Bill Text: NY S00398 | 2021-2022 | 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 11-0)

Status: (Introduced - Dead) 2022-01-05 - REFERRED TO CONSUMER PROTECTION [S00398 Detail]

Download: New_York-2021-S00398-Introduced.html



                STATE OF NEW YORK
        ________________________________________________________________________

                                           398

                               2021-2022 Regular Sessions

                    IN SENATE

                                       (Prefiled)

                                     January 6, 2021
                                       ___________

        Introduced by Sens. BIAGGI, BENJAMIN, GAUGHRAN, HARCKHAM, HOYLMAN, JACK-
          SON,  KENNEDY,  MAY,  MYRIE, PARKER, SALAZAR -- read twice and ordered
          printed, and when printed to be committed to the Committee on Consumer
          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

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02926-01-1

        S. 398                              2

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