BILL ANALYSIS Ó
AB 1668
Page 1
ASSEMBLY THIRD READING
AB
1668 (Calderon)
As Amended March 7, 2016
Majority vote
------------------------------------------------------------------
|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Health |18-0 |Wood, Maienschein, | |
| | |Bonilla, Burke, | |
| | |Campos, Dababneh, | |
| | |Cooley, Roger | |
| | |Hernández, Lackey, | |
| | |Nazarian, Olsen, | |
| | |Patterson, | |
| | |Ridley-Thomas, | |
| | |Rodriguez, Santiago, | |
| | |Steinorth, Thurmond, | |
| | |Waldron | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Business & |14-0 |Salas, Brough, Baker, | |
|Professions | |Bloom, Campos, | |
| | |Chávez, Dahle, Dodd, | |
| | |Burke, Gatto, Jones, | |
| | |Mullin, Ting, Wood | |
| | | | |
|----------------+-----+----------------------+--------------------|
AB 1668
Page 2
|Appropriations |20-0 |Gonzalez, Bigelow, | |
| | |Bloom, Bonilla, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, Eggman, | |
| | |Gallagher, Eduardo | |
| | |Garcia, Roger | |
| | |Hernández, Holden, | |
| | |Jones, Obernolte, | |
| | |Quirk, Santiago, | |
| | |Wagner, Weber, Wood | |
| | | | |
| | | | |
------------------------------------------------------------------
SUMMARY: Authorizes the manufacturer of an investigational
drug, biological product, or device (investigational drug) that
is not yet approved by the United States Food and Drug
Administration (FDA) to make the investigational drug available
to a patient with a serious or immediately life-threatening
disease, when that patient has considered all other treatment
options currently approved by the FDA, has been unable to
participate in a relevant clinical trial, and for whom the
investigational drug has been recommended by the patient's
primary physician and a consulting physician. Specifies other
criteria and parameters for the use of such investigational
drugs in this way.
FISCAL EFFECT: According to the Assembly Appropriations
Committee:
1)Minor and absorbable costs to the California Department of
Health Services (DPH), the Medical Board of California, and
Osteopathic Medical Board of California to receive and review
biannually reports from institutional review boards on the
requests for treatment with an investigational product
(various funds).
AB 1668
Page 3
2)Costs of $380,000 in the first year of implementation, and
$200,000 ongoing to Department of Managed Health Care (DMHC)
(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 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: 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 could
be their last hope for survival. The author further states that
those patients that have exhausted all other treatment options,
and are not eligible for clinical trials, often seek access to
investigational new drugs but face a variety of hurdles. These
patients may seek compassionate use exemptions from the FDA, but
the process is cumbersome and approval comes too late for many.
The author explains this bill removes barriers for patients who
need to immediately obtain investigational treatments, while
also protecting physicians, hospitals, and manufacturers from
retribution.
Patient requests for access to drugs and biologics prior to
their approval have long created a dilemma for regulators, who
must balance the needs of patients and their families who
believe that an experimental product could save their life, with
AB 1668
Page 4
ensuring the safety of the greater population through tightly
controlled clinical trials and drug approval. This issue has
become increasingly visible and difficult in recent times, as
views about the inherent right of patients in certain situations
to unapproved products have been expressed by patients and their
advocates, state legislators, members of Congress, and some
court cases. In 2014 four states adopted legislation similar to
this bill (Colorado, Louisiana, Michigan, and Missouri) and one
state (Arizona) adopted a resolution to place the issue on the
November 2014 ballot, where it was approved by voters.
According to the National Conference on State Legislatures, at
least 41 other states considered similar right-to-try
legislation in 2015.
Supporters argue that patients with no other treatment options
should be able to take on more risk than healthy patients would
otherwise choose. The Los Angeles County Board of Supervisors
supports this bill, stating that terminally ill patients, who
have exhausted their options to find a cure and who have
identified a physician and pharmaceutical company willing to
assist them, deserve the right to experimental treatments that
could prolong their lives.
The Medical Oncology Association of Southern California (MOASC)
opposes, stating that "while we appreciate the interest in
supporting patients, there are substantive dangers in a "right
to try" outside the context of a clinical trial, including the
damage to adult clinical trial enrollment, which hold the
promise of the future of medicine." MOASC additionally raises
concerns about the difficulty identifying an "immediately
life-threatening condition", the lack of sufficient informed
consent process to protect patients seeking these drugs, and the
lack of appropriate physician supervision of the use of these
drugs. The California Nurses Association (CNA) states that this
bill erroneously suggests that consumers do not have access to
these drugs because physicians fear their liability to practice
medicine would be compromised and their liability increased if
AB 1668
Page 5
they were to recommend such treatment. CNA points out that
nothing in this legislation impacts the availability of drugs to
terminally ill patients unless the manufacturer of a drug allows
it to be used in advance of FDA approval.
Analysis Prepared by:
John Gilman / HEALTH / (916) 319-2097 FN:
0003206