BILL ANALYSIS
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Mark Leno, Chair A
2009-2010 Regular Session B
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AB 1414 (Hill) 4
As Amended March 8, 2010
Hearing date: June 15, 2010
Health & Safety Code
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APOMORPHINE - CONTROLLED SUBSTANCES
HISTORY
Source: Author
Prior Legislation: SB 24 (Johnson) - 1997, died in Assembly
Appropriations
AB 258 (La Suer) - Ch. 841, Stats. 2001
Support: California Healthcare Institute; San Bernardino
Sheriff's Department
Opposition:None known
Assembly Floor Vote: Ayes 73 - Noes 0
KEY ISSUE
SHOULD APOMORPHINE - A MEDICATION USED IN THE TREATMENT OF CERTAIN
SYMPTOMS OF PARKINSON'S DISEASE - BE STRICKEN FROM THE CONTROLLED
SUBSTANCE SCHEDULES?
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PURPOSE
The purpose of this bill is to remove apomorphine from the
controlled substance schedules.
Existing law classifies controlled substances in five schedules
according to their danger and potential for abuse. Schedule I
controlled substances have the greatest restrictions and
penalties, including prohibiting the prescribing of a Schedule I
controlled substance. (Health & Saf. Code 11054 to 11058.)
Existing law includes apomophine in Schedule II of the
controlled substance schedules. (Health & Saf. Code 11055,
subd. (b)(1)(G).)
Existing law provides that possession of apomorphine is a
felony, punishable by a prison term of 16 month, two years or
three years and a fine of up to $10,000. (Health & Saf. Code
11350.)
Existing law provides that possession of apomorphine for sale is
a felony, punishable by a prison term of two, three or four
years and a fine of up to $10,000. (Health & Saf. Code
11351.)
Existing law provides that selling, providing or furnishing
apomorphine is a felony, punishable by a prison term or three,
four or five years and a fine of up to $10,000. (Health & Saf.
Code 11352.)
Existing federal law includes controlled substance schedules
based on the following criteria:
Schedule I
o The drug has a high potential for abuse
o The drug has no currently accepted medical use in
treatment in the United States.
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o There is a lack of accepted safety for use of the drug
under medical supervision.
Schedule II
o The drug has a high potential for abuse
o The drug has a currently accepted medical use in
treatment in the United States or a currently accepted
medical use with severe restrictions.
o Abuse of the drug may lead to severe psychological or
physical dependence.
Schedule III
o The drug has a potential for abuse less than the drugs
or other substances in Schedules I and II.
o The drug has a currently accepted medical use in
treatment in the United States.
o Abuse of the drug or other substance may lead to
moderate or low physical dependence or high psychological
dependence.
Schedule IV
o The drug has a low potential for abuse relative to the
drugs in Schedule III.
o The drug has a currently accepted medical use in
treatment in the United States.
o Abuse of the drug may lead to limited physical
dependence or psychological dependence relative to the
drugs or other substances in Schedule III.
Schedule V
o The drug has a low potential for abuse relative to the
drugs or other substances in Schedule IV.
o The drug has a currently accepted medical use in
treatment in the United States.
o Abuse of the drug may lead to limited physical
dependence or psychological dependence relative to the
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drugs or other substances in Schedule IV. (21 USC 812.)
Existing federal law classifies opiates and narcotic drugs in
the federal schedules, particularly in Schedule II. (21 USC
812.)
Existing federal regulations exclude apomorphine (and other
specified drugs) from the regulations that implement the federal
controlled substances law. (21 CFR 1308.12 (b)(1).)
This bill removes apomorphine, currently included in Schedule
II, from the schedules of the California Controlled Substances
Act.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
The severe prison overcrowding problem California has
experienced for the last several years has not been solved. In
December of 2006 plaintiffs in two federal lawsuits against the
Department of Corrections and Rehabilitation sought a
court-ordered limit on the prison population pursuant to the
federal Prison Litigation Reform Act. On January 12, 2010, a
federal three-judge panel issued an order requiring the state to
reduce its inmate population to 137.5 percent of design capacity
-- a reduction of roughly 40,000 inmates -- within two years.
In a prior, related 184-page Opinion and Order dated August 4,
2009, that court stated in part:
"California's correctional system is in a tailspin,"
the state's independent oversight agency has reported.
. . . (Jan. 2007 Little Hoover Commission Report,
"Solving California's Corrections Crisis: Time Is
Running Out"). Tough-on-crime politics have increased
the population of California's prisons dramatically
while making necessary reforms impossible. . . . As a
result, the state's prisons have become places "of
extreme peril to the safety of persons" they house,
(Governor Schwarzenegger's Oct. 4, 2006 Prison
Overcrowding State of Emergency Declaration), while
contributing little to the safety of California's
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residents, California "spends more on corrections
than most countries in the world," but the state
"reaps fewer public safety benefits." . . . .
Although California's existing prison system serves
neither the public nor the inmates well, the state has
for years been unable or unwilling to implement the
reforms necessary to reverse its continuing
deterioration. (Some citations omitted.)
. . .
The massive 750% increase in the California prison
population since the mid-1970s is the result of
political decisions made over three decades, including
the shift to inflexible determinate sentencing and the
passage of harsh mandatory minimum and three-strikes
laws, as well as the state's counterproductive parole
system. Unfortunately, as California's prison
population has grown, California's political
decision-makers have failed to provide the resources
and facilities required to meet the additional need
for space and for other necessities of prison
existence. Likewise, although state-appointed experts
have repeatedly provided numerous methods by which the
state could safely reduce its prison population, their
recommendations have been ignored, underfunded, or
postponed indefinitely. The convergence of
tough-on-crime policies and an unwillingness to expend
the necessary funds to support the population growth
has brought California's prisons to the breaking
point. The state of emergency declared by Governor
Schwarzenegger almost three years ago continues to
this day, California's prisons remain severely
overcrowded, and inmates in the California prison
system continue to languish without constitutionally
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adequate medical and mental health care.<1>
The court stayed implementation of its January 12, 2010 ruling
pending the state's appeal of the decision to the U.S. Supreme
Court. That appeal, and the final outcome of this litigation,
is not anticipated until later this year or 2011.
This bill does not appear to aggravate the prison overcrowding
crisis described above.
COMMENTS
1. Need for This Bill
According to the author:
Assembly Bill 1414 would remove the substance
apomorphine from California controlled substances
schedules. Currently, apomorphine is classified as a
schedule II controlled substance, a classification
that is generally defined by drugs that have an
accepted medical value, present a high potential for
abuse, and may lead to severe psychological or
physical dependence if abused. Schedule II substances
generally require more oversight due to the potential
dangers associated with misuse of the substances.
However, beyond the name, apomorphine has little
relation to morphine and its properties. While
morphine is appropriately classified as a schedule II
controlled substance, apomorphine does not meet the
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<1> Three Judge Court Opinion and Order, Coleman v.
Schwarzenegger, Plata v. Schwarzenegger, in the United States
District Courts for the Eastern District of California and the
Northern District of California United States District Court
composed of three judges pursuant to Section 2284, Title 28
United States Code (August 4, 2009).
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criteria set forth above and should be classified as a
standard, non-scheduled prescription drug.
2. Parkinson's Disease Background
According to the National Institute of Neurological Disorders
and Stroke:
Parkinson's disease (PD) belongs to a group of
conditions called motor system disorders, which are
the result of the loss of dopamine-producing brain
cells. The four primary symptoms of PD are tremor, or
trembling in hands, arms, legs, jaw, and face;
rigidity, or stiffness of the limbs and trunk;
bradykinesia, or slowness of movement; and postural
instability, or impaired balance and coordination. As
these symptoms become more pronounced, patients may
have difficulty walking, talking, or completing other
simple tasks. PD usually affects people over the age
of 50. Early symptoms of PD are subtle and occur
gradually. In some people the disease progresses more
quickly than in others. As the disease progresses,
the shaking, or tremor, which affects the majority of
PD patients may begin to interfere with daily
activities. Other symptoms may include depression and
other emotional changes; difficulty in swallowing,
chewing, and speaking; urinary problems or
constipation; skin problems; and sleep disruptions.
There are currently no blood or laboratory tests that
have been proven to help in diagnosing sporadic PD.
Therefore the diagnosis is based on medical history
and a neurological examination. The disease can be
difficult to diagnose accurately. Doctors may
sometimes request brain scans or laboratory tests in
order to rule out other diseases.
3. Apomorphine Background Information
According to the National Library of Medicine at the National
Institutes of Health:
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Apomorphine is used to treat 'off' episodes (times of
difficulty moving, walking, and speaking that may
happen as medication wears off or at random) in
patients with Parkinson's disease (PD; a disorder of
the nervous system that causes difficulties with
movement, muscle control, and balance) who are taking
other medications for their disorder. Apomorphine
will not work to prevent 'off' episodes, but will help
improve symptoms when an episode has already begun.
Apomorphine is in a class of medications called
dopamine agonists. Apomorphine works by mimicking the
action of dopamine, a natural substance in the brain
that is lacking in patients with PD.
Side effects include nausea, vomiting, constipation,
diarrhea, headache, yawning, runny nose, weakness,
paleness, flushing, bone or joint pain, pain or
difficulty in urination, and soreness, redness, pain,
bruising, swelling, or itching in the place where you
injected apomorphine.
Some side effects can be serious, although uncommon:
shortness of breath, cough, fast or pounding
heartbeat, chest pain, swelling of the hands, feet,
ankles, or lower legs, bruising, sudden uncontrollable
movements, falling down, hallucinations (seeing things
or hearing voices that do not exist), depression,
confusion, abnormal behavior, change in vision, and
painful erection that does not go away. Some
laboratory animals that were given apomorphine
developed eye disease. It is not known if apomorphine
increases the risk of eye disease in humans.
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4. Apomorphine Hydrochloride Formulation known as Apokyn
It appears that the only apomorphine medication that is
available for productive clinical use is Apokyn, which is
distributed in the United States by Tercica in Brisbane,
California. Tercica was recently acquired by Ipsen, a European
company. It further appears that Ipsen acquired the rights to
market Apokyn in the United States from Vernalis, a British
company. Tercica reports that Apokyn has been available in
Europe since 1993 and in the United States since 2004. Approval
for use of Apokyn in the United States was obtained by Bertek
Pharmaceuticals, a West Virginia company.
The federal Food and Drug Administration (FDA) approved Apokyn
in 2004 as an "orphan drug." Orphan drugs are drugs that likely
would not be protected by a patent, are expected to provide
subtantial benefits to a limited number of patients (generally
200,000 or fewer) and will be expensive to produce and market.
To encourage pharmaceutical companies to produce and distribute
orphan drugs, federal law provides companies with tax credits
and legal protections and benefits similar to those that
accompany issuance of a patent for a drug, including seven years
of exclusive distibution rights. The makers and distributors of
Apokyn thus lose exclusivity protection for apomorphine
hydrochloride in 2011.
The Tercica Apokyn Website states that Apokyn is only available
through "specialty pharmacy providers," not local pharmacies.
The Apokyn Website defines a specialty pharmacy as one that
"focuses on the distribution of specialty medicines, and that
also offers various support services for patients." Tercica
noted that two specialty pharmacies, one in Memphis, Tennessee,
and one in Pittsburgh, Pennsylvania, distribute Apokyn.
The prescribing, distribution and administration of a drug that
is listed on the controlled substance schedules is, of course,
subject to restrictions and special procedures. Removing a drug
such as apomorphine from the schedules may decrease costs and
barriers to access for patients.
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SHOULD THE DOPAMINE AGONIST<2> APOMORPHINE - A DRUG FOR THE
TREATMENT OF CERTAIN SYMPTOMS OF PARKINSON'S DISORDER - BE
REMOVED FROM THE CONTROLLED SUBSTANCE SCHEDULES?
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<2> An agonist is a drug or chemical that binds to the same
neuro-receptors as the target drug or chemical.