. 
   (d) 
    (e)  "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" 
    (f)    "Primary physician"  means a
physician and surgeon licensed under the Medical Practice Act or an
osteopathic physician and surgeon licensed under the Osteopathic Act.

   (f) 
    (g)  "State regulatory board" means the Medical Board of
California or the Osteopathic Medical Board of California. 
   (g) 
    (h)  (1) "Written, informed consent" means a written
document that has been approved by the  primary  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 
 when  the patient lacks the capacity to consent, and
attested to by the patient's  primary  physician and a
witness that, at a minimum, does all of the following:
   (A) Explains the currently approved products and treatments for
the serious or immediately life-threatening disease or condition from
which the patient suffers.
   (B) Attests to the fact that the patient, or  where
  when  the patient lacks the capacity to consent,
his or her legally authorized representative, concurs with the
patient's  primary  physician in believing that all
currently 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  primary 
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).
   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 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 is given for an investigational drug,
biological product, or device taken by a patient outside of a
clinical trial, the manufacturer and the patient's primary physician
shall notify the patient of the information from the safety committee
of the clinical trial.  
   (d) 
    (e)  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.  
protocol approved by the physician's institutional review board or an
accredited independent institutional review board.  
   (b) The physician's institutional review board or an accredited
institutional review board shall biannually report the following
information to the State Department of Public 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 status of the requests made.  
   (3) The duration of the treatment. 
   (4) The costs of the treatment paid by eligible patients. 

   (b) 
    (c)  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)
    (d)  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) 
    (e)   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.