BILL NUMBER: S4150
SPONSOR: HARCKHAM
 
TITLE OF BILL:
An act to amend the mental hygiene law and the public health law, in
relation to the availability of opioid reversal agents
 
PURPOSE OR GENERAL IDEA OF BILL:
Provide access to all formulations and doses of opioid reversal agents
approved the Federal Drug and Administration
 
SUMMARY OF PROVISIONS:
Section 1 amends subdivision (I) of Section 19.09 of the Mental Hygiene
Law to require the Department of Health to make available any formu-
lation and dosage of opioid reversal agents that are approved by the
Federal Food and Drug Administration. It also mandates the maintenance
of a publicly available directory of opioid reversal agent distributors,
including pharmacies, prevention programs, and nonprofits.
Section 2 amends subparagraph (i) of paragraph (a) of subdivision 3 of
Section 3309 of the Public Health Law to update the definition of opioid
reversal agents and require the Department of Health to make available
any formulation and dosage approved by the Federal Food and Drug Admin-
istration.
Section 3 adds a new subdivision to Section 3309 of the Public Health
Law, ensuring that any purchase, distribution, or authorization to
prescribe opioid reversal agents allows for the choice of any FDA-ap-
proved formulation or dosage. It also specifies that the Department of
Health will cover the cost of FDA-approved nasal naloxone products,
while purchasers will bear the cost of other products if they exceed the
highest-priced nasal naloxone product.
Section 4 sets the effective date.
 
JUSTIFICATION:
This legislation is critically important as New York continues to
confront an alarming increase in the rate of overdose deaths. Data from
the CDC reports that the share of drug overdose deaths in the State
involving opioids increased to 85% in 2020 and 2021 from 69% in 2010,
and overdose fatalities grew across all racial and ethnic groups. Death
rates increased five-fold for Black New Yorkers, quadrupled for Hispanic
or Latino New Yorkers, and nearly tripled for white New Yorkers. In
2021, 30 out of every 100,000 New Yorkers lost their lives to drug over-
doses; of that, 30, 25 died specifically from opioid overdoses. A stag-
gering rise from 2010, which saw 5 opioid-related deaths per 100,000
residents. This public health crisis has evolved and continues to grow
significantly. The transition from prescription drugs to heroin, and now
predominantly to fentanyl, a synthetic opioid is responsible for a
substantial portion of overdose incidents in recent years. Synthetic
opioids, especially fentanyl, present a formidable challenge due to
their unparalleled .potency-up to 50 times stronger than heroin and 100
times more potent than morphine. The numbers in New York are striking,
with synthetic opioid-related overdoses, mainly due to fentanyl, rising
from just 18 cases in 1999 to 4,950 in 2022. As we work to develop
effective strategies to reduce overdose fatalities, it is essential that
all communities in New York State have access to every life-saving FDA-
approved opioid reversal agent.
As the Food and Drug Administration continues to approve various formu-
lations and dosages of FDA-approved opioid reversal agents to combat the
rise of synthetic opioid overdose, it becomes essential for New York to
offer the flexibility to make all formulations and dosages readily
available. This approach aligns with a 2020 advisory from the CDC, which
was directed at first responders, harm reduction organizations, and
other stakeholders. The CDC's recommendations include the imperative to
"expand distribution and use of FDA-approved opioid reversal agents and
overdose prevention education." Increasing the resources accessible to
first responders and individuals within the community is of paramount
importance, particularly considering that 40% of all overdoses occur in
the presence of another individual.
This legislation will ensure that New York State is equipped with a
comprehensive toolkit to effectively combat the overdose crisis and the
surge in synthetic opioids, which is profoundly impacting communities
and families across the state.
 
PRIOR LEGISLATIVE HISTORY:
2023-2024: S8991A/A8075D - Died in Alcoholism & Substance Use Disorders/
Passed Assembly
 
FISCAL IMPLICATIONS:
TBD
 
EFFECTIVE DATE:
This act shall take effect immediately.

Statutes affected:
S4150: 19.09 mental hygiene law, 3309 public health law, 3309(3) public health law