senate Bill S6739A

2013-2014 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


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

do you support this legislation?

You must fill out the form below in order to support or oppose this bill. X

You must login or fill out the fields below for the senator to have an accurate account of the support or opposition to this bill.

Create an account. An account allows you to officially support or oppose key legislation, sign petitions with a single click, and follow issues, committees, and bills that matter to you. When you create an account, you agree to this platform's terms of participation.
Use this box to enter a message to your senator.

Actions

view actions (3)
Assembly Actions - Lowercase
Senate Actions - UPPERCASE
Jun 02, 2014 print number 6739a
amend and recommit to health
Mar 05, 2014 referred to health

S6739 - Details

See Assembly Version of this Bill:
A8057A
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L

S6739 - Summary

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

S6739 - Sponsor Memo

S6739 - Bill Text download pdf

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

                                  6739

                            I N  S E N A T E

                              March 5, 2014
                               ___________

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health law is REPEALED.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-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.
  2. THE DISTRIBUTOR OR MANUFACTURER OF A  GENERIC  DRUG  PRODUCT  SHALL
MAKE  AVAILABLE TO THE DEPARTMENT THE BIOPHARMACEUTIC STUDIES AND SUMMA-
RIES, INCLUDING BIOEQUIVALENCE DATA AND INCIDENCE OF ADVERSE EVENTS, AND
ASSOCIATED ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METH-
ODS PROVIDED TO THE FEDERAL FOOD AND DRUG ADMINISTRATION AS PART OF  THE

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11513-01-3

S6739A (ACTIVE) - Details

See Assembly Version of this Bill:
A8057A
Law Section:
Public Health Law
Laws Affected:
Rpld §206 sub 1 ¶(o), add §280-a, Pub Health L; amd §§6810 & 6816-a, Ed L

S6739A (ACTIVE) - Summary

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

S6739A (ACTIVE) - Sponsor Memo

S6739A (ACTIVE) - Bill Text download pdf

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

                                 6739--A

                            I N  S E N A T E

                              March 5, 2014
                               ___________

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.
  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.
  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
ANALYTICAL METHODS, INCLUDING DISSOLUTION DATA AND TEST METHODS PROVIDED

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

Comments

Open Legislation comments facilitate discussion of New York State legislation. All comments are subject to moderation. Comments deemed off-topic, commercial, campaign-related, self-promotional; or that contain profanity or hate speech; or that link to sites outside of the nysenate.gov domain are not permitted, and will not be published. Comment moderation is generally performed Monday through Friday.

By contributing or voting you agree to the Terms of Participation and verify you are over 13.