Senate Bill S2391A

2019-2020 Legislative Session

Requires the commissioner of health to establish and publish a list of generic drug products; repealer

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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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Bill Amendments

2019-S2391 - Details

See Assembly Version of this Bill:
A612
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:
2013-2014: S6739, A8057
2015-2016: S5099, A145
2017-2018: S5471, A236
2021-2022: S5158, A1923
2023-2024: S4181, A144

2019-S2391 - Summary

Requires the commissioner of health to establish and publish a list of generic drug products.

2019-S2391 - Sponsor Memo

2019-S2391 - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2391
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                             January 24, 2019
                                ___________
 
 Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law and the education law, in relation
   to generic drug products; and to repeal paragraph (o) of subdivision 1
   of section 206 of the public health law relating thereto

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
 health law is REPEALED.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   §  280-D.  GENERIC  DRUG PRODUCTS. 1. THE COMMISSIONER SHALL ESTABLISH
 AND PUBLISH A LIST OF DRUG PRODUCTS, REFERRED  TO  IN  THIS  SECTION  AS
 "GENERIC  DRUG"  PRODUCTS, EACH OF WHICH SHALL MEET THE FOLLOWING CONDI-
 TIONS:
   (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
 ER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND  EFFEC-
 TIVE  FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION OR
 AN ABBREVIATED NEW-DRUG APPLICATION APPROVED  PURSUANT  TO  THE  FEDERAL
 FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
   (B)  THE  COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMINISTRATION HAS
 EVALUATED SUCH DRUG  PRODUCT  AS  PHARMACEUTICALLY  AND  THERAPEUTICALLY
 EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
 PRODUCTS  WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED, HOWEV-
 ER, THAT THE LIST PREPARED BY THE COMMISSIONER  SHALL  NOT  INCLUDE  ANY
 DRUG  PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMIN-
 ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
 PROBLEM.
   2. THE MANUFACTURER OF A GENERIC DRUG PRODUCT SHALL MAKE AVAILABLE  TO
 THE  DEPARTMENT  THE  BIOPHARMACEUTIC  STUDIES  AND SUMMARIES, INCLUDING
 BIOEQUIVALENCE DATA AND INCIDENCE  OF  ADVERSE  EVENTS,  AND  ASSOCIATED
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

2019-S2391A (ACTIVE) - Details

See Assembly Version of this Bill:
A612
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:
2013-2014: S6739, A8057
2015-2016: S5099, A145
2017-2018: S5471, A236
2021-2022: S5158, A1923
2023-2024: S4181, A144

2019-S2391A (ACTIVE) - Summary

Requires the commissioner of health to establish and publish a list of generic drug products.

2019-S2391A (ACTIVE) - Sponsor Memo

2019-S2391A (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  2391--A
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                             January 24, 2019
                                ___________
 
 Introduced  by  Sen.  LANZA  -- 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 and the education law, in relation
   to generic drug products; and to repeal paragraph (o) of subdivision 1
   of section 206 of the public health law relating thereto
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
 health law is REPEALED.
   § 2. The public health law is amended by adding a new section 280-d to
 read as follows:
   § 280-D. GENERIC DRUG PRODUCTS. 1. THE  COMMISSIONER  SHALL  ESTABLISH
 AND  PUBLISH  A  LIST  OF  DRUG PRODUCTS, REFERRED TO IN THIS SECTION AS
 "GENERIC DRUG" PRODUCTS, EACH OF WHICH SHALL MEET THE  FOLLOWING  CONDI-
 TIONS:
   (A) THE DRUG PRODUCT HAS BEEN CERTIFIED OR APPROVED BY THE COMMISSION-
 ER  OF THE FEDERAL FOOD AND DRUG ADMINISTRATION AS BEING SAFE AND EFFEC-
 TIVE FOR ITS LABELED INDICATIONS FOR USE, AND A NEW-DRUG APPLICATION  OR
 AN  ABBREVIATED  NEW-DRUG  APPLICATION  APPROVED PURSUANT TO THE FEDERAL
 FOOD, DRUG, AND COSMETIC ACT IS HELD FOR SUCH DRUG PRODUCT; AND
   (B) THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG  ADMINISTRATION  HAS
 EVALUATED SUCH DRUG PRODUCT AS: (I) PHARMACEUTICALLY AND THERAPEUTICALLY
 EQUIVALENT AND HAS LISTED SUCH DRUG PRODUCT ON THE LIST OF APPROVED DRUG
 PRODUCTS  WITH THE THERAPEUTIC EQUIVALENCE EVALUATIONS, PROVIDED, HOWEV-
 ER, THAT THE LIST PREPARED BY THE COMMISSIONER  SHALL  NOT  INCLUDE  ANY
 DRUG  PRODUCT WHICH THE COMMISSIONER OF THE FEDERAL FOOD AND DRUG ADMIN-
 ISTRATION HAS IDENTIFIED AS HAVING AN ACTUAL OR POTENTIAL BIOEQUIVALENCE
 PROBLEM OR (II) AS AN INTERCHANGEABLE BIOLOGICAL PRODUCT AND HAS  LISTED
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00594-03-9
              

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