NY State Senate Bill 2023-S4786A

Current Bill Status - In Assembly 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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Actions

View Actions

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 30, 2024	referred to health delivered to assembly passed senate
Jan 16, 2024	advanced to third reading
Jan 09, 2024	2nd report cal.
Jan 08, 2024	1st report cal.80
Jan 03, 2024	referred to health
Dec 20, 2023	print number 4786a
Dec 20, 2023	amend and recommit to health
Feb 14, 2023	referred to health

Votes

- Jan 30, 2024 - Floor Vote
  S4786A
  
  52
  
  Aye
  
  10
  
  Nay
  
  0
  
  Absent
  
  1
  
  Excused
  
  0
  
  Abstained
  - - Floor Vote: Jan 30, 2024
      
      aye (52)
      
      Addabbo Jr.
      
      Bailey
      
      Borrello
      
      Breslin
      
      Brisport
      
      Brouk
      
      Canzoneri-Fitzpatrick
      
      Chu
      
      Cleare
      
      Comrie
      
      Cooney
      
      Felder
      
      Fernandez
      
      Gianaris
      
      Gonzalez
      
      Gounardes
      
      Griffo
      
      Harckham
      
      Hinchey
      
      Hoylman-Sigal
      
      Jackson
      
      Kavanagh
      
      Kennedy
      
      Krueger
      
      Liu
      
      Mannion
      
      Martinez
      
      Martins
      
      Mattera
      
      May
      
      Mayer
      
      Murray
      
      Myrie
      
      Parker
      
      Persaud
      
      Ramos
      
      Rhoads
      
      Rivera
      
      Rolison
      
      Ryan
      
      Salazar
      
      Sanders Jr.
      
      Scarcella-Spanton
      
      Sepúlveda
      
      Serrano
      
      Skoufis
      
      Stavisky
      
      Stewart-Cousins
      
      Tedisco
      
      Thomas
      
      Webb
      
      Weber
      
      nay (10)
      
      Ashby
      
      Gallivan
      
      Helming
      
      Lanza
      
      O'Mara
      
      Oberacker
      
      Ortt
      
      Palumbo
      
      Stec
      
      Weik
      
      excused (1)
      
      Walczyk
  Jan 8, 2024 - Health Committee Vote
  S4786A
  
  10
  
  Aye
  
  1
  
  Nay
  
  4
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: Jan 8, 2024
      
      aye (10)
      
      Brouk
      
      Felder
      
      Hoylman-Sigal
      
      Mannion
      
      May
      
      Myrie
      
      Rivera
      
      Salazar
      
      Thomas
      
      Webb
      
      nay (1)
      
      Gallivan
      
      aye wr (4)
      
      Ashby
      
      Martins
      
      Rhoads
      
      Stec

Bill Amendments

Original

A (Active)

2023-S4786 - Details

See Assembly Version of this Bill:: A8345
Current Committee:: Assembly Health
Law Section:: Public Health Law
Laws Affected:: Add Art 2-A Title IV §§282 - 285, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S9020
2021-2022: S3048

2023-S4786 - Summary

Enacts the "New York affordable drug manufacturing act" to direct the commissioner of health to enter into partnerships 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.

2023-S4786 - Sponsor Memo

                                 
BILL NUMBER: S4786

SPONSOR: RIVERA

 
TITLE OF BILL:

An act to amend the public health law, in relation to enacting the "New
York affordable drug manufacturing act"

 
PURPOSE:

Enacts the "New York affordable drug manufacturing act".

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1 provides a short title, the "New York affordable drug manufac-
turing act."

Section 2 amends article 2-A of the public health law by adding a new
title IV, the New York Affordable Drug Manufacturing Act, which will
help increase patient access to affordable drugs. This section provides
definitions for the terms "generic drug" and "partnerships."  This

section provides language regarding criteria for the commissioner to
enter into a partnership resulting in the production or distribution of
generic prescription drugs with the intent it will be affordable to
private and public consumers. This section also identifies points that
the department should consider when setting drug prices, along with
reporting requirements and proprietary information.

Section 3 provides the severability clause.

Section 4 provides the effective date.

 
JUSTIFICATION:

Prescription drugs costs, even for generics, continue to rise out of
reach for patients and insurers, both public and private. New York State
itself spends millions of dollars on prescription drugs through its
public health insurance programs and self-funded coverage of our state
workforce. One cause of drug price increases is lack of competition.
Nearly 90% of prescription drugs are generic, yet a small number of
companies manufacture them. Many contend this lack of competition has
led to large price increases of widely-used and important medications
like antibiotics and epinephrine without evidence of increased costs of
manufacturing. Aside from cost, there are some medications that are at
risk of being in short supply. It is important to find creative ways to
lower drug costs and ensure medications are available.

This bill does not propose a new concept. U.S. Senator Elizabeth Warren
during her 2020 presidential run called for the U.S.  government to
begin manufacturing generic medications to address rising prices, lack
of competition in the market, and the potential for shortages in essen-
tial medications. California became the first state in the nation to
sign into law legislation to begin the process of state manufacturing or
distribution of generic medications. This New York legislation is
modeled after the California statute and would allow New York to partner
with various entities, including other states, to lower costs and
protect against short supplies.

Similar to California's statute, this legislation directs the Department
of Health (DOH) to identify generic drugs that are high cost or suscep-
tible to shortages for possible manufacturing partnerships. It specif-
ically requires that the DOH consider one type of insulin, given the
high costs and life-saving nature of this medication that over 7 million
diabetics in the U.S. depend upon daily. The "New York Affordable Drug
Manufacturing Act" would provide New York with an important tool to
control drug costs for its taxpayers, residents, and those who lack
health insurance by allowing. New York to pursue its own drug manufac-
turing and partner with other states moving in this direction to both
lower costs and protect against shortages of certain drugs.

 
LEGISLATIVE HISTORY:

2019-2020: S9020/No Same As

2021-2022: S3048/No Same As

 
FISCAL IMPLICATIONS:

Initial costs to be determined, but substantial long term savings as
generic prescription drug costs for the state would be much lower.

 
EFFECTIVE DATE:
This act shall take effect immediately.

2023-S4786 - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4786
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             February 14, 2023
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law, in relation to enacting the  "New
   York affordable drug manufacturing act"
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Short title. This act shall be known and may  be  cited  as
 the "New York affordable drug manufacturing act".
   §  2.  Article 2-A of the public health law is amended by adding a new
 title IV to read as follows:
                                 TITLE IV
                NEW YORK AFFORDABLE DRUG MANUFACTURING ACT
 SECTION 282. DEFINITIONS.
         283. PARTNERSHIPS; PRODUCTION AND DISTRIBUTION  OF  PRESCRIPTION
                DRUGS.
         284. REPORTING.
         285. PROPRIETARY INFORMATION.
   § 282. DEFINITIONS.  AS  USED IN THIS TITLE, THE FOLLOWING TERMS SHALL
 HAVE THE FOLLOWING MEANINGS:
   1. "GENERIC DRUG" MEANS A DRUG THAT IS APPROVED PURSUANT  TO  SUBDIVI-
 SION  (J) OF SECTION 355 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (21
 U.S.C.  SEC. 301 ET SEQ.), OR A BIOSIMILAR, AS DEFINED UNDER THE FEDERAL
 PUBLIC HEALTH SERVICE ACT (42 U.S.C. SEC. 262).
   2. "PARTNERSHIPS" SHALL INCLUDE, BUT ARE NOT  LIMITED  TO,  AGREEMENTS
 FOR THE PROCUREMENT OF GENERIC PRESCRIPTION DRUGS BY WAY OF CONTRACTS OR
 PURCHASING  BY  A  PAYER,  STATE  GOVERNMENTAL  AGENCY, GROUP PURCHASING
 ORGANIZATION, NONPROFIT ORGANIZATION, OR OTHER ENTITY.
   § 283.  PARTNERSHIPS;  PRODUCTION  AND  DISTRIBUTION  OF  PRESCRIPTION
 DRUGS. 1. (A) THE COMMISSIONER SHALL ENTER INTO PARTNERSHIPS, CONSISTENT
 WITH  PARAGRAPH  (B) OF SUBDIVISION TWO OF THIS SECTION, IN CONSULTATION
 WITH ALL APPROPRIATE STATE AGENCIES AND  THE  DEPARTMENT  OF  HEALTH  OR
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD08090-01-3

 S. 4786                             2
 
 EQUIVALENT  INSTITUTION  OF ANY OTHER STATE AS DETERMINED BY THE COMMIS-
 SIONER, 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.
   (B) THE DEPARTMENT SHALL HAVE THE ABILITY TO HIRE STAFF TO OVERSEE AND
 PROJECT-MANAGE THE PARTNERSHIPS FOR  MANUFACTURING  OR  DISTRIBUTION  OF
 GENERIC PRESCRIPTION DRUGS.
   2. (A) THE COMMISSIONER SHALL ENTER INTO PARTNERSHIPS RESULTING IN THE
 PRODUCTION  OR  DISTRIBUTION  OF  GENERIC  PRESCRIPTION  DRUGS, WITH THE
 INTENT THAT THESE DRUGS BE MADE WIDELY AVAILABLE TO PUBLIC  AND  PRIVATE
 PURCHASERS, FACILITIES LICENSED PURSUANT TO ARTICLE TWENTY-EIGHT OF THIS
 CHAPTER, AND PHARMACIES AS DEFINED IN SECTION SIX THOUSAND EIGHT HUNDRED
 TWO OF THE EDUCATION LAW, AS APPROPRIATE. THE GENERIC PRESCRIPTION DRUGS
 SHALL  BE  PRODUCED  OR  DISTRIBUTED  BY  A DRUG COMPANY OR GENERIC DRUG
 MANUFACTURER THAT IS REGISTERED WITH THE UNITED  STATES  FOOD  AND  DRUG
 ADMINISTRATION.
   (B)  (I)  THE COMMISSIONER SHALL ONLY ENTER INTO PARTNERSHIPS PURSUANT
 TO PARAGRAPH (A) OF THIS SUBDIVISION TO PRODUCE A  GENERIC  PRESCRIPTION
 DRUG  AT A PRICE THAT RESULTS IN SAVINGS, TARGETS FAILURES IN THE MARKET
 FOR GENERIC DRUGS, AND IMPROVES PATIENT  ACCESS  TO  AFFORDABLE  MEDICA-
 TIONS.
   (II)  FOR  TOP  DRUGS  IDENTIFIED  PURSUANT  TO THE CRITERIA LISTED IN
 SUBPARAGRAPH (V) OF THIS PARAGRAPH, THE DEPARTMENT  SHALL  DETERMINE  IF
 VIABLE  PATHWAYS  EXIST  FOR  PARTNERSHIPS  TO MANUFACTURE OR DISTRIBUTE
 GENERIC PRESCRIPTION DRUGS BY  EXAMINING  THE  RELEVANT  LEGAL,  MARKET,
 POLICY, AND REGULATORY FACTORS.
   (III) THE DEPARTMENT SHALL CONSIDER THE FOLLOWING, IF APPLICABLE, WHEN
 SETTING THE PRICE OF THE GENERIC PRESCRIPTION DRUG:
   (1) UNITED STATES FOOD AND DRUG ADMINISTRATION USER FEES.
   (2)  ABBREVIATED NEW DRUG APPLICATION ACQUISITION COSTS AMORTIZED OVER
 A FIVE-YEAR PERIOD.
   (3) MANDATORY REBATES.
   (4) TOTAL CONTRACTING AND PRODUCTION COSTS FOR THE DRUG,  INCLUDING  A
 REASONABLE  AMOUNT  FOR  ADMINISTRATIVE,  OPERATING,  AND RATE-OF-RETURN
 EXPENSES OF THE DRUG COMPANY OR GENERIC DRUG MANUFACTURER.
   (5) RESEARCH AND DEVELOPMENT COSTS ATTRIBUTED TO THE DRUG OVER A FIVE-
 YEAR PERIOD.
   (6) OTHER INITIAL START-UP COSTS AMORTIZED OVER A FIVE-YEAR PERIOD.
   (IV) EACH DRUG SHALL BE MADE AVAILABLE  TO  PROVIDERS,  PATIENTS,  AND
 PURCHASERS AT A TRANSPARENT PRICE AND WITHOUT REBATES, OTHER THAN FEDER-
 ALLY REQUIRED REBATES.
   (V)   THE   DEPARTMENT  SHALL  PRIORITIZE  THE  SELECTION  OF  GENERIC
 PRESCRIPTION DRUGS THAT HAVE THE GREATEST IMPACT ON LOWERING DRUG  COSTS
 TO  PATIENTS,  INCREASING  COMPETITION  AND  ADDRESSING SHORTAGES IN THE
 PRESCRIPTION DRUG MARKET, IMPROVING PUBLIC HEALTH, OR REDUCING THE  COST
 OF PRESCRIPTION DRUGS TO PUBLIC AND PRIVATE PURCHASERS.
   (C)  (I) IN IDENTIFYING GENERIC PRESCRIPTION DRUGS TO BE PRODUCED, THE
 DEPARTMENT SHALL CONSIDER PRESCRIPTION  DRUG  RETAIL  PRICE  LISTS  MADE
 PURSUANT TO SECTION TWO HUNDRED SEVENTY-EIGHT OF THIS ARTICLE.
   (II)  THE  PARTNERSHIPS ENTERED INTO PURSUANT TO PARAGRAPH (A) OF THIS
 SUBDIVISION SHALL INCLUDE THE PRODUCTION OF AT LEAST ONE FORM  OF  INSU-
 LIN,  PROVIDED THAT A VIABLE PATHWAY FOR MANUFACTURING A MORE AFFORDABLE
 FORM OF INSULIN EXISTS.
   (III) THE DEPARTMENT SHALL PRIORITIZE DRUGS FOR CHRONIC AND  HIGH-COST
 CONDITIONS.
 S. 4786                             3
 
   (D)  THE DEPARTMENT SHALL CONSULT WITH ALL OF THE FOLLOWING PUBLIC AND
 PRIVATE  PURCHASERS  TO  ASSIST  IN  DEVELOPING  A   LIST   OF   GENERIC
 PRESCRIPTION  DRUGS  TO  BE MANUFACTURED OR DISTRIBUTED THROUGH PARTNER-
 SHIPS AND TO DETERMINE THE VOLUME OF EACH GENERIC PRESCRIPTION DRUG THAT
 CAN  BE PROCURED OVER A MULTIYEAR PERIOD TO SUPPORT A MARKET FOR A LOWER
 COST GENERIC PRESCRIPTION DRUG:
   (I) THE DEPARTMENT OF MENTAL  HYGIENE,  THE  OFFICE  FOR  PEOPLE  WITH
 DEVELOPMENTAL  DISABILITIES,  THE  OFFICE  OF  GENERAL SERVICES, AND THE
 DEPARTMENT OF CORRECTIONS AND COMMUNITY  SUPERVISION,  OR  THE  ENTITIES
 ACTING ON BEHALF OF EACH OF THOSE STATE PURCHASERS.
   (II) HEALTH INSURERS LICENSED PURSUANT TO THE INSURANCE LAW.
   (III) HOSPITALS.
   (IV) ANY OTHER ENTITY AS DETERMINED BY THE COMMISSIONER.
   (E)  BEFORE  EFFECTUATING  A PARTNERSHIP PURSUANT TO THIS SECTION, THE
 COMMISSIONER SHALL DETERMINE MINIMUM THRESHOLDS FOR  PROCUREMENT  OF  AN
 ENTITY'S EXPECTED VOLUME OF A TARGETED DRUG FROM THE COMPANY OR MANUFAC-
 TURER OVER A MULTIYEAR PERIOD.
   (F)  ALL  STATE  AGENCIES  SHALL  BE REQUIRED TO PURCHASE PRESCRIPTION
 DRUGS FROM THE DEPARTMENT OR ENTITIES THAT CONTRACT OR PARTNER WITH  THE
 DEPARTMENT PURSUANT TO THIS CHAPTER.
   (G)  THE DEPARTMENT SHALL NOT BE REQUIRED TO CONSULT WITH EVERY ENTITY
 LISTED IN SUBPARAGRAPHS (II), (III) AND (IV) OF PARAGRAPH  (D)  OF  THIS
 SUBDIVISION,  SO  LONG  AS  PURCHASER  ENGAGEMENT  INCLUDES A REASONABLE
 REPRESENTATION FROM THESE GROUPS.
   § 284. REPORTING. 1. ON OR BEFORE JANUARY FIRST, TWO THOUSAND  TWENTY-
 SIX,  THE  DEPARTMENT  SHALL  SUBMIT  A  REPORT  TO THE LEGISLATURE THAT
 ASSESSES THE FEASIBILITY OF DIRECTLY MANUFACTURING GENERIC  PRESCRIPTION
 DRUGS AND SELLING GENERIC PRESCRIPTION DRUGS AT A FAIR PRICE. THE REPORT
 SHALL  INCLUDE,  BUT NOT BE LIMITED TO, AN ANALYSIS OF GOVERNANCE STRUC-
 TURE OPTIONS FOR MANUFACTURING FUNCTIONS, INCLUDING CHARTERING A PRIVATE
 ORGANIZATION, A PUBLIC-PRIVATE PARTNERSHIP, OR A PUBLIC BOARD OF  DIREC-
 TORS.
   2.  ON OR BEFORE MARCH FIRST, TWO THOUSAND TWENTY-FIVE, THE DEPARTMENT
 SHALL REPORT TO THE LEGISLATURE ON BOTH OF THE FOLLOWING:
   (A) A DESCRIPTION OF THE STATUS OF ALL DRUGS TARGETED UNDER THIS CHAP-
 TER.
   (B) AN ANALYSIS OF HOW THE ACTIVITIES OF  THE  DEPARTMENT  MAY  IMPACT
 COMPETITION, ACCESS TO TARGETED DRUGS, THE COSTS OF THOSE DRUGS, AND THE
 COSTS OF GENERIC PRESCRIPTION DRUGS TO PUBLIC AND PRIVATE PURCHASERS.
   §  285.  PROPRIETARY INFORMATION. NOTWITHSTANDING ANY PROVISION OF LAW
 TO THE CONTRARY, ALL NONPUBLIC INFORMATION AND DOCUMENTS OBTAINED BY THE
 DEPARTMENT PURSUANT TO THIS TITLE SHALL NOT BE REQUIRED TO BE  DISCLOSED
 PURSUANT TO ARTICLE SIX OF THE PUBLIC OFFICERS LAW.
   § 3. Severability. If any clause, sentence, paragraph, section or part
 of  this act shall be adjudged by any court of competent jurisdiction to
 be invalid and after exhaustion of  all  further  judicial  review,  the
 judgment  shall  not affect, impair or invalidate the remainder thereof,
 but shall be confined in its operation to the  clause,  sentence,  para-
 graph,  section or part of this act directly involved in the controversy
 in which the judgment shall have been rendered.
   § 4. This act shall take effect immediately.

co-Sponsors

2023-S4786A (ACTIVE) - Details

See Assembly Version of this Bill:: A8345
Current Committee:: Assembly Health
Law Section:: Public Health Law
Laws Affected:: Add Art 2-A Title IV §§282 - 285, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2019-2020: S9020
2021-2022: S3048

2023-S4786A (ACTIVE) - Summary

2023-S4786A (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S4786A

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend the public health law, in relation to enacting the "New
York affordable drug manufacturing act"

 
PURPOSE:

Enacts the "New York Affordable Drug Manufacturing Act".

 
SUMMARY OF SPECIFIC PROVISIONS:

Section 1 provides a short title, the "New York Affordable Drug Manufac-
turing Act."

Section 2 amends article 2-A of the public health law by adding a new
title IV, the New York Affordable Drug Manufacturing Act, which will
help increase patient access to affordable drugs. This section provides
definitions for the terms "generic prescription drug" and "partner-
ships." This section provides language regarding criteria for the

commissioner to enter into a partnership resulting in the production or
distribution of generic prescription drugs with the intent it will be
affordable to private and public consumers. This section also identifies
points that the department should consider when setting drug prices,
along with reporting requirements and proprietary information.

Section 3 provides the severability clause. Section 4 provides the
effective date.

 
JUSTIFICATION:  Prescription drugs costs, even for generics, continue
to rise out of reach for patients and insurers, both public and private.
New York State itself spends millions of dollars on prescription drugs
through its public health insurance programs and self-funded coverage of
our state workforce. One cause of drug price increases is lack of compe-
tition. Nearly 90% of prescription drugs are generic, yet a small number
of companies manufacture them. Many contend this lack of competition has
led to large price increases of widely-used and important medications
like antibiotics and epinephrine without evidence of increased costs of
manufacturing. Aside from cost, there are some medications that are at
risk of being in short supply. It is important to find creative ways to
lower drug costs and ensure medications are available.

This bill does not propose a new concept. U.S. Senator Elizabeth Warren
during her 2020 presidential run called for the U.S.  government to
begin manufacturing generic medications to address rising prices, lack
of competition in the market, and the potential for shortages in essen-
tial medications. California became the first state in the nation to
sign into law legislation to begin the process of state manufacturing or
distribution of generic medications. This New York legislation is
modeled after the California statute and would allow New York to partner
with various entities, including other states, to lower costs and
protect against short supplies.

Similar to California's statute, this legislation directs the Department
of Health (DOH) to identify generic drugs that are high cost or suscep-
tible to shortages for possible manufacturing partnerships. It specif-
ically requires that the DOH consider one type of insulin, given the
high costs and life-saving nature of this medication that over 7 million
diabetics in the U.S. depend upon daily. The "New York Affordable Drug
Manufacturing Act" would provide New York with an important tool to
control drug costs for its taxpayers, residents, and those who lack
health insurance by allowing. New York to pursue its own drug manufac-
turing and partner with other states moving in this direction to both
lower costs and protect against shortages of certain drugs.

 
LEGISLATIVE HISTORY:

2019-2020: S9020/No Same As

2021-2022: S3048/No Same As

 
FISCAL IMPLICATIONS:

Initial costs to be determined, but substantial long term savings as
generic prescription drug costs for the state would be much lower.

 
EFFECTIVE DATE:
This act shall take effect on the first January next succeeding one year
after it shall have become a law.

2023-S4786A (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  4786--A
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             February 14, 2023
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed  to  the  Committee  on  Health  --  committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee
 
 AN  ACT to amend the public health law, in relation to enacting the "New
   York affordable drug manufacturing act"

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Short  title. This act shall be known and may be cited as
 the "New York affordable drug manufacturing act".
   § 2. Article 2-A of the public health law is amended by adding  a  new
 title IV to read as follows:
                                 TITLE IV
                NEW YORK AFFORDABLE DRUG MANUFACTURING ACT
 SECTION 282. DEFINITIONS.
         283. PARTNERSHIPS;   PRODUCTION   AND  DISTRIBUTION  OF  GENERIC
                PRESCRIPTION DRUGS.
         284. REPORTING.
         285. PROPRIETARY INFORMATION.
   § 282. DEFINITIONS. AS USED IN THIS TITLE, THE FOLLOWING  TERMS  SHALL
 HAVE THE FOLLOWING MEANINGS:
   1.  "GENERIC PRESCRIPTION DRUG" MEANS A DRUG THAT IS APPROVED PURSUANT
 TO AN APPLICATION SUBMITTED UNDER SUBDIVISION (J) OF SECTION 355 OF  THE
 FEDERAL FOOD, DRUG, AND COSMETIC ACT (21 U.S.C.  SEC. 301 ET SEQ.), OR A
 BIOSIMILAR,  AS  DEFINED UNDER THE FEDERAL PUBLIC HEALTH SERVICE ACT (42
 U.S.C. SEC. 262) THAT IS NOT UNDER PATENT.
   2. "PARTNERSHIPS" MEANS AGREEMENTS  FOR  THE  PROCUREMENT  OF  GENERIC
 PRESCRIPTION  DRUGS  BY WAY OF CONTRACTS OR PURCHASING BY A PAYER, STATE
 GOVERNMENTAL AGENCY, GROUP PURCHASING ORGANIZATION, NONPROFIT  ORGANIZA-
 TION, OR OTHER ENTITY.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD08090-02-3
 S. 4786--A                          2

 
   §   283.   PARTNERSHIPS;   PRODUCTION   AND  DISTRIBUTION  OF  GENERIC
 PRESCRIPTION DRUGS. 1. (A) THE COMMISSIONER SHALL  ENTER  INTO  PARTNER-
 SHIPS, CONSISTENT WITH PARAGRAPH (B) OF SUBDIVISION TWO OF THIS SECTION,
 IN  CONSULTATION  WITH ALL APPROPRIATE STATE AGENCIES AND THE DEPARTMENT
 OF  HEALTH OR EQUIVALENT INSTITUTION OF ANY OTHER STATE AS DETERMINED BY
 THE COMMISSIONER, 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.
   (B) THE DEPARTMENT SHALL HAVE THE ABILITY TO HIRE STAFF TO OVERSEE AND
 PROJECT-MANAGE THE PARTNERSHIPS FOR  MANUFACTURING  OR  DISTRIBUTION  OF
 GENERIC PRESCRIPTION DRUGS.
   2. (A) THE COMMISSIONER SHALL ENTER INTO PARTNERSHIPS RESULTING IN THE
 PRODUCTION  OR  DISTRIBUTION  OF  GENERIC  PRESCRIPTION  DRUGS, WITH THE
 INTENT THAT THESE DRUGS BE MADE WIDELY AVAILABLE TO PUBLIC  AND  PRIVATE
 PURCHASERS, FACILITIES LICENSED PURSUANT TO ARTICLE TWENTY-EIGHT OF THIS
 CHAPTER, AND PHARMACIES AS DEFINED IN SECTION SIX THOUSAND EIGHT HUNDRED
 TWO OF THE EDUCATION LAW, AS APPROPRIATE. THE GENERIC PRESCRIPTION DRUGS
 SHALL  BE  PRODUCED  OR  DISTRIBUTED  BY  A DRUG COMPANY OR GENERIC DRUG
 MANUFACTURER THAT IS REGISTERED WITH THE UNITED  STATES  FOOD  AND  DRUG
 ADMINISTRATION.
   (B)  (I)  THE COMMISSIONER SHALL ONLY ENTER INTO PARTNERSHIPS PURSUANT
 TO PARAGRAPH (A) OF THIS SUBDIVISION TO PRODUCE A  GENERIC  PRESCRIPTION
 DRUG  AT A PRICE THAT RESULTS IN SAVINGS, TARGETS FAILURES IN THE MARKET
 FOR GENERIC DRUGS, AND IMPROVES PATIENT  ACCESS  TO  AFFORDABLE  MEDICA-
 TIONS.
   (II)  FOR  TOP  DRUGS  IDENTIFIED  PURSUANT  TO THE CRITERIA LISTED IN
 SUBPARAGRAPH (V) OF THIS PARAGRAPH, THE DEPARTMENT  SHALL  DETERMINE  IF
 VIABLE  PATHWAYS  EXIST  FOR  PARTNERSHIPS  TO MANUFACTURE OR DISTRIBUTE
 GENERIC PRESCRIPTION DRUGS BY  EXAMINING  THE  RELEVANT  LEGAL,  MARKET,
 POLICY, AND REGULATORY FACTORS.
   (III) THE DEPARTMENT SHALL CONSIDER THE FOLLOWING, IF APPLICABLE, WHEN
 SETTING THE PRICE OF THE GENERIC PRESCRIPTION DRUG:
   (1) UNITED STATES FOOD AND DRUG ADMINISTRATION USER FEES.
   (2)  ABBREVIATED NEW DRUG APPLICATION ACQUISITION COSTS AMORTIZED OVER
 A FIVE-YEAR PERIOD.
   (3) MANDATORY REBATES.
   (4) TOTAL CONTRACTING AND PRODUCTION COSTS FOR THE DRUG,  INCLUDING  A
 REASONABLE  AMOUNT  FOR  ADMINISTRATIVE,  OPERATING,  AND RATE-OF-RETURN
 EXPENSES OF THE DRUG COMPANY OR GENERIC DRUG MANUFACTURER.
   (5) RESEARCH AND DEVELOPMENT COSTS ATTRIBUTED TO THE DRUG OVER A FIVE-
 YEAR PERIOD.
   (6) OTHER INITIAL START-UP COSTS AMORTIZED OVER A FIVE-YEAR PERIOD.
   (IV) EACH DRUG SHALL BE MADE AVAILABLE  TO  PROVIDERS,  PATIENTS,  AND
 PURCHASERS AT A TRANSPARENT PRICE AND WITHOUT REBATES, OTHER THAN FEDER-
 ALLY REQUIRED REBATES.
   (V)   THE   DEPARTMENT  SHALL  PRIORITIZE  THE  SELECTION  OF  GENERIC
 PRESCRIPTION DRUGS THAT HAVE THE GREATEST IMPACT ON LOWERING DRUG  COSTS
 TO  PATIENTS,  INCREASING  COMPETITION  AND  ADDRESSING SHORTAGES IN THE
 PRESCRIPTION DRUG MARKET, IMPROVING PUBLIC HEALTH, OR REDUCING THE  COST
 OF PRESCRIPTION DRUGS TO PUBLIC AND PRIVATE PURCHASERS.
   (C)  (I) IN IDENTIFYING GENERIC PRESCRIPTION DRUGS TO BE PRODUCED, THE
 DEPARTMENT SHALL CONSIDER PRESCRIPTION  DRUG  RETAIL  PRICE  LISTS  MADE
 PURSUANT TO SECTION TWO HUNDRED SEVENTY-EIGHT OF THIS ARTICLE.
   (II)  THE  PARTNERSHIPS ENTERED INTO PURSUANT TO PARAGRAPH (A) OF THIS
 SUBDIVISION SHALL INCLUDE THE PRODUCTION OF AT LEAST ONE FORM  OF  INSU-
 S. 4786--A                          3
 
 LIN,  PROVIDED THAT A VIABLE PATHWAY FOR MANUFACTURING A MORE AFFORDABLE
 FORM OF INSULIN EXISTS.
   (III)  THE DEPARTMENT SHALL PRIORITIZE DRUGS FOR CHRONIC AND HIGH-COST
 CONDITIONS.
   (D) THE DEPARTMENT SHALL CONSULT WITH ALL OF THE FOLLOWING PUBLIC  AND
 PRIVATE   PURCHASERS   TO   ASSIST  IN  DEVELOPING  A  LIST  OF  GENERIC
 PRESCRIPTION DRUGS TO BE MANUFACTURED OR  DISTRIBUTED  THROUGH  PARTNER-
 SHIPS AND TO DETERMINE THE VOLUME OF EACH GENERIC PRESCRIPTION DRUG THAT
 CAN  BE PROCURED OVER A MULTIYEAR PERIOD TO SUPPORT A MARKET FOR A LOWER
 COST GENERIC PRESCRIPTION DRUG:
   (I) THE DEPARTMENT OF MENTAL  HYGIENE,  THE  OFFICE  FOR  PEOPLE  WITH
 DEVELOPMENTAL  DISABILITIES,  THE  OFFICE  OF  GENERAL SERVICES, AND THE
 DEPARTMENT OF CORRECTIONS AND COMMUNITY  SUPERVISION,  OR  THE  ENTITIES
 ACTING ON BEHALF OF EACH OF THOSE STATE PURCHASERS.
   (II) HEALTH INSURERS LICENSED PURSUANT TO THE INSURANCE LAW.
   (III) HOSPITALS.
   (IV) ANY OTHER ENTITY AS DETERMINED BY THE COMMISSIONER.
   (E)  BEFORE  EFFECTUATING  A PARTNERSHIP PURSUANT TO THIS SECTION, THE
 COMMISSIONER SHALL DETERMINE MINIMUM THRESHOLDS FOR  PROCUREMENT  OF  AN
 ENTITY'S EXPECTED VOLUME OF A TARGETED DRUG FROM THE COMPANY OR MANUFAC-
 TURER OVER A MULTIYEAR PERIOD.
   (F)   ALL  STATE  AGENCIES  SHALL  BE  REQUIRED  TO  PURCHASE  GENERIC
 PRESCRIPTION DRUGS FROM THE DEPARTMENT  OR  ENTITIES  THAT  CONTRACT  OR
 PARTNER WITH THE DEPARTMENT PURSUANT TO THIS CHAPTER.
   (G)  THE DEPARTMENT SHALL NOT BE REQUIRED TO CONSULT WITH EVERY ENTITY
 LISTED IN SUBPARAGRAPHS (II), (III) AND (IV) OF PARAGRAPH  (D)  OF  THIS
 SUBDIVISION,  SO  LONG  AS  PURCHASER  ENGAGEMENT  INCLUDES A REASONABLE
 REPRESENTATION FROM THESE GROUPS.
   § 284. REPORTING. 1. ON OR BEFORE JANUARY FIRST, TWO THOUSAND  TWENTY-
 SIX,  THE  DEPARTMENT  SHALL  SUBMIT  A  REPORT  TO THE LEGISLATURE THAT
 ASSESSES THE FEASIBILITY OF DIRECTLY MANUFACTURING GENERIC  PRESCRIPTION
 DRUGS AND SELLING GENERIC PRESCRIPTION DRUGS AT A FAIR PRICE. THE REPORT
 SHALL  INCLUDE,  BUT NOT BE LIMITED TO, AN ANALYSIS OF GOVERNANCE STRUC-
 TURE OPTIONS FOR MANUFACTURING FUNCTIONS, INCLUDING CHARTERING A PRIVATE
 ORGANIZATION, A PUBLIC-PRIVATE PARTNERSHIP, OR A PUBLIC BOARD OF  DIREC-
 TORS.
   2.  ON OR BEFORE MARCH FIRST, TWO THOUSAND TWENTY-FIVE, THE DEPARTMENT
 SHALL REPORT TO THE LEGISLATURE ON BOTH OF THE FOLLOWING:
   (A) A DESCRIPTION OF THE STATUS OF ALL DRUGS TARGETED UNDER THIS CHAP-
 TER.
   (B) AN ANALYSIS OF HOW THE ACTIVITIES OF  THE  DEPARTMENT  MAY  IMPACT
 COMPETITION, ACCESS TO TARGETED DRUGS, THE COSTS OF THOSE DRUGS, AND THE
 COSTS OF GENERIC PRESCRIPTION DRUGS TO PUBLIC AND PRIVATE PURCHASERS.
   §  285.  PROPRIETARY INFORMATION. NOTWITHSTANDING ANY PROVISION OF LAW
 TO THE CONTRARY, ALL NONPUBLIC INFORMATION AND DOCUMENTS OBTAINED BY THE
 DEPARTMENT PURSUANT TO THIS TITLE SHALL NOT BE REQUIRED TO BE  DISCLOSED
 PURSUANT TO ARTICLE SIX OF THE PUBLIC OFFICERS LAW.
   § 3. Severability. If any clause, sentence, paragraph, section or part
 of  this act shall be adjudged by any court of competent jurisdiction to
 be invalid and after exhaustion of  all  further  judicial  review,  the
 judgment  shall  not affect, impair or invalidate the remainder thereof,
 but shall be confined in its operation to the  clause,  sentence,  para-
 graph,  section or part of this act directly involved in the controversy
 in which the judgment shall have been rendered.
   § 4. This act shall take effect on the first of January next  succeed-
 ing one year after it shall have become a law.

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Senate Bill S4786A

Sponsored By

Current Bill Status - In Assembly Committee

Jan 30, 2024 - Floor Vote

Floor Vote: Jan 30, 2024

Jan 8, 2024 - Health Committee Vote

Health Committee Vote: Jan 8, 2024

Bill Amendments

2023-S4786 - Details

2023-S4786 - Summary

2023-S4786 - Sponsor Memo

2023-S4786 - Bill Text download pdf

co-Sponsors

2023-S4786A (ACTIVE) - Details

2023-S4786A (ACTIVE) - Summary

2023-S4786A (ACTIVE) - Sponsor Memo

2023-S4786A (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S4786A

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Sponsored By

Gustavo Rivera

Current Bill Status - In Assembly Committee

Bill Amendments

2023-S4786 - Details

2023-S4786 - Summary

2023-S4786 - Sponsor Memo

2023-S4786 - Bill Text download pdf

co-Sponsors

Jeremy A. Cooney

Rachel May

2023-S4786A (ACTIVE) - Details

2023-S4786A (ACTIVE) - Summary

2023-S4786A (ACTIVE) - Sponsor Memo

2023-S4786A (ACTIVE) - Bill Text download pdf

Comments