Bill Text: NY A00895 | 2023-2024 | General Assembly | Introduced


Bill Title: Enacts the manufacturer disclosure and transparency act requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic medications.

Spectrum: Partisan Bill (Democrat 25-1)

Status: (Introduced) 2024-01-03 - referred to consumer affairs and protection [A00895 Detail]

Download: New_York-2023-A00895-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                           895

                               2023-2024 Regular Sessions

                   IN ASSEMBLY

                                    January 11, 2023
                                       ___________

        Introduced  by  M. of A. GALLAGHER, STIRPE, DICKENS, FORREST, MAMDANI --
          read once and referred  to  the  Committee  on  Consumer  Affairs  and
          Protection

        AN  ACT  to  amend  the  general  business law, in relation to requiring
          prescription drug manufacturers to  notify  the  attorney  general  of
          arrangements  between  pharmaceutical  manufacturers  resulting in the
          delay of the introduction of generic drugs

          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:

     1    Section  1.  This act shall be known and may be cited as the "manufac-
     2  turer disclosure and transparency act".
     3    § 2. The general business law is amended by adding a new section  396-
     4  rrr to read as follows:
     5    §  396-rrr.  Delay of introduction of generic medications. 1. (a) Each
     6  pharmaceutical manufacturer doing business in this state  that  manufac-
     7  tures  a  brand  name  prescription drug and enters into an arrangement,
     8  through agreement or otherwise, with another pharmaceutical manufacturer
     9  that has the purpose or effect of  delaying  or  preventing  such  other
    10  manufacturer  from  introducing  a generic substitute for such drug into
    11  the marketplace shall, not later than thirty days  after  entering  into
    12  such  arrangement,  send  notice  to the attorney general, in a form and
    13  manner prescribed by the attorney general, disclosing the name  of  such
    14  drug,  the wholesale price, the disease such drug is commonly prescribed
    15  to treat, the manufacturer  of  such  drug,  the  name  of  the  generic
    16  manufacturer, and the length of the delay.
    17    (b)  The  attorney  general  shall,  no  later  than thirty days after
    18  receiving a notice pursuant to paragraph (a) of this subdivision,  share
    19  the information with the drug utilization review board established under
    20  section  three  hundred  sixty-nine-bb  of  the social services law, all
    21  medicaid managed care  plans,  health  carriers  and  pharmacy  benefits

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00235-01-3

        A. 895                              2

     1  managers  doing  business in the state in a format and manner prescribed
     2  by the attorney general.
     3    2.  The  office  of the attorney general shall post on its website all
     4  the notices required pursuant to paragraph (a)  of  subdivision  one  of
     5  this  section  in  a format and manner developed by the attorney general
     6  that is searchable by drug, cost, disease, and manufacturer both for the
     7  brand and generic drug for public review.
     8    3. For a violation by a manufacturer of a brand name drug who knowing-
     9  ly or negligently fails to notify the attorney general  as  required  in
    10  paragraph  (a)  of subdivision one of this section, the attorney general
    11  shall fine such manufacturer no less than five thousand dollars for  the
    12  first  violation for each day such manufacturer fails to properly notify
    13  the attorney general pursuant to the requirements of this section and no
    14  less than ten thousand dollars for each violation  thereafter  for  each
    15  day  such  manufacturer  fails  to  properly notify the attorney general
    16  pursuant to the requirements of this section.
    17    4. The attorney general is authorized to promulgate  rules  and  regu-
    18  lations necessary for the implementation of this section.
    19    § 3. This act shall take effect on the one hundred eightieth day after
    20  it shall have become a law.
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