Amended in Senate June 16, 2015

Amended in Senate June 1, 2015

Amended in Assembly April 28, 2015

Amended in Assembly April 13, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 159

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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and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 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. 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. begin delete 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. end delete

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.  

For purposes of 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:

begin delete

(A)

end delete

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

begin delete

(B)

end delete

begin insert (2) end insert  Confirms, in writing, the primary physician’s diagnosis and
prognosis.

begin delete

(C)

end delete

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

(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.

(c) “Health benefit plan” means a 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, and a policy of health insurance, as defined in
Section 106 of the Insurance Code, issued by a health insurer.

(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.

(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.

(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.

(g) “State regulatory board” means the Medical Board of
California or the Osteopathic Medical Board of California.

(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 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 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 begin delete or otherwise affect end delete 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 begin insert of closure of a clinical trial end insert 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.

(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 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) 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.

begin insert

(5) The success or failure of the investigational drug, biological
product, or device in treating the serious or immediately
life-threatening disease or condition from which the patient suffers.

end insert begin insert

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

end insert

(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.

begin delete

(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.

end delete begin delete

(e) 

end delete

begin insert (d) end insert begin insert   end insert 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,
and actions taken pursuant to this article shall not serve as a basis
for a civil, criminal, or disciplinary claim or cause of action,
including, but not limited to, product liability, medical negligence,
or wrongful death, 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 for harm done to
the eligible patient or his or her heirs resulting from the
investigational drug, biological product, or device, or the use or
nonuse thereof, if the manufacturer or other person or entity has
complied with the terms of this article in relation to the eligible
patient, unless there was a failure to exercise reasonable care.