S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  8345--A
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             December 13, 2023
                                ___________
 
 Introduced by M. of A. RAJKUMAR -- read once and referred to the Commit-
   tee  on Health -- recommitted to the Committee on Health in accordance
   with Assembly Rule 3, sec. 2 -- 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.
                                                            LBD08090-03-3
 A. 8345--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-
 A. 8345--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.

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  8345--B
 
                        2023-2024 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             December 13, 2023
                                ___________
 
 Introduced  by  M.  of A. RAJKUMAR, L. ROSENTHAL, SEAWRIGHT -- read once
   and referred to the Committee on Health -- recommitted to the  Commit-
   tee  on Health in accordance with Assembly Rule 3, sec. 2 -- committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee -- again reported from said  committee  with  amend-
   ments, ordered reprinted as amended and recommitted to said committee
 
 AN  ACT  in  relation to requiring the department of health to report on
   the feasibility of establishing a generic drug  manufacturing  program
   aimed at reducing the cost of prescription drugs and to address short-
   ages in the market for generic prescription drugs
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. On or before January first, two  thousand  twenty-six,  the
 department  of  health  shall  submit  a  report to the legislature that
 assesses the feasibility of establishing a  generic  drug  manufacturing
 program  aimed at reducing the cost of prescription drugs and to address
 shortages in the market for generic prescription drugs by directly manu-
 facturing generic prescription drugs and  selling  generic  prescription
 drugs  at  a  fair price. The report shall conduct an analysis of gover-
 nance structure options for manufacturing functions, including  charter-
 ing  a  private  organization, a public-private partnership, or a public
 board of directors.  Additionally, the report shall include, but not  be
 limited to an analysis of the:
   (a) feasibility of entering into a partnership with a drug manufactur-
 er to produce insulin and generic drugs for chronic and high-cost condi-
 tions;
   (b) feasibility of entering into a partnership with a drug manufactur-
 er to produce and make generic prescription drugs widely available;
   (c)  generic prescription drugs that would have the greatest impact on
 lowering drug costs to patients, including high-cost drugs, high  utili-

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD08090-04-4
 A. 8345--B                          2
              

 
 zation  drugs,  or  drugs experiencing shortages in the market which the
 program may prioritize;
   (d)  amount  of  staff required to oversee and manage the partnerships
 for manufacturing or distribution of generic prescription drugs;
   (e) research and development costs and start up costs associated  with
 the generic drug manufacturing program; and
   (f)  volume  of  generic  prescription  drugs  and insulin that can be
 produced over the first five years of the program.
   § 2. This act shall take effect on the first of January next  succeed-
 ing one year after it shall have become a law.