NY State Senate Bill 2023-S8991A

Current Bill Status - In Senate Committee Alcoholism And Substance Use Disorders Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jun 03, 2024	print number 8991a
Jun 03, 2024	amend and recommit to alcoholism and substance use disorders
Apr 08, 2024	referred to alcoholism and substance use disorders

Bill Amendments

Original

A (Active)

co-Sponsors

2023-S8991 - Details

See Assembly Version of this Bill:: A8075
Current Committee:: Senate Alcoholism And Substance Use Disorders
Law Section:: Mental Hygiene Law
Laws Affected:: Amd §19.09, Ment Hyg L; amd §3309, Pub Health L

2023-S8991 - Summary

Relates to the availability of opioid reversal agents; requires the department of health to make available any formulation and dosage of opioid reversal agents approved by the federal food and drug administration.

2023-S8991 - Sponsor Memo

                                 
BILL NUMBER: S8991

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 (1) 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.

Section 2 amends section 25.18 of the Mental Hygiene Law to require any
expenditures for the purchase or distribution of opioid reversal agents

shall allow for any formulation or dosage that is approved by the Feder-
al Food and Drug Administration.

Section 3 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 the Department of Health to make
available any formulation and dosage approved by the Federal Food and
Drug Administration.

Section 4 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 the Federal Food and Drug Administration.

 
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 significant-
ly. The transition from prescription drugs to heroin, and now predomi-
nantly to fentanyl, a synthetic opioid is 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 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-ap-
proved 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:

New Bill

 
FISCAL IMPLICATIONS:

TBD

 
EFFECTIVE DATE:
This act shall take effect immediately.

2023-S8991 - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8991
 
                             I N  S E N A T E
 
                               April 8, 2024
                                ___________
 
 Introduced  by Sen. HARCKHAM -- read twice and ordered printed, and when
   printed to be committed to the Committee on Alcoholism  and  Substance
   Use Disorders
 
 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:
 
   Section 1. Subdivision (l) of section 19.09 of the mental hygiene law,
 as  added  by  chapter  434  of  the laws of 2021, is amended to read as
 follows:
   (l)(1) The office, in consultation  with  the  department  of  health,
 shall  maintain  on  its  website  a publicly available directory of all
 distributors of opioid [antagonists]  REVERSAL  AGENTS  to  the  public,
 including  but  not limited to, pharmacies, prevention programs and not-
 for-profits. As used in this subdivision, the following terms shall have
 the following meanings:
   (i) "Opioid" means  an  opiate  as  defined  in  section  thirty-three
 hundred two of the public health law.
   (ii)  "Opioid  [antagonist]  REVERSAL AGENTS" means a federal food and
 drug administration-approved drug that, when  administered,  negates  or
 neutralizes in whole or in part the pharmacological effects of an opioid
 in  the  body.  The  [opioid  antagonist shall be limited to naloxone or
 other medications approved by the department of health for this purpose]
 DEPARTMENT OF HEALTH SHALL MAKE AVAILABLE ANY FORMULATION AND DOSAGE  OF
 OPIOID  REVERSAL  AGENTS  THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION.
   (2) The directory required by this subdivision shall  include  and  be
 searchable by the following information:
   (i)  addresses  of  each  distributor of opioid [antagonists] REVERSAL
 AGENTS;
   (ii) contact information, such as phone numbers  or  email  addresses,
 for each distributor;

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD11983-05-4
 S. 8991                             2

 
   (iii)  services  offered  by each distributor at each location if more
 than one, as well as information providing  which  opioid  [antagonists]
 REVERSAL AGENTS are currently available at each distributor;
   (iv) special populations served;
   (v) insurance providers accepted;
   (vi) hours of operation of each distributor;
   (vii) contact information of opioid addiction prevention programs; and
   (viii) any other information the commissioner deems necessary.
   (3)  The  office  may  utilize  an  existing  directory to satisfy the
 requirements of this subdivision.
   (4) THE OFFICE SHALL ALLOW FOR CHOICE OF ANY FORMULATION AND DOSAGE OF
 OPIOID REVERSAL AGENTS THAT ARE APPROVED BY THE FEDERAL  FOOD  AND  DRUG
 ADMINISTRATION   IN  THE  PURCHASE,  DISTRIBUTION  OR  AUTHORIZATION  TO
 PRESCRIBE OR DISPENSE SUCH PRODUCTS.
   § 2. Subdivision (b) of section 25.18 of the  mental  hygiene  law  is
 amended by adding a new paragraph 4 to read as follows:
   4.  ANY EXPENDITURE USED FOR THE PURCHASE OR DISTRIBUTION OF AN OPIOID
 REVERSAL AGENT, AS DEFINED IN SUBPARAGRAPH  (II)  OF  PARAGRAPH  ONE  OF
 SUBDIVISION  (L)  OF SECTION 19.09 OF THIS TITLE, SHALL ALLOW FOR CHOICE
 OF ANY FORMULATION OR DOSAGE THAT IS APPROVED BY THE  FEDERAL  FOOD  AND
 DRUG ADMINISTRATION.
   §  3.  Subparagraph  (i)  of paragraph (a) of subdivision 3 of section
 3309 of the public health law, as amended by chapter 42 of the  laws  of
 2014, is amended to read as follows:
   (i) "Opioid [antagonist] REVERSAL AGENTS" means a drug approved by the
 Food  and  Drug  Administration  that,  when  administered,  negates  or
 neutralizes in whole or in part the pharmacological effects of an opioid
 in the body. ["Opioid antagonist reversal agents" shall  be  limited  to
 naloxone  and  other  medications  approved  by  the department for such
 purpose] THE DEPARTMENT SHALL MAKE AVAILABLE ANY FORMULATION AND  DOSAGE
 OF OPIOID REVERSAL AGENTS THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION.
   §  4. Section 3309 of the public health law is amended by adding a new
 subdivision 9 to read as follows:
   9. ANY PURCHASE, DISTRIBUTION OR AUTHORIZATION TO  PRESCRIBE  PURSUANT
 TO THIS SECTION BY THE COMMISSIONER SHALL ALLOW FOR CHOICE OF ANY FORMU-
 LATION  OR DOSAGE THAT IS APPROVED BY THE FEDERAL FOOD AND DRUG ADMINIS-
 TRATION.
   § 5. This act shall take effect immediately.

co-Sponsors

View additional co-sponsors

2023-S8991A (ACTIVE) - Details

See Assembly Version of this Bill:: A8075
Current Committee:: Senate Alcoholism And Substance Use Disorders
Law Section:: Mental Hygiene Law
Laws Affected:: Amd §19.09, Ment Hyg L; amd §3309, Pub Health L

2023-S8991A (ACTIVE) - Summary

2023-S8991A (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S8991A

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 OR 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 (1) 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.

Section 2 amends section 25.18 of the Mental Hygiene Law to require any
expenditures for the purchase or distribution of opioid reversal agents

shall allow for any formulation or dosage that is approved by the Feder-
al Food and Drug Administration.

Section 3 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 the Department of Health to make
available any formulation and dosage approved by the Federal Food and
Drug Administration.

Section 4 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 the Federal Food and Drug Administration.

 
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 significant-
ly. The transition from prescription drugs to heroin, and now predomi-
nantly to fentanyl, a synthetic opioid is 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 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-ap-
proved 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:

New Bill

 
FISCAL IMPLICATIONS:

TBD

 
EFFECTIVE DATE:
This act shall take effect immediately.

2023-S8991A (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  8991--A
 
                             I N  S E N A T E
 
                               April 8, 2024
                                ___________
 
 Introduced by Sens. HARCKHAM, ASHBY, COONEY, GALLIVAN, OBERACKER -- read
   twice  and  ordered  printed,  and when printed to be committed to the
   Committee on Alcoholism  and  Substance  Use  Disorders  --  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:
 
   Section 1. Subdivision (l) of section 19.09 of the mental hygiene law,
 as  added  by  chapter  434  of  the laws of 2021, is amended to read as
 follows:
   (l)(1) The office, in consultation  with  the  department  of  health,
 shall  maintain  on  its  website  a publicly available directory of all
 distributors of opioid [antagonists]  REVERSAL  AGENTS  to  the  public,
 including  but  not limited to, pharmacies, prevention programs and not-
 for-profits. As used in this subdivision, the following terms shall have
 the following meanings:
   (i) "Opioid" means  an  opiate  as  defined  in  section  thirty-three
 hundred two of the public health law.
   (ii)  "Opioid  [antagonist]  REVERSAL AGENTS" means a federal food and
 drug administration-approved drug that, when  administered,  negates  or
 neutralizes in whole or in part the pharmacological effects of an opioid
 in  the  body.  The  [opioid  antagonist shall be limited to naloxone or
 other medications approved by the department of health for this purpose]
 DEPARTMENT OF HEALTH SHALL MAKE AVAILABLE ANY FORMULATION AND DOSAGE  OF
 OPIOID  REVERSAL  AGENTS  THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION.
   (III) "PURCHASER"  MEANS  ANY  COMMUNITY  ORGANIZATION,  MUNICIPALITY,
 PHARMACY, MEDICAL FACILITY, HOSPITAL, OR ANY OTHER ENTITY, THAT ACCESSES
 OPIOID REVERSAL DRUGS THROUGH THE NEW YORK STATE STANDING ORDER.
   (2)  The  directory  required by this subdivision shall include and be
 searchable by the following information:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD11983-07-4

 S. 8991--A                          2
 
   (i) addresses of each distributor  of  opioid  [antagonists]  REVERSAL
 AGENTS;
   (ii)  contact  information,  such as phone numbers or email addresses,
 for each distributor;
   (iii) services offered by each distributor at each  location  if  more
 than  one,  as  well as information providing which opioid [antagonists]
 REVERSAL AGENTS are currently available at each distributor;
   (iv) special populations served;
   (v) insurance providers accepted;
   (vi) hours of operation of each distributor;
   (vii) contact information of opioid addiction prevention programs; and
   (viii) any other information the commissioner deems necessary.
   (3) The office may  utilize  an  existing  directory  to  satisfy  the
 requirements of this subdivision.
   (4) THE OFFICE SHALL ALLOW FOR CHOICE OF ANY FORMULATION AND DOSAGE OF
 OPIOID  REVERSAL  AGENTS  THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION  IN  THE  PURCHASE,  DISTRIBUTION  OR  AUTHORIZATION   TO
 PRESCRIBE OR DISPENSE SUCH PRODUCTS. THE DEPARTMENT SHALL COVER THE COST
 OF  ANY  FORMULATION AND/OR DOSAGE OF ANY FEDERAL FOOD AND DRUG ADMINIS-
 TRATION-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.
   § 2. Subparagraph (i) of paragraph (a) of  subdivision  3  of  section
 3309  of  the public health law, as amended by chapter 42 of the laws of
 2014, is amended to read as follows:
   (i) "Opioid [antagonist] REVERSAL AGENTS" means a drug approved by the
 Food  and  Drug  Administration  that,  when  administered,  negates  or
 neutralizes in whole or in part the pharmacological effects of an opioid
 in  the  body.  ["Opioid antagonist reversal agents" shall be limited to
 naloxone and other medications  approved  by  the  department  for  such
 purpose]  THE DEPARTMENT SHALL MAKE AVAILABLE ANY FORMULATION AND DOSAGE
 OF OPIOID REVERSAL AGENTS THAT ARE APPROVED BY THE FEDERAL FOOD AND DRUG
 ADMINISTRATION.
   § 3. Section 3309 of the public health law is amended by adding a  new
 subdivision 9 to read as follows:
   9.  ANY  PURCHASE, DISTRIBUTION OR AUTHORIZATION TO PRESCRIBE PURSUANT
 TO THIS SECTION BY THE COMMISSIONER SHALL ALLOW FOR CHOICE OF ANY FORMU-
 LATION OR DOSAGE THAT IS APPROVED BY THE FEDERAL FOOD AND DRUG  ADMINIS-
 TRATION.  THE  DEPARTMENT SHALL COVER THE COST OF ANY FORMULATION AND/OR
 DOSAGE OF ANY FEDERAL FOOD AND DRUG ADMINISTRATION-APPROVED NASAL NALOX-
 ONE PRODUCT.  ANY OTHER PRODUCT WHERE THE COST EXCEEDS THAT OF  HIGHEST-
 PRICED  NASAL  NALOXONE PRODUCT, THAT COST OVERRUN SHALL BE BORNE BY THE
 PURCHASER.
   § 4. This act shall take effect immediately.

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Senate Bill S8991A

Sponsored By

Current Bill Status - In Senate Committee Alcoholism And Substance Use Disorders Committee

Bill Amendments

co-Sponsors

2023-S8991 - Details

2023-S8991 - Summary

2023-S8991 - Sponsor Memo

2023-S8991 - Bill Text download pdf

co-Sponsors

2023-S8991A (ACTIVE) - Details

2023-S8991A (ACTIVE) - Summary

2023-S8991A (ACTIVE) - Sponsor Memo

2023-S8991A (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S8991A

Share this bill

Sponsored By

Current Bill Status - In Senate Committee Alcoholism And Substance Use Disorders Committee

Bill Amendments

co-Sponsors

2023-S8991 - Details

2023-S8991 - Summary

2023-S8991 - Sponsor Memo

2023-S8991 - Bill Text download pdf

co-Sponsors

2023-S8991A (ACTIVE) - Details

2023-S8991A (ACTIVE) - Summary

2023-S8991A (ACTIVE) - Sponsor Memo

2023-S8991A (ACTIVE) - Bill Text download pdf

Comments