NY State Senate Bill 2019-S9020

Archive: Last Bill Status - In Senate Committee Rules 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
Oct 02, 2020	referred to rules

2019-S9020 (ACTIVE) - Details

Current Committee:: Senate Rules
Law Section:: Public Health Law
Laws Affected:: Add Art 2-A Title 4 §§282 - 285, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2021-2022: S3048
2023-2024: S4786

2019-S9020 (ACTIVE) - Summary

Enacts the "New York affordable drug manufacturing act of 2020" 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.

2019-S9020 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S9020

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 2020"

 
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 2020"

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 on 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: 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 are 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 distrib-
ution 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 2020" 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:

New Bill.

 
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.

2019-S9020 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   9020
 
                             I N  S E N A T E
 
                              October 2, 2020
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed to the Committee on Rules
 
 AN ACT to amend the public health law, in relation to enacting the  "New
   York affordable drug manufacturing act of 2020"
 
   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 2020".
   §  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 2020
 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
 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                       [ ] is old law to be omitted.
                                                            LBD17279-02-0

 S. 9020                             2
 
 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.
   (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-

 S. 9020                             3
 
 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-
 THREE, 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-TWO,  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 S9020

Sponsored By

Archive: Last Bill Status - In Senate Committee Rules Committee

2019-S9020 (ACTIVE) - Details

2019-S9020 (ACTIVE) - Summary

2019-S9020 (ACTIVE) - Sponsor Memo

2019-S9020 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S9020

Share this bill

Sponsored By

Gustavo Rivera

Archive: Last Bill Status - In Senate Committee Rules Committee

2019-S9020 (ACTIVE) - Details

2019-S9020 (ACTIVE) - Summary

2019-S9020 (ACTIVE) - Sponsor Memo

2019-S9020 (ACTIVE) - Bill Text download pdf

Comments