BILL ANALYSIS Ó
AB 159
Page 1
Date of Hearing: May 13, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB
159 (Calderon) - As Amended April 28, 2015
-----------------------------------------------------------------
|Policy |Health |Vote:|17 - 0 |
|Committee: | | | |
| | | | |
| | | | |
|-------------+-------------------------------+-----+-------------|
| |Business and Professions | |14 - 0 |
| | | | |
| | | | |
|-------------+-------------------------------+-----+-------------|
| | | | |
| | | | |
| | | | |
-----------------------------------------------------------------
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 product, or medical
devices (investigational products). Specifically, this bill:
AB 159
Page 2
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 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, 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, and
prohibits a state agency from altering a 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
on the recommendation, prescription, or treatment of the
investigational product, provided the recommendation or
AB 159
Page 3
prescription is consistent with protocol approved by an
institutional review board.
6) Prohibits an official, employee, or agent of the state
from blocking or attempting to block an eligible patient's
access to an investigational product pursuant to this
article.
7) 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 in
good faith with the terms of this article, unless there was
a failure to exercise reasonable care.
8) 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:
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.
COMMENTS:
AB 159
Page 4
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,
stage one of which establishes safety and assesses toxicity.
Once a drug or devices 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.
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
AB 159
Page 5
more than 99% of those applications.
3)Support. The Los Angeles County Board of Supervisors supports
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.
5)Related Legislation.
a) SB 149 (Stone), pending in Senate Appropriations
Committee, is largely 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.
AB 159
Page 6
c) SB 128 (Wolk), pending in the Senate Appropriations
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