BILL ANALYSIS Ó
AB 159
Page 1
ASSEMBLY THIRD READING
AB
159 (Calderon)
As Amended April 28, 2015
Majority vote
-------------------------------------------------------------------
|Committee |Votes |Ayes |Noes |
| | | | |
| | | | |
|----------------+------+----------------------+--------------------|
|Health |17-0 |Bonta, Maienschein, | |
| | |Burke, Chiu, Gomez, | |
| | |Gonzalez, | |
| | | | |
| | | | |
| | |Roger Hernández, | |
| | |Lackey, Nazarian, | |
| | |Patterson, | |
| | | | |
| | | | |
| | |Ridley-Thomas, | |
| | |Rodriguez, Santiago, | |
| | |Steinorth, Thurmond, | |
| | |Waldron, Wood | |
| | | | |
|----------------+------+----------------------+--------------------|
|Business & |14-0 |Bonilla, Jones, | |
|Professions | |Baker, Bloom, Campos, | |
| | |Chang, Dodd, Eggman, | |
| | |Gatto, Holden, | |
| | |Mullin, Ting, Wilk, | |
AB 159
Page 2
| | |Wood | |
| | | | |
|----------------+------+----------------------+--------------------|
|Appropriations |15-0 |Gomez, Bigelow, | |
| | |Bloom, Bonta, | |
| | |Calderon, Chang, | |
| | |Daly, Eggman, Eduardo | |
| | |Garcia, Holden, | |
| | |Jones, Rendon, | |
| | |Wagner, Weber, Wood | |
| | | | |
| | | | |
-------------------------------------------------------------------
SUMMARY: Permits a manufacturer of a drug, biological product, or
device (experimental drug or device) that has not yet received
federal or state approval to market to make the product available
to eligible patients with serious or immediately life-threatening
diseases, as specified.
EXISTING STATE LAW:
1)Prohibits, under the Sherman Food, Drug, and Cosmetic Law, the
sale, delivery, or giving away of a new drug or device unless it
is either
a) A new drug or new device for which the California
Department of Public Health (DPH) has approved a new drug or
device application, and has not withdrawn, terminated, or
suspended that approval; or,
b) A new drug, and a new drug application has been approved
for it by the United States Food and Drug Administration
(FDA).
EXISTING FEDERAL LAW: Prohibits any new drug from being
introduced into interstate commerce unless an application has been
approved by the FDA.
AB 159
Page 3
FISCAL EFFECT: According to the Assembly Appropriations
Committee, minor and absorbable costs to DPH, the Medical Board of
California, and the Osteopathic Medical Board of California to
receive and review biannually reports from institutional review
boards on the requests for treatment with an investigational
product.
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. This bill
removes barriers for patients who need to immediately obtain
investigational treatments, while also protecting physicians,
hospitals, and manufacturers from retribution.
Background. 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.
Expanded Access to investigational products through the FDA.
Patients who are not eligible for a clinical trial because of
where they live, their age, or some other disqualifying factor
AB 159
Page 4
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 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.
Court History. In 2005, the Abigail Alliance for Better Access to
Developmental Drugs, with the mission of facilitating access to
experimental drugs for patients, sued the FDA, claiming a
constitutional due process right for terminally ill patients to
access unapproved drugs. A United States District court disagreed
and the case was heard by the United States Court of Appeals for
the District of Columbia Circuit. In 2006, a divided three-judge
panel of the District of Columbia Circuit agreed with the
Alliance, finding that where there are no other FDA-approved
treatment options, a terminally ill patient has a
constitutionally-protected "fundamental right" to access
investigational drugs. In 2007, the District of Columbia Circuit
AB 159
Page 5
reheard the case "en banc" and reversed the panel decision. The
Alliance then filed a petition asking the United States Supreme
Court to hear the case but the Supreme Court denied the petition,
so for now the Court of Appeals decision stands.
Support. The Los Angeles County Board of Supervisors supports
this bill.
Opposition. The California Medical Association, California Nurse
Association/National Nurses United (CNA), 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. 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
manufacturer provided an experimental drug or device to a patient
without FDA approval under this law, they would be in violation
for federal law.
Statement of Concern. The Pharmaceutical Research and
Manufacturers Association (PhRMA) filed a letter of concern with
this Committee, stating that Right-to-Try legislation, while
well-intentioned, could have serious unintended consequences that
must be taken into consideration. Robust clinical trials are one
of the key elements in bringing new therapies to market. PhRMA
states that it is imperative that investigational drugs be used
within the boundaries of carefully constructed and monitored
clinical trials to ensure patient safety, and to glean key
understandings about the safety, efficacy, and uses of
investigational drugs. Furthermore, PhRMA is concerned with the
lack of oversight and accountability in this legislation. Both
clinical trials and the FDA's expanded access program require that
patients be given these under the close supervisions of a
AB 159
Page 6
physician and other health care providers to closely monitor
patient reactions. Allowing blanket access to these drugs outside
of monitored trials could yield catastrophic results for the
patient.
Analysis Prepared by:
Dharia McGrew / HEALTH / (916) 319-2097 FN:
0000390