BILL ANALYSIS Ó
AB 1668
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Date of Hearing: April 6, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
AB
1668 (Calderon) - As Amended March 7, 2016
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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 provide the product for free or require a
patient to pay for the costs of the 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, or the
costs of services related to the use of the investigational
product.
5) Prohibits a state regulatory board from taking
disciplinary action against a physician's license based on
the recommendation or prescription of, or treatment with,
the investigational product, provided it is consistent with
protocol approved by an institutional review board.
Similarly prohibits a state agency from altering a
recommendation made to the federal Centers for Medicare and
Medicaid Services regarding a health care provider's
AB 1668
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certification to participate in the Medicare or Medicaid
program based on such recommendation, prescription, or
treatment.
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,
provided certain conditions are met.
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
(various funds).
2)$380,000 in the first year of implementation, and $200,000
ongoing to Department of Managed Health Care (Managed Care
Fund). First year costs are higher because of probable
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. DMHC indicates any of the investigational and/or
experimental Independent Medical Review (IMR) requests require
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thorough analysis to determine if literature and studies on
the treatments are available, and to review clinical trials,
if completed or available.
3)The California Department of Insurance may, similarly to DMHC,
experience unknown costs related to IMR requests, PRA
requests, or other requests for other assistance to the extent
these requests increase. (Insurance Fund).
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.
2)Background. Prior to being available for sale, drugs and
devices must pass through clinical trials regulated by the
FDA. Phase one of these trials establishes safety 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 stage 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.
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There are, however, other ways to gain access to drugs that
are not yet approved. 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 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 such applications per year,
and has approved more than 99% of those applications. Critics
of this process have raised concerns that the application is
too cumbersome for physicians and patients to complete. In
February 2015, the FDA proposed a new, much shorter form,
which the agency has stated is a top priority to finalize.
Based on regulatory timelines, it is possible this new form
may be available later this year.
3)Support. The Los Angeles County Board of Supervisors and the
Amyotrophic Lateral Sclerosis Association Golden West Chapter
support this bill, they support expanded use of experimental
treatments.
4)Opposition. The California Nurse Association and the Medical
Oncology Association of Southern California oppose this bill.
The 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)Prior Legislation.
a) AB 159 (Calderon) of 2015 was identical to this bill.
It was vetoed by Governor Brown, who stated, "Patients with
life threatening conditions should be able to try
experimental drugs, and the FDA'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." This bill is similar
to AB 159 and does not appear to address the veto message.
b) SB 149 (Stone) of 2015 was largely similar to this bill
and to AB 159, and was held on the Suspense File of this
committee.
c) SB 715 (Anderson) of 2015 was also similar to this bill,
and was referred to Senate Health Committee and not heard.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081