Relates to the availability of opioid reversal agents; requires the department of health to make available any formulation and dosage of opioid reversal agent approved by the federal food and drug administration.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A8075D
SPONSOR: Steck 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:
Provide access to all formulations and dosages of opioid reversal agents
approved the Federal Drug and Administration
SUMMARY OF PROVISIONS:
Section 1 - 1. Definitions
4. Amends subdivision (1) of Section 19.09 of the Mental Hygiene Law to
require the Department of Health to make available any formulation and
dosage of opioid reversal agents that are approved by the Federal Food
and Drug Administration. The department shall cover the cost of any
formulation and/or dosage of any federal food and drug administration
approved nasal naloxone product. Any other product where the cost
exceeds that of highest priced nasal naloxone product, that cost overrun
shall be borne by the purchaser.
Section 2 - Amends subparagraph (i) of paragraph (a) of subdivision 3 of
section 3309 of the Public Health Law to include in the definition of
opioid reversal agents and require Department of Health to make avail-
able any formulation and dosage approved by the Federal Food and Drug
Administration.
Section 3 - Adds a new subdivision of Section 3309 of the Public Health
Law pertaining to opioid overdose prevention to require that any
purchase, distribution or authorization to prescribe opioid reversal
agents as authorized shall allow for choice of any formulation or dosage
that is approved by Federal Food and Drug Administration. The department
shall cover the cost of any formulation and/or dosage of any federal
food and drug administration approved nasal naloxone product. Any other
product where the cost exceeds that of highest priced nasal naloxone
product, that cost overrun shall be borne by the purchaser.
Section 4 - Effective Date.
JUSTIFICATION:
The enactment of this legislation is critically important as New York
continues to confront an alarming increase in the rate of overdose
deaths. CDC data 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 York-
ers. In 2021, 30 out of every 100,000 New Yorkers lost their lives to
drug overdoses; of that, 30, 25 died specifically from opioid overdoses.
A staggering rise from the 5 opioid-related deaths per 100,000 residents
recorded in 2010.
This public health crisis has evolved and continues to grow significant-
ly, transitioning from prescription drugs to heroin, and now predomi-
nantly to Fentanyl, a synthetic opioid responsible for a substantial
portion of overdose incidents in recent years. Synthetic opioids, espe-
cially Fentanyl, present a formidable challenge due to their unparal-
leled 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 a staggering 4,950 in 2022. As we work to
develop effective strategies to reduce overdose fatalities, it is essen-
tial 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 agent 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.
The enactment of this legislation is designed to 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.
LEGISLATIVE HISTORY:
New Bill
FISCAL IMPLICATIONS:
None
EFFECTIVE DATE:
Immediately
STATE OF NEW YORK
________________________________________________________________________
8075--D
2023-2024 Regular Sessions
IN ASSEMBLY
September 27, 2023
___________
Introduced by M. of A. STECK, FAHY, GUNTHER, McDONALD, NOVAKHOV, DeSTE-
FANO, SIMON, DAVILA, BENDETT, K. BROWN, CHANG, LEVENBERG, WEPRIN,
SOLAGES, PAULIN -- Multi-Sponsored by -- M. of A. WOERNER -- read once
and referred to the Committee on Alcoholism and Drug Abuse -- commit-
tee discharged, bill amended, ordered reprinted as amended and recom-
mitted to said committee -- again reported from said committee with
amendments, ordered reprinted as amended and recommitted to said
committee -- recommitted to the Committee on Alcoholism and Drug Abuse
in accordance with Assembly Rule 3, sec. 2 -- committee discharged,
bill amended, ordered reprinted as amended and recommitted to said
committee -- reported and referred to the Committee on Ways and Means
-- committee discharged, bill amended, ordered reprinted as amended
and recommitted to said committee
AN ACT to amend the mental hygiene law and the public health law, in
relation to the availability of opioid reversal agents
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivision (l) of section 19.09 of the mental hygiene law,
2 as added by chapter 434 of the laws of 2021, is amended to read as
3 follows:
4 (l)(1) The office, in consultation with the department of health,
5 shall maintain on its website a publicly available directory of all
6 distributors of opioid [antagonists] reversal agents to the public,
7 including but not limited to, pharmacies, prevention programs and not-
8 for-profits. As used in this subdivision, the following terms shall have
9 the following meanings:
10 (i) "Opioid" means an opiate as defined in section thirty-three
11 hundred two of the public health law.
12 (ii) "Opioid [antagonist] reversal agents" means a federal food and
13 drug administration-approved drug that, when administered, negates or
14 neutralizes in whole or in part the pharmacological effects of an opioid
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD11983-06-4
A. 8075--D 2
1 in the body. The [opioid antagonist shall be limited to naloxone or
2 other medications approved by the department of health for this purpose]
3 department of health shall make available any formulation and dosage of
4 opioid reversal agents that are approved by the federal food and drug
5 administration.
6 (iii) "Purchaser" means any community organization, municipality,
7 pharmacy, medical facility, hospital, or any other entity, that accesses
8 opioid reversal drugs through the New York state standing order.
9 (2) The directory required by this subdivision shall include and be
10 searchable by the following information:
11 (i) addresses of each distributor of opioid [antagonists] reversal
12 agents;
13 (ii) contact information, such as phone numbers or email addresses,
14 for each distributor;
15 (iii) services offered by each distributor at each location if more
16 than one, as well as information providing which opioid [antagonists]
17 reversal agents are currently available at each distributor;
18 (iv) special populations served;
19 (v) insurance providers accepted;
20 (vi) hours of operation of each distributor;
21 (vii) contact information of opioid addiction prevention programs; and
22 (viii) any other information the commissioner deems necessary.
23 (3) The office may utilize an existing directory to satisfy the
24 requirements of this subdivision.
25 (4) The office shall allow for choice of any formulation and dosage of
26 opioid reversal agents that are approved by the federal food and drug
27 administration in the purchase, distribution or authorization to
28 prescribe or dispense such products. The department shall cover the cost
29 of any formulation and/or dosage of any federal food and drug adminis-
30 tration-approved nasal naloxone product. Any other product where the
31 cost exceeds that of highest-priced nasal naloxone product, that cost
32 overrun shall be borne by the purchaser.
33 § 2. Subparagraph (i) of paragraph (a) of subdivision 3 of section
34 3309 of the public health law, as amended by chapter 42 of the laws of
35 2014, is amended to read as follows:
36 (i) "Opioid [antagonist] reversal agents" means a drug approved by the
37 Food and Drug Administration that, when administered, negates or
38 neutralizes in whole or in part the pharmacological effects of an opioid
39 in the body. ["Opioid antagonist reversal agents" shall be limited to
40 naloxone and other medications approved by the department for such
41 purpose] The department shall make available any formulation and dosage
42 of opioid reversal agents that are approved by the federal Food and Drug
43 Administration.
44 § 3. Section 3309 of the public health law is amended by adding a new
45 subdivision 9 to read as follows:
46 9. Any purchase, distribution or authorization to prescribe pursuant
47 to this section by the commissioner shall allow for choice of any formu-
48 lation or dosage that is approved by the federal Food and Drug Adminis-
49 tration. The department shall cover the cost of any formulation and/or
50 dosage of any federal Food and Drug Administration-approved nasal nalox-
51 one product. Any other product where the cost exceeds that of highest-
52 priced nasal naloxone product, that cost overrun shall be borne by the
53 purchaser.
54 § 4. This act shall take effect immediately.
