BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1668|
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THIRD READING
Bill No: AB 1668
Author: Calderon (D), et al.
Amended: 8/15/2016 Senate
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 6/22/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 6/27/16
AYES: Hill, Bates, Block, Gaines, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 77-2, 5/31/16 - See last page for vote
SUBJECT: Investigational drugs, biological products, and
devices
SOURCE: Author
DIGEST: This bill permits a manufacturer of an investigational
drug, biological product, or device to make available an
investigational drug, biological product, or device to an
eligible patient, as defined.
ANALYSIS:
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Existing federal law:
1) Establishes the federal Food, Drug, and Cosmetic Act, which
grants authority to the U.S. Food and Drug Administration
(FDA) to oversee the safety of food, drugs, and cosmetics.
Prohibits any new drug from being introduced into interstate
commerce unless an application has been approved by the FDA.
2) Provides, under regulation, for the following:
a) Requires clinical trial sponsors to submit an
Investigational New Drug (IND) application to the FDA for
clinical investigation of a new drug or new indication of
an approved drug, with certain exceptions;
b) Requires review and approval from an Institutional
Review Board (IRB) before a clinical study can be
initiated under an IND;
c) Defines an IRB as an appropriately constituted group
that has been designated to review and monitor biomedical
research involving human subjects, to ensure that a
clinical trial is ethical and that the rights of study
participants are protected; and
d) Authorizes an IRB to approve, require modifications
in, or disapprove research, or to suspend or terminate
approval of research that is not being conducted in
accordance with the IRB's requirements or that has been
associated with unexpected serious harm to subjects.
Existing state law establishes the Sherman Food, Drug, and
Cosmetic Law (Sherman Law), which regulates the packaging,
labeling, and advertising of drugs and devices, administered by
the Department of Public Health (DPH). Prohibits, under the
Sherman Law, the sale, delivery, or giving away of a new drug or
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device unless it is either:
1) A new drug or new device for which DPH has approved a new
drug or device application, and has not withdrawn,
terminated, or suspended that approval; or,
2) A new drug, and a new drug application has been approved for
it by the FDA, pursuant to federal law, or it is a new device
for which a premarket approval application has been approved,
and that approval has not been withdrawn, terminated, or
suspended under the FDA.
This bill:
1)Permits a manufacturer of an investigational drug, biological
product, or device to make available an investigational drug,
biological product, or device to an eligible patient, as
defined. Prohibits this bill from requiring that a
manufacturer make available an investigational drug,
biological product, or device to an eligible patient.
2)Defines "eligible patient" as a person who:
a) Has a serious or immediately life-threatening disease
or condition. Defines "immediately life-threatening
disease or condition" as a stage of disease in which there
is a reasonable likelihood that death will occur within a
matter of months;
b) Has considered all other treatment options currently
approved by the FDA;
c) Has not been accepted to participate in the nearest
clinical trial to his or her home for the immediately
life-threatening disease or condition within one week of
completion of the clinical trial application process, or,
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in the treating physician's medical judgment, it is
unreasonable for the patient to participate in that
clinical trial due to the patient's current condition and
stage of disease;
d) Has received a recommendation from his or her primary
physician and a consulting physician, as defined, for an
investigational drug, biological product, or device.
e) 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. Defines "written
informed consent" as a written document that has been
approved by the primary physician's IRB or an accredited
independent IRB, 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, as
specified.
3) Permits a manufacturer to provide an investigational drug,
biological product, or device to an eligible patient without
receiving compensation and to require an eligible patient to
pay the costs of or associated with the manufacture of the
investigational drug, biological product, or device.
4) Prohibits this bill from expanding or otherwise affecting
coverage provided by health plans or insurers, the Medi-Cal
program, or county organized health systems.
5) Specifies that this bill does not require a health plan or
insurer 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 bill, but
permits one to provide such coverage.
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6) Prohibits an investigational drug, biological product, or
device from being offered if a clinical trial for that
investigational drug, biological product, or device is closed
due to the lack of efficacy or for toxicity. Requires the
manufacturer and the patient's primary physician, if notice
is given for an investigational drug, biological product, or
device taken by a patient outside of a clinical trial, to
notify the patient of the information from the safety
committee of the clinical trial.
7) Prohibits the heirs and health benefit plan, as specified,
of an eligible patient, if he/she dies while being treated by
an investigational drug, biological product, or device made
available pursuant to this bill, from being liable for any
outstanding debt related to the treatment or lack of
insurance for the treatment.
8) Prohibits a state regulatory board from revoking, failing to
renew, or taking 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 IRB or an accredited independent institutional
review board.
9) Requires the physician's IRB or an accredited IRB to
biannually report to DPH, the Medical Board of California,
and the Osteopathic Medical Board of California specified
information about requests made under this bill.
10)Prohibits 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.
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11)Makes a violation of this bill not subject to the Sherman
Law.
12)Specifies that this bill does not create a private cause of
action, and that actions taken pursuant to this bill do 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.
Background
According to an April 9, 2015 Health Policy Brief on the issue
of right-to-try laws in Health Affairs, under current federal
regulations, patients with serious or life-threatening illness
have two primary options to access experimental therapies that
may treat their condition but that have not been approved by the
FDA: participate as a human subject in a clinical trial or, for
patients who cannot be enrolled in that trial (because of their
medical status or geographic location, for example), apply to
the FDA for the expanded access (also known as compassionate
use) program.
1)Clinical trials. According to the Health Affairs brief,
clinical testing of an experimental drug is typically a
three-phase process. Phase I trials are small (20 to 80
patients) and are used primarily to evaluate safety and dosing
ranges, usually in healthy volunteers. Phase II trials are
larger (typically 100 to 300 patients) and are designed to
show early evidence of efficacy in the patients that the drug
is intended to treat. Phase III trials may include hundreds or
thousands of patients and are used to demonstrate that the
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drug is effective compared to a control (such as a placebo or
a comparator drug). Typically, a manufacturer submits an
application to the FDA for marketing approval once a drug has
successfully completed Phase III trials. Any drug company
wishing to conduct a clinical trial must first submit an IND
application to the FDA, which allows the company to
manufacture the drug and ship it across state lines for use in
the trial. The drug may be only administered to patients who
are formally enrolled in that clinical trial. The study
population for that trial may be limited based on any number
of factors, including specific diagnosis, age, stage of
illness, or comorbidities.
2)Expanded access program. According to the Health Affairs
brief, the expanded access program is an attempt at
flexibility in the regulatory process and to allow patients
with no other treatment options a chance to try therapies they
may not otherwise have access to. The program allows patients
who meet certain eligibility requirements to receive an
experimental therapy outside of the formal clinical research
process. An application for expanded access can be submitted
by either the drug manufacturer or a licensed physician. There
are three categories of expanded access: treatment, single
patient, and intermediate, which are further split into two
subcategories. One is "expanded access INDs," through which
the manufacturer submits a separate IND for a patient or group
of patients, and the other is "expanded access protocols,"
whereby the manufacturer amends the protocol under an existing
IND to include the patient (or patients) seeking access. Under
treatment INDs, a relatively large group of patients (hundreds
or thousands) are permitted to access an experimental drug,
provided that the sponsor is actively pursuing FDA approval
and is in later stages of testing (or has already submitted
trial results to the FDA for review). According to an article
published in the January 15, 2015 New England Journal of
Medicine, the FDA has permitted almost all expanded access
requests regardless of category. The FDA estimated that by
2006, approximately 100,000 patients had obtained expanded
access to experimental drugs. Between 2010 and 2013, the FDA
imposed clinical holds on only two of the 2,472 individual,
non-emergency protocols, on one of 66 intermediate-size
requests, and on none of the 41 widespread expanded-access
protocols it received.
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The Health Affairs brief states that critics of the expanded
access program have argued that the application process is
unnecessarily burdensome and lengthy (it is estimated that the
IND application requires about 100 hours to complete), which
discourages doctors and manufacturers from applying. An IRB
review adds an additional layer of paperwork and potential
delay. These requirements were put in place in response to
highly publicized incidents of harm caused by unsafe drugs. In
the past decade, there have been several attempts made at the
federal and judicial levels to further relax restrictions on
the administration of experimental therapies to terminally ill
patients. One, led by the Abigail Alliance for Better Access
to Developmental Drugs, submitted a Citizen Petition to the
FDA in 2003 requesting that it make experimental therapies
available to terminally ill patients, provided that the drug
had passed Phase I testing. Following several years of
litigation, the DC Court of Appeals ruled against the Abigail
Alliance, stating that terminally ill patients have no
constitutional right to access experimental therapies. The
U.S. Supreme Court subsequently declined to review the case.
3)FDA action. According to a June 2, 1016 statement from the
Commissioner, the FDA has finalized its efforts to streamline
the process used by physicians to request the expanded access
program, which was prompted due to reports that navigating
that process can be challenging and time consuming. According
to the FDA, in order to make things simpler for physicians and
reduce the amount of time they spend filling out a request for
access to an investigational drug, the FDA released the final
Individual Patient Expanded Access Investigational New Drug
Application, which is much shorter than the form previously
used and should take about 45 minutes for a physician to
complete. The FDA also released step-by-step instructions on
how to complete it.
Comments
Author's statement. According to the author, AB 1668 seeks to
allow terminally ill patients the right to pursue non-FDA
approved medications in hopes of saving their lives. Terminally
ill patients often do not have the luxury of waiting for the FDA
to grant compassionate use or participating in the lengthy
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process of clinical trials. AB 1668 gives terminally ill
patients a chance to try potentially life-saving treatments
after all other options have been exhausted. AB 1668 removes
barriers for patients and doctors who believe an investigational
drug or device could be their last hope for survival, while also
protecting physicians, hospitals, and manufacturers from
retribution.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
1)One-time costs of $20,000 and ongoing costs of $10,000 per
year to review plan filings by the Department of Insurance
(Insurance Fund).
2)One-time costs of $380,000 in 2015-16 to respond to requests
for information about prior independent medical review
decisions and ongoing costs of $210,000 per year to respond to
consumer complaints and requests for independent medical
review for access to investigational drugs by the Department
of Managed Health Care (Managed Care Fund).
3)Uncertain impact on state-funded California Public Employees'
Retirement System health care coverage (General Fund and
special funds).
SUPPORT: (Verified8/12/16)
ALS (Amyotrophic Lateral Sclerosis) Association Golden West
Chapter
Los Angeles County Board of Supervisors
National Association of Social Workers, California Chapter
OPPOSITION: (Verified8/12/16)
AB 1668
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California Nurses Association
Medical Oncology Association of Southern California, Inc.
ASSEMBLY FLOOR: 77-2, 5/31/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth
Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto,
Gipson, Gomez, Gonzalez, Gray, Grove, Hadley, Harper, Roger
Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey,
Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty,
Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell,
Olsen, Patterson, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Rendon
NOES: Levine, Quirk
NO VOTE RECORDED: Gordon
Prepared by:Melanie Moreno / HEALTH / (916) 651-4111
8/15/16 20:33:20
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