Assembly Bill A145A

2015-2016 Legislative Session

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

download bill text pdf

Sponsored By

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

co-Sponsors

2015-A145 - Details

See Senate Version of this Bill:
S5099
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:
2013-2014: A8057, S6739
2017-2018: A236, S5471
2019-2020: A612, S2391
2021-2022: A1923, S5158
2023-2024: A144, S4181

2015-A145 - Summary

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

2015-A145 - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                   145

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 7, 2015
                               ___________

Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, HOOPER,
  JAFFEE, MARKEY, MILLER, RIVERA  --  read  once  and  referred  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health law is REPEALED.
  S 2. The public health law is amended by adding a new section 280-a to
read as follows:
  S 280-A. 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.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD00283-01-5
              

co-Sponsors

2015-A145A (ACTIVE) - Details

See Senate Version of this Bill:
S5099
Current Committee:
Senate Health
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Other Legislative Sessions:
2013-2014: A8057, S6739
2017-2018: A236, S5471
2019-2020: A612, S2391
2021-2022: A1923, S5158
2023-2024: A144, S4181

2015-A145A (ACTIVE) - Summary

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

2015-A145A (ACTIVE) - Bill Text download pdf

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 145--A

                       2015-2016 Regular Sessions

                          I N  A S S E M B L Y

                               (PREFILED)

                             January 7, 2015
                               ___________

Introduced  by  M.  of  A.  PAULIN,  GOTTFRIED, DINOWITZ, GALEF, HOOPER,
  JAFFEE, MARKEY, MILLER, RIVERA, WEPRIN -- read once  and  referred  to
  the  Committee  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 commit-
  tee

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.
  S 2. The public health law is amended by adding a new section 280-b to
read as follows:
  S  280-B.  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-

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

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