BILL ANALYSIS Ó
SB 149
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Date of Hearing: August 19, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
SB 149
(Stone) - As Amended July 13, 2015
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| |Business and Professions | |14 - 0 |
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Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill sets up a legal structure whereby individuals with
serious or immediately life-threatening conditions can gain
access to investigational drugs, biological products, or medical
devices (investigational products). Specifically, this bill:
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1) Defines investigational drug, biological product, or
device as 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
(FDA), but has not been approved for general use and
remains under investigation in an approved clinical trial.
2) Allows, but does not require, the manufacturer of an
investigational product to make the product available to an
eligible patient, as defined. Specifies that the
manufacturer may require a patient to pay for the costs of
the investigational product.
3) Defines an eligible patient as one who has met a number
of specified criteria, including having a serious or
life-threatening condition, as defined, and having
considered all FDA-approved treatment options.
4) Allows, but does not require, a health plan or insurer
to provide coverage for the investigational product.
5) Prohibits a state regulatory board from taking
disciplinary action against a physician's license, and
prohibits a state agency from taking action against a
facility's license, based on the recommendation,
prescription, or treatment of the investigational product,
provided the recommendation or prescription is consistent
with protocol approved by an institutional review board.
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6) Specifies it does not create a private cause of action
against a manufacturer of an investigational product, or
against any other person or entity involved in the care of
an eligible patient using the investigational product, for
any harm done to the patient resulting from it, so long as
the manufacturer or other person or entity is complying
with the law in good faith and exercising reasonable care.
7) Requires institutional review boards to report
information about requests for investigational products to
the California Department of Public Health (CDPH), the
Medical Board of California (MBC), and the Osteopathic
Medical Board of California (OBMC).
FISCAL EFFECT:
1)Minor and absorbable costs to CDPH, MBC, and OMBC to receive
and review biannually reports from institutional review boards
on the requests for treatment with an investigational product.
2)$380,000 in the first year of implementation, and $210,000
ongoing to Department of Managed Health Care (Managed Care
Fund). First year costs are higher because of additional legal
analysis and processing Public Records Act (PRA) requests for
experimental procedures previously authorized or rejected by
health plans. Ongoing costs are related to patient and
provider inquiries to the DMHC's Help Center. Many of the
investigational and/or experimental Independent Medical Review
(IMR) requests require thorough analysis to determine if
literature and studies on the treatments are available, and to
review clinical trials, if completed or available.
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3)CDI costs are minor and absorbable, projected at under $10,000
annually (Insurance Fund). This committee's fiscal analysis of
a very similar bill, SB 159 (Calderon), did not identify this
to insurance regulators due to an assumption that the narrow
eligibility criteria of the bill would apply to very few
people, if any. However, it has since come to this
committee's attention that although few individuals may
qualify to receive treatment under this bill, responding to
patient inquiries may result in increased costs to regulators.
COMMENTS:
1)Purpose. 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.
This bill removes barriers for patients who need to
immediately obtain investigational treatments, while also
protecting physicians, hospitals, and manufacturers from
retribution.
2)Background. Drugs and devices go through clinical trials,
phase one of which establishes safety and assesses toxicity.
Once a drug or devices passes phase one, there are two more
phases before being approved for sale. This bill would allow
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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.
Experimental treatments are often available by participating
in a clinical trial. If a patient is unable to enroll in a
clinical trial, the FDA expanded access exemption, also called
"compassionate use," provides a pathway for patients to gain
access to investigational drugs or devices for serious
diseases or conditions. A licensed physician is able to apply
for expanded access on behalf of the patient. The physician
must be willing to commit to oversee the treatment, work with
the manufacturing company and FDA, obtain the drugs, monitor
the patient during the course of treatment, and file necessary
paperwork. The FDA states that they receive approximately
1,000 expanded use applications per year, and has approved
more than 99% of those applications.
3)Support. The ALS Association - Golden West Chapter, City of
Murrieta, and Union of American Physicians and Dentists
support this bill.
4)Opposition. The California Medical Association, California
Nurse Association/National Nurses United, Association of
Northern California Oncologists oppose this bill, citing
patient safety and other concerns. The Association of
Northern California Oncologists believe this bill threatens
the viability of adult clinical trial enrollment and would
result in slowing the development of cancer care in the
future.
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5)Related Legislation.
a) SB 159 (Calderon), pending in Senate Appropriations
Committee, is substantially similar to this bill, with
differences primarily in definitions and liability
exemptions.
b) SB 715 (Anderson) is largely the same as this bill with
some differences in definitions. SB 715 was referred to
Senate Health Committee and not heard.
c) SB 128 (Wolk), pending in the Assembly Health Committee,
permits a competent, qualified individual who is a
terminally ill adult to receive a prescription for aid in
dying medication if certain conditions are met.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081