NY State Senate Bill 2021-S3048A

Archive: Last Bill Status - In Senate Committee Health 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
Apr 28, 2022	print number 3048a
Apr 28, 2022	amend (t) and recommit to health
Jan 05, 2022	referred to health
Jan 27, 2021	referred to health

Bill Amendments

Original

A (Active)

2021-S3048 - Details

Current Committee:: Senate 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
2023-2024: S4786

2021-S3048 - 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.

2021-S3048 - Sponsor Memo

                                
 
BILL NUMBER: S3048

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend the public health law, in relation to enacting the "New
York affordable drug manufacturing act of 2021"

 
PURPOSE:

The purpose of the bill is to have New York enter into arrangements with
interested parties and other states around manufacturing or distribution
of generic drugs to increase competition, lower prices, and address
shortages in the market for generic prescription drugs.

 
SUMMARY OF PROVISIONS:

Section 1 makes the law be known as "New York Affordable Drug Manufac-
turing Act of 2021"

Section 2 creates a new Title IV under Article 2-A of the public health

law directing the Department of Health to work to develop plans for
partnering with other entities and states to manufacture or distribute
generic and biosimilar drugs approved by the FDA for certain
prescriptions that are high cost or experience shortages. Of those the
Department decides to pursue, at least one form of insulin shall be
included, provided that a viable pathway for manufacturing a more
affordable form of insulin exists. It establishes new section 282
setting forth definitions, section 283 establishing how drug manufactur-
ing partnerships, production and distribution of prescription drugs
would operate, section 284 setting forth reporting requirements and
section 285 protecting proprietary information.

Section 3 provides for a 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. The state should have a strong interest in finding creative
ways to lower drug costs and ensure those medications which may be at
risk of being in short supply is available.  This is not a new concept.
US Senator Elizabeth Warren during her 2020 presidential run called for
the US government to begin manufacturing generic medications given the
rising prices, lack of competition in the market, and potential for
shortages in essential medications.  More recently, 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 on the California statute and would
allow New York to partner with various entities including other states
to lower costs and protect against short supplies.

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 prices increases of widely used and important medications

like antibiotics and epinephrine without evidence of increased costs of
manufacturing.

This legislation, like California's new statute, directs the Department
of Health to identify generic drugs that are high cost or susceptible to
shortages for possible manufacturing partnerships. It specifically
requires that the Department consider one type of insulin, given the
high costs and life saying nature of this medication that over 7 million
diabetics in the US depend upon daily.  The "New York Affordable Drug
Manufacturing Act of 2021" would provide New York with an important tool
to control drug costs for its taxpayers and for those who lack health
insurance and allow New York to 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

 
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.

2021-S3048 - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3048
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             January 27, 2021
                                ___________
 
 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 of 2021"
 
   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 of 2021".
   §  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 OF 2021
 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.

                                                            LBD07229-01-1

 S. 3048                             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. 3048                             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-
 FOUR,  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-THREE, 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.

2021-S3048A (ACTIVE) - Details

Current Committee:: Senate 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
2023-2024: S4786

2021-S3048A (ACTIVE) - Summary

2021-S3048A (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S3048a

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:

The purpose of the bill is to have New York enter into arrangements with
interested parties and other states around manufacturing or distribution
of generic drugs to increase competition, lower prices, and address
shortages in the market for generic prescription drugs.

 
SUMMARY OF PROVISIONS:

Section 1 makes the law be known as "New York Affordable Drug Manufac-
turing Act"

Section 2 creates a new Title IV under Article 2-A of the public health
law directing the Department of Health to work to develop plans for

partnering with other entities and states to manufacture or distribute
generic and biosimilar drugs approved by the FDA for certain
prescriptions that are high cost or experience shortages. Of those the
Department decides to pursue, at least one form of insulin shall be
included, provided that a viable pathway for manufacturing a more
affordable form of insulin exists. It establishes new section 282
setting forth definitions, section 283 establishing how drug manufactur-
ing partnerships, production and distribution of prescription drugs
would operate, section 284 setting forth reporting requirements and
section 285 protecting proprietary information.

Section 3 provides for a 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. The state should have a strong interest in finding creative
ways to lower drug costs and ensure those medications which may be at
risk of being in short supply is available. This is not a new concept.
US Senator Elizabeth Warren during her 2020 presidential run called for
the US government to begin manufacturing generic medications given the
rising prices, lack of competition in the market, and potential for
shortages in essential medications. More recently, 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 on the California statute and would
allow New York to partner with various entities including other states
to lower costs and protect against short supplies.

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 prices increases of widely used and important medications
like antibiotics and epinephrine without evidence of increased costs of
manufacturing.

This legislation, like California's new statute, directs the Department
of Health to identify generic drugs that are high cost or susceptible to
shortages for possible manufacturing partnerships. It specifically
requires that the Department consider one type of insulin, given the
high costs and life saying nature of this medication that over 7 million
diabetics in the US 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 and for those who lack health
insurance and allow New York to 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

 
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.

2021-S3048A (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  3048--A
 
                        2021-2022 Regular Sessions
 
                             I N  S E N A T E
 
                             January 27, 2021
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health --  recommitted  to
   the  Committee  on  Health in accordance with Senate Rule 6, sec. 8 --
   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 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.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD07229-03-2
 S. 3048--A                          2

 
   §  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
 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-
 S. 3048--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 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-
 FIVE,  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-FOUR, 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.

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Senate Bill S3048A

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

Bill Amendments

2021-S3048 - Details

2021-S3048 - Summary

2021-S3048 - Sponsor Memo

2021-S3048 - Bill Text download pdf

2021-S3048A (ACTIVE) - Details

2021-S3048A (ACTIVE) - Summary

2021-S3048A (ACTIVE) - Sponsor Memo

2021-S3048A (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S3048A

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Sponsored By

Gustavo Rivera

Archive: Last Bill Status - In Senate Committee Health Committee

Bill Amendments

2021-S3048 - Details

2021-S3048 - Summary

2021-S3048 - Sponsor Memo

2021-S3048 - Bill Text download pdf

2021-S3048A (ACTIVE) - Details

2021-S3048A (ACTIVE) - Summary

2021-S3048A (ACTIVE) - Sponsor Memo

2021-S3048A (ACTIVE) - Bill Text download pdf

Comments