Bill Text: NY S05099 | 2015-2016 | General Assembly | Amended

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

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2016-01-19 - PRINT NUMBER 5099A [S05099 Detail]

Download: New_York-2015-S05099-Amended.html

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                STATE OF NEW YORK
        ________________________________________________________________________
                                         5099--A
                               2015-2016 Regular Sessions
                    IN SENATE
                                     April 30, 2015
                                       ___________
        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:
     1    Section 1. Paragraph (o) of subdivision 1 of section 206 of the public
     2  health law is REPEALED.
     3    § 2. The public health law is amended by adding a new section 280-b to
     4  read as follows:
     5    § 280-b. Generic drug products. 1. The  commissioner  shall  establish
     6  and  publish  a  list  of  drug products, referred to in this section as
     7  "generic drug" products, each of which shall meet the  following  condi-
     8  tions:
     9    (a) The drug product has been certified or approved by the commission-
    10  er  of the Federal Food and Drug Administration as being safe and effec-
    11  tive for its labeled indications for use, and a new-drug application  or
    12  an  abbreviated  new-drug  application  approved pursuant to the Federal
    13  Food, Drug, and Cosmetic Act is held for such drug product; and
    14    (b) The commissioner of the Federal Food and Drug  Administration  has
    15  evaluated  such  drug  product  as  pharmaceutically and therapeutically
    16  equivalent and has listed such drug product on the list of approved drug
    17  products with the therapeutic equivalence evaluations, provided,  howev-
    18  er,  that  the  list  prepared by the commissioner shall not include any
    19  drug product which the commissioner of the Federal Food and Drug  Admin-
    20  istration has identified as having an actual or potential bioequivalence
    21  problem.
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00283-02-6