HR 58
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Date of Hearing: April 23, 2024
ASSEMBLY COMMITTEE ON HEALTH
Mia Bonta, Chair
HR 58 (Jackson) – As Introduced September 6, 2023
SUBJECT: Access to care.
SUMMARY: Urges the California Health and Human Services Agency (CHHSA) to: 1) hold
pharmaceutical companies, distributors, and pharmacies accountable for the current attention
deficit hyperactivity disorder (ADHD) medication shortage and develop initiatives for the
prevention and management of further shortages of ADHD medications; and, 2) meet with
United States Department of Health and Human Services, and the federal Drug Enforcement
Agency (DEA) regarding modification of any insufficiently justified quotas on the supply of
ingredients to manufacturers of critical ADHD medications. Makes declarations including that
reliable and safe access to medical care includes reliable access to psychiatric medications.
Makes findings including that increased recognition, diagnosis, and need for treatment of ADHD
has led to a shortage of ADHD medications and that irreparable harm from a lack of access to
ADHD medications accrues to children who regress behaviorally and academically, adults who
are now unable to perform in their jobs and function in other areas of life, and communities that
are experiencing increased illicit substance distribution, car accidents, and prevalence of
depression, anxiety, and other comorbidities of untreated ADHD.
EXISTING LAW creates the California Affordable Drug Manufacturing Act of 2020 which
requires CHHSA to enter into partnerships, in consultation with other state departments as
necessary, to increase competition, lower prices, and address shortages in the market for generic
prescription drugs, to reduce the cost of prescription drugs for public and private purchasers,
taxpayers, and consumers, and, to increase patient access to affordable drugs. [Health and Safety
Code §127690, et seq]
FISCAL EFFECT: None.
COMMENTS:
1) PURPOSE OF THIS RESOLUTION. According to the author, there is a need for this
resolution because as it currently stands patients are either having to forego medication all
together or switch to other forms of medication that do not adequately treat the symptoms
they are experiencing. This leads to avoidable negative health outcomes. This resolution will
help ensure future accessibility to the many safe and effective controlled substance
medications for mental health disorders. The author concludes that during the current mental
health crisis, priority must be given to improving access to effective treatments like these
medications.
2) BACKGROUND.
a) U.S. Food and Drug Administration (FDA) Announcement on Shortage of Adderall.
On October 12, 2022, FDA posted a shortage of the immediate release formulation of
amphetamine mixed salts, commonly referred to by the brand name Adderall or Adderall
IR, on their drug shortage website. FDA is in frequent communication with all
manufacturers of amphetamine mixed salts, and one of those companies, Teva, is
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experiencing ongoing intermittent manufacturing delays. Other manufacturers continue to
produce amphetamine mixed salts, but there is not sufficient supply to continue to meet
U.S. market demand through those producers.
Amphetamine mixed salts, including Adderall, are FDA-approved for the treatment of
ADHD and narcolepsy. Until supply is restored, there are alternative therapies including
the extended-release version of amphetamine mixed salts available to health care
professionals and their patients for amphetamine mixed salts’ approved indications.
b) August 1, 2023: FDA Actions to Address Shortages in Prescription Stimulants. On
August 1, 2023, the FDA issued a notice on the shortage in ADHD medications stating
that the shortage of stimulant medications was the result of many factors that began last
fall due to a manufacturing delay experienced by one drug maker. While this delay has
since resolved, the country is continuing to experience its effects in combination with
record-high prescription rates of stimulant medications. Data show that, from 2012 to
2021, overall dispensing of stimulants (including amphetamine products and other
stimulants) increased by 45.5% in the United States. According to a U.S. Centers for
Disease Control and Prevention report, particularly during 2020-21, when virtual
prescribing was permitted on a widespread basis during the COVID-19 Public Health
Emergency, the percentages in certain age groups grew by more than 10%. The FDA
called on key stakeholders, including manufacturers, distributors, pharmacies, and
payors, to do all they can to ensure access for patients when a medication is appropriately
prescribed.
According to the FDA, stimulants are controlled substances with a high potential for
abuse, which can lead to addiction and overdose. Therefore, there are limits (also known
as quotas) set by DEA for how much of these drugs can be produced. However, for
amphetamine medications, in 2022, manufacturers did not produce the full amount that
these limits permitted them to make. Based on DEA's internal analysis of inventory,
manufacturing, and sales data submitted by manufacturers of amphetamine products,
manufacturers only sold approximately 70% of their allotted quota for the year, and there
were approximately one billion more doses that they could have produced but did not
make or ship. Data for 2023 so far show a similar trend. The DEA and FDA have called
on manufacturers to confirm they are working to increase production to meet their
allotted quota amount. If any individual manufacturer does not wish to increase
production, that manufacturer has been asked to relinquish their remaining 2023 quota
allotment. This would allow DEA to redistribute that allotment to manufacturers that will
increase production. DEA is also committed to reviewing and improving the quota
process.
The FDA are asking professional groups and healthcare providers to accelerate efforts to
support appropriate diagnosis and treatment of ADHD, such as further development of
additional clinical guidelines for ADHD in adults. In recognition of this need, FDA
awarded a grant to the National Academies of Sciences, Engineering, and Medicine to
support a scientific meeting on ADHD in adults and considerations for diagnosis and
treatment. The FDA also recognized that further research is needed into the diagnosis and
treatment of ADHD and that research can help inform the development of alternative
treatments and an understanding of the behavioral and societal issues leading to
widespread misuse of these medications in certain groups.
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3) RELATED LEGISLATION. SR 90 (Rubio) proclaims April to be Neurodiversity
Awareness Month during which every Californian is encouraged to promote, understand, and
accept neurodivergent students and to raise awareness of the challenges neurodivergent
students face in their educational journey. States that neurodiversity refers to the diversity of
all people and is often used in the context of autism spectrum disorder and other neurological
or developmental disorders such as ADHD or dyslexia. SR 90 is currently pending in the
Senate Rules Committee.
4) PREVIOUS LEGISLATION.
a) AB 118 (Committee on Budget), Chapter 42, Statutes of 2023, extends the authority of
CHHSA to enter into exclusive or nonexclusive contracts on a bid or negotiated basis, for
purposes of the California Affordable Drug Manufacturing Act of 2020, indefinitely.
b) SB 852 (Pan), Chapter 207, Statutes of 2020, requires CHHSA to enter into partnerships,
in consultation with other state departments as necessary, to increase competition, lower
prices, and address shortages in the market for generic prescription drugs, to reduce the
cost of prescription drugs for public and private purchasers, taxpayers, and consumers,
and, to increase patient access to affordable drugs.
REGISTERED SUPPORT / OPPOSITION:
Support
None on file.
Opposition
None on file.
Analysis Prepared by: Patty Rodgers / HEALTH / (916) 319-2097