BILL ANALYSIS Ó
AB 159
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GOVERNOR'S VETO
AB
159 (Calderon)
As Enrolled September 4, 2015
2/3 vote
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|ASSEMBLY: |74-2 |(May 18, 2015) |SENATE: |40-0 |(September 1, |
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|ASSEMBLY: |76-2 |(September 2, | | | |
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Original Committee Reference: HEALTH
SUMMARY: Authorizes the manufacturer of an investigational drug
to make an investigational drug that is not yet approved by the
United States Food and Drug Administration (FDA) available to a
patient, under certain circumstances.
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The Senate amendments limit the patients able to participate to
those with an immediately life-threatening disease or condition,
adds types of information about the treatment that is reported
by the institutional review board to agencies collecting the
data, removes language prohibiting an official, employee, or
agent of this state from blocking or attempting to block an
eligible patient's access to an investigational drug or device,
and clarifies language stating that this bill does not create a
private right of action including but not limited to, product
liability, medical negligence, or wrongful death against a
physician or manufacturer involved in the use of an
investigational drug pursuant to this bill.
EXISTING STATE LAW prohibits, under the Sherman Food, Drug, and
Cosmetic Law, the sale, delivery, or giving away of a drug or
device unless it has been approved to market by either the FDA
or the California Department of Public Health.
EXISTING FEDERAL LAW prohibits any new drug from being
introduced into interstate commerce unless an application has
been approved by the FDA.
FISCAL EFFECT: According to the Senate Appropriations
Committee, 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). Additionally, 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). Uncertain impact on state-funded CalPERS health care
coverage (General Fund and special funds).
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COMMENTS: According to the author, this bill removes barriers
to accessing potentially life-saving drugs for terminally-ill
patients and doctors who believe an investigational drug or
device could be their last hope for survival. These patients
may seek compassionate use exemptions from the FDA, but the
process is cumbersome and approval comes too late for many. The
author asserts that this bill removes barriers for patients who
need to immediately obtain investigational treatments, while
also protecting physicians, hospitals, and manufacturers from
retribution.
A clinical trial is a study that is carefully designed to test
the benefits and risks of a specific medical treatment or
intervention, such as a new drug. The FDA requires a
multi-phase clinical trials process to be completed before
deciding if an investigational medicine is safe and effective
for a broader patient population. Experimental drugs and
devices go through clinical trials, stage one of which
establishes very basic safety level and assesses toxicity. Once
a drug or device passes stage one, there are two more phases
before being approved for sale. This bill would allow
manufacturers to make available investigational products, that
have passed phase one trials, to patients meeting specified
criteria, and would protect from liability doctors who recommend
or prescribe the investigational products, as well as
manufacturers who make them available.
Patients who are not eligible for a clinical trial because of
where they live, their age, or some other disqualifying factor
have the option to seek expanded access if they have serious or
life-threatening conditions and no comparable or satisfactory
alternative is available. The FDA has in place processes to
allow patients access: expanded access, which is sometimes
called "compassionate use," supplements the clinical trials
process. A licensed physician is able to apply for expanded
access on behalf of the patient. The FDA states that they
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receive approximately 1,000 expanded use applications per year,
and has approved more than 99% of those applications. In the
last four years, the FDA has denied only 33 of nearly 6,000
expanded access requests. Emergency requests are often granted
immediately over the phone. For non-emergencies, the FDA states
that they strive to respond promptly and, in general, approve
the request within 30 days.
Critics of the FDA process have raised concerns that the
expanded access application is too cumbersome for physicians and
patients to complete. Critics claim that it currently requires
an application that takes doctors 100 hours to fill out. On
February 4, 2015, the FDA announced that it would be
streamlining the expanded use application process, and stated
that the proposed application will allow physicians to apply for
experimental drugs in just 45 minutes. The FDA draft guidance
on the new application process is currently in the public
comment period and the new final rule should be released
shortly.
The Los Angeles County Board of Supervisors supports this bill,
stating that seriously ill patients who have exhausted their
options to find a cure and who have identified physicians and a
pharmaceutical company willing to assist them, deserve the right
to experimental treatments that could improve their health
conditions or prolong their lives.
The California Nurses Association/National Nurses United (CNA)
and the Association of Northern California Oncologists (ANCO)
oppose this bill, citing patient safety and other concerns.
ANCO states that this bill threatens the viability of adult
clinical trial enrollment and would result in slowing the
development of cancer care in the future. CNA points out that
"nothing in this legislation impacts the availability of drugs
to terminally ill patients unless the manufacturers of the drugs
allow it to be used in advance of FDA approval". If a
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manufacturer provided an experimental drug or device to a
patient without FDA approval under this law, they would be in
direct violation of federal law.
GOVERNOR'S VETO MESSAGE:
This bill would permit a pharmaceutical manufacturer to make an
investigational drug available to a patient with an immediately
life-threatening disease on the recommendation of two
physicians.
Patients with life threatening conditions should be able to try
experimental drugs, and the United States Food and Drug
Administration's compassionate use program allows this to
happen. The proposed changes to this program will streamline
access to these drugs. Before authorizing an alternative state
pathway, we should give this federal expedited process a chance
to work.
Analysis Prepared by:
Dharia McGrew / HEALTH / (916) 319-2097 FN:
0002503
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