senate Bill S5471

2017-2018 Legislative Session

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

download bill text pdf

Sponsored By

Current Bill Status - In Senate Health Committee


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Actions

view actions (4)
Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Feb 09, 2018 print number 5471a
Feb 09, 2018 amend and recommit to health
Jan 03, 2018 referred to health
Mar 30, 2017 referred to health

S5471 - Details

See Assembly Version of this Bill:
A236
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-c, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Previous Legislative Sessions:
2015-2016: S5099A, A145A
2013-2014: S6739A, A8057A

S5471 - Summary

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

S5471 - Sponsor Memo

S5471 - Bill Text download pdf

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

                                  5471

                       2017-2018 Regular Sessions

                            I N  S E N A T E

                             March 30, 2017
                               ___________

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health law is REPEALED.
  S 2. The public health law is amended by adding a new section 280-c to
read as follows:
  S  280-C.  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.
                                                           LBD01072-02-7

S5471A (ACTIVE) - Details

See Assembly Version of this Bill:
A236
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-c, Pub Health L; amd §§6810 & 6816-a, Ed L
Versions Introduced in Previous Legislative Sessions:
2015-2016: S5099A, A145A
2013-2014: S6739A, A8057A

S5471A (ACTIVE) - Summary

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

S5471A (ACTIVE) - Sponsor Memo

S5471A (ACTIVE) - Bill Text download pdf

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

                                 5471--A

                       2017-2018 Regular Sessions

                            I N  S E N A T E

                             March 30, 2017
                               ___________

Introduced  by  Sen.  LANZA  -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health --  recommitted  to
  the  Committee  on  Health in accordance with Senate Rule 6, sec. 8 --
  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.
  S 2. The public health law is amended by adding a new section 280-c to
read as follows:
  S 280-C. 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.
                                                           LBD01072-03-8

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