Assembly Bill A500

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    500
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 8, 2025
                                ___________
 
 Introduced  by M. of A. STECK -- read once and referred to the Committee
   on Health
 
 AN ACT to amend the public health law, in  relation  to  establishing  a
   generic drug research and development laboratory and production facil-
   ity and the empire state biosimilar insulin initiative

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. 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 285. DEFINITIONS.
         286.  GENERIC  DRUG  RESEARCH  AND  DEVELOPMENT  LABORATORY  AND
                 PRODUCTION  FACILITY;  EMPIRE  STATE  BIOSIMILAR INSULIN
                 INITIATIVE.
         287. PARTNERSHIPS; PRODUCTION AND DISTRIBUTION  OF  PRESCRIPTION
                DRUGS.
         288. PROPRIETARY INFORMATION.
   §  285.  DEFINITIONS. 1. FOR THE PURPOSES OF THIS TITLE, THE FOLLOWING
 TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (A) "GENERIC DRUG" SHALL MEAN A DRUG  THAT  IS  APPROVED  PURSUANT  TO
 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).
   (B)  "PARTNERSHIPS"  SHALL  INCLUDE, BUT NOT BE 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.
   § 286. GENERIC DRUG RESEARCH AND DEVELOPMENT LABORATORY AND PRODUCTION
 FACILITY; EMPIRE STATE BIOSIMILAR INSULIN INITIATIVE. 1. (A) THE DEPART-

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD00670-01-5
 A. 500                              2
 
 MENT  SHALL ESTABLISH A GENERIC DRUG RESEARCH AND DEVELOPMENT LABORATORY
 AND PRODUCTION FACILITY WITHIN THE UNIVERSITY OF THE STATE OF  NEW  YORK
 SYSTEM.
   (B)   THE   GENERIC  DRUG  RESEARCH  AND  DEVELOPMENT  LABORATORY  AND
 PRODUCTION FACILITY ESTABLISHED PURSUANT TO PARAGRAPH (A) OF THIS SUBDI-
 VISION SHALL PRODUCE AND DISTRIBUTE 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.
   (C)  EACH  DRUG PRODUCED PURSUANT TO PARAGRAPH (B) OF THIS SUBDIVISION
 SHALL BE MADE AVAILABLE TO PROVIDERS,  PATIENTS,  AND  PURCHASERS  AT  A
 PRICE  NOT  TO  EXCEED  THE COST OF SUCH PRODUCTION FOR RESIDENTS OF THE
 STATE.
   (D) THE DEPARTMENT SHALL PRIORITIZE THE DEVELOPMENT AND PRODUCTION  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.
   2. THE FIRST INITIATIVE OF THE GENERIC DRUG RESEARCH  AND  DEVELOPMENT
 LABORATORY  AND  PRODUCTION FACILITY ESTABLISHED PURSUANT TO SUBDIVISION
 ONE OF THIS SECTION SHALL BE THE EMPIRE STATE BIOSIMILAR INSULIN  INITI-
 ATIVE.  SUCH  INITIATIVE  SHALL  INCLUDE  THE RESEARCH, DEVELOPMENT, AND
 PRODUCTION OF GENERIC FORMS OF THE THREE MOST WIDELY USED FORMS OF INSU-
 LIN. SUCH INSULIN SHALL BE  PRODUCED  OR  DISTRIBUTED  BY  A  NON-PROFIT
 GENERIC DRUG MANUFACTURER THAT IS REGISTERED WITH THE UNITED STATES FOOD
 AND DRUG ADMINISTRATION.
   3.  UNTIL SUCH TIME AS THE GENERIC DRUG RESEARCH AND DEVELOPMENT LABO-
 RATORY AND PRODUCTION FACILITY IS COMPLETED AND THE EMPIRE STATE  BIOSI-
 MILAR INSULIN INITIATIVE BEGINS, THE COMMISSIONER SHALL ENTER INTO PART-
 NERSHIPS  RESULTING  IN  THE  PRODUCTION OR DISTRIBUTION OF AT LEAST ONE
 GENERIC FORM OF INSULIN PURSUANT TO SECTION TWO HUNDRED EIGHTY-SEVEN  OF
 THIS TITLE.
   §  287.  PARTNERSHIPS;  PRODUCTION  AND  DISTRIBUTION  OF PRESCRIPTION
 DRUGS.  1. THE COMMISSIONER SHALL ENTER INTO PARTNERSHIPS  RESULTING  IN
 THE  PRODUCTION OR DISTRIBUTION OF AT LEAST ONE GENERIC FORM OF INSULIN,
 WITH THE INTENT THAT SUCH INSULIN 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. SUCH INSULIN SHALL  BE
 PRODUCED  OR  DISTRIBUTED BY A NON-PROFIT GENERIC DRUG MANUFACTURER THAT
 IS REGISTERED WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
   2. EACH FORM OF INSULIN PRODUCED PURSUANT TO SUBDIVISION ONE  OF  THIS
 SECTION  SHALL  BE MADE AVAILABLE TO PROVIDERS, PATIENTS, AND PURCHASERS
 AT A PRICE NOT TO EXCEED THIRTY DOLLARS PER MONTHLY DOSE  FOR  RESIDENTS
 OF THE STATE.
   §  288.  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.
   § 2. This act shall take effect immediately.